October 2023 issue
October 31, 2023 | Medical device industry professionals traveled to Anaheim, CA for the 2023 MedTech Conference, produced by the trade group AdvaMed earlier this month. Neurotechnology firms played an active role in the meeting.
One of the unique attributes of this conference was a series of “reverse pitches” in which large strategic medtech firms informed startups of the advantages of partnering with them. Chris Cleary, senior vice president for business development at Medtronic, was one such presenter. He has led more than 40 acquisitions for Medtronic in the last decade, include deals with Covidien, Smith & Nephew, and HeartWare. He also led the spinoff of Medtronic’s supplies business to Cardinal Health, a $6 billion deal.
“We’re anxious to partner in the ecosystem—we’re a serial acquirer,” he said. Medtronic has about a $1.6 billion venture portfolio, half of which is in structured deals and half in investments in early-stage companies. “The number one thing we talk about is how do we tweak the portfolio to get it to higher growth?” Cleary said. “We are capable of a really heavy lift. When the company decides to lower the shoulder, dig in.” As an example, Cleary said that Medtronic is still committed to bringing Ardian to the market, despite the uncertain regulatory status of the renal denervation therapy. “That’s a long winding road—we still think this is a very viable platform,” he said. Cleary also pointed to Medtronic’s MiniMed franchise as another example of the company’s staying power with key acquisitions. “That’s where scale really helps—to be able to spend money when it really matters.”
Other reverse pitch presenters included Ryan Yearsley, vice president of business development & commercial operations for Stryker’s endoscopy division, Charlie Attlan, senior vice president of new business development, corporate strategy, and portfolio at Boston Scientific Corp., Peter Schulam, CSO at Johnson & Johnson Med Tech, Felicia Kurz, senior vice president and head of advanced therapies at Siemens Medical Solutions USA, and Finn Haley, vice president of corporate development at Edwards Lifesciences.
A MedTech Innovator Showcase dedicated to neurotechnology featured three CEOs of emerging firms; Carolina Aguilar, CEO of INBRAIN Neuroelectronics, Richard Foust, CEO of MicroTransponder, and Kirt Gill, CEO and co-founder of NeuraStasis. Gill said the company is still working through clinical trials and is stressing conducting robust sham-controlled trials with the company’s noninvasive technology. Aguilar said that we need to create a global standard that would allow regulators to benchmark therapies across markets and enable risk-sharing. Foust pointed out that it is hard to turn new technology into a commercial product. Noting that many hospitals came out of COVID financially injured, so we’re in an environment where vendors have to prove that they can be paid for their procedures. “We’d rather have a fast no than a slow yes,” he said. MicroTransponder currently only has one Medicare coverage decision, and that is in New York.
A session devoted to M&A activity featured Geoff Martha, CEO of Medtronic, Rachel Ellingson, senior vice president and chief strategy officer at Zimmer Biomet, and Deepak Nath, CEO of Smith & Nephew. Nath noted that M&A has always been a source of value creation in medtech. “Growth is a factor in medtech, despite all the focus we see on margins today,” he said. Murtha said that the current market volatility has take a hit on valuations. “Volatility matters, but we’re looking at the long term,” he said. He also pointed out that higher interest rates have affected valuations. Still, Murtha said he was optimistic about the future.
In one of a series of “patient stories,” Allen Burton, CMO at Abbott Neuromodulation, interviewed Darryn Wright, a Parkinson’s disease patient who received one of the company’s DBS systems. Wright told the story of being diagnosed at age 44, after noticing symptoms in his feet and hands first. He said he was on one medication, taking 20 pills a day, before deciding to go for the DBS surgery. Wright’s movement disorder specialist played a key role in educating him about DBS, as did the Abbott rep.
“DBS gave me my life back,” Wright said. “Before that, even with medications, I didn’t know how I was going to function day-to-day or even hour-to-hour. I was double-clicking on things I didn’t want to.”
The final day of the meeting featured a town hall meeting with several members of the FDA’s Center for Devices and Radiological Health. CDRH head Jeff Shuren gave attendees an update on MDUFA V, the fifth iteration of the Medical Device User Fee Amendments. “So far, we are either meeting, or on track to meet, all of our goals,” he said. “This is real encouraging news, despite an increase in our workload.” During COVID, CDRH saw a 60% increase in premarket submissions, and that level has not receeded. There’s also been an uptick in pre-submission meeting requests.
While stressing that CDRH is not in competition with regulatory bodies in other regions, Shurn noted that more than 60% of manufacturers of novel technologies for the U.S. market intended to bring their device to the U.S. first or in parallel with other regions.
