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President/CEO Tim Looney (Northeast Biomedical) breaks down the engineering plan founders actually need (DHF, phased reviews, and right-sized documentation) to move faster without tripping FDA/CE. We cover startup blind spots, big-company constraints, and how to “do it right once” so you don’t pay for DHF remediation later.

Tim’s LinkedIn - https://www.linkedin.com/in/tlooney/ 

00:00 Why med device engineering fails
00:16 Who is Tim Looney
03:04 What founders miss in early engineering
06:11 Why the FDA rejects “it’s all in my head”
08:13 Hidden tests and documentation you must plan for
12:24 Move fast the right way
15:53 How phased engineering speeds up approvals
20:23 How to avoid costly founder mistakes
24:44 Why the system blocks unprepared founders
27:11 Case study on fast clearance done correctly
 
In medtech, “move fast and break things” breaks people. Tim Looney leads Northeast Biomedical, a product development and contract manufacturing firm that lives where speed meets compliance. In this episode, Tim explains the engineering plan most founders skip: phase-gated reviews, checklists that prevent “oops” moments at submission, and documentation that’s lean early but complete enough to avoid costly DHF remediation. We unpack startup blind spots (biocompatibility, shelf-life, packaging, verification), how larger companies get stuck in resource bottlenecks, and why the fastest path to clearance is often meticulous—just not bloated. Tim also shares a class-III European dossier story that moved in weeks because the package was complete, plus practical guidance for early founders on prototypes, notebooks, and IP strategy. If you’re building the next device, this conversation is your map to “right the first time.”

 https://meshagency.com/fcmo-fractional-cmo-fractional-marketing/

#MedTech #MedicalDevices #GoToMarket