The US Food and Drug Administration noted frequent complaints about a permanent birth control device called Essure. A medical group at Weill Cornell Medicine in New York reported a 10-fold higher incidence of reoperation within the first year of implantation. In Europe, the PIP breast implant remains an ongoing scandal. The question here is why the approved devices cause serious security problems in the market? Clearly, strict regulatory oversight does not prevent the rise of malfunctioning medical devices. On the part of the device manufacturer, following the standards alone does not guarantee that all safety, quality and efficacy parameters must be addressed.
Essure, produced by Bayer, was approved through the 510(k) process. This route excludes medical devices from clinical trials if they are shown to be substantially equal to a similarly marketed instrument. As a result, clinical data obtained from abridged studies would be insufficient to provide valid and representative conclusions on device safety and performance. Should Bayer have conducted a completely randomized, blinded clinical trial instead? The answer to this must be derived from sound business-based decision-making, not from a general one. Fully understanding product features from a profit and risk perspective is an important cornerstone of the value proposition for medical devices. Core customers for medical devices are end users and/or patients whose requirements should take higher priority than regulatory standards.
An explicit effective business tool for medical devices that could help address this is the ISO14971 risk management standard. The requirements of this standard are common to all medical devices, regardless of risk classification and approval methodologies. It requires all device manufacturers to take all valid steps to confirm that risk levels are minimized to the lowest possible. Conversely, approval pathways for lower risk devices offer no relief from risk reduction measures. Therefore, if a full clinical trial is required to provide a full benefit/risk profile for a device, then this should be done in conjunction with the regulatory process. This implies that a risk management process for a 510(k) approval should not be compellingly less valid than for a PMA.
Any device manufacturer that uses a streamlined approval procedure as an excuse to reduce risk reduction will not only put a dangerous medical device on the market, but that disregard for basic total quality is itself harmful to medical device innovation. and long-term business competitiveness.