Medical Design & Outsourcing – WOMEN IN MEDTECH 2023

ALSO INSIDE: THE DESIGN WORLD ENGINEERING DIVERSITY + INCLUSION ISSUE

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Women in Medtech

2023

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Medical Design & OUTSOURCING

October 2023 • Vol.9 No.6 • medicaldesignandoutsourcing.com

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WOMEN IN MEDTECH | ENGINEERING DIVERSITY + INCLUSION | CONTENTS

Medical Design & OUTSOURCING HERE’S WHAT WE SEE: ......................................12

INSIGHTS: ...........................................................86

208 women in executive roles at the top medical device companies in the world .........15

Designing the Future of DEI in Engineering ........88

Empowering medtech innovation through diverse leadership

How Ambu seeks to hold its top spot in single-use scopes .......... 16 The secret behind Intuitive’s surgical robotics success .................. 26 Patient-centered VR design fuels Penumbra's Immersive Healthcare future .............................. 36

10 emerging medtech leaders ............................42 Ananya Health wants to bring battery-powered cryoablation to the global fight against cancer ..................... 42 Medasense’s finger probe makes pain management easier for anesthesiologists.............................. 46

Four steps medtech startups can’t put off .........50

Making the Case for DEI in Engineering .............94 Changes in Engineering Demographics .............100 Problem solving in space and life ......................104 Eileen Collins Telecom’s fighting spirit ....................................110 Eugina Jordan From high school interest to test engineer .......114 Kathryn Baisley

Medical device litigator and consultant Ginger Pigott highlights early decisions for startups that could have major ramifications down the road.

Strong engineers aren’t afraid to ask for help .....118 Laine Chan

Medtech founder Jennifer Fried is back with a new startup.............................52

An engineer since childhood .............................122 Nortbera Lu

Explorer Surgical’s former CEO now has her sights set on treating pulmonary embolism with a new catheter system.

Diversity in medtech: Women hold less than a quarter of executive roles ...........57 An analysis of the largest medical device companies shows little progress, with some companies still reporting no women in top leadership positions.

Biosense Webster aims to expand access to AFib care ...........................67 Electrophysiology is "an incredibly vibrant space," said Nikki Sidi, but access remains a challenge.

Accumold - Kayla Whitesel ..................................... 70 Carl Stahl Sava Industries - Chaitali Pawar ............. 71 Confluent Medical Technologies - Jill Ellison ......... 72 Cretex Medical - Lauren Roy .................................. 73 Donatelle Plastics Inc. - Treasa Springett ............... 74 Eurofins Medical Device Testing - Liz Sydnor ........ 75 Flexan - Dani Rojas ................................................ 76 Infus Medical Co., Ltd. - Prim Chanarat ................. 77 Instron - Dania Neiroukh ........................................ 78 Integer - Carol Russell ............................................ 79 Intricon - Sofía Vargas ............................................ 80 LEMO USA, Inc. - Doty Lazareto ............................ 81 Medbio LLC - Monica Restorff ................................ 82 Phillips-Medisize - Bailey Harder ............................ 83 Resonetics - Audrey Bell ........................................ 84

6

Let’s address the culture-war issue

Medical Design & Outsourcing

|

DESIGN WORLD

10 • 2023

Allegro MicroSystems - Casey Alvarado .............. 124 B&R Industrial Automation - Kristen Gallett ........ 125 B&R Industrial Automation - Rachel Luczak ......... 126 Beckhoff Automation - Ronda Devereaux ............ 127 Bishop-Wisecarver - Alina Kim ............................. 128 Cinch Connectivity Solutions Inc. Rachael Eustice .................................................... 129 DigiKey NW NM Chapter of Women in Electronics............. 130 LEMO USA, Inc. - Courtney Francis ...................... 131 Mitsubishi - Roberta Talarico Galeno Cavalcanti ..... 132 Rockwell Automation - Linda A. Freeman ............ 133 WAGO Corporation - Alexandra Olson ................ 134 Ad Index ............................................................. 136

Women in Medtech

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2023

HERE’S WHAT WE SEE

Empowering medtech innovation through diverse leadership

A

“While there has been progress in increasing the representation of women in medtech leadership, much work is needed. A diverse C-suite is not only a reflection of the patients served but also a prerequisite for innovation.”

12

Medical Design & Outsourcing

s we dive into the annual Women in Medtech special edition of Medical Design & Outsourcing, it’s evident that the conversation around medical device executive diversity continues to be a pressing one.

In this edition, we analyze the composition of women executives at the largest medtech companies, shedding light on the progress made and the ground that still needs to be covered for gender equity at the top. The numbers tell an important story as women currently hold just 23.6% of executive leadership roles at the top medtech companies worldwide. Notably, our 2022 analysis showed a similar figure of 23%, indicating incremental progress.

It is also essential to recognize some of the leaders who are breaking barriers and making a difference.

We’ve rebranded our former “Startups” section as “Emerging Leaders” to showcase innovations from smaller medtech companies, ranging from those that have a prototype to others that are commercial-stage and anything in between.

This year, we feature Ananya Health’s story with co-founder and CEO Anu Parvatiyar, who aims to create a batterypowered cryoablation device that works at the point-of-care in emerging markets.

We also feature Medasense Biometrics and its founder, Galit Zuckerman-Stark, who is changing how pain management is measured intraoperatively.

As we explore stories of women leaders in this edition, it becomes clear that diversity is not merely a matter of representation, but a catalyst for innovation.

Danielle Kirsh | Diverse teams bring diverse Senior Editor | perspectives and experiences to Medical Design & Outsourcing | the table, allowing companies to dk i rsh @ wtwh m e di a .c o m | develop products that cater to the diverse needs of the global patient population.

Featured leaders in this issue include Ambu CEO Britt Meelby Jensen, Penumbra President of Immersive Healthcare Gita Barry and Biosense Webster U.S. President Nikki Sidi. In our cover story, Intuitive Surgical Chief Medical Officer Dr. Myriam Curet outlines how data and surgeon collaboration keep the surgical robotics company at the forefront of innovation.

While there has been progress in increasing the representation of women in medtech leadership, much work is needed. A diverse C-suite is not only a reflection of the patients served but also a prerequisite for innovation.

Find more insights from women leaders in this sixth edition of Medical Design & Outsourcing’s Women in Medtech issue.

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2023 WOMEN IN MEDTECH

Our Life Sciences editorial team drew on its resources to create this list of who’s who in medtech leadership. The list is alphabetized by company and includes presidents, VPs and CEOs, along with the year they were appointed, according to personal LinkedIn profiles and company websites (as of Aug. 21).

Theresa Reinseth

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

Karina Chavez

Group President, Consumer 3M Appointed in 2021

Zoe Dickson

EVP and Chief Human Resources Officer 3M

Lisa Earnhardt

Julie Tyler

Appointed in 2019

Appointed in 2021

Mary Moreland

Suzanne Winter

Appointed in 2019

Appointed in 2022

Andrea Wainer

Nathalie McCaughley

EVP, Medical Devices Abbott

EVP, Human Resources Abbott

EVP, Rapid and Molecular Diagnostics Abbott

SVP, Vascular Abbott

President and CEO Accuray

President HealthCare IT Agfa-Gevaert Appointed in 2022

Appointed in 2019

Appointed in 2021

www.medicaldesignandoutsourcing.com

(continued on the following pages)

10 • 2023

Medical Design & Outsourcing

15

2023 WOMEN IN MEDTECH

how

Ambutop spot

seeks to hold its

in single-use scopes

Jennifer Olson

EVP, Customer Success Align Technology

Sue-Jean Lin

Appointed in 2022

SVP, Chief Information and Transformation Officer Alcon

Kelli Howell

EVP, Clinical Strategies Alphatec

Appointed in 2018

Britt Meelby Jensen

President and GM, Global Surgical Franchise Alcon

CEO Ambu

Appointed in 2019

Appointed in 2022

Kim Martin

Francesca Morichini

SVP, Chief Human Resources Officer Alcon Appointed in 2020

Sreelakshmi Kolli

EVP, Chief Digital Officer Align Technology Appointed in 2020

Julie Coletti

EVP, Chief Legal and Regulatory Officer Align Technology Appointed in 2022

16

Medical Design & Outsourcing

Chief HR Officer Amplifon Appointed in 2017

Amy Horton

SVP, Global Head Quality and Regulatory Affairs Alcon Appointed in 2022

CHRI S N EWMARKER EXECUT I VE EDI TOR

Appointed in 2018

Jeannette Bankes

Heather Attra

AMBU’S CEO SEEKS TO “ZOOM IN” ON WHAT THE DANISH COMPANY HAS DONE BEST.

VP, Chief Accounting Officer Artivion Appointed in Appointed in 1998

Jean Holloway

SVP, General Counsel, Chief Compliance Officer and Corporate Secretary Artivion Appointed in 2015

Rochelle Maney

VP, Global Quality Artivion

M

ore than a year after she took over the corner office at Ambu, Britt Meelby Jensen recalls what brought her into leadership. She already had a seat on the board at the maker of single-use endoscopes, anesthesia and airway management devices, and patient monitoring technology.

“We were in a situation where we saw challenges with declining profitability and we were not able to meet our revenue targets that we had put out to The Street. So it was around that time the chairman asked if I wanted to run the company,” Jensen said during a recent DeviceTalks Weekly interview.

In many ways, Ambu’s challenges stemmed from its success. The Danish company, founded in 1937, launched the Ambu Bag in the 1950s. The self-inflating, manual resuscitator is still a fixture in hospital emergency departments to this day.

Ambu’s close connections with health providers’ ICU and anesthesia departments led the company to develop single-use scopes. Disposability addressed concerns over reusable scopes causing infections and also reduced delays in availability from having to wait for scopes to get cleaned and repaired before each use, according to Jensen, who recounted the history.

“The customers were looking for a solution that they would have ready at hand when a patient cart came in,” Jensen said.

In 2009, Ambu launched the first single-use bronchoscope, the Ambu aScope Broncho. The device developer now sells its fifth-generation Ambu aScope 5 Broncho.

Appointed in 2019

10 • 2023

www.medicaldesignandoutsourcing.com

Ambu CEO Britt Meelby Jensen Image courtesy of Ambu

The visualization business that includes single-use scopes makes up more than half of Ambu’s more than $600 million in annual revenue.

“I was and continue to be very excited about the potential we have as a company, having really proven that we are able to move into a new area and change the paradigm working closely with our customers,” Jensen said.

In recent years, Ambu has expanded its single-use scope lineup from pulmonology into new endoscopy segments: urology, gastroenterology and ear, nose and throat.

However, the strategy has required building new relationships with health professionals elsewhere in health systems to educate them on the operational efficiencies and clinical benefits that could come with single-use scopes.

“We're facing a situation where we underestimated some of the time it took for our customers to adopt a new way of working,” Jensen said.

Meanwhile, Boston Scientific and other companies have entered the singleuse scope space. Jensen welcomes the competition: “I think it's good for us to have more companies with single-use endoscopes that can help bring attention to the benefits for our customers there.”

www.medicaldesignandoutsourcing.com

10 • 2023

Medical Design & Outsourcing

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2023 WOMEN IN MEDTECH

BR IT T ME E L BY JE NS E N ON HOL D ING AMBU’S TOP S P OT IN S ING L E US E S C OP E S ; AL S O, WHY IS WAL L ST R E E T CR ANK Y ?

In this interview, Jensen highlights the benefits of single-use endoscopes, such as improved workflow and reduced waiting times, and emphasizes Ambu’s focus on sustainability. She also discusses the company’s plan to retain its position in the white-hot single-use scope industry. devicetalks.com/podcast/

Jensen, who originally entered the life sciences sector as a consultant and a Novo Nordisk executive, successfully led Atos Medical until the laryngectomy care company’s acquisition by Humlebaek, Denmark-based Coloplast in early 2022. Before that, she was CEO of Zealand Pharma from 2015 to 2019, leading the Copenhagen-based diabetes company through its 2017 IPO. “I could see that some of my experience fitted very well into some of the challenges that we had, both in terms of getting the financial situation back on track, as well as also getting investor credibility back,” Jensen said.

“In every job I’m in, I am very curious to learn and to develop. … I think I leveraged what I've learned from my past career, and then I bring that into a new situation. I'm very focused that it's not only about me, but it's about the whole organization starting with the executive leadership team [and] building a strong leadership team that collaborates well and engages.” (continued on page 21)

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2023 WOMEN IN MEDTECH

Ann Desender

(continued from page 18) Since taking over Ambu in May 2022, Jensen has made some tough choices to set up the company for future success, including laying off 200 employees. The company’s new Zoom In strategy centers on meeting true customer needs, executing efficiently, sustainability, and people and culture.

As of the writing of this article in September 2023, Ambu was wrapping up its fiscal year with expectations of 6-8% revenue growth, up from 4% the year before. During Q3, pulmonology scopes returned to positive growth year-over-year, and sales of urology and ENT scopes was growing strongly.

Said Jensen: “With our new Zoom In strategy, it's all about focus and execution, making sure that we really focus in on all the segments that we're in to do a good job and then also focus on how we execute, because we've had a couple of years where things have really moved fast.”

Ambu’s strategy has always been to be close to its health provider customers, according to Jensen.

“We continue to challenge ourselves, understanding the customer's needs [to] come up with new and greater things.”

