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November 26, 2018

Focus on Value, Mitigate Risk

A medical device development expert’s advice on charting the path to the medtech market

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November 01, 2018

MedTech Mindset Podcast: Clinical Evidence Insights with Joe Popowicz

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.

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October 04, 2018

Regulation Meets Collaboration: MDIC Five Year Reflective

Last 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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August 23, 2018

Innovation Hurdles: Why Pediatric Medical Devices Don't Make it to Market

While it’s easy to say that we should focus resources on the devices that will bring the greatest good to the greatest number of patients, the calculus shifts when we consider one of the most vulnerable, and yet underserved, patient populations--children.

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