In this episode, Don Pohl and Sheri Krajewski at NAMSA and Duane Mancini discuss ISO 10993 and biocompatibility testing for medical devices, the history of the standard and how it has evolved, why following the risk-based approach is becoming more important, tips to avoid having your submission delayed with various regulatory bodies across the globe, common mistakes and so much more.

Don Pohl LinkedIn

Sheri Krajewski LinkedIn

NAMSA LinkedIn

NAMSA Website

Duane Mancini LinkedIn⁠⁠⁠

⁠⁠⁠Project Medtech LinkedIn⁠⁠⁠

⁠⁠⁠Project Medtech Website

Mittal Consulting

Rook Quality Systems

Kymanox

In this episode, Omar Khateeb at Khateeb & Co. and Duane Mancini discuss carrying the bag, growth marketing, talking to investors, meeting with early adopters, his podcast The State of Medtech, speed learning, building loyal customers and so much more.

Omar Khateeb LinkedIn

Khateeb & Co. Website

State of Medtech Podcast

⁠Duane Mancini LinkedIn⁠⁠

⁠⁠Project Medtech LinkedIn⁠⁠

⁠⁠Project Medtech Website

In this episode, Kristen Mittal and Mridul Mittal at Mittal Consulting and Duane Mancini discuss their unique backgrounds in medtech, why they started Mittal Consulting, what medtech companies should expect from a regulatory strategy report, breakthrough designation, 513(g) vs. pre-submission meetings, common pitfalls, their advice for entrepreneurs, and so much more.

⁠Kristen Mittal LinkedIn⁠

⁠Mridul Mittal LinkedIn⁠

⁠Mittal Consulting LinkedIn⁠

⁠Mittal Consulting Website ⁠

⁠Duane Mancini LinkedIn⁠

⁠Project Medtech LinkedIn⁠

⁠Project Medtech Website

In this episode, Monica Vajani at mHUB and Duane Mancini discuss her background at Abbott and Medtronic, carrying the bag, early adopters vs. laggers, mHUB, the next cohort of companies for their medtech accelerator, and so much more.

Monica Vajani LinkedIn

mHub Medtech Accelerator Application

mHub LinkedIn

mHub Website

Duane Mancini LinkedIn

Project Medtech LinkedIn

Project Medtech Website

In this episode, Craig Misrach at UpLyft and Duane Mancini discuss what has changed since his last appearance on the podcast, choosing and changing your contract manufacturer based on the commercialization stage, the importance of quality, creative ways to finance your startup, and so much more.

Craig Misrach LinkedIn

UpLyft LinkedIn

UpLyft Website

Duane Mancini LinkedIn

Project Medtech LinkedIn

Project Medtech Website

In this episode, Hilary Swan at Rebel Scout Consulting and Duane Mancini discuss her background in the medtech space, inside sales vs. outside sales, tips for selling into a hospital, the user journey, the importance of implementation and so much more.

Hilary Swan LinkedIn

Rebel Scout LinkedIn

Rebel Scout Website

Duane Mancini LinkedIn

Project Medtech LinkedIn

Project Medtech Website

In this episode, Megan Doberstein at Ignite Medtech and Duane Mancini discuss her background in the medical device space, marketing for a direct to consumer medical device, understanding all your customer profiles, strategically marketing to all of those customers and so much more.

Megan Doberstein LinkedIn

Ignite Medtech LinkedIn

Ignite Medtech Website

Duane Mancini LinkedIn

Project Medtech LinkedIn

Project Medtech Website

In this episode, Tim Lucas at The NeuroTech Institute and Duane Mancini discuss why Universities have historically struggled to commercialize innovation, the Broad Institute, how he modeled the NeuroTech Institute after it, achieving clinical adoption, and so much more.

Tim Lucas LinkedIn

The NeuroTech Institute Website

Duane Mancini LinkedIn

Project Medtech LinkedIn

Project Medtech Website