Events

MEDx Café

Wednesdays | 10:30 a.m.-12:00 p.m.

An informal time set aside by MEDx leadership for discussions with faculty, staff and students. Learn more about MEDx, an initiative between the School of Medicine and the Pratt School of Engineering, and get help finding collaborators, resources, and connections. To chat, contact Donna Crenshaw directly at donna.crenshaw@duke.edu or 919-660-1915.

There are no MEDx Café meetings currently scheduled. Please check back during the academic year.

Upcoming Events

Fundamentals of Intellectual Property: A Workshop for Inventors

Tuesday, January 26

7:00 pm to 10:00 pm Online

Presenter: Greg Carlin, M.S., J.D.

As an engineer or scientist you conceive new product ideas, discover new treatments for disease, or write original software. But do you know how to protect these ideas so that they can be effectively disseminated? Do you know whether your idea is patentable, and what it takes to get a patent? Do you know what other forms of intellectual property are available to protect your innovations, such as copyrights for your software? Gregory J. Carlin will provide an oversight of intellectual property law - including the different forms of intellectual property - with a deep dive into patent structure and the patenting process. He will share insights developed over a career spent in academia, industry, and his own boutique IP law firm. This interactive workshop will teach you how to read a patent, understand its legal meaning, and protect your own ideas. Zoom link provided upon registration. Registration: https://duke.qualtrics.com/jfe/form/SV_25K0Y8DQJ8OVhpb

Greg Carlin headshot

Product Design, Brand and Product Marketing

Tuesday, March 2

7:00 pm to 10:00 pm Online

Presenter: Julie Bryce and Michael Laut

Workshop description coming soon! Zoom information provided upon registration. Register: https://duke.qualtrics.com/jfe/form/SV_8cTadnh2zARJUkl

Julie Bryce and Michael Laut headshot

Working Within Regulatory Boundaries to Win in Medical Product Development

Thursday, March 18

7:00 pm to 10:00 pm Online

Presenter: Erika Segear, Ph.D., RAC

This workshop will discuss the regulation of investigational medical products by the U.S. Food and Drug Administration (FDA). It will give an overview of FDA's role in regulating medical products and it will offer guidance on how to classify your product and determine the regulatory requirements that apply. The workshop will offer a deeper dive into medical devices, discussing marketing pathways and the application process for clinical studies using unapproved devices. Case scenarios will be presented to enhance learning and stimulate audience participation. This workshop will address the following questions (and more): 1) How does the FDA regulate medical products?, 2) Is my product a drug, device or biologic?, 3) How do I classify my medical device?, 4) What is FDA's approach to regulating the commercialization of medical devices?, 5) What are the benefits of a pre-submission meeting with the FDA?, 6) What is the difference between an abbreviated and "full" IDE and when is the "full" IDE applicable?, 7) What information needs to be included in an IDE? Zoom link provided upon registration. Registration: https://duke.qualtrics.com/jfe/form/SV_3q3yrsUdV4fymTH

Erika Segear headshot

Innovative Product Design in a Regulated Market

Tuesday, April 6

7:00 pm to 10:00 pm Online

Presenter: Scott Corey

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. Zoom link provided upon registration. Registration: https://duke.qualtrics.com/jfe/form/SV_bCyrnblAWnF5grz

Scott Corey headshot

Startup Sales and Marketing: Even the Greatest Products Don't Sell Themselves

Tuesday, April 20

7:00 pm to 10:00 pm Online

Presenter: Chris Morrison

You can develop a best in class medical device and the world will NOT "make a beaten path to your door." Chris will challenge you to undertake a disciplined approach to develop the market, educate, and sell your concept to deliver medical innovation and improve patients' lives. While worthwhile endeavors start with a mission and vision, market intelligence, objectives, strategies and tactics still rule the day. From selling your idea to investors to obtaining market access, product trial, luminary advocacy, sales, social evidence, coverage and growth, the process requires disciplines, an open mind, ability to pivot and perseverance. We will share examples of success and of great products that failed to achieve their potential and uncover the reasons. You will work to develop your own product go-to-market strategy and have opportunity for questions. Zoom link provided upon registration. Registration: https://duke.qualtrics.com/jfe/form/SV_cRVqPR6um6l4dIF

Chris Morrison headshot