Innovative Product Design in a Regulated Market: A Workshop for Medical Device Designers
Saturday, April 21, 2018 - 11:00am to 3:00pm
The Bullpen, 3rd Floor, 215 Morris Street, Du
F. Scott Corey, Jr., Key Technologies, Inc.
As scientists and engineers, it is tempting to think that the key to making a successful product is just a great idea. In reality, that is only one small step on the way to a successful product. This is particularly true in regulated industries like medical devices where even great products can fail to see the light of day because a disciplined design process was not followed AND documented. Fixing an undisciplined development process can be prohibitively expensive and cause unacceptably long delays in getting a product to market. During this workshop, Scott Corey will review the guiding principles behind the medical regulatory framework so that participants will have an intuitive understanding of what to focus on during medical device development. This interactive workshop will walk through the development of a hypothetical medical device with breakout sessions where the audience will work through critical steps in the process. Scott will augment the instruction with first hand lessons learned. Participants should leave the workshop with a good understanding of the critical steps in medical device development. Registration Required: https://duke.qualtrics.com/jfe/form/SV_0OQgs3jGrvOqIIt