We invite you to download our latest paper as we provide practical advice for device manufacturers in executing a successful market entry strategy that involves navigating the FDA approval process, designing and conducting efficient and cost-effective clinical trials, and adeptly evaluating the existing marketplace.
In this paper our medical device experts cover:
Navigating regulatory pathways
- Premarket Notification 510(k) and Premarket Approval
- Investigational device exemption
- Importance of seeking feedback
Designing and Conducting Efficient Clinical Trials
- Be design intelligent
- Protocol considerations
- Use of technology
- Run a transparent, efficient study
- Establishing clinical efficacy
Evaluating the marketplace
- Know your target addressable market
- Know the marketplace
- Understand the reimbursement environment
- Coverage decisions by the Center for Medicare and Medicaid Services
- Importance of HCPCS codes in new product reimbursement
- Charges made through hospitals
- Physician reimbursement
- Private carrier payment