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...
Caitlin Morse, PMP says you can minor in biomedical engineering, but – for your sake – don't major in it. If you do, you won't likely start as an engineer. Caitlin says, Many who are excited about going into medical device or other life science compa...
Rob Packard tells me the three most common ways companies wreck their FDA submissions are: Wrong pathway. They take the wrong pathway. Say, a 510(k) instead of a De Novo. Wrong test. They spend their money on the wrong tests. Ignored advice. They ign...
How much more could you sell if you reached only the call points most likely to buy from you? My friends Rick Grape and Rebecca Hauck from LexisNexis Risk Solutions can help you identify those call points – they'll tell you how on a live event, Wedne...
So asked a group member. I replied, a smart request is "help me build awareness among decision makers who buy my products and services." And, perhaps, "and end users so they ask their doctors" – but I don't recommend it for medical device companies. ...
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 ...
FDA has an agreement with EPA where low-level disinfectants used in areas like hospital rooms are regulated by EPA. A client has a low-level EPA-approved disinfectant cleared to inhibit microbial growth on the surface to which it is applied. But rece...
It appears this topic was covered in this forum back in 2012 and the HIDA conference was suggested as a possible resource. I've heard both positive and negative experiences concerning finding medical device distribution partners at HIDA and was hopin...
After a three-year absence, Deborah Douglas returned to the 10x stage with advice how to (and not to) sell your medical device company. "Too many come to us before their technical approval is quite in place," she explained, "but it hurts value too mu...
I use a FDA and CE registered sub-contract manufacturer for a FDA and CE registered Class 2a hand-held device., which my company sells around the world (in small numbers). We have implemented the UDI requirements. All fine. The issue comes when the m...
