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?