7 women in medtech you should know

Women-In-Medtech-2019

Women hold more executive leadership roles in the medtech industry today than they did 20 years ago, but there’s still a long way to go.

There is still a women’s leadership gap in the U.S., though. According to a report from the Centers for American Progress, women hold 52% of professional jobs in the U.S. Only 14.6% are CEOs. A mere 8.1% are top earners, and a scant 4.6% are Fortune 500 CEOs. The Equal Employment Opportunity Commission also reports that only a fifth of executives, senior officers and managers in the U.S. high-tech industries are women.

Keeping with the theme of Women’s History Month and International Women’s Day, here are seven women medtech executives making a difference in the industry.

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Reva Medical cuts 44% of workforce

Reva MedicalReva Medical (ASX:RVA) said this week that it plans to cut its workforce by 44%, leaving 22 employees at the San Deigo-based company.

In a statement, Reva CEO Reggie Groves cited current market conditions as the primary reason for the staffing reduction.

Get the full story at our sister site, Drug Delivery Business News.

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Reva brings bioresorbable scaffolds to new markets

Reva MedicalReva Medical (ASX:RVA) said this week that it inked four new distribution agreements, bringing its commercial operations to seven European countries.

The San Diego, Calif.-based company said the deals serve to expand the reach of its drug-eluting bioresorbable scaffold, Fantom Encore.

Get the full story at our sister site, Drug Delivery Business News.

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Insulet taps former Medtronic finance exec McMillan as CFO | Personnel Moves – January 8, 2019

Insulet CFO Wayde McMillan

Insulet (NSDQ:PODD) said yesterday that it tapped former Medtronic minimally invasive therapies CFO and finance VP Wayde McMillan as its new chief financial officer, replacing Michael Levitz.

The Acton, Mass.-based diabetes-focused medtech company said that McMillan will join the company in February and that Levitz will continue as an advisor for a period following the succession to ensure a smooth transition. McMillan will officially take the role of CFO on March 1.

Prior to joining Insulet, McMillan held executive roles in finance at Medtronic, having come to the company during its acquisition of Covidien in 2015. After the acquisition, McMillan helped reorganize the new acquisition into the Medtronic Group structure, the company said.

“We are excited to welcome a leader of Wayde’s caliber to Insulet as the company transitions to profitability, expands internationally, and enters its next phase of rapid growth. Wayde has significant expertise scaling large organizations and a thorough understanding of the strategies we are pursuing globally to accelerate growth and build on our strong foundation. We look forward to benefitting from Wayde’s experience as we continue to position the company for long-term success and solidify our leadership in the global management of diabetes. On behalf of the board of directors and the entire company, I want to thank Mike Levitz for his numerous contributions, as well as his support during this transition period. Over the last four years, Mike has helped develop and execute our strategic imperatives, strengthen our infrastructure and capabilities in support of future growth, and generate exceptional value for shareholders. We wish Mike all the best in his future endeavors,” prez & CEO Shacey Petrovic said in a prepared statement.

“I am honored to join the team at Insulet, a company with a strong mission dedicated to improving the lives of people impacted by diabetes. I look forward to working alongside the Insulet leadership team and contributing to the company’s initiatives to drive growth, profitability and value creation for shareholders,” McMillan said in a press release.

 Senseonics appoints Isaacson as CFO

Senseonics (NYSE:SENS) said yesterday that it named Jon Isaacson as its new chief financial officer, replacing R. Don Elsey.

Elsey will remain on with the Germanton, Md.-based company in an advisory role to support the transition and to assist in preparation of the company’s annual report filings for the previous fiscal year. Elsey is slated to stay on until his planned retirement date of February 28, or a later date if another agreement is made.

Prior to joining Senseonics, Isaacson acted as CFO of Edelman Financial Services from November 2017 to December 2018, and as managing director of private equity firm American Capital, the company said.

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 Livongo names Shapiro as CFO

Livongo said last week that it appointed board member and audit committee chair Lee Shapiro as its new chief financial officer, effective on February 1.

Shapiro currently serves as a member of the board and audit committee for Medidata Solutions and as the audit committee chair of Tivity Health, Mountain View, Calif.-based Livongo said. He also served at Allscripts Healthcare Solutions as president from 2001 to 2012, the company added.

