Medical Design & Outsourcing — WOMEN IN MEDTECH 2021 by WTWH Media LLC

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: INSIDnE in Womeeering Engin

omen in

Medtech INSULET CEO SHACEY PETROVIC IS PUMPED UP TO LAUNCH OMNIPOD 5 BOSTON SCIENTIFIC’S MEGHAN SCANLON FORECASTS THE FUTURE OF UROLOGY

How

Hologic made a major

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10 • 2021

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WOMEN IN MEDTECH | WOMEN IN ENGINEERING | CONTENTS

Medical Design & OUTSOURCING

WOMEN IN MEDTECH MANUFACTURING ..................46 Marie Ottum, TE Connectivity ..................................................................... 46

The pandemic exposed healthcare inequities near and far ...................................................50 To address disparities in COVID-19 testing, treatment and vaccination, we must ﬁrst understand them.

Women in medtech leadership: Small gain, big opportunity ...........................................54 The prevalence of women in corporate leadership positions within the medical device industry remains low, and the rate of increase is stagnant despite new initiatives to increase diversity in the industry.

Women researchers receive a fraction of funding from the world’s biggest medtech companies .............................60 The gender divide in medtech extends beyond leadership and into funding for investigational studies by U.S. physicians.

3M - Audrey A. Sherman .................................................63 Agillis Consulting Group - Shannon Hoste ......................64 Argon Medical Devices - Sarah Ehrlich, Sophie Marcoux ....65/66 Avient Corp. - Lindsay Fleming .......................................67 Berry Global - Svetlana Contrada ....................................68 Celanese - Laura Brand ...................................................69 CPC Worldwide - Kira Switalla ........................................70 Cretex Medical - Angie Hillyard ......................................71 Euroﬁns Medical Device Testing - Liz Sydnor .................72 Flex - Jennifer Samproni .................................................73 Flexan - Gabriela Jaquinto ..............................................74 Hobson & Motzer - Kim Gross ........................................75 Integer - Jennifer Bolt .....................................................76 Isometric Micro Molding - Donna M. Bibber...................77 Nordson MEDICAL - Shannon Diamond .........................78 Porex - Yuan Chang ........................................................79 Resonetics - Shawna Pearson ..........................................80 Steris - Betty Howard, Kimberly Mollohan.................. 81/82 TE Medical - Madhulika (Maddy) Srikanth ........................83 Teamvantage - Kelly L. Stichter .......................................84 6

DESIGN WORLD | Medical Design & Outsourcing

10 • 2021

Accumold - Angela Williams ............................................ 158 Advantech - Shannon Steward ........................................ 159 CentroMotion - Miriam Prieto ......................................... 160 Digi-Key - Autumn Richardson ........................................ 161 Dodge Mechanical Power Transmission Company Inc. - Toha Poveda ................... 162 ECIA - Tobi Cornell, Juliet Rene Fajardo, Teri Ivaniszyn .................................................163-165 Encoder Products Company - Sarah Walter ................... 166 GE Digital - Sowjanya Chalamkuri, Kristen Sanderson ............................... 167/168 Honeywell Process Solutions - Alicia Kempf ................. 169 igus - Nicole Lang ............................................................ 170 Master Electronics - Jennifer Paukert ............................. 171 maxon - Virginie Mialane ................................................. 172 Microchip Technology - Ingrid Tay .................................. 173 Mitsubishi Electric Automation - Agnieszka Zupancic .....174 Phoenix Contact - Melissa Sommer ................................ 175 Porex - Denisa Peshkatari ................................................ 176 Quantum Devices - Samantha Ludt ................................ 177 Sager Electronics - Lisa Auffrey....................................... 178 Siemens Digital Industries Software Laura Allison, Amanda Beaton................... 179/180 Wolfspeed - Yueying Liu .................................................. 181 Würth Indsutry North America - Sandy Emry................ 182

www.medicaldesignandoutsourcing.com OCTOBER 2021

INSIDE:in Womenring Enginee www.designworldonline.com

October 2021

omen in

Medtech

omen in engineering

INSULET CEO SHACEY PETROVIC IS PUMPED UP TO LAUNCH OMNIPOD 5 BOSTON SCIENTIFIC’S MEGHAN SCANLON FORECASTS THE FUTURE OF UROLOGY

2021

How

Hologic

: insidein

made a major Hologic CFO Karleen Oberton reﬂects on key decisions and turning points of the COVID-19 pandemic.

Women Medtech

ign G DesURCIN Medical & OUTSO

COVER_WIE 10-21_FINAL.indd 1

Cover art courtesy of Adobe Stock

PROFILES IN THE LIST: Sandra Saldana, Alva Health ....................................................................... 42 Allisa Song, Nanodropper ........................................................................... 44

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10 WOMEN-LED MEDTECH STARTUPS ........................42

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PROFILES IN THE LIST: Karleen Oberton, Hologic ........................................................................... 24 Shacey Petrovic, Insulet ............................................................................... 32 Meghan Scanlon, Boston Scientiﬁc ............................................................. 36

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200 WOMEN IN EXECUTIVE ROLES .............................15

Ella Atkins ........................................................................... 86 Kara Branch ........................................................................ 94 Amanda French .................................................................. 98 Caitlin Kalinoswki.............................................................. 104 Hester Anderiesen Le Riche ............................................. 112 Maureen Lincoln ............................................................... 118 Danielle Lower .................................................................. 124 Sibongile Manthata .......................................................... 130 Karen Panetta ................................................................... 136 Jill Tietjen ......................................................................... 144 Dr. Amy Wang .................................................................. 152

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Women in executive leadership roles barely ticks up in 2021

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HERE’S WHAT WE SEE: .................................................12

10/15/21 10:31 AM

Ad Index ......................................................................184

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omen in

Medtech 2021

HERE’S WHAT WE SEE

Rate of women in executive leadership roles barely ticks up in 2021 There is still a long way to go to close the gender leadership gap in the medical device industry, but hope is on the horizon.

omen still account for less than a quarter of all executive leadership roles within the biggest medical device companies in the world, according to our annual analysis in this Women in Medtech edition of Medical Design & Outsourcing. Just 21% of the executives in the top 100 medical device companies are women — up one percentage point from last year — and the number of those companies with a female CEO remains unchanged at four. For comparison, about 40% of the 660,000 employees in the medical equipment and supplies manufacturing industry are women, according to the U.S. Bureau of Labor Statistics. “Ultimately, organizations must make a top-down commitment to meaningful change,” said AdvaMed Chief Financial Ofﬁcer and Chief Operating Ofﬁcer Jen Brearey, who’s also executive director of the association’s inclusion diversity programs. “They must be willing to invest both time and resources into implementing best practices, particularly those with regards to awareness, recruitment, retention and shared commitment.”

The industry’s gender disparity extends beyond the executive ranks, as we explore in our analysis of research payments to physicians from the top 20 medtech companies in 2020. About one-tenth of those $3.9 million worth of payments went to women physicians, who represented about 7% of all recipients. This edition also takes a deeper look at leadership roles with the top 100 medtech companies, and features women executives at some of medtech’s largest companies — Insulet, Hologic and Boston Scientific — who are making big moves, as well as startup founders working on groundbreaking innovations. In 2019, our first analysis of executive roles in the medtech industry found that 18% of executives were women, a figure that increased to 20% in 2020 and 21% this year. That’s progress, but slow progress with so much at stake. “The medtech workforce must mirror the patients we serve,” Brearey said, “if we are going to succeed in delivering innovative technology to populations who need it.”

"Ultimately, organizations must make a topdown commitment to meaningful change. They must be willing to invest both time and resources into implementing best practices, particularly those with regards to awareness, recruitment, retention and shared commitment." Ethnically diverse women make up 51% of the industry’s entry-level female workforce, but only 15% of C-suite women, Brearey said. “We’ve found that looking at gender alone doesn’t help us identify and address the challenges and that we must take a more holistic approach to truly understand the journeys and barriers that are preventing diverse talent from progressing,” she said. 12

Medical Design & Outsourcing

10 • 2021

www.medicaldesignandoutsourcing.com

Danielle Kirsh Senior Editor Medical Design & Outsourcing dk i rsh @ wtwh m e di a .c o m

| | | |

Celebrating Woman Power

Here’s to our female engineers, who bring invaluable talent and leadership to our team every day.

“It’s no mystery that guys in the tech industry like to hire other guys. Being a woman engineer, you definitely change perceptions, because you prove that you can do everything a man can do, maybe even better.” — Mahsa Sharafi, Torque Division Engineer

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2021 WOMEN IN MEDTECH

Our Life Sciences editorial team drew on its resources to produce an alphabetical list of 200 women executives in the medtech industry. The list is a who's who of women presidents, VPs and more who are breaking down the barriers in a male-dominated industry.

Monica Aguirre Berthelot

Heather Attra

Michele Allegretto

Tonya Austin

Kara Andersen Reiter

Jeannette Bankes

Carrie Anderson

Michelle Basil

Suzanne Armstrong

Sophie Bechu

chief of staff Hologic

SVP, human resources Glaukos

SVP, general counsel and chief compliance ofﬁcer Intuitive Surgical EVP and CFO Integra Lifesciences

VP, human resources Orthoﬁx

SVP, head, global quality Alcon chief human resources ofﬁcer AtriCure president and GM, global surgical franchise Alcon EVP, general counsel Haemonetics EVP, COO Royal Philips

(continued on the following pages)

10 • 2021

Medical Design & Outsourcing

2021 WOMEN IN MEDTECH (continued)

Yin Becker

VP, communications and public affairs Stryker

Annette Beller

board member, ﬁnance, taxes and controlling, central service departments B. Braun Melsungen

Diane Biagianti SVP, general counsel Glaukos

Barbara Bodem CFO Hillrom

Jennifer Bolt

SVP, global operations and ESG Integer

Stephanie Bolton president, Europe LivaNova

Karen Boylan

Wendy Carruthers

Birgit Conix

Erania Brackett

Andrea Caruso

Kathy Conner

Ellen Bradford

Jean Casner

CVP, strategic projects Teleﬂex SVP, chief marketing ofﬁcer Dentsply Sirona SVP and corporate secretary Baxter

Anna Maria Braun CEO B. Braun Melsungen

Darleen Caron

SVP, human resources Boston Scientiﬁc

CVP, business development Integra Lifesciences

VP, marketing and communications Varian Medical Systems

SVP and chief human resources ofﬁcer Cantel Medical

Ashley Cordova

Lori Ciano

Shanna CottiOsmanski

chief human resources ofﬁcer Nevro

chief human resources ofﬁcer and labor director Siemens Healthineers

Heather Cohen

Victoria Carr-Brendel

Julie Coletti

GVP, cochlear implants Sonova

CFO Sonova

EVP, human resources Conmed SVP, chief legal and regulatory ofﬁcer Align Technology

CFO Novocure

EVP, information technology and CIO Conmed

Laetitia Cousin

VP, regulatory and quality affairs SeaSpine

Myriam Curet

EVP and chief medical ofﬁcer Intuitive Surgical

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2021 WOMEN IN MEDTECH (continued)

Holly Desantis

EVP and CFO Konica Minolta (healthcare segment)

Ann Desender CFO Barco

Julie Dewey

VP, investor relations and corporate communications Nevro

Zoe Dickson

EVP and chief human resources officer 3M

Kate Dobbs

SVP, marketing and communications, Fresenius Medical Care North America Fresenius Medical Care

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Lisa Earnhardt

EVP, medical devices Abbott

Jodi Eddy

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SVP and chief information and digital officer Boston Scientific

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Stacey Eisen

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SVP, global communications and president, Baxter International Foundation Baxter

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Medical Design & Outsourcing

10 • 2021

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2021 WOMEN IN MEDTECH (continued)

Rachel Ellingson

SVP and chief strategy officer Zimmer Biomet

Kimberley Elting

chief legal and development officer Orthofix

Myra Eskes

Catherine Estrampes president and CEO, EMEA GE Healthcare

chief people and brand officer Sectra

Lisa Evoli

EVP and chief human resources officer Integra Lifesciences

Angela Goodwin

Jean Holloway

Heather Knight

SVP and chief information technology officer Invacare VP, investor relations Insulet

Sarah Grauze

VP, chief human resources officer Stryker

Kjersti Grimsrud

president, Cardinal Health athome solutions Cardinal Health

Michelle Fox

CVP and chief medical officer Teleflex

Livia Freudl

SVP, head of human resources Varian Medical Systems

Britta Fünfstück CEO Paul Hartmann

SVP, people and culture Cochlear

Ellie Humphrey

VP, global digital transformation office Baxter

Meghan Hansen general counsel Smiths Medical

Trui Hebbelinck

chief human resources officer LivaNova

Jeanette Hedén Carlsson

EVP, communications and brand management Getinge SVP, human resources Hologic

Marie Hendrixson VP, internal audit Teleflex

10 • 2021

VP, chief accounting officer Cryolife SVP and chief transformation officer Zimmer Biomet

Heidi Hunter

president, specialty solutions Cardinal Health

Moji James

SVP and general counsel Avanos Medical

Cheryl James

chief human resources officer Hillrom

Tobi Karchmer

Lisa Hellmann

SVP, general counsel, chief ethics and compliance officer and corporate secretary Integer

EVP Danaher

Laila Gurney

Jessica Hameline

Suzanne Foster

Jennifer Honeycutt

Amy Horton

EVP, quality regulatory compliance Getinge

head, orthodontics business unit Straumann

SVP, general counsel, chief compliance officer and corporate secretary Cryolife

president and COO, global continence care ConvaTec

Lena Hagman

Camila Finzi

EVP, chief strategy and business development officer Cardinal Health

Jennifer Hornery

chief quality and regulatory officer GE Healthcare

Kathryn Fink

Medical Design & Outsourcing

Karen King

SVP and treasurer 3M

Lisa Everhill

Michele Holcomb

general counsel, Fresenius Medical Care North America Fresenius Medical Care

Deborah Gordon

president, Asia Pacific Smith+Nephew

Elizabeth Giddens

Karen Gledhill

VP, worldwide medical Baxter

Vered Keisar

chief people officer ResMed

Kolleen Kennedy

president, proton solutions and growth office Varian Medical Systems

Deeptha Khanna

EVP, chief business leader, personal health Royal Philips

www.medicaldesignandoutsourcing.com

SVP, investor relations and communications Alcon GM, U.S. hospital products Baxter

Sreelakshmi Kolli SVP, chief digital officer Align Technology

Natalia Kozmina

EVP, chief human resources officer ConvaTec

Susan Krause

CVP, chief quality officer Integra Lifesciences

Katya Kruglova VP, human resources GE Healthcare

Lisa Kudlacz

president and GM, vascular Teleflex

Jacqueline Kunzler SVP, chief quality officer Baxter

Mary Kay Ladone

SVP, corporate development, strategy and investor relations Hillrom

Veena Lakkundi

SVP and chief strategy officer 3M

Angela Lalor

SVP, human resources Danaher

Patricia Lang

SVP, chief human resources officer Colfax

Margrét Lára Fri∂riksdóttir

EVP, human resources and corporate secretary Össur

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(continued)

Betty Larson

EVP and chief human resources officer BD

Angela Lee

chief talent and diversity officer Hillrom

Karen Leets

SVP and treasurer Baxter

Kathleen Leneghan SVP and CFO Invacare

Valérie Leyldé

EVP, human resources and communications BioMerieux

Sue-Jean Lin

SVP, chief information and transformation officer Alcon

Anila Lingamneni

EVP, chief technology officer Haemonetics

Kim Martin

SVP, chief human resources officer Alcon

Jeanne Mason

SVP, human resources Baxter

Jill Mason

chief ethics and compliance officer Orthofix

Keri Mattox

SVP, investor relations and chief communications officer Zimmer Biomet

Lauri Mauri

SVP, chief clinical and regulatory officer Medtronic

Jessica Mayer

chief legal and compliance officer Cardinal Health

Christine McCauley CVP, human resources Edwards Lifesciences

Angela McClure

chief human resources officer Smith+Nephew

chief experience officer, Fresenius Medical Care North America Fresenius Medical Care

Trang Ly

Elizabeth McCombs

Karen Mahoney

Ashley McEvoy

Elga Lohler

SVP and medical director Insulet head, global human resources Abiomed

Angela Main

EVP and chief technology officer BD EVP, worldwide chair, medical devices Johnson & Johnson

SVP, global chief compliance officer and associate general counsel, Asia Pacific Zimmer Biomet

Lorelei McGlynn

Rochelle Maney

Aviva McPherron

Lesly Marban

Jennifer Meade

VP, global quality Cryolife

SVP, corporate marketing Intuitive Surgical

Medical Design & Outsourcing

SVP, chief human resources officer Henry Schein VP, information technology NuVasive division president, breast and skeletal health solutions Hologic 10 • 2021

2021 WOMEN IN MEDTECH (continued)

How Hologic made a major pandemic pivot

Wendy Millette

chief compliance ofﬁcer, Fresenius Medical Care North America Fresenius Medical Care

Hologic CFO KARLEEN OBERTON reﬂects on key decisions and turning points of the COVID-19 pandemic.

