Medical Device Conference Wrap-Up: FDA Emphasis on Purchasing Controls

At a recent MiniTec half-day technical conference on medical devices, medical polymers, and emerging trends (co-sponsored by the Society of Plastics Engineers Philadelphia Section and Medical Plastics Division), a topic that generated many comments was the upcoming US FDA [Food and Drug Administration] emphasis on and scrutiny of purchasing controls for medical devices. Dr. Vinny Sastri, president of consulting company Winovia LLC, explained that FDA's philosophy has been evolving to an emphasis on risk management and purchasing controls of total quality systems for medical devices. In the total systems approach, companies need to understand the fundamentals of their products and processes throughout the product life cycle, and identify the sources of variation in both the raw materials and the process in order to have a "quality by design" approach. Purchasing controls may involve supplier evaluations, selection and controls, record keeping, and monitoring of incoming materials. Dr. Sastri explained that the extent of controls should depend on risk, with greater controls on more critical parts.

Because FDA regulations make the finished medical device manufacturer (OEM) responsible for the safety and effectiveness of the device, OEMs following the total quality systems approach need to understand which material or component specifications are critical for the intended use. "For example, they should not just specify 'steam sterilizable' but also specify the physical, mechanical and other performance requirements needed to produce consistent products," says Dr. Sastri. However, conference participants noted that medical device manufacturers may not have enough experience in materials to accurately identify critical material specifications. "There must be a collaborative design and development effort between device manufacturers and their suppliers to create clear specifications," says Dr. Sastri.

Processors supplying to OEMs expressed concern that resin suppliers might not want to meet narrower material specifications, and that solutions like going to a custom compounder would greatly increase their raw material costs. Dr. Sastri agreed that suppliers further down the value chain might be less willing to change, but his opinion is that the practice of device manufacturer's purchasing departments buying only on price will be changing as they are forced to comply with the new guidance on purchasing controls.

Dr. Sastri noted that the FDA has adopted the Global harmonization Task Force's "Guidance on the control of products and services obtained from suppliers" introduced in December 2008. He says that the FDA's inspections of device manufacturers will look for objective evidence of control over their products and services from their suppliers. He warns, "Suppliers should be prepared for more controls."