The US Food and Drug Administration noticed frequent complaints of a permanent birth control mechanism called Essure. A medical group from Weill Cornell Medicine in New York registered a 10 times higher occurrence of reoperation during the first year of implantation. In Europe, the PIP breast implant remains a permanent scandal. The question here is why are approved devices causing serious safety concerns in the market? Clearly, strict regulatory oversight does not avoid the rise of malfunctioning medical devices. On the device manufacturer side, following the regulations alone does not assure all safety, quality and effectiveness parameters have to be addressed.
Essure, produced by Bayer, was approved via the 510(k) process. This route excludes medical devices from clinical testing if they are proven to be considerably equal to a similarly marketed instrument. As a result, any clinical data achieved from abbreviated studies would be insufficient to give valid and representative conclusions about safety of devices and performance. Should Bayer have conducted a full randomized, blinded clinical investigation instead? The answer to this should be derived from sensible business based decision-making, and not a general one. Completely understanding the features of the product from both profit and risk perspectives is an important keystone of the value proposition for medical devices. The base customers of medical devices are the end-users and/or patients whose requirements should rightfully take higher priority above regulatory rules.
An effective business tool explicit to medical devices that could help to address this is the ISO14971 risk management standard. The requirements of this standard are common for all medical devices irrespective of risk classification and approval methodologies. It requires all device manufacturers to take every valid step to confirm that risk levels are minimized to as low as possible. Vice versa, approval pathways for lower risk devices do not offer relief to risk reduction measures. Therefore, if a complete clinical trial is required to provide a total risk/benefit profile for a device, then this should be done along with the regulatory process. This implies that a risk management process for a 510(k) approval should not be compulsorily less valid than for a PMA.