Camilla Møhl

SVP, people and culture Coloplast

Mary Moreland

EVP, human resources Abbott

B Y J I M H AMMER AN D MAN AG I N G ED I TO R

Francesca Morichini chief HR ofﬁcer Ampliﬁon

ologic's fiscal year closes in September, but Chief Financial Officer Karleen Oberton had seen enough by late July to call it: 2021 would be the best financial year ever. Oberton and the women's-healthfocused company have come a long way since sketching out doomsday scenarios in March 2020. "We quickly went from counting every penny to these exponential sales on the COVID testing," Oberton said in an interview with Medical Design & Outsourcing. She shared the company's path through the pandemic, ramping up its diagnostics business to support and grow its surgical and breast health lines for the post-pandemic future.

Anthea Muir EVP, APAC Ampliﬁon

Atsuko Murakami CFO HU Group

Kelly Murphy

SVP and general counsel Henry Schein

Shana Neal

EVP, chief human resources ofﬁcer Owens & Minor

Anne-Françoise Nesmes

CFO Smith+Nephew

Carrie Nichol

VP, controller and chief accounting ofﬁcer Zimmer Biomet

Judith O'Grady

CVP, global regulatory affairs Integra Lifesciences

Catheryn O'Rourke

chief legal and compliance ofﬁcer Smith+Nephew

Karleen Oberton CFO Hologic

Medical Design & Outsourcing

we generated from sales of our COVID assays, buying back our own stock and making several acquisitions to accelerate our growth and ensure that we to come out of this pandemic a stronger company." It's a story that starts well before COVID-19, back in December 2013 when MacMillan came on as CEO. "He was the third CEO in six months. ... I was brushing off my resume," Oberton said. "[But] he was focused on commercial excellence, he was focused on accountability and he expected more of ﬁnance." In his ﬁrst 14 months, MacMillan ousted every executive who was on board when he joined except for Oberton. She met with MacMillan as he prepared to bring in a new CFO, sharing her perspective on the company and offering

10 • 2021

"While already a strong leader, Karleen became an even stronger partner to me and the entire Hologic leadership team through her quick actions, clear communication and thoughtful ideas and actions early on and throughout the pandemic," CEO Steve MacMillan told MDO. "Karleen made moves to preserve cash and retain our financial flexibility, [enabling] Hologic to make a significant impact in addressing the global crisis. … Karleen and the team efficiently redeployed the strong cash flow www.medicaldesignandoutsourcing.com

to draw up plans to support the new ﬁnance chief. MacMillan gave her a call the next day "in Steve fashion," she said, telling her the two executives between her and the CFO were out. "He's like, 'Hey, those two guys are gone. It's all yours. Don't do homework, just do the work.'" MacMillan promoted Oberton to chief accounting ofﬁcer in 2014 and CFO in 2018.

2021 WOMEN IN MEDTECH

The first test Marlborough, Massachusetts–based Hologic has approximately 2,700 of its Panther diagnostic machines testing for COVID-19 across the globe, including 1,000 boxes deployed throughout the pandemic. In the early months of the pandemic, the first wave of machines went to large reference labs running Hologic's older Tigris system, which only has four approved assays versus the Panther's 19. "It was a really unique opportunity to essentially recapitalize our biggest customers with our latest instrumentation," Oberton said. "... Once the pandemic wanes, they'll port those legacy assays over to the new instrumentation, which creates not only opportunity for us, but efficiencies as well to only have one instrument in the field that we're supporting." Manufacturing partner Stratec made about 160 Panthers per year before the pandemic, and Hologic wanted to ship Panthers to smaller, regional hospital labs as it became clear that COVID testing would be decentralized. "We took Panthers out of our research labs to give it to customers," Oberton said. "We were finding Panthers that needed to be refurbished ... to get capacity out to our customers." The third wave of Panthers went overseas, increasing the share of machines outside the U.S. from 30% to 45% percent, mainly in Western Europe. A critical decision came after Hologic's diagnostics team developed their first SARS-CoV-2 test to run on Panthers with a PCR-capable Fusion accessory. "It was the realization that this is much bigger than we ever thought, and we need to get a TMA test on our legacy Panther so we have a test that can be run on that entire footprint, not just the 15% that have Fusion capability," she said. Hologic and its suppliers scaled test production from around 21 million per quarter to 75 million. That increased capacity will let Hologic offer more molecular tests to Panther customers new and old — not just tests for COVID-19, but also other respiratory viruses, cancers and sexually transmitted infections. "We were very focused on making sure that we had discussions with those customers about commitments beyond COVID," Oberton said. "When COVID testing wanes, what other assays are they going to agree to? >>

Hologic CFO Karleen Oberton at the Nasdaq MarketSite in New York City on Oct. 4, 2021, for Hologic’s ringing of the Nasdaq opening bell to mark Breast Cancer Awareness Month. Photo by Nasdaq

www.medicaldesignandoutsourcing.com

10 • 2021

Medical Design & Outsourcing

2021 WOMEN IN MEDTECH

HOLOGIC'S PROJECT HEALTH EQUALITY AND GLOBAL WOMEN'S HEALTH INDEX

(continued)

Sarah Oliker

assistant, general counsel, assistant secretary Conmed

Jennifer Olson

SVP and managing director, customer success Align Technology

Katherine Owen

VP, strategy and investor relations Stryker

Karen Parkhill EVP and CFO Medtronic

Lisa Paul

VP and chief people officer Natus Medical

Lynn Pawelski

KARLEEN OBERTON (continued on page 29)

Hologic launched two key women's health initiatives this year, starting with the $20 million Project Health Equality initiative that launched in May to improve health care for Black and Hispanic women in the U.S. Then in September, Hologic debuted its Global Women's Health Index, surveying women and girls through the Gallup World Poll to measure action and attitudes about women's health, focusing on preventive care, opinions of health and safety, emotional health, individual health and basic needs. Those five factors explain more than 80% of women’s average life expectancy at birth and are used in the index to rank countries and territories. For example, heart disease is the leading cause of death globally, but only about one in three women are estimated to have had their blood pressure tested in the last 12 months. “Preventive measures are a crucial first step to combating diseases and infections affecting life expectancy and fertility in

women,” Hologic Vice President of Global Medical Affairs Susan Harvey said in a news release. “Failing to ensure women get routine testing for cancers, sexually transmitted diseases and infections, and cardiometabolic diseases can lead to larger complications that would otherwise be preventable if monitored or treated early.” An estimated 1.5 billion women have not been tested in the past year for critical diseases, based on the survey results. The worldwide average of the Global Women’s Health Index was a score of 54 out of 100, with preventative care (19 out of 100) trailing well behind the other four factors, which ranked from 68 to 75. Among all 116 countries and territories ranked in the index, Taiwan performed best with a score of 69, while Peru ranked last with a score of 36. The United States ranked 26th with an index score of 61. You can find a link to the full report at www.bit.ly/3AkYWvQ.

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2021 WOMEN IN MEDTECH KARLEEN OBERTON

(continued)

"This company is making some very smart moves to optimize its newly enlarged installed base."

One of the things we use to measure that is something called a test of record — we call it a TOR. The value of a test of record is the estimated one year's revenue of a newly validated assay on the Panther system. Prior to 2020, our highest year of TORs was $20 million. We did $35 million in 2020. And then we have done another $35 million through the ﬁrst three quarters of 2021. … We believe that we will be able to considerably increase molecular sales given the explosion of the Panther footprint."

COVID cash With the diagnostic business gearing up for record sales, Oberton and the team wanted that free-flowing cash to fuel long-term success in all three business lines. So they reactivated their full-time R&D operations and sent their business development teams searching for M&A opportunities. "Business development sits in the divisions — it doesn't sit at corporate, per se — and the divisions are out there identifying assets, cultivating relationships, always with the intent of finding those assets that we feel that we're the rightful owners of, meaning we have a point of leverage, we are an expert in the area and believe that fundamentally, that asset will do better as part of Hologic versus on a standalone basis," Oberton said. Hologic's first pandemic acquisition was in August 2020, when the surgical business bought Acessa Health for $80 million. Hologic already had a laparoscopic treatment for smaller fibroids, and Acessa similarly treats larger fibroids. In January 2021, Hologic announced its $64 million purchase of Somatex Medical Technologies, which develops minimally invasive devices for tumor diagnostics, biopsy and interventional specialties. Diagnostics — which had not made an acquisition since 2012 — followed with three deals, "deploying all of this, what we call our COVID cash that we had generated, in acquiring things that prior to the pandemic we probably couldn't afford to actually buy," Oberton said. The day after announcing the Somatex deal, Hologic revealed another: its $230 million purchase of Biotheranostics, maker of a molecular oncology test that can tell a woman

whether endocrine therapy after breast cancer treatment will help enough to justify its side effects. The next deal was the $159 million acquisition of Diagenode, a PCR assay manufacturer that developed assays for Hologic and will offer more Panther test options. Hologic's latest and largest deal was its $808 million purchase of Mobidiag, a Finnish-French developer of molecular low-plex and high-plex testing. Hologic, which closed the deal in June, had long wanted in on that near-patient, acute care space but couldn't find a way past high per-unit testing costs. "Mobidiag solved that issue in that they designed a simplified cartridge with a low number of parts and more simple parts that allow not only a cheaper per-cartridge cost, but also allows better and more efficient scalability of the manufacturing of the test," Oberton said. "A lot of companies set out with that goal, but during the course of development kind of stray from that simplified cartridge. They stuck to it." The road ahead Hologic is still on the hunt for deals, though executives seem to have a smaller appetite following their $1.65 billion acquisition of Cynosure in 2017. Hologic sold that underperforming medical aesthetics business for about $205 million in November 2020. "We're looking for ... those assets that are close adjacencies, where we're experts, we have a point of leverage," Oberton said. "I'll give an example. Surgical is our smallest division, basically three products, but our largest sales force. Our sales force there is focused on the OB-GYN. So what else can we put in the bag of that sales force that the OB-GYN is already buying or would like to buy? What we're trying to do is find those points of leverage and high confidence in the revenue growth rate across all of the portfolios." Morningstar analyst Debbie Wang started following Hologic before MacMillan’s tenure and said she sees the recent acquisitions as more strategically sound than the Cynosure chapter. >> www.medicaldesignandoutsourcing.com

Debbie Wang Analyst Morningstar

DESIGN NOTES

The Hologic Panther diagnostic device is a fully automated high throughput, random access testing machine. "Random access means you can load the sample as it comes in," Hologic CFO Karleen Oberton said. "Most of the machines, like a Roche Cobas, are a batch system, so you have to wait to have a bolus of samples before you can run them through the machine. Our low hands-on time for the techs really makes it desirable, as well as the size. The size of a Panther is probably the footprint of an office photocopier, but a little taller, so it can fit in a hospital lab. It can fit in a smaller regional lab versus some of these other machines. And even with our legacy Tigris machine, sometimes you have to take down walls to get it into a lab. … We've also done Panther scalable solutions where we can link several Panthers together and run them through one kind of central operating station to create more efficiency in a larger lab setting." Photo courtesy of Hologic

10 • 2021

Medical Design & Outsourcing

2021 WOMEN IN MEDTECH

KARLEEN OBERTON

(continued)

"This company is making some very smart moves to optimize its newly enlarged installed base. … Can they expand the test menu quickly enough that they can get adoption of those tests going to offset the pressure that they're going to feel on the COVID-19 tests as demand for that starts to dial down?" she said. "I will be watching very carefully what happens in Europe. Hologic has historically not had a very robust presence in Europe, even though I think that a lot of the company’s technologies are actually a very good fit for Europe, [where] smaller labs and their needs would be a really good match for what Panther can do: smaller numbers of specimens run, but versatility in the different types of tasks and flexibility in the timing of it. … Can they ramp up usage of those machines?" Wang said she’s always been puzzled by the mid-sized medtech’s “mish-mash of businesses” and how they will work together in the long term. “What does Hologic want to grow up to be? This pandemic has offered a real opportunity and clear prioritization to put a lot of resources behind the in vitro diagnostics (IVD) business and grow molecular diagnostics,” she said. “A lot of times, it's hard for management to make very tough decisions about where are resources going to go. In this particular case, the pandemic has made it clear that this company needs to bolster its presence and really invest in the IVD business and make that the priority. Just from an organizational standpoint, I always think it's good to have that kind of clarity.” For the first time, all three of Hologic's business lines expect annual growth of 5–7%. The company has more of its diagnostic machines in labs across the world than ever before, and it's all because the business moved quickly to fight one of the deadliest pandemics of the modern age. "Heading into fiscal 2022, it feels like the company has never been stronger," Oberton said. "For me as a CFO, enabling the company to take advantage of that opportunity (was) a oncein-a-lifetime experience — hopefully."

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Medical Design & Outsourcing

10 • 2021

2021 WOMEN IN MEDTECH (continued)

Niamh Pellegrini

chief commercial ofﬁcer Nevro

Johonna Pelletier treasurer and VP, tax Conmed

Jaclyn Peterson

VP, manufacturing and advanced engineering Conmed

Shacey Petrovic president and CEO Insulet

Mojdeh Poul

president, healthcare 3M

Nicole Priest

chief wellness ofﬁcer Merit Medical Systems

Katrin Pucknat

president, ResMed Germany ResMed

Gitte Pugholm Aabo CEO GN Hearing

Jane Rady

SVP, corporate strategy and business development Glaukos

Deborah Rasin

chief legal ofﬁcer and secretary Hillrom

Theresa Reinseth

SVP, corporate controller and chief accounting ofﬁcer 3M

Vicky Ringwood

SVP, human resources Konica Minolta (healthcare segment)

Rhonda Robb

COO Cardiovascular Systems

Medical Design & Outsourcing

10 • 2021

www.medicaldesignandoutsourcing.com

2021 WOMEN IN MEDTECH

SHACEY PETROVIC is pumped up to launch Omnipod 5 With FDA clearance imminent, Petrovic says Insulet’s latest device oﬀers real change in diabetes care. BY SEAN WHOOLEY ASSOCI AT E EDI TOR

aced with either a bulky insulin pump or delivering multiple daily injections, Boston-based entrepreneur and venture capitalist John Brooks III sought an easier way to treat his young son’s newly diagnosed type 1 diabetes. He assembled a team of engineers and they created Omnipod, Insulet's wearable, automated insulin delivery patch system. "The company was founded in 2000 based on that innovation and ingenuity and that sort of spirit stays with the company," CEO Shacey Petrovic said in an interview with Medical Design & Outsourcing. "We're continuing to invest in innovation and look for a better way. The origin story was born of patient need and that is at the core of our mission." The latest iteration of Omnipod, the Omnipod 5, will deliver a number of ﬁrsts to the market, building upon the Omnipod DASH, which was cleared in 2019. With pairing to

Dexcom's G6 continuous glucose monitoring (CGM) system, Omnipod 5 will be the first tubeless, wearable, automated insulin delivery system, Petrovic said. Patients will be able to use a dedicated handheld controller or control the system with a secure app on their smartphone, marking another first, according to the CEO. "We've seen in previous generations of other systems where complexity can really prevent people from getting good outcomes and having a good experience," Petrovic said. "We worked very hard to take as much of the complexity out of the system and make it as easy for people to use as possible." Recent data presented at the European Association for the Study of Diabetes (EASD) 2021 annual meeting demonstrated significantly improved time in range and reduced levels of glycosylated hemoglobin (HbA1c) in a clinical trial. The age range of 6 years old to 70 years old for the indication Insulet seeks is the broadest on the market. Omnipod 5 already holds FDA breakthrough device designation. Petrovic and Insulet expect FDA clearance and a limited market release in the U.S. before the end of 2021. Despite difficulties from the COVID-19 pandemic, 2020 was Insulet’s fifth consecutive year of more than 20% top-line growth. Insulet expanded into five new countries in 2020 and added two more in 2021. Insulet had about 500 employees in February 2015 when Petrovic joined the company — then headquartered in Billerica, Massachusetts — as chief commercial officer. Today, Insulet has what

The Insulet Omnipod 5 paired with a Dexcom G6 continuous glucose monitor Photo courtesy of Insulet

she describes as a highly automated, world-class headquarters facility in Acton, Massachusetts, with approximately 2,000 full-time employees across three continents. "Growth has been driven by the fact that diabetes is an epidemic and there is a signiﬁcant unmet need among people living with the disease," Petrovic said. "It's been driven by how differentiated the technology is and by global expansion." Barclays analyst Travis Steed has a positive outlook on Omnipod 5, although he said the impact on Insulet's revenues will likely take a few quarters because of the limited launch and because Insulet's business model recognizes revenue over time, rather than upfront. While the full impact of Omnipod 5 on Insulet's growth may not register until late 2022 or even 2023, Steed said, investors will be keeping an eye on new patient additions as the leading indicator for how successful the launch is going. "Omnipod 5 is the product that will ﬁnally bring Insulet to the world of automated insulin delivery," Steed said. "Despite being the only major U.S. insulin pump company today without an automated insulin delivery algorithm, Insulet has still been growing >>

