BCHT Medical Device Research: Overview
The medical device sector is known for its intense innovation, short product life cycles, and rapid growth in utilization and revenues. Most "big ticket" devices that attract attention—such as cardiac rhythm management devices, coronary stents, and hip joints—are implanted in hospital-based procedures, but there is a trend towards moving these to the outpatient setting. Some medical devices have strong clinical data supporting their use, but others are approved by the FDA only on the basis of being similar to existing devices. Many, moreover, are used for conditions quite different from those for which they were studied and originally intended. The use and outcomes of many cardiac devices are recorded in clinical registries, but, in the orthopedic sphere, registries are limited to those managed by Kaiser Permanente and to national registries in other countries such as Sweden.
Implantable medical and surgical devices are referred to as "physician preference items" because the choice of brand as well as type of device is not made by the hospital's purchasing department, but by the surgeon. Device preference may depend on a surgeon's personal and financial relationship with a specific device manufacturer or distributor, which can create a conflict of interest.
The strong affinity between surgeons and manufacturers contrasts with the often-strained relationships between surgeons and hospitals. In some instances, hospitals are precluded from sharing price information with physicians because of confidentiality clauses in their contracts with device manufacturers.