“I couldn’t be more excited about working with Lee. His intimate knowledge of Livongo, his close working relationships with the leadership team, and his connections across the industry, including virtually every analyst in the healthcare and technology space, will allow us to rapidly accelerate our business and better serve our members and clients,” CEO Zane Burke said in a press release.

“Lee’s experience in scaling companies is a perfect fit for Livongo as the company moves to the next level. I speak for the entire team in sharing my enthusiasm in gaining Lee’s experience in building great companies for Livongo,” exec chair Glen Tullman said in prepared remarks.

“I have been impressed with what the Livongo team has accomplished in such a short time. As the company continues its rapid acceleration, my hope is to contribute in both financial and strategic ways to serve Livongo’s mission of empowering more people with chronic conditions to live better and healthier lives,” Shapiro said in a prepared statement.

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 Reva Medical lifts Elkolli to CFO

Reva Medical (ASX:RVA) said last week that it promoted Leigh Elkolli to the office of chief financial officer and corporate secretary, replacing Brandi Roberts who resigned, effective January 4.

Elkolli joined San Diego-based Reva Medical in August 2017 as finance senior director and corporate controller, the company said. Elkolli previously worked with privately held biotech company Avidity Biosciences, serving as finance director.

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 Wright Medical shuffles the exec roster

Wright Medical (NSDQ:WMGI) yesterday announced a number of internal organizational changes, including lifting current prez Kevin Cordell to the position of chief global commercial officer and exec VP and promoting senior VP and CFO Lance Berry to the newly created position of chief financial and operations officer and exec VP.

Cordell joined Wright in 2014, and has helped integrate the U.S. commercial teams of Tornier after the companies merged, Wright said. In conjunction with his promotion, current int’l prez Peter Cooke will assume the role of president of emerging markets, Australia and Japan and current upper extremities marketing VP Steve Wallace was promoted to int’l prez, the company said.

In his new role, Amsterdam-based Wright Medical said that Berry will be responsible for global finance and accounting, operations, quality, regulatory, information technology, strategy and corporate development.

“Wright Medical is quickly becoming a $1 billion high-growth medtech company that is built to win in the fast-growing Extremities and Biologics markets.  As we continue to grow and progress, there is a need to better align our team to support long-term revenue growth, profitability and day-to-day execution.  At the same time, we must stay strategically focused to maintain our technology differentiation and leadership positions.  It is with these goals in mind that I am creating two new executive vice president positions, reporting to me, to advance our global commercial focus and to further transform our global business processes. With significant opportunities ahead, these organizational changes will allow for further alignment of our cross functional organizations with a stronger and sharper focus on long-term growth and profitability, including a greater emphasis on the emerging market opportunity.  I am looking forward to working with Kevin and Lance in their new leadership roles and am confident that these appointments, along with our other organizational changes, will further bolster our ability to capitalize on the growth opportunities in front of us and accelerate our market performance,” prez & CEO Robert Palmisano said in a prepared statement.

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Medtech veteran Reggie Groves on leading with ‘patients first’

Reva Medical CEO Reggie GrovesIn guiding Medtronic through the Fidelis lead recall, medtech veteran Reggie Groves always took a “patients first” perspective. At DeviceTalks West 2018, Groves explained how her time at Medtronic influenced her as a leader and how she has brought those lessons into her role as CEO of Reva Medical.

Once the world’s most popular defibrillator lead, Medtronic’s Fidelis leads were in hundreds of thousands of patients in the U.S. So when the device began delivering random, painful shocks to people about a decade ago, Medtronic officials were worried. That included Reggie Groves, who was charged with running Medtronic’s regulatory and quality business.

“It was in so many patients that even a very, very low rate of failure was pretty visible,” Groves told the attendees at DeviceTalks West, held December 2018 in Orange County, Calif.

“The challenge was that we had a lead that wasn’t statistically any different, but the failure mechanism was worse. So what do you do? If you want to stop selling and you want to take something off the shelves in the hospital, you must recall it.”

A recall concerned Groves, who was worried that physicians would misinterpret the recall and put patients through the dangerous procedure of extracting leads. But she also understood that the company needed to act.

“Ultimately we made the decision that we didn’t want anybody else implanted with it until we knew for certain whether the lead was going to have a higher ultimate failure rate or not. So we did the recall,” she said.

