Innovative Product Design in a Regulated Market: A Workshop for Medical Device Designers
F. Scott Corey, Jr.
VP Product Development, Key Technologies, Inc.
Sponsored by MEDx, Duke Engineering Entrepreneurship, and Duke Innovation and Entrepreneurship
11 a.m. - 3 p.m. (lunch provided)
Saturday, February 8, 2020
Schiciano Auditorium, Fitzpatrick Center, Duke University
Registration is required: https://duke.qualtrics.com/jfe/form/SV_3EPXwMseRn5aPYx
Attendance is limited to 50
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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. Likewise, exiting the research phase too early or too late can significantly impact the time to market and potential success of the product.
During this workshop, Scott Corey will provide guidance on the transition from research to product development including a discussion of the pitfalls of waiting too long or rushing to development too soon. He will then 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.
Scott Corey received a B.S. in Electrical Engineering from Lehigh University. He co-founded Key Technologies over 25 years ago and has over 30 years of experience designing medical products ranging from diagnostic devices to surgical systems. He has learned through direct experience how to efficiently and successfully develop products in a regulated market. Scott has seen from both the buyer's and seller's side how the salability and ultimate value of a medical device can be driven by the quality of the design process.
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