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Katie Weimer from 3D Systems gave us a gift: The most informative update on 3D printing for medical devices. Here are the entire video, slides, and transcript: http://medgroup.biz/Katie-in-3D She fascinated us with before-and-after patient photos who...
A group member asks, "Does a device manufacturing site need to be GMP-certified by local authorities or is ISO certification enough for a CE mark application?" Dr. Peter Drechsler Senior TQM Manager at Allmed Medical Industries GmbH Dear all, first o...
At MDMS, the Medical Device Marketing and Sales Workshop, last February, Utah-based Nic Anderson from Intermountain Healthcare made such a great point I asked him to write today’s post. He writes, Payers go to conferences, symposia, lectures and read...
Was talking with a Wharton classmate of mine. Her "day job" is project management but she has a non-profit organization to raise awareness of diabetes on the side. She's considering "coming out" as a Type I Diabetic but she's afraid it will carry a s...
Whew. You got through the unique device identification (UDI) submission process. But you're not done yet. In http://medgroup.biz/UDI-next-steps, John Lorenc from Reed Tech explains UDI doesn’t end with your submission to the FDA’s GUDID database. "Af...
Gavin Bogle, an intellectual property lawyer I met at PEDS2040 surprised me when he said, "At this point, diagnostics are really not patentable." I recorded his 5-minute answer at http://medgroup.biz/not-patentable Gavin: Under “The Mayo Clinic v. Pr...
An AmericanEHR Partners survey said just 34% of physicians were satisfied or very satisfied with their EHR system in 2014. I'd say this is bad: • 72% said EHRs made it difficult to decrease their workload • 54% complained about higher operating costs...
And 200,000 is the low estimate. Medical errors will take 200,000+ lives in the U.S. this year. It's 3 million lives worldwide. I attended the World Patient Safety Forum this weekend and learned: - Medical errors are the third leading cause of death....
During last week's JP Morgan Healthcare Conference, Andy Slavitt, acting administrator of the Centers for Medicare and Medicaid Services (CMS), said, "In 2016, meaningful use as it has existed – with MACRA – will now be effectively over and replaced ...
Do you know what your Extended Producer Responsibility (EPR) reporting obligations are? I hadn't even heard of EPR until Graham Margetson, the CEO of Lorax Compliance, wrote me. When I saw he signed Fresenius Kabi as a client, I asked (and he agreed)...