Deborah Yount Chief HR Officer AtriCure Appointed in 2022

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

Moji James

SVP and General Counsel Avanos Medical Appointed in 2021

Michelle Quinn

CEO Barco

EVP, General Counsel BD

Appointed in 2021

Appointed in 2023

Jeanne Mason

Dara Wright

EVP and Chief Human Resources Officer Baxter

EVP; President, Clinical Diagnostics Group Bio-Rad

Appointed in 2006

Appointed in 2020

Stacey Eisen

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

VP, Corporate Communications and Community Relations Avanos Medical Appointed in 2023

Anna Maria Braun

CEO B. Braun Melsungen MDO could not confirm date of appointment

Annette Beller

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

EVP, Global Supply Chain Bio-Rad Appointed in 2020

SVP, Chief Quality Officer Baxter

SVP, Global Quality and Regulatory Boston Scientific

Appointed in 2016

Appointed in 2017

Heather Knight

Jodi Eddy

EVP and Group President, Medical Products and Therapies Baxter

Katrine Kubis

Diane Dahowski

Rosaleen Burke

Jacqueline Kunzler

Appointed in 2022

Appointed in 2020

Appointed in 2022

An Steegen

SVP, Quality Avanos Medical

CFO AtriCure

EVP and Chief People Officer BD

Appointed in 2016

Angela Cushman

Angela Wirick

Shana Neal

CFO Barco

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

Appointed in 2019

Meghan Scanlon

Tobi Karchmer

SVP and Chief Medical Officer Baxter Appointed in 2021

EVP, Chief Quality and Regulatory Officer and Public Affairs BD Appointed in 2020

SVP, Market Access and Chief Marketing Officer Boston Scientific Appointed in 2021

Wendy Carruthers

EVP, Human Resources Boston Scientific

Elizabeth McCombs

EVP and Chief Technology Officer BD

Appointed in 2022

Debbie Weitzman

CEO, Pharmaceutical Segment Cardinal Health

Appointed in 2021

Appointed in 2022

MDO could not confirm date of

EVP, Technology and Global Services and Chief Information Officer BD

appointment

Appointed in 2022

www.medicaldesignandoutsourcing.com

Appointed in 2020

Mary Beth Moynihan

Ami (Doshi) Simunovich

Denise Fleming

SVP and President, Urology Boston Scientific

Ola Snow

Chief Human Resources Officer Cardinal Health Appointed in 2018

10 • 2023

Medical Design & Outsourcing

21

2023 WOMEN IN MEDTECH

Natalia Kozmina

EVP, Chief Human Resources Officer and ESG Stewardship ConvaTec

Jessica Mayer

Chief Legal and Compliance Officer Cardinal Health

Appointed in 2020

EVP, Chief of Corporate Strategy and Business Development, General Counsel and Company Secretary ConvaTec

Michelle Greene

EVP, Chief Information Officer Cardinal Health Appointed in 2022

Appointed in 2020

Jennifer Hornery

Kjersti Grimsrud

SVP, Global People and Culture Cochlear

President and COO, Infusion Care ConvaTec

Appointed in 2017

Appointed in 2022

Lisa Aubert

Anne Belcher

President, North America Cochlear

President and COO, Global Emerging Markets ConvaTec

Appointed in 2022

Karen O’Driscoll

Appointed in 2022

Chief Information Officer Cochlear

Holly Sheffield

President, CooperSurgical CooperCos.

Appointed in 2023

Dorthe Rønnau

Appointed in 2020

SVP, People and Culture Coloplast

Erania Brackett

SVP, Orthodontic Aligner Solutions and Customer Experience, and Head of Sustainability Dentsply Sirona

Appointed in 2022

Victoria Styles

VP and GM, Advanced Endoscopic Technologies Conmed

Appointed in 2021

Appointed in 2003

Emily Miner

Johonna Pelletier

SVP, Quality and Regulatory Dentsply Sirona

Treasurer and VP, Tax Conmed Appointed in 2015

Appointed in 2023

Shanna Cotti-Osmanski

Sadie Stern

EVP, Information Technology and CIO Conmed Appointed in 2020

Heather Cohen

EVP and Chief Human Resources and Legal Officer Conmed

22

Medical Design & Outsourcing

Appointed in 2015

Anna Conneryd Lundgren

EVP and Chief People Officer Elekta

Care Enablement Fresenius Medical Care MDO could not confirm date of appointment

Helen Giza

CEO and acting CFO Fresenius Medical Care Appointed in 2022

Laila Gurney

Chief Quality and Regulatory Officer GE HealthCare Appointed in 2020

Colleen Riley

Catherine Estrampes

Appointed in 2021

Appointed in 2021

Ginny Blocki

Betty Larson

SVP, Chief Technology Officer Embecta

SVP, Global Marketing and Product Management Embecta Appointed in 2022

Jean Casner

President and CEO, US and Canada GE HealthCare

Chief People Officer GE HealthCare Appointed in 2022

Danielle Halstrom

SVP and Chief Human Resources Officer Embecta

Chief Corporate Marketing and Communications Officer GE HealthCare

Appointed in 2023

Appointed in 2022

Patricia Lang

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the secret behind

intuitive’s surgical robotics success

INTUITIVE SURGICAL CHIEF MEDICAL OFFICER MYRIAM CURET SHARES HOW INTUITIVE HAS BUILT AN ECOSYSTEM OF SUCCESS AROUND DATA AND COLLABORATION TO SUPPORT THE ADOPTION AND USE OF THE TECHNOLOGY. DA N I ELLE K IR SH S E N I OR ED ITO R

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ntuitive Surgical has pioneered robotic surgery since the 1990s, continuously driving innovation and collaboration through data to advance patient care.

Teamwork between surgeons and engineers has been a crucial factor behind Intuitive developing effective surgical platforms that solve real-world problems that surgeons face.

Multibillion-dollar companies including Medtronic and Johnson & Johnson — and smaller up-and-comers including CMR Surgical and Vicarious Surgical — have sought to take on Intuitive in the soft-tissue surgical robotics space in recent years, but Intuitive remains the dominant company. An important element of Intuitive’s continued success has been its ability to harness data, collaborate with surgeons, and innovate.

As a practicing surgeon who actively uses robotic surgery technology, Intuitive Chief Medical Officer Dr. Myriam Curet understands the importance of the company’s partnership with surgeons more than most.

“I can obviously work with the engineers directly and work with them about what kind of innovations we need, how to make things better and give some feedback. That’s a large part of what I’ve done. There are many surgeons who do that.

There’s nothing unique about me as a CMO,” Curet told Medical Design & Outsourcing. “We get input from many surgeons of all levels — academics, novice surgeons, community experience, GYN, many different kinds of specialties — because that’s important. We serve a broad customer base.”

She and other surgeons provide immediate feedback to engineers with data on how specific technologies work, what innovations are needed and how to improve things.

Such cooperation drove the development of the da Vinci Xi surgical robot, which launched in the 2010s. In fact, the da Vinci Xi robot addressed most of the issues surgeons and care teams complained about in previous models, including the need for better ergonomics and longer instrument reach, said Curet, who joined Intuitive in 2005 and became CMO in 2014.

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2023 WOMEN IN MEDTECH The da Vinci surgical ecosystem, including patient cart, surgeon console and vision tower

Photo courtesy of Intuitive Surgical

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

Lesly Marban

SVP, Corporate Marketing Intuitive Surgical Appointed in 2020

Iman Jeddi

SVP and GM, Single Port Platform Intuitive Surgical Appointed in 2022

Cintia Ferreira

This level of collaboration — where surgeons identify the needs and engineers develop the solutions — appears to be key if Intuitive is to continue to dominate robotic surgery though exciting innovations.

“Intuitive took such a lead for many years that they’ve done a very good job of increasing the moat around the system by enhancing the value, and that has made the stickiness of the system greater. As a result, it’s hard for competitors to come in,” BTIG analyst Ryan Zimmerman told MDO.

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Committing to clinical validation and evidence-based practice With the trial and error of surgical systems comes rigorous clinical validation and evidence-based practice. Intuitive Surgical does studies on its surgical systems, the surgeons that use the systems do studies, and there is literature published that Intuitive Surgical considers in the clinical validation process.

Zimmerman has watched the process evolve, as an analyst and previously as a director of surgery inside health providers.

“For a while, the pathway to approval was not clear. There was uncertainty.

There were discussions for many years about whether companies need clinical trials,” Zimmerman said. “I think, for that reason, that has informed developments in this space.”

Intuitive’s pre-market validation process involves extensive testing by engineers to compare new products to existing technologies and ensure they can fully and safely perform intended

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www.medicaldesignandoutsourcing.com

functions. Post-market validation includes analyzing real-world clinical outcomes data, reviewing complaints and adverse events and monitoring published literature to identify where risks were effectively mitigated and areas still needing improvement. Intuitive also conducts clinical studies in post-market.

Curet said both validation processes aim to gather information on patient outcomes and how products function to determine what needs improvement or adaptation with new products and technologies. Patient safety is a top priority throughout the development and ongoing use of Intuitive Surgical’s technology, Curet said.

“What safety systems can we put in place? What training systems can we put in place? What can we do? And then we follow that up with watching it being used in real life to see where they effectively mitigated where some risks we had and identified,” she said.

Because of these data systems in the validation process, patient outcomes and industry standards were positively impacted in a few key ways.

It has helped demonstrate robotic surgery’s clinical value and benefits over traditional open or laparoscopic approaches in areas like reduced recovery time, pain and complications. Gathering extensive real-world use data has allowed Intuitive to continuously improve its technologies and address any risks, helping lead to better patient safety outcomes. (continued on page 30)

2023 WOMEN IN MEDTECH

(continued from page 28)

operating room to understand real-world usage of the technology.

Curet said the best example of this collaboration is Intuitive Surgical’s shift from its Si surgical robot to the da Vinci Xi. “That was years and thousands of surgeons coming in and trying things. That was hundreds of engineers going into the OR and seeing how our current system, or Si at that point, was being utilized and tens of thousands of interviews with people,” she said. “We follow that process.”

As a result of the feedback, da Vinci Xi was built to be boom-mounted with slimmer arms and longer-reaching instruments. Intuitive also added integrated tabled motion to dynamically position patients while the surgeon operates.

“It was so clear when Xi came out that it was about solving every problem that surgeons and care team members had complained about,” Curet said. “Everything that was limiting for surgeons and care teams in [da Vinci] Si got addressed in Xi.”

Publishing clinical studies and data has established evidence that robotic surgery provides benefits, raising industry standards of practice. This clinical validation is essential for regulatory approval and adoption.

“There are now so many robots out there with various form factors that I would argue companies will not be able to make it to market without clinical validation,” Zimmerman said.

Surgeon-engineer collaboration is essential for robust validation data Intuitive Surgical’s clinical validation process is based on collaborative relationships between surgeons and engineers.

The company gathers extensive feedback from thousands of surgeons on how they use current systems and what improvements could be made to develop the next generation of surgical robotics.

Engineers also regularly observe surgical procedures using Intuitive’s systems in the

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The influence of data on surgeon adoption Data and insights from using the da Vinci robot have helped influence the adoption of robotic surgery in the operating room.

Some surgeons need hands-on experience while, others want increasingly strong evidence from published data, showing the need for multiple types and data sources to drive adoption among different groups.

For early adopters, personal experience using the robot and seeing its capabilities firsthand was enough to convince them of its benefits over other approaches.

“There was a surgeon many years ago who said he used the da Vinci for a ventral hernia, where you put mesh in, and he used the tackers that he normally uses laparoscopically on one side. He used suturing with the da Vinci on the other side, and the next day, the patient was complaining of a lot of pain on the side where they use the tackers, and no pain on the side where they use the da Vinci,” Curet said. (continued on page 33)

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(continued from page 30)

Publications from initial clinical experiences and case studies demonstrated potential value in outcomes like reduced recovery times. This influenced the early majority surgeons.

More extensive database studies and randomized controlled trials providing data on improved outcomes across patient populations addressed concerns of the late majority surgeons who wanted more robust evidence before adopting.

Ongoing collection of real-world use data helps demonstrate the persistent value of robotic surgery and builds the case for its benefits compared to traditional methods.

For use data, the My Intuitive app captures surgical data on each procedure a surgeon performs using the da Vinci system. It tracks details like how long the surgeon was on the system, which instruments they used, how long each step took and how long each instrument was utilized.

This data is then provided back to the surgeon so they can track improvements A surgeon uses the in their da Vinci surgeon OR time, console during a compare their procedure.

Photo courtesy of instrument Intuitive Surgical usage to others and identify higherperforming surgeons to learn from. The app aims to provide individualized and comparative performance data to help drive surgeon improvement.

“Intuitive has done a very good job of providing physicians and hospital administrators alike with information and analytics about their surgical programs.

Just as a golfer would study their golf swing with video, so can a surgeon study their surgeries,” Zimmerman said. “That’s something we’ve been exploring for years in hospital management — making sure that our robotic programs are effective but also financially sound. And Intuitive is embracing that.”

Where is surgical robotics headed?

Analysts think there will be more widespread adoption of surgical robotics, as long as the platforms have a more universal approach. There’s also a potential to combine therapeutic care and diagnostics in the same episodic care.

“Robotics is going to be increasingly more universal in that you can’t have ten disparate systems inside of hospitals that treat ten disparate indications. Hospitals can’t afford that.

And I think you’ll see more expansion of existing systems in the new applications,” Zimmerman said.

Intuitive Surgical is working on moving toward that pathway. Curet said that the future of surgical robotics will have a focus more on leveraging technology and data.

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Karen Frey “Most of our competitors’ platforms are not radically different from ours,” Curet said. “So if you look at that type of platform, we’re going to be able to penetrate more into benign surgery in the U.S., we’re going to penetrate more into cancer surgery outside the U.S.” Another prospect in surgical robotics is more flexible robotics, such as Intuitive’s Ion robotic bronchoscopy system with an ultrathin, maneuverable catheter that lets surgeons reach small lesions deep in the lungs. It enables minimally invasive biopsies that could become crucial to early diagnosis. >> www.medicaldesignandoutsourcing.com

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2023 WOMEN IN MEDTECH

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Curet also sees advances in imaging capabilities to help surgeons view things like cancer cells and nerves that are not currently visible.

“What I think is really exciting is that with robotics, the biggest difference is you’ve put a computer between the patient and whoever the care provider is. And that expands your ability in terms of what you can do, what information you can give the provider that he or she didn’t have before,” she said.

Intuitive Surgical is exploring fluorescence imaging to look at cells that surgeons cannot see with the naked eye. Some of that includes structures like the ureter, which is at risk of getting cut during surgery. If surgeons can see using an imaging agent, it can decrease complications. Cancer cell imaging are also an area of interest for the company.

The company is looking at its single-port platform for nipple-sparing mastectomy procedures to reduce pain and other associated complications. There’s also potential to use the surgical robotic platform to go inside the prostate to do a prostatectomy for patients with benign prostatic hypertrophy.

However, surgical robotics in general have a lot of growth opportunities and potential in the future as more companies enter the space, according to Zimmerman.

“There is increasingly more competition,” Zimmerman said.

“There’s a lot of opportunities, but we haven’t quite figured out how essentially to democratize it so that it’s accessible for everyone.”

Surgical instruments on the da Vinci Xi surgical robot Photo courtesy of Intuitive Surgical

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Penumbra's REAL y-Series in use for physical therapy Photo courtesy of Penumbra

PENUMBRA IS STRATEGICALLY EXPANDING ITS FOCUS ON IMMERSIVE HEALTHCARE, CREATING VIRTUAL REALITY APPROACHES TO OCCUPATIONAL AND PHYSICAL THERAPY.

Penumbra President of Immersive Healthcare Gita Barry

DAN I ELLE KI RSH SEN I OR EDI TOR

P

enumbra is leveraging virtual reality to transform how patients interact with their care, offering therapeutic devices that give clinicians the tools to monitor and enhance therapy outcomes.

The company’s Immersive Healthcare division is developing virtual reality (VR) technology to enhance patient care. The REAL system gives clinicians tools to monitor patient progress, improve engagement and enhance satisfaction during rehabilitation, as well as address cognition and mental wellbeing. By integrating VR technology with patient-centric design principles, Penumbra aims to transform the therapy experience.

