Question
I met a molecular biologist last week at BRINK 2015 (which was excellent). He's turned his attention to oncology. I paraphrase, but he basically asked if we knew any billionaires with cancer. He wasn't being elitist. Or looking to deny service to any...
The Wired article today on Hospira's ongoing insecure infusion pump software and hardware over the last year does not give confidence. The FDA has gotten involved over the last year & Hospira reportedly has over 400,000 infusion pumps in the fiel...
There's a lot of talk about innovation in the medical device sector but it isn't always clear what it is meant. How should innovation be measured? Perhaps the main metric these days are the ability of a medical device to make the healthcare system mo...
Hi,I was hoping to get some help and alternative opinions on a classification query I have. We sell instrument trays used to hold the instruments during reprocessing and sterilisation. I'm not sure whether they should be classified as a medical devic...
Some incubator exits have made great headlines. St. Jude Medical bought CardioMEMS. Stryker bought Concentric. Both were incubator graduates. I suspect these two are outliers. How do most participants fare? Your answers will be good background for th...
CFDA announced last week new fees for registrations, with higher fees for importers of high risk Class III devices than charged to locals. This was justified on the grounds of higher costs for international inspections. Thoughts people: * Discriminat...
Jorge Franceschi (ホルヘ)
Eliminating bulk purchasing by leveraging retail pharmacy distribution channels for clinical trials. #RxStudyCard
May 2015
Time, cost, and quality are the major drivers in outsourcing research. How many members have opted to conduct their device research in LATAM? What kind of experience did you have in that country and would you do it again?source: https://www.linkedin....
Come September 24, 2015, all medical device manufacturers of Implants, life-sustaining, and life-supporting devices marketed in the U.S. need to submit unique device identifiers to the FDA. It's complex, so please accept this free help from my friend...
My company services Clinical pathology equipment. i.e. microtomes Cryostats Tissue process, stainer, embedders etc. Since theya re not directly hooked to the patient I believe they are class 2 devices. We are exploring doing AC leakage testing on the...
What is the ROI on products that are outsourced, depending on the products, and removal of head count when you can eliminate people in mfg by outsourcing?source: https://www.linkedin.com/groups/78665/78665-6007319912278736900
