Quality is an ever-growing problem in the field of medical products, including medical devices, medical diagnostics, pharmaceuticals, dietary supplements, and combination products. Its negative impact is felt by manufacturers as well as their patients, employees, and investors. As the globe's dependence on medical products continues to heighten, as does the trend toward pervasive personalized medicine, the avenues of postmarket quality are getting harder for many firms to navigate, which can be attributed mainly to inadequate quality reporting and analysis infrastructure on behalf of the manufacturers.
Regulatory bodies across the globe impose regulations and guidelines for manufacturers on what their postmarket surveillance program shall cover, including complaint handling/investigations and reporting serious injuries/deaths (e.g., Medical Device Reports, Vigilance Reports). These regulations require a company to actively seek postmarket data, and analyze the data to confirm the existing risk management profile of the product is consistent with the expectations of the company. This postmarket program and the analysis of postmarket data must be incorporated into the technical documentation, including the product family’s clinical evaluation report. Without an adequate PMS program, serious regulatory actions can be taken against a company. In the US, Warning Letters related to Product Complaint handling are the second most frequently cited observation.
With a better recognition of the value of postmarket data and with proper support and resources, a medical products company can better protect patients and respond more quickly to quality issues while complying with the regulatory bodies.