Question
We had a discussion, "Got a $10-million idea? Who cares!" at nearly two years ago. At the time I asked a panel of VCs, "What about the guy who has the $10 or $20 million idea, where does he go?" Serial entrepreneur Danny Sachs answered, "Pick another...
Prior to its suspension, the 2.3% medical device excise tax was seen by many as a "job killer" due to the noticeable rounds of layoffs seen by all during its roll up and tenure. Others saw the layoffs as a natural occurrence associated with an evolvi...
Last week I received this question specifically about 510(k) reviews, but I expanded the question to address both types of submissions.The most important thing is to be aware of the review process for submissions and understand the chain of command. ...
We had a discussion, "Got a $10-million idea? Who cares!" at nearly two years ago. At the time I asked a panel of VCs, "What about the guy who has the $10 or $20 million idea, where does he go?" Serial entrepreneur Danny Sachs answered, "Pick another...
I would like to know if some of you have issues with this procedure ? What is your Notified Body and does it still accept OBL procedure for CE marking ? I think that is a huge concern for many Medical Device companies and it deserves a discussion. so...
China has published its long awaited second wave of devices not requiring clinical trial for regulatory approval in China. manufacturers of surgical instruments, certain diagnostic analyzers, endoscopy equipment, and dental equipment will be happy.Se...
Did you know 77% of the cost to develop a 510(k) device is spent in clinical research and regulatory submissions? It's 80% for PMA devices. "A lot of that cost is due to how poorly we handle data," explained Jim Rogers, President of Nextrials, at the...
When Theranos crashed, many proximate and root causes were suggested for the disaster. One was that the management team and investors seemed to be dominated by Silicon Valley software types, with little to no expertise in the medical device industry ...
Does anyone have examples of investigations about medical device recalls that they could share that was something upper management actually LIKED? I swear this is about the most political aspect of the medical device industry I've found and I really ...
I am trying to figure out the best way to either do some bench tests or animal tests to obtain a CE mark/510K for my new nasogastric tube. Does anyone know the circumstances in which the FDA/CE would prefer some animal testing over bench data, or jus...