Insulet CEO Shacey Petrovic Photo courtesy of Insulet www.medicaldesignandoutsourcing.com

10 • 2021

Medical Design & Outsourcing

2021 WOMEN IN MEDTECH

SHACEY PETROVIC

(continued)

The Insulet Omnipod 5 Photo courtesy of Insulet

U.S. Omnipod revenues 20% to 30% over the past couple of years. When this product comes to market it could attract more people to insulin pumps who today use multiple daily injections to deliver their insulin and it could also help Insulet win the incremental patient who today is going to a competitor only because that competitor has an automated insulin delivery algorithm." Even with the much-anticipated launch of Omnipod 5, Petrovic said Insulet is "never happy with the status quo," having considered the next three or four generations of the platform before even submitting Omnipod 5 to the FDA. Beyond the Omnipod 5, integrated with the Dexcom G6 and Samsung smartphones, are still-to-come systems that will integrate with future generations of sensors from Dexcom's, which has its G7 CGM on the horizon. In addition to compatibility with Dexcom's platforms, Insulet will look to offer control from phones using Apple’s iOS software, while also integrating with Abbott's FreeStyle Libre, another major sensor platform on the market. "We have a whole host of digital innovations coming which are really exciting when you think about what we can do with CGM and insulin delivery data, and we believe we're in a unique position to be able to generate really valuable insight for our users," Petrovic said. She said those updates are all expected in the coming years, while the company will look to expand its label down to users as young as 2 years old and aims to expand to people living with type 2 diabetes. "We're really focused on continuing to iterate on the Omnipod platform and making sure that everyone can use it, regardless of the sensor they want, regardless of their phone platform, regardless of their age and regardless of their type of diabetes," Petrovic said. "We know that this technology has shown to make a remarkable impact on outcomes and quality of life." 34

Medical Design & Outsourcing

10 • 2021

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2021 WOMEN IN MEDTECH (continued)

Forecasting the future of urology with MEGHAN SCANLON

Anna Romberg

EVP, legal, compliance and governance Getinge

Denise Rutherford

SVP and chief corporate affairs officer 3M

Boston Scientific’s president of urology and pelvic health discusses the field and the challenges and opportunities ahead.

Rahma Samow head, dental service organizations Straumann

BY TOM SALEMI EDI TORI AL DI RECTOR DEVICETALKS

Virginia Sanzone CVP, general counsel ICU Medical

he urology specialty faces a critical moment, with 10 urologists ready to retire for every new urologist entering the field, said Meghan Scanlon, SVP and president, urology and pelvic health at Boston Scientific. That puts the onus on medical device companies to develop faster, safer and more efficacious ways to break down kidney stones, shrink enlarged prostates and handle other critical treatments. In an interview with our DeviceTalks Weekly Podcast, Scanlon laid out Boston Scientific’s plans to build a broad platform of scopes, imaging and AI to aid urologists. Go to DeviceTalks.com to hear the entire conversation, including details of the company’s $1.1 billion acquisition of Lumenis’ surgical business. (We’ve edited the following excerpt for brevity and clarity.)

Meghan Scanlon

SVP and president, urology and pelvic health Boston Scientific

Michelle Scharfenberg

SVP, chief ethics and compliance officer Avanos Medical

Verena Schiller

president, neuro solutions Elekta

Daniela Seabrook

EVP, chief human resources officer Royal Philips

Why did you decide to join the medtech industry? Scanlon: I'm a recovering mechanical engineer. In my previous life, I worked at the Gillette company designing razors, which is a remarkable job. I left Gillette to go to graduate school at MIT where I got my master’s in engineering and my MBA. That was the springboard to change industries. I graduated in 2000 when it was dot-com everything. Very few people were interested in healthcare but there was just something about helping people while still doing something technical still, even though I wasn't planning to go back into an engineering profession.

Sandra Sedo

chief compliance officer Cardiovascular Systems

Holly Sheffield

president, CooperSurgical Cooper Cos.

Sumi Shrishrimal SVP, chief risk officer Dexcom

Ilana Shulman

chief compliance officer Hillrom

Ami Simunovich

What was your first job in medtech? Scanlon: I spent 15 years with Johnson & Johnson in their sports medicine business. I held different roles in

EVP and chief regulatory officer BD 36

Medical Design & Outsourcing

10 • 2021

www.medicaldesignandoutsourcing.com

marketing, operations, finance, and then came to Boston scientific. I knew a couple of the leaders here, including our CEO, Mike Mahoney, and I made that jump seven years ago now. And I haven't looked back since. It was a great move for me. I have one of the coolest jobs in the company. I have the honor of serving as the president of this division. Most division leaders come from sales and marketing. You're coming with an engineering background. Do you still draw on your engineering skills? Scanlon: I love this question. I get asked it quite a bit. I will never, ever completely put my engineering skills behind me. The nice thing about medical devices is it's very technical, both the biomechanics of the procedures that we're doing as well as the biomechanics of how the devices work. The loads that they go under, the energy that is being deployed, it’s very technical. So my learning curve to understand the technical aspects of these procedures, of these devices and of what surgeons are trying to accomplish was quite quick. My technical foundation was poured in those early years in Gillette, but the rest of the house — the commercial part — has been built since 2000 when I joined Johnson & Johnson and it's been, it's been quite nice because I feel like it's made me a very well-rounded business professional. Urology has benefited from one of the fastest-growing technologies, singleuse endoscopes. How does that fit into your business? Scanlon: Boston Scientific created the first disposable flexible ureteroscope, LithoVue. I spent my first three and a half years at Boston Scientific working on our endoscopy business and was part of that device’s innovation journey. So I was delighted when I came over to urology and pelvic health to see the way LithoVue has just

2021 WOMEN IN MEDTECH

BOSTON SCIENTIFIC AND ZENFLOW ARE BRINGING CRITICAL NEW TOOLS TO HELP UROLOGISTS TREAT PATIENTS In this episode, we’ll speak with Meghan Scanlon, SVP and president, Urology and Pelvic Health at Boston Scientiﬁc about that company’s growing pipeline bolstered by the acquisition of Lumenis. www.devicetalks.com/podcast/

transformed the market. We launched that in 2017 and it continues to grow double digits for us. It is a huge growth driver. How is it being received by the clinical community and what are the benefits? Scanlon: First and foremost, it's always ready. It's always sterile. And urology is a specialty right now that has more demand than supply in terms of physician capacity. We've seen surgery centers that have moved completely to disposable ureteroscope because of just the efficiency benefit of how they're able to run their clinical practice. It absolutely outweighs the reprocessing burden. Second, the device always works. To get at kidney stones you must torque these devices into some tight radius bends again and again. When you multiply that across many surgeries for reusable scopes, sometimes if your reusable scope is in its later stages of needing to be serviced, the last thing you want is to have to swap out a reusable scope because it can’t make that tortuous curve. So what we have found is that in complex cases, a disposable ureteroscope like LithoVue is always game-time ready. What has happened technically that allowed for the creation of disposable scopes that have the functionality of a reusable scope for a much lower cost? Scanlon: It’s a remarkable engineering feat, right? To be able to sell disposable scopes for a price in the low thousands of dollars (compared to $30,000 or $50,000) is incredible. >>

Meghan Scanlon is a senior vice president at Boston Scientiﬁc and president of its urology and pelvic health business. Image courtesy of Boston Scientiﬁc

www.medicaldesignandoutsourcing.com

10 • 2021

Medical Design & Outsourcing

2021 WOMEN IN MEDTECH (continued)

Keyna Skeffington

Carol Surface

SVP, general counsel LivaNova

Jessica Smith Claire Smith

VP, customer excellence Nevro

EVP, chief human resources ofﬁcer Dexcom

Janet Stevens

VP, quality assurance Hillrom

Jennifer Taubert

Andrea Wainer

EVP, human resources Elekta

EVP, worldwide chair, pharmaceuticals Johnson & Johnson

Susan Swabey

Julie Tay

Heather Wechet

Gabriella Szekely

Clare Trachtman

company secretary Smith+Nephew

chief human resources ofﬁcer Cardinal Health

Sadie Stern

Julie Tyler

Karin Svenske Nyberg

VP, regulatory affairs Hillrom

Ola Snow

Nicola Talbot

SVP and chief human resources ofﬁcer Medtronic

SVP, commercial strategy Align Technology

VP, R&D, combination pharmaceutical products Glaukos

Katie Szyman

CVP, critical care Edwards Lifesciences

Hisako Takada

VP, human resources Fisher & Paykel Healthcare

senior GM, CEO ofﬁce Omron

VP, investor relations Baxter

Medical Design & Outsourcing

10 • 2021

EVP, rapid and molecular diagnostics Abbott VP, human resources, global functions, talent management and employee relations Baxter

Debbie Weitzman

SVP, compliance and quality Varian Medical Systems

president, pharmaceutical distribution and The Medicine Shoppe International Cardinal Health

Annette Tumolo

Kathy Wengel

Vy Tran

EVP, president, life sciences Bio-Rad

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2021 WOMEN IN MEDTECH MEGHAN SCANLON

(continued)

If you look at the heritage of Boston Scientiﬁc, we are the masters of long catheter-based technologies, guidewires, etc. So it's very much in our core competency. Also, imaging chains used to be the most expensive part 10 or 15 years ago. But the cost of the digital imaging chain and chips have come down so much that now so much of the complexity is really in just the precision engineering to be able to get working channels, aspiration channels, the steer wires, and all the knobs down to these small seven-, nine-French devices. But we have a legacy of developing long, skinny, sophisticated devices. But it’s a pretty great engineering feat. You get a chance to see how innovation can truly transform the way care is delivered. Are you concerned about the global shortage of chips? Scanlon: We have an incredible global supply chain organization. That's done

a lot to get us a secure supply base for the chips that we need. It's obviously something we continue to stay close to. Where will urology be in ﬁve years? What technologies will change the game? Scanlon: We are facing a critical impasse in urology. Twelve percent of the population is going to have kidney stone disease at some point in their life. This onslaught of patient demand is not getting matched with the number of urologists. That means we've got to make sure we are making these procedures more efﬁcient, more predictable, and more available to help patients. We want to create a comprehensive ecosystem of technology platforms. For example, LithoVue is a beautiful imaging device. We’re leapfrogging ourselves at the end of this year with a scope that now allows you to monitor and measure pressure in the kidney. Because when you're in there

doing a lot of work in the kidney, you're adding fluid, you're adding energy and the pressures can be highly variable. We want to basically be able to provide a pressure speedometer, if you will, to the physician. We also want to track fluid and monitor the energy source, the laser fiber. How do you modulate your energy source based on what you see? Kidney stones are not all the same. Some stones are soft, some are hard, some are small, some are enormous. We're developing an interconnected ecosystem, which we're calling intelligent intrarenal surgery, where each of these platforms — whether it be scope, fluid management or laser — can work on their own with meaningful clinical advantage. Then, we are going to work to be connecting that ecosystem through something called Stone Cloud, which allows these systems to talk to one another with the aim of speed, predictability, efficiency and improved clinical outcomes.

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10 • 2021

Medical Design & Outsourcing

2021 WOMEN IN MEDTECH (continued)

Esther Wick

EVP, legal, IP and compliance BioMerieux

Sarah Wills

EVP, chief corporate affairs officer Cardinal Health

Lori Winkler

SVP and chief human resources officer Zimmer Biomet

Suzanne Winter president Accuray

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Victoria Womack Styles

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VP and GM, advanced endoscopic technologies Conmed

Dara Wright

EVP, president, clinical diagnostics Bio-Rad

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Lisa Yankie

SVP, chief human resources officer Dentsply Sirona

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WOMEN-LED STARTUPS

10 women-led medtech startups The Medical Design & Outsourcing editorial team drew on its resources to produce this list of women-led medtech startups. These are companies that are less than 10 years old and were founded by women and/or are led by women.

Alva Health wins MedTech Innovator startup prize Led by CEO SANDRA SALDANA, this startup developed a wearable stroke monitor. B Y JIM H A MM ER A N D M A NA G ING ED ITO R

edTech Innovator awarded its $350,000 global startup competition grand prize to Alva Health, a wearable, real-time stroke monitor developer. The New Haven, Connecticut– based startup won the medical device accelerator competition after a Sept. 29 vote by attendees of The MedTech Conference, organized by AdvaMed. “Alva Health’s mission is to develop, commercialize and make accessible a ﬁrst-in-class medical device that accurately detects strokes using patient-worn wearables,” Alva Health co-founder and CEO Sandra Saldana said in a news release. “This award represents a recognition of the tremendous clinical unmet need for patients and an important milestone in Alva Health’s journey. We are grateful to the MedTech Innovator community for their support and for the opportunity to receive mentorship from top leaders in the medical device industry as we work toward fulﬁlling our mission to deliver this much-needed technology to the millions of people who are at high risk for stroke.”

Alva Health’s stroke monitor

MedTech Innovator received more than 1,100 applications. Four other finalists — BioDevek, Caretaker Medical, Cooler Heads Care and Nutromics — each received a $25,000 prize. The MedTech Innovator accelerator program provides early-stage companies with industry mentorship, virtual networking and workshops, and pitch sessions with investors, manufacturers, providers and customers. “Each year, we are on a mission to find the most promising startups from around the globe and connect them with the right stakeholders with the goal of reaching patients and improving lives,” MedTech Innovator Founding CEO Paul Grand said in the news release. “I can say with full confidence that not only Alva Health, but all of this year’s finalist companies are on track to bring life-changing health solutions into the hands of clinicians and their patients.”

Alva Health cofounder and CEO Sandra Saldana

Photo courtesy of Alva Health

Medical Design & Outsourcing

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www.medicaldesignandoutsourcing.com

WOMEN-LED STARTUPS 10 WOMEN-LED MEDTECH STARTUPS ALVA HEALTH SANDRA SALDANA, CO-FOUNDER AND CEO Alva Health developed a wearable, real-time stroke monitor for older, high-risk patients. New Haven, Connecticut Founded: 2017

BIODEVEK NATALIE ARTZI, FOUNDER BioDevek is a medical device company that has developed internal, external and reversible adhesive materials that react with each tissue to provide adhesion while maintaining biocompatibility. Allston, Massachusetts Founded: 2014 COREMAP SARAH KALIL, CO-FOUNDER, CEO AND PRESIDENT CoreMap is developing a catheter to visualize the drivers of atrial ﬁbrillation to overcome the problems of poor spatial resolution. Burlington, Vermont Founded: 2016

ENVISION ENDOSCOPY AZADEH KHANICHEH, CO-FOUNDER AND PRESIDENT Envision Endoscopy is developing a single-use, disposable image guided suturing system for use with ﬂexible endoscopes. Lowell, Massachusetts Founded: 2018

"Alva Health's mission is to develop, commercialize and make accessible a first-in-class medical device that accurately detects strokes using patientworn wearables." www.medicaldesignandoutsourcing.com

LIVONYX CARMELA MASCIO, CO-FOUNDER AND PRESIDENT LivOnyx is developing a rapid, fully automated hand sanitization system to reduce the spread of viruses, resistant bacteria, Clostridioides diﬃcile spores and more. Lowell, Massachusetts Founded: 2016

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Medical Design & Outsourcing

WOMEN-LED STARTUPS

Medicine-saving Nanodropper makes history in Minnesota Cup win The student-led startup wants to save patients from wasted eye drops.

