Course Description
Taking medical technologies from concept to market. Covers technology transfer, patent strategy, FDA regulatory pathways, clinical trials, reimbursement coding, and market launch. Focus on medical devices, diagnostics, and therapeutics. Guest speakers from industry and regulatory agencies.
Credit Hours
3 credits (3 lecture)
Prerequisites
ENT 601 or instructor permission
Student Learning Outcomes
- Evaluate technology readiness and commercial potential
- Develop intellectual property strategies for medical technologies
- Navigate FDA regulatory pathways (510(k), PMA, De Novo, BLA)
- Design clinical trial strategies for regulatory approval
- Obtain CPT codes and CMS coverage for new technologies
- Execute market launch and commercialization plans
Course Topics
- Technology Assessment and Market Opportunity
- Intellectual Property: Patents, Trade Secrets, Licensing
- Technology Transfer from Academic Medical Centers
- FDA Regulatory Strategy: Device Classification, Predicate Selection
- Clinical Evidence Requirements: Bench Testing to Pivotal Trials
- Reimbursement: CPT Applications, Coverage with Evidence Development
- Manufacturing Scale-Up and Quality Systems
- Market Access: Sales Force, Distribution, KOL Development
Deliverables
- Technology Assessment Report (15%)
- IP Strategy Analysis (15%)
- Regulatory Submission Plan (20%)
- Commercialization Plan (35%)
- Final Presentation (15%)
Required Textbooks
- Yock et al.: Biodesign (3rd ed., Stanford)
- FDA Guidance Documents (provided)