Medical Device companies, especially those bringing their first product to market, face significant challenges. In recent years, regulatory authorities have become more demanding of the clinical proof of efficacy and safety. Healthcare cost containment and the Affordable Care Act create added pressure on new technologies to demonstrate clinical benefit over existing technologies.
In the past, new device technologies depended on “experience use” to support clinical efficacy and safety. The new healthcare environment calls for more robust clinical data to gain regulatory approvals, market uptake, and reimbursement.
While device trials are similar to the conduct of pharma trials (defined protocol, IRB approvals, patient consent, data collection, etc.), they pose their own unique set of challenges. In addition, the conduct of clinical trials is new to many device companies.
Peachtree has supported numerous medical device trials, and applied our expertise to the benefit of our clients. Understanding each client’s unique set of challenges is critical. And with a flexible approach to each situation, we provide the right service in a cost-efficient manner.
Want to discuss your challenges? Give us a call.