Posts categorized as“Uncategorized”

Alexandra Reid

FDA Guidance on Non-Clinical Bench Performance Testing Information

Your Roadmap for Premarket Submissions Are you wondering how best to organize your test plans and reports to make them submission ready? Look no further. The FDA provides a roadmap to follow for your premarket submission in their new guidance, ‘Recommended Content and Format of Non-Clinical Bench Performance Testing Information in Premarket Submissions’.

Laura Gouzecky

How ERP Benefits Medical Device Commercialization

I’m often asked how ERP benefits medical device commercialization. Enterprise resource planning (ERP) is a very powerful tool that helps many companies succeed.  The medical device industry faces unique challenges from FDA and CFR requirements, regulations, and standards. These challenges mean that ERP can aid medical device commercialization even more than other industries and products.

Dana Trousil

First-to-Market Vs. robust commercialization: trade-offs, tips, and tactics

Bringing your medical device to market involves a lot of trade-offs. First-to-Market Vs. robust commercialization process. Do you launch quickly with a minimum viable product? There may be significant post-launch changes in order to be the first to market. Possible negative feedback from rushing to market may destroy any device adoption. Perhaps going through an […]

David Felix

3 ways to leverage talent in medtech development  

I would like to take us all back to high school Biology for a moment to remember the concept of emergent properties. These properties only come out when individual parts start interacting with each other in any given system. Take common salt for example. The fact that it tastes salty does not mean that the sodium and chlorine which make up salt also taste salty. Saltiness […]

Brian Hanrahan

Michael May discusses the intersection of medical devices in regenerative medicine

I recently spoke with Michael May, President and Chief Executive Officer of CCRM, a Canadian not-for-profit that develops technologies and launches new companies by supporting both academic and industry activities in the field of regenerative medicine, including cell and gene therapy. Our conversation focused on the intersection of medical devices in Regenerative Medicine.

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