Question
I’ll be honest: I can’t even imagine what it’s like to learn my implant is being recalled. But that’s what happened to a group member who prefers anonymity for legal reasons. She writes: “I was appalled to receive a letter that my two-year-old hip re...
If you manufacture Class III medical devices, you've got a panic-inducing 71 days to comply with Unique Device Identification (UDI) and Global Unique Device Identification Database (GUDID) guidelines. Are you ready? http://medgroup.biz/UDI-goes-in-ef...
[Adapted from a true story I heard at last night's meetup in Boston] A guy walks into a gynecologist's office with a device designed to help women suffering from urinary stress incontinence. The doctor is intrigued. Doctor says, "Is it reimbursed?" T...
"Looking for investment" is the number one request I get as leader of the Medical Devices Group. That's a hard one especially because (a) early stage investments in medical device startups are drying up and (b) without understandng the deal intimatel...
Last week FDA issued some social media guidance for medical device and prescription drug companies. See http://medgroup.biz/FDA-social-media-guidance for commentary and the downloadable 18-page guidance. In short, the guidance says if you need more r...
I am interested in hearing from individuals/companies regarding the potential development of a medium term project to develop a universal surgical ostomy port strengthening the abdominal wall. Thank you in advance for your enquiries.source: https://w...
At this year's 10x Medical Device Conference, Seth Goldenberg Ph.D., Senior Principal Scientist at NAMSA, gave an illustrative talk entitled, "Thinking Globally During Medical Device Development: Accelerating Products to International Markets." The f...
Dr. Seth Goldenberg gave a talk, "Thinking Globally During Medical Device Development: Accelerating Products to International Markets," at the 2014 10x Medical Device Conference. The main takeaway: Bringing medical devices to foreign markets gets com...
When you began your medical device company, you had an idea – and maybe a prototype, funding, and some customer interest. At what point did you start implementing a quality system? It's required to generate the product documentation for regulatory ap...
Have you heard the expression, "I don't know what I don't know?" I was talking with group members Matts Bell and Mike Coon. Both are in business development. Matts Bell works for Argos Global, a complaint handling company. He said, "In 2013, 75 perce...
