Domestic and Foreign Medical Device Regulatory/Reimbursement Strategies
Mike Colvin Ph.D.
Mike has over 30 years of experience developing medical devices and systems. Over his career, he has been in charge of safety & efficacy testing and Regulatory & Clinical strategies. He has also served as a technical advisor/consultant in the medical device industry for over 25 years, giving him exposure to both large medical device companies and startups.
Mike has taught college for over 25 years and has contributed/participated on many domestic and international technical committees. He holds a Ph.D. in Physical Chemistry from the University of Southern California/California Institute of Technology.
In general, all commercial medical devices require regulatory approval, for obvious reasons. Of equal importance, is to have a reimbursement pathway in each country where the device sale is targeted. One must get a reimbursement assessment early--while still in the product design phase. One must understand how your device may or may not fit within current payment methodologies such as DRGs, resource-based relative value scale (RBRVS), or bundled payments. Understanding the reimbursement strategies is critical for the short and long-term success of the industry.
Similarities and differences in regulatory approval/reimbursement between the US and abroad. DRG’s, HRG’s, CPT’s, HTA’s, and centralized vs. non-centralized reimbursement. How does one change the reimbursement posture? Introducing new medical procedures and or technologies; how to effectively manage future reimbursement? Is reimbursement easier to secure in any country outside the United States (OUS)? If so, which ones? How will the reimbursement environment in the United States/OUS change in the next 10 years?
The objective of the Webinar is to teach participants how to develop their domestic and international strategies for effective reimbursement in parallel with achieving Regulatory Approval. Reimbursement can be just as important to obtaining Regulatory approval for the success of a company. What key factors should companies keep in mind about reimbursement as they build a new medical device? What are the necessities CMS and private payers look for when deciding whether to cover a new device? What can you do for improving a device's likelihood of reimbursement coverage?
Who Should Attend
- Medical industry Managers, Supervisors, Employees
- Quality Assurance Personnel
- Marketing Personnel
- Strategic Planners
- Technical Consultants