“It’s a really different point of view. It’s leveraging the perspective of Penumbra versus a lot of the other companies that are in the space,” Penumbra Immersive Healthcare President Gita Barry said in an interview with Medical Design & Outsourcing. “There’s incredible tech expertise in this space looking to bring the technology into healthcare. But what we do very differently is we see this no different than any other medical device that we’ve created.”

There are several companies in medtech that use virtual reality for surgical planning. For example, AppliedVR’s RelieVRx is an immersive therapy to help patients adjust their cognitive, emotional and physical responses to chronic pain. MindMaze’s MindMotionPRO is an augmented reality approach to hone therapy. >> www.medicaldesignandoutsourcing.com

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2023 WOMEN IN MEDTECH

But Penumbra’s REAL Immersive systems were the first exerciser and measuring VR platforms for physical medicine that were FDA cleared, according to the FDA’s Digital Health Center of Excellence.

The company is developing VR platforms for rehabilitation, mental wellness, and cognition. Penumbra designed its REAL y-Series VR rehabilitation tool for clinicians to monitor and advance patient goals, drive patient engagement and increase satisfaction and adherence to therapy. Its mental wellness and cognition VR system, the REAL i-Series, has VR-enabled immersive experiences for cognitive activation, distraction therapy, reminiscence therapy, mindfulness therapy and relaxation therapy.

Penumbra’s VR systems measure and gather insights that Penumbra gives to the therapist, who can then give them to the patient. Barry says the systems can collect new information beyond what therapists could previously only capture with eyeballs.

“The idea that you can immerse and you can see things in a different way – that’s where patients can benefit. That’s where clinicians can benefit. And it really comes down to how [to] create some really interesting use cases that are really well designed from the clinical ground up to really be able to advance the field, just like you would with a catheter or coil or anything else that you were designing to address the clinical condition,” Barry said.

Virtual reality also has the potential to transform medical training. It can help with communication and collaboration as clinicians visualize patient cases in VR. Using VR during actual procedures allows clinicians to plan the best surgical approach and pathway before an operation, based on patient imaging. It also enables new opportunities for patient education by visualizing procedures and conditions. Once clinicians see the benefits of VR training, it opens doors to exploring other uses of immersive technology.

How Penumbra’s VR technology works Penumbra’s REAL y-Series product uses full-body sensors with Velcro straps on patients like a motion capture suit. These sensors facilitate the creation of an avatar and skeleton, enabling comprehensive patient movement tracking.

This proprietary sensor positioning approach offers advantages over camerabased tracking, as it ensures a broader range of motion that is accurately captured even when the patient’s movements aren’t directly visible to the headset’s camera.

The collected data is then processed using AI, machine learning and algorithmic analysis, creating valuable measures and insights for clinicians to enhance the therapeutic experience.

“Because we use our own proprietary tracking technology, you have a much broader world of motion that you can do, which is really well suited for physical therapy and occupational therapy,” Barry said.

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Sharon Bracken Penumbra's VR software for therapy

Head of Diagnostics Siemens Healthineers

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Penumbra gamifies the therapy experience to create better outcomes for the patient. Typically, the company would focus on the physician’s needs, such as how they hold a catheter or how the catheter can be incorporated with other devices.

“But we apply game design principle. We apply the fun of, ‘How do we take advantage of this incredible immersive technology to engage the patient in a way to achieve those outcomes?’ And I’ve never had a medical device where we’ve had that kind of experience,” Barry explained.

The patient-centric design behind VR and resulting positive outcomes In the context of patient-centric design within VR therapy, the primary goal is to engage patients and enhance their overall clinical progress actively. The effectiveness of VR therapy hinges on patient engagement. Unlike traditional medical interventions, which focus primarily on physician-centric aspects, VR therapy involves meeting patient needs and creating a beneficial experience that the patient can enjoy.

The process begins with defining specific patient actions and outcomes. Similar to creating a marketing specification in medical device design, VR therapy lays a foundation rooted in clinical science. The emphasis is placed on the desired outcomes and the metrics that need to be generated for the patient’s benefit.

VR therapy introduces the possibility of challenging, enjoyable, and safe activities for patients, which may not be feasible in a typical clinical setting. Activities like playing catch or dodgeball can be incorporated into therapy, providing patients with a sense of accomplishment and positive reinforcement.

Game design principles are crucial, guiding how settings and difficulty levels are adjusted. However, the design is approached from a clinical perspective, aligning with parameters like range of motion, ease of movement, and the speed at which challenges are presented. This approach ensures that the therapy remains tailored to the patient’s needs while providing an immersive, game-like experience. >>

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Appointed in 2023

Appointed in 2019

Meg Carr

Birgit Conix

VP, Regulatory Affairs Shockwave Medical

CFO Sonova

Appointed in 2019

Appointed in 2021

Cathy Harnett

Katya Kruglova

VP, Human Resources Shockwave Medical

GVP Human Resources and Communications Sonova

Appointed in 2020

Appointed in 2023

Chief Human Resources Officer Siemens Healthineers Appointed in 2021

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Chief Compliance Officer Smith+Nephew Appointed in 2022

EVP and Chief Business Leader Personal Health Royal Philips

Darleen Caron

Alison Parkes

Camila Finzi

Head of Orthodontics Straumann Appointed in 2020

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2023 WOMEN IN MEDTECH

“The idea that you can immerse and you can see things in a different way — that’s where patients can benefit. That’s where clinicians can benefit.

And it really comes down to how [to] create some really interesting use cases that are really well designed from the clinical ground up to really be able to advance the field.”

Rahma Samow

Head of Dental Service Organizations Straumann Appointed in 2021

Yin Becker

VP, Chief Corporate Affairs Officer Stryker

One significant advantage of VR therapy is its ability to help patients overcome pain-related fears. Patients often shy away from specific movements due to the anticipation of pain. In the immersive world of VR, the focus shifts from pain avoidance to enjoying the experience, encouraging patients to push their boundaries.

The impact of VR therapy is evident in the immediate response of patients, Barry said.

“The first thing that happens when you put a headset on someone is they smile uncontrollably. They don’t even know they’re smiling. It’s an amazing thing to just see somebody smile, especially someone who’s not excited about going to therapy,” she said.

Appointed in 2012

Jeanne Blondia

VP, Finance and Treasurer Stryker Appointed in 2014

Irene Corbe

VP, Internal Audit Stryker Appointed in 2014

Katy Fink

VP, Chief Human Resources Officer Stryker Appointed in 2016

Jody Powell

Navigating regulatory challenges Penumbra’s key strategy for ensuring compliance and safety when developing immersive technologies is to assume the technology is a medical device from the beginning of development. It applies a quality system and works closely with its regulatory team as it would for any other medical device.

“We see it as a medical device, treat it like a medical device, treat claims as a medical device, treat the way you think about your product,” Barry said. “If you think about your FMEA (failure mode and effects analysis) in terms of how does this device function, you’ll get to the right spot.”

Cybersecurity and personal health information (PHI) is also a concern with the transfer of personal information through technology. A lot of information about the patient is included in the therapy, so the company engages with partners and customers as it relates to any data. It offers an offline version of the treatment that won’t store data, but HIPAA, personal health information and personally identifiable information are also concerns

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

Dana McMahon

VP, Chief Compliance Officer Stryker Appointed in 2021

Marie Hendrixson VP, Internal Audit Teleflex Appointed in 2009

Karen Boylan

Corporate VP, Strategic Projects Teleflex Appointed in 2019

Michelle Fox

Corporate VP and Chief Medical Officer Teleflex Appointed in 2020

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that Penumbra takes into consideration when developing the VR systems.

“We bring all of those fundamentals together and we’re currently we’re SOC 2 certified. We’re continuing to look at how do we continue to increase the level of security of our devices in terms of what that looks like and making sure that we’re complying with all the applicable standards that are out in the space for medical devices, but also FTC standards,” said Barry.

The future of Penumbra’s Immersive Healthcare business Penumbra’s plans for the future involve creating more awareness about the technology, advancing the technology and scaling it for more widespread use and building trust with doctors and therapists to encourage more adoption.

According to Barry, these elements form the crux of a transformative journey poised to reshape the landscape of patient care.

One of the main objectives is to shine a light on the existence of these technologies and their capacity to enhance patient care. Whether catering to veterans or individuals seeking healthcare in commercial settings, the need for awareness is essential.

There are many types of therapists in healthcare. While occupational therapists and physical therapists can benefit from these immersive technologies, but Barry said Penumbra is committed to advancing the technology for more applications.

She also thinks this evolution hinges on the technology’s scalability to support clinicians.

“There are a lot of therapists in the world, and there are a lot of different settings in which therapy is provided on a daily basis,” Barry said. “We’ve got more work to do. ... We just scratched the surface.”

2023 WOMEN IN MEDTECH

Angela Main Lisa Kudlacz

President and GM, Vascular Teleflex Appointed in 2021

Whitney Reynolds

VP, Global Customer Experience Teleflex Appointed in 2021

Marianne Wiinholt CFO WS Audiology Appointed in 2022

Annemarie van Neck

President Region EMEA WS Audiology Appointed in 2022

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

Rachel Ellingson

SVP and Chief Strategy Officer Zimmer Biomet Appointed in 2018

Keri Mattox

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

Lori Winkler

SVP and Chief Human Resources Officer Zimmer Biomet Appointed in 2022

Laura Driscoll

VP, Communications ZimVie Appointed in 2021

Heather Kidwell

SVP, Chief Legal, Compliance, and Human Resources Officer ZimVie Appointed in 2022

Ann Vu

SVP, Regulatory Affairs, Quality Assurance and Clinical ZimVie Appointed in 2022

EMERGING MEDTECH LEADERS

10 emerging medtech leaders The Medical Design & Outsourcing editorial team drew on its resources to create this list of emerging medtech leaders. These companies are led by founders and CEOs that have demonstrated significant potential and are on the path to becoming influential players in the medtech industry.

Ananya Health wants to bring battery-powered cryoablation to the global fight against cancer Ananya Health aims to help overcome barriers to cervical pre-cancer treatment due to a lack of infrastructure, resources and follow-up care.

C

ANANYA HEALTH Founded in 2020 CO-FOUNDER AND CEO ANU PARVATIYAR Ananya Health is developing a portable cryoablation device for use in every primary care clinic worldwide, specifically for use in developing countries and emerging markets.

Danielle Kirsh Senior Editor

CORAVIE MEDICAL Founded in 2020 FOUNDER AND CEO AIMEE GARZA CoraVie Medical’s implantable, circadian blood pressure monitor informs treatment decision. It improves patient compliance to monitoring and improves blood pressure reliability and actionability by monitoring hemodynamic trends over day and night.

HYPERFINE Founded in 2014 PRESIDENT AND CEO MARIA SAINZ Hyperfine makes the Swoop Portable MR Imaging system that addresses the limitations of current imaging technologies. Swoop can be wheeled directly to the patient’s bedside, plugs into a standard electrical out and uses an Apple iPad as the controller. (continued on page 46) 42

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The CRCL device is designed to address the challenges in cervical cancer diagnosis and treatment.

Illustration courtesy of Ananya Health

www.medicaldesignandoutsourcing.com

ervical cancer is the fourth most common cancer among women and has a high mortality rate globally, according to the World Health Organization. Screening and effective interventions can reduce cervical cancer deaths, but that access is limited in emerging markets and developing countries.

Ananya Health, co-founded by Anu Parvatiyar, is at the forefront of tackling this global health disparity. The company is developing a cryoablation device that can freeze abnormal cells in the cervix at the point of care, all on a batterypowered system designed to bridge the accessibility gap in regions that typically lack these resources.

Typically, when a Pap smear comes back as abnormal in places like the U.S., doctors refer patients to a specialist at a hospital or larger specialty clinic with the tools and operating space to treat the lesions.

But in many places, various socioeconomic and cultural factors cause low prioritization of cervical cancer screening and treatment, Parvatiyar told Medical Design & Outsourcing.

“India has 25% of the world’s cervical cancer burden,” Parvatiyar said.

“I’m not even talking about remote villages you’re hiking to that don’t have electricity. I’m just talking about urban areas in countries that have a relatively large middle class. There just aren’t cryogen supplies.”

Following up on abnormal screening results can be difficult if patients travel long distances or to different clinics for confirmation and treatment. This extra step leads to a large decrease in follow-up rates and a greater risk of cervical cancer.

(continued on page 44)

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(continued from page 42)

The challenges of treating cervical cancer in emerging markets Traditional cryoablation equipment requires specialized facilities, staff and consumable supplies that make it difficult for most primary care clinics globally to offer this treatment.

“Cryogenic gas is largely unavailable in large parts of the world,” Parvatiyar said Demand for those resources are unpredictable for clinics in rural areas and emerging markets. Because clinics don’t know how many women may come in for diagnosis and treatmentthey don’t know how much cryogenic gas to purchase or how often. That results in clinics not offering the service because there is too much risk.

San Francisco-based Ananya Health has a solution. The company’s batterypowered Cryo Refrigerant Closed Loop (CRCL) system achieves ablative temperatures in a compact format, making

it ideal for clinics in India, Africa and emerging markets where cervical cancer is most prevalent.

How the CRCL system bridges the gap in care Closed-system ablation removes reliance on heavy, hard-to-find compressed gas. The portable, battery-powered compressor can be used by trained health workers in any setting, from mobile clinics to hospitals. CRCL is self-contained, allowing clinicians to perform cryoablation procedures as needed over a defined time. The system combines diagnostics and treatment in the same place to eliminate the loss in follow-up rates.

Cryoablation is a relatively low-risk procedure compared to some of the other gold-standard methods, which may require a six-week recovery time. CRCL is used in an outpatient procedure, allowing the provider to treat without potentially losing the patient in the follow-up process.

Ananya Health also uses miniaturization to make the compressor condenser system more accessible.

The features are similar to a small refrigerator or freezer that you would put on a boat or in an RV, but it needs to get colder on a smaller point.

“We spent a lot of engineering time making sure that it works in the way that we wanted to. And with that comes a lot of the robustness. You don’t want it to just get in there and stop working,” said Parvatiyar.

Design challenges and looking ahead However, Parvatiyar said a lot more engineering goes into making the system successful. CRCL combines a refrigeration system with electronics and PCBA interfaces within the system’s body.

Designing a refrigeration/cooling system that can get cold enough using batteries is technically complex.

Significant engineering time is required to optimize that, Parvatiyar said.

EMERGING MEDTECH LEADERS

“With all those subsystems, 90% of the work is in the last 10% of the design,” she said. “And I think just finalizing some of those refrigeration parameters and giving ourselves that time and runway to do that is always a good management challenge.”

