There have been many recent trends in the FDA approval process for low-volume prostheses. This has most affected the Pediatric Orthopedic Oncology realm for which almost all devices are custom-made. The whole process takes a significant amount of very valuable time. And, once made, the prosthesis must be approved through the current "compassionate use" clause. This delays onset of treatment and provides many hurdles for both the surgeon and the patient.
The FDA has recently increased it's demands for a product to gain approval in the field of medical devices; they define a medical device as any health care product that does not achieve it’s primary intended purposes by chemical action or by being metabolized. Almost all products most go through a rigorous process of FDA informed consent and IRB approvals. Once this is obtained, the manufacturer must perform research and demonstrate the product’s safety and usefulness. This process can take months, if not years, to complete. Despite all this hard work to obtain approval, less than 50% of devices are still on the market 10 years later. Most are removed due to poor market performance, not safety issues; less than 2% of products get removed because of safety or health concerns after obtaining approval.
Devices and implants that are undergoing investigation are categorized into two groups: Significant Risk (SR) and Non-Significant Risk (NSR). The distinction is that SR devices pose "a potential for serious risk to the health, safety, or welfare of a subject," which is the category implantable orthopedic devices are categorized by the IRB. This process works well in adults and in areas with large case volumes such as trauma and total joint reconstruction. But, the field with the most difficulty with this process is the pediatric oncology orthopedic implants.
Pediatric Orthopedic Oncology is an incredibly small niche; there is such a rare occurrence of primary bone tumors, approximately 800 cases nationwide per year, that it is nearly an impossible task to gain approval through the standard methods. The numbers needed to generate quality data are lacking, therefore most devices gain a secondary approval through the "Compassionate Treatment Use" protocol. This allows an investigational device to be available for use prior to completion of research in immediately life-threatening disease.
At this time, unfortunately, this is the only approval method available. All of the prostheses are custom implants and each manufacturer has their own protocol and process, in addition to the FDA and IRB standards. All of these things contribute to a time lapse between diagnosis, treatment, and implantation of the device; this delay can add weeks to months and overall poorly influence the outcome in this critical time. Hopefully, we can continue to provide valuable feedback to those over this process and reduce the "red-tape." This time is invaluable to the child and their family. The truth is that we will probably never reach adequate research numbers to fulfill the requested obligations. Our hope would be that a better, more timely, secondary process could be generated and a global approval process could be created.