Strategic Considerations When Building a Clinical Program in a Medical Device Start-up Environment
Medical devices have unique regulatory framework and are diverse in technology, clinical applications, and risk profiles. The clinical development cycle for medical devices is different from pharmaceuticals and the vast majority of medical device companies are small start-up companies with limited resources.
The following topics will be discussed:
- A typical clinical development cycle for medical devices
- Unique aspects of medical device trials
- Strategic considerations and practice implications at various phases
- Optimize a clinical program when only limited resources are available as a start-up company patient recruitment.