May 14, 2022
10:00 am to 1:00 pm
Event sponsored by:
Duke Innovation & Entrepreneurship Initiative
Pratt School of Engineering
School of Medicine (SOM)
Scott Corey, VP Product Development, Key Tech Inc.
"Innovative Product Design in a Regulated Market" Scott Corey, VP Product Development, Key Tech Inc. 10 a.m. - 1 p.m. Sat., May 14, 2022 Location TBD - Duke West Campus Lunch is provided and is free of charge but registration is required in advance: https://medx.duke.edu/innovative-product-design-regulated-market-0 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. If you have questions or after registering you find that you will be unable to attend, contact Donna Crenshaw at firstname.lastname@example.org Sponsored by Duke MEDx and Duke Engineering Entrepreneurship