B Y JIM H A MM ERAN D MA NA G ING ED ITOR

he Minnesota Cup awarded its grand prize for innovative entrepreneurs to a student-led startup for the ﬁrst time. Medical device developer Nanodropper took home top honors from the awards ceremony, held Sept. 20 at the University of Minnesota. “We have created an eyedrop bottle adaptor that will save billions in medication waste, one drop at a time,” Nanodropper CEO Allisa Song said. Song, an MD candidate at the Mayo Clinic Alix School of Medicine in Rochester, Minnesota, launched the company with three other founders — Chief Operating Officer Elias Baker, Chief Commercialization Officer Mackenzie Andrews and Chief Scientific Officer Jennifer Steger — after learning that drug companies make eye drops too large to be fully absorbed, and that smaller drops are more efficient and just as efficacious. Rochester-based Nanodropper reduces drop size from 40 microliters to 10 44

Medical Design & Outsourcing

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The Nanodropper

Photo courtesy of Nanodropper

"We decided that patients deserve better. ... Our competitors have made smaller droplets, yes, but Nanodropper is the only solution that both reduces the droplet size and the cost of the medication."

microliters (what Song calls the “ideal-size drop”) to extend the life of each bottle of medicated eye drops three or four times, saving hundreds or thousands of dollars per year on a single prescription. “We decided that patients deserve better. … Our competitors have made smaller droplets, yes, but Nanodropper is the only solution that both reduces the droplet size and the cost of the medication,” Song said. The startup has already secured seed funding from Golden Seeds and Rochester Area Economic Development Inc. (RAEDI), has its product in more than 250 eye clinics and landed a $500,000 contract with the U.S. Air Force. Nanodropper won $25,000 for winning the Minnesota Cup Student Division and the $50,000 grand prize as the overall winner. Minnesota Cup does not take an equity stake in exchange for the prizes. “We trust them to invest that money in their business in any way they choose.” Minnesota Cup Director Jessica Berg said. It’s the ﬁrst time in Minnesota Cup’s www.medicaldesignandoutsourcing.com

17 seasons that a student-led startup has won the overall competition. This year’s contest drew nearly 2,000 earlystage companies earning less than $1 million in revenue. Aimee Garza’s CoraVie Medical, which is developing a subcutaneous continuous blood pressure monitor for hypertension, won the competition’s LifeScience/Health IT division.

WOMEN-LED STARTUPS 10 WOMEN-LED MEDTECH STARTUPS

(continued)

NASUS MEDICAL ASHLEY SEEHUSEN, CEO Nasus Medical is developing an intranasal drug delivery to treat conditions like chronic sinusitis and improve outcomes in a noninvasive way. Pleasanton, California Founded: 2019

NANODROPPER ALLISA SONG, CO-FOUNDER AND CEO Nanodropper developed an eyedrop bottle adaptor that makes medicated eyedrops smaller, reducing waste without losing eﬃcacy. Rochester, Minnesota Founded: 2018

RESPIRA LABS DR. MARIA ARTUNDUAGA, FOUNDER AND CEO Respira Labs is developing an “acoustic resonance” technology to detect air trapping to quickly diagnose and predict lung dysfunction and deterioration. Mountain View, California Founded: 2019

STERADIAN TECHNOLOGIES ASMA MIRZA, CEO Steradian Technologies is developing a portable, single-step rapid detection test for communicable and non-communicable diseases. Houston, Texas Founded: 2018

Nanodropper co-founder and CEO Allisa Song Photo courtesy of Nanodropper

XACT ROBOTICS CHEN LEVIN, CEO Xact Robotics is developing a hands-free robotic system that uses image-based planning and navigation with instrument insertion and steering capabilities for percutaneous interventional procedures. Caesarea, Israel Founded: 2013

Medical Design & Outsourcing

WOMEN IN MANUFACTURING

Set the stage for your 'Ah-ha!' moment Here’s how a futureminded medtech engineer ﬁnds inspiration, innovation and creativity.

Jim Hammerand | Managing Editor |

TE Connectivity single-use bronchoscope Photo courtesy of TE Connectivity

TUESDAYS

Building a better single-use endoscope Ottum was recently featured on MassDevice’s DeviceTalks Tuesdays. To watch the replay, go to www.bit.ly/3FkHEmq.

Medical Design & Outsourcing

he future of medtech is the focus of TE Connectivity’s Advanced Technology Group, a team of experienced engineers tasked with identifying trends and developing new technology for devices and challenges that might not yet even exist. Marie Ottum, principal R&D engineer in TE Connectivity’s Advanced Technology Group and global leader of the TE women’s networking group, is an expert on single-use endoscopes. Medical Design & Outsourcing caught up with Ottum to learn more about how and where she finds inspiration, innovation and creativity. (We’ve edited the following for brevity and clarity.) “There’s always a need for problemsolving and coming up with new and better ways to do things, but in our Advanced Technology Group, it’s particularly important because we’re actually trying to predict the future in a way and anticipate what products and processes our customers are going to need three to five years from now. In most cases, our successes are a series of small innovations pulled together rather than one flashy spectacular product innovation — for example, the single-use (SU) bronchoscope. There are SU bronchoscopes on the market today, so this isn’t something totally new. But for TE, it is a combination of really unique innovative solutions: our 10 • 2021

novel method for automating the cable manufacture, prep and termination to small substrates; plus our method for taking a single hypotube and cutting it in a pattern that mimics the behavior of hinged solutions that typically require dozens of components welded together; plus our additive manufacturing mindset and equipment that allow us to design and implement additive manufacturing handles or endoscope components like the tip in production. So often the case is that we have a series of smaller innovations that, when packaged together, allow for new and better solutions.” “Cross-pollination can really ramp up your creativity. And it can also kind of break some ruts if you’ve got new teams of people you’re working with on occasion. We all get to know our teams and collaborate well with them, but it can be exciting to work with new people.” “TE’s an enormous company. We have tens of thousands of employees around the globe, working in the energy sector, automotive, defense or, in my case, medical. So by paying attention to and networking with the other engineers in the company, I can also look to different types of products for inspiration. Maybe I’m working on a surgical product where it needs to be able to survive an autoclave 500 times so that it’s sterile and safe for >>

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WOMEN IN MANUFACTURING

use in the body, and I’m struggling with a material selection or something. I could also go talk to people who work in aerospace or even automotive. They may have similar harsh environment applications where they’ve taken drastically different approaches than some of our medical devices that I can use as inspiration to think about the problem in a different way. TE has a big engineering event in a different region of the world every year called TechCon, where all of the engineers can submit their work, and a small percentage gets selected to present tools or best practices or innovative ideas they’ve had. And then, there are open forums afterward for collaboration. It’s a really great way to not only get new ideas, but also to meet new people that you might pull into future brainstorming sessions or reach out to for a fresh perspective.” “I need natural light. In my home office, I’ve got windows looking out at flowers and trees. And I try to spend part of my day outside while I’m working. I find that that is very relaxing for me, and I do better work when I’m relaxed.” “I use music for focus. I change the type of music I’m listening to during the day, depending on what I’m trying to do. I can’t explain it, but when I’m in a CAD system designing, listening to old-time country music works for me. That’s not what I listen to pretty much any other time. Willie Nelson, Johnny Cash, and the like. One of my previous colleagues had a band that played this type of music, and he used to occasionally have it playing at his

Women in Medtech MANUFACTURING

Marie Ottum TE CONNECTIVITY PRINCIPAL R&D ENGINEER IN TE CONNECTIVITY’S ADVANCED TECHNOLOGY GROUP AND GLOBAL LEADER OF THE TE WOMEN’S NETWORKING GROUP Wilsonville, Oregon 48

Medical Design & Outsourcing

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Photo courtesy of Marie Ottum

desk. It made me laugh, but whenever he’d have it going, I would be able to get more into what I was doing from a design perspective. How strange is that? I don’t know. It works for me. My dad’s an engineer as well, and that was his type of music. I think a little part of me is channeling him.” “I get inspiration from my children. I like to go to the schools and do science and STEM activities with the kids. We put together fun activities like figuring out how to get a little car to move from one end of the table to the other without touching it, an exercise in different types of energy — potential energy, kinetic energy — and different materials. Or how tall a structure can you build with uncooked spaghetti and tape, or can you light up LEDs using lemons or potatoes? The kids and their creative solutions are inspiring, and getting out into a different environment is inspiring. I always take other engineers with me, and before we go, I have us all do the activity together in our cafeteria. These little engineering challenges are things that we all know how to do, but we get competitive about who can do it in the craziest way or the most out-of-the-box way, and it’s loads of fun. We do less of this with COVID, but we’re still finding ways to put little challenges out there to get our brains flowing in different ways and to have a little bit of fun and lighten up a little bit.” “I put a podcast on this week that led me to reconsider some designs I was working on: ‘People I (Mostly) Admire’ from Freakonomics. There was one particular episode called ‘Leidy Klotz on Why the Best Solutions Involve Less — Not More’ that challenges that idea that to improve any solution you have to add something. Rather, in many cases you can subtract to create better outcomes. I also listen to Harvard Business Review’s ‘Women at Work’ podcast. Not for innovation inspiration necessarily, but because I have found that I can relate to some of the struggles and successes they discuss. I watch ‘How It’s Made’ with my kids. My youngest, Jacob, is into fishing right now, and we watched one on fly fishing rods, which was followed by an episode on how they make micro-drill bits and then breakfast cereal. The variety is amazing, and the exposure and reminders of different manufacturing methods and design elements is useful.”

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COVID HEALTHCARE INEQUITIES

The pandemic exposed healthcare inequities near and far To address disparities in COVID-19 testing, treatment and vaccination, we must first understand them.

I Marissa Fayer | CEO and founder | HerHealthEQ |

Medical Design & Outsourcing

magine if you lived in a place where only 2% of the adult population was vaccinated against COVID-19, where there are only a quarter of hospital beds available as compared to the U.S., and where SARS-CoV-2 testing capacity is virtually nonexistent. Then imagine if you were a woman who is taking care of her community, her family and her co-workers during the pandemic while trying to ensure everyone was still happy and educated. In the U.S., 75% of healthcare workers are women, but in low- and middle-income countries, 90% of healthcare workers are women. Women also account for a majority of frontline workers, which include healthcare workers, grocery attendants, warehouse workers and other essential workers we have relied on throughout the pandemic. As I sit in my New York City apartment, in a city with an adult vaccination rate over 80% and in a

10 • 2021

country that has more than double the needed supply of vaccines on hand and increased COVID-19 testing from zero to almost excess capacity, I am aware of my privilege. Because of where I live, I have had access to testing, the ability to comfortably isolate/quarantine/ distance as required, and I know that if I get infected and possibly hospitalized, I have a high chance of surviving and easy access to treatment and knowledge. Others who live 5,000 miles from me — or just 5 miles — are not as privileged or lucky. In the United States, more than 70% of the 700,000-plus people who have died from COVID-19 lived in less advantaged communities. Around the world, over 75% of the 4.5 million reported COVID-19 deaths are in low- and middle-income countries and communities. Counting the many lost lives yields another grim statistic — the >>

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COVID HEALTHCARE INEQUITIES actual death toll is believed to be twice the officially reported number, in part due to disparities in testing access. The inequities that COVID-19 has prominently displayed are hardly new. They are now magnified for everyone to see and are hard to ignore. People in less advantaged communities have twice as many comorbidities such as diabetes and heart disease. These co-morbidities caused significant health inequities before COVID-19, but in the pandemic they are more likely to be life-ending conditions. Women in these communities are equally at risk, as they often do not have the ability to receive treatment as quickly due to differing gender diagnoses, lack of insurance and greater burdens of time. Similarly, people in less advantaged communities face longer lines for testing, causing line fatigue and fewer tests being performed. Hospitals in those communities are often public and more crowded, where individuals might receive

less attention and care, which leads to less treatment and later interventions that worsen outcomes. Additionally, vaccine deployment requires more intensive campaigns and outreach than federal and state funding has supported, so we see fewer vaccinations and higher infection rates. In comparison to past mobilizations, the U.S. and Europe quickly stepped up and increased capacity for testing, treatments and vaccine development, approval and deployment — a herculean effort. The rest of the world waits for action: from us, from their own governments, and from manufacturers, suppliers, distributors and health care providers all trying to meet this challenge. I have been fortunate to be part of the effort ﬁrsthand for the past 16 months through the National Institutes of Health supported Rapid Acceleration of Diagnostics (RADx) program. The daily work and discussions show how much has changed in a relatively short amount of time.

It shows how much we can achieve when we work together for a common cause and goal. I wonder what the rest of the world — let alone the less advantaged communities in our own nation — think of the testing, treatment and vaccines that have not yet made it their way to their communities. We have the ability, access, resources and brilliance to make these advances. Now, we need to use them to equitably distribute and make them accessible to all who need them so that we can collectively get out of this pandemic together and with our health. Marissa Fayer is a 20-plus-year medtech executive, entrepreneur and philanthropist. She is the CEO and founder of social enterprise non-proﬁt HERHealthEQ, the president of advisory ﬁrm Fayer Consulting, EVP of women’s health at DeepLook Medical and venture partner at Assiduity Capital. Her mission is to move innovation and the health of women forward throughout the world.

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DIVERSITY BY THE NUMBERS

Jen Brearey is AdvaMed's chief financial officer, chief operating officer and executive director for AdvaMed’s inclusion diversity programs, which includes AdvaMed Advance and AdvaMed’s Women’s Executive Network. Photo courtesy of AdvaMed

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DAN I ELLE K I R S H S EN I O R ED I TO R

WO M E N I N

S M A L L G A I N , B I G O P P O RT U N I T Y The prevalence of women in corporate leadership positions within the medical device industry remains low, and the rate of increase is stagnant despite new initiatives to increase diversity in the industry.

ust 21% of top executives at the world’s 100 world's biggest medical device companies are women, according to an analysis of Medical Design & Outsourcing's annual Big 100 breakdown of the top revenue-generating medical device companies in the world. The analysis involved seeing who shows up on the leadership pages on the corporations’ websites. While the overall number of women executives on such pages is up 1 percentage point from 2020, the average percentage of women in medtech companies’ top executive ranks remained unchanged from last year at 19%. “The medtech workforce must mirror the patients we serve if we are going to succeed in delivering innovative technology to populations who need it,” AdvaMed Chief Financial Ofﬁcer and Chief Operating Ofﬁcer Jen Brearey told Medical Design & Outsourcing. “As an example, the CDC lists the leading cause of death for women as heart disease, yet despite a robust pipeline of female medical students, females only make up 13% of the adult cardiologist population. With our industry developing innovative solutions in this space and directly interfacing with patients and physicians, a representative female sales force and R&D team has the potential to make a meaningful difference in patient outcomes,” said Breary, who is also executive director for AdvaMed’s inclusion diversity programs, which include AdvaMed Advance and AdvaMed’s Women’s Executive Network. >>

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10 • 2021

Medical Design & Outsourcing

DIVERSITY BY THE NUMBERS

TOP WOMEN EXECUTIVE BY POSITION The leading women at the 100 largest medical device companies in the world have titles that break down into the following roles:

36 Of the 963 executive roles in medtech companies this year, 204 were held by women, with an average composition of 19%. More than a dozen of the companies listed no women executives on their websites, down slightly from 2020. The leading women at the 100 largest medical device companies in the world have titles that break down into the following roles: 48 human resources; 40 finance; 39 divisional presidents; 36 regulatory affairs; 21 legal; 12 medical or clinical; 11 information and technology; 10 communications or public affairs; eight marketing; eight corporate secretaries; two manufacturing; two chiefs of staff and one in charge of R&D. Four companies on the list have a female CEO, reflecting no change from the year prior: B. Braun Melsungen, GN Hearing, Insulet and Paul Hartmann. Within those four companies, women hold an above-average percentage of executive roles: 33% at both B. Braun Melsungen and GN Hearing, 30% at Insulet and 20% at Paul Hartmann. The company with the highest percentage of executive roles held by women is Hillrom, where nine out of 17 executives (53%) are women. Baxter is in the process of acquiring Hillrom for roughly $12.4 billion. Thirteen of the companies listed no women in executive roles, while 21 companies had only one female executive. The remaining firms had at least one woman in an executive role, and Baxter leads that subset with 12 women executives, up one from the year prior. The following companies listed no women in the leadership sections of their websites: • • • • • • • • • • • • •

Surgalign (0/10) Nihon Kohden (0/7) Bruker (0/6) Dräger (0/5) Masimo (0/5) Agfa-Gevaert (0/5) Nikkiso (0/5) Carl Zeiss Meditec (0/3) Medacta (0/3) Medline Industries (0/3) Ambu (0/2) Demant (0/2) Nipro (0/1)

12 11 40 8

10 8

1 2 2

The top 20 medical device companies have a slightly higher number of women in top executive roles than the rest of the list. Women account for 25% of leadership roles within the top revenue generators, which include medtech giants like Medtronic, Stryker, Abbott and Boston Scientiﬁc. Ranking the lowest in the top 20 was Medline Industries with no women executives and Henry Schein and Owens & Minor with 13% of their executive roles being held by women. The average composition within those companies is also slightly above-average with women in 23% of executive roles. “The medical device industry is full of women and men striving to make a better world through health technology. There’s been no better example of the virtue of this mission driven industry than its performance during the COVID-19 pandemic,” MassMedic President Brian Johnson said. “However, like many industries, there is a persistent disparity in gender equality in the executive suites of our industry, despite recent gains and heightened attention to the issue,” he said. “While many companies have done a commendable job of nurturing and promoting women to the highest ofﬁces, the only way to truly improve gender equality in the executive suite, as an industry, is to benchmark, set goals and execute relentlessly on creating an environment where women feel they have allies and have their voices heard.” 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 and board members in the mix. www.medicaldesignandoutsourcing.com

