Quality assurance of joint replacement Legal regulation and medical judgement

Failed innovation in total hip replacement: Diagnosis and proposals for a cure

“…The latter, I believe, is the case. Figure 10 depicts the life cycle of THR (Faro and Huiskes 1992). which represents the innovation process as well.…”

“…This new information leads to new research, new designs and the cycle starts again. The arrow in the cycle signifies possible barriers to market introduction, such as government regulation, e.g., FDA approval (Faro and Huiskes 1992). I see three principal problems associated with the way in which the cycle runs today.…”

“…However, there are no satisfactory regulatory mechanisms to prevent them from being sold freely on the market (Faro and Huiskes 1992). Although the U.S.A. has its FDA approval requirements, and a number of other countries have government regulations to monitor market introduction, these hardly consider the long-term endurance of a new THR concept.…”

“…Although the U.S.A. has its FDA approval requirements, and a number of other countries have government regulations to monitor market introduction, these hardly consider the long-term endurance of a new THR concept. In our recent publication (Faro and Huiskes 1992), we have shown that disastrous THR products have been marketed in the past, government regulations notwithstanding.…”

“…Government regulation of market approval cannot be expected to solve the innovation impasse effectively and efficiently (Faro and Huiskes 1992). Selfregulation of the innovation cycle by the orthopedic community as a whole, however, and individual selfcontrol, could change the present culture.…”