Medical Design & Outsourcing – WOMEN IN MEDTECH 2022 by WTWH Media LLC

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Women in Medtech

2022

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October 2022 ∞ Vol8 No6 ∞ medicaldesignandoutsourcing.com

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WOMEN IN MEDTECH | WOMEN IN ENGINEERING | CONTENTS HERE’S WHAT WE SEE: ................................................12 Diverse executive teams bring more innovation to medtech

218 women in executive roles .......................................15 Rachel Ellingson, Zimmer Biomet ................................................................ 20 Laura Mauri, Medtronic ............................................................................... 26 Lara Simmons, Medline Industries .............................................................. 32

10 women-led medtech startups ..................................36 Maureen Mulvihill, Actuated Medical ......................................................... 36 Gabi Niederauer, Bluegrass Vascular Technologies .................................... 40 Kate Rosenbluth, Cala Health...................................................................... 44

3 questions with women in pharma ..............................48 AstraZeneca Oncology R&D EVP Dr. Susan Galbraith, Ferring Pharmaceuticals Chief Scientiﬁc Ofﬁcer Dr. Elizabeth Garner and Insmed CFO Sara Bonstein discuss barriers for women and ways to break through.

Cathy Burzik's ﬁve essential leadership lessons for medtech's next generation of women leaders .............52 Burzik, a seasoned senior executive in the healthcare industry, has successfully led major medical device, diagnostic, diagnostic imaging and life sciences businesses.

Diversity in medtech: 2022 markedly the best for women in medtech ...........54 This year has been one of the most formative for women in medtech leadership roles as representation in the C-suite has reached a new high.

How medical device companies can better protect themselves from lawsuits ......................62 Getting hit with a lawsuit isn't an if, but a when for medical device developers and manufacturers. Greenberg Traurig lawyer Ginger Pigott shares advice for staying secure.

Abbott is looking to address biases for cardiovascular patients ..................................................66 Jennifer Jones-McMeans, Abbott's divisional VP of global clinical affairs, explains how small anatomical differences compound in cardiac care.

B. Braun - Dawn Kentner .................................................71 Carl Stahl Sava Industries - Angelica Flores ....................72 Clinical Research Strategies - Alethea Wieland...............73 Conﬂuent - Christine Trepanier........................................74 Cretex Medical - Janelle Swanson ..................................75 Donatelle - Treasa Springett ............................................76 Euroﬁns - Susan Shorter ..................................................77 Flexan - Desiree Williford ................................................78 Flexcon - Aditi Subramanian ...........................................79 Hobson & Motzer - Kristin Backus ..................................80 Integer - Margaret Carthy ...............................................81 Isometric Micro Molding - Donna M. Bibber...................82 Johnson Matthey - Venkata Pokkuluri .............................83 Medbio - Christine Marie Nolan ......................................84 Phillips MediSize - Cheryl Norder ...................................85 PSN Labs - Laura Beringer, Ph.D......................................86 Resonetics - Danielle Wingerter ......................................87 Tegra Medical - Nidhi Agrawal ........................................88 6

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DESIGN WORLD

10 • 2022

Women in Engineering 2022 Salary and Career Update ...................................90 Ellen Ferraro ................................................. 98 Christine Georgia ....................................... 106 Jasmine Jauregui ........................................ 114 Kathy Miller ................................................ 122 Meghan Olds .............................................. 130 Kate Schneidau........................................... 136 Allegro Microsystems Yejee Choi .................................................. 146 Allied Electronics & Automation Or Yacobi .................................................... 147 B&R Industrial Automation Apurva Deota ............................................. 148 B&R Industrial Automation Brittany Langston........................................ 149 Beckhoff Automation Alyssa Hiedeman ........................................ 150 Cinch Connectivity Solutions Karen Vintroux ............................................ 151 Digi-Key Electronics Kristin McKenzie ......................................... 152 Elma Electronic, Inc. Melissa Heckman ........................................ 153 Encoder Products Melissa Wallin ............................................. 154 igus Kristen Copeland Moore ............................ 155 Inﬁneon Jaya Bindra ................................................. 156 maxon Nicole Mathieu ........................................... 157 Microchip Annalisa Regalado ...................................... 158 Mitsubishi Electric Automation Deana Fu .................................................... 159 nVent Dana Myers ................................................ 160 Velo3D Ana Montes ................................................ 161 Velo3D Maritza Ruiz ................................................ 162 WAGO Corporation Michelle Goeman ....................................... 163 Wind River Kitty Kong ................................................... 164 Wind River Stephanie Moscrip...................................... 165 Würth Industry North America Anna Wint ................................................... 166 Ad Index .................................................168

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Medtech 2022

HERE’S WHAT WE SEE

Diverse executive teams bring more innovation to medtech Diversifying the executive suite is more than just a push for representation — it helps bring more diverse ideas to the table to innovate for more than half of the global population.

he leadership gap in the medical device industry closes slightly every year, but women still account for less than a quarter of executive roles, according to our annual analysis in this Women in Medtech edition of Medical Design & Outsourcing. Women hold just 23% of executive roles at the top 100 medical device companies, up 2 percentage points since 2021. After Accuray and Ambu appointed females to their top offices, the number of women CEOs has ticked up to six despite some recent leadership changes. For comparison, women make up 38.8% of the more than 644,000 medical equipment and supplies manufacturing employees in the U.S. The pharmaceutical and medicine manufacturing industry is slightly better with women as 46.4% of the sector’s 654,000 employees. While 2020 was the year that changed the world, it was seemingly a formative year for women in leadership roles. As of this analysis, the average time for women in the executive office is 2.95 years. On the cover of this edition is Zimmer Biomet Chief Strategy Officer Rachel Ellingson, who gives us

"The leadership gap in the medical device industry closes slightly every year, but women still account for less than a quarter of executive roles." an inside look into the orthopedic company’s plans for digital technology in its products and its introduction into surgical robotics. For this Women in Medtech issue, Associate Editor Sean Whooley spoke with one of the longest-serving women leaders in the industry, Medline President of Quality and Regulatory Affairs Lara Simmons. She joined Medline in 1992 and has worked her way up to her current position overseeing the regulatory aspects of the multibillion-dollar medical equipment manufacturer. 12

Medical Design & Outsourcing

10 • 2022

Whooley also interviews Abbott Divisional VP of Global Clinical Affairs Jennifer Jones-McMeans about gender biases for cardiovascular patients. Also in this edition, Managing Editor Jim Hammerand tells Laura Mauri’s story of a key moment in the Medtronic chief scientific, medical and regulatory officer’s first months at the company. And Pharma Editor Brian Buntz spoke with women in the pharmaceutical industry to get their insights into barriers facing women in the industry and ways to break through them. We’ve also included a list of all 218 top women executives within the largest 100 medical device companies in the world and highlighted the many personnel changes over the past year. This edition of Women in Medtech also takes a look at the technologies and innovations from private companies and startups that are led by women, Women in Medtech’s founding value. Bluegrass Vascular Technologies is developing an insideDanielle Kirsh out vascular access Senior Editor system that simplifies catheter Medical Design & placement, Actuated Medical is Outsourcing bringing motion to medicine and dk i rsh @ wtwh m e di a .c o m Cala Health is using wearables to treat essential tremor. The major lesson learned this year through interviews and conversations with women in the industry is that diversity is a necessity if companies want to innovate. A diverse team of decision makers enables a company to create devices that are designed specifically for more than half of the global patient population. While the prevalence of women in leadership roles is slightly higher since I started this project in 2018, it won’t be enough until the C-suite represents the patients it serves. Find all this and many more insights from women leaders in our latest edition of Medical Design & Outsourcing.

| | | |

2022 WOMEN IN MEDTECH

women in Our Life Sciences editorial team drew on its resources to produce an alphabetical list of 218 women executives at the world's largest medical device companies from our latest Medtech Big 100 ranking. The list includes CEOs, presidents, VPs and other executives listed on corporate leadership pages, plus the year they were appointed to their role, according to corporate leadership listings and personal LinkedIn proﬁles. It's a who's who of women leaders in a male-dominated industry, and their numbers are growing — last year's list topped out at 200 women.

Monica Aguirre Berthelot

Carrie Anderson

Lisa Aubert

Appointed in 2005

Appointed in 2019

Appointed in 2022

Angela Ahmad

Suzanne Armstrong

Jeannette Bankes

Appointed in 2020

Appointed in 2017

Appointed in 2019

Michele Allegretto

Guðný ný Arna Sveinsdóttir

Helen Barraclough

Appointed in 2019

Appointed in 2022

Kara Andersen Reiter

Heather Attra

Michelle Basil

Appointed in 2018

Appointed in 2022

VP, Chief of Staff Hologic

General Counsel Inari Medical

SVP, Human Resources Glaukos

SVP, General Counsel and Chief Compliance Ofﬁcer Intuitive Surgical

EVP and CFO Integra Lifesciences

VP, Human Resources Orthoﬁx

CFO Össur

SVP, Head Global Quality and Regulatory Affairs Alcon

President, North America Cochlear

President and GM, Global Surgical Franchise Alcon

Group General Counsel and Company Secretary Smith+Nephew

EVP, General Counsel Haemonetics Appointed in 2017

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10 • 2022

Medical Design & Outsourcing

2022 WOMEN IN MEDTECH (continued)

Yin Becker

VP, Chief Corporate Affairs Ofﬁcer Stryker Appointed in 2012

Anne Belcher

President and Chief Operating Ofﬁcer, Global Emerging Markets ConvaTec Appointed in 2022

Annette Beller

Member of the Board Finance, Taxes and Controlling, Central Service Departments B. Braun Melsungen

Diane Biagianti

SVP, General Counsel Glaukos Appointed in 2020

Laura Blackmer

President, Dealer Sales Konica Minolta Appointed in 2017

Lucile Blaise

President of Sleep & Respiratory Care ResMed Appointed in 2022

Jeanne Blondia

B. Braun Melsungen could not conﬁrm

VP, Finance and Treasurer Stryker

date of appointment

Appointed in 2014

Leigh Benowitz

SVP and Chief Global Digital Transformation Ofﬁcer Henry Schein Appointed in 2022

Jennifer Bolt

EVP, Global Operations and ESG Integer Appointed in 2022

Stephanie Bolton President, International Region LivaNova Appointed in 2021

Karen Boylan

Corporate VP, Strategic Projects Teleﬂex Appointed in 2019

Sharon Bracken

Head of Diagnostics Siemens Healthineers Appointed in 2022

Erania Brackett

SVP and Chief Marketing Ofﬁcer Dentsply Sirona Appointed in 2021

Anna Maria Braun CEO B. Braun Melsungen Appointed in 2019

Vanessa Broadhurst

EVP, Global Corporate Affairs Johnson & Johnson Appointed in 2022

Rosaleen Burke

SVP, Global Quality and Regulatory Boston Scientiﬁc Appointed in 2017

Janet Byk

VP, Finance and Accounting Inari Medical Appointed in 2020

(continued on page 18)

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2022 WOMEN IN MEDTECH (continued)

Darleen Caron

Chief Human Resources Officer and Lab Director Siemens Healthineers

Margaret Carthy

SVP Quality and Regulatory Affairs Integer

EVP, Human Resources Conmed

Appointed in 2022

Meg Carr

Andrea Caruso

Corporate VP, Business Dev. Integra Lifesciences

EVP, Chief Legal and Regulatory Officer Align Technology

Appointed in 2019

Appointed in 2020

Appointed in 2022

Victoria Carr-Brendel

Karina Chavez

Birgit Conix

Appointed in 2021

Lori Ciano

Irene Corbe

Appointed in 2019

Appointed in 2014

Trinh Clark

Ashley Cordova

Group VP Cochlear Implants and President of Advanced Bionics Sonova Appointed in 2019

Wendy Carruthers EVP, Human Resources Boston Scientific Appointed in 2022

EVP, Information Technology and CIO Conmed

Appointed in 2015

Appointed in 2021

VP, Regulatory Affairs Shockwave Medical

Shanna CottiOsmanski

Heather Cohen

Julie Coletti

SVP and Chief Strategy Officer 3M

Chief Human Resources Officer Nevro

SVP and Chief Global Customer Experience Officer Henry Schein

Appointed in 2020

Velinda Cox SVP, Commerce Konica Minolta Appointed in 2021

Myriam Curet

CFO Sonova

EVP and Chief Medical Officer Intuitive Surgical Appointed in 2017

Angela Cushman

VP, Internal Audit Stryker

SVP, Quality Avanos Medical Appointed in 2022

Diane Dahowski

CFO Novocure

EVP, Global Supply Chain Bio-Rad

Appointed in 2020

Appointed in 2022

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Que Dallara

EVP and President, Diabetes Operating Unit Medtronic Appointed in 2022

Sujata Dayal

VP and Chief Compliance Officer Medline Industries Appointed in 2020

Holly DeSantis EVP and CFO Konica Minolta Appointed in 2021

Ann Desender CFO Barco

Appointed in 2016

Julie Dewey

Chief Corporate Communications and Investor Relations Officer Nevro Appointed in 2020

Zoe Dickson

EVP and Chief Human Resources Officer 3M Appointed in 2021

Michele DiMartino

Chief Human Resources Officer Intuitive Surgical Appointed in 2022

Kerri DiPietro

SVP, Global Quality Assurance Haemonetics Appointed in 2021

Kate Dobbs

SVP, Marketing and Communications, Fresenius Medical Care North America Fresenius Medical Care Appointed in 2018

Amy Dodrill

President, Patient Support Systems and Global Surgical Solutions Baxter Appointed in 2021

Evelyn Douglas

EVP, Chief of Corporate Strategy and Business Development ConvaTec Appointed in 2020

10 • 2022

Medical Design & Outsourcing

2022 WOMEN IN MEDTECH (continued)

Laura Driscoll

VP, Communications ZimVie Appointed in 2021

Kay Du Fernandez

Global Branding and SVP, Marketing Konica Minolta Appointed in 2016

Gillian Duncan

SVP, Professional Education and Program Services– Worldwide Intuitive Surgical Appointed in 2019

Tara Dunn

VP of Clinical Affairs and Market Development Inari Medical Appointed in 2022

Lisa Earnhardt

EVP, Medical Devices Abbott Appointed in 2019

Jodi Eddy

SVP and Chief Information and Digital Ofﬁcer Boston Scientiﬁc Appointed in 2020

Hildur Einarsdóttir EVP of R&D Össur

Appointed in 2022

Stacey Eisen

SVP, Global Communications and President, Baxter International Foundation Baxter Appointed in 2016

Rachel Ellingson

SVP and Chief Strategy Ofﬁcer Zimmer Biomet Appointed in 2018

Kimberley Elting

President, Global Orthopedics Orthoﬁx Appointed in 2022

Medical Design & Outsourcing

10 • 2022

www.medicaldesignandoutsourcing.com

2022 WOMEN IN MEDTECH

RACHEL ELLINGSON is driving Zimmer Biomet toward new tech Rachel Ellingson has been Zimmer Biomet's chief strategy ofﬁcer and SVP since 2018.

Photo courtesy of Zimmer Biomet

Zimmer Biomet has transformed and reinvented itself through various partnerships and product innovations, and Chief Strategy Oﬃcer Rachel Ellingson has been a driving force behind the success. BY DAN I ELLE K I R S H SE N I O R ED I TO R

immer Biomet has been one of the leading orthopedic companies in the medical device industry for years. With $6.8 billion in revenue for its most recently reported fiscal year and $435.9 million in R&D spending, the company is ramping up its portfolio. Chief Strategy Officer and SVP Rachel Ellingson has played a significant role in Zimmer Biomet’s revitalization. She joined the orthopedic company in 2018 from St. Jude Medical, where she was the VP of corporate strategy until its acquisition by Abbott. Ellingson started as St. Jude’s

revenue growth to achieve your mission.” Ellingson “has served a critical role in the ongoing transformation of Zimmer Biomet,” Zimmer Biomet President and CEO Bryan Hanson told MDO. “As a result of her vision and hard work to drive forward our active portfolio management strategy, we have forged key partnerships with technology leaders inside and outside of healthcare, driven growth through business development efforts to advance our portfolio, and completed the spinoff of ZimVie — allowing us to increase our

"Our strategy at the core is about how are we going to drive the growth so that we can help reach more patients. It's that virtuous cycle of revenue growth to achieve your mission." senior director of corporate strategy and planning in 2006 and moved her way up to VP of investor relations and corporate communications, then VP of corporate relations, VP of global communications and ultimately VP of corporate strategy. Zimmer Biomet has launched many innovative products since 2018, including the ZB Edge Connected Intelligence suite, Persona smart knees and the Rosa robotic system, and divested its spine and dental businesses in the process. But Ellingson says the company is just getting started. “Our strategy at the core is about how are we going to drive the growth so that we can help reach more patients,” Ellingson told Medical Design & Outsourcing. “It’s that virtuous cycle of

focus on our core areas of growth and strengthen our position as a global leader in the medtech space,” Hanson said. “Personally, I value her perspective, counsel and friendship. She consistently demonstrates a commitment to our mission to improve the quality of life for patients in all that she does.” The three-step approach Innovation on Zimmer Biomet’s digital side is in part driven by the desire to grow revenue faster in its lower core markets. Now the company is focused on transforming for the future

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through active portfolio management, which means deploying resources into innovations or mergers and acquisitions to drive growth in its most attractive markets. “My team spends a lot of time looking at all of our end markets, and then those submarkets to determine the most attractive areas for growth, and then building out,” Ellingson said. “We then rank them in terms of prioritization and consider how best to build those businesses through internal and external opportunities. Robotics as an example, was an acquisition, and then with that as our base we invested our R&D dollars to bring this exciting innovation to the knee space.” First, Zimmer Biomet wants to drive growth in its lower growth core markets, including hip and knees. Zimmer recently announced a partnership with Surgical Planning Associates to commercialize HipInsight, which is the ﬁrst FDA-cleared, mixed-reality navigation system for total hip replacement. It is customized for Zimmer Biomet’s hip implant portfolio. Second, the company wants to generate more revenue in its higher growth markets. The company’s ZBEdge portfolio, for example, was a combination of ﬁnding the right attractive markets and submarkets to invest in. ZBEdge is the company’s connected intelligence suite of digital and robotic technologies. It includes the Rosa robotic surgery platform, anatomical visualization and guidance systems such as the Signature One, the iAssist knee alignment system and optical navigation tools. Strategic acquisitions are also part of generating revenue in those higher growth markets. >> 10 • 2022

