Question
Acceptance sampling is a technique often used in verification of product. The sampling methods depend on either variables or attributes. Most device companies used published documents such as Z1.4, c=0, or Z1.9. There are other methods, although not ...
Do you any experience working with CROs? I'd be interested to hear from those who have, eg:- What did the CRO(s) seem to do well/not so well?- What kinds of studies did the CRO manage? Feasibility, safety, pivotal, usability?- What was your take-away...
Many recently published studies showed that, thanks to telemonitoring, the number of exacerbations, hospitalizations and emergency department visits was reduced by 38 to 58% in COPD patients. Moreover, in case of hospitalization the number of hospita...
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...
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...
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 ...
I know it's risky but if we play nice this could be a productive conversation. With one Presidental debate behind us, which candidate would be better for the medical devices industry? Or will either candidate be equally good (or bad) for industry? Th...
There are, in distillation, three ways to go in the medical device industry. Many medical device companies work to treat unmet medical needs. That is the holy grail for wealth, job, and life satisfaction. It's a very tough way to go, requiring the mo...
Can anyone recommend a good NB in the UK? Both SGS and Intertek are refusing to take on any new work. We have been with LRQA for 18 months but we are getting nowhere with them BSI and UL are promising certification in a few months, but they all do th...
