Question
If there were ever a question worth asking the worldwide group, this is it. Laura Velez wrote me from Afghanistan, saying, "I am working as Biomedical Engineer for Doctors Without Borders. This NGO is a medical humanitarian organization which works a...
Do you believe it's worthwhile to market a medical device used in surgery directly to patients? I don't. To be clear, I'm not talking about durable medical equipment (wheelchairs, diabetic supplies). I'm talking about devices that "improve patient ou...
Mark Armstrong, MD, MSBE
Associate Medical Director for Colorectal Health and PACE Curriculum Manager at Medtronic
March 2015
Preliminary studies used nanoparticles targeting arterial wall damage. Once at the damaged site, the particles released the protein annexin A1. Researchers had a 70% targeting rate and reported signs of vessel healing after the therapy.Precision nano...
Claude P. Bobin
President at T-MedRobotics, Adjunct MBA Professor at Benedictine University
November 2017
source: https://www.linkedin.com/groups/78665/78665-6339193416852738052
Today we are discussing medical device manufacturers' corrective and preventive action (CAPA) processes. First, so we're all on the same page, visit http://medgroup.biz/CAPA for free resources from MasterControl. The http://medgroup.biz/CAPA link giv...
A rather explosive conversation started in the group this week when @Richard Bollinger posted "FDA compliance crisis still a threat." His post, verbatim: "New FDA data continues to show an industry in crisis. One third (1/3) of all site inspections s...
If you were asked to name a price at which you'd sell your company, could you do it? What can you do today to achieve the greatest enterprise value, even if you have no immediate plans to sell? Dave Sheppard (formerly VP, Covidien) and Florence Joffr...
Another 10x video ready for you at http://medgroup.biz/Kaiser In it, Chief Information Officer John Mattison said, "So what do we want from device manufacturers? A lot, and these are really problematic. So this is not a wish list; these are things th...
This may be a sobering post for entrepreneurs. You may be working on the wrong project. Go pick a bigger one. That's essentially what a panel of experts told me this month at the IN3 conference in San Francisco. We were discussing financing options f...
How'd you like to have one audit instead of four? In an effort to accelerate international medical device regulatory harmonization and convergence, the International Medical Device Regulators Forum (IMDRF) developed common standards for quality manag...