Medical Design & Outsourcing

2022 WOMEN IN MEDTECH RACHEL ELLINGSON

(continued)

Myra Eskes

President, APAC Region Smith+Nephew Appointed in 2019

Catherine Estrampes President and CEO, U.S. and Canada GE Healthcare Appointed in 2021

Lisa Evoli

EVP and Chief Human Resources Ofﬁcer Integra Lifesciences Appointed in 2016

Karen Ferraro

Chief Human Resources Ofﬁcer Medline Industries Appointed in 2012

Katy Fink

VP, Chief Human Resources Ofﬁcer Stryker Appointed in 2016

Camila Finzi

Head Orthodontics Business Unit Straumann Appointed in 2020

Denise Fleming

EVP, Technology and Global Services and Chief Information Ofﬁcer BD Appointed in 2022

Michelle Fox

Corporate VP and Chief Medical Ofﬁcer Teleﬂex Appointed in 2020

Elin Frostehav

President, Acute Care Therapies Getinge Appointed in 2022

Britta Fünfstück CEO Paul Hartmann Appointed in 2018

(continued on page 24) 22

Medical Design & Outsourcing

10 • 2022

(continued)

The A&E Medical acquisition in 2020 added A&E’s sternal closure devices, including sternal sutures, cable systems and rigid fixation and single-use complementary temporary pacing wire and surgical punch products, to Zimmer Biomet’s portfolio. That $250 million acquisition added more scale in those higher-growth markets and submarkets. The third approach to transforming Zimmer Biomet is divesting non-core, lowergrowth businesses where the company doesn’t have a clear path to leadership, or a right to win. That resulted in the ZimVie spinoff of the company’s spine and dental businesses, which was completed in March 2022. “It’s interesting because I find a lot of people say to me, ‘How does that align to our strategy?’ Because our strategy is to drive growth. And I always tell people, it’s not about the size, it’s about the growth. Because that’s the vitality of that virtuous circle to continue to invest in your mission,” Ellingson said. Partnerships to drive revenue Driving growth goes beyond allocating R&D dollars in attractive markets. Sometimes it means bringing in the right partnerships. Zimmer Biomet’s recent partnerships have brought major gains for the company. For example, its collaboration with Canary Medical led to the development of one of the industry’s first “smart” orthopedic implants. Canary Medical and Zimmer Biomet have a long-term partnership in which the startup provides proprietary use of its Canary Health Implantable Reporting Processor (CHIRP) smart sensor technology for all areas where Zimmer Biomet is active, including its Persona IQ smart knee implants. Persona IQ knee implants capture gait metrics, including functional knee range of motion, step count and sampled average walking speed using sensor-based technology. The technology allows physicians and care teams to collect more patient-specific data during the course of patient monitoring. The company has also partnered with Apple on its MyMobility technology. MyMobility with Apple Watch is a digital care management platform that uses an iPhone to deliver support and guidance to patients through a connected experience. Zimmer Biomet’s MyMobility also delivers continuous data and patient-reported feedback to facilitate care, outcomes and satisfaction with a patient’s surgical preparations and recovery. Zimmer Biomet continues to speed up investments in other companies, such as NeuroOne, which is developing sEEG www.medicaldesignandoutsourcing.com

electrode technology for temporary recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. Zimmer Biomet has exclusive rights to sell the Evo sEEG device to neurosurgeons, pending FDA review. Opportunities on the horizon The COVID-19 pandemic hit most orthopedic companies by postponing or canceling elective procedures like knee replacements, but Zimmer Biomet managed through the crisis, Ellingson said. She credited the various partnerships Zimmer Biomet built prior to the pandemic because it allowed the company to drive more growth and bring innovative technology in a time when capital was constrained. Ellingson also said that many of the digital health technologies that have been leading Zimmer Biomet’s innovation in the last few years are still in their earliest stages, so there is still signiﬁcant room to transform orthopedics care. Whether it’s changing care through innovation or bringing what Zimmer Biomet has into new markets, the company is going to continue on the path of digital health innovation in orthopedics. “I also am personally really excited about the opportunity to look at how do we get bigger in some of our new markets as well,” Ellingson said. “Whether they are some of our current adjacency spaces, or just looking at what are the different and new ways we can take — whether it’s our technologies or everything that we’ve built in the last couple of years — and deploy it into some new markets, that’s really interesting to me too.” Zimmer Biomet's MyMobility app connects joint surgery patients with their care team before and after surgery. Image courtesy of Zimmer Biomet

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2022 WOMEN IN MEDTECH (continued)

Michelle Garsha

Cathy Harnett

President, Diagnostic Solutions Hologic

Karen King

Appointed in 2020

Appointed in 2018

Chief Human Resources Officer LivaNova

Moji James

Heather Knight

Appointed in 2019

Appointed in 2021

Jeanette Hedén Carlsson

Iman Jeddi

Appointed in 2020

Appointed in 2022

Trui Hebbelinck

Karen Gledhill

SVP and General Counsel, Fresenius Medical Care North America Fresenius Medical Care Appointed in 2016

Tammy Gomez

EVP, Chief Human Resources Officer Owens & Minor Appointed in 2022

EVP Communications and Brand Management Getinge Appointed in 2017

SVP and Chief Information Technology Officer Invacare

SVP, Global Human Resources and Corporate Communications Hologic

Appointed in 2019

Appointed in 2021

Deborah Gordon

Marie Hendrixson

VP, Investor Relations Insulet

VP of Internal Audit Teleflex

Appointed in 2015

Appointed in 2009

Sarah Grauze

Michele Holcomb

SVP and Treasurer 3M

EVP, Chief Strategy and Business Development Officer Cardinal Health

Appointed in 2021

Appointed in 2017

Michelle Greene

EVP, Chief Information Officer and Global Business Services Cardinal Health Appointed in 2022

Jennifer Hornery

SVP, Global People and Culture Cochlear Appointed in 2017

Kjersti Grimsrud

President and Chief Operating Officer, Infusion Care ConvaTec

Kelli Howell

Appointed in 2022

Appointed in 2018

Laila Gurney

Kelly Huller

Chief Quality and Regulatory Officer GE Healthcare

EVP, Clinical Strategies Alphatec

SVP, General Counsel, and Corporate Secretary Globus Medical Appointed in 2018

Lena Hagman

Ellie Humphrey

Appointed in 2015

Medical Design & Outsourcing

SVP and General Counsel Avanos Medical

SVP and GM, Single Port Business Unit Intuitive Surgical Appointed in 2022

SVP, Chief Legal Officer, General Counsel and Secretary Dentsply Sirona Appointed in 2022

Dietra Jones

EVP of Clinical Operations iRhythm Appointed in 2019

Tobi Karchmer

SVP and Chief Medical Officer Baxter Appointed in 2021

Debbie Kaster

VP, Investor Relations Shockwave Medical Appointed in 2020

Vered Keisar

Chief People Officer ResMed Appointed in 2021

Appointed in 2020

EVP Quality compliance, Regulatory and Medical Affairs Getinge

President, Cardinal Health Specialty Solutions Cardinal Health

Cherée Johnson

Lisa Hellmann

Angela Goodwin

Heidi Hunter

VP, Human Resources Shockwave Medical

SVP and Chief Transformation Officer Zimmer Biomet

Deeptha Khanna

EVP and Chief Business Leader Personal Health Royal Philips Appointed in 2020

Heather Kidwell SVP, Chief Legal and Compliance Officer ZimVie Appointed in 2022

Appointed in 2021

10 • 2022

SVP, Investor Relations and Communications Alcon

President, Acute Therapies, Clinical Nutrition, Medication Delivery, Latin America and Canada Baxter Appointed in 2019

Sreelakshmi Kolli

EVP, Chief Digital Officer Align Technology Appointed in 2020

Natalia Kozmina

EVP, Chief Human Resources Officer and ESG Stewardship ConvaTec Appointed in 2020

Susan Krause

Corporate VP, Chief Quality Officer Integra Lifesciences Appointed in 2021

Lisa Kudlacz

President and GM, Vascular Teleflex Appointed in 2021

Jacqueline Kunzler SVP, Chief Quality Officer Baxter Appointed in 2016

Patricia Lang

SVP and Chief Human Resources Officer Enovis Appointed in 2022

Margrét Lára Friðriksdóttir

EVP of People, Strategy and Sustainability Össur Appointed in 2022

Betty Larson

Chief People Officer GE Healthcare Appointed in 2022

www.medicaldesignandoutsourcing.com

Kathleen Leneghan SVP and CFO Invacare

Appointed in 2018

Valérie Leyldé

A Global Leader in Hydrophilic Coatings for Medical Devices

EVP, Human Resources, Communication and CSR BioMérieux Appointed in 2019

Sue-Jean Lin

SVP, Chief Information and Transformation Officer Alcon Appointed in 2018

Anila Lingamneni

EVP, Chief Technology Officer Haemonetics Appointed in 2020

Elga Lohler

Chief Human Resources Officer Smith+Nephew Appointed in 2015

Trang Ly

SVP and Medical Director Insulet Appointed in 2018

Karen Mahoney

VP, Chief Human Resources Officer Abiomed Appointed in 2017

Angela Main

SVP, Global Chief Compliance Officer and Associate General Counsel, Asia Pacific Zimmer Biomet Appointed in 2015

Lesly Marban

SVP, Corporate Marketing Intuitive Surgical Appointed in 2020

Diane Marsilio

Director of Human Resources and Compliance Paul Hartmann

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10 • 2022

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2022 WOMEN IN MEDTECH (continued)

What DR. LAURA MAURI learned from a 'firestorm' in her first months at Medtronic

Jeanne Mason

SVP, Human Resources Baxter Appointed in 2006

Keri Mattox

Medtronic’s chief scientiﬁc, medical and regulatory oﬃcer recalls a formative conversation with former CEO Omar Ishrak shortly after she joined the company.

SVP, Chief Communications and Administration Ofﬁcer Zimmer Biomet Appointed in 2022

Laura Mauri

SVP and Chief Scientiﬁc, Medical and Regulatory Ofﬁcer Medtronic Appointed in 2022

Jessica Mayer

DR.

Chief Legal and Compliance Ofﬁcer Cardinal Health Appointed in 2019

Christine McCauley Corporate VP, Human Resources Edwards Lifesciences Appointed in 2012

Angela McClure

Chief Experience Ofﬁcer, Fresenius Medical Care North America Fresenius Medical Care Appointed in 2017

Elizabeth McCombs EVP and Chief Technology Ofﬁcer BD Appointed in 2021

Ashley McEvoy

EVP, Worldwide Chair, MedTech Johnson & Johnson Appointed in 2018

Lorelei McGlynn

SVP, Chief Human Resources Ofﬁcer Henry Schein Appointed in 1999

Dana McMahon

VP, Chief Compliance Ofﬁcer Stryker Appointed in 2021

(continued on page 30) 26

Medical Design & Outsourcing

BY J I M HAMMERAN D MAN AGI N G EDI TOR

10 • 2022

Laura Mauri faced a monumental moment with former Medtronic CEO Omar Ishrak shortly after she joined the company as VP of global clinical research and analytics. It was late 2018, and Mauri — who’s now an SVP and the chief scientific, medical and regulatory officer at Medtronic — was in a meeting about the safety of a product. A drug-coated balloon for lower leg angioplasty offered long-lasting relief to patients who had pain when walking, but outside investigators had questions about whether the device increased patient mortality, Mauri told DeviceTalks Editorial Director Tom Salemi in an interview. “This created kind of a firestorm,” she said. “I had experienced firestorms like that in the past and other subject areas and been really involved. But what surprised me about that was the response of the company.” After the meeting, Ishrak asked Mauri for her thoughts. “I started to talk about the details of what we might do and what our plan might be,” Mauri said. “And he said, ‘No, no, no. What do you really think? Because if, if there’s a problem here and we need to stop, we’re ready to do that.’” That interaction from her first months at Medtronic still sticks with her. “It wasn’t just all about calculating the balancing of risks and all. It really came down to, ‘Is there a value here for patients?’ And that to me was really reinforcing that I was in the right place for what I wanted to do,” Mauri said. www.medicaldesignandoutsourcing.com

How Laura Mauri landed at Medtronic Mauri’s parents were first-generation immigrants from China and Italy. Her father was an engineer, and her mother, a librarian, was diagnosed with lung cancer when Mauri was in high school. “Living through that with her and her experience was really impactful for my decision to take my interests and apply them to medicine,” Mauri said. “Even before that, though, I had some sort of indication that I was interested in medicine. Whenever there was an emergency in the house or first aid was needed, other people in the family fainted at the sight of blood, and somehow I just found I had an interest and aptitude for jumping in those situations.” After completing her undergrad studies at Harvard College, she earned her M.D. from Harvard Medical School and a master of science in clinical epidemiology from Harvard School of Public Health. She started practicing medicine at Boston’s Brigham and Women’s Hospital with a residency in internal medicine and fellowships in cardiovascular disease and interventional cardiology as new drugs and medical devices offered improved cardiac care. “That connection between biology and science and then seeing things move really rapidly from bench research to understand what the targets were to seeing how these were working in clinical settings, I had firsthand experience with that,” she said, recalling her time rotating through the cardiac care unit and seeing how heart attack care improved first with medication, then with stents and eventually drug-eluting stents. “While I was practicing, I always had a combination of that practical experience and really enjoying working with patients and working with teams

in the procedural setting, [developing] better and better technologies and the personal satisfaction of being able to actually change the course of somebody’s illness that dramatically and quickly,” she said.

"While I was practicing, I always had a combination of that practical experience and really enjoying working with patients and working with teams in the procedural setting." After 15 years of clinical practice in interventional cardiology and running research programs in clinical trials, she said she was drawn to Medtronic by its global reach and range of its products and expertise. “The range of expertise that exists within the company to bring new things forward was really exciting,” She said. “That opportunity to extend the impact to healthcare leadership was really interesting.” Two years after joining Medtronic, she was promoted to SVP and chief clinical and regulatory officer, joining the company’s executive committee. This April, she became chief scientific, medical and regulatory officer. >>

Dr. Laura Mauri brings years of patient care experience to top clinical, regulatory, scientific post

wtwh.me/mauri

In this episode, Dr. Laura Mauri shares the career path that started with an early interest in medicine brought, at least partly, by her mother’s cancer diagnosis. This year, she was named senior vice president and chief scientific, medical and regulatory oﬃcer. We’ll talk with her about the “good surprises’ she encountered at Medtronic as well as the impact that the pandemic’s fallout will have on clinical trials and clinical workflow going forward.

Dr. Laura Mauri is an SVP and the chief scientiﬁc, medical and regulatory ofﬁcer at Medtronic. Photo courtesy of Medtronic

10 • 2022

Medical Design & Outsourcing

2022 WOMEN IN MEDTECH DR. LAURA MAURI

(continued)

“With this appointment, we’re enabling a patient-centered approach to healthcare technology innovation at every stage of the product lifecycle,” Medtronic Chair and CEO Geoff Martha said when announcing Mauri’s latest promotion. “Dr. Mauri’s expertise and leadership connects medical and scientiﬁc intelligence, ensuring we have a clear appraisal of the medical and scientiﬁc landscape as we make investment decisions, and helping to deliver effective and reliable innovations for patients and healthcare providers.” Changes from Medtronic’s reorganization and the COVID-19 pandemic Following Medtronic’s recently completed reorganization into 20 operating units (OUs), Mauri has a team that works with the OUs and also has employees inside the OUs. “We have a central team that is shared services and centers of excellence around clinical medical and regulatory, but

then the work on the speciﬁc programs for clinical trials or regulatory submissions or the chief medical ofﬁcers that do work is all within the operating units and that’s through an indirect organization,” Mauri said. “When we think about how to move the needle for Medtronic, we want to think about it in totality.” Mauri believes many of the changes in how Medtronic and other companies conducted trials during the COVID-19 pandemic are going to become permanent. COVID boosted remote technology out of necessity. Technicians can now make programming changes to ventilators for intensive care patients without entering the room for their safety. “Whether it’s in the surgical suite with our surgical programs, avoiding the need to have somebody turn off your pacemaker when you go into an MRI setting, or the remote interrogation of devices that can happen directly from a patient through a phone, these are all things that I think are

important and the measured beneﬁts are to the healthcare system and the experience for patients as well,” Mauri said. Another example is the adoption of remote methods for clinical research, with more focus on what data can be easily and reliably collected directly from patients through an app rather than hospital visits. One pandemic surprise was enrollment increased for some trials — such as renal denervation procedures for hypertension — despite all the COVID-related challenges because Medtronic reached patients directly through social media. “Patients had more time at home, they were interacting more with us without going to the hospital,” she said. “We could do a lot of the screening to check their interest in eligibility for the trial before they even had to go to a hospital location. Those are becoming the ways of working in clinical research.” Hear the entire DeviceTalks interview with Dr. Laura Mauri at wtwh.me/mauri

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Medical Design & Outsourcing

10 • 2022

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2022 WOMEN IN MEDTECH (continued)

Aviva McPherron

Atsuko Murakami

Niamh Pellegrini

Appointed in 2018

Appointed in 2019

Jennifer Meade

Kelly Murphy

Johonna Pelletier

Appointed in 2021

Appointed in 2015

Tomoko Nakagawa

Jaclyn Peterson

SVP, Information Technology NuVasive

CFO HU Group

Division President, Breast & Skeletal Health Solutions Hologic

SVP and General Counsel Henry Schein

Appointed in 2020

Britt Meelby Jensen

Chief Sustainability Officer Hoya

CEO Ambu

Appointed in 2022

SVP, Chief Human Resources Officer Haemonetics Appointed in 2021

Wendy Millette

Chief Compliance Officer, Fresenius Medical Care North America Fresenius Medical Care Appointed in 2019

