Due Diligence On Your Medical Device Manufacturing Partner

A number of healthcare market forces – from cost pressures and global competition to strong demand from emerging nations – have converged to drive increasing use of design & manufacturing services companies to design, engineer, manufacture, package and distribute a wide range of medical devices. Outsourcing all or some of these functions can help medical device OEMs accelerate time to market, control costs and push multiple products through the pipeline simultaneously – even with limited internal resources.

However, in an era of tighter regulations and a laser focus on patient safety, a medical device company needs to have complete confidence in the ability of its manufacturing partner to meet the highest levels of quality, control and compliance. This issue becomes even more complex when considering all the differences in requirements for various device types and across different regions, each with local regulations. For example, in the United States, medical devices must pass muster with the U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH), but an entirely different set of FDA regulations exists for imported medical devices.

Highly publicized recalls of medical devices, including defibrillators and pacemakers, make it clear that there is room for improvement in quality control and other compliance aspects. Further, regulations are a moving target, subject to frequent changes and updates. Finally, manufacturers and their manufacturing partners must be familiar with requirements over the entire device lifecycle, including adverse event reporting and end of life disposal.