The company applied for its second National Institutes of Health (NIH) grant in September and plans to submit its system for FDA review. While the device is pre-regulatory with none on the market, it has had technical wins.

“We’ve been able to get down colder than -40° C consistently and really colder than -50° C,” Parvatiyar said. “We’re seeing really great outcomes on that and looking to submit to the FDA next year.”

Ananya Health has established partnerships with clinical organizations, advocacy groups and screening companies to support adoption in target regions like Kenya, Nigeria and India. Ananya Health works with cervical cancer organizations like those associated with Nigeria’s First Ladies Against Cancer Initiative. The company is also in talks with traditional global health groups that focus specifically on cervical cancer like the Clinton Health Access Initiative, Parvatiyar said.

Fundraising for the CRCL system has been challenging, given its focus on global health markets, but Parvatiyar sees a significant market opportunity for battery-powered cryoablation. If the system is successful at primary care clinics, it could open the door to developing and supplying cryoablation for other procedures in an outpatient setting like dermatology.

“We’re trying to drive the adoption of visits to primary care in emerging markets or even rural areas within the U.S.,” Parvatiyar said. “If you can build the trust, you’ll hear from people what it is they need, and what it is you should be working on next. …

Building the kind of tool that people trust in to work anywhere, they are and whatever clinic that they’re in, I think is a great entry point to do lots of different things.”

“We spent a lot of engineering time making sure that it works in the way that we wanted to. And with that comes a lot of the robustness.

You don’t want it to just get in there and stop working.”

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EMERGING MEDTECH LEADERS

10 emerging medtech leaders (continued) (continued from page 42)

IFPX CEO AMANDA FRENCH

Medasense’s finger probe makes pain management easier for anesthesiologists By leveraging artificial intelligence, Medasense Biometrics is changing surgical pain management with personalized treatment, overcoming the subjectivity of current methods.

IFPx is creating differentiated, minimally-invasive continuous heart failure monitoring technology to address preventable heart failure hospitalizations. IFPx is a portfolio company of medical device incubator NXT Biomedical.

P

MEDASENSE BIOMETRICS Founded in 2008 CO-FOUNDER AND CEO GALIT ZUCKERMAN-STARK Medasense is changing the way pain is assessed and treated. The flagship product is used in critical care settings where patients cannot communicate pain.

Danielle Kirsh Senior Editor

PROSOMNUS Founded in 2016 FOUNDER LAING RIKKERS ProSomnus is developing CPAP alternatives for the treatment of obstructive sleep apnea.

ProSomnus intraoral medical devices are engineered to track the treatment plan and anatomy for each patient.

“The issue of pain during surgery and post-surgery and pain in general is a big issue with limited tools to assess them.”

“The issue of pain during surgery and post-surgery and pain in general is a big issue with limited tools to assess them. [The pain scale chart is] all smiley faces,” Zuckerman-Stark said in an interview with Medical Design & Outsourcing.

In conscious patients, current approaches often rely on subjective assessments of pain, which can be influenced by individual perception and expression, leading to potential delays in intervention and inconsistent care.

RHAEOS Founded in 2018 CEO ANNA LISA SOMERA Rhaeos is a clinical-stage medical device company developing FlowSense, a platform technology and a noninvasive wireless, wearable skin patch that can assess and monitor fluid flow subdermally throughout the body.

(continued on page 48)

(continued on page 48) 46

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ain management is vital to patient comfort and treatment success in medical care. Effective pain management alleviates suffering and optimizes medical outcomes, particularly surgical procedures. However, existing methods for gauging and addressing pain have significant limitations.

Medasense Biometrics is a commercialstage pain management technology company that develops AI-powered patient monitoring solutions to help clinicians manage physiological pain. The company’s mission is to personalize and optimize pain treatment to reduce patient suffering from pain and its side effects.

Galit Zuckerman-Stark, an engineer with a background in high tech and a love for science and technology, founded Medasense almost 15 years ago. With her expertise in AI, she saw an opportunity to provide better objective tools for clinicians to personalize pain treatment.

www.medicaldesignandoutsourcing.com

EMERGING MEDTECH LEADERS

10 emerging medtech leaders (continued) (continued from page 46)

SOVN Founded in 2020 CO-FOUNDER SELINA TIRTAJANA SOVN is developing smart, AI-powered, in-ear wearables that reduce excessive clinching and grinding of the teeth to treat bruxism.

VENTRIPOINT Founded in 2005 PRESIDENT AND CEO ALVIRA MACANOVIC Ventripoint’s technology uses an AII to create applications to monitor heart disease. VMS+ is an AI tool for measuring whole heart function using conventional ultrasound.

(continued from page 46)

During surgery the anesthetized patient experiences physiological responses to painful stimuli — nociception in medical terms. Current techniques to assess the level of nociception have relied on indirect parameters. The opioid crisis has underscored the urgent need for alternatives to conventional pain management.

Medasense has a mission to revolutionize pain management through its technology. The company’s AI-driven algorithms promise to provide a more objective and real-time assessment of pain levels during times when the patient cannot convey the level of pain they are in. Currently focused on pain management during surgery (nociception), Medasense’s technology offers clinicians actionable data to inform their perioperative pain management decisions. Medasense aims to enhance patient care, reduce opioid reliance and improve surgical outcomes.

How Medasense’s technology works Medasense says its approach is robust and adaptable, unlike other commercial solutions, and able to work in various scenarios and with different patient populations.

Medasense’ pain monitoring solution uses physiological parameters and derivatives to analyze the non-linear

VISURA TECHNOLOGIES Founded in 2015 CEO CHRISTINE HORTON Visura is delivering visualization solutions to improve the quality of transesophageal echocardiogram probe intubations. Visura has developed the TEECAD System, a disposable camera that connects to a TEE probe, giving physicians real-time visualization for more efficient probe placement.

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relationship between them using AI, creating a unique pain signature for each patient. This allows for a personalized approach to pain monitoring, considering factors like medication, surgery type and individual patient response.

“For one patient, it might be one set of parameters; for the other, it could be another set. This is extremely important, especially in the operating room,” Zuckerman-Stark said. “You have certain scenarios where certain medications affect certain physiological parameters.”

For example, if a patient is taking a medication that affects heart rate, then using the heart rate parameter to measure pain won’t work well in surgical procedures. Medasense’s algorithms find the parameters that work best, Zuckerman-Stark said.

Medasense’s flagship device, the PMD-200, uses the company’s Nociception Level Index (NOL), a technology used to monitor a patient’s pain level during surgery. The PMD-200 has a finger probe connected to the patient and monitors Medasense's pain monitoring solution for the operating room Photo courtesy of Medasense

EMERGING MEDTECH LEADERS

different physiological responses to pain, including pulse waves, sweating, movement and peripheral temperature changes. The data collected by the probe is analyzed to produce a number between zero and 100 for the pain level the patient is experiencing.

The NOL technology is wired to a bedside monitor in the operating room, which displays the patient’s index number. The threshold for intervention is set at 25, which means that if the patient’s index number is above 25 for more than 60 seconds, the anesthesiologist should consider giving more medication.

“They see the whole picture, but now they have to be a bit more sensitive and specific information about the pain that can help them make different decisions compared to the information they had before,” Zuckerman-Stark said.

One feature of the NOL technology is that it provides more sensitive and specific information about a patient’s pain (nociception) level than traditional vital sign monitors, Medasense says. Traditional monitors may not detect physiological responses to pain early enough, leading to delayed intervention or pain management.

The NOL monitoring also helps differentiate between pain and other physiological responses, such as changes in heart rate and blood pressure due to medication or surgical manipulation. The company says this real-time data gives surgeons and anesthesiologists the ability to fine-tune anesthesia and pain medications to precisely match the patient’s needs. It minimizes the risk of undermedication, which can lead to patient discomfort, or overmedication, which can result in complications, Zuckerman-Stark said.

Medasense Biometrics founder and CEO Galit Zuckerman-Stark Beyond the operating room, Medasense’s pain monitoring solution has broader implications for critical care. In intensive care units, for example, it could assist in managing pain for patients who may be unable to communicate their discomfort, such as those under sedation or on ventilators. The system’s real-time feedback ensures that pain management remains tailored to the patient’s condition, preventing unnecessary suffering and complications.

Medasense’s PMD-200 pain monitoring technology has been met with enthusiasm and interest from the medical community, particularly among early adopters who recognize its potential to revolutionize pain management, Zuckerman-Stark said. It is currently used in Europe, Canada, Australia, Israel, Turkey, the United Arab Emirates and Latin America. It can work alone or connected to Philips and Mindray patient monitors.

Its integration into medical practice has garnered attention for its ability to

“We see how [integration] moves from that very specific early adopter into the rest of the [care] team who realizes that there is information that is helpful that they didn’t have before or they couldn’t see. They say, ‘We were blind in a way, and now we have it, so we can’t go back.’”

provide objective and real-time pain assessment, Zuckerman-Stark said.

“We see how it moves from that very specific early adopter into the rest of the [care] team who realizes that there is information that is helpful that they didn’t have before or they couldn’t see. They say, ‘We were blind in a way, and now we have it, so we can’t go back,’” she said.

According to the company, clinical studies and economic analyses have demonstrated that the system results in 33% less postoperative pain, 80% fewer hypotensive events, and a return on investment within the first year of use.

What does the future hold at Medasense?

The recent FDA de novo approval of Medasense’s technology is a significant milestone for the company.

Medasense is setting its sights on an ambitious future, with plans to expand the commercial use of its innovative pain monitoring technology in the U.S. and other global markets.

Medasense is actively looking to collaborate with partners across the medical and technology sectors to refine and expand their technology capabilities. Medtronic Patient Monitoring distributes Medasense’s technology in Europe.

“We have a very good collaboration with Medtronic,” Zuckerman-Stark said.

“There is a strong clinical synergy with the other patient monitoring solutions that they provide in the perioperative space.”

The company also envisions a future where its technology can seamlessly integrate into wearable devices and home monitoring solutions.

This would allow individuals to monitor and manage their pain levels in real time, giving them greater control over their healthcare and well-being.

The company’s pipeline includes the NOLedge pain management solution for home-based care. It gives patients objective feedback on individual pain trends and therapy progress, improves self-management and treatment compliance and helps regulate patient anxiety, according to Medasense, while care providers get accurate information for effective decision-making accessible remotely, streamlining pain care.

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STARTUP TIPS

Four steps medtech startups can’t put off Medical device litigator and consultant Ginger Pigott highlights early decisions for startups that could have major ramifications down the road.

D Jim Hammerand Managing Editor

eveloping and commercializing a new medical device is a success worth toasting for medtech startups — but that success also makes it more likely that litigation is in their future.

There are steps medtech startups can take to protect themselves down the road, said Greenberg Traurig shareholder Ginger Pigott, a litigator who defends major medical device manufacturers in court. She also advises medtech startups on early decisions and strategies that could have major ramifications down the road.

Pigott and three other women — Materna Medical Chief Operating Officer Kelly Ashfield, Greenberg Traurig lawyer Miki Kolton and Fogarty Innovation Chief Innovation Officer Denise Zarins — will offer their expertise at our DeviceTalks West show in an Oct. 18 panel, “Going the Distance: Building Startups to Last.”

Pigott offered a preview of the panel for Medical Design & Outsourcing readers, discussing four steps that medtech startups can’t afford to put off.

1. Understand your path to market “Sometimes the fastest way to market is not the best. We urge that companies understand not just the regulatory pathways, [but for their] medical device, what classification is it and what are the options to market based on that classification? ... A medical device that is premarket approved has legal defenses that most categories of 510(k) devices don’t have. Knowing your options and understanding not only the cost ... but understanding what those risks mean helps you not only with your own company and getting the product to market, but also being able to discuss that with investors and having them understand that you’ve made a decision and understand those risks. ... The first thing I look at when I get a case about a medical device is how did

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it get to market? Is it a PMA product, a 510(k), de novo review? Are there any special controls? All of those things immediately tell me whether I have an early motion to dismiss this case because of preemption. It’s the first thing I have to check off the list because it impacts the way I will approach the claim or complaint, and it also impacts hugely the amount of legal spend there will be on the case.”

2. Intellectual property “Understand and make sure that you have solid advice on how to protect and understand your own intellectual property. This goes in three directions.

One is, obviously, protect your intellectual property. The second is other developments that may come along as a result as you continue to do research.

And the third is whether you may be potentially infringing on somebody else’s existing rights, so avoiding that waste of time and energy. Most smaller companies spend money in this area already, [but] making sure that you have the right resources to help you understand that is something that cannot be understated.”

3. Define what success looks like “Ultimately, what’s the goal, what’s the passion, what’s the unmet need? This goes along with the path to market — what ultimately are we looking to do here? Some companies have a goal of being acquired. ... The critical thinking that goes along with that is to avoid that tunnel vision. You need to be nimble, in a sense of understanding what the data is telling you. Most companies are constantly getting information and having to adjust. It’s been really illuminating to work with companies when they’re getting information they weren’t necessarily expecting, and then how do they deal with that?”

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STARTUP TIPS

4. Have a plan before problems pop up “Before you get bad news, have a plan for how you’re going to discuss things. What kinds of things are discoverable in litigation later? When do you ask a lawyer or consultant for space under attorney-client privilege to talk this through? Not because you want to hide anything — that’s really important — it’s about the fact that communications can be manipulated in hindsight [during litigation]. It’s the same reason why we want doctors that have peer review privilege. We want them to talk about the things that went wrong in an honest and open way. So here, it’s about understanding how to deal with problems if they arise and understanding that things may not always go right. Everybody knows that going in, but they don’t always set up for it. The things that I always emphasize are, ‘How are we communicating?

What are we putting in emails? What

protocols do we have in place? And are we following them in terms of reporting and understanding adverse events?’ If you’re a company that has clinical trials, it’s really important that you have a lawyer review the clinical trial agreements, the informed consent documents and understand what those actually mean in terms of adverse events coming out of clinical trials and how to communicate with the sites. That can be super important if you’re relying on that data for the development of your product.”

Greenberg Traurig shareholder Ginger Pigott

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JENNIFER FRIED

Medtech founder Jennifer Fried is back with a new startup

A pulmonary embolism visualized using computed tomography Image courtesy of Flow Medical

Explorer Surgical’s former CEO now has her sights set on treating pulmonary embolism with a new catheter system.

J Jim Hammerand Managing Editor

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ennifer Fried has joined medtech startup Flow Medical as CEO and co-founder, she said in an exclusive interview with Medical Design & Outsourcing.

Fried was previously co-founder and CEO of Explorer Surgical, which sold to GHX in 2021. She resigned from the company in June 2022, leaving us to wonder what was next for the venture capital investor.

One year later, she’s an investor and the chief executive at Flow Medical. The Chicago-based startup is developing a new catheter system for treating pulmonary embolism (PE). PE is caused by blood clots that break off from deep vein thrombosis (DVT) and head to the lungs.