Sandrine Moirez

EVP, Human Resources Abbott

Appointed in 2020

Karleen Oberton CFO Hologic

Chief Human Resources Officer Amplifon Appointed in 2017

Mary Beth Moynihan

SVP, Market Access and Chief Marketing Officer Boston Scientific

VP, Manufacturing and Advanced Engineering Conmed

Trinh Phung

VP, Finance Shockwave Medical Appointed in 2017

Nancy Pounder

Chief Human Resources Officer Cordis Appointed in 2021

Jody Powell

VP, Global Regulatory Affairs and Quality Assurance Stryker Appointed in 2020

Nicole Priest

Chief Wellness Officer Merit Medical Systems Appointed in 2019

Sarah Oliker

Francesca Morichini

Appointed in 2020

CFO Smith+Nephew

Appointed in 2021

Appointed in 2019

EVP APAC Amplifon

Anne-Françoise Nesmes

Senior GM, Management Strategy HQ Omron Healthcare

Mary Moreland

Anthea Muir

Appointed in 2022

Ayumu Okada

Appointed in 2022

Appointed in 2021

EVP and Chief People Officer BD

Appointed in 2018

International GM iRhythm

Treasurer and VP, Tax Conmed

Appointed in 2021

Shana Neal

Laurie Miller

Chief Commercial Officer Nevro

Assistant General Counsel, Assistant Secretary Conmed

Katrin Pucknat

Appointed in 2018

Jennifer Olson

Gitte Pugholm Aabo

Appointed in 2022

Appointed in 2019

Alison Parkes

Jane Rady

EVP, Customer Success Align Technology

Chief Compliance Officer Smith+Nephew Appointed in 2022

Karen Parkhill

President and CEO GN Hearing

SVP, Corporate Strategy and Business Development Glaukos Appointed in 2018

EVP and CFO, IT and Enterprise Excellence Medtronic Appointed in 2016

President in Germany ResMed

Theresa Reinseth

SVP, Corporate Controller and Chief Accounting Officer 3M Appointed in 2019

Medical Design & Outsourcing

10 • 2022

www.medicaldesignandoutsourcing.com

Whitney Reynolds VP, Global Customer Experience Teleflex Appointed in 2021

Vicky Ringwood SVP, Human Resources Konica Minolta Appointed in 2018

Anna Romberg

EVP Legal, Compliance and Governance Getinge Appointed in 2020

Dorthe Rønnau

SVP, People and Culture Coloplast Appointed in 2022

Rahma Samow Head Dental Service Organizations Straumann Appointed in 2021

Virginia Sanzone Corporate VP, General Counsel ICU Medical Appointed in 2018

Meghan Scanlon

SVP and President, Urology and Pelvic Health Boston Scientific Appointed in 2020

Michelle Scharfenberg

SVP, Chief Ethics and Compliance Officer Avanos Medical Appointed in 2020

Verena Schiller

President, Neuro Solutions Elekta Appointed in 2019

Lee Ann Schuette President, Renal Care Baxter Appointed in 2021

(continued on page 32)

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2022 WOMEN IN MEDTECH (continued)

How Medline maintains quality while innovating and growing

Daniela Seabrook Chief Human Resources Ofﬁcer Royal Philips Appointed in 2019

Medline President of Quality and Regulatory Aﬀairs LARA SIMMONS oﬀers insight into innovation and quality as the company grows.

Sandra Sedo

Chief Compliance Ofﬁcer Cardiovascular Systems Appointed in 2016

Holly Sheffield

President of CooperSurgical Cooper Cos. Appointed in 2020

Sumi Shrishrimal

BY SEAN WHOOLEY ASSOCI AT E EDI TOR

EVP and Chief Risk Ofﬁcer iRhythm Appointed in 2022

hen Lara Simmons joined Medline Industries in 1992, she began by performing packaging validations. At the time, Medline was bringing in $250 million in sales per year, and the company’s quality assurance team had only about nine members. In 2021, the Northﬁeld, Illinois–based company reported more than $20 billion in annual revenue — making it the ﬁfth largest medical device company in the world, according to Medical Design & Outsourcing‘s most recent Big 100 report. There are now around 1,800 people in Medline’s quality organization worldwide. “You don’t get that kind of growth if you don’t have rock solid quality,” Simmons said in an interview with MDO. “You can win customers on price and promises. But, you lose them on bad quality and bad service.” Simmons is one of the longestserving women in medtech. She’s currently president of quality and regulatory affairs at Medline and has been leading that division since 2008. The company evolved with the R&D team, testing laboratories and EHS under Simmons. Medline reported doubledigit growth in all but one of the last 50 years, Simmons said. The company has grown to the point where it has boots on the ground in different countries to onboard new

Lara Simmons

President, Quality and Regulatory Affairs Medline Industries Appointed in 2008

Ami Simunovich

EVP and Chief Regulatory Ofﬁcer BD Appointed in 2020

Keyna Skeffington SVP, General Counsel LivaNova Appointed in 2017

Jessica Smith

Corporate VP, Global Regulatory Affairs Integra Lifesciences Appointed in 2022

Ola Snow

Chief Human Resources Ofﬁcer Cardinal Health Appointed in 2018

Elisabeth Staudinger Member of the Managing Board, Head of Asia Paciﬁc Siemens Healthineers Appointed in 2021

An Steegen Co-CEO Barco

Appointed in 2021

Medical Design & Outsourcing

10 • 2022

suppliers, verify production processes and environmental controls and look at ethical sourcing. “We literally can have somebody on an airplane or train to wherever in a day to go check something out if there’s a need to do that. That really helped us navigate the pandemic,” she said. “When I look back at it, it’s amazing to think that I used to know every single product manager by name. We have hundreds of product managers, and it’s just not possible nowadays. It’s incredible.” Dealing with recalls “Recalls — they’re unavoidable,” Simmons said. “Things happen, and the blessing we have is that our customers all know that.” She said that Medline’s approximately 2,000 sales representatives in the U.S.

Lara Simmons is Medline’s president of quality and regulatory affairs. Image courtesy of Medline

2022 WOMEN IN MEDTECH can quickly communicate significant recalls to customers. A more significant step, she said, is Medline’s automation of its paperbased recall process over the past year or so. The company tried having third parties handle recall notifications but was unhappy to lose the personal connection, Simmons said, so it tried automation. The system sends notices to customers. Then, it takes them to a portal where they can respond to the recall and generate all return information and everything else they need. The main challenge is getting customers to provide a monitored, central email box for these communications, with response rates representing a bump in the road, Simmons said. “They get so many recalls,” Simmons said. “They get bombarded with so many communications because we are a large distributor of other folks’ medical products as well. We notify them of the recall. The OEM notifies them of the recall. If they have multiple locations, they might get 10 or 12 notices in one day, all about the same recall, and they might have to respond to more than one recall notice. It’s frustrating for them. And for us, it’s getting to that response rate that the FDA requires to get us to close it out. That’s one of the biggest hurdles for recalls.” Managing through tightening regulations Simmons said she’s done 40 to 45 FDA 510(k) submissions. She recalls submitting her first antimicrobial device for 510(k) clearance years ago. At the time, all the FDA required was a simple zone of inhibition test, while requirements today are “magnitudes higher,” she said. “It’s not a bad thing,” said Simmons. “It just makes it far more complex. But, if you manage those expectations with the product divisions in your team, it’s very navigable.” She expects regulations will become increasingly stringent but said Medline is prepared. The company’s product mix of disposables, reusables and reprocessed single-use devices offers familiarity with those particular markets and processes. In addition, Medline has opportunities to serve on certain committees for developing new standards. The level of information required is “amazing” to Simmons, who said old submissions came in at just five pages long. The tightened regulations also apply to international bodies and data requirements. 10 • 2022

Medical Design & Outsourcing

2022 WOMEN IN MEDTECH LARA SIMMONS

(continued)

Sadie Stern

Andrea Wainer

Appointed in 2020

Appointed in 2019

Carol Surface

Debbie Weitzman

EVP, Chief Human Resources Ofﬁcer Dexcom

Chief Human Resources Ofﬁcer Medtronic

President, Pharmaceutical Distribution and The Medicine Shoppe International Cardinal Health

Appointed in 2013

Karin Svenske Nyberg EVP Human Resources Elekta

Appointed in 2017

Katherine Wengel

EVP and Chief Global Supply Chain Ofﬁcer Johnson & Johnson

Appointed in 2017

Gabriella Szekely

Appointed in 2014

VP, R&D, Combination Pharmaceutical Products Glaukos

Rebecca Whitney

SVP, Global Spine President ZimVie

Appointed in 2018

Appointed in 2022

Katie Szyman

Sarah Wills

Corporate VP, Critical Care Edwards Lifesciences

EVP, Chief Corporate Affairs Ofﬁcer Cardinal Health

Appointed in 2015

Hisako Takada

Appointed in 2019

Senior GM, CEO Ofﬁce Omron Healthcare

Lori Winkler

Appointed in 2021

Nicola Talbot

VP, Human Resources Fisher & Paykel Healthcare Appointed in 2020

SVP and Chief Human Resources Ofﬁcer Zimmer Biomet Appointed in 2022

Suzanne Winter President and CEO Accuray

Jennifer Taubert EVP, Worldwide Chair, Pharmaceuticals Johnson & Johnson

Appointed in 2022

Angela Wirick CFO AtriCure

Appointed in 2018

Urvashi Tyagi

Appointed in 2020

Chief Technology Ofﬁcer ResMed

Victoria Womack Styles

Appointed in 2022

VP and GM, Advanced Endoscopic Technologies Conmed

Julie Tyler SVP, Vascular Abbott

Appointed in 2003

Appointed in 2021

Ann Vu

EVP, Rapid and Molecular Diagnostics Abbott

Dara Wright

SVP, Regulatory Affairs, Quality Assurance and Clinical ZimVie

EVP, President, Clinical Diagnostics Group Bio-Rad Appointed in 2020

Appointed in 2022

Medical Design & Outsourcing

10 • 2022

(continued)

“It’s frustrating from a bureaucracy standpoint and a cost standpoint,” Simmons said. “But for patients, it’s the right thing to do, and that’s what Medline is all about: customers and patients and focusing on what’s right for them.” How Medline handles regulatory and quality processes At Medline, the process for a new product usually starts with a division presenting the product to Simmons and her team. Then, her team determines the appropriate pathway for regulatory review, sets a meeting with the FDA, prepares a pre-submission and makes sure the company understands the FDA”s expectations and the likely timeline. “That’s something really different for Medline, because when we started in the industry, we started with textiles. We were providing butcher’s aprons to the marketplace and stockyards in Chicago way back when the original founder started Medline,” Simmons said. “Textiles has always been a strong backbone. With textiles, there’s not a lot of heavy regulation or a lot of standards, so it was easy when I started at Medline to launch a new product.” But as the company grew and innovated new products, regulatory timelines stretched from months to years while its medical devices became more complex and required more testing. “It’s about managing those expectations and really making sure you understand what the agency expects as much as possible upfront, and then working with them to navigate any kind of additional requirements that come up throughout the process,” she said. With quality assurance, regulatory affairs and more eventually feeding one pipeline to Simmons, nothing must fall off-kilter. In some ways, she said it creates an easier development environment. “If regulatory says no and quality disagrees, they all end up in my office, and it’s like, alright, let’s figure this out,” said Simmons. “If this is something that we really think is the right thing for the market, and the right thing for the patients, then there is a pathway. We just have to find it.” Relationships ensure quality “Good quality people make a good quality organization, which makes

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2022 WOMEN IN MEDTECH (continued)

good quality products,” Simmons said, sharing her favorite quote and what she sees as representative of how Medline maintains quality. She said she’s always sought to hire people who are smarter than her (“fortunately not that hard to do,” she jokes) and looks for inquisitive, creative problem solvers who take the initiative with what she calls “that spark.” “It’s about giving them the tools that they need and getting out of their way,” said Simmons. “Since we’re a very data-driven company, it’s easy to monitor results. We can tell

right away when there’s a hiccup or a problem. And the organization, as big as we are, still really retains that family atmosphere. … There are such strong relationships, which is so critical in managing an organization.”

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10 women-led medtech startups you should know The Medical Design & Outsourcing editorial team drew on its resources to create this list of womenled startups. These companies are less

than 10 years old or are still working toward commercialization of products and were founded by women and/or are led by women.

Bringing motion to medicine: How Actuated Medical is innovating deep brain stimulation and more Actuated Medical is making electrode placement for deep brain stimulation easier and less traumatic.

B Y DA NIELLE K IR SH S E N IO R ED ITO R

10 WOMEN-LED MEDTECH STARTUPS

early 16 years ago, Actuated Medical co-founder, President and CEO Maureen Mulvihill was working for a company making actuators that were the size of a grain of rice. While the company was focused on components, she wanted to help patients more. "I was actually sitting in a doctor's office and I was showing him the little

actuators. He's like, 'Maureen, I don't need that. I need the whole system FDA approved,'" she told Medical Design & Outsourcing. Mulvihill understood that sentiment and went on to start Actuated Medical with the idea of putting motion into medicine. Bellefonte, Pennsylvania-based Actuated Medical is a medical device

ACTUATED MEDICAL Bellefonte, Pennsylvania CEO, PRESIDENT AND CO-FOUNDER MAUREEN MULVIHILL

BLUEGRASS VASCULAR TECHNOLOGIES San Antonio, Texas CEO AND PRESIDENT GABRIELE NIEDERAUER

Actuated Medical develops disruptive devices that integrate electronically controlled motion to improve outcomes in ICU care, deep brain stimulation and more.

Bluegrass Vascular Technologies is developing devices for central venous access procedures, including its Surfacer Inside-Out access catheter system.

Medical Design & Outsourcing

10 • 2022

product development company with devices that have some kind of motion built in. It has three commercial devices, including the NeuralGlider neural implant inserter that reduces tissue deformation during trans-pial insertion of deep brain stimulation electrodes, TubeClear feeding tube clearing system and GentleSharp blood sampling system.

BONE HEALTH TECHNOLOGIES San Francisco CEO LAURA YECIES Bone Health Technologies makes wearable, vibrating technology that prevents osteoporosis.

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CALA HEALTH San Mateo, California CEO RENEE RYAN Cala Health is developing wearable technology that uses vibrations to non invasively treat essential tremor.

WOMEN-LED STARTUPS

The company also has eight products in its pipeline: the GripTract GI endoscopic tissue manipulator, Baby GentleStick heel stick helper, IntelliNeedle for epidurals, OsteoAccess that enables angled bone entry, TumorSite CNB tissue edge identifier, BleedClear endoscopic clot clearing system, GentleClear endotracheal suction catheter and GentleDispense for needle-free drug delivery. Actuated Medical received funding through a National Institute of Health Small Business Innovation Research (SBIR) grant, which is the biggest source of seed funding for medical device startups in the product development and proof-ofconcept stages. I caught up with Mulvihill at the Life Science Women's Conference in September to discuss some of the innovations her company is working on. MDO: I sat in on an NIH funding session in which they talked about their (SBIR) grant, and they specifically mentioned the success Actuated Medical has had in the program. They touted the company's NeuralGlider in particular. Is that your only device for which you received that NIH grant? Mulvihill: We've received several grants from the NIH. We have three products that are on the market that have been developed with SBIR grants. The first one is a device called the TubeClear System. The TubeClear System is a device that clears feeding tubes while the tube stays in the patient. It's critical care. When people can't self-feed, they put a tube through the sinus passage, down the esophagus and into the stomach or below into the pylorus. These tubes are very narrow and they clog at about a 25% clog rate. That technology is in about nine hospitals across the country, and it's a critical care device. It's in a lot of ICUs and a lot of ERs. MDO: I know with the NeuralGlider neural implant inserter, it's really hard to make or it's just a difficult device to successfully achieve, and your company has done it because it's a commercial product now, right? Mulvihill: It is a commercial product for preclinical research. It is not for human use yet. Under NIH SBIR grants, we developed the device to be compatible with many electrodes. There are researchers across the country and the world that are studying the brain. >>

Actuated Medical cofounder, President and CEO Maureen Mulvihill Photo courtesy of Actuated Medical

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Medical Design & Outsourcing

WOMEN-LED STARTUPS

They want to understand what the brain's doing so they can treat neurological conditions, and most labs have their own electrodes that are really different. Our device has to mate or couple with each one of these. That's what our goal is under that NIH funding. We went from being compatible with one to 13 now. We have commercial sales of our NeuralGlider to about 12 research labs. Then we have other ones that are just participating in evaluating it to see if it works for their electrode. Then, under that SBIR are another six labs that are using it as part of the SBIR project. MDO: Neuromodulation and neurostimulation are a trend right now, so obviously, that's a really important innovation. How does the NeuralGlider work? Mulvihill: Right now, one way that researchers insert electrodes into the brain is by using high-force air. It forces

the electrode into the brain tissue, but the brain tissue dimples, and therefore it’s hard to achieve to a precise location. There’s also a lot of hemorrhaging, which then causes a foreign body response, where the body attacks the electrode and decreases its lifetime. NeuralGlider, our device uses ultrasonic energy — very frequent but short displacements. We’re vibrating those electrodes into the tissue with less dimpling, so we’re more precise and less tissue trauma, so lower body response. Then we believe that our electrodes will have a longer life. MDO: Could that kind of technology be used in another application like blood draws? Mulvihill: Correct. So we started actually looking at it for spinal insertions and epidural insertions and even bone biopsies. And it was when DARPA (Defense Advanced Research Projects Agency) saw what we were doing and said, "Can

you use that same technology to insert electrodes into the brain?" We started with the other application areas and really moved into the neural space. MDO: DARPA saw there was a need for it somewhere else, and so your team decided to shift toward that? Mulvihill: Yeah, pretty much. We're still doing other things. We actually have 21 employees, so we're not all doing neural devices. MDO: What is the regulatory status of NeuralGlider and your other two commercial devices? Mulvihill: The TubeClear system is FDAcleared. It has six 510(k)s behind it because there's different types of feeding tubes. With each different feeding tube, we had pretty much a new indication or a new FDA clearance. The other device we have is GentleSharp, and that device is for animal research or for more humane blood

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sampling of rodents. That did not require FDA. The NeuralGlider inserter, we're in the preclinical market, so we did not need to go to the FDA. But we right now are interacting with the FDA to see what is the regulatory path for it. The Blackrock NeuroPort is FDA-cleared for their specific electrode. We know there is a path forward. It could be a 510(k) pathway. MDO: What are some of the challenges of designing, especially for the NeuralGlider? Mulvihill: You do have to consider the tissue you're going into. Then our device, which is a piezoelectric actuator, has to have a coupling mechanism to couple to the electrode because everyone's electrode design is different. That mechanism that does the coupling is definitely our intellectual property. That would be one of the things to think about. Then the other part is we do want to get this into the human clinical stage. Now we have to look at verification validation testing. Actuated Medical is ISO 13485-certified, which means that we can manufacture medical devices. We're compliant with the FDA. We're now looking at getting NeuralGlider FDA cleared, getting all the data ready so that we can go quickly to a clearance once we have the safety and efficacy data. MDO: What's next for Actuated? What are you excited about? Mulvihill: The future for it is this neural device space. We also have three other products that are very close to FDA [review]. We have a regulatory submission going in for an endoscopic tool. That should be going through the FDA in the next couple months. GripTract will be going to the FDA before the end of the year. Then we have another product called Baby GentleStick, and it will be going to the FDA probably in the first quarter or second quarter of 2023. We have a clinical study going on for the Baby GentleStick. We're waiting for that data. Once that data's in, then we'll go to the FDA because everything else is done. We're just waiting on clinical data. GripTract, for which we're receiving additional SBIR funding that'll support two clinical studies. We have these three products and TubeClear — we continue pushing TubeClear.

