1. Brainstorming – This is a tool that is most commonly leveraged among all disciplines, and Starfish encourages active participation with our innovative multi-disciplinary teams. The first and most important part of a brainstorm session is to … Continued
Monthly Archives for
January 2012
New FDA Draft Guidance on 510(k) Program
On Dec 27, 2011, the FDA released an important new draft guidance entitled “The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications”. Once issued, this guidance will replace “Guidance on the CDRH Premarket Notification Review Program, 510(k) Memorandum K86-3” from … Continued
Right Brains and Left Brains – Can They Work Together?
Each day when I come to work, I’m surrounded by a large group of very smart, extremely analytical engineers, physicists….and others of the same ilk. You can easily spot them when you enter the office, because they carry the tell-tale … Continued
To cloud or not to cloud – FDA’s Part 11 implications
These days you can read a lot about the advantages of cloud–based, shared infrastructure. Public virtual server providers are praised for scalable and flexible storage, affordable pay-per-use service or subscriptions, and convenient back up and disaster recovery. Many providers are … Continued
What’s your problem?
It’s easy to send a project sideways: all you need to do is identify a brilliant, expedient solution and unleash your brightest designers and engineers to implement it. You’ll reach your destination even faster if you add some schedule pressure … Continued
5 not so obvious things to consider when qualifying a development partner
Over the last 2 decades I’ve watched how companies evaluate and choose a development partner. Some are given to impulse and others are highly analytical and methodical in their approach. Of all the things I’ve learned, five things stand out … Continued