Innovations in design and technology - The story of hip arthroplasty

The current study reviews the early history of surgeon-initiated trial and error development in hip joint arthroplasty acid the subsequent methodologi cal evolution to proper criteria for hypothesis testing using bioengineers and other research scientists. The interplay and relationships to industry, universities, scientific organizations, and the Food and Drug Administrati on with respect to device development in hip arthroplasty are reviewed. The ethics of and responsibilities to involved parties are outlined, citing th e history of many contemporary developments. Examples are provided from the evolution and introduction of unsuccessful innovations, and the problems i nherent ill the current methodology of the approval process from the Food a nd Drug Administration using the 5-10 K, Investigative Device Exemption, an d the Pre-Market Approval protocols. The pros and cons of randomized trials for devices are outlined with the conclusion that they are not appropriate for device introduction. The proper, rational methodology for introduction of new devices is a phased-in clinical trial process after pertinent bench testing, Finally, the ethical dilemmas created by managed care are address ed. Industry involvements of the surgeon-spokesmen are cited.