"There are researchers across the country and the world that are studying the brain. They want to understand what the brain's doing so they can treat neurological conditions, and most labs have their own electrodes that are really different. Our device has to mate or couple with each one of these."

MDO: Which one are you most excited about? Mulvihill: Probably NeuralGlider. Each one is so different. Each one has a different application area, clinical need. Each one gets me excited about different things. One of the great things with TubeClear is when you have a feeding tube, and it's clogged — you can't get your food, your medication and nutrition — our device clears that so they don't have to have a surgical procedure. During COVID, we had a doctor call us. He had a patient that hadn't eaten in eight days. They used our device. That patient avoided having surgery. That's a great day. NeuralGlider — I have family members that have had Parkinson's. Can we help them? Rather than the drugs that have cerebral side effects, can we do a minimally invasive procedure and make their quality of life better? And then GripTract, anyone over 50 that has had a colonoscopy, we all know how serious it is, right? Our device gives doctors a third hand, gives them ﬁngers, and then they can manipulate tissue, and they can do better procedures faster for patients and make outcomes better. >>

Actuated Medical's NeuralGlider Image courtesy of Actuated Medical

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How this inside-out vascular access system simplifies catheter placement B Y DA N IE L L E K IR SH S E N I O R E D ITOR

Bluegrass Vascular Technologies is making catheter placement procedures for dialysis and chemotherapy easier and safer using insideout technology, explains CEO and President GABI NIEDERAUER.

10 WOMEN-LED MEDTECH STARTUPS (continued)

luegrass Vascular Technologies has ﬁgured out a way to make a catheter sheath go inside the body and back out for easy catheter placement in standard access procedures. The San Antonio, Texas–based company’s Surfacer Inside-Out access system facilitates catheter insertion into the central venous system. The company designed it for use in patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods. One of the challenges of having a catheter in the body for weeks or months for dialysis or chemotherapy is the risk of blood clots. Thrombosis forms 50% of the time when health providers insert catheters into people for an extended period of time. When thrombosis occurs in a longterm catheter, it can turn into a chronic occlusion — which happens in an estimated 16% of long-term catheters, according to

DEEPLOOK MEDICAL New Haven, Connecticut CEO MARISSA FAYER DeepLook Medical makes radiology software that instantly delineates segmentation margins in tumor imaging to measure the size of any object to automate the manual process.

Gabi Niederauer, president and CEO of Bluegrass Vascular Technologies. Catheter placement can also become difﬁcult if the right internal jugular becomes chronically occluded. When this happens, a doctor may try to gain access to the central venous systems through the outside of the body using a sharp needle. However, this can further complicate the procedure and create a dangerous situation as it often requires blind placement of the needle near the heart and lungs. “Some doctors try to go in the femoral vein and push a sharp guide wire through the occlusion and snare it on the other side. But what’s most commonly done is if they don’t get access on this side, they just go to the other side,” Niederauer told Medical Design & Outsourcing. “What then happens is for patients who are dependent on catheters like a dialysis patient, they just burn up all of that central vasculature.

EVOENDO Centennial, Colorado CEO AND CO-FOUNDER HEATHER UNDERWOOD EvoEndo makes single-use gastroscopes, virtual reality patient distraction tech and comprehensive training programs for unsedated alternatives to upper endoscopy.

They essentially cause the same thing to happen on the left side.” Simplifying catheter placement for safer procedures Interventional cardiologist Dr. John Gurley developed Bluegrass Vascular’s Surfacer technology to assist in catheter placement. It goes in through the femoral vein and essentially straight through the body to just above the clavicle, where the distance from occlusion to the skin surface is just a few centimeters. There, the doctor can push a sharp wire out to safely pull a catheter in. The operator navigates the Surfacer from the femoral vein and exits the venous vasculature. A sheath advances over a guidewire to the venous obstruction and

PHIEX TECHNOLOGIES Boston CEO CL TIAN Phiex Technologies is a materials manufacturer that is developing a new method for sterilizing of medical devices. Gabi Niederauer is president and CEO of Bluegrass Vascular Technologies. Photo courtesy of Bluegrass Vascular Technologies

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WOMEN-LED STARTUPS

provides a conduit for all instruments used during the procedure. A target goes on the exit area of the body, and the device then pushes through to the obstruction. The system operator adjusts Fluoro, an imaging agent, until the tip of the device is visible within the exit target. Next, the person operating the Surfacer rotates its handle until the target window appears and advances the needle out of the tip. The occlusion acts as a stabilizer for the needle wire to pierce the skin at the exit point, and the operator inserts a sheath from the outside in. Finally, there is the removal of the Surfacer removal. Catheter placement takes place through a standard access procedure. The entire process takes about 20 minutes. “Essentially, it helps provide vascular access in the right internal jugular for patients whose veins have closed up chronically or permanently. Placement of central venous catheters are done for dialysis access, for nutrition, for chemo, for a number of different reasons. Approximately 6 million central venous catheters are placed each year and about 20% of those are long-term catheters,” Niederauer said. Bluegrass Vascular Technologies’ Surfacer vascular access device is already in the commercial stage. Health providers have used it in nearly 700 cases. The Surfacer has 13 peerreviewed publications. It has a CE mark approved, and the FDA granted it a de novo clearance in February 2020. The Centers for Medicare and Medicaid Services assigned the device a New Technology Ambulatory Payment Classiﬁcation (APC) in September 2021.

"This is such a novel concept. There's no other device that enters the body and then comes out of the body, so that was a challenge for the FDA since no other cleared devices operate in that manner."

Innovative technology creates bumps in the road One of the main challenges when developing medical devices is the regulatory pathway, and the Surfacer was no exception. “This is such a novel concept,” Niederauer said. “There’s no other device that enters the body and then comes out of the body, so that was a challenge for the FDA since no other cleared devices operate in that manner.” >> Medical Design & Outsourcing

WOMEN-LED STARTUPS

The Surfacer went through different divisions of the FDA before it got de novo clearance and the divisions had different expectations on the data set used, she said. With de novo classiﬁcations, the FDA is reviewing devices that are new to the market and do not have substantially equivalent predicates already on the market. The process is typically more rigorous. “Our de novo review by FDA was actually very predictable. We were able to get it approved within their 150 days, where only around 42% of de novo [applications] get reviewed and cleared that quickly,” Niederauer said. “So that was a good accomplishment on our end, but then with the pandemic hitting shortly after our FDA approval, we couldn’t really get into hospitals to train physicians and proctor cases. So that slowed down our launch.” Because the Surfacer System is so unique, another challenge Bluegrass

Vascular had to face was obtaining a reimbursement code from CMS. The company applied for a new technology payment classiﬁcation which would cover the device and the associated procedure the device is used for; however, CMS felt the procedure was already described by

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10 • 2022

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the code utilized for the placement of a tunneled catheter. “It was not just placing a tunnel catheter though, so we had to go back and forth with CMS and that took 19 months, which is a lot longer than 90 days,” Niederauer said.

WOMEN-LED STARTUPS

The Surfacer Inside-Out vascular access system Image courtesy of Bluegrass Vascular Technologies

Focused, direct sales team to drive product adoption Bluegrass Vascular Technologies has used distributors for its Surfacer since it’s been on the commercial market. But the company is establishing its own sales force and will begin selling the device directly in the U.S. starting Jan. 1, 2023. The Surfacer technology is new to the medical device industry, so Bluegrass Vascular is still establishing the importance of the device with physicians — and that’s why it is recruiting sales managers with expertise in the vascular space, Niederauer said. “We believe the type of missionary selling needed to promote a practice-

changing device is best done by our own team. The individuals we have hired are passionate about the Surfacer System and the opportunity to promote our life-saving technology. Building out our own direct sales is what’s in store for us in 2023, and I’m really excited about the team we have put together to drive our business forward.” >>

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WOMEN-LED STARTUPS

This wrist-worn device can treat essential tremor Cala Health co-founder KATE ROSENBLUTH developed a solution for essential tremor. This debilitating disorder can make it diﬃcult to perform daily tasks like drinking from a glass or writing checks. B Y DA N IE L L E K IR SH S E N I O R E D ITOR

10 WOMEN-LED MEDTECH STARTUPS (continued)

neuroscientist and engineer by training, Cala Health co-founder and Chief Scientific Officer Kate Rosenbluth saw the necessity for an easy treatment option for essential tremor while doing her biodesign fellowship at Stanford University. She was performing observations at Stanford Hospital and clinics for several months, following neurosurgeons, neurologists, practitioners and any nurse willing to allow her to observe unmet needs in medicine. That’s when she noticed an opportunity to help patients in the field of essential tremor and hand tremor. Essential tremor is a nervous system disorder that causes involuntary and rhythmic shaking. It most often occurs in the hands but can affect almost any part of the body, making it difficult to do simple tasks like drinking from a glass. The disorder is not caused by other

STARLIGHT CARDIOVASCULAR San Diego CEO AND CO-FOUNDER BEVERLY TANG Starlight Cardiovascular is developing tools and devices to treat pediatric congenital heart defects.

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conditions and is often confused with Parkinson’s disease. Essential tremor is most common in people age 40 or older and affects more than 6.4 million people in the U.S., according to a study from the American Academy of Neurology. Rosenbluth, who has an extensive background working in deep brain stimulation, was aware that the site of deep brain stimulation is accessible through peripheral nerves in the wrist. Through more research, Rosenbluth discovered that the same signals that cause tremors could be sent to the same location in the brain non-invasively by stimulating those nerves. “This insight came out of realizing that functional neurosurgeons, when they were implanting the deep brain stimulators, will often sweep the sensory distribution of the hand to ﬁnd that location in the brain,” Rosenbluth told Medical Design & Outsourcing. Teaming up with co-founder Scott Delp, director of the Stanford Neuromuscular Biomechanics Laboratory,

Rosenbluth began to reverse engineer the circuitry of movement disorders outside of the brain. They brought another cofounder, engineer Serena Wong, onto the team to lead research and development. Along with CEO Renee Ryan — who co-led the $18 million Series A fundraising round with Lux Capital — they started Cala Health in May 2014. “Clearly what Kate was doing in her early work while still at Stanford was a wearable wrist-like form factor, but it was responsive neuromodulation,” Ryan told MDO. “In that first meeting with her, I said, ‘Kate, we’re going to go start a company.’ That’s how we first came into touch with Cala Health.” How Cala Health’s Cala Trio works Cala Health’s flagship device is the Cala Trio, a wearable worn on the wrist to target the same site in the brain where tremor is well-controlled by deep brain stimulation

TRACTUS VASCULAR Eatontown, New Jersey CEO JANET GALTES

ULTRASOUND AI Highlands Ranch, Colorado CEO PAMELA BONNETT

Tractus Vascular develops endovascular catheters for chronic total occlusion, including its FDA-cleared Tractus crossing support catheter with its Jigsaw technology.

Ultrasound AI is developing an artiﬁcial intelligence platform that uses ultrasound to predict preterm birth as early as eight weeks of gestation and is delivered using existing clinical workﬂows.

10 • 2022

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WOMEN-LED STARTUPS

(DBS) — the thalamus. Cala Trio is FDA cleared as an external upper limb tremor stimulator, available by prescription only. Early on, the team found they could put motion sensors on the wearable to detect the speed of the tremor because oscillations in the brain are wellcorrelated to the speed of hand tremors. “It’s typically between a slow tremor of about 4 Hz and a fast tremor of about 12 Hz,” Rosenbluth said. “So, we realized that onboard a single device, we could both measure the frequency or the speed of a patient’s tremor and deliver the electrical stimulation to treat the tremor. And by bringing those two areas of the individualized monitoring and calibrated stimulation into a wrist-worn form factor, we could offer patients tremor relief.” In developing the device, Cala Health also had to ﬁgure out the optimal timing of the stimulation needed to interrupt the tremor signal sent from the hand and the wrist and to the brain. That distribution was an indicator that the signal from the nerves that pass very close to the skin near the carpal tunnel would be able to send a signal to the same location in the brain as DBS, but non-invasively. The company’s transcutaneous afferent patterned stimulation (TAPS) therapy sends patterned signals to the brain across the skin to stimulate the thalamus. The therapy can be individualized and measure how fast each patient’s tremor is to deliver a signal that alternates between the medial and radial nerves in the wrist at the same frequency of the tremor. It can bring tremor relief both during and after the stimulation. >>

Cala Health CEO Renee Ryan Cala Health co-founder and Chief Scientiﬁc Ofﬁcer Kate Rosenbluth

Photo courtesy of Cala Health

10 • 2022

Medical Design & Outsourcing

WOMEN-LED STARTUPS Cala Health's Cala Trio

Image courtesy of Cala Health

Patients wear the device for 40-minute sessions throughout the day as needed. The FDA clearance does not limit the number of sessions per day. “To me, what was really exciting about that is offering the therapy that is truly meeting patients’ needs,” Rosenbluth said. “They are looking for help with everything from eating, drinking, doing buttons, signing checks. What we really wanted to do was develop a therapy that was usable by different patients for tremor relief.” Dr. Yasar Torres-Yaghi is a neurology physician specializing in movement disorders and co-investigator on a homeuse study of Cala Trio. “It’s not just about the clinical tremor beneﬁt we see, but the quality of life changes and the different functional impact — being able to hold things, for example, all the things that essential tremor can affect,” Torres-Yaghi said. “Telling [patients] that those things that

they are doing might be able to improve with non-pharmacological therapy does open their eyes. You can see very happily surprised looks in patients’ eyes.” A future in treating central nervous system conditions Cala Health aims to use the noninvasive therapy in treating other conditions. It recently received FDA breakthrough device designation for expansion into hand tremors associated with Parkinson’s disease. “As we saw increasing success in growing our healthcare professional conﬁdence in our technology and also the patients’

WOMEN-LED STARTUPS

"As we saw increasing success in growing our healthcare professional confidence in our technology and also the patients' receptivity to the wearable technology, this year we are likely to 4X our sales footprint, so we're going to be growing revenue substantially over the next few years."

Innovation Redefined

receptivity to the wearable technology, this year we are likely to 4X our sales footprint, so we’re going to be growing revenue substantially over the next few years,” Ryan said. In some of Cala Health’s larger clinical studies, there were tens of thousands of data points of individual sessions by individual patients that could be captured and measured noninvasively to treat essential tremor, Rosenbluth said. Using that information, the company is focusing on indications where a peripheral nerve can be stimulated to signal into the central nervous system and have physiological signals that calibrate the stimulation to get the best possible efficacy for a patient. “It’s really interesting when you look at these sort of platform technologies where I deeply believe that by bringing together areas of physiologic monitoring and of stimulation, critically we think of this sort of as sensing and treating. That’s what was so beautiful about tremor as a first place to start,” Rosenbluth said. “You could use the same motion sensors that are used onboard the device to calibrate the stimulation and measure someone’s tremor and actually measure efficacy on a per patient, per dose.” 10 • 2022

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WOMEN IN PHARMA

3 questions with women in pharma AstraZeneca Oncology R&D EVP DR. SUSAN GALBRAITH, Ferring Pharmaceuticals Chief Scientiﬁc Oﬃcer DR. ELIZABETH GARNER and Insmed CFO SARA BONSTEIN discuss barriers for women and ways to break through.

Brian Buntz | Pharma Editor |

ne of Medical Design & Outsourcing’s sister websites, Drug Discovery & Development, has taken a page from our annual Women in Medtech edition for a new series of Women in Pharma interviews. These pharmaceutical leaders offered their perspective on barriers facing women in the industry, ways to overcome them and steps needed to recruit and retain more women in pharma. To read the full conversations with these women and others in the Women in Pharma series — including how they got into the industry, leadership lessons they’ve learned and the projects they love — go to wtwh.me/wip

ensuring women have the support they need to succeed. It’s important to continue educating about why achieving gender equity in this industry is critical. I strongly believe more female leaders at the table leads to better representation and more informed decision-making. (continued on page 50)

Drug Discovery & Development: What are some barriers women face in the drug development industry? How can the industry work to overcome those barriers? AstraZeneca EVP of Oncology R&D Dr. Susan Galbraith

Photo courtesy of AstraZeneca

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AstraZeneca EVP of Oncology R&D Dr. Susan Galbraith: There has been substantial growth in gender equality in the industry, but there’s still more to do to reach true parity. Although we may enter the ﬁeld with the same advanced degree as our male counterparts, some barriers — such as wage gaps, career breaks to raise a family or belief in gender stereotypes — can hamper women’s upwards mobility. The industry must focus its efforts on building a truly inclusive culture,

10 • 2022

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WOMEN IN PHARMA

I met at a conference, who is about to start medical school. She said (and I’m paraphrasing) that she is usually not a shy or quiet person but being around more what she called “experienced” physicians prevented her from speaking up. It’s a trait that she recognized, and she is now focused on building her skill set of speaking her mind as she begins her exciting journey in medicine. We must teach our young women to change these behavioral patterns and learn from their male colleagues who have no problem speaking up, even when they might not have that much to say.

