For medical device manufacturers, the prospect of transferring any part of their company’s operations to an outside vendor is among the most complex and difficult processes they will ever undertake. Whether the transfer involves reliance on an outside product design and development firm, the complete replication of manufacturing and assembly lines at a vendor’s location, or simply hiring a specialized packaging and distribution firm to take on order fulfillment, the manufacturer’s entire business is always at stake.
Contract manufacturing organizations (CMOs) that cannot meet the quality requirements of their OEM customers can do permanent harm to the manufacturer’s reputation, regulatory status, and customer contracts—not to mention the potential for increasing risks to patient safety. To make sure that they do not misstep when taking on the process of selecting outside vendors, manufacturers should pay particular attention to the quality management capabilities of the firms they are considering.
To find out what this process looks like in detail, we spoke with Jonathan Wacks, principal of Jonathan Wacks Consulting (Chicago) and formerly vice president for quality at Flexan LLC (Lincolnshire, IL), a CMO specializing in product development and cleanroom manufacturing of silicone and thermoplastic components for medical technologies.