CLINICAL CONSULTING In this episode, clinical study expert Joe Popowicz, founder of Emergent Clinical Consulting, sits down with Smithwise President Eric Sugalski to talk about clinical evidence strategies surrounding new medtech. They cover pre/postmarket data needs, regulatory pathways, Value Analysis Committees, Significant Risk vs. Nonsignificant Risk, Institutional Review Boards, and more.
Read MoreWe're joined this episode by Wamis Singhatat, VP of Product Development and CTO of Active Protective, a medtech company working to bring a really cool new piece of technology to market. Their product is a smart belt that can detect a fall in progress and deploy airbags to cushion the hips of the wearer. You can see a video of the deployment in action on the Smithwise blog. Wamis sat down with Smithwise President Eric Sugalski to discuss their strategies for bringing this product to market.
Read MoreThis episode is a great way to tell if this podcast is for you. Eric Sugalski and Dan Henrich sit down to discuss the big picture of bringing a new piece of medical technology to market. We touch on product development and design, regulatory pathways, clinical evidence, go-to-market strategy, intellectual property, and other themes.
Read MoreLast month, I attended a public meeting to design new ways to improve U.S. competitiveness in our industry. The group is called the Medical Device Innovation Consortium.
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