On the
Cutting Edge of Engineering and Design

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

Read More

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.

Read More

October 31, 2018

Podcast Launch: A MedTech Mindset with Eric Sugalski

This 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 More

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.

Read More