48 40 39 36 21 12 11 10 8 8 2 2 1

human resources finance divisional presidents regulatory affairs legal medical or clinical information and technology communications or public affairs marketing corporate secretaries manufacturing chiefs of staff R&D

Hillrom

53% women in executive roles (n/a in 2020) 17 key personnel; nine women

BARBARA BODEM, CFO; AMY DODRILL, president, global surgical solutions; CHERYL JAMES, chief human resources officer; MARY KAY LADONE, SVP, corporate development, strategy and investor relations; ANGELA LEE, chief talent and diversity officer; DEBORAH RASIN, chief legal officer and secretary; ILANA SHULMAN, chief compliance officer; JESSICA SMITH, VP, regulatory affairs; JANET STEVENS, VP, quality assurance

Cardinal Health

39% women in executive roles (42% in 2020) 18 key personnel; seven women

HEIDI HUNTER, president, specialty solutions; DEBBIE WEITZMAN, president, pharmaceutical distribution and The Medicine Shoppe International; SUZANNE FOSTER, president, Cardinal Health at-home solutions; MICHELE HOLCOMB, EVP, chief strategy and business development officer; SARAH WILLS, EVP, chief corporate affairs officer; JESSICA MAYER, chief legal and compliance officer; OLA SNOW, chief human resources officer

Zimmer Biomet

38% women in executive roles (36% in 2020) 16 key personnel; six women

CARRIE NICHOL, VP, controller and chief accounting officer; KERI MATTOX, SVP, investor relations and chief communications officer; ANGELA MAIN, SVP, global chief compliance officer and associate general counsel, Asia Pacific; ELLIE HUMPHREY, SVP and chief transformation officer; RACHEL ELLINGSON, SVP and chief strategy officer; LORI WINKLER, SVP and chief human resources officer 10 • 2021

Medical Design & Outsourcing

DIVERSITY BY THE NUMBERS

Baxter

Stryker

Medtronic

35 key personnel; 12 women

10 key personnel; three women

17 key personnel; three women

Johnson & Johnson

11 key personnel; three women

17 key personnel; three women

34% women in executive roles (35% in 2020) TOBI KARCHMER , VP, worldwide medical; CLARE TRACHTMAN, VP, investor relations; HEATHER WECHET, VP, human resources, global functions, talent management and employee relations; LYNN PAWELSKI, VP, global regulatory affairs; JESSICA HAMELINE, VP, global digital transformation ofﬁce; JEANNE MASON, SVP, human resources; STACEY EISEN, SVP, global communications and president, Baxter International Foundation; JACQUELINE KUNZLER, SVP, chief quality ofﬁcer; KAREN LEETS, SVP and treasurer; ELLEN BRADFORD, SVP and corporate secretary; HEATHER KNIGHT, GM, U.S. hospital products; SHIRLEY XU, GM, greater China

B. Braun Melsungen

33% women in executive roles (no change from 2020) Six key personnel; two women

30% women in executive roles (no change from 2020) KATHERINE OWEN, VP, strategy and investor relations; YIN BECKER, VP, communications and public affairs; KATHRYN FINK, VP, chief human resources ofﬁcer

27% women in executive roles (no change from 2020) JENNIFER TAUBERT, EVP, worldwide chairperson, pharmaceuticals; ASHLEY MCEVOY, EVP, worldwide chairperson, medical devices; KATHY WENGEL, EVP, chief global supply chain ofﬁcer

Siemens Healthineers

25% women in executive roles (0% in 2020)

ANNA MARIA BRAUN, CEO; ANNETTE BELLER, board member, ﬁnance, taxes and controlling, central service departments

Four key personnel; one woman

Alcon

Royal Philips

33% women in executive roles (31% in 2020) 15 key personnel; ﬁve women

KAREN KING, SVP, investor relations and communications; HEATHER ATTRA, SVP, head, global quality; SUE-JEAN LIN, SVP, chief information and transformation ofﬁcer; KIM MARTIN, SVP, chief human resources ofﬁcer; JEANNETTE BANKES, president and GM, global surgical franchise

3M Co.

32% women in executive roles (40% in 2020) 19 key personnel; six women

THERESA REINSETH, SVP, corporate controller and chief accounting officer; SARAH GRAUZE, SVP and treasurer; VEENA LAKKUNDI, SVP and chief strategy officer; DENISE RUTHERFORD, SVP and chief corporate affairs officer; MOJDEH POUL, president, healthcare; ZOE DICKSON, EVP and chief human resources officer

DARLEEN CARON, chief human resources ofﬁcer and labor director

23% women in executive roles (20% in 2020) 13 key personnel; three women

SOPHIE BECHU, EVP, chief operations ofﬁcer; DANIELA SEABROOK, EVP, chief human resources ofﬁcer; DEEPTHA KHANNA, EVP, chief business leader, personal health

Danaher

Medical Design & Outsourcing

10 • 2021

LAURI MAURI, SVP, chief clinical and regulatory ofﬁcer; CAROL SURFACE, SVP and chief human resources ofﬁcer; KAREN PARKHILL, EVP and CFO

18% women in executive roles (11% in 2020) ELIZABETH MCCOMBS, EVP and chief technology officer; AMI SIMUNOVICH, EVP and chief regulatory officer; BETTY LARSON, EVP and chief human resources officer

Abbott

17% women in executive roles (13% in 2020) 23 key personnel; four women

JULIE TYLER, SVP, vascular; ANDREA WAINER, EVP, rapid and molecular diagnostics; LISA EARNHARDT, EVP, medical devices; MARY MORELAND, EVP, human resources

GE Healthcare

13% women in executive roles (12% in 2020) 23 key personnel; three women

KATYA KRUGLOVA, VP, human resources; CATHERINE ESTRAMPES, president and CEO, EMEA; LAILA GURNEY, chief quality and regulatory ofﬁcer

20% women in executive roles (11% in 2020)

Henry Schein

10 key personnel; two women

16 key personnel; two women

ANGELA LALOR, SVP, human resources; JENNIFER HONEYCUTT, EVP

Boston Scientific

18% women in executive roles (25% in 2020) 16 key personnel; three women

WENDY CARRUTHERS, SVP, human resources; MEGHAN SCANLON, SVP and president, urology and pelvic health; JODI EDDY, SVP and chief information and digital ofﬁcer

Managing Editor Jim Hammerand contributed to this report. 58

18% women in executive roles (17% in 2020)

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13% women in executive roles (7% in 2020) LORELEI MCGLYNN, SVP, chief human resources ofﬁcer; KELLY MURPHY, SVP and general counsel

Owens & Minor

13% women in executive roles (11% in 2020) Eight key personnel; one woman.

SHANA NEAL, EVP, chief human resources ofﬁcer

Medline Industries

0% women in executive roles (not listed in 2020) Three key personnel; zero women

Quality Applications. Endless Solutions. Guide Wires

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For over 49 years, Argon Medical has been a global leader in the manufacturing and distribution of devices for interventional radiology, cardiology, vascular surgery, spine access and related accessories. With manufacturing facilities in Wheeling, IL, Athens, TX and Rochester, NY, our highly skilled employees are committed to providing off-the-shelf or contract manufacturing solutions to fit your needs. We operate major facilities in a controlled manufacturing environment and offer a wide range of specialty devices, components and services that can be configured to your requirements. We are a vertically-integrated GMP medical device manufacturer and take great pride in maintaining an effective quality system, regulatory expertise and ISO 13485:2016 certification.

Manufacturing

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RESEARCH BY THE NUMBERS

DAN I ELLE KI R S H SEN I OR EDI TO R

Women researchers receive a fraction of funding from the world's biggest medtech companies The gender divide in medtech extends beyond leadership and into funding for investigational studies by U.S. physicians.

nly 6.7% of physicians who received research payments from the world's largest medical device companies in 2020 were women, according to an analysis of Medical Design & Outsourcing's Big 100 list of medtech companies and CMS Open Payments data. Among the 20 medical device companies that fund research by U.S. physicians are 3M, Abbott, BD, Boston Scientiﬁc, Johnson & Johnson (dba J&J Surgical Vision and J&J Vision Care), Medtronic (dba Medtronic, Medtronic

Medical Design & Outsourcing

10 • 2021

Minimed, Medtronic USA, Medtronic Vascular), Royal Philips (dba Philips Electronics), Stryker and Zimmer Biomet. Together, those companies paid $3.9 million to 312 doctors in 2020, but only 21 were women, receiving a collective $402,600. Women physicians, on average, received 15.7% of payments from each of the top medtech companies, but accounted for a total of 6.7% of all research payments from the nine companies that reported on the CMS website. Here's a closer look at the funding: >>

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Turbocharge Hospital-Grade Power: NEMA 5-20, 6-15, & 6-20 Cords! Interpower® NEMA 5-20, 6-15, and 6-20 Hospital-Grade cord sets provide the correct amperages and voltages for high-powered medical devices such as portable CT Scanners and X-ray machines, medical-grade treadmills, and ECMO machines—and you won’t find them sitting in a shipping container halfway across the world. The Mark of Excellence NEMA 5-20, 6-15, and 6-20 Hospital-Grade cord sets bear the green dot, signifying rigorous testing in meeting UL 817 (18.2.4.1) and C22.2 No. 21-14 requirements for Hospital-Grade power cords and cord sets. All Interpower Hospital-Grade cords are tested in design and production phases and ready to use right out of the box. Interpower Hospital-Grade cord sets arrive when and where you need them, and they come with Same Day Shipping if in stock—we won’t let your cords degrade week after week inside a sweltering shipping container!

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RESEARCH BY THE NUMBERS

RESEARCH FUNDING BREAKDOWN • 3M doled out $7,430 in research payments to one woman physician in 2020. • Abbott paid $238,380 to 41 physicians last year, two (4.9%) of which were women who received a collective $2,430 (1.02%). • BD's funded $85,102 worth of research payments to ﬁve physicians, none of whom were women. • Boston Scientiﬁc also funded zero women physicians in 2020 out of the $456,397 in research payments to 15 physicians. • Johnson & Johnson, through its two reporting businesses Surgical Vision and Vision Care, paid 10 physicians $96,043 in 2020. Only three (30%) were women, who received collectively $69,320 (72%).

• Medtronic and its three reporting businesses (Medtronic Minimed, Medtronic USA and Medtronic Vascular) doled out a total of $1,115,332 to 107 physicians in 2020. Just 12 (11.21%) of those physicians were women who received a total of $63,923 (5.73%) • Of the 87 physicians funded by $1,450,373 from Royal Philips (dba Philips Electronics), two (2.30%) were women who collectively received $99,497 (6.86%). • Stryker's $189,892 to 24 physicians in 2020 included no women researchers. • Zimmer Biomet backed one woman physician out of 22 total physicians (4.55%), paying $160,000 (65.16%) of the total $245,534.

NOVEMBER 16 @ 11AM Introduction to Autonomous Mobile Robots sponsored by Cornerstone, 6 River Systems, Mouser Electronics

NOVEMBER 16 @ 2PM Robotics-as-a-Service Business Models for Autonomous Mobile Robots

sponsored by Otto Motors, Mouser Electronics

NOVEMBER 17 @ 11AM

Mobile Robots in Manufacturing Environments: Recent Case Studies sponsored by Sick, Mouser Electronics, maxon, ForwardX

NOVEMBER 17 @ 2PM Autonomous Mobile Robots: Scaling from

• Alcon, B. Braun Melsungen, Baxter, Cardinal Health, Danaher, EssilorLuxottica, Fresenius, GE Healthcare, Henry Schein, Owens & Minor and Siemens Healthineers were excluded from this analysis because the CMS database didn't show them giving research payments to doctors in 2020.

NOVEMBER 18 @ 11AM Selection Criteria for Autonomous Mobile Robots

sponsored by Robotnik, Locus Robotics, Mouser Electronics

NOVEMBER 18 @ 2PM Safety and Standards for Autonomous Mobile Robots

sponsored by Sick, FORT Robotics, Texas Instruments, Mass Robotics, Mouser Electronics

NOVEMBER 19 @ 11AM Cloud Based Fleet Management for Autonomous Mobile Robots

sponsored by InOrbit, Mouser Electronics

Pilots to Fleets

sponsored by MiR, Geek Plus, Mouser Electronics

Learn more about upcoming and on-demand sessions at roboweeks.com

RoboWEEK21_halfhorizontal_10-21_Vs1.indd 1

10/20/21 3:11 AM

SPONSORED

2021 Women in Medtech

Audrey A. Sherman Division Scientist 3M Co. B.S. Chemistry Augsburg College

Audrey A. Sherman received her BS in Chemistry from Augsburg College. Audrey has over 30 years of experience at 3M in roles working with all aspects of R&D laboratory operations, organic synthesis, and condensation polymerizations. She holds 140+ US patents, which earned her the honor of becoming the ﬁrst woman at the company to hold 100 patents. She has been an internal 3M instructor on pressure-sensitive adhesive courses including topics on microreplication, silicone, and optical. Audrey has experience working on the scale of grams up to tons. Her technical expertise includes acrylate and silicone pressuresensitive adhesives, release materials, and the cross-linking of polymers. She works bringing technologies, such as, reactive extrusion processing and release liners to large-scale manufacturing polymerization processes.

What first drew you to medtech? I have worked in all kinds of industries from Industrial to Consumer, and Electronics to Graphics, but the ability to combine all that experience existed only in Med Tech. So here I am! When did you first know you wanted to be in the industry? When the trend from consumer electronics began to creep into the health-related areas, I knew that I wanted to lean that way. What are some of the barriers women face in today’s medtech industry, if any? I think that some barriers may exist for women in this field because it is such a combination of traditional industrial and electronics. I do think bringing in the health and wellness and the fact that this area will need so much collaboration across multiple functions. To me, this speaks to women taking more leading roles. Describe your biggest leadership challenge. My biggest leadership challenge was when I first moved from team member to team leader. A team of 8 men and myself. How did you conquer it or resolve it, or what was the outcome? Another leader told me to make a stand and delegate more work to the team, including taking the minutes. He suggested I not even bring any devices to take minutes and simply ask if others would do so. They did just what was asked, and I have never stopped asking and delegating since. The delegation felt just like leaving my baby with the first babysitter, and of course it all worked out once I got over that fear of letting go. In your opinion, what more can be done to promote greater participation of young women in the medtech industry today? I think that the more and more this industry seeks to solve life issues for women, in a true non-invasive way, women should see where and how they are needed to make this a reality and can step in to do so. If you want something that can work for women, you will need women to design it. For the rest of Audrey A. Sherman’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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10 • 2021

Medical Design & Outsourcing

SPONSORED

2021 Women in Medtech

Shannon Hoste MSM, MSSE

President Agilis Consulting Group Asst. Professor Pathway for Patient Health B.S. Mechanical Engineering University of Toledo M.S. in Management Mount Vernon Nazarene University M.S. in Cognitive Systems Engineering Ohio State University

Shannon is the president of Agilis Consulting Group and an assistant professor in the Quality Science Education program at Pathway for Patient Health. She is active on several standards and conference committees for medical devices and combination products. Formerly, Shannon worked as team lead for human factors in FDA’s Center for Devices and Radiological Health (CDRH) and as reviewer within the Center for Drug Evaluation and Research (CDER). Shannon has a earned a B.S. in mechanical engineering from the University of Toledo, a M.S. in management from Mount Vernon Nazarene University, and a M.S. in cognitive systems engineering from the Ohio State University.

What first drew you to medtech? When did you first know you wanted to be in the industry? It was a journey. At 17, armed with a Pell grant and two jobs, I went to study Mechanical Engineering at my local university. I knew I wanted to use my ‘geek’ skills and to help people. I considered medical school; however, I could not figure out how to make the financials work. At 19 I started working in the power transmission industry (conveyor systems for steel mills, sugar mills etc.) This helped me be financially independent; however, I had not yet found my career passion. This came at 23, when I took a job at Battelle Memorial Institute working on Medical Device Development within their Product Development Group. As a mechanical engineer, I was working on material selection, mechanism design, design for manufacturability, etc. I found my calling in medtech. I knew it immediately. My journey did take a turn though. I was investigating field failures on devices that were fracturing, due to, as it turns out, users lubricating their devices with butter and motor oil. This embrittled the plastics and voila: fracture. My analytical, engineer brain was frozen. I remember asking myself, how do I write requirements and predict risks when a user can do anything? How do I better understand the users? From this question, being a learner, I started to walk from Battelle over to Ohio State and discovered Cognitive Systems Engineering or as I think of it, how humans and technology work together. This is where I could make a difference in the medtech industry! While common in aviation and nuclear science, use-related risk and human factors engineering were not common fixtures in medtech product development at this point in the 1990’s. As my job transitioned from mechanical engineering to systems engineering at Battelle, I continued to take classes and bring that knowledge back to medical device product development. Eventually I completed a MS degree in Cognitive Systems Engineering and a MS degree in Management; because it was clear that, if I wanted to drive Human Factors principles in the medical product development process, I better be good at driving organizational change. I took this to Intel, Stryker, FDA, Illumina, and now to our clients here at Agilis Consulting Group. For the rest of Shannon Hoste’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

Medical Design & Outsourcing

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SPONSORED

2021 Women in Medtech

Sarah Ehrlich Sustaining Mechanical Engineer Argon Medical Devices B.S in Mechanical Engineering University of Texas at Tyler

My parents knew I would become an engineer before I did. Growing up, I was the big sister who put back together whatever my younger siblings decided to tear apart. I started as an English major in college with aspirations of becoming a journalist. However, I grew bored and desired something more challenging, where I could make an impact, help solve problems, and improve someone’s quality of life. That is when my dad suggested engineering. I switched programs and knew that this was where I am supposed to be. Fast forward and I am a part of the CIP Team (Sustaining Engineering) where I have the privilege of working on projects which improve product quality, grow the company’s portfolio, and solve challenges related to new product launch or on-going design changes.

