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News & Insights

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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October 04, 2018

EpiCase Demo

Dr. Ed Pribitkin of Thomas Jefferson University Hospitals demonstrates EpiCase, a device to ensure life-saving medications are always in reach.

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