Question
Amy DeWinter
Founder, Ascenda Medical Marketing | Expertise in Advancing Medical Technology
November 2019
Hello, Med Device Community. I am consulting with an early commercialization company that has a device used in emergent situations, so use is not planned. Our challenge is trying to collect evaluation forms for prospective accounts with the intention...
I had been trying to get a packaging expert on the 10x stage for three years because we'd never covered it in depth as a group. It was worth the wait. Adept Packaging sent 35+ year veteran Jan Gates to speak and she did not disappoint. This video is ...
In layman's terms, post-market data means regulators want to know how your market is doing in the marketplace. Christine Zomorodian and Anne Leijsen gave an easy-to-follow talk about it at the 10x Medical Device Conference in October, 2018. Before we...
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If you want an education about human factors, who better than a university professor who is an AAMI chair to teach it? I have the recording, slides, and transcript from MaryBeth Privitera's 10x talk for you today. Human Factors: MB's Main Takeaways U...
I'm really hoping this message gets out to anyone planning a clinical trial, so please forward it to your network. This is an ambitious post, sharing two great 10x Conference presentations.Doug Fankell, Ph.D. (on left) is an engineer with Structural ...
That's a fancy health tracker on your wrist. Is it medically accurate? Tracking devices – monitors, if you will – have been around for a long time. In the intensive care unit, the patient is monitored 24 hours. Your fitness tracking device may not ev...
Does a medical device manufacturer have to re-label research only products (animal research only, not for use in humans) as investigational use (per 21 CFR 812) for use in IRB or IDE?The devices are not cleared and some may or may not be on a path to...
If you make the selection just on cost, in about a year, you may be very sorry about the decision you made, began Mark Rutkiewicz, VP, Quality at Innovize. His was a really solid talk. I'll share the first of his five questions here. You can find the...
I’m currently a student at the University of North Carolina at Chapel Hill, studying economics. I am taking an Entrepreneurship class, where we must create a venture in relation to health care.My group has come up with an idea to create wristbands th...
