Case Study: When does “technology” turn into medical device

This semester I’ve embarked on an adventure to co-teach a class in the University of Wisconsin-Madison Masters in Biotechnology program. What sold me on the experience was the majority of my responsibility is interacting with second year students on their final major project (essentially their thesis). That said, I will give one lecture, which will be “health technology” from the drug development perspective. The topic has been of ever growing interest for me since I discovered Patient Reported Outcomes (PROs) related to oncology (flashback post from ASCO 2011: Is Safety a Strategy in Cancer Drug Development?). I aim to pull some blog posts from my course materials but am starting by sharing the topic I carved out for a group of  students to present at that session. To avoid overlap, their topic is how and when “technology” becomes a medical device for patients with diabetes. If you have other resources or suggestions for their topic, please share them in the comments. I’m looking forward to a great discussion.

UW Madison MS Biotech Program – Advanced Biotechnology: Global Perspectives – Session 5 Panel Topic:  

Case study on how and when “technology” becomes a medical device for patients with diabetes.

Subtopics Related to Session Topic:
Please consider these perspectives in your presentations:

• Technical overview of glucose monitoring devices and their use by diabetic patients
• Regulatory explanation of when a technology is a device and the level of risk the new product entails
• Ethical exploration of patients developing (and potentially sharing) their own technology solutions
• Business model for device makers in providing new technology, including the potential need for (and cost of) FDA review

References Related to Panel Topic:

• Patient “Hackers” and Diabetes
  • Wall Street Journal article 
  • The Nightscout project
  • Wired story 
• Dexcom Continuous Glucose Monitoring (CGM)
  • Dexcom Mobile Apps
  • Dexcom SHARE
• FDA recently “permitted marketing” of Dexcom SHARE.
  • FDA announcement
  • News report with additional context 
• National Medical Device Curriculum is a series of fictional case studies designed to help academic institutions and science and technology innovators understand FDA’s medical device regulatory processes
  • Regulatory Pathways for Medical Devices: Choosing the Right One
    • Case Study
    • Instructor’s Guide