What first drew you to medtech? When did you first know you wanted to be in the industry? During a lecture in Linear Circuits, my professor used the example of an EKG to introduce noise removal techniques. I knew instantly that I wanted to apply the tools and knowledge I would learn throughout my undergrad in the medical field in order to help people – to contribute in developing and improving medical devices/ technology in order to enhance the lives of patients and end users. What could be more rewarding? Describe your biggest leadership challenge. How did you conquer it or resolve it, or what was the outcome? Communication. I know – this is one of the most important qualities for a successful project manager. I tend to lean on the side of quiet, introverted tendencies and take the burden of picking up slack, missed tasks or any failures upon myself to resolve without “bothering” the team. While there has been improvement, this is a challenge I am still working on with help from my very patient mentor because you can always be better at communicating. In your opinion, what more can be done to promote greater participation of young women in the medtech industry today? Communicate the accomplishments and successes of women in medtech industry. Encouragement to pursue a STEM path that could lead to the medtech industry should not be limited to those ready to start a career. We should also focus on the young girls and providing them the encouragement and opportunities to develop their problem solving and critical thinking skills and expose them to the impacts that they could make in the medtech industry. Why is it important for companies to be more inclusive and have more women in charge? If a company is inclusive, that shows me they value different viewpoints. How could you fail if you have the opportunity to look at a problem or task from various perspectives? It takes a team and being more inclusive and promoting women into position of leadership and decision making could only strengthen the outcomes within a company. For the rest of Sarah Ehrlich’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech www.medicaldesignandoutsourcing.com

10 • 2021

Medical Design & Outsourcing

SPONSORED

2021 Women in Medtech

Sophie Marcoux Director of Product Development Argon Medical Devices B.S in Food Engineering Université Laval, Quebec City, Canada I graduated from the University of Laval in Quebec City with my Bachelor of Engineering. After a year of experience in consulting with SNC Lavalin, I joined Medical Devices Technologies in Gainesville, Fl as an Engineer I. Throughout my time with Medical Devices Technologies, I was promoted to a management role and tasked with overseeing the development of single-use disposable medical devices. In 2006, the company was acquired by Angiotech Pharmaceuticals, and I was promoted to Director of Product Development. My team and I were responsible for the development and clearance of a growing portfolio of interventional radiology medical devices. In 2013, I joined Argon Medical Devices, Inc. as the Director of Product Development. My focus was on growing a team of talented people to focus on the “D” of product development. In 20218, Argon Medical Devices was acquired by Weigo. The acquisition has led to a signiﬁcant investment in our product development capabilities. As an organization, this year is our “Year of Innovation” with multiple new product market releases.

What first drew you to medtech? When did you first know you wanted to be in the industry? Honestly, it was the first employment opportunity I had in the United States. The tragic events of 2001 rightfully complicated employment of foreign professionals in the United States. After being employed as Engineer I to support equipment maintenance and labeling for a medical device company, I wanted to be more involved in product development, and seized the opportunity to become a Project Engineer. After almost 20 years, I never looked behind, I found my calling in the world of medical technologies. Describe your biggest leadership challenge. How did you conquer it or resolve it, or what was the outcome? In our industry, a challenge is to lead competent engineers to embrace Design Control. It is a useful and powerful tool. Furthermore, it is the regulation. Embracing it and moving through it makes everyone better at what they do. In your opinion, what more can be done to promote greater participation of young women in the medtech industry today? Start young! We need to bring a focus on STEM careers in high school. I have seen a lot of positive changes in general attitude towards women in STEM careers. I’ll reiterate what I said earlier, a woman can do whatever she concentrates on and pursues with all her passion. Why is it important for companies to be more inclusive and have more women in charge? I think a diversity is a great thing. It brings different ways to approach a project and different solutions to problems. However, I do not think “positive discrimination” is the solution. If a woman wants a specific job or title then she needs to be willingly to put forth the effort to make herself the most qualified candidate for the position. As a woman myself, I never want anyone to have the thought that I got the position because I was the “female candidate”. For the rest of Sophie Marcoux’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

Medical Design & Outsourcing

10 • 2021

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SPONSORED

2021 Women in Medtech

Lindsay Fleming Commercial Manager, Healthcare— Color & Additives Avient Corp. B.S.E. & M.S. in Chemical Engineering Arizona State University

Lindsay Fleming is the Healthcare Commercial Manager for the Color & Additives division at Avient Corporation, a premier provider of specialty polymer formulations, color and additive systems, packaging solutions, and polymer distribution. She has been with the company for over 7 years and oversees the commercial growth development of the healthcare segment. She focuses on fostering innovation, collaboration, and speciﬁcation support for polymer color & additive technology solutions to satisfy unmet needs and challenges of medical device companies. Lindsay received her Bachelor of Science in Engineering and Master of Science degrees in Chemical Engineering from Arizona State University. Prior to joining Avient, she spent several years in the beverage manufacturing industry working as an engineering intern focused on continuous improvement initiatives.

What first drew you to medtech? When did you first know you wanted to be in the industry? Growing up, I was surrounded by family in the healthcare space. I always had a love for science and innovation to improve the quality of life. My undergraduate and master’s education was in chemical engineering and I wanted to be able to use that foundation in my career. I was offered a position at Avient (formerly PolyOne) which immersed me into the medical device industry. I knew I would have the freedom to support the development of material solutions that make a difference in medtech. As time went on, I discovered a strong affinity for supporting the development and specification of materials used to produce medical devices. Describe your biggest leadership challenge. How did you conquer it or resolve it, or what was the outcome? My biggest leadership challenge is probably one that has yet to be conquered. Motivating others and managing stress, especially in the environment caused by the COVID-19 pandemic, has been a significant and ongoing challenge. There are so many things outside the control of myself, our team and even our organization, it can be difficult to inspire others to navigate these situations. Almost everyone has experienced some amount of burnout due to these circumstances, but reinforcing that our colleagues have an experienced team supporting them, and ensuring that they do not feel alone in the challenges they face, we work together to overcome these obstacles. I do all I can to set a good example for my team and be a source of optimism. By modelling the behaviors that will help ensure their success, and appreciating my team for their achievements, I feel that we can work through any challenges that we face. In your opinion, what more can be done to promote greater participation of young women in the medtech industry today? As Marian Wright Edelman once said, “You can’t be what you can’t see.” That’s not to say that there haven’t been tremendous strides over the past few years with women in medtech, but I think we’ve only just begun to scratch the surface. Starting at a young age, having girls engage in a diverse set of projects or activities is a great way to encourage passion, confidence, and curiosity for STEM related industries. From there, as young women develop through the course of their education, hands-on experiences (internships or co-ops) and strong role models can provide them with motivation, empowerment and a desire to continue to learn and grow. For the rest of Lindsay Fleming’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech www.medicaldesignandoutsourcing.com

10 • 2021

Medical Design & Outsourcing

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2021 Women in Medtech

Svetlana Contrada Product Development Manager Berry Global M.Sc. in Chemical Engineering Moscow Academy of Fine Chemical Technology Ph.D. in Polymer Science Moscow Research Institute for Plastics MBA in Strategic Management Rutgers

I took the exciting opportunity in medical adhesive tapes with Berry in 2009 as a principal scientist, and became a product development manager in 2012. I have over 23 years of the industrial experience in PSA tapes R&D. Since 2002, I was actively involved with the Pressure Sensitive Tape Council (PSTC), a trade association for PSA adhesive tape manufacturers and suppliers. I have 27 granted patents and over 120 patent publications. I live in New Jersey with Richard, my husband of 25 years, and our son Edward, 21.

What first drew you to medtech? When did you first know you wanted to be in the industry? For the first time, I was fascinated with polymeric materials in the ninth grade of high school, when I first learned about polarization of polymer-based dielectric materials. I still have that textbook and refer to it occasionally for inspiration! Early on, my attraction was to the applied research and development of new materials for practical use. I started my career as a polymer scientist in the industrial sector. Over time, I gravitated toward the medical product applications because of the profound positive impact they have on human life. When an opportunity at Berry presented itself, the product line and nature of the products for medical applications is what drew me the most. Describe your biggest leadership challenge. How did you conquer it or resolve it, or what was the outcome? In the year 2000, after two years with the company as a product developer, I was promoted to a manager position of the R&D department. It was my first time in the management position, and the challenge was to build a strong team. I learned that one employee, who was with the company for over 15 years, was very upset, mostly with my lack of managerial experience. He was oppositional and not willing to communicate. However, this was before the first technical problem occurred, where he could use some help and needed to bounce ideas around. Over the next five years we worked on multiple technical projects and challenges together. Earning his respect and trust in the process was the best outcome I could wish for, and the one I am proud of. His opinion did matter to me a lot! He actually helped to build the stronger R&D team, as a result. After our professional paths took us in different directions, we stayed in touch. Once, he told me that when faced with a technical challenge he often thinks: “What would Svetlana say? What would she do in this situation?” It helps him find the solution. As a leader, I could not dream of better praise. For the rest of Svetlana Contrada’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

Medical Design & Outsourcing

10 • 2021

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SPONSORED

2021 Women in Medtech

Laura Brand VP, Medical & Pharmaceuticals Celanese Corporation B.A., History & Journalism University of Wisonsin-Madison MBA, Marketing, Operations The Wharton School

Laura Brand, VP, Medical & Pharmaceuticals, leads Celanese’s global medical business. She is responsible for delivering on the medical pipeline while focusing on growth opportunities in the Long Acting Dosage and Drug Delivery Device segments. Laura joined Celanese in July 2020 from Amgen where she spent 11 years in roles of progressive commercial leadership, including responsibility for marketing, sales, lifecycle management and P&L in innovative oncology and biosimilars. Prior to joining Amgen, Laura spent 10 years with the Boston Consulting Group, primarily focused on the biopharmaceutical industry. Laura has an MBA from the Wharton School in Marketing and Operations and a BA from the University of Wisconsin (Madison) in History and Journalism.

What first drew you to medtech? When did you first know you wanted to be in the industry? Working in life sciences at my previous company, I was exposed to many innovative treatments that dramatically improved the lives of patients. But I also became aware of the challenges of drug delivery and ensuring the best patient experience and outcomes. At Celanese, I am very proud to play a role in optimizing drug delivery devices that are more sustainable and improve the overall patient experience. Describe your biggest leadership challenge. How did you conquer it or resolve it, or what was the outcome? I have been in several situations where I have been asked to lead a team where I don’t have the specific experience or expertise that many of the people on the team possess. As a district sales manager without much therapeutic area experience, I did a lot of listening and was very clear about the value I could bring (and not bring). Our team landed a first-place spot (important in sales), retained key at-risk employees, and I am still in touch with many of my team members almost a decade later. In my current role I brought medical experience, but did not have knowledge about polymers and their applications. Our team is successfully growing the business. Building a high-functioning team, actively listening and openly acknowledging vulnerabilities have been critical success factors in both examples. In your opinion, what more can be done to promote greater participation of young women in the medtech industry today? Since career ambitions start at a young age, it’s important to make young women aware of opportunities in the medtech industry — both the engineering and business opportunities. Many of these women have relatives or friends who are also patients who receive some sort of treatment for an ailment. Connecting at this fundamental level and describing how they can have an impact on patient lives and the evolution of med tech, as early as high school (speakers, conferences) and continuing through college and graduate school can promote greater participation of young women in the medtech industry. For the rest of Laura Brand’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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10 • 2021

Medical Design & Outsourcing

SPONSORED

2021 Women in Medtech

Kira Switalla Custom Applications Engineer CPC (Colder Products Company) B.S. Mechanical Engineering University of Minnesota-Twin Cities MBA Concordia University - St. Paul

After completing a co-op program with CPC and graduating from the University of Minnesota with a bachelor’s degree in mechanical engineering in 2017, I accepted a position as a test engineer for CPC’s biopharmaceutical business. During this time, I also completed my MBA. Recently, I transitioned into a new role as a custom applications engineer where I work on custom solutions for another rapidly growing business unit within the company. I’m also an active member of the CPC Green Team, which leads initiatives that promote environmental sustainability. Outside of work, I volunteer for TC Food Justice, which reduces food waste and hunger within the community.

What first drew you to medtech? When did you first know you wanted to be in the industry? My interest in medtech began while I was undergoing physical therapy for a knee injury I experienced playing high school soccer. Over the course of many PT sessions, the physical therapist talked about exciting medical innovations in prosthetics for athletes. My fascination with these innovations led me to pursue a degree in mechanical engineering. I was eager to apply math and science to help people through product development in the medical space. Describe your biggest leadership challenge. How did you conquer it or resolve it, or what was the outcome? An organizational restructuring resulted in significant changes in my department. In the short term, the change substantially increased my workload and responsibilities, which was very challenging. I learned a great deal about the importance of adaptability and how to ask for help when I needed it. The department added new team members who I helped train and integrate into the company. Although the situation was stressful at the time, I discovered a lot about myself in terms of how I can empower others and contribute to the team. In your opinion, what more can be done to promote the greater participation of young women in the medtech industry today? Increasing awareness of gender stereotypes and subliminal bias would be beneficial. Healthy work environments that include anti-discrimination policies will also help more women feel confident in the workplace. Organizations also need to offer meaningful career advancement opportunities. Encouraging networking and mentorship and creating situations where women can make an impact are important steps in improving participation within the industry. Leadership teams need to stress the importance of diversity and incorporate this into their company’s strategic goals. For the rest of Kira Switalla’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

Medical Design & Outsourcing

10 • 2021

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SPONSORED

2021 Women in Medtech

Angie Hillyard Engineering Director Spectralytics B.S. Mechanical Engineering North Dakota State University

Angie joined Spectralytics in her current role in March 2020. She leads a technical team that works directly with customers to develop component solutions to meet the complex requirements of state-of-the-art medical devices. Her team is responsible for various stages of component production including program and project management, process development, production support and process improvement. Angie has decades of experience in medical device engineering including more than ﬁfteen years of engineering leadership experience; ten years of experience in manufacturing process development for coronary and peripheral vascular devices, diagnostic, and disposable products; and seven years in spinal implant and surgical instrument development. She is passionate about the medical device industry and about contributing to products that improve people’s lives. As a leader, she fosters a collaborative environment and is continually striving for improvements at all levels. Angie leads by example and through personal expertise, direct involvement, providing clear direction, and timely feedback.

What first drew you to medtech? When did you first know you wanted to be in the industry? I went into my mechanical engineering degree thinking I would pursue a career in the industrial or heavy industries after college. I really did not know about opportunities for Mechanical Engineering in the medtech field until after my sophomore year of college when I had the opportunity to intern at Medtronic. That internship opened new a world of possibilities for me. After seeing so many various product types and how they directly and positively impacted lives I knew I found my calling. From that point on, I was only interested in pursuing a career in the medical device industry and have worked in medtech ever since. In your opinion, what more can be done to promote greater participation of young women in the medtech industry today? STEM education has seen great growth over the years at the high school and middle school levels. Universities and colleges should be aggressively recruiting women to get involved in STEM and the medtech industry. For companies, I suggest having a presence at college & university career fairs and facilitating discussions between young women considering a technical career and those currently in that type of role. My advice for young women is to explore different career opportunities and seek out internships and experiences. Once you understand what companies in medtech do, you will see the meaning and value in the work. In medtech, you can have a fulfilling career actively helping to improve people’s lives, solving complex problems, and challenging yourself. Another way we can promote greater participation of young women in the medtech industry is through education of our teams. Specifically, education around communication and communication differences. Men and women do not always communicate in the same ways. Women tend to be more hesitant to share their ideas, especially if they are not sure they are correct. People in leadership need to provide an environment that encourages and empowers young women to speak their thoughts and share their ideas. Many times, we need to do a better job of listening to the quiet voice in the room and seek out an opinion if one is not offered. For the rest of Angie Hillyard’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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10 • 2021

Medical Design & Outsourcing

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2021 Women in Medtech

Liz Sydnor Director of Microbiology Euroﬁns Medical Device Testing

As Director of Microbiology at Euroﬁns Medical Device Testing, Ms. Sydnor oversees the microbiological testing of medical devices. With extensive industry experience, speciﬁcally in sterility assurance of medical devices and manufacturing, Ms. Sydnor is experienced in standard microbiological test methods, microbiological investigations, protocol validations, test method validations, and data analysis. She spent several years working with leaders in the healthcare testing and manufacturing industries and served in the United States Army as a Petroleum Laboratory Specialist. Ms. Sydnor holds a B.S. degree in biology from Cleveland State University, and is currently pursuing her MBA at Temple University, Fox School of Business.

