Video: A Drop of DMR (Device Master Record)

This is part of an ongoing series of “droplet” videos intended to communicate key concepts in the medical device development process. Our hope is that these videos will create a higher level of dialogue and inherent understanding in our local, regional, and national innovation ecosystem.

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Gene Parunak
Flag It! FDA's New Guidance is Here to Streamline Things

Based on a successful pilot program, FDA, as of March 4th, 2019, has implemented a “least burdensome flag” program for the 510(k) clearance process. This program allows the submitter (within 60 days) to “throw a flag” on up to two areas in FDA’s response if they feel that the reviewers have not followed FDA’s least burdensome principles.

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Gene Parunak
Video: A Drop of Intended Use

This is the first in an ongoing series of “droplet” videos intended to communicate key concepts in the medical device development process. Our hope is that these videos will create a higher level of dialogue and inherent understanding in our local, regional, and national innovation ecosystem.

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Gene Parunak
New Electronics Prototyping Oven

This beautiful new shuttle batch oven just arrived to support our growing medical electronics prototyping capability. It will work right next to our high speed chip mounter. We’ve found in recent years that early stage medical device efforts struggle to find good electronic design and short run prototyping support and have been glad to be able to relieve that need! 

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Aaron Kehrer
Government Shutdown

Do you hear that sound? It's the clock ticking away the days with no recourse for many medical device startups. Things are coming to a head with certain milestones that require interaction with and/or clearance by FDA. The agency has made this process increasingly smooth, but as of late December, FDA has been suddenly hamstrung by the government shutdown.

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Gene Parunak