In 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?”