Of the estimated 900,000 PE cases in the U.S. each year, around 100,000 are fatal.

The other two co-founders of Flow Medical are Chief Scientific Officer Dr. Jonathan Paul and Chief Medical Officer Dr. Osman Ahmed. They both practice medicine at the University of Chicago Medical Center: Paul is an interventional cardiologist, while Ahmed is an interventional radiologist.

The two doctors came up with the idea for their catheter-directed thrombolysis (CDT) device in December

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2020. They had both just received their first COVID-19 vaccine dose and were sitting together during the brief postinjection observation period.

“It’s rare and unique for interventional radiologists and interventional cardiologists to be friends to begin with,” Ahmed said. “We’re both very passionate about DVT and PE. ...

During COVID, the number of DVT and PE cases just exploded because there was this association with the virus making a patient prone to developing clots. A lot of patients at that time were started on blood thinners as soon as they were diagnosed with COVID-19. It was really at the forefront of our minds.”

As the two doctors discussed the limitations of current PE treatments and the shift from thrombolysis toward thrombectomy, they saw an opportunity to innovate with a new device. Today, they have a prototype three-in-one angiography, infusion, and monitoring CDT system.

Flow Medical’s catheter-directed thrombolysis system Flow Medical designed its steerable catheter to navigate to the blood clot and deploy an expandable basket. (continued on page 54)

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(continued from page 52) Made of nitinol, that basket engages with the clot and delivers clot-busting tissue plasminogen activator (tPA) medicine directly into the blockage. The basket’s length is adjustable to match the size of the clot.

Nitinol’s superelastic properties allow the basket to compress down into a slim profile — the team is targeting an 8 Fr catheter size — and expand inside the pulmonary artery, then compress back down into the catheter for removal.

The catheter system will also have built-in angiography capabilities to perform a diagnostic quality pulmonary angiogram to help the interventionalist locate the clot and navigate the catheter within the clot.

“This is something we commonly and routinely do,” Ahmed said. “But it requires an exchange with a different device. The goal is to make a relatively painless procedure even more pain-free.”

The most important feature, Ahmed said, might be the system’s ability to monitor pulmonary blood pressure.

“CDT is an imperfect science.

Currently, we infuse the medication for a pre-set time and leave it in the patient, but unfortunately that’s very imprecise and can lead to bleeding complications,” Ahmed said. “Being able to monitor [pulmonary pressure] in real-time will allow us to discontinue the procedure exactly when we need to.”

The largest design challenge will be packing all those features into an 8 Fr catheter, which is slightly larger than current CDT devices but much smaller than mechanical thrombectomy catheters.

The team’s latest prototypes are currently in the 10-11 Fr range.

“We have all the components, and everything we’re pretty happy with,” Ahmed said. “We’re trying to just now miniaturize it into 8 Fr, which is doable.

We’re working on making sure we have a prototype that we’re happy with and then just shrinking it down a little bit.”

They’re working with contract development and manufacturing organization Medical Murray as well as Ontogen Medtech co-founder Tyler Panian. Panian was formerly director of R&D at Endotronix, which developed the Cordella pulmonary artery pressure sensor implant.

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Flow Medical co-founders (from left) Dr. Jonathan Paul, Jennifer Fried and Dr. Osman Ahmed

Photo courtesy of Flow Medical

“We’re confident in our engineering teams,” Ahmed said. “We’ve been making great progress, really only limited by supply chain shortages that everybody’s experienced.”

How Fried met Flow Medical One of Fried’s former investors is Dr. Steve Gould, the consulting director for Polsky Science Ventures at the University of Chicago’s Polsky Center for Entrepreneurship and Innovation. Fried said Gould — a Flow Medical advisor and board member — had been trying to get her to take a look at the startup ever since Explorer Surgical’s sale to GHX. In February, he tried again, and Fried agreed to meet Paul and Ahmed to explore an advisory role.

“They were so passionate and also so confident that they did not have the tools that they needed as physicians to do right by these patients,” Fried said. “And that’s why I said, ‘I want to help you.’ I did not go into the advisory relationship thinking I was going to be the CEO of another early-stage company.”

One factor that made a difference: Fried said her father was diagnosed a few years ago with a rare form of blood www.medicaldesignandoutsourcing.com

cancer that makes him more likely to have blood clots.

“I wanted to know how to take care of my dad, if and when that time came,” she said. “Because of that, I just really wanted to dig in.”

“Jennifer completes our team,” Paul said in a statement. “Jennifer’s experience building early-stage healthcare companies as both an investor and operator will enable us to rapidly accelerate our efforts to bring our novel device to market to serve our patients.”

As CEO, she’ll help Flow Medical build its team and select a path for regulatory approval while fundraising.

The company has already won Small Business Innovation Research (SBIR) funding from the National Institutes of Health and plans to apply for a phase II SBIR grant.

Fried also said Flow Medical is backed by a medical device manufacturer, but declined to name the strategic investor.

“Getting Jennifer has been one of our biggest milestones,” Ahmed said.

“In our first meeting with Jennifer, we just both knew she was the right person. ... Her expertise, her knowledge, her enthusiasm — she loves this as much as we do.”

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DIVERSITY BY THE NUMBERS

AN ANALYSIS OF THE LARGEST MEDICAL DEVICE COMPANIES SHOWS LITTLE PROGRESS, WITH SOME COMPANIES STILL REPORTING NO WOMEN IN TOP LEADERSHIP POSITIONS.

DA N IELLE K IR S H S E N IO R ED ITO R

W

omen hold 23.6% of executive leadership roles at the largest medical device companies in the world, according to an analysis of Medical Design & Outsourcing's latest Medtech Big 100 ranking of the top companies by revenue.

That number is not significantly different from our 2022 analysis, when women held 23% of executive roles. However, the average composition has increased yearwww.medicaldesignandoutsourcing.com

over-year. The average composition within the top 100 companies is 23.1%, a 1.3 percentage point increase over 2022.

Composition refers to the number of women in leadership roles as a share of the total number of top executives within a certain company. The rise in average composition means that companies are creating more gender-diverse executive teams year after year. (continued on page 59) 10 • 2023

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DIVERSITY BY THE NUMBERS

9

7

6 511 47

15

18

45 19

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23

44

23

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

47 Divisional president 45 Human resources 44 Regulatory 23 Finance 23 Medical 19 General counsel/legal 18 Communications

The Mullings Group VP and Senior Partner Holly Scott

15 9 7 6 5 1 1

Information Marketing CEO Operations Corporate secretary R&D Chief of staff

(continued from page 57) These modest improvements from the previous year underscore the persistent gender gap in highranking medtech roles. These executive leadership roles help shape the direction and decision-making of companies responsible for saving and improving patient lives, so it’s crucial to diversify the executive ranks to be more representative of the patient population.

Women are half of the workforce and make 90% of household healthcare decisions, but only around a quarter to a third of engineers are women, said Holly Scott, VP and senior partner at The Mullings Group. www.medicaldesignandoutsourcing.com

“In order to serve our diverse world in healthcare, we need individuals who think, innovate and develop solutions for problems for all of us,” she said.

While there was a significant uptick in diversity, equity and inclusion (DEI) activity in 2020 and 2021, initiatives impacting the leadership level will take time, Scott said.

And many companies have pulled back on their DEI programs “based on market demands — not uncommon when times become lean,” she noted.

“Unfortunately, emphasis on DEI has long been a luxury rather than a requirement,” Scott said.

Thirty-three executives joined our list this year, a drop from the 50 new executives in 2022.

"This all comes down to the end game," said Jill Canada, VP of corporate/ enterprise sales at Avail Medsystems.

“If what we are trying to influence is the number of women in C-suite roles, what we need to focus on is the feeder roles for the C-suite and make sure we have enough qualified women thriving in those roles. If the funnel for those roles isn’t robust, we’ll never have the ideal number of women in the C-suite.”

Our analysis looks at job titles from the leadership pages on corporate websites and the executives' personal LinkedIn pages. We excluded 18 Medtech Big 100 companies from this analysis because they did not list executive leaders on their websites or provide information to determine an executive’s gender, such as pronouns and/or executive portraits. >> 10 • 2023

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DIVERSITY BY THE NUMBERS

Prevalence and composition of women in leadership roles Of the 882 listed executives at the largest medical device companies, 208 were women with an average composition of 23.1%. The executives in this year’s analysis have spent on average of 3.4 years in their roles.

Seven companies listed no women in leadership roles as of August 20. That's three fewer companies than in 2022, and six fewer than 2021. Those companies include: • • • • • • •

Carl Zeiss Meditec (0/2) Demant (0/3) Dräger (0/5) Konica Minolta (0/8) Masimo (0/6) Medacta (0/3) Nevro (0/8)

“If what we are trying to influence is the number of women in C-suite roles, what we need to focus on is the feeder roles for the C-suite and make sure we have enough qualified women thriving in those roles. If the funnel for those roles isn’t robust, we’ll never have the ideal number of women in the C-suite.”

The women executives at each company have titles that break down

into the following roles: divisional president (47), human resources (45), regulatory (44), finance (23), medical (23), general counsel/legal (19), communications (18), information (15), marketing (9), CEO (7), operations (6), corporate secretary (5), R&D (1) and chief of staff (1). Note that some leaders hold one title for multiple roles, such as “SVP, general counsel and corporate secretary.”

The companies with the highest percentage of female executives are Medline Industries, Ambu, Fresenius Medical Care and Paul Hartmann, all of which have women in at least 50% of their C-suite roles. Three of those companies have women CEOs (more on that in a bit). Medline Industries had the highest composition of women in leadership roles at 52.6%, with women holding those roles for an average of 4.6 years. (continued on page 62)

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DIVERSITY BY THE NUMBERS

New to our list and/or their roles The following women are executives who are new to our list this year or were appointed to their current roles in 2023.

Amy Horton, VP and chief accounting officer at Artivion Jean Holloway, SVP, general counsel, chief compliance officer and corporate secretary at Artivion Rochelle Maney, VP, global quality at Artivion Katrine Kubis, VP, corporate communications and community relations at Avanos Medical (formerly executive sponsor, Avanos diversity, equity and inclusion council at Avanos Medical) Michelle Quinn, EVP, general counsel at BD (formerly SVP, deputy general counsel, chief ethics and compliance officer at BD) Karen O’Driscoll, chief information officer at Cochlear (formerly group executive digital at Ventia Pty) Emily Miner, SVP, quality and regulatory at Dentsply Sirona (formerly SVP, global quality and regulatory at Terumo Cardiovascular) Teri Lawver, EVP, chief commercial officer at Dexcom (formerly worldwide VP of immunology at Johnson & Johnson ‘s Janssen Pharmaceuticals) Anna Conneryd Lundgren, EVP and chief people officer at Elekta (formerly SVP, acting head of HR at Elekta) Colleen Riley, SVP, chief technology officer at Embecta Ginny Blocki, SVP, global marketing and product management at Embecta Jean Casner, SVP, chief HR officer at Embecta (formerly SVP and Chief HR Officer at Renalytix) Claudia Ortiz, SVP, regulatory affairs and quality assurance at Envista Katarzyna Mazur-Hofsäß, care enablement at Fresenius Medical Care Danielle Halstrom, chief corporate marketing and communications officer at GE HealthCare Carolynne Borders, chief investor relations officer at GE HealthCare Abigail Epane-Osuala, chief diversity, equity and inclusion officer and HR strategic initiatives at GE HealthCare Joanna Engelke, EVP quality compliance, regulatory and medical affairs at Getinge 62

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Agneta Palmér, EVP of operational services at Getinge Jennifer Schneiders, president, diagnostic solutions at Hologic (formerly VP of U.S. commercial sales and excellence at Hologic) Kathy Sherwood, SVP, global market access at Inspire Medical Systems Lauren Budden, Group VP, chief accounting officer and controller at Insulet Laetitia Cousin, SVP, regulatory affairs, quality assurance and compliance at Insulet (formerly VP, regulatory affairs and quality assurance at SeaSpine) Gurpreet Kaur, VP and chief information officer at Integra LifeSciences (formerly VP of global analytics and strategic initiatives at Integra LifeSciences) Lea Daniels Knight, EVP and CFO at Integra LifeSciences (formerly EVP of finance at Booz Allen Hamilton International) Cintia Ferreira, SVP and chief HR officer at Invacare (formerly VP of HR, EMEA and interim chief HR officer at Invacare) Magda Stepniewicz, VP, global categories at Invacare (formerly EMEA head of manual mobility and seating at Invacare) Caryn Arnold, medical science liaison at Medline Industries Patricia Turner, director of clinical services of acute care skin health sales team at Medline Industries (continued on page 64)

10 • 2023

Fresenius Medical Care CEO Helen Giza (continued from page 60) The biggest challenge, Scott said, is that change will take the same long decades it takes for women to build their careers to the executive level.

“These efforts take time, and because economic conditions drive company commitment for resources, the programs that support these efforts need to be sustaining. With that said, this kind of change starts at the individual level," she said.

More women in the corner office Seven women held CEO roles at the top companies, up one from last year. Those companies are Accuray, Ambu, B. Braun Melsungen, Barco, Fresenius Medical Care, GN Hearing and Paul Hartmann.

Fresenius Medical Care is new this year as Helen Giza took over as CEO in December 2022.

She was previously deputy CEO, CFO and chief transformation officer. (continued on page 64)

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DIVERSITY BY THE NUMBERS

New to our list and/or their roles (continued) (continued from page 62) Angela Carranza, manager of clinical resources at Medline Industries Karen Frey, senior manager, philanthropy at Medline Industries Michelle Christiansen, VP of clinical sales, support and marketing – Personal Care at Medline Industries Donna Matocha, manager of clinical resources – Critical Care at Medline Industries Kim Haines, director of clinical services for SPT Perioperative Solutions at Medline Industries Angela Newman, director of clinical services – Acute Care at Medline Industries Amy Rogers, senior clinical resource manager at Medline Industries Francesca Olivier, VP, environmental, social and governance (ESG) at Medline Industries JoAnne Alkire, EVP of global marketing and strategy at Merit Medical Systems

Puja Leekha, SVP, chief ethics and compliance officer at Orthofix (formerly VP, chief compliance officer and corporate counsel, North America at Lundbeck) Britta Fünfstück, CEO at Paul Hartmann Johanna Roberts, EVP, general counsel and secretary at Penumbra Maggie Yuen, CFO at Penumbra Gita Barry, president, Immersive Healthcare at Penumbra Julia Strandberg, EVP and chief business leader connected care at Royal Philips (formerly chief commercial officer at Pear Therapeutics) Vy Tran, head of Asia Pacific Japan at Siemens Healthineers Katya Kruglova, GVP HR and communications at Sonova (formerly VP of HR at GE Healthcare) Marianne Wiinholt, CFO at WS Audiology Annemarie van Neck, president region EMEA at WS Audiology

(continued from page 62) Women are attracted to organizations where they see other women represented at the executive level, because that shows they will have a voice and be able to make a difference, Scott said. “This starts with thought leadership from the top.”

