Medical Device Regulation and Nanotechnologies: Determining the Role of Patient Safety Concerns in Policymaking

Balancing acceptable risks and early release of products for new treatments in patient care with the rights of patients and the rights of stakeholders-device makers and regulators-is a complex task. With the rapid technological innovations of the last two decades, providing a balanced voice to all participants is essential, but a sense of urgency depends on which side of the aisle one is sitting: on the side of patients, surgeons, regulators, and device makers; or that of providers and scientific advisors. A review of the medical device political economy suggests why patient safety concerns are or should be kept alive throughout the entire regulatory cycle from clinical evaluation and premarket checks to their final use in a huge variety of clinical settings around the globe. The key issue for nano-enhanced devices now is whether the uncertainties and perceived risks can be reduced through more stringent regulatory requirements and proactive measures without stifling innovation and development of new treatments for patients.