Ferring Pharmaceuticals Chief Scientiﬁc Ofﬁcer Dr. Elizabeth Garner Photo courtesy of Ferring Pharmaceuticals

(continued from page 48)

I’m proud to be part of AstraZeneca, where 56% of our employees working in oncology R&D are women, and 48% of AstraZeneca’s leadership roles are filled by women. We must all continue to be strategic and intentional in developing the next generation of leaders in science. Ferring Pharmaceuticals Chief Scientific Officer Dr. Elizabeth Garner: This will sound surprising for an industry specializing in the care of women, but there are few women in top leadership positions. Moreover, there are even fewer women of color within the industry. This is unacceptable both for the many qualified women leaders who miss the opportunity to lead and for patient communities who miss out on the ideas and innovations they could bring forward. I want our industry to focus on amplifying the voices of women within our ranks, to share our experiences with 50

Medical Design & Outsourcing

10 • 2022

other leaders in the field, better identify solutions and work together to overcome such barriers. Specifically, we need more women in top positions, influencing company culture and being the final decision-makers on strategy, investment and other areas. We also need more diversity among women leaders — for example, women of color — who are best able to represent the needs of the underserved. I often hesitate to say it, but women are sometimes our own barriers. As an example, we continue to talk about imposter syndrome, which I strongly believe must be eradicated from our conversations. Women are every bit as capable as men but often tend to doubt themselves. As a timely example, I recently received an email from a young woman www.medicaldesignandoutsourcing.com

Insmed CFO Sara Bonstein: In finance even today, there are not a lot of women, and when I attend an investor conference people generally do not assume that I’m the CFO. It’s an unfortunate reality, but I just don’t let it bother me. My attitude is that no matter who you are, whatever gender, race, age or background, you need to just go in and make the impact you’re capable of making. I credit my parents and my upbringing with that mentality. Yes, it can be overwhelming to walk into a meeting or a Zoom call and be the only woman, but you just have to be a good person, do your job and let your work speak for itself. And I think the most important thing women in those roles can do is help other women support other women. Encourage young women to surround themselves with people who respect them and their work. DDD: What can be done to promote greater participation of young women in the pharma industry? Bonstein: While some areas of the industry tend to be more balanced or female-skewed, finance is not one of them. We need to break those barriers of participation by leading by example. It can be intimidating when you don’t see other people like you, so we need to be more visible — going to colleges and business schools and sharing different opportunities in the industry. Surprisingly, I think some of the unintended effects of COVID may help women enter fields they wouldn’t have before. The added

WOMEN IN PHARMA

ﬂexibility that many companies have embraced will hopefully make it more palatable for both women and men to manage work life and family life and not feel like it’s a tradeoff. Garner: Mentorship opportunities can stem from so many places in today’s world — from online communities and forums, to in-person networking events — and it is the responsibility of both employers and potential leaders to invest in these opportunities to make the most out of their future careers. In my opinion, sponsorship is every bit as important, if not more so, than mentorship. Women need to learn how to ask their mentors and managers to sponsor them for leadership positions, and to say yes when asked to lead. Speaking from personal experience,

and to what drew me into the pharma industry with a medical background, was recognizing my potential to contribute in a different way than “traditional” clinical practice taking care of patients. What ultimately gave me what felt like the permission to leave patient care was seeing one of the woman physicians I respected tremendously enter the industry. At that time, leaving academic medicine was not viewed favorably, particularly at Ivy League academic institutions, so her departure from the practice, while devastating for me personally at the time, was freeing and helped me realize this career path was a potential one for me. Examples such as this are so important in helping to promote greater participation of young women in the pharma industry.

are encouraged to be curious and to keep asking questions. We must look at the points in the career journey when women may take a step back — for example, when starting a family — and help address barriers in development and workplace re-entry. One of the biggest challenges I see, especially among young women, is that they sometimes self-limit. The phrase “I could never do that” is something that I hear more frequently than I’d like. I would strongly encourage everyone not to self-limit — you might not be able to do it yet but think about the skills and experiences needed to reach your goal and approach it that way. Also, seek out a mentor. With the right encouragement and support, all of us can exceed our own and others’ expectations.

Galbraith: We need to cultivate a space where young women

"We need to break those barriers of participation by leading by example. It can be intimidating when you don't see other people like you, so we need to be more visible. "

Insmed CFO Sara Bonstein Photo courtesy of Insmed

www.medicaldesignandoutsourcing.com

10 • 2022

Medical Design & Outsourcing

5 LEADERSHIP LESSONS

CATHY BURZIK's five essential leadership lessons for medtech's next generation of women leaders Burzik, a seasoned senior executive in the healthcare industry, has successfully led major medical device, diagnostic, diagnostic imaging and life sciences businesses.

ne key to being a successful women leader in MedTech: “Play nice, but play to win.” Cathy Burzik, who received a Lifetime Achievement Award from AdvaMed in 2019, shared this advice during a recent MedExecWomen conference fireside chat with co-founder Maria Shepherd. Burzik explained how you can apply this to your own career path and leadership style, along with many other powerful lessons she’s learned throughout her career.

Cathy Burzik | CFB Interests |

as told to Maria Shepherd | MedExecWomen |

Medical Design & Outsourcing

Build connections early in your career If you’re just starting your career or have taken a detour and are finding your new path, build and grow your network of trusted professionals as early as possible. Find sponsors. Attend industry events. Get to know people. Develop and nurture relationships at work. Join industry peer groups and follow up with members one-on-one. Need work advice to navigate a particular situation? Assessing what you should learn to advance your career? If you’ve grown your network and invested in those relationships, they will help you along the way. However, remember, you own your career path. You need to take personal accountability for your career. Those early-career mentors will see your growth potential and likely become your biggest advocates, and may even challenge you into new areas of growth beyond your comfort zone to propel you to your next career phase. And when you reach the executive level, you will have a trusted group of peers providing advice as you navigate an entirely new set of executive-related challenges. 10 • 2022

Establish your voice Women often have a difficult time being heard in the workplace. Studies show that women are interrupted two times more often than men when speaking. If you’ve directly experienced this or witnessed it done to others, it’s discouraging. To counteract, lean into your voice by indicating, when interrupted, that you are not finished and will get to that individual’s point when you’re done. If you’ve witnessed other women being interrupted, take a similar approach and say, “I was really interested in what she had to say, I’d like to hear that,” to bring the woman that was interrupted back into the conversation. Make your voice heard and be an ally to your colleagues. Have the courage to raise your hand during a meeting and make your thoughts and ideas known. If you’re early in your career, establishing your voice early shows confidence and perseverance. If you sit back — especially if you disagree — and raise the point after the meeting, the point often becomes irrelevant since decisions are likely to have already been made. Raising your hand, while challenging at first, becomes easier with practice. Assume noble intent of your colleagues Assume your colleagues have noble intent — the foundation of any effective professional working relationship. This indicates respect to your colleagues and an open mind, which fosters dialogue, understanding and productivity. By acting with noble intent, you can prevent yourself from traveling through wrong inferences, establish yourself as a leader in positive communication and cultivate an atmosphere of respect and understanding in your organization.

www.medicaldesignandoutsourcing.com

5 LEADERSHIP LESSONS

Those small steps are essential to preparing yourself for success as a leader. Practice three-dimensional leadership Whether you’re building your personal brand of leadership or incorporating lessons learned, that personal brand element never goes out of style. It defines how we are perceived in our industry and our organization. Your leadership style and the quality of work are essential components to your overall image, but so is your ability to be vulnerable. One way of being vulnerable with your colleagues is to share interests and passions you have outside of the office. You like to hike, have a dog, or enjoy ballroom dancing? Share what is comfortable to develop more meaningful connections with your colleagues. Come across as approachable and threedimensional versus flat and only focused on the business at hand. That comfort can

translate into meetings where your colleagues feel secure being open with you not only about successes at the organization, but also about areas for improvement and enable them to enter into difficult conversations so you can navigate obstacles together. Do not be the executive that people are afraid of in the elevator. Be the executive that employees want to talk with, both in personal and work-related discussions. In return, you’ll have fostered a leadership style that is open, honest and comfortable.

Mistakes in business — challenging to manage in real time — often lead to better decision making and successes later. So lean into those failures and utilize them for better decision-making. And let us never forget to “Play nice, but play to win!”

Turn failures into successes Failure is an inevitable part of every career, but it’s how you reflect, manage and learn from failures that contribute to your effectiveness as a leader. For example, did you lead a new project that went way over budget? Identify where things went wrong, own your mistakes and propose a new process so that issues and risks are identified and mitigated early in the future.

Maria Shepherd is co-founder of MedExecWomen and president of MediVantage, helping medtech, diagnostics, drug delivery and digital health companies with strategy research, done by subject matter and medical device experts. MedExecWomen is an organization focused on empowering female executives to accelerate the positive impact of medical devices, diagnostics, drug delivery, and digital healthcare around the world.

Cathy Burzik is CEO of CFB Interests and is a member of the board of directors of Becton-Dickinson and the board of directors of Haemonetics, among others.

Medical Design & Outsourcing

B Y DA NIELLE K IR SH S E N I OR ED ITO R

Medical Design & Outsourcing

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www.medicaldesignandoutsourcing.com

Illustration courtesy of Adobe Stoc k

THIS YEAR HAS BEEN ONE OF THE MOST FORMATIVE FOR WOMEN IN MEDTECH LEADERSHIP ROLES AS REPRESENTATION IN THE C-SUITE HAS REACHED A NEW HIGH.

ust 23% of the top executives at the world's 100 largest medical device companies are women, according to an analysis of Medical Design & Outsourcing's annual Big 100 ranking of the top revenuegenerating medtech companies. While that number is up 2 percentage points from 2021, the average composition within the top 100 companies is also up slightly to 22%. This year has been one of the most formative for women in leadership roles. There were 49 new C-suite appointments. However, 2020 seemingly started the shift in leadership diversity. That year, 37 women moved into C-suite roles in the top 100 companies, followed by 34 new appointments in 2021. Overall, women have moved into 120 new roles in the last three years. "The fact that the management teams are now tapping into this in 2020 and 2021 are incredibly formative because life changed. Women want to make a change, and companies need to react to that," Marissa Fayer, the incoming CEO of women's health company DeepLook Medical, told MDO. "They need to be more accepting and flexible and adaptive to all types of people, including women." Our analysis uses information from leadership pages on corporate websites as well as their executives' LinkedIn pages. (continued on page 57) www.medicaldesignandoutsourcing.com www.medicaldesignandoutsourcing.com

10 10 •• 2022 2022

Medical Design & Outsourcing

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DIVERSITY IN MEDTECH

TOP WOMEN EXECUTIVES BY POSITION

1 2

The leading women at the top 100 medical device companies in the world have titles that break down into the following roles:

39 4

8 8 38

13 14 19 20

(continued from page 55)

Prevalence and composition of women in C-suite roles ticks up Of the 942 leadership roles at the top companies, 218 were held by women, for an average composition of 22% within each company. Just 10 companies listed no women in leadership roles as of Sept. 15. That's three fewer than in 2021. Those companies include: • • • • • • • • • •

Bruker (0/6) Nikkiso (0/6) Agfa-Gevaert (0/5) Masimo (0/5) Drager (0/5) Demant (0/4) JMS Co. (0/4) Carl Zeiss Meditec (0/3) Medacta (0/3) Artivion (0/1)

The leading women at the 100 largest medical device companies in the world have titles that break down into the following roles: human resources (48), regulatory (39), divisional presidents (38), ﬁnance (36), medical (20), general counsel/legal (19),

48 39 38 36 20 19 14 13 8 8 4 2 2 1

Human resources Regulatory Divisional presidents Finance Medical General counsel/legal Information Communications/public affairs Marketing Operations Corporate secretary R&D Manufacturing Chief of staff

information (14), communications/ public affairs (13), marketing (eight), operations (eight), corporate secretary (four), R&D (two), manufacturing (two) and chief of staff (one). Note that some leaders hold one title for multiple roles, such as "SVP, general counsel and corporate secretary." Companies with the highest percentage of female executives are Haemonetics and Ambu, each with a 50% composition of women in C-suite roles. At Haemonetics, women have held those roles on average for 2.25 years, compared to less than one at Ambu. Diverse leadership “makes the business much more proﬁtable, effective and creates better products,” Bluegrass Vascular Technologies President and CEO Gabi Niederauer told MDO. “From the design standpoint, you will have diverse people looking at how to make something and clinically evaluating it.” Among the top 20 medical device companies in the world, women hold an above-average percentage of leadership roles at 26%, which is one percentage point higher than 2021's tally. However, the average time spent in those positions is just three years. >> www.medicaldesignandoutsourcing.com

Diverse leadership "makes the business much more profitable, effective and creates better products. From the design standpoint, you will have diverse people looking at how to make something and clinically evaluating it."

10 • 2022

Medical Design & Outsourcing

DIVERSITY IN MEDTECH

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Few companies have women in the top ofﬁce Six companies have women as CEOs: GN Hearing, Barco, Ambu, B. Braun Melsungen, Paul Hartmann and Accuray. Within those ﬁve companies, women hold varying percentages of executive roles. Women account for 50% of C-suite positions at Ambu, 40% at B. Braun Melsungen, 33.3% at GN Hearing, 13.3% at Barco and 12.5% at Accuray. The number of women CEOs is up one from last year, as women CEOs took over at Ambu and Accuray, while Insulet’s former CEO, Shacey Petrovich, stepped down on June 1. New Ambu CEO Britt Meelby Jensen was previously CEO of Atos Medical prior to its acquisition by Coloplast. Ambu listed no women in leadership roles on their website in 2021, so having it led by a woman just one year later is a big step toward diversifying its decision-making team. "Progress is not being made fast enough," Fayer said. "There are amazing, incredible women who are looking for different and new executive positions in the life science space and in the healthcare industry." A note on our methodology: We use each company's leadership/management pages on their website to count top executives at each company. We do not include directors or board members.

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Medical Design & Outsourcing

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DIVERSITY IN MEDTECH

PERSONNEL CHANGES Some medtech leaders have taken on new roles in their organization or moved to other companies within the industry. Below are the women executives from last year's list who have new jobs, followed by executives who are new to the list this year:

Stephanie Bolton, president of international region at LivaNova (previously president of Europe region) Victoria Carr-Brendel, group VP of Cochlear implants and president of advanced bionics (previously group VP of Cochlear implants) Julie Dewey, chief corporate communications and investor relations ofﬁcer at Nevro (previously VP of investor relations and corporate communications)

Catherine Estrampes, president and CEO of U.S. and Canada at GE Healthcare (previously president and CEO EMEA)

Margrét Lára Friðriksdóttir, EVP of people, strategy and sustainability at Össur (previously EVP of human resources and corporate secretary)

Kjersti Grimsrud, president and chief operating ofﬁcer of infusion care at Convatec (previously president and chief operating ofﬁcer of global continence care)

Betty Larson, chief people ofﬁcer at GE Healthcare (previously EVP and chief human resources ofﬁcer at BD)

Lisa Hellmann, SVP of human resources and corporate communications at Hologic (previously SVP of human resources)

Laura Mauri, SVP and chief scientific, medical and regulatory officer at Medtronic (previously SVP and chief clinical and regulatory officer) Tobi Karchmer, SVP and chief medical officer at Baxter (previously VP of worldwide medical)

Amy Dodrill, president of patient support systems and global surgical solutions at Baxter (previously president of global surgical solutions at Hillrom) Kimberley Elting, president of global orthopedics at Orthoﬁx (previously chief legal and development ofﬁcer)

Keri Mattox, SVP, chief communications and administration ofﬁcer at Zimmer Biomet (previously SVP of investor relations and chief communications ofﬁcer)

Shana Neal, EVP and chief people officer at BD (previously EVP and chief human resources officer at Owens & Minor) Sumi Shrishrimal, EVP and chief risk officer at iRhythm (previously SVP and chief risk officer at Dexcom)

Heather Knight, president of acute therapies, clinical nutrition, medication delivery, Latin America and Canada at Baxter (previously GM of U.S. hospital products)

www.medicaldesignandoutsourcing.com

Jessica Smith, corporate VP of global regulatory affairs at Integra Lifesciences (previously VP of regulatory affairs at Hillrom) Suzanne Winter, president and CEO of Accuray (previously president)

10 • 2022

Medical Design & Outsourcing

DIVERSITY IN MEDTECH

NEW TO THIS YEAR'S LIST

Lisa Aubert, president of North America, Cochlear Helen Barraclough, group general counsel and company secretary, Smith+Nephew

Hildur Einarsdóttir, EVP of R&D, Össur Denise Fleming, EVP of technology and global services and chief information ofﬁcer, BD

Tomoko Nakagawa, chief sustainability ofﬁcer, Hoya

Elin Frostehav, president acute care therapies, Getinge

Alison Parkes, chief compliance ofﬁcer, Smith+Nephew

Michelle Garsha, president of diagnostic solutions, Hologic

Leigh Benowitz, SVP and chief global digital transformation ofﬁcer, Henry Schein

Dorthe Rønnau, SVP, people and culture, Coloplast

Tammy Gomez, EVP and chief human resources ofﬁcer, Owens & Minor

Sumi Shrishrimal, EVP and chief risk ofﬁcer, iRhythm

Lucile Blaise, president of Sleep & Respiratory Care, Resmed

Michelle Greene, EVP, chief information ofﬁcer and global business services, Cardinal Health

Urvashi Tyagi, chief technology ofﬁcer, ResMed

Anne Belcher, president and chief operating ofﬁcer of global emerging markets, ConvaTec

Sharon Bracken, head of diagnostics, Siemens Healthineers Vanessa Broadhurst, EVP of global corporate affairs, Johnson & Johnson Margaret Carthy, SVP of quality and regulatory affairs, Integer Trinh Clark, SVP and chief global customer experience ofﬁcer, Henry Schein Angela Cushman, SVP of quality, Avanos Medical