What first drew you to medtech? When did you first know you wanted to be in the industry I joined the Army almost 20 years ago as a petroleum laboratory specialist. I fell in love with the lab and later stumbled on microbiology during my time in undergrad. My first industry opportunity was with a microbiology lab that tested medical devices. I was immediately intrigued at the vast array of medical devices and clear correlation we had with ensuring patient safety. Describe your biggest leadership challenge. How did you conquer it or resolve it, or what was the outcome? In the beginning I noticed a pattern of not feeling welcomed or accepted in my leadership roles. What I learned is I’m here for a reason, I have a unique set of experiences that make me who I am and that allows me to bring value to my role. Sharing my experiences with my colleagues really helps build lasting relationships. In your opinion, what more can be done to promote greater participation of young women in the medtech industry today? I think it’s extremely important for companies and universities to make a dedicated effort in engaging young women leaders at the grade school level. This gives them an opportunity early on to see what women in this industry do. I’ve met so many young ladies in my career who have said to me “I’ve never met a scientist before”. I’d like to normalize young women considering S.T.E.M. careers. Why is it important for companies to be more inclusive and have more women in charge? Representation matters. There is something encouraging about seeing leaders who look like you. I specifically remember two women leaders early on in my career and I remember thinking to myself “I want to lead an organization like them someday”. Additionally, corporate diversity, equality and inclusion initiatives help cultivate an environment where people feel more comfortable being themselves. From a business perspective there is data to support companies that have a diverse workforce are more profitable. For the rest of Liz Sydnor’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

Medical Design & Outsourcing

10 • 2021

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2021 Women in Medtech

Jennifer Samproni CTO and Head of Global Design and Engineering for the Health Solutions division Flex Jennifer Samproni is the Chief Technology Officer and Head of Global Design and Engineering for the Health Solutions division at Flex, a $24B diversified manufacturing company with 160,000 employees across 30 countries. Flex makes a diverse set of products that touch our everyday lives – from medical devices to coffee machines to cloud solutions and autonomous driving systems for electric cars. As a key member of the executive leadership team, Samproni oversees the $2.4B business unit through industryleading R&D solution delivery and strategic innovation. Prior to Flex, she was the Vice President and Head of Critical Care R&D for the Point of Care Division at Siemens Healthineers. Samproni has more than 25 years of industry experience in medical device product development; she has led engineering and scientific organizations with a specialized focus on functions related to assay development, advanced technology and processes, operational excellence, and systems engineering. A transformational business leader, Samproni is also an accomplished inventor with more than 30 issued patents and patent applications. She sits on the Board of Directors of BrightInsight, the leading global platform for biopharma and medtech regulated digital health solutions, and is based in Boston, Massachusetts.

What first drew you to medtech? When did you first know you wanted to be in the industry? As an early career professional, I was eager to gain experience in an industry where I could meaningfully contribute. I received two job offers coming out of university: the first was developing environmentally friendly pesticides and the other was developing products for diabetes management. My grandmother had been diagnosed with diabetes that year, so I accepted the medical device product development job in the hopes of helping to improve her experience as a patient. In that role, I was able to experience the full product development lifecycle from scientific discovery and engineering through manufacturing and commercial launch. During this time, I witnessed first-hand the tremendous positive impact that meaningful technology and design can have on people’s lives. At Flex, I have the privilege of amplifying that positive impact by helping companies accelerate their medical product time to market through innovation, integration, and disciplined execution. Describe your biggest leadership challenge. How did you conquer it or resolve it, or what was the outcome? Like many others who provided critical products during the pandemic, my team had to navigate supplier shutdowns, material shortages, remote working conditions, and significant uncertainty about the future. We were fortunate in that we had already embarked on our digital transformation and had adopted several methods that eased our transition into the new way of working. For example, digital communication platforms like Teams and project management tools such as Azure or Jira helped our team maintain communication and the ability to collaborate without being physically close to one another. Whether leading through a period of change as we have for the last 18 months or simply leading change, focusing on actions, tools, and processes that amplify trust and transparency has helped to keep the team motivated and alleviated many of the challenges that come with uncertainty. For the rest of Jennifer Samproni’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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10 • 2021

Medical Design & Outsourcing

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2021 Women in Medtech

Gabriela Jaquinto Sr. Quality Engineer Flexan, LLC. Bachelor’s degree in Industrial Engineering University of Illinois at Chicago

I was born and raised in São Paulo, Brazil, and have always been passionate about traveling and exploring different cultures. I permanently moved to the US in 2009 where I went on to graduate from the University of Illinois at Chicago with a Bachelor’s degree in Industrial Engineering. My ﬁrst exposure to the MedTech world transpired when I came across the opportunity to work at Flexan a couple years after graduating. From a young age, I was drawn to activities that allowed me to solve problems and make an impact. It was always important to me to work for an organization that matched my energy and was also committed to making an impact. After 4 years with Flexan, I have not been disappointed. It has been such a challenging yet fulﬁlling journey. I can no longer imagine myself working in any other industry.

What first drew you to MedTech? When did you first know you wanted to be in the industry? When I was first introduced to Industrial Engineering, I was captivated by the flexibility associated with the degree. The idea of being exposed to a variety of engineering tools while still being able to forge my own path was very exciting. When I came across the opportunity to work in MedTech and play a role in the development of medical components and devices designed to improve and even save people’s lives, I knew I had to pursue it. Describe your biggest leadership challenge. How did you conquer it or resolve it, or what was the outcome? Understanding that motivation looks different for each person has been a challenge for me. Each person is unique and brings a different set of skills to the table. That is really what makes the world so beautiful, and chaotic at times. I am slowly learning the different ways to communicate and engage individuals to perform at their highest level to achieve common goals. In your opinion, what more can be done to promote greater participation of young women in the MedTech industry today? I believe it is important for companies to encourage an open dialogue and discussion about diversity in the workplace and demonstrate a commitment to giving women an active voice. In my experience, women tend to be more modest when it comes to their own achievements. Companies should acknowledge the skills and expertise that women bring to the workplace, and foster a culture that empowers, not just women, but all employees to be their best versions. Why is it important for companies to be more inclusive and have more women in charge? Women can be powerful, effective leaders capable of promoting innovation, challenging the status quo, and pushing companies to become more adaptable to changes. I am a firm believer that when individuals from different backgrounds work together, unique ideas are exchanged which ultimately leads to more creative ways to solve complicated problems. For the rest of Gabriela Jaquinto’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

Medical Design & Outsourcing

10 • 2021

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2021 Women in Medtech

Kim Gross Compliance Manager Hobson & Motzer

Kim Gross is the Compliance Manager at Hobson & Motzer, a vertically integrated manufacturer of precision metal components and assemblies that excels at precision metal stamping, coining, and CNC machining, and host of other value-added services and capabilities serving the medical device industry. Kim joined Hobson & Motzer in the engineering department in 1995, contributing to Hobson & Motzer’s early quality management system (QMS) and the ISO 9001 certiﬁcation Hobson & Motzer earned in 1996. As Compliance Manager, Kim lead Hobson & Motzer’s 2020 effort to complete medical-device component certiﬁcation to ISO 13485. In 2019, she was named one of MetalForming Magazine’s Women of Excellence in Metal Forming and Fabricating for her leadership and encouragement of women to pursue a career in manufacturing.

What first drew you to medtech? When did you first know you wanted to be in the industry? Many members of my family are in healthcare—and while I respect that—when I started my career, I was more interested in business. I wasn’t at the company very long when I got the bug for medical component manufacturing. I was able to combine my business management interest with manufacturing products that help save lives, and I got hooked. Describe your biggest leadership challenge. How did you conquer it or resolve it, or what was the outcome? In the early part of my career, it was being a young female systems manager in circles dominated by older men. I’m speaking more of external auditors, customers, and suppliers. Hobson & Motzer trusted a 28-year-old woman—at a time when this was more of a rarity—with the keys to the quality systems, and allowed me to handle the biggest customers with autonomy. When working with people outside our organization, I often was met with a mix of novice bias or straight-up chauvinism. I felt the pressure to always be on my A game. But I didn’t get upset about it; I carried on professionally, and consistently demonstrated that I knew what I was doing. The internal support bolstered that. I won them over, got their respect, and their trust in me grew. It still rears its head externally at times, but very infrequently. In your opinion, what more can be done to promote greater participation of young women in the medtech industry today? Educating children in middle school (even younger) about the vast opportunities for women. If we can expose them to the possibilities, we can begin the interest and foster belief that there is a broader horizon, influencing their trajectory at a younger age. It wasn’t on my radar as a young girl, but I feel fortunate that my upbringing was one that supported the belief that I could do anything, so when I did encounter it later in life, I was not intimidated by it. For the rest of Kim Gross’ insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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10 • 2021

Medical Design & Outsourcing

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2021 Women in Medtech

Jennifer Bolt Senior Vice President, Global Operations and ESG Integer MBA Massachusetts Institute of Technology, Sloan School of Management BS, Industrial Engineering State University of New York at Buﬀalo Jennifer Bolt is responsible for driving consistent, world class performance across Integer’s global operations. She also oversees the Supply Chain, Lean Enterprise, and Environmental Health, Safety & Security functions. Under Jen’s leadership, Integer is implementing sustainable systems that enable the full engagement of the organization to achieve excellence in manufacturing, safety, quality, delivery, responsiveness and efﬁciency. She also leads efforts to instill a culture of continuous improvement within the company. During her 15-year career with Integer, Jen has held numerous executive roles, including leading the Electrochem and Portable Medical businesses, managing supply chain, directing operations across multiple manufacturing facilities and overseeing engineering teams. Prior to joining Integer in 2005, Jen spent 12 years at General Motors/Delphi Corporation in quality and manufacturing leadership roles.

Medical Design & Outsourcing

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What career advice would you give to your younger self? Take control of your career. Do not wait for someone to come and tell you what’s next. The more experience and perspective you gain, the better leader you become. I’ve been very fortunate to advance through a number of functions both as promotions and as lateral moves, but to some extent it was more luck than by design. I believe the experience of sitting in multiple chairs and knowing what it’s like to “walk in the shoes” of my team has helped me gain a higher level of empathy and understanding, which has enabled me to become a better leader. As a young manufacturing engineer, I often hesitated to raise my hand or voice my opinion unless I was 100 percent sure of my answer. I feared being judged or viewed as incapable. If I could go back in time, I would tell my younger self to speak up, to be heard, and to raise my hand for that next opportunity! Why is it important for companies to be more inclusive and have more women in charge? Research has demonstrated time and time again that a diverse leadership team results in increased performance. Companies that embrace diversity and create inclusive environments outperform their peers. At Integer, I’m proud to be the executive sponsor of our Athena Alliance employee resource group (ERG), which focuses on gender diversity and inclusion. Our purpose is to bring gender diversity to all levels and functions of our organization through awareness, mentorship, leadership behaviors, talent development, and support of an environment that fosters gender diversity and inclusion. Our mission is to lead the creation, execution, and adoption of behaviors, policies, materials, and programs that will address the gender diversity gap at all levels and functions within the organization. We believe that ultimately, the efforts of this ERG will provide Integer with access to a larger, more diverse talent pool in a competitive market. By fostering gender diversity at the leadership level and throughout the organization, Integer will beneﬁt from the diverse perspectives that women bring to decision making and innovation, in turn improving business performance. For the rest of Jennifer Bolt’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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2021 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, bio-resorbable polymers, and PEEK implants gave rise to many new devices commercially available today.

What first drew you to medtech? When did you first know you wanted to be in the industry? I remember the moment in the summer of 1988 when I was wowed into the world of miniaturization. I was working for Costar, which later became Corning Life Sciences’ diagnostic disposables division. In the very back of the building, in a tiny room was a research scientist who was working on the early stages of lab-on-a-chip. The scientist, whom I was peering over his shoulder, explained to me that with this technology, we would soon be able to prick your finger, place it on the polymer chip, and through capillary action, the blood would travel to a test area and we would be able to get a blood result within seconds vs. weeks it took at that time. I was hooked! I had to be involved in this industry! Describe your biggest leadership challenge. How did you conquer it or resolve it, or what was the outcome? Two years after receiving my plastics engineering degree, I was promoted to a manufacturing managerial position with process engineering responsibilities over process technicians (not that it should matter but then it did, all of the process technicians were men) who had many more years of practical processing experience than I had. We worked together to address the biggest efficiency challenges, setting achievable goals- first small ones and then challenging ourselves to much more difficult processing issues. We found that we had a lot in common- we all liked to solve problems. The results were that the process technicians were empowered, engaged, and successful in improved process control, reduced scrap, higher efficiency, and also engaged operators and other production personnel shift to shift in a fun and competitive way. I was pleased to see how much this type of team took off in the organization and the impact it had on everyone involved. In your opinion, what more can be done to promote greater participation of young women in the medtech industry today? Volunteer to be mentors to young women at the earliest possible impressionable years. Educate at career fairs, volunteer STEM groups, and bring visually stimulating and interesting applications to show them, starting at the 5th grade level when children naturally articulate interest with inquisitiveness. For the rest of Donna Bibber’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech www.medicaldesignandoutsourcing.com

10 • 2021

Medical Design & Outsourcing

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2021 Women in Medtech

Shannon Diamond Tooling Engineer III Nordson MEDICAL B.S. Mechanical Engineering Rochester Institute of Technology

Shannon Diamond has worked at Nordson MEDICAL since 2010, working her way to a senior tooling engineer. She started her career as a process engineer in semiconductors and a chance meeting propelled her into medical manufacturing. Shannon is responsible for 10-20 mold projects every year in addition to sustaining and improving molds in production. She overhauled the ECO process and drove an update to the general FMEA used on legacy parts at Nordson MEDICAL. She is an ISO-9001 auditor and worked with Nordson corporate EHS to setup and run an on-site safety observation program to empower all employees to own safety. Shannon is a graduate of the Rochester Institute of Technology and holds a Bachelor of Science degree in Mechanical Engineering.

What drew you to medtech? When did you first know you wanted to be in the industry? Honestly, I never knew about the medtech industry. I went to school with dreams to be an aerospace engineer, and the practical nature to realize that a mechanical engineering degree would keep me employed. I found that I enjoyed manufacturing. Knowing that your work leads to an actual product that can be held and used is very rewarding. Being in the medtech field adds value since the components I help make are used to heal and help people. I have even seen my products used to help my family. In your opinion, what more can be done to promote greater participation of young women in the medtech industry today? I believe that most students going into college for science and technology degrees do not know about medtech as an industry. Guidance counselors need to be educated on the variety of work that an engineering degree can lead to and how broad the medical field truly is. Booths at career fairs at any schooling level help with awareness, and companies need to support sending representatives to events and letting the public know what they do every day. Company tours and apprenticeship programs can also help if they are engaged with school resources. Why is it important for companies to be more inclusive and have more women in charge? Companies win when they have diversity. More diverse backgrounds mean more innovation, and innovation leads to profit. Women need to have leadership roles to encourage the younger generation to pursue the career option. Women with talent may not seek a position in medtech because they do not see anyone like themselves in a role they want to obtain. It is easy to pivot into another career that has a history of promoting women. This is a cycle that must be broken. Women need to pursue those roles, and businesses need to be advocates—not only the C-suite executives or Human Resource departments, but employees throughout an entire organization. For the rest of Shannon Diamond’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

Medical Design & Outsourcing

10 • 2021

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2021 Women in Medtech

Yuan Chang Principal Scientist Porex Life Sciences Institute (part of Filtration Group) Bachelor’s of Science in Chemistry Shandong University (China) Ph.D. in Chemistry Emory University

Yuan is the Principal Scientist for the Porex Life Sciences Institute, a business of Filtration Group. The Porex Life Sciences Institute is a new business that brings unique integrated solutions to market to further the ﬁeld of life sciences, including the innovative saliva collection device, Saletto™. Born in northern China, Yuan moved to Atlanta to pursue her Ph.D. at Emory University, where she studied biomolecular chemistry with the application in biomedical engineering. Her research has been published in top journals, including the Journal of American Chemical Society (JACS) and Nature Methods. After completing her Ph. D., Yuan worked in R&D for Alcon, a global medical device company, developing ocular health medical products. While there, she authored over 10 patents and patent applications. She joined Porex Life Sciences Institute (PLSI) as one of the ﬁrst team members in 2021.

