Question
Hi all, I was wondering if anyone had much experience with the safety and performance guidance that came in at the start of Feb? I was trying to find the list of eligible device types but have had no luck as yet.
You have a milestone. To achieve it, you need research… so you search. In-house? Crazy talk. Contract Research Organization? Your budget is too small.The University down the road? Now we're talking, you think. They have smart people, cutting-edge equ...
Google "Consumer Electronics Show 2014 wearable devices" and you'll discover they were this year's hot topic. Qualcomm's CEO Paul Jacobs: "We're doing a clinical trial in San Diego of a sensor that will actually get injected into your bloodstream and...
Mike Drues is one of the most gifted regulatory people I know. At 10x he said, If you're going to change a medical device in an administrative way, you have two options to handle that. • You notify the FDA (and if you do, how?); or, • You don't notif...
I am working to compile a list of recommended MDR compliant EU Authorised Reps for small medical device manufacturers. Any suggestions are greatly appreciated.
If you want an education about human factors, who better than a university professor who is an AAMI chair to teach it? I have the recording, slides, and transcript from MaryBeth Privitera's 10x talk for you today. Human Factors: MB's Main Takeaways U...
"Hip, hip, hooray! There's a new CPT code! I'm going to get paid!" you gleefully exclaim. "No you're not," health economist Nic Anderson said in this exceptionally valuable $350 consultation. I'm sharing approved, redacted portions of our call (yours...
Many start-ups and early-stage biotech companies have this dilemma. Build or borrow?If I build - big expense, but more security for my IP.Contract and risk my tech escaping into the wild.
The story about my financial loss, "We just lost a lot of money, and boy, is my wife upset!" generated more feedback than anything I've shared in my seven years with you. Many wrote me privately about their own flirtations with loss. Others about how...
No, I'm not kidding. We made our first investment in August, 2015. It was the first time we invested in a medical device startup. When selling Beth on the investment, I began, "I know this sounds cliched, but this is a sure thing." She gave me a...