Iman Jeddi, SVP and GM, Single Port Business Unit, Intuitive Surgical Cherée Johnson, SVP, chief legal ofﬁcer, general counsel and secretary, Dentsply Sirona Heather Kidwell, SVP, chief legal and compliance ofﬁcer, ZimVie

Britt Meelby Jensen, CEO, Ambu

Michele DiMartino, chief human resources ofﬁcer, Intuitive Surgical Tara Dunn, SVP of clinical affairs and market development, Inari Medical

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10 • 2022

Ann Vu, SVP, regulatory affairs, quality assurance and clinical, ZimVie Rebecca Whitney, SVP, global spine president, ZimVie Deborah Yount, chief human resources ofﬁcer, AtriCure

Patricia Lang, SVP and chief human resources ofﬁcer, Enovis

Que Dallara, EVP and president of diabetes, Medtronic

Sandrine Moirez, international GM, iRhythm

www.medicaldesignandoutsourcing.com

New Ambu CEO Britt Meelby Jensen

Photo courtesy of Atos Medical

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How medical device companies can

better protect

themselves from lawsuits

B Y C H R IS N E WMA R K ER E XE C U T I V E E D ITO R

s with pharmaceutical companies and health providers, medtech is emerging from the COVID-19 pandemic with a great deal of goodwill, says Ginger Pigott, a Greenberg Traurig shareholder. Pigott has seen the industry's improved image helping device companies with juries, mock juries and the litigation process in general. But don't bet on the trend lasting. "I've been practicing for 30 years, and it goes in that cycle all the time," Pigott said in a recent interview with Medical Design & Outsourcing. In fact, Pigott suspects the present economic uncertainty will cause an uptick in lawsuits. "When the economy goes into where it seems to be heading, we often see an uptick in litigation because people are struggling. Whether it is business disputes or product liability claims, we often see a rise in ﬁlings that seems linked to a change in the economy." Over her career, Pigott has gone from entirely handling litigation to also consulting with

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10 • 2021 2022

medtech companies about how they can reduce risk. Here are three general pieces of advice from Pigott for how medical device companies can better protect themselves: 1. Have solid quality and regulatory processes Pigott often goes over the landscape in which a particular medtech company is competing, not only to understand competitors but also the potential liability risk. For example, when a particular type of product is the source of signiﬁcant litigation across an industry of competitors, even other innovators in the same ﬁeld who use different products to treat the same medical condition have to understand the litigation risk. The main risk comes from the presence and attention of experienced attorneys evaluating claims and they might take advantage of what they believe is applicable industry experience by targeting or bringing your company into the litigation. (continued on page 64)

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Illustration courtesy of Adobe Stoc k

PRECISION METAL COMPONENTS & ASSEMBLIES

Precision. Quality. Consistency. Each word accurately describes the parts we produce here at Hobson & Motzer. It should come as no surprise that they also describe the hundreds of talented associates who manufacture them every day. We are proud of all our associates. This month, we recognize some of the many women in manufacturing at Hobson & Motzer who help our company make a difference with each part we produce. They’re proud of their work and we’re proud of them! Visit hobsonmotzer.com to learn more about them in our October blog post.

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LAWSUIT PROTECTION

(continued from page 62)

This is why it is so important to make sure your company is set up to do what it takes to have a robust quality and regulatory process. You must take into account the likelihood a litigation lawyer will be looking at your processes and your ﬁles. "We look at, 'What are your procedures? How do you understand and process the adverse event data when it comes in?' The way companies report can also be a source of risk if it is carelessly worded, such as adopting language from a reporting source without qualifying properly about what the company knows at that time. Oftentimes people writing medical device reports are busy and focused on the priority of compliance and not necessarily thinking about how it might be viewed under the lens of litigation." Pigott talks through procedures and how various regulatory documents work so companies are prepared. That includes their sales representatives and clinical specialists, too. FDA regulatory approval can provide some liability protection, particularly where devices have Premarket Approval (PMA) status, but lawyers love it when they see there's a salesperson involved. "You can almost see them thinking, 'Sweet. Maybe I can get around that by alleging sales rep negligence.'" 2. Communications practices are key Pigott recalled a client that was trying to track down the source of some failures with an implantable device. A multidisciplinary crew from manufacturing, regulatory and other departments met to get to the bottom of the problem. "They're saying, 'Go back to your desk. Let's really think about what this could be.' So some guy

"I've personally experienced change in who I'm working with in these companies — how many more women, how many more people of diverse backgrounds, people of different abilities, people who come from all different categories." goes back, and he sits down, and he types up this email of, 'Maybe it's this. Maybe it's that. Maybe it's the other thing.' Just a total brain dump. It was brainstorming, none of which he had looked [into further]." 64

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Greenberg Traurig Shareholder Ginger Pigott www.medicaldesignandoutsourcing.com

LAWSUIT PROTECTION

Once the problem became the subject of a lawsuit, the email became a key piece of evidence for the plaintiffs. "Months and months later, when these documents get produced, this looks like a list of terrible, outrageous things that are existing on the manufacturing ﬂoor that were never actual facts." The lesson of the story is that medical device companies need to train their employees so that they're aware that their communications could become evidence in a litigation. It might even be years later, when the people who made the communications aren't around anymore or don't remember ever sending a particular email in the ﬁrst place. "What we don't want to do is tell companies, 'Don't ever communicate.' Because that doesn't help either. They have to be able to communicate," Pigott said. "What we do want to say is, 'When you communicate, you have to be aware, and you can avoid creating documents

that are actually not true, that are misleading or incomplete.'" Good etiquette in communications can help, too. Pigott recalled a CEO who was a wonderful leader who cared about his company and its products — but he also occasionally dropped an F-bomb in communications. "It's just a little piece, but it made a difference." 3. Diverse leadership goes a long way "Diverse teams are going to be more effective, more innovative," Pigott said. She's also found that juries respond better when they can see a company is run by a diverse group of people, not just a bunch of older white men. "I've personally experienced change in who I'm working with in these companies — how many more women, how many more people of diverse backgrounds, people of different abilities, people who come from all different categories."

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Women as a group have worse cardiac care outcomes than men, especially older women and Black women.

Photo via Adobe Stock

Medical Design & Outsourcing

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Jen ni fer J o n e s - M c M e a n s , A b bo t t 's d i v i s io n a l V P o f g l o bal cl in i ca l a f fa irs , ex pl a i ns h ow s m a ll ana to m i ca l d i f fe re n ce s co m p o u n d in ca rd ia c ca re . S E A N W H O O L EY A S S O C I AT E D ITO R

bbott Divisional VP of Global Clinical Affairs Jennifer Jones-McMeans has been looking to address gender biases in cardiovascular care, particularly for women suffering from coronary artery disease (CAD) who report poorer clinical outcomes and patient experience compared to their male counterparts. Earlier this year, Abbott’s vascular business released a supplement on gender and racial biases in cardiovascular care. According to the 2021 ACC/AHA/SCAI guidelines for coronary artery revascularization, women are less likely to receive cardiac catheterization and more likely to have worse outcomes than male counterparts. They’re also less likely to be recommended for cardiac catheterization compared to males, despite both parties having the same clinical guidelines, according to Abbott. Jones-McMeans offered her thoughts in a conversation that’s been edited by Medical Design & Outsourcing for space and clarity: MDO: If the clinical guidelines for both males and females are the same, what is behind the reduced likelihood of women receiving cardiac catheterization? Jones-McMeans: Numerous factors contribute to this reduced likelihood, but almost all can be traced back to one simple fact: Even though all sexes have the same basic heart anatomy, women with heart disease or cardiac events may present differently due to individual differences in physiology. In general, women have smaller coronary arteries and radial artery vessels, and they tend to have more comorbidities such as diabetes or hypertension. Furthermore, natural hormonal phases and fluctuations have significantly impacted women’s cardiovascular health. >>

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PATIENT BIASES

For instance, post-menopausal women are at greater risk of cardiac events. Postpartum women with adverse pregnancy outcomes are also at high risk for future cardiac issues. A difference of a few millimeters in artery size or a dip in estrogen levels may not seem signiﬁcant, but those small differences compound when you consider the changes in how symptoms present, how medications are distributed through the body, and how medical devices are sized and inserted. For example, women have worse outcomes than men in percutaneous coronary intervention (or receiving a stent to treat coronary artery disease), most likely due to inaccurate estimation of the size of a stent needed for a woman’s smaller artery. In this way, physiological differences can contribute to the misdiagnosis and treatment of a cardiac event or illness, which results in women not receiving proper cardiac care as often as men, especially for women more than 65 years of age.

Abbott Divisional VP of Global Clinical Affairs Jennifer JonesMcMeans 68

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MDO: The increased likelihood of worse outcomes for females compared to males — can that be correlated to fewer catheterizations, or are there other factors at play? Jones-McMeans: Multiple factors contribute to these outcomes, as discussed above. Misdiagnosis and ineffective treatment plans,

including the lack of catheterization when warranted, will impact the patient’s outcomes and overall mortality rates. Treatment strategies should be based on the patient’s unique clinical presentation and take into account physiological differences. For example, there is evidence that a high-risk woman with a non-ST-elevation myocardial infarction might need more invasive strategies than a woman at low risk. During cardiac events, women are also less likely than men to report the “chest pain” commonly associated with heart attacks. Failing to account for such differences and individual risk levels in treatment plans can result in poor patient outcomes. MDO: With the impact of socioeconomic status, education, and healthcare access on medical care, do those tie into the inequities purely between males and females? Jones-McMeans: Recent research has put data to a trend we have been seeing in the ﬁeld for some time: women who present with heart disease are less likely to receive the care they needed and have poorer outcomes overall. Percutaneous coronary intervention (PCI) is a good example. This procedure involves using a catheter to install a device called a stent to open blood vessels. When treating women with PCI, there are several additional considerations. In the words of Dr. Natalia Pinilla, “Women usually have smaller caliber blood vessels and more tortuosity. We are very cautious when doing heart interventions because there is a higher risk of complications; like blood vessel tears, due to vessel caliber and narrowing percentage overestimation. This is how procedural complications are higher in women compared to men.” Social determinants of health (SDoH) also play a role here and impact the treatment of patients as well as access to diagnostic tools and quality care. Today, it’s well established that patients from historically oppressed or disadvantaged backgrounds have less access to quality care, on average. We see evidence of that in the fact that women and Black patients are much less likely than white men to receive invasive revascularization when presenting with a blocked artery. (continued on page 70)

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PATIENT BIASES

(continued from page 68)

MDO: What are the actions that can be taken to increase access so that women can begin to receive the proper care in this area? Jones-McMeans: In addition to the adjustments to diagnostic measures and treatment plans mentioned above, we also need to think about how medical interventions are developed and tested today. This means diversifying clinical trials and ensuring they include women and people of color as participants. If a new cardiac stent is being evaluated, for instance, then the stent should be tested on men and women to ensure it is measured appropriately. After all, that’s not a one-size-ﬁts-all situation. As clinical trials become more diverse, we hope to see more nuance in the applications for medical interventions and devices for women and people of color presenting with cardiac disease.

MDO: Can you provide a status update on the Beyond Intervention initiative? Jones-McMeans: We launched the Beyond Intervention initiative in 2020 to analyze the vascular care landscape, adjust care to better meet the unique needs of diverse patient populations, and re-envision the future of vascular care. Although heart disease is the leading cause of death for women in the U.S., women account for just 38% of participants in cardiovascular clinical trials (despite being about 50.5% of the U.S. population). Our goal is to create a reality in which the percentage of those treated within clinical trials matches the percentage of those burdened with the disease. Our supplement, “Addressing Racial and Gender Bias in Cardiovascular Care: Why Improving Health Equity Is an Urgent Need for the Healthcare Community,” shines a light on many of the issues we’ve discussed, providing scientiﬁc data and experiential insight into the cardiac care

experience for women. For example, women have reported experiencing more challenges than men in their cardiac care, including access to care and good relationships with their physicians. Marginalizing women’s vascular health has clinical and economic consequences directly at odds with the ideals of the Institute for Healthcare Improvement’s “Triple Aim” initiative, which seeks to improve population health, improve patient experience and quality of care, and lower the cost of care. This supplement also proposes a solution to the challenges we’ve discussed: health equity. In particular, conscious inclusion in every element of the healthcare industry, from R&D to clinical research to trial participant demographics and primary care providers. Clinical trials need to be representative of women and other underrepresented groups. If we are to better understand and treat the diverse patient population of the U.S., we need diverse and inclusive researchers and caregivers.

2022

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Dawn Kentner Associate Director of Material Compliance & Science B. Braun Medical B.S. Mechanical Engineering Rutgers University Master of Business Administration Moravian University I always liked sketching things and building with Lego as a child, but my interest in engineering was really solidiﬁed by a wonderful Physics teacher I had in High School. She helped me see that there was more I could do with those childhood interests and really helped guide me toward science and engineering as a career. I have a Bachelor of Science degree in Mechanical Engineering and a Master of Business Administration degree. I’m also a certiﬁed and practicing Project Management Professional. I’ve been fortunate to hold positions in new product development, sustaining engineering, manufacturing and operations. My career has progressed from supporting projects to leading projects and then to leading people. That diverse background, the experiences I had, and the lessons learned in those varying roles continue to allow me to be successful today.

What first drew you to medtech? When did you first know you wanted to be in the industry? Honestly, there was no specific draw to medtech for me. I knew I wanted to design and develop products but never gave it much thought beyond that. I felt the first role I held at BBMI was a good fit for my interests and skill sets and applied for it. I got the job and my interest in medtech simply grew from there. What are some of the barriers women face in today’s medtech industry? I think one of the two biggest barriers is pervasiveness. There simply aren’t as many women in medtech, especially in leadership positions, as there are men. In fact, until just a few years ago, the team I led was predominately male. That’s changed now, but it’s not the case with all the engineering teams in our company. The second barrier is work-life balance and, more specifically, the priorities and choices that come with that. Balancing the demands of a career with those of being a mother are challenging at times. It is possible to be successful in both endeavors though. Describe your biggest leadership challenge. How did you conquer it or resolve it, or what was the outcome? I handled a situation poorly with a departing employee when I was a new manager. This person worked on my team for about a year and a half and decided to leave for a role that was very different than the current one. That role was more exciting, paid more and required this employee to move away from friends and family. I went into transition and succession planning mode almost immediately upon receiving the resignation but that wasn’t what the person needed. That person simply wanted a “congratulations” and a “good luck” from me. I was so focused on the tasks and ensuring the team would be okay because it was the first time someone had quit my team that I failed to consider what the person needed. I learned that leading is about people as much as it is about tasks. A successful leader knows how to effectively develop and serve people while also ensuring the work is done effectively and efficiently. For the rest of Dawn Kentner’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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2022

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Women in Medtech

Angelica Flores Production Control Planner Carl Stahl Sava Industries Industrial Engineer, Manufacturing & Automation Instituto Tecnologico Superior de Zapopan - Mexico

What first drew you to MedTech? It’s amazing to work with the ultrasmall mechanical cables we produce for the MedTech space because our components are helping people get treatment faster, get well faster, and are exposed to fewer surgical risk. It’s wonderful to participate in creating such tiny parts that make such a huge impact on the entire world. When did you first know you wanted to be in the industry? I have family who are medical doctors and chemists all who chose careers that help people. So, it was a natural urge to work with MedTech. I chose engineering because I wanted to produce the tools that help medical professionals help their patients. What are some of the barriers women face in today’s MedTech industry? I grew up in Mexico. Since childhood, the mentality was that engineers are largely men. Upon entering the workforce, after completing my degree, I recall being asked, “Are you going to be able to do this?” Today I don’t experience the inequality as much as when I was a student in Mexico. Today, on the merits of my contributions I am measured, and that fact has reduced the barriers dramatically. In your opinion, what more can be done to promote the greater participation of young women in the MedTech industry today? I think schools could do more to publicly advocate for young, female learners in general. When I was a student, I didn’t see a great deal advertising or campus signage that urged females to enter engineering. I think women make incredible engineers in MedTech, or any discipline. I would recommend high schools and colleges, around the world, plainly encourage women to see themselves as the engineering difference-makers I am grateful to have become. Why is it important for companies to be more inclusive and have more women in charge? For me, the emphasis on gender, as a defining principle, leads to missed opportunity. Diversity is important because one can easily overlook great talent in favor of the antiquated comforts had in assigning value to gender. When a company spots talent, over gender, its poised to succeed due to its commitment to diversity, not in spite of it. For the rest of Angelica Flores’ insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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Women in Medtech

Alethea Wieland President & COO, Founder Clinical Research Strategies, LLC Alethea is a life sciences veteran with 30+ years of experience in quality assurance, risk management, regulatory submissions & strategy, patient safety, privacy, corporate compliance, and clinical operations. She provides invaluable insight into various growth stages of biopharmaceutical and medtech companies. Her true passion is helping sponsors and research sites mitigate the risks of clinical trials and facilitating transparent, accountable sponsor-CRO partnerships. Alethea began her career in the early 1990’s in oncology research working for a governmentally funded adult cooperative group, and advanced through start-up organizations in the laboratory developed test (LDT) and biomarker space, and a class III medical device company in critical care. From the sponsor side, she moved to the services side in several contract research organizations (CROs) as an executive, and in 2018, founded her own ﬁrm to address signiﬁcant unmet needs of her clients.

