Week 3

The focus this week is FDA & additional regulatory considerations. Below you will find educational videos and supplemental reading material that will help you complete week 3 activities for the course.

Remember, conducting customer discovery interviews is critical to your success in the course.  Challenge yourself to conduct a minimum of 10 interviews per week.

Video Lectures

FDA Regulation: Introduction (1 of 3)

Donna-Bea Tillman, PhD, MPA provides an in-depth look at FDA regulation of medical devices and software in this 3-part series. The first video gives an introduction to FDA regulation with a focus on basic concepts from a “medical device” definition through typical pathways.

FDA Regulation: Medical Device Software (2 of 3)

Donna-Bea Tillman, PhD, MPA looks at special considerations for medical device software. In this portion of her talk, you will learn about FDA expectations now, as well as the history of software-specific regulation through examples of both success and failure.

FDA Regulation: Innovator Implications (3 of 3)

Donna-Bea Tillman, PhD, MPA continues the discussion of FDA regulation with a focus on implications for the innovator. How can you make sure to get it right the first time? This video is recommended for both medical device and software projects.

Therapeutics: Regulatory & Clinical Trials

Jeanne Wright, Clinical Research Project Manager with U-M MICHR, gives an overview of the therapeutic drug development process with a focus on FDA and clinical trials. In this video, she addresses the review process and surrounding regulations.

AlertWatch: Our FDA 510k Journey

As Justin Adams, AlertWatch CEO, and his team review the regulatory challenges faced by their software solution and the treacherous path to FDA approval.

Optional Videos

FDA Regulations: Device and Health IT

Kevin Weatherwax, MICHR Administrative Program Director and Adjunct Associate Clinical Professor, U-M College of Pharmacy, reviews the basics around regulatory considerations for medical devices from nuanced definitions to pathways, approval, and application processes.

FDA Regulations and Medical Device Pathways to Market

Russ King, president of Method Sense, gives a high-level overview of FDA regulatory considerations specific to medical devices.

Reading & Resources

Course text: “BioDesign, The Process of Innovating Medical Technologies” Zenios, Makower, Yock. Week 3: p. 237-298 or view online resources.

Additional resources for therapeutics project teams:

Assignment Template

Week 3 Assignment Template
Complete and upload the Assignment 3 slide deck in advance of the upcoming webinar.
March 27, 2017