Among the women-led companies, women hold 50% of executive leadership roles at Ambu, 12.5% at Accuray, 40% at B. Braun Melsungen, 13.3% at Barco, 50% at Fresenius Medical Care, 33.3% at GN Hearing and 50% at Paul Hartmann.

Men and women alike in executive leadership positions and on boards must do their part, said Jill Canada at Avail Medsystems. And she added that it’s not just about how many CEOs are women.

"The end game is increasing the number of women thriving in CEO roles, not just in CEO roles," she said.

"That means we need to be intentional about development.”

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BIOSENSE WEBSTER

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biosense webster aims to expand to afib care ELECTROPHYSIOLOGY IS “AN INCREDIBLY VIBRANT SPACE,” SAID NIKKI SIDI, BUT ACCESS REMAINS A CHALLENGE.

N

ikki Sidi, the U.S. president of Johnson & Johnson’s Biosense Webster, can look at her own company as one of those paving the way in electrophysiology (EP). Its recent milestones include multiple atrial fibrillation (AFib) mapping catheters, including ablation and mapping devices.

Sidi has worked across a number of businesses at J&J, including leading U.S. marketing for Biosense Webster. She took on the post of U.S. president at Biosense Webster in December 2022 after a stint with J&J Vision.

Her return to Biosense Webster — and her return to AFib treatments — has been nothing short of “amazing,” she told Medical Design & Outsourcing. Biosense Webster competes in a market that also includes Boston Scientific, Medtronic and Abbott — with excitement growing around the potential of new pulsed-field ablation treatments and more.

“There’s so much that is happening, so much innovation that’s coming,” Sidi said. “With Biosense being the market leader, it’s great to be at the helm of that and seeing what else we can do, not just from an innovation perspective, but also

from removing some of the barriers that impact our physicians and customers alike to get access to care.”

Sidi and Biosense Webster want to continue to battle AFib and the barriers preventing people from receiving proper care for the disease.

“It’s incredible because we’ve been at this for decades, but the penetration of patients accessing this treatment is still relatively low,” she said. “There’s still a lot of work to do, and a lot of innovation to come to hopefully unlock that as well.”

Biosense Webster’s Thermocool SmartTouch SF ablation catheter Image courtesy of Biosense Webster

Health disparities build up AFib barriers AFib is the most common heart arrhythmia.

Studies cited by the Centers for Disease Control and Prevention estimate that 12.1 million people in the U.S. will have AFib by the end of the decade.

Sidi referenced a Journal of the American College of Cardiology article stating that Black and Hispanic patients have a higher prevalence of AFib risk factors. These include high blood pressure, diabetes and obesity. Black patients are 30% more likely to have high blood pressure and 60% more likely to have diabetes. >> www.medicaldesignandoutsourcing.com

10 • 2023

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BIOSENSE WEBSTER

“Just the fact that [Hispanic patients] are disproportionately more prone to having these types of risks, that means a more disproportionate amount affected by AFib. There’s a huge opportunity for us to impact them.”

And Hispanic patients are 1.2 times more likely to be obese compared to other ethnic groups, Sidi said.

“Just the fact that they’re disproportionately more prone to having these types of risks, that means a more disproportionate amount affected by AFib,” Sidi explained. “There’s a huge opportunity for us to impact them.”

Most alarming to the Biosense Webster executive: Only about one-third of Black AFib patients are likely to be aware that they have AFib. “It’s important to get the awareness out if we want to eliminate some of these inequities,” Sidi said.

According to Sidi, a lack of trust leads to roadblocks for people in these communities who need care. She said it centers around the simple fact that people want to see physicians and receive care from people who look like them, have the same experiences they do, have gone through some of the same challenges and understand their circumstances.

“For us, that just means we need more diversity in medicine in general so these physicians reflect the patients they serve,” Sidi said. “That’s ultimately our goal.”

Biosense Webster’s diversity initiatives Sidi outlined a number of programs for which Biosense Webster helps to combat these gaps in care.

The company serves as the founding sponsor of Heart Rhythm Society’s Growth and Leadership

Opportunities for Women in Electrophysiology (GLOWE). This program helps women navigate the challenges in EP, as Sidi said the field has one of the lowest percentages for female representation.

This year, Biosense Webster also collaborated with HRS on a program for Black electrophysiologists called Growth and Leadership Opportunity for Black Electrophysiologists (GLOBE).

“Black EPs have traditionally been underrepresented at the executive level, in healthcare in general and certainly within EP,” Sidi said. “Putting in those programs to help create an environment where these minority groups feel supported has been really critical and core to the way we’ve approached it.”

Biosense Webster also invested in STEM programs to tap into the student population and help guide them toward EP. Last year, the company awarded 10 students with a scholarship through a program with the Association of Black Cardiologists (ABC). Sidi said the program helps students participate in leadership groups and gives them an opportunity to “get a flavor for what electrophysiology is.”

The company also aims to provide tools and resources for people with AFib. The best way to address the condition, Sidi said, is to ensure that people are educated on their options.

“Ultimately, as a newly diagnosed patient, we want them to understand that AFib is a progressive disease,” she explained. “If it’s not treated early, it can get worse. And the treatment options are more effective when done earlier.”

Biosense Webster has a website dedicated to helping patients learn about their options that includes patient testimonials. The company also announced new materials online that have been translated into 10 different languages to widen accessibility.

“We’re making sure we can get the most people, being inclusive in the way we approach them and hopefully, ultimately impact the care that they get,” Sidi said.

NIKKI SIDI BIOSENSE WEBSTER U.S. PRESIDENT

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2023

SPONSORED

Women in Medtech

Kayla Whitesel Manufacturing Engineer Accumold BS Industrial Engineering Iowa State University Kayla Whitesel is a dedicated Manufacturing Engineer with a Bachelors of Science degree in Industrial Engineering from Iowa State University.

Her career in manufacturing was motivated by a desire to make a meaningful impact in the medical field. Amid the diverse domains of manufacturing, the healthcare industry stood out as an area where efficiency is paramount.

Throughout her academic years, the concept of efficiency resonated deeply and in her role as a Manufacturing Engineer at Accumold, she collaborates with professionals who share a passion for maximizing efficiency. Whitesel’s team embraces change as a constant, recognizing its potential to drive progress and innovation and continually challenge conventions. Shestrives to make a difference in the dynamic world of manufacturing.

Outside of work, you’ll find her lacing up a pair of running shoes, exploring new places, and experimenting with exciting recipes in the kitchen.

What initially attracted you to the MedTech industry? How has your perspective on the industry evolved over the course of your career?

During the summer preceding my senior year of high school, I had the privilege of attending an engineering conference held at the University of Nebraska at Omaha. This three-day event provided high school students like me with a unique opportunity to explore various engineering disciplines and engage with companies specializing in them.

The conference’s final presentation left a lasting impression on me. It was delivered by a company committed to optimizing existing processes to make them eco-friendly and highly efficient. The presenter showed a lush forest, progressively zooming in until it focused on a single plant. At the micro-level, they demonstrated how the intricate processes of plant survival had been optimized to an astounding 99.9%, benefiting the surrounding ecosystem. This revelation showcased how the principles of efficient evolution in the natural world could be applied to enhance existing business operations – a perspective that expanded my horizons.

I realized that I could choose an engineering degree that would empower me to work on projects aimed at optimizing and transforming specific fields. My preexisting interest in the medical field seamlessly merged with this newfound passion, as I envisioned a career dedicated to enhancing and streamlining existing processes in healthcare. I have been able to learn how the medical parts field operates, and what is needed to bring a medical product to market. My perspective of the MedTech industry is growth. The industry is ever growing, with the use of various technologies and design of medical parts. Professionals in this industry are challenging the norm and designing applications to better fit the needs of the specific medical field, and it is inspiring to see.

How do you think diversity and inclusion can contribute to the advancement of MedTech engineering?

To foster a collaborative environment that breeds innovation, diversity needs to be aligned as the fresh perspectives it brings are crucial for driving growth. In the ongoing development of the MedTech Engineering field, diversifying, and embracing various cultures can greatly enhance creative thinking and teamwork. It’s truly encouraging to witness the increasing presence of women in the engineering realm. As a young woman in this field, I find it inspiring to witness the progress made in promoting gender diversity and inclusion. The path continues to expand, and engaging in discussions with women who have firsthand experience of this growth keeps my ambition alive, not only for myself but also for other young women pursuing careers in engineering.

For the rest of Kayla Whitesel’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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2023

SPONSORED

Women in Medtech

Chaitali Pawar Quality Engineer Carl Stahl Sava Industries BS Aircraft Maintenance Engineering Indus University

What initially attracted you to the MedTech industry? How has your perspective on the industry evolved over the course of your career?

There is no room for error in MedTech and that is an exciting proposition because it means my work in this area is meant to keep people safe, well and healthy.

What emerging technologies or trends do you believe will have the most significant impact?

As a quality engineer, AI has been instrumental in helping me get extremely precise in vetting vendors and comparing their pluses and minuses with one another.

From your experience, what are some of the key challenges that medtech engineers are likely to face in the coming years?

MedTech engineers are often tasked with competing priorities. Everything is important, so the challenges are often how to prioritize amid a host of collaborations all equally worthy of my time and attention.

How can professionals in the industry prepare for and navigate these challenges effectively?

It’s important that each project be the shared responsibility of many scientific professionals to ensure collaborations are given their proper due, but while leveling the load across various competencies.

How do you think diversity and inclusion can contribute to the advancement of MedTech engineering?

As a quality engineer who was born, raised and studied in India, I can personally testity to the net postitive of inclusion and diversity in MedTech. It’s an exciting notion to think that our unique, personal experiences can lend to our problem-solving skillsets because it means we’re stretching the bounds of our education with personal, often cultural, experiences combined.

How do you foster a culture of innovation within your team or organization?

As a quality engineer I always need to ask, “why?” In my view, it is imperative to question what you’re seeing and learning. A culture that prioritizes the “why” is a culture that will break new ground often.

For the rest of Chaitali Pawar’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech www.medicaldesignandoutsourcing.com

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2023

SPONSORED

Women in Medtech

Jill Ellison VP of Operations Confluent Medical Technologies BS in Chemical Engineering South Dakota School of Mines and Technology Jill Ellison, VP of Operations for Confluent Medical Technologies, leads Operations at the Orange County, CA and Chattanooga, TN facilities. She is a proud mother of 3 grown children. Jill brings more than 20 years of medical device experience with a focus on Operations Management, Engineering and Continuous Improvement.

Prior to Confluent, Jill was a Sr. Director of Operations for Integer, where she was responsible for profitability, strategic planning, new product introduction and customer service for multiple sites. Jill’s sites at both Confluent Medical and Integer have consistently seen double digit revenue growth year-over-year along with year-over-year improvement on key KPIs. Prior to working in the medical device field, Jill held key engineering and leadership positions with Dow Chemical and the Dial Corporation. Jill holds a BS in Chemical Engineering from South Dakota School of Mines and Technology and is a certified Six Sigma Black Belt.

What initially attracted you to the medtech industry? How has your perspective on the industry evolved over the course of your career?

I was initially attracted to the industry due to job stability/recession proof due to essential nature. After working in the industry for just a short time, I realized the impact we as employees make in the world.

We are helping design and manufacture medical devices that are lifesaving and this is why I have stayed in the industry over 20+ years. I take a lot of pride knowing we are making a difference in the world.

We are helping people live better lives and, in some cases, saving lives.

As a seasoned professional in the industry, how do you envision the future of medtech? What emerging technologies or trends do you believe will have the most significant impact?

The industry will continue to push capabilities making medical devices less invasive for the patient for quicker recovery. This typically means smaller diameter, thinner walls and the ability to access more torturous parts of the anatomy.

How do you think diversity and inclusion can contribute to the advancement of medtech engineering? How do you foster a culture of innovation within your team or organization?

Diversity and inclusion in engineering is not just about fairness or representation; it’s a key driver of innovation. Diverse teams bring a wider range of ideas, perspectives, and approaches to problemsolving, leading to more creative and effective solutions. Innovation is one of Confluent Medical’s Company Values. Key to our Mission Statement; creating a work environment of growth, leadership and innovation in which our employees can impact the world by doing work that matters! A culture of continuous improvement allows team members to make mistakes but then learn and grow otherwise you damper innovation. Leaders need to encourage collaboration and empower their employees.

For the rest of Jill Ellison’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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Women in Medtech

Lauren Roy Engineering Supervisor Cretex Medical B.S. Manufacturing Engineering North Dakota State University Lauren Roy graduated with a Bachelor of Science in Manufacturing Engineering from North Dakota State University in 2014. She began her career at Cretex Medical as a Quality Intern and her dedication and performance led to a full-time role after graduation. Over nine years, she progressed from Quality Engineer to Quality Engineer III, and eventually, a Senior Quality Engineer.

Lauren also held the role of Quality Engineering Supervisor, leading a team of inspectors, technicians, and programmers. Recently, she transitioned to an Engineering Supervisor in the Manufacturing Engineering department, showcasing her versatility and commitment to professional growth. Lauren is an emerging leader at Cretex Medical with a diverse skill set and a strong record of achievement in quality and manufacturing engineering.

What initially attracted you to the medtech industry? How has your perspective on the industry evolved over the course of your career?

I was drawn to the medtech industry because two of my cousins were diagnosed with Type II (Juvenile) diabetes as toddlers. Over the years, I watched how they went from injections after meals to their first insulin pumps and now to continuously monitored Bluetooth devices. Seeing how those devices changed their lives made me want to go into the industry and be part of impacting lives for the better.

At the beginning of my career I was aware of the well-known devices like pacemakers, surgical tools, and pumps and monitors for diabetes. It didn’t take long to realize that the medtech industry encompasses so much more than these innovations. I’ve learned even small advancements can make a significant difference in patients’ lives – improving their comfort, convenience, and overall well-being.

As a seasoned professional in the industry, how do you envision the future of medtech? What emerging technologies or trends do you believe will have the most significant impact?

I think the future of the medtech industry is moving towards a proactive stance on health, with emerging technologies playing a key role in improving healthcare outcomes and patient experiences. Many of the new projects we see are focused on preventative care and early diagnosis, to help patients avoid invasive procedures and intensive treatments for everything from cancer to cardiac rhythm management. The integration of Bluetooth technology into medical devices has been a pivotal development. It enables continuous data collection and transmission, allowing healthcare providers to access real-time patient information. This approach reduces the need for frequent in-person appointments, making healthcare more efficient and patient-centric.