What first drew you to medtech? When did you first know you wanted to be in the industry? I was first drawn to Medtech when I saw the rapid technological advances of electronic health records (EHR), clinical trial data collection systems, and the synergies that could be achieved with the streaming of continuous medtech data. I also became intrigued by signal detection with the deployment of AI and ML which could improve individual patient’s health. What projects are you most looking forward to? I am very proud of our association with special US defense programs and sponsors with unique breakthrough technologies that have the potential to improve acute and chronic conditions of our military and civilian populations. I am also gearing up for Federated Medicine initiatives that show promise to reduce obstacles to direct patient care and maintain patient privacy in a trusted infrastructure. Enabling real-time learning, including in silico, is here to stay. What are some of the barriers women face in today’s medtech industry? As a business owner and entrepreneur, I do not see many barriers today. I believe that when you demonstrate consistently in words and in action, your core competencies and compassion, and you make trust the fundamental building block of your business model, that you will attract those who appreciate these values. For our customers, we pay attention to the 80/20 rule, or concepts of the Pareto Principle. We also remain authentic in our relationships. These types of business attributes appeal to people who crave honesty and integrity which has nothing to do with being a woman. Why is it important for companies to be more inclusive and have more women in charge? I believe the real answer to this issue is growing women to command and earn (not demand) positions that are higher in the hierarchical pyramid of an organization. There is a key difference between command versus demand. No one respects a woman who demands her place. Competency speaks on its own merit. I believe over time women will achieve these leadership roles, however, I am more encouraged with them as entrepreneurs of their own enterprises simply because their success rates have been independently proven. For the rest of Alethea Wieland’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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2022

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Christine Trepanier Chief Technology Officer Confluent Medical Technologies B.S. Materials Engineering École Polytechnique of Montreal M.S. Biomedical Engineering École Polytechnique of Montreal Christine leads the Technology Strategy for Confluent Medical Technologies. She also manages the Nitinol Product Development, Technical Services, and Engineering teams, focusing on Materials and Components development. With over 25 years of experience with product development, optimization of the corrosion behavior, and biocompatibility of Nitinol, Christine is recognized by the industry and by the FDA as an expert in the field of surface engineering and corrosion of Nitinol. Christine joined NDC/Johnson & Johnson in 1997 and has held various positions over the years from process engineer to Director of Product Development to most recently, Senior Vice President of our Fremont site where she was responsible for Operations and Development. Christine holds a BS in Materials Engineering and an MS in Biomedical Engineering from École Polytechnique of Montreal.

What first drew you to medtech? When did you first know you wanted to be in this industry? Several aspects of medtech drew me to this discipline. First, the ability to use engineering concepts & creativity to develop medical devices and improve, save lives and have a positive impact on people’s health was a primary driver. Second, the broad range of disciplines from sales, R&D, design, testing, product development, regulatory and operations provides great opportunities for learning and growth. Finally, the broad range of products & applications, from neurovascular devices to sport medicine applications, metals, polymers and biomedical textiles, again provides opportunity for learning and growth. What are some of the barriers women face in today’s medtech industry? I believe some of the challenges women face in today’s industry is limiting our own growth, not having enough confidence in our potential and feeling like we do not belong or deserve a certain role or promotion. We need to push past these feelings and get more comfortable taking calculated risks. As leaders, our responsibility is to support and encourage women to challenge themselves as well as sometimes push them to develop new skills and confidence. In your opinion, what more can be done to promote greater participation of young women in the medtech industry today. Providing more visibility into the variety of roles offered in medtech and opportunities women can contribute to is key. Having mentors, both men and women, that can help support & inspire young women to enter the field would also be greatly beneficial. Why is it important for companies to be more inclusive and have more women in charge? Team diversity is a key factor in having a stronger and more well-rounded team. Having more women in lead roles fosters more creative solutions and discussions based on the diversity of background and personalities and lead to better outcomes in the end. I’ve also observed that more women in leading roles also serves as a catalyst to attract more women and more diverse talent in general. For the rest of Christine Trepanier’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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Women in Medtech

Janelle Swanson Business Unit Director QTS, a Cretex Medical company B.S. in Education and Business Management University of Wisconsin - River Falls Janelle Swanson, Business Unit Director for one of two business units at QTS, leads a cross-functional team of customer account managers, project engineers and quality coordinators. Janelle also manages relationships with strategic customers and is responsible for growing sales revenue, increasing market share and meeting business unit KPIs. Over the past seven years under Janelle’s leadership, her business unit’s sales have tripled. Janelle’s business development and executive sales leadership experience comes from a variety of industries. She spent seven years with St. Croix, a promotional products distributor, as Vice President of Sales & Marketing and in other sales management roles, leading both internal and external sales efforts. Janelle also has operational management experience from her time with UPS. Janelle has a bachelor’s degree in Education and Business Management with a minor in Coaching from University of Wisconsin-River Falls.

What first drew you to MedTech? When did you first know you wanted to be in the industry? I was looking to make a career change out of the printing industry, and into an industry where I could make a difference in the lives of others. One of my friends was in the MedTech industry at QTS and encouraged me to tour QTS to learn more about medical device outsourcing. I immediately felt a connection to the purpose, culture and passion of the organization and was fortunate to have an opportunity to join QTS a short time later. What are some of the barriers women face in today’s MedTech industry? In today’s MedTech industry women face inclusivity obstacles, a shortage of women role models and networking groups, and lack of career pathing. While I think these are improving, we still have a long way to go. In your opinion, what can be done to promote the greater participation of young women in the MedTech industry today? We need to do a better job of educating young women about career opportunities in the MedTech industry. MedTech companies, both large and small, should partner with school administrators and guidance counselors to offer programs that encourage young women to learn more about the diverse opportunities available in MedTech, including engineering, quality, business, and manufacturing roles. It is imperative that we pair students with women mentors in the industry and provide flexible learning opportunities during the school day for credit, summer programs and internships. Why is it important for companies to be more inclusive and have more women in charge? There are a lot of very intelligent and talented women that can improve and bring new perspectives to the MedTech industry. It is also important for young women to see other women in leadership positions and as role models in the industry. For the rest of Janelle Swanson’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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2022

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Women in Medtech

Treasa Springett President Donatelle Plastics Inc. Treasa Springett is president of Donatelle Plastics Inc. - a world-class contract manufacturer of medical components and devices, specializing in injection molding, LSR, precision machining, device assembly, and tool building. Springett joined Donatelle in 2004 and built an executive staff and Leadership Team that have continued to grow the business by developing and expanding processes, capabilities, and technologies, and offering these enhanced capabilities to our global Medical Device OEM customers. With over 55 years of experience, Donatelle manufactures products across many markets within this industry, including cardiac & vascular, neuromodulation, orthopedic, ophthalmic, diabetes & drug delivery, diagnostics, and surgical technology. Springett has more than 35 years of contract manufacturing industry experience in medical device product development and manufacturing; having served in many leadership roles spanning from engineering, sales, operations, and administrative functions. Prior to joining Donatelle, Springett was vice-president of manufacturing for a major contract manufacturer responsible for over 15 manufacturing sites and more than 2000 employees. A transformational business leader, Springett has lead cultural change and technology advancements that have become foundational in achieving organizational success at all levels and across multiple disciplines. Springett contributed to numerous technical papers and industry handbooks to further advancement of technology related to injection molding.

What first drew you to medtech? When did you first know you wanted to be in this industry? In my earlier years as a student, I never really thought about the MedTech industry. I went to school to be a mechanical engineer and was fortunate enough to get a summer job with a custom injection molder in a town where I attended college. Immediately I found my passion for engineering and manufacturing. Then in my first full-time engineering position, I was able to work on products that served the automotive and medical industry. The opportunity to work on life-changing and possibly life-sustaining medical devices became a compelling passion for me in my career. Having an opportunity to design and build products and devices that touch people at a point of care and can improve the quality of life for them is very rewarding work. I have been pursuing this passion ever since that first engineering position and today 100% of the focus for the company I lead is on the medical industry. Talk about your leadership skills. What is the most important lesson you have learned that has guided you in your career? Leading is all about people and communication. It is about creating an environment where people feel they are valued and can bring their best to the work they do each day. I learned early in my leadership career the most important work we do as leaders is working to create and maintain a culture that is purposeful and based on core values that are well communicated and expectations understood. As a leader, I work to help provide opportunities that allow our people to grow their skills and careers to reach their highest potential and career goals. Leading in a way that communicates company direction and setting clarity for expectations and what needs to be accomplished for the overall success of the organization. It is important the Leadership Team fully embraces the company values and culture expectations and then leads in that way for every decision and everything we do as leaders. Having clarity on goals and expectations (whether corporate or individual contributors), communicating them on a regular basis, and having key metrics aligned to expectations will provide clarity and feedback on the success in reaching the end goal. For the rest of Treasa Springett’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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Women in Medtech

Susan Shorter Quality Assurance, Scientific Group Leader III Eurofins Medical Device Testing B.S. Mathematics Cedar Crest College B.S. Chemistry Cedar Crest College M.S. Regulatory Affairs and Quality Assurance Temple University, Lewis Katz School of Pharmacy As Group Leader of the Medical Device Testing Quality Assurance Team/Unit, Susan oversees the quality and regulatory program for medical devices and combination products tested at the Lancaster site. Ms. Shorter has extensive experience in the quality field, specifically with pharmaceutical, medical device, instrument and software validation, vendor approval, and internal and external auditing. She has spent several years working in the contract laboratory compliance vector of the industry. Ms. Shorter holds undergraduate degrees in both chemistry and mathematics from Cedar Crest College and an M.S. in Regulatory Affairs and Quality Assurance from Temple University, Lewis Katz School of Pharmacy.

What first drew you to medtech? When did you first know you wanted to be in the industry? I have had a love for science since I was young. I have always wanted to know how things worked and why. It also helped that I had a mother who was a biologist and wanted to work in medicine. She never said “girls don’t do science” and encouraged me to explore many scientific fields. By the time I was in 7th grade, I knew a STEM career was for me. I took all of the advanced courses I could in chemistry and physics while in high school. I started college thinking I was going to be a chemical engineer but ended up with a dual major in chemistry and mathematics. Throughout my career, I knew I wanted to stay in quality, and when the opportunity came up to help develop a quality program for a new medical device business unit at Eurofins, I jumped. Working in medical devices inspired me to get my master’s degree. What are some of the barriers women face in today’s MedTech industry? Themselves. We bring our unconscious biases with us about women working in a career that is traditionally dominated by men. I believe women get too insecure about failing, feeling it is not culturally acceptable to be working in a man’s world, or feeling as though they have something to prove. I suggest that those interested in learning about Medtech, go for it. Seek out a mentor that can help you stay on the path of your Medtech career. Acknowledge your biases, and work to move beyond them. Describe your biggest leadership challenge. How did you conquer it or resolve it, or what was the outcome? My biggest challenge was my own self-doubt that people didn’t take me seriously when first moving into a leadership role. I made sure that I did my research to gain the knowledge that I may or may not have been lacking. I did confidence boosters, practiced my presentation skills, and built relationships with those I was working with. In the end, I am a better leader for all the work I put in at the beginning, and the relationships are still strong with the teams I work with. For the rest of Susan Shorter’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech 10 • 2022

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2022

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Women in Medtech

Desiree Williford Project Manager Flexan B.S. Operational Management Project Management Colorado Christian University My career in manufacturing began as a working mom while juggling going to college. I completed my Bachelor of Science degree in Operation Management Project Management at night while working during the day. I now have been in manufacturing for over 20 years, 10 of those with Medtech companies. I have worked hard to achieve a wealth of knowledge for business, operations, and manufacturing holding roles that include supply chain management, project management, and operation management. Today I am a Project Manager for Flexan, leading and managing large projects that bring in new business and manufacturing product lines. Most of my time in Medtech has been spent in plastic injection molding, as such I am RJG master molder I certiﬁed. The most rewarding aspect of being in Medtech is seeing how the products impact lives on a daily basis and knowing that I have had a part in that. I am a mother of three fantastic adult to near adult children. When I am not working, I enjoy spending time with my family and traveling to new places.

What first drew you to medtech? When did you first know you wanted to be in the industry? The beginning years of my career were spent working in the aerospace industry, but my passion has always been to help others and make an impact in their lives. The medtech industry has allowed me to fulfill that purpose. I went to a doctor appointment shortly after starting at my first medtech company, when I scanned the room and saw the med devices in use that my team had created, I knew then that this is where I belonged. The feeling of accomplishment I get every day in this career is one that is hard to supersede. To this day, anytime I am in a medical facility I scan the room to see what I recognize, to see how the work we do in medtech truly effects people every day! What are some of the barriers women face in today’s medtech industry? I think one of the barriers women face today in the medtech industry, not unlike the greater manufacturing industry, is representation at all levels of management, particularly at the senior and executive levels. The mentorship and example that is provided by having women in senior and executive leadership roles has a huge impact on my career. Once I understood it was possible, I began to adjust my career development towards those goals. In your opinion, what more can be done to promote the greater participation of young women in the medtech industry today? Medtech is a largely unknown field for women, I think there are two critical things that can help include the next generation of women in this wonderful career. First, we should provide more mentorship and sponsorship programs for women in medtech companies. Mentorship provides great opportunity for young women ask advice and seek counsel as they become more confident in their skills, this was a big part of my career growth. Sponsorship at the executive level can help drive a culture that can guide more women to pursue a career in medtech. Second, we need more general communication around the opportunities medtech has to offer young women looking to start their career. For the rest of Desiree Williford’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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Women in Medtech

Aditi Subramanian Strategic Business Unit Manager - Healthcare FLEXcon Company, Inc. B.S. Biomedical Engineering North Carolina State University Masters in Biomedical Engineering University of Connecticut Masters in Business Administration Duke University Aditi has over 12 years of experience in the Adhesives and Healthcare Industry, starting her career at Henkel with increased responsibilities to Global Product Manager, followed by different roles in Strategic Marketing and Global Product Management. Being born in India and immigrating to the US at a young age, education was of utmost importance, and after her undergraduate degree in Biomedical Engineering from NC State, Aditi worked full time while pursuing her M.Sc. in Biomedical Engineering from the University of Connecticut and an MBA in Marketing and Strategy from Duke University. Since Joining FLEXcon, Aditi is responsible for leading the development of a Growth Strategy for FLEXcon within the Healthcare market. She works closely with Product Management, Sales, R&D and Marketing Communications to position FLEXcon for the future.

What first drew you to medtech? When did you first know you wanted to be in the industry? I knew I wanted to be in medtech in college when I discovered the major of biomedical engineering. Fusing together math, engineering, biology, and material science really intrigued me… though it was not easy. NC State placed an emphasis on problem-solving design, seeking out current problems in healthcare, and finding the true pain points to solve for. I love this concept, and the process, which is how I really knew that this was the right industry for me. What projects, past or present, have made you love what you do? I am passionate about problem-solving design, no matter if it’s in blood pressure devices or endoscopy. I love understanding the pain points, the “why” and then blending the technical needs with the business goals to deliver innovative solutions. In your opinion, what more can be done to promote the greater participation of young women in the medtech industry today? Recruiting and networking! It’s important for companies and universities to highlight the possibilities of a career in medtech and to provide career roadmaps and ladders forward. Where a person starts is not where they will end. There is no straight line in one’s career, so it’s also important to highlight capabilities in various possible roles and departments to help women get a better vision of their own path forward. Why is it important for companies to be more inclusive and have more women in charge? I truly believe that diversity only makes for better products, experiences, and outcomes. Different walks of life and views allow us to think outside the box and create more innovative products and solutions. It’s important to be more inclusive because ultimately all our customers are diverse - we don’t sell to one type of customer so why would we only have one type of employee? Bottom line is diversity and inclusivity only help the bottom line. For the rest of Aditi Subramanian’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech www.medicaldesignandoutsourcing.com

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Medical Design & Outsourcing

2022

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Women in Medtech

Kristin Backus Account Management Hobson & Motzer B.S. Psychology Post University Kristin Backus has been in manufacturing for 16 years. She began as a shipping and receiving clerk at a special process facility and worked her way up to Quality Manager. From there, Kristin took on a role that was more production focused in a CNC machine shop. Last year, she joined the team at Hobson & Motzer in an Account Management position–that she “absolutely loves.” She received her B.S. in psychology, summa cum laude, as an adult learner just last year from Post University.

What first drew you to medtech? When did you first know you wanted to be in the industry? Prior to working at Hobson & Motzer, my experience was centered in the aerospace world. I’ve learned there are many similarities between the industries from a production perspective. The same types of machines are used, and many of the same standards and regulations apply to the production of both products. Personally, the difference I’ve noticed is that it feels great to be a part of something that truly helps save lives every single day. Going home at the end of the day knowing you helped get lifesaving products into doctors’ hands is something I take pride in. I really didn’t know I wanted to be in this industry until I got here, and I am so grateful to be a part of it. What are some of the barriers women face in today’s medtech industry? Throughout my career, I haven’t felt that I’ve faced barriers because I am a woman. I imagine I may be in the minority of women that feel this way, but I think an individual’s drive is what will lead them to be successful, regardless of gender. For example, I advanced from a shipping clerk to quality manager in a multimillion-dollar company in under five years when I was just 28 years old. While I was only the second female in 74 years to hold the position, I believe I was given the opportunity because they saw my drive and determination. Fast forward to now … my experience working at Hobson & Motzer has been fantastic and includes complete inclusion and equality. I feel that same respect, equality, and inclusion when working with our customers. Why is it important for companies to be more inclusive and have more women in charge? Diversity within a company is so important. Many new ideas are brought to the table from people with different backgrounds and views. A company will not be successful, and progress cannot be made with like-minded people being the only ones making decisions. Women have experiences through their lives that are different from men, and different perspectives should be embraced. For the rest of Kristin Backus’ insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

Medical Design & Outsourcing

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Women in Medtech

Margaret Carthy Senior Vice President, Quality & Regulatory Aﬀairs Integer B.S. Information Technology Dublin City University As part of Integer’s Executive Leadership Team, Margaret is responsible for leading quality assurance, regulatory and clinical affairs and playing a primary role in driving a culture of quality at Integer. Under Margaret’s leadership, Integer is focused on maintaining a quality system that puts the patients served by Integer’s products ﬁrst in all decisions and actions. She reports directly to the CEO, leading an organization that collaborates crossfunctionally to develop and execute a strategy in accordance with the latest FDA, applicable ISO, and other international requirements. Margaret has been with Integer since 2004 serving in a variety of quality and regulatory roles. Her in-depth expertise extends to international quality and regulatory laws and standards in North and South America, Asia, Australia, and across Europe. Prior to her appointment to lead Integer’s overall quality efforts, she was Vice President of Quality and Regulatory for the Cardio & Vascular product category. Before joining Integer, Margaret was a Quality & Regulatory Leader for the European Region at Sola International (now Carl Zeiss).

