Workshop hosted by the University of Minnesota, Medical Device Center (MDC)
Thursday, October 20th, 2016
Sponsored by MForesight
- Identify orphan markets
- Identify best candidates for low volume manufacturing
- Collaboration of key resources, industry, academic, hospital, insurance, FDA regulations
- Potential teaming arrangements
- Identify sources for pilot programs
- Preliminary program team structure and objectives
- Final Report
Workshop Discussion Topics
Identification of Needs for Orphan Population
- What constitutes an orphan population?
- What are the medical needs for the orphan population?
- How do industry, doctors, hospitals and academic institutions collaborate in identifying low volume production for orphan needs?
Barriers to Low Volume Orphan Populations
- What are the economic barriers to low volume production and cost competitive medical devices for orphan populations?
- Are there technology barriers? If so, what are these barriers?
- Is the lack of medical device ecosystem collaboration a barrier to serving orphan populations?
- How is FDA regulation for compliance a potential barrier?
Opportunities for Low Volume Production
- What are the best opportunities to develop medical devices for low volume production for an orphan population?
- What existing technologies are best suited for low volume orphan populations?
- What new technology/research should be conducted to enhance and allow low volume production?
- How do we best collaborate among industry, hospitals, doctors, academic institutions, FDA and insurance to successfully improve outcomes for the patients needing low volume medical devices?
Thank you to all the workshop participants!