Groves was asked to testify in front of a congressional committee. She was called to speak to the FDA. Doctors and folks within the industry challenged Groves, telling her that she should have pushed for a recall sooner.

Medtronic lost billions in market cap after it declared a recall for Fidelis, Groves said. But one phone call from Medtronic founder Earl Bakken assured her that she did the right thing.

“Earl Bakken called us that day. He was probably the single biggest loser of value that day, but he thanked us for doing the right thing for the patients,” Groves said.

“Patients come first,” she added. “If you think what you’re doing is better for patients, whatever roadblock, whatever challenge comes in front of you, it’s easy.”

The challenges of bioresorbable tech

With years of experience at the world’s top medtech firm under her belt, Groves now serves as CEO of Reva Medical – a publicly-traded, commercial-stage company that makes bioresorbable devices.

The firm touts its proprietary Tyrocore polymer as the only bioresorbable, X-ray visible product on the market. This year, Reva launched its third-generation coronary scaffold, Fantom Encore. The company also has CE Mark clearance for a bioresorbable device for below-the-knee peripheral artery disease. Groves noted at DeviceTalks West that the company is also moving forward with bioresorbable, X-ray visible embolic beads to treat vascularized tumors.

While drug-eluting stents remain the gold standard in interventional cardiology, studies have shown that leaving a permanent metal stent inside the body presents its own challenges, according to Groves. It would be ideal to create a product that delivered an adequate dose of drugs to a patient, kept the patient’s vessel open throughout the healing process and then dissolved away, she said.

Companies around the world have tried to tackle bioresorbable devices, and many have failed. Most notably, Abbott pulled its bioresorbable Absorb device off the market in 2017, reportedly due to low commercial sales. But long-term trial results have indicated that Absorb had an increased risk of target lesion failure and scaffold thrombosis compared to Abbott’s Xience everolimus-eluting stent.

After Abbott’s stumble with Absorb, European Union regulators wrote new guidelines encouraging doctors to limit the use of bioresorbable devices to clinical trials.

“My view is that Abbott correctly saw that bioresorbable scaffolds are a major disruption to the coronary space and are the right thing for patients,” Groves said. “I think the mistake Abbott made was to believe that first mover advantage was what was important.”

Reva’s chief executive said that Abbott’s challenges represent an obstacle to convincing doctors and potential investors to buy into bioresorbable technology. But winning the hearts and minds of clinicians is all about showing them the value of Reva’s devices with solid clinical data, she added.

“The average interventional cardiologist understands completely that bioresorbable, if we can get one that does as well as metal while it’s there, is going to beat metal when it’s gone. And so they want it. Now the question is, ‘Can I get it through my hospital administration? Can I get it through my chief? Will the payer pay for it because of these guidelines?’ We have a series of headwinds that are certainly a challenge,” she said.

“The good news is we don’t have a lot of competition.”

Having the patience for disruption

Whether it was managing the Fidelis lead recall or navigating the challenges of a technology’s bruised reputation, Groves has learned to endure through challenging work environments.

“Disruption takes time,” she said. “You’re probably going to fail. There are very few technologies that the first iteration is going to be a home run.”

“So be prepared for the fact that it isn’t going to work the first time out of the gate. Don’t drink your own Kool-Aid about how perfect you are and how perfect the technology is and how it’s going to change the world in 60 days,” she added.

For people just breaking into the medical device industry, Groves advised that they lean into difficult situations and try to take the road less traveled. She also noted that young people, particularly women, who are working to advance their careers shouldn’t underestimate the power of speaking up.

“Make sure that you are reaching out and networking with folks who can help your career. I didn’t do that. I thought if I did my job well, I’ll be noticed. Don’t believe that,” Groves said. “That’s just not true. You’ve got to speak up. I remember one time, while I was in a smaller company, I went to my boss and said, ‘I think all my male peers are making more money than I’m getting.’ I got a $100,000 raise. Gee. You think I was making less money?”

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How Reggie Groves reinvented Medtronic’s atrial fibrillation biz

Reva Medical (ASX:RVA) CEO Reggie Groves got her start in the medical device industry at medtech titan Medtronic. In her upcoming keynote interview at DeviceTalks West, Groves will discuss how that experience has shaped her as a leader and an innovator. Here’s a preview:

When Reggie Groves joined Medtronic (NYSE:MDT) in 2002, she didn’t know very much about the medical device industry. That was by design, she told MassDevice – the company was looking for somebody outside of the medtech world to launch their CareLink Network. It was the world’s first remote monitoring system designed to link the data in patients’ implanted devices with physicians.