How do you think diversity and inclusion can contribute to the advancement of medtech engineering? How do you foster a culture of innovation within your team or organization?

Inclusion and diversity are key to moving the medtech industry forward – without it the industry will become stagnant. Including diverse perspectives allows you to understand “both sides of the coin” and keeps you open to exploring new ideas. At the end of the day, you have to put everything aside and be inclusive to ensure everyone’s voice is being heard, because we all have an important voice.

For the rest of Lauren Roy’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech www.medicaldesignandoutsourcing.com

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Women in Medtech

Treasa Springett President Donatelle Plastics Inc. Treasa Springett is president of Donatelle Plastics Inc. - a world-class contract manufacturer of medical components and devices, specializing in injection molding, LSR, precision machining, device assembly, and tool building. Springett joined Donatelle in 2004 and built an executive staff and Leadership Team that have continued to grow the business by developing and expanding processes, capabilities, and technologies, and offering these enhanced capabilities to our global Medical Device OEM customers. With over 55 years of experience, Donatelle manufactures products across many markets within this industry, including cardiac & vascular, neuromodulation, orthopedic, ophthalmic, diabetes & drug delivery, diagnostics, and surgical technology.

Springett has more than 35 years of contract manufacturing industry experience in medical device product development and manufacturing; having served in many leadership roles spanning from engineering, sales, operations, and administrative functions. A transformational business leader, Springett has led cultural change and technological advancements that have become foundational in achieving organizational success at all levels and across multiple disciplines.

What initially attracted you to the medtech industry? How has your perspective on the industry evolved over the course of your career?

As I started my career as a mechanical engineer, I never really thought about the specific industry I would work in, rather my interest was more about the type of work, that being mechanical engineering and how it supported manufacturing. Early in my career, I worked as a manufacturing engineer for a custom contract manufacturer whose customers included many major medical device companies. Having an opportunity to design and build products and devices that touch people at a point of care and can improve the quality of life for them is very rewarding work. I have been pursuing this passion ever since that first engineering position and today 100% of the focus for the company I lead is on the medical industry.

As technologies advanced in manufacturing processes, automation, metrology, and other areas, contract manufacturers such as Donatelle partnered with medical device OEMs to design, develop, and manufacture devices that at one time were not possible to produce.

As a seasoned professional in the industry, how do you envision the future of medtech? What emerging technologies or trends do you believe will have the most significant impact?

Medtech has an exciting future offering devices and therapies that in the past would not have been possible. Wearable devices, Telemedicine, and Robotic surgical technologies along with use of AI in diagnostics will have a greater impact in Medtech’s future. COVID 19 accelerated telemedicine and this will expand to enable accessible and affordable healthcare. Advances in additive manufacturing that include plastics, metal, and tissues at microscale will further the medtech to the levels that were unimaginable in the recent past.

As technology continues to advance rapidly, how do you think medtech engineers can stay ahead of the curve and ensure they are equipped with the necessary skills and knowledge?

Engineers can stay ahead of the curve by researching and keeping abreast of innovations and technologies, attending industry tradeshows, seminars, and being actively involved with industry-specific professional organizations. They should explore and adapt to emerging technologies relevant to their field. These include Additive Manufacturing, data analytics, virtual reality and artificial intelligence along with machine learning. Another way is by collaborating within their own organizations and sharing lessons learned from current and past projects.

For the rest of Treasa Springett’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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Women in Medtech

Liz Sydnor Director of Microbiology Eurofins Medical Device Testing B.S. Biology Cleveland State University As director of microbiology at Eurofins Medical Device Testing, Liz Sydnor oversees the microbiological testing of medical devices.

With extensive industry experience specifically in sterility assurance of medical devices and manufacturing, Ms. Sydnor is an expert in standard microbiological test methods, investigations, CAPAs, protocol development, test method validations, and data analysis.

She spent several years working with leaders in the healthcare testing and manufacturing industries supporting regulatory inspections with FDA, TUV, MDSAP during ISO 13485 accreditations and other site certifications. Ms. Sydnor has supported the launch of several innovative products currently sold in global markets today. She also served in the United States Army as a Petroleum Laboratory Specialist.

What initially attracted you to the medtech industry? How has your perspective on the industry evolved over the course of your career?

During my time in the Army, I worked closely with medics, and I knew I wanted to work in healthcare at some point. After getting out of the military and graduating from college, my first industry job was focused on testing a variety of medical devices. I was so intrigued by the vastness of the medical device industry and realized technology advances could improve a patient’s quality of life. I knew then that I found an industry I was passionate about and wanted to spend my career contributing to the advancement of healthcare.

Over the course of my career I’ve learned the intricacies of the regulatory hurdles that many organizations face. This often presents a certain set of challenges for innovation and technological advances in medical devices. However, I’ve seen teams succeed and rise to the challenge when collaboration is at the center of the conversation.

As a seasoned professional in the industry, how do you envision the future of medtech? What emerging technologies or trends do you believe will have the most significant impact?

Automation initiatives continue to be at the forefront for many organizations, from device manufacturers to testing laboratories and more. Automating certain processes has the ability to increase accuracy and throughput but presents significant implementation and validation challenges.

From your experience, what are some of the key challenges that medtech engineers/scientist are likely to face in the coming years? How can professionals in the industry prepare for and navigate these challenges effectively?

Innovation presents a unique set of challenges because it often means there is no roadmap to the finish line. In the medical device regulatory world, it is common practice to adopt a change based on historical data of a previous or similar device.

However, with new technologies and the complexities of computer software validations, there will be a new set of challenges to overcome.This is a good thing that will certainly move the industry forward.

For the rest of Liz Sydnor’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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Women in Medtech

Dani Rojas Project Engineer Flexan B.S. Biomedical Engineering Florida International University Dani Rojas graduated from Florida International University with a B.S. degree in Biomedical Engineering. She is currently a project engineer at Flexan, where she is responsible for a complex, multi-product transfer to a new ISOcertified manufacturing facility in Mexico.

Prior to her work at Flexan, Daniella was an instrumental part of a cross-functional pandemic team at Abbott Laboratories, working to increase production of 45 million COVID-19 tests to 75 million.

She began her career as a manufacturing engineer at Beckman Coulter, and also worked in the R&D department at Beckman Coulter.

As a seasoned professional in the industry, how do you envision the future of medtech? What emerging technologies or trends do you believe will have the most significant impact?

We should anticipate advancements in technologies for molecular devices, implantables, and robotics, as these areas are converging with each other and with predictive analytics, remote monitoring, and artificial intelligence. The ways we are using sensors now, in implantables and wearables, as well as the advancements we are seeing in silicone and thermoplastic materials, will continue to drive progress for many years to come.

Flexan works with many of the world’s leading medical device companies to manufacture extremely innovative devices that save lives like sensor-enabled catheters, and hydrocephalus shunt systems. We are going to see many breakthroughs in these areas in the coming years, in addition to continued breakthroughs in medical device design and materials. Very exciting.

Another innovative area, and it’s one that I fell in love with at FIU at the Adaptive Neural Systems (ANS) Lab, was the work we were doing on prosthetic limbs to restore sensation in limbs again. The ANS lab is pioneering neural-enabled prosthetic hand (NEPH) investigation device system, which restores a sense of touch/ grasp force and hand opening by stimulating sensory nerve fibers in the residual limb with fine wires implanted inside nerves, allowing amputees to “feel” again. We are seeing significant advancements in this area.

How do you think diversity and inclusion can contribute to the advancement of medtech engineering? How do you foster a culture of innovation within your team or organization?

As a female in a male-dominated profession, I value diverse perspectives, and it’s empowering when there are more women in engineering, and women of color. When teams are diverse, it opens up a door for collaboration and differences of opinion and that fosters innovation.

There is no lack of diverse talent at med tech companies; we are here and we can be found at manager and individual contributor levels; now it’s time to nurture this talent so they can to step up into higher level roles. What I love about Flexan is that we are working to foster a culture of innovation, inclusivity, and diversity because we know it is not only the right thing to do, it is good for business and the bottom line.

For the rest of Dani Rojas’ insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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Women in Medtech

Prim Chanarat Assistant Plant Director Infus Medical (Thailand) Co., Ltd. Bachelor of Architecture Cornell University, USA MBA Sasin School of Management, Thailand Prim Chanarat is the Assistant Plant Director at Infus Medical (Thailand) Co., Ltd, and has been with the company for 7 years. Her main responsibilities include overseeing the operations at both of the Infus facilities in Thailand, with a main focus on new product development. Prim works closely with all of Infus’ customers to ensure that their products are optimally developed and manufactured with quality, cost efficiency, and most importantly, patient safety in mind.

What initially attracted you to the medtech industry? How has your perspective on the industry evolved over the course of your career?

My undergraduate educational background is in architecture, but I was intrigued by the medtech industry and saw an opportunity to contribute to my family business, Infus Medical (Thailand) Co., Ltd., which was founded by my father and his partner over 30 years ago. The medtech industry is constantly innovating and evolving, improving procedures and patients’ safety and lives, making working in this industry extremely rewarding.

As a seasoned professional in the industry, how do you envision the future of medtech? What emerging technologies or trends do you believe will have the most significant impact?

The medtech industry today is so much more integrated in our everyday lives than it once was, ranging from the integration of data and AI to assist in diagnostics, to robotics to assist in manufacturing processes. Robotics will no doubt play a huge role in not only the physician and patient interface, but also in the manufacturing sector as well.

From your experience, what are some of the key challenges that medtech engineers are likely to face in the coming years? How can professionals in the industry prepare for and navigate these challenges effectively?

One of the key challenges that medtech engineers might face is the use of AI to perform some of the tasks, taking over the role of some engineers. However, the tangible aspect of working in product development, whether prototyping, physically handling and manufacturing of the product is still very integral to the medical device manufacturing industry. There should be a healthy balance between the adopting of technology such as AI to assist in the process, and not letting the technology become the dominating mechanism.

As technology continues to advance rapidly, how do you think medtech engineers can stay ahead of the curve and ensure they are equipped with the necessary skills and knowledge?

There are multiple sources of knowledge and experiences to learn from, whether from articles and podcasts or attending conferences and meeting other people in the field. I think medtech engineers should be open to reach for these resources and widen their horizon on what the industry and its people have to offer.

For the rest of Prim Chanarat’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech www.medicaldesignandoutsourcing.com

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Women in Medtech

Dania Neiroukh Global Biomedical Account Manager Instron B.S. Chemical Engineering University of Southern California My career at Instron started five years ago as a technical sales engineer and over time has evolved into my current role as Global Biomedical Account Manager.

I was born in Jordan and moved to the U.S. in 2006 to attend college at the University of Southern California, where I graduated with a bachelor’s degree in chemical engineering with an emphasis on materials science. My time at USC introduced me to R&D studies that helped to grow my interest in the biomedical world.

Today, I work closely with our biomedical partners to help navigate their challenges in medical device testing. Being a world-class manufacturer of materials testing systems, Instron has given me opportunities and tools to support our biomedical partners and ensure they meet all the quality testing requirements to the highest standards. It is truly the most rewarding experience knowing that our biomedical partners can count on us.

I am honored to be an immigrant woman working in the medtech industry, and I will always be grateful for the opportunities I’ve been given throughout my journey. I am a mother to two wonderful children and when I am not working, I love spending time with my family creating cherished memories.

What initially attracted you to the medtech industry? How has your perspective on the industry evolved over the course of your career?

During my initial years at Instron, I was exposed to a variety of different industries. What attracted me the most to medtech was knowing that I could be part of a solution that brings healthcare closer to patients, essentially by giving them more power over their own care.

My perspective on the industry has shifted significantly over the course of my career. Traditionally, there has always been a disconnect between healthcare providers and patients. Now, I am seeing this gap being bridged as patients become more connected to their healthcare setting. The mindset of many medtech companies has also shifted — the primary consumer is no longer healthcare facilities or professionals, but patients themselves. It is great to see this transition in the industry — giving patients more control over their healthcare than ever before.

From your experience, what are some of the key challenges that medtech engineers are likely to face in the coming years? How can professionals in the industry prepare for and navigate these challenges effectively?

I think one of the biggest challenges medtech engineers are likely to face in the future is how to mitigate risks related to cybersecurity. These connected biowearable devices are consumer products that collect large amounts of personal data and dispense drugs based on specific readings. Creating cybersecurity teams that help keep this data secure will be very important in order to mitigate any risks of data breaches.

How do you think diversity and inclusion can contribute to the advancement of medtech engineering? How do you foster a culture of innovation within your team or organization?

Building a diverse environment can lead to innovations that better serve a wide range of patients. Including people from different backgrounds and experiences will enrich the discussions around medtech and new ideas. To advance innovation, you need great new ideas — and these are best created when you have a diverse team that is more agile and brings in new perspectives.

At Instron, we pride ourselves in a decentralized and entrepreneurial culture that empowers everyone to think and act like a business owner. This mentality fosters a culture of innovation and inspires the organization to continue innovating.

For the rest of Dania Neiroukh’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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Women in Medtech

Carol Russell Vice President and Chief Information Officer Integer B.S. Organizational Leadership Quinnipiac University Associate in Applied Science in Information Technology John Tyler Community College Carol Russell is Vice President and Chief Information Officer for Integer Holdings Corporation, responsible for overseeing Integer’s IT strategies, programs and operations globally.

Her career spans more than 30 years in IT and Finance, during which time she has led multiple award-winning transformation programs.

Carol began her career as a programmer and grew into progressively challenging leadership positions. Prior to joining Integer, her most notable roles included Leader of Global Finance Business Services at Alexion Pharmaceuticals, Senior Information Officer at American International Group (AIG), and CIO for Supply Chain, Operations and Finance at GE Industrial Solutions.

Carol serves as Co-Chair of Integer’s women’s Employee Resource Group, Athena Alliance, and is a board member of American Heart Association’s Go Red campaign (Minneapolis).

What initially attracted you to the medtech industry? How has your perspective on the industry evolved over the course of your career?

I was first attracted to the medical industry because of what I viewed as an opportunity to give back to society. I’ve worked in many industries throughout my career, including CPG manufacturing, industrial manufacturing, telecommunication and higher education, before joining the medtech field.

During my first role in the medical industry, I was amazed at how motivating it was to come to work every day knowing I was truly making a difference in the lives of others. When I was approached about a role with Integer and learned what the company does, I was intrigued. Integer’s vision of enhancing the lives of patients worldwide is especially meaningful to me as my family has a history of heart disease. As a technology professional, becoming part of the medtech industry has been an extremely rewarding way to blend my professional background with my passion for giving back.

How do you think diversity and inclusion can contribute to the advancement of medtech engineering? How do you foster a culture of innovation within your team or organization?

