Whether conducting trials for orthopedic medical devices or therapeutic agents, planning and execution of clinical trials are extremely important. The ultimate goal of developing a device or therapeutic agent is having it be both useful and profitable in the clinical setting. Doing so requires keen insight and careful planning into several unique processes—clinical testing, regulatory approval, and coding and payment procedures.
Poorly designed or executed clinical studies fail to convince payers. Trials should be designed to glean the information necessary for proving the primary and secondary objectives without gathering extraneous material. Economic information necessary for future reimbursement applications should also be obtained.
In orthopedics, good engineering does not guarantee clinical trial or commercial success. The climate for introducing new medical devices and therapeutic agents into the market has become increasingly difficult in recent years. At times, regulators and device manufacturers seem to be on opposing sides of the playing field. Regulators often contend with pressure to fast-track approvals while at the same time ensuring product safety and efficacy. On the other hand, manufacturers risk spending time and resources to develop a product, only to not receive approval to go to market. For products that reach the market, several factors, including the reimbursement environment and coverage decisions, can influence profitability. Executing a successful market strategy involves navigating the U.S. Food and Drug Administration (FDA) approval process, designing and conducting efficient clinical trials, and adeptly evaluating the existing marketplace.
Let the Regulatory and Strategic Development (RSD) and Clinical Operations teams at Clinipace Worldwide help guide the successful execution of your orthopedic medical device or therapeutic agent clinical trial. We have expertise in navigating the challenging regulatory pathways, including developing premarket notification 510(k) and premarket approvals, obtaining investigational device exemptions and working directly with the FDA for feedback during the development cycle. We can help you design and conduct an efficient clinical trial for your orthopedic product, including providing expertise on unique protocol design considerations and deploying the right technology to bring visibility and a level of collaboration and control not possible in a traditional CRO environment.