Clinical & Regulatory

Clinical & Regulatory

What we’ve learned from Healthegy’s Medtech Conference in Minneapolis



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Healthegy’s 16th annual MedTech Conference took place in Minneapolis, Minnesota on 1 June. Mike Lagerquist highlights key themes and soundbites of the day.

Medtech Conference in Minneapolis

The event stage was set by Tom Salemi, Content Director at Healthegy, Inc., in his opening remarks. Although he said it while speaking about the host city, his sentiment could equally be applied to the entire day: ‘This is the place where I really feel medtech is a part of the fabric of the area.’ The ‘fabric,’ he implied, is resistant to forces that threaten to tear it apart. For whilst funding from VC sources may be down in the short term – this change is bringing with it some necessary disruption, introspection and deliberate thinking – and in many ways, a more positive outlook.

Five key common threads of the day:

  1. While investment dollars are down, the investors themselves are stronger in their dedication to innovation and the creation of new and better products to serve patient needs. Today’s investors generally are less risk averse and open to investment at various stages of product development;
  2. Your company’s team can make the difference. It’s important to create a corporate culture where people know their ideas and opinions are sought, accepted and utilised. When personal styles don’t mesh, it’s okay if current employees or team members added through M&A move on;
  3. Regulation processes, both in the U.S. and abroad, are changing. The FDA has adjusted processes that allow faster and smoother paths to approval. These changes can spark further innovation and a stronger collaborative spirit;
  4. Data collection at all levels of development is key to future success. Because paths to approval are unknown, data eventually can be used to solve unforeseen challenges and further shorten approval costs and time;
  5. Reimbursement has replaced regulation as a top concern.

Soundbites of the day:

Joe Almeida, Chairman & CEO at Baxter International: ‘If you do it, do it always the best way you can. It’s not about what you did in the past. It’s what you learned in the past and what you’ll do in the future.’

Kevin Hykes, Operating Partner at Versant Ventures/Chairman & CEO at Metavention: ‘In my mind, although these headwinds are daunting at times, the fundamentals that drive demands for the things we do are intact and unassailable. Number one, the demographic bubble has created an ever-growing pool of people who need what we do and benefit from improvements in medical technology. Second, the opportunities in the developing markets are massive and largely untapped. Third, there are huge opportunities to improve the management of chronic disease and, in doing so, improve the quality of life of patients who suffer from those conditions and save the healthcare industry billions of dollars.’

Michael Mahoney, Chairman & CEO at Boston Scientific: ‘When I joined [Boston Scientific], I was committed for the long term. So, the first thing we did, we literally looked at it as a startup and we started over. We actually talked. We had very candid conversations and we encouraged our team to take risks. We [created] a culture that didn’t punish people for making bad decisions.’

William Maisel, MD, Deputy Director for Science and Chief Scientist at FDA/CDRH: ‘We really set out to change the philosophy of our organisation. We also focused on customer service. We want our staff to be interactive. We want them to answer your questions. When they’re reviewing your file and they have a question, we don’t want them to wait 60 more days and send you a letter. We want them to pick up the phone and call you, or send you an email, and resolve it interactively.’

Todd Berg, Co-Founder, President & CEO at Torax Medical: ‘You develop a relationship with that [FDA] reviewer and the continuity becomes critical. They actually become experts in your product. And they are able to become internal advocates at the FDA.’

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Andrew Cleeland, CEO at Fogarty Institute / VP & General Manager at Medtronic TVVR Venture: ‘We interact on a weekly basis with our [FDA] review team. We’re now working with them on a pivotal trial design and that process has been, again, remarkably interactive all the way through. We want to congratulate you on what you’ve been able to accomplish. My experience there has been remarkable, and my advice to anybody in the room is to interact early and interact often with FDA. Take the risk…it’s worth it.’

Mark Deem, Venture Partner at Lighthouse Ventures / Managing Partner – The Foundry: ‘It’s no secret that the market has changed dramatically. The number of investors has gone down. I don’t necessarily think that’s an unhealthy thing for the ecosystem though. … For those companies that can finance and survive, I think that the possibilities for successful outcomes are quite good.’

Bonnie Handke, VP, Health Economics, Policy & Payment at Medtronic: ‘Today, it is recognised that you should focus on the early stage and what the economic impacts will be, and then determine if you need to change your path.’

Andrew Weiss, President & CEO at ReCor Medical: “When you look at the macro standpoint, there’s never been a time when there’s been more technology, more wealth, more fast access to markets, I would argue, for medical device innovations that make a difference in patient healthcare.”

About the author

Mike Lagerquist is a US-based writer, editor and communications professional.

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