I’m a big believer in diversity, including diversity of thought. With my teams, I work to create an environment where everyone is comfortable sharing ideas and challenging the status quo. Diversity then becomes a key part of our work.

Additionally, I support a variety of associate-led diversity and inclusion (D&I) initiatives that impact Integer associates around the world. I am an active member of the steering committee for two Employee Resource Groups (ERGs), and I serve as Co-Chair for Integer’s women’s ERG, Athena Alliance.

We champion the advancement of female associates across our organization through executive-led mentoring, networking, and recognition activities – all intended to build awareness and celebrate the impact of women in our industry and business.

Our unique backgrounds bring differing points of view, and I am committed to developing an inclusive environment where associates are empowered to share openly and build upon each other’s ideas to create innovative solutions to business challenges.

For the rest of Carol Russell’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech www.medicaldesignandoutsourcing.com

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Women in Medtech

Sofía Vargas Business Development Manager Intricon Costa Rica Masters in Trade and International Markets Lead University Sofía Vargas is business development manager at Intricon Costa Rica. Her mission is to bridge opportunity and technology for Intricon customers by creating new, impactful partnerships between the company and medical device pioneers in Costa Rica and beyond. Sofía joined Intricon as it announced plans to build a new state-of-the-art development and manufacturing facility in Costa Rica.

Before joining Intricon, Sofía was part of the team at CINDE. CINDE is Costa Rica’s private investment promotion agency, dedicated to supporting multinational companies as they establish operations in the country. Sofia worked exclusively for the Life Sciences sector, and she was integral in attracting new investment opportunities through international outreach, including consultation about Costa Rica’s Free Trade Zone Regime, supporting companies with real estate decisions, benchmarking, providing stakeholder relations, and supporting the establishment of businesses in the local medical device ecosystem. Prior to CINDE, Sofia worked with the Ministry of Foreign Trade of Costa Rica, as part of the Market Access Negotiating Team for Free Trade Agreements and on the country’s compliance with the World Trade Organization.

What initially attracted you to the medtech industry? How has your perspective on the industry evolved over the course of your career?

I’ve always liked to work for a purpose. Developing the life sciences industry in Costa Rica brings innovation that saves people’s lives and provides quality jobs to the Costa Rican people. My job has a double impact. That’s what attracted me to the industry, which keeps me focused and fascinated with the work.

The deeper I go in the industry, the more it amazes me. I’m always thinking about how to improve peoples’ lives, how to create a much less invasive technology for patients. At Intricon, we have a highly motivated team because it’s very easy to create passion around saving lives. I firmly believe that Intricon moves medical technology forward, bringing ideas that make a difference in people’s lives to reality.

What has evolved for me is understanding the importance of a resilient supply chain to medical device original equipment manufacturers (OEMs). That’s what Intricon’s new facility in Costa Rica will bring: the chance for customers to have proximity to this important supplier of sensor-driven medical devices, supported by a cost-efficient manufacturing plant that allows OEMs to scale production of their devices to meet market demand.

How do you think diversity and inclusion can contribute to the advancement of the medtech field? How do you foster a culture of innovation within your team or organization?

We are diverse people. I think you can be a better professional and a happier person in a place that allows you to be the most real version of yourself.

Giving this opportunity to your employees will help a company’s environment to innovate and create. It’s crucial to foster interaction because that’s where people can exchange different knowledge, experiences, and perspectives.

It’s also important to generate spaces where creativity is promoted and opinions are validated, because a great idea can come from anywhere.

For the rest of Sofía Vargas’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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Women in Medtech

Doty Lazareto Field Application Engineer LEMO USA, Inc. Bachelor of Science Electrical, Electronics, and Communication Engineering Doty Lazareto is a remarkable engineering professional with a diverse background and a passion for innovation.

Born and raised in the Philippines, she developed a strong work ethic and a determination to pursue her dreams.

Doty’s journey led her to the United States, where she embarked on a successful career as a Women Field Application Engineer. With over 15 years of experience in new product development and engineered interconnect solutions, Doty has worked across various industries, including aerospace, defense, oil and gas, and industrial applications.

Her exceptional skills, adaptability, and problem-solving abilities have made her an invaluable asset to any organization she works with. With her experience and expertise, Doty has been able to successfully develop and implement innovative solutions to complex problems.

What initially attracted you to the medtech industry? How has your perspective on the industry evolved over the course of your career?

I was attracted to the MedTech industry for several reasons. Firstly, being passionate about improving people’s quality of lives, I recognized the immense potential of MedTech in revolutionizing healthcare. Secondly, the industry’s focus on innovation and cutting-edge technology appealed to my curious and problem-solving nature.

As I progressed in my career, my perspective on the industry evolved. I witnessed the transformative impact of MedTech on patient outcomes, which further fueled my drive to make a difference. Additionally, I realized the importance of collaboration between engineers, healthcare professionals, and patients to develop effective and user-friendly medical solutions. This holistic approach has shaped my vision for future of MedTech.

From a broader perspective, how do you see the role of medtech engineering in shaping the future of healthcare? What impact do you anticipate it will have on patient care and outcomes?

I believe MedTech engineers will have crucial role in shaping the future of healthcare.

MedTech engineers have the power to drive innovation and transform patient care. Overall, I anticipate that MedTech engineering will have a transformative impact on patient care, building trust between patients and healthcare systems, and keeping the integrity and confidentiality of patient information. All of these will lead to an improved patient care and outcomes, enhancing the accessibility and quality of critical medical service.

How do you think diversity and inclusion can contribute to the advancement of medtech engineering? How do you foster a culture of innovation within your team or organization?

I think diversity and inclusion play a crucial role in advancing MedTech engineering. I recognize the diverse teams bring together a wide range of perspectives, experiences, and expertise, which fosters innovation and creativity. By embracing diversity, MedTech engineering can benefit from multitude of ideas and approaches, leading to the development of groundbreaking solutions in healthcare. To foster a culture of innovation, I encourage open communication, knowledge sharing, and mentorship within teams and organizations. By valuing diverse voices and experiences, MedTech engineering can drive transformative advancements in patient care and outcomes.

For the rest of Doty Lazareto’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech www.medicaldesignandoutsourcing.com

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Women in Medtech

Monica Restorff Director of Quality Medbio LLC (formerly Polymer Conversions Inc.) B.S. Metallurgical Engineering & Materials Science Carnegie-Mellon University (CMU) Ph.D. Ceramics Massachusetts Institute of Technology (MIT) Monica Restorff has over 20 years of experience in positions of increasing responsibility, most recently as Director of Quality at Medbio LLC (formerly Polymer Conversions Inc.). Prior to that she was a Sr. Supplier Quality Manager supervising a staff providing supplier quality support to 15 facilities throughout the Eastern US and Europe for Integer (formerly Greatbatch Medical). Additionally, she has 5 years of experience in developing and implementing supplier quality systems in the highly regulated medical device industry. As a Six Sigma Black Belt, she has managed projects resulting in millions of dollars of savings from yield improvement initiatives, efficiency gains, and quality improvements. She started the medtech portion of her career doing research and development on batteries and capacitors for implantable medical devices such as pacemakers and implantable cardio-defibrillators (ICDs).

What initially attracted you to the medtech industry? How has your perspective on the industry evolved over the course of your career?

After spending 7 years working on microgravity materials science experiments on the space shuttle, I realized that I wanted a change to something that mattered more in the immediate. The work that I was doing with NASA mattered to the advancement of science in the big picture, but the work I was doing on medical devices mattered to people’s lives every day. I liked knowing that I was improving people’s quality of life every day when I went to work and that has not changed. I still like knowing that if I do my job well, I can positively affect the lives of many others.

As a seasoned professional in the industry, how do you envision the future of medtech? What emerging technologies or trends do you believe will have the most significant impact?

Artificial Intelligence combined with robotics is going to drive rapid change.

Specifically, the ability to use robots to present parts to cameras, that then use AI to determine if the parts are acceptable will drive Quality consistency farther than we’ve seen previously.

From your experience, what are some of the key challenges that medtech engineers are likely to face in the coming years? How can professionals in the industry prepare for and navigate these challenges effectively?

Cost pressures are going to impact most businesses and medtech is no exception.

Everyone is going to need to be aware of the costs of materials, labor, waste, etc.

People that develop skills in things like Lean Six Sigma will be best positioned for this.

How do you think diversity and inclusion can contribute to the advancement of medtech engineering? How do you foster a culture of innovation within your team or organization?

Every individual brings something unique to the table as a result of their individual life experiences. It’s the ability of different people to see things differently that leads to the fastest problem solving and best group brainstorming. I have always believed that if you treat everyone with respect, get to know them as an individual, and value their strengths, you can foster the growth of every individual leading to a great team.

For the rest of Monica Restorff’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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Women in Medtech

Bailey Harder Plant Manager Phillips-Medisize B.S. Mechanical Engineering University of Wisconsin-Platteville Bailey Harder is a Plant Manager at Phillips-Medisize New Richmond with 11+ years in manufacturing in various capacities. She’s held roles in Engineering, Quality, Operational Excellence and Operations prior to her current role, and she uses that experience to promote virtuous cycles of mutual benefit for the company, their customers and patients.

What initially attracted you to the medtech industry? How has your perspective on the industry evolved over the course of your career?

The medtech industry is rapidly changing and growing at an unprecedented rate. While a good portion of my background is in automotive and commercial type manufacturing, the opportunity to be a part of the medtech industry growth and change was very exciting.

From your experience, what are some of the key challenges that medtech engineers are likely to face in the coming years? How can professionals in the industry prepare for and navigate these challenges effectively?

Medtech engineers face the continued increase of rate of change of knowledge and technological advances, both in understanding the medical science and the technology available to innovate care. In the coming years, knowing how to connect quickly with emerging topics on both sides will be very important for medtech engineers.

In your opinion, what areas or applications within medtech have the greatest potential for growth and innovation? Why do you consider them promising?

As medtech continues to evolve, our end customers (patients) are taking more ownership in their healthcare decisions as well as understanding that preventive care and early detection are crucial to improving outcomes. Understanding how we can best serve patients through innovative products and processes that address these needs will be an ongoing potential for growth.

How do you think diversity and inclusion can contribute to the advancement of medtech engineering? How do you foster a culture of innovation within your team or organization?

Diversity and inclusion are foundational to advancement of any environment. I’m grateful to work for a company that is intentional about understanding, creating and fostering a diverse and inclusive culture. Phillips-Medisize focuses heavily on challenging all processes and ideas, in a healthy and respectful way. Without this, we risk becoming complacent, and in today’s environment and the rate of change of all industries, you quickly can fall behind the innovation curve.

For the rest of Bailey Harder’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech www.medicaldesignandoutsourcing.com

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SPONSORED

Women in Medtech

Audrey Bell Director of Product Development Resonetics BS Mechanical Engineering Tufts University MS Mechanical Engineering Tufts University

What initially attracted you to medtech and how has your perspective on the industry evolved over your career?

I think a lot of people get into Med tech because the connection between your work and its positive influence on people is very direct. It’s work that has purpose, and you can see your impact clearly - that is something that holds true for me as well.

I also find it intellectually interesting. I enjoyed biology and math in school, but spent my freshman year of college taking a variety of courses because I really wasn’t certain what direction I wanted to go in. I took an intro to biomedical engineering class that made me look forward to the time I would leave school and enter the industry, which is a feeling I hadn’t gotten from any other course before.

I’ve found that this is a field where you can have a lifetime of learning because technology is always changing and improving over time. There’s such a diversity of technology across different clinical spaces that there’s always something new to learn.

As a seasoned professional, how do you envision the future of medtech and what emerging technologies or trends do you think will have the most significant impact?

I think that the trends we’re seeing in this industry are similar to the technology trends you see in other industries. I see a trend towards miniaturization - smaller cameras, smaller sensors, smaller delivery systems. I think we will see more wearables and devices that have user interaction, like things that will give patients better access to their own data. I’m seeing an emphasis on robotic surgery and the ability to do things remotely, whether it’s operating instruments remotely or directing a case remotely. The world is getting smaller in that way, and there’s more of a drive towards being able to do things virtually.

There’s a continued push towards overcoming access and delivery challenges to make minimally invasive and transcatheter technologies go further.

I also think we’re seeing more with the idea of a smart device, something that a user could interact with more, whether it’s reading off their data or having input into the way it works for them, or customizing a device for the patient.

For the rest of Audrey Bell’s insights, visit www.medicaldesignandoutsourcing.com/women-in-medtech

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Sponsorship opportunities are available for future DeviceTalks and Robotics programs.

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WOMEN IN MEDTECH | ENGINEERING DIVERSITY + INCLUSION | AD INDEX

Accumold ......................................................................... 35 Advanced Powder Products ........................................... 38 Allegro Microsystems .................................................... 121 Altech Corporation ........................................................ 8, 9 B. Braun ........................................................................... BC Bay Associates Wire Technologies, Inc. ......................... 30 Beckhoff Automation ...................................................... 91 Biomerics .......................................................................... 61 Bishop Wisecarver ......................................................... 113 Carl Stahl Sava Industries ................................................ 20 CGI Inc. ............................................................................. 87 Cinch Connectivity Solutions .................................. 10, 109 Cirtec Medical .................................................................. 53 Clippard .............................................................................. 7 COMSOL .......................................................................... 63 Confluent Medical Technologies.................................... 18 Cretex ............................................................................... 29 Digi-Key Electronics .......................................................... 1 Donatelle ............................................................................ 5 Encoder Products Company ......................................... 117 Eurofins Medical Device Testing ...................................... 2 Filmecc USA, Inc, subsidiary of Asahi Intecc USA......... 24 Flexan ............................................................................... 23 Hobson & Motzer ............................................................ 14

Infus Medical .................................................................... 65 Instron ............................................................................... 34 Integer .............................................................................. 58 Interpower ........................................................................ 69 Intricon.............................................................................. 45 John Evans’ Sons, Inc. ..................................................... 41 Johnson Matthey ............................................................. 32 LEMO USA ................................................................. 56, 97 maxon ..........................................cover/corner (MD&O), 3 Medbio ............................................................................. 51 MICRO Medical ............................................................... 25 Mitsubishi Electric Automation ...................................... 93 New England Wire & Tubing Technologies .................. 19 OKAY Industries ............................................................... 43 Phillips Medisize .............................................................. 13 PSN Labs .......................................................................... 31 Resonetics ...................................................................... IFC Rockwell Automation .................................................... 107 Saint-Gobain .................................................................... 55 Senko Advanced Components....................................... 44 SigmaTron ........................................................................ 47 Tegra Medical ................................................................ IBC Viant .................................................................................. 66 WAGO Corporation ........................................................ 99

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Protecting caregivers, treating patients and delivering confidence.

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