Reggie Groves“I knew that (Medtronic) was a big company that was well respected and that was about all I really knew about them,” she said. “I saw what they were doing in remote device check as the start of a complete transformation of the medical device industry – moving away from being the implant to being the data managers.”

After commercializing CareLink and then moving to the regulatory and quality side of the business, Groves stepped up to build Medtronic’s atrial fibrillation ablation business. At the time, according to Groves, Johnson & Johnson (NYSE:JNJ) held a sizable lead in the AF space, followed by St. Jude.

Medtronic’s AF unit “basically didn’t exist,” Groves said – the company had previously sold its electrophysiology business. It was Groves’ job to determine how the company could build an AF division that would stand out among fierce competition.

Catch Groves’ keynote interview at DeviceTalks West on Dec. 11 – register today!

She decided to rethink the way that the company’s sales force was selling its newest technologies to electrophysiologists.

“Most companies would have said, ‘We’ve got this great big sales force, here’s another product in their tool bag. Give it to them and let them sell it.’ And I said, ‘That’s the worst thing we could do because it’s a disruptive technology and we don’t want every customer to have it.’ If you’re the sales rep who’s also selling CRT devices and ICT devices, you’re going to bundle,” she said. “Something is going to be given away and the easiest thing to give away is the new novel thing. You’ll never make any money in AF, which is why Medtronic walked away from it the first time.”

Groves set up her own sales team and told them to only sell Medtronic’s AF technology to early adopters.

“When you walk in the door for the sales meeting, if you get the ‘Oh, it’s too expensive, oh it’s not flexible enough, oh it doesn’t do enough,’ – turn around and walk out the door. That’s not an early adopter. You need to find the customers who get the value proposition,” she explained.

At the time, competitive devices from St. Jude and J&J were designed to allow the very best doctors to perform an ablation anywhere in the heart. At Medtronic, Groves was positioning the company’s AF device as usable by any electrophysiologist who was looking to isolate the pulmonary vein.

Her plan was not without pushback, according to Groves.

“It wasn’t easy, even within Medtronic. I had lots of naysayers and it took the CEO stepping in, listening to the argument and making the call,” she said. “But I got really lucky that I believed in a different approach to launching a product compared to most big companies and Medtronic let me do it my way.”

Don’t miss out on the rest of Groves’ exciting story – see her at DeviceTalks West on Dec. 11-12.

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Reva touts first implant of Fantom Encore bioresorbable scaffold in Italy

Reva MedicalReva Medical (ASX:RVA) touted this week the first implant of its newly-launched Fantom Encore bioresorbable scaffold in Italy.

The company’s third-generation coronary bioresorbable scaffold features a thin strut profile and Reva’s Tyrocore polymer.

Get the full story at our sister site, Drug Delivery Business News.

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Sales for Reva Medical up in Q3 following launch of bioresorbable scaffold

Reva MedicalShares in Reva Medical (ASX:RVA) rose today after the medical device maker posted its third-quarter financial results.

The San Diego, Calif.-based company recorded a net loss of -$9 million on sales of $93,000 for the 3 months ended Sept. 30, for sales growth of 447% compared with the same period last year. Earnings per share were -22¢.

Get the full story at our sister site, Drug Delivery Business News.

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Reva launches Fantom Encore bioresorbable scaffold

Reva MedicalReva Medical (ASX:RVA) said this week that it launched its Fantom Encore bioresorbable, drug-eluting scaffold and that the first person was treated in a post-market trial of the device.

The Fantom Encore product is a third-gen coronary bioresorbable scaffold featuring a thin strut profile and Reva’s Tyrocore polymer.

Get the full story at our sister site, Drug Delivery Business News.

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Reva Medical’s Fantom bioresorbable scaffold succeeds in two-year trial

Reva Medical (ASX:RVA) touted sustained safety and efficacy results for its Fantom bioresorbable scaffold at this year’s EuroPCR meeting.

The company also revealed new information about its suite of Fantom Encore products, noting that the devices will have strut profiles of 95 microns, 105 microns and 115 microns.

Get the full story at our sister site, Drug Delivery Business News.

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