What first drew you to MedTech? When did you first know you wanted to be in the industry? I was fortunate in that when I finished graduate school there was a large factory within a few miles of my home that was part of a multinational medical device manufacturing company. I obtained a junior position in the Technical Services group whose objective was to improve the manufacturing yield of the polymer lenses through experimentation with the chemistry. The work was varied, interesting and challenging, and I received excellent training. I was lucky in those first years to be involved in many continuous improvement and automation projects and process improvements. My move into Quality seemed a natural one, where I could help ensure improvements were properly embedded into procedures and systems, ultimately ensuring compliance while meeting business and customer needs. It was in this capacity that I learned the importance of the products the MedTech industry brings to the marketplace and the corresponding significance of effective and efficient Quality systems to the business and the end patient. What are some of the barriers women face in today’s MedTech industry? I believe that unconscious bias is one of the largest barriers women face in the MedTech industry today. Education across all levels of organizations is the first step in removing the gender bias. We need to think more creatively to retain women in the industry. At Integer, I’m proud to be part of the steering committee for our Athena Alliance Employee Resource Group (ERG), which focuses on gender diversity and inclusion, to help remove these barriers. Our focused workstreams are structured to bring awareness to gender diversity, inclusion, and its benefits. This in turn helps develop female talent by addressing gender gaps while supporting and connecting women within Integer and the communities where we live and work globally. Why is it important for companies to be more inclusive and have more women in charge? There are different dynamics between male-majority groups and more diverse groups. With more diverse and inclusive groups, I believe there is less likelihood of the dominance of an individual overpowering the quality of an argument. Less groupthink and more wide-ranging discussion lead to more options being considered and better decisions, which is ultimately better for business. For the rest of Margaret Carthy’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech www.medicaldesignandoutsourcing.com

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Medical Design & Outsourcing

2022

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Women in Medtech

Donna M. Bibber CEO Isometric Micro Molding, Inc. Bachelor of Science in Plastics Engineering The University of Massachusetts-Lowell 1988 Donna Bibber has assisted in over 1,000 micro molding and assembly device programs. Ms. Bibber’s plastics engineering background, expertise and unique problem-solving skills earned her an excellent reputation and is recognized nationally and internationally for her work in micro manufacturing. Her expertise in intraocular implants, bioresorbable polymers, and PEEK implants gave rise to many new devices commercially available today.

Is there a perception problem that makes women less likely to pursue medtech careers? If so, how can we change that? I would say that is not the case at all. It’s all about work ethic and networking with suppliers and customers of your industry. If we believe in ourselves and work hard, there’s nothing that can’t be accomplished. My Dad, now 87 years old, told me when I started my ﬁrst job scooping ice cream at age 15, there were two ways to be noticed: 1. 2.

Come in late, submit shoddy work, do the minimum, and leave before the boss. Arrive early before the boss and leave after the boss, work hard, be vocal for what you believe is important, and excel in the most menial task asked of me.

He would say, “which way do you want to be noticed?” This still rings true for me today. What are some of the barriers women face in today’s medtech industry, if any? I would be lying if I said there are no barriers, and everything will go smoothly. We encounter barriers every day. What I learned early in my career is to deal with barriers the best way I knew how - with facts and a good bit of humor. I found the best way to address this was to be educated on the subject at hand, and no matter what the circumstance, be genuine and transparent with responses. If you don’t know something, it’s okay to say, “I don’t know”, but ﬁnd the answer and circle back to whomever asked. What career advice would you give to your younger self? Don’t take life so seriously. Expand your horizons by injecting fun into your daily life, including your work life. Humor and humility are fantastic ways to show both integrity and genuineness. For the rest of Donna M. Bibber’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

Medical Design & Outsourcing

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Women in Medtech

Venkata Pokkuluri Engineering Manager Johnson Matthey Bachelor of Technology in Materials and Metallurgical Engineering National Institute of Technology, Warangal, India M.S. Materials Science and Engineering Indian Institute of Technology, Kanpur, India M.S. Engineering San Jose State University As the engineering manager of Johnson Matthey Medical Device Components (San Jose, CA), Venkata Pokkuluri leads the team with the mission of innovation and growth in medical device components. Under her strategic guidance, her team collaborates with customers and operations to take an idea from concept to commercialization. With her expertise in Materials Science, lean manufacturing, and failure analysis, she provides technical support in manufacturing of Nitinol medical components. Venkata brings more than 12 years of experience in the development of medical device components. In her previous role as Operations Manager, Venkata built and optimized plant operations to deliver products to market on time with speciﬁc focus on safety and quality. Venkata holds Master’s degree in Materials Science and engineering and has Lean Six Sigma Black Belt certiﬁcation.

What first drew you to medtech? When did you first know you wanted to be in the industry? My educational background is Metallurgical and Materials Science engineering. Materials and their structures can be altered to obtain desired shape, properties, etc. My exposure to bio-compatible and implantable materials in graduate school inspired me and drove me to look for opportunities in the medical field. The opportunity presented with JM-MDC’s Nitinol facility was a gateway to my technical and career aspirations. Nitinol is a fascinating material to work with due to its unique shape memory and super-elastic properties and is used in numerous biomedical devices such as delivery catheters, stents, orthopedic, orthodontic applications etc. I am fortunate to be able to contribute to the technology that enriches people’s lives. The work we do, the products we make truly saves or enhances people’s lives and there is no greater satisfaction than that. Why is it important for companies to be more inclusive and have more women in charge? Coming from India with a degree in Materials Science and Engineering, inclusion and diversity is close to my heart. I truly believe being inclusive means all of us feel valued for our unique characteristics and feel a sense of belonging. At Johnson Matthey, an inclusive culture is integral to our values and ambitions for the future. I am a firm believer in leveraging Diversity and Inclusion. Women bring unique perspective to the table that will enhance organizational excellence as it stimulates productivity and growth. In my 12-year career with Johnson Matthey, I am very fortunate to have witnessed numerous women lead projects that went on to be more successful in terms of safety, quality, and efficiency. I also had an incredible opportunity to lead and mentor many young women engineers through JM Graduate rotation program that went on to excel in their careers and truly contributed to business growth. For the rest of Venkata Pokkuluri’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech 10 • 2022

Medical Design & Outsourcing

2022

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Women in Medtech

Cristina Marie Nolan Project Engineer Medbio LLC B.S. Biological Sciences University at Buffalo M.S. Materials Design and Innovation University at Buffalo Cristina Nolan is a project engineer at Medbio LLC, an injection molding facility focused on medical device manufacturing. Skilled in project management, problem solving, and Lean Six Sigma, she enjoys working with multifaceted teams in order to complete projects. Cristina worked her way up from engineering intern to project engineer at Medbio LLC and spent time working in every department of the company to understand each facet of the company. Cristina is a Lean Six Sigma Green Belt, a certified ISO 13485:2016 Internal Auditor, and has completed University at Buffalo’s Project Management Certificate program. Her coworkers describe her as a driven, intelligent, quick learner with a bright future ahead of her. Outside of work, Cristina enjoys traveling, skiing, and hiking with her husband and German Shepherd.

What first drew you to medtech? When did you first know you wanted to be in the industry? I ended up in medtech by trial and error. In high school engineering intimidated me, and my physics class was interesting, but challenging. When I went to college, I chose to major in biology because I wanted to work in the medical field. After working in both a hospital and a medical research environment, I realized that biology was not the path for me. Around the same time, I met my husband who was studying industrial engineering. When we went to the library to study together, I discovered that I enjoyed learning about engineering more than biology. When I finally came to the realization that I should be studying engineering, it was too late to change majors. I ended up graduating with a B.S. in Biological Sciences, but I quickly applied to a master’s program for materials science. Every other student in my class had engineering backgrounds, but I was able to use my biological background and apply it to materials engineering. In 2017, I presented my master’s thesis on 3D printing hydrogels that could replace worn cartilage. This blending of the medical and engineering fields seemed to be the perfect fit for me, and fortunately I found the perfect internship at Medbio. I was hired as an engineering intern in 2017, and I became engrossed in manufacturing medical devices. I have been working for Medbio ever since, and I have advanced from an engineering intern to a project engineer. In your opinion, what more can be done to promote the greater participation of young women in the medtech industry today? EXPOSURE! My company, Medbio, does a wonderful job of bringing both high school and college interns in throughout the year. I wish I would have had the opportunity to at least tour a manufacturing facility when I was in high school just to see the different types of careers it can lead to. Even if students are not interested in manufacturing, they should at least be exposed to it. It is such a massive industry, and I think most people simply think of manufacturing as Ford’s Model T assembly line. In reality, it is so much more. I hope every manufacturing facility opens its doors the way Medbio does and sends their employees to career days to speak at high schools and colleges about working in manufacturing. More students would enter manufacturing if they just knew what it was. For the rest of Cristina Marie Nolan’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

Medical Design & Outsourcing

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Women in Medtech

Cheryl Norder Vice President of Quality Phillips-Medisize B.A. Business Management Concordia University Master of Science in Management Cardinal Stritch University As Vice President of Quality for PhillipsMedisize, a Molex company, Cheryl oversees the 900-person global quality organization, which spans the Pharma, Med-Tech, Regulated Commercial Products and Commercial business sectors. Cheryl has over 28 years of Medical Device and Pharmaceutical experience and has been with Phillips-Medisize since 1999 in various roles, from Quality Manager to her current position. Cheryl has experience in ISO 9000, 13485, cFDA, MHRA, MHLW, FDA QSR and FDA 210/211. Prior to joining the company, she was a Quality Manager and Validation Manager for PCI in Rockford, Illinois.

What first drew you to MedTech? When did you first know you wanted to be in the industry? I have always gravitated to healthcare starting with my early college choice to study Biology, Chemistry and Psychology with a path into healthcare. My original plans were to work in laboratory research sciences; however, my career path took me into management within the industry with the devoted support of my mentors. What are some of the barriers women face in today’s MedTech industry? Women are still the minority in executive leadership within our industry, with less than 25% in 2021. We need to continue to understand the barriers and work-life balance needs as well as improve development programs to encourage young women to seek advancement allowing them to contribute their full value and embrace the challenge. Talk about your leadership skills. What is the most important lesson you have learned that has guided you in your career? Always be flexible, keep an open mind to changes. The cliché “the only thing constant is change” is true in our industry. Technology and learning to move quickly as well as knowing that we must adapt our skills to match the people we are managing. I strive to lead by example, to always be inclusive and seek the team’s input. Collaboration and diversity are what makes a company successful. In your opinion, what more can be done to promote the greater participation of young women in the MedTech industry today? There are great organizations that support young women in STEAM and into our industry. Working within our organizations to ensure that young women have strong mentors that create an environment where they feel encouraged and supported as they navigate their careers. Mentors come from all areas of the business and do not need to just be women but advocates of young women and career growth. Get involved and allow young women to see you as a positive role model. For the rest of Cheryl Norder’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech www.medicaldesignandoutsourcing.com

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Medical Design & Outsourcing

2022

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Women in Medtech

Laura Beringer, Ph.D. Toxicologist/Principal Biocompatibility Scientist PSN Labs B.S. Biomedical Engineering • M.S. Materials Science and Engineering • Ph.D. Materials Science and Engineering with an emphasis in Tissue Engineering and Biomaterials Drexel University

What first drew you to medtech? When did you first know you wanted to be in the industry? I have always wanted to be in a career which helped people and both my parents were in the medical/pharmaceutical space, so from a very early age I saw the impact they made. My dad worked within the rare genetic disease space and interfacing with some of those families devastated by some of these diseases left a huge impact on me. During my undergraduate days at Drexel, I learned there was a field that combines biology with engineering in order to help people, whether that be in the form of medical devices, targeted drug delivery, personalized pharmaceuticals etc. Medtech is a space where I can bring my knowledge about polymers, biology, and toxicology together to ensure medical devices are safe for patients.

Laura Beringer, Ph.D., is a passionate scientist who loves combining her expertise in biology, chemistry, and materials science in order to help ensure medical devices are biologically safe and meet patient needs. She discovered this passion at a young age under the mentorship of her parents, who were both involved in the medical industry. In graduate school she decided that working within the biomedical industry was her calling and had an amazing advisor who showed her having both a scientiﬁc career and a family was achievable as a woman. When Laura isn’t at work, her two sons Alex and Ben, and her husband Carl keep her on the go! Laura loves spending time with her family, watching and reading horror books, and horseback riding in her free time.

In your opinion, what more can be done to promote the greater participation of young women in the medtech industry today? One of the biggest keys would be having senior leadership women role models to look up to and to emulate. Women with a passion to teach the younger generation some techniques and discuss some of the challenges honestly. I would say if there is a woman that ﬁts this proﬁle as you grow into your career, make sure you learn and watch from her. I also hope that doing features like this helps inspire young women starting out in their education or career to pursue careers in the industry. Why is it important for companies to be more inclusive and have more women in charge? Women and men tend to tackle problems differently and communicate them from different points of view. It’s so important to be inclusive of all of those views in order to get the best product made, have the best test plans created, ensure that all avenues have been visited. The idea that “this is the way we always have done it” is still accepted in a lot of the medtech space which just goes to show that we need new opinions, new recommendations, new perspectives. Being inclusive of everyone allows you to reach new goals, be innovative, and solve some of the toughest medical device problems. Having women in senior leadership positions can also help ensure that some of the cultural issues that are present throughout the industry start to shift into positive directions. For the rest of Laura Beringer’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

Medical Design & Outsourcing

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Women in Medtech

Danielle Wingerter Lightspeed Engineering Manager Resonetics B.S. Biology University of Kentucky Master’s in Biomedical & Medical Engineering Cleveland State University Danielle Wingerter is a Lightspeed Engineering Manager for Resonetics, a leader in advanced engineering, prototyping, and manufacturing solutions. Danielle joined Resonetics in 2018 as an Application Development Engineer where she developed laser cutting and welding processes from initial prototypes to large scale manufacturing. She has worked her way up to Lightspeed Engineering Manager, managing the Lightspeed team focused on laser cutting and welding process development. Danielle’s focus is on innovation and speed, she is driven to lead her team to develop prototypes that efﬁciently translate to manufacturing solutions which enable customers to develop and launch products in record time. Danielle received a Bachelor of Science in Biology from the University of Kentucky and has a Master’s in Biomedical & Medical Engineering from Cleveland State University. She is also Lean Six Sigma Green Belt certiﬁed from Purdue University.

What first drew you to medtech? When did you first know you wanted to be in the industry? I originally went to college on a pre-veterinary track. I started doing undergraduate research in a microbiology lab on campus and fell in love with the structure of research. I loved setting up an experiment where I had no idea what the outcome would be. It kept me guessing, engaged, and wanting to know more. As I went through my classes I found I had a passion for mathematics and engineering. With some guidance from my college advisor, I ended up taking all engineering classes my senior year and applied to a master’s program for biomedical engineering. This was definitely the right choice for me. I truly enjoyed my grad school classes and am ultimately happy in the career path I am on! What are some of the barriers women face in today’s medtech industry? I think the biggest barrier for women in the medtech industry and STEM in general, is the number of women candidates for engineering or leadership positions. There still are not as many of us out there interviewing for these positions, which means there aren’t as many of us in the field. The only way to change this is to expose more young women and children to the options of STEM career paths. I think seeing someone like you in a role you want to be in helps make that goal feel more achievable. I’d love to see more female leadership within my own company and have that mentorship on my career path. I hope one day I can also be that mentor for other young female engineers/managers. Why is it important for companies to be more inclusive and have more women in charge? Studies show that a more diverse workplace leads to more innovation and ultimately better financial performance. This makes sense to me, the more diverse your work force is the more diverse the solutions for problems are going to be. In my experience working with other women, they tend to be more eager to jump into projects, more proactive with solving problems, and more likely to listen to other ideas. I think adding this perspective or any new perspective is a great addition to any company. For the rest of Danielle Wingerter’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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Medical Design & Outsourcing

2022

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Women in Medtech

Nidhi Agrawal Project Manager Tegra Medical Masters Degree, Industrial Engineering Northeastern University I am Nidhi, born and brought up in India. I moved to the United States four years ago to pursue my masters in industrial engineering from Northeastern University. Boston has been my home for the last four years and it has a special place in my heart. I have always liked to explore more opportunities and my keen interest in travelling that have played a major role in making the decision to move to US leaving my family behind. I have always been fascinated by the way manufacturing facilities function and various kind of machinery; this made me pursue a career in industrial engineering. Working for a medical device manufacturer is even more fascinating, when you are manufacturing products that are saving other people’s lives.

What drew you to medtech? When did you first know you wanted to be in the industry? I joined Tegra Medical as a Quality engineer intern. That was my very first job. It has been an interesting and wonderful experience since day one. As I learned more and more about the applications of the products we make at Tegra Medical, it drew my interest and then I just knew that I want to be in this industry and make it a part of my life. What are some of the barriers women face in today’s medtech industry? As it is very evident, the medtech industry is still male-dominant. I come from a culture where women are told that they don’t have a place in manufacturing industries, it is a job that only men can do. But here in the US, I have noticed that we are heading towards the right direction where people don’t look at gender when they are reviewing qualifications and skills to hire someone for a job. If 100 percent of the population follows this, we will make a huge difference in the medtech industry in the coming years. In your opinion, what more can be done to promote the greater participation of young women in medtech industry? Hiring a person by just looking at their qualifications and not the gender would be a start. Organizations also need to offer training and other opportunities for young women that can give them more exposure and build their confidence. Equal promotional and leadership opportunities should be given to women if they qualify for it based on their skills and knowledge. Equal rights are not enough; we need to overcome the inequality that exists in our minds. Why is it important for companies to be more inclusive and have more women in charge? Gender diversity in a workplace always adds more perspective and ideas to fulfill the needs of a company. In all developed countries, the educational levels achieved by women are equal to men. So if companies are not inclusive, they are losing the potential value of knowledge, skills, and experience that women have. Thus, a mixed-gender workplace can utilize all the talent available to try to get more benefits in all terms. For the rest of Nidhi Agrawal’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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Medical Design & Outsourcing – WOMEN IN MEDTECH 2022

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Maureen Mulvihill, Actuated Medical

Gabi Niederauer, Bluegrass Vascular Technologies