What first drew you to MedTech? When did you first know you wanted to be in the industry? In college, I worked in medicinal chemistry as a student researcher. During that time, I was fascinated with how organic synthesis can turn simple small molecules into very complicated structures that can then function as therapeutic medicine. It amazed me that a drug could be made more effective with even the tiniest of chemical modifications. That is the moment I realized how research and advances in technology and engineering can indeed help save people’s lives and improve the quality of lives. When I discovered this passion, I determined that I wanted to pursue a career in the MedTech industry. Describe your biggest challenge. How did you conquer it or resolve it? The biggest challenge so far from my industry job experience was when I became pregnant and had to balance the physical and emotional demands of pregnancy with my work expectations. I found that the best way to overcome this was to find resources for support, including friends, family, and online resources and communities. What is the most important lesson that has guided you in your career? My most important lesson so far has been to learn from mentors. I feel very lucky that I have had several valuable mentors in my career who have unconditionally helped me, guided me, and empowered me. Furthermore, they were very honest and candid regarding career development and the potential challenges that I would face, and they provided invaluable advice through my training and beyond. Why is it important for companies to be more inclusive and have more women in medtech? We need to create a world where equal opportunities exist for all. Women provide unique perspectives and backgrounds, and we should be able to channel that insight into producing products and services that are more applicable and relevant to the female demographic of our consumer base. Furthermore, having more women in the MedTech industry, and especially in positions of leadership, will inspire the younger generation of women brilliant minds and leaders. For the rest of Yuan Chang’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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10 • 2021

Medical Design & Outsourcing

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2021 Women in Medtech

Shawna Pearson VP of Operations Resonetics BS in Mechanical Engineering The University of Miinnesota Shawna Pearson has 25 years of experience in lean manufacturing, process engineering and operations leadership across multiple industries, including 10 years in medical device manufacturing. As VP of Operations at Resonetics, Shawna is responsible for managing four facilities. With a relentless emphasis on continuous improvement, she focuses her teams on creating flow and quality at the source. Prior to Resonetics, Shawna was Sr. Director of Operations at Safe Fleet where she led the operations team to successfully execute best in class service metrics while doubling in size over 4 years. She was a key integrator of new businesses to the platform, drove critical strategic initiatives and led the Continuous Improvement program across the organization. Shawna also led operations and engineering teams to record growth and profits in the switchgear industry at EMI and plastics industry at Ottertail Corporation. Shawna earned her BS in Mechanical Engineering from the University of Minnesota after spending a year studying Automotive Mechanics at Triton College in Illinois. She is a certified Lean Expert and Six Sigma Master Blackbelt.

Describe your biggest leadership challenge. How did you conquer it or resolve it, or what was the outcome? I’ve been through a number of challenges throughout my career, many of them textbook problems, such as capacity constraints during exponential growth. Usually it’s related to various operational levers that we can manipulate, like adding equipment capacity, variable labor, or new capabilities to create competitive advantage. Sometimes it’s downsizing like so many businesses were faced with during COVID shutdowns. Focusing on operational and engineering solutions that provide our commercial team and ultimately our customers with best in class lead-times, quality and cost is part of my DNA. Today’s current labor shortage is one of the most challenging environments I’ve ever been faced with. People are amazingly resilient and adaptable. I’m confident we will come out of this with break-through solutions that will drive much faster conversion to automation and integration of systems. Here at Resonetics, we have quickly shifted our focus to lean manufacturing and automation opportunities to reduce our dependence on labor. We are fast forwarding these efforts because we have to in order to succeed and keep up with the extreme growth we’re experiencing. In your opinion, what more can be done to promote greater participation of young women in the medtech industry today? I’ve struggled with how to do more and impact more people in a positive way throughout my career. I’ve spoken at schools and talked about the importance of math and science. Every chance I get when talking to kids I ask, “what is your favorite subject” and if they say math or science, I’m like great, you should consider engineering! If they don’t say math or science I ask if they like math or science and encourage them to stick with it because you want them to keep all those doors open. The other thing I do now as a seasoned professional in my career is mentoring younger female (and male) team members. This is really fulfilling for me. I think if we all did a few things like these; encouraging children, both boys AND girls, to like math and science, speaking to high school students about the opportunities there are with math and science-based career paths, encouraging young team members in the industry though mentoring, we can make a huge difference. A little support and encouragement can go a long way, especially when it comes from those of us who have been successful in the field. For the rest of Angie Hillyard’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

Medical Design & Outsourcing

10 • 2021

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2021 Women in Medtech

Betty Howard Sr. Radiation Sterilization Manager STERIS Applied Sterilization Technologies B.S., M.S, MBA in Marketing University of Illinois Chicago

Betty has more than 30 years in the Medtech industry and disciplines. She began her career with Public Health RD bench testing and virology, moving through Drug Discovery and new product assessment and applications development, and technical support and education across a variety of Biological Sciences and Chemistry areas. Betty currently supports irradiation sterilization technologies, validations and problem solving, a role she has held for nearly 20 years.

What first drew you to MedTech? When did you first know you wanted to be in the industry? To me the definition of MedTech wasn’t anything to considered or firmly defined. All my positions and focuses have been related to Biology, and support of safety and health care needs. With each position or each class taken you learn more skills, and the beauty of Medtech is you can apply all of the things learned and experiences every day to solve problems or support products that touch millions of people. Describe your biggest leadership challenge. How did you conquer it or resolve it, or what was the outcome? The hardest part is convincing others of the financial value to an organization of having a strong scientist development program, not just a seminar and a quiz, but development of analytic / problem solving skills. Also, that these disciplines can apply across many other disciplines in an organization. Talk about your leadership skills. What is the most important lesson you have learned that has guided you in your career? The most important lesson I’ve learned is you must challenge people to use the skills they are developing, using all the experiences you’ve had the privilege to gain. Also, remember that not everyone learns the same way. In your opinion, what more can be done to promote greater participation of young women in the medtech industry today? This is probably the easiest question here. Expose young girls to science. Don’t focus on the cost or number of years of education, or assume girls will not like something. Make it fun. Children of all ages have a wonder of the world around them; they question everything around them. Scientists never stop asking questions. Learning how things work can be just as exciting to girls as boys. When you are interested in something, the tools you need to learn more about it are not a penalty, they are gift. In general, we should all focus on a family as a team, not just one member of a family doing defined functions. For the rest of Betty Howard’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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10 • 2021

Medical Design & Outsourcing

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Kimberly Mollohan EO Technology Center Manager STERIS Applied Sterilization Technologies B.S. Biology Radford University

Kimberly Mollohan has 23 years of medical device industry experience, beginning her career in a laboratory that supported sterilization validation testing before moving to STERIS. At STERIS, Kim worked her way from assisting with R&D programs to being the manager of a very talented and diverse team of validation specialists. They assist medical device manufacturers with their ethylene oxide sterilization needs, to ensure the products they supply to the public meet the stringent requirements of the medical device industry.

What first drew you to MedTech? When did you first know you wanted to be in the industry? I fell into medtech by accident as I wasn’t aware of it as a career path when I was in college. My original plan was to follow in the footsteps of my aunt and uncle who worked with the US Fish and Wildlife Service. When my husband and I moved to South Carolina, I found the job at the laboratory, and it was there that I learned about the medical device industry. Describe your biggest leadership challenge. How did you conquer it or resolve it, or what was the outcome? My biggest leadership challenge has been delegation. I’ve had to overcome the need to control every aspect of how my team operates and trust them to fly solo and successfully, which of course they have! Talk about your leadership skills. What is the most important lesson you have learned that has guided you in your career? I have patterned my leadership skills after the mentors who have helped me get to where I am today. I will never ask my team to do something I have not done or will not do. As a manager, you must be willing to get in the trenches with your team. In your opinion, what more can be done to promote greater participation of young women in the medtech industry today? We somehow need to expose young women of all ages to the various opportunities in the medtech field. It needs to start in elementary school and follow them throughout the school years. There is no one size fits all answer, but engaging girls at a young age plants the seeds for their future interests. Why is it important for companies to be more inclusive and have more women in charge? Diversity is key in any work environment. Everyone can bring a different perspective to a job and the collaboration that ensues makes for a strong team. Having women in management positions is just one way a company can grow and compete in today’s landscape. For the rest of Kimberly Mollohan’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

Medical Design & Outsourcing

10 • 2021

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2021 Women in Medtech

Madhulika (Maddy) Srikanth Engineering Manager, R&D/ Product Development Team TE Connectivity PhD in Mechanical Engineering Wichita State University Dr. Madhulika (Maddy) Srikanth has been with TE Connectivity for over 5 years, working with the R&D/Product Development Team as an Engineering Manager. Maddy leads multiple projects and validation work with the R&D and product development team for minimally invasive medical device applications. She’s a creative visionary with a track record of key-development inputs in critical-tobusiness projects and acquisitions. Maddy holds a PhD in Mechanical Engineering with her thesis in Biomedical Application of Nanomaterials from Wichita State University. She is a big soccer (football) and Formula-1 racing fan and during weekends enjoys spending time with her family and 2 dogs.

Describe your biggest leadership challenge. How did you conquer it or resolve it, or what was the outcome? My biggest leadership challenge has been keeping my team motivated throughout the Covid crisis. A lot of the work that we do requires hands on activity and a certain amount of physical presence at our workplace. We had a habit of seeing each other and working together every day and we thrive on each others energy – it’s a team effort. During the pandemic a lot of those interactions were restrained and I could see how those distances between teams, over an extended period, had an impact on collaboration and well being. During this time it was very important for me to be present at work every day and keep those interactions going - even as simple as eating lunch together while chatting about life across plastic barriers in our cafeteria. Being supportive and flexible with time off for family support, making it easy for them to reach out to me for any questions they may have and trying my best to be there for them helped to keep our team cohesive in a very difficult time. In your opinion, what more can be done to promote greater participation of young women in the medtech industry today? To inspire young minds into this industry I feel more importance needs to be put on the reality of engineering in medtech. You are affecting a person’s life, and advancing the future of medicine. Often one can get caught up in day-to-day activities at work and lose focus on the big picture. I believe if they took a step back to look at how they potentially impact people’s lives it would inspire them to be a part of it. However, I also feel very strongly that keeping women in medtech is of equal importance. Many women join the industry and come to a cross roads when they want to take a career break or start a family. Companies such as TE Connectivity are taking solid steps to move towards more flexible working arrangements both in where and when they work. This transformation encourages all employees and especially women to stay in the workplace and work in a way that is flexible and accommodating to them. I believe these options help keep women connected to their careers through a crucial time in their lives. For the rest of Dr. Madhulika Srikanth’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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Medical Design & Outsourcing

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2021 Women in Medtech

Kelly L. Stichter General Manager Teamvantage BMSE, University of Michigan MBA, University of St. Thomas Kelly joined Teamvantage as General Manager in 2017 where she leads a team focused on developling and producing products for the medical and defense markets. Her responsibilities include executing the company’s business plan and strategy, integrating operating functions, driving continuous improvement, interfacing with sales to secure new business, sustaining and cultivating the company’s core values and culture and leading special initiatives to drive growth and ensure resources and technologies are in place to support growth and ever-evolving customer and market needs. Kelly has worked in contract manufacturing for over 25 years and has held positions in engineering, operations, quality and executive management in both privately held and public corporations. She embraces the fast pace and challenges associated with growing a business, applying technology to streamline processes, driving continuous improvement and developing teams to deliver creative solutions that improve lives.

What first drew you to medtech? When did you first know you wanted to be in the industry? When I relocated to Minnesota, I was employed by a company involved in the production of products for automotive, consumer and medical markets. Since my experience was in the automotive and industrial markets, initially I was assigned products and customers in those markets. I soon learned more about the medical market and was assigned to work with medical products and customers. I really enjoyed being involved early in the development process - sometimes starting with conceptual idea that required industrial and mechanical design - and working with a cross-functional team, that included the customer, to develop products that could be manufactured and eventually released to the market. The automotive industry provided with a strong foundation in automation, assembly, continuous improvement and root cause methodologies that I have been able to leverage throughout my career, however, the ability to work on products that sustain or improve lives provides me with a greater sense of personal fulfillment. In your opinion, what more can be done to promote greater participation of young women in the medtech industry today? I would like to see greater engagement from high schools and colleges to increase visibility to career opportunities in medtech. Teamvantage participates in programs with high schools and colleges to expose students to careers in manufacturing, specifically medtech. As a result, not only the students but the educators as well have been surprised about the variety positions, skillsets and career options that are available. The implementation of internships and apprenticeships are another great way to expose students to careers in medtech. Teamvantage has utilized both of these options to attract and retain talent. I believe additional efforts can be taken to create partnerships, or an alliance, that would involve OEMs, universities and manufacturers. The focus of this alliance would be to provide students with the opportunity to be part of a team at an OEM or university and then be part of a team at a manufacturing site. This type of exposure would provide a comprehensive oversight in regard the skills and careers required to develop and release a medical product from start to finish. Mentorship opportunities via partnerships or networking with high schools and universities also make a difference. I have personally spoken with several young women and have successfully convinced them to pursue technical or business degrees that have resulted in them obtaining careers with medtech companies. For the rest of Kelly L. Stichter’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

Medical Design & Outsourcing

10 • 2021

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AD INDEX | WOMEN IN MEDTECH | WOMEN IN ENGINEERING

3M Medical....................................................................... 56 Accumold........................................................................ 133 Agilis Consulting Group................................................... 23 Altech Corporation..................................................... 10, 11 Argon Medical Devices.................................................... 59 Asahi Intecc....................................................................... 26 Avient................................................................................. 35 B. Braun............................................................................ BC Beckhoff Automation..................................................... 107 Berry Global........................................................................ 8 Bishop Wisecarver.......................................................... 151 Celanese............................................................................ 21 CentroMotion................................................................. 115 Clippard............................................................................... 7 CGI Inc............................................................................. 157 CPC Worldwide................................................................ 17 Cretex Medical.................................................................. 27 Digi-Key............................................................................. 89 Dodge Mechanical Power Transmission Company, Inc.....97 Eagle Stainless Tube......................................................... 34 ECIA............................................................. 2, 111, 117, 127 Emerson............................................................................ 30 Encoder Products Company.......................................... 102 Eurofins Medical Device Testing..................................... 51 Flex.................................................................................... 47 Flexan................................................................................ 19 FUTEK Advanced Sensor Technology, Inc...................... 13 GE Digital.................................................................. 91, 143 Hobson & Motzer............................................................... 5 Honeywell Process Solutions......................................... 155 igus.................................................................................. 149

Integer............................................................................... 53 International Polymer Engineering................................. 18 Interpower......................................................................... 61 Isometric Micro Molding.................................................. 28 Johnson Matthey.............................................................. 41 Master Electronics.......................................................... 142 maxon ............................................................................. 129 Medbio.............................................................................. 52 MICRO............................................................................... 40 Microchip Technology.................................................... 141 MicroLumen................................................................ 38, 39 Mitsubishi Electric Automation..................................... 103 New England Wire & Tubing........................................... 31 Nordson MEDICAL........................................................... 22 Phoenix Contact............................................................. 147 Porex ............................................................................. 3, 93 Quantum Devices........................................................... 110 RECOM Power GmbH.................................................... 123 Resonetics....................................................................... IFC Sager Electronics............................................................ 109 Siemens Digital Industries Software............................. 101 Siemens Industry, Inc...................................................... 121 SMC Corporation of America........................................ 116 Steris.................................................................................... 1 TE Medical........................................................................ 14 Teamvantage..................................................................... 16 Tegra Medical................................................................. IBC Toxikon.............................................................................. 49 Wago............................................................................... 139 Wolfspeed....................................................................... 100 Würth Industry North America...................................... 135

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Protecting caregivers, treating patients and delivering confidence. It starts with decades of product development expertise. Our vast catalog of standard components can be customized to generate endless possibilities for sets and kits. We put in place processes for ensuring stringent quality levels, managing volumes of documentation and tracking all project details. Add in a full suite of capabilities, and you have a turnkey solution that’s more like a partnership for creating confidence. B. Braun Medical | OEM Division | USA | us.bbraunoem.com | 1-800-359-2439 ©2020 B. Braun Medical Inc. Bethlehem, PA. RX only. All rights reserved. OEM 16-5563 05/20 LMN

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Medical Design & Outsourcing — WOMEN IN MEDTECH 2021

Articles inside

Sandra Saldana, Alva Health

Karleen Oberton, Hologic

Allisa Song, Nanodropper

Shacey Petrovic, Insulet