Packaging and sterilization are dynamic markets these days in the medical device industry, thanks to the new EU Medical Device Regulation (MDR), the COVID-19 pandemic, wobbly supply chains, tougher regulations, and changing healthcare demands. Although there is still an abundance of change to contend with, medical device manufacturers (MDMs) are settling (cautiously) into a "new normal" for packaging and sterilization. However, "there is still some pressure on supply chains with raw material shortages, especially with recent market tightening for sourcing and lead times," said Tom Williams, general manager for Millstone Medical Outsourcing, a Fall River, Mass.-based provider of packaging and distribution solutions for the medical device industry.
With the EU MDR newly launched, MDMs that are still behind are hustling to convert from non-sterile to sterile packaging. With MDR's sharper focus on risk and safety, grandfathered devices with a CE mark will require recertification. "In some cases, this may also require re-validation of the packaging materials and design," said Nora Crivello, president and CEO of Westpak, a San Jose, Calif.-based test laboratory specializing in product and package testing. "New rules requiring more technical documentation and labeling will have ripple effects on packaging and validation efforts. This includes adherence to and evidence of package testing to validated test methods."
As MDM optimism grows, and delayed projects move forward with more orders coming in, time has never been more of an essence--yet there are still frustrating delays with packaging and sterilization, most notably the shortage of ethylene oxide (EO) facilities, which until very recently sterilized billions of devices in the U.S. every year. The EO sterilization industry has been hit hard by the FDA, with some facilities closed permanently and others temporarily, due to concerns over the toxicity of EO emissions.
"Making things worse, since COVID-19 hit, there has been additional demand for sterilization for personal protective equipment, which puts further strain on sterilization capacity," said Peggy Fasano, COO for Boulder Sterilization and Boulder iQ a Boulder, Colo.-based ethylene oxide contract sterilizer and provider of design and development services for medical device and in-vitro diagnostic companies. "The FDA is closely monitoring the supply chain effects of closures and potential closures of certain facilities that use EO to sterilize medical devices prior to their use" Further, even though the medical device industry is working hard to adapt quickly to the changes and reduced capacity regarding EO, the U.S. Environmental Protection Agency is soon expected to propose even stricter emission requirements for contract sterilizers, which may further impact sterilization availability.
With such confusion and uncertainty, MDMs are turning to their supply chain partners for guidance and expertise regarding the best approach to sterilize and package their products, and even for ways to design medical devices that bypass these packaging and sterilization challenges.
"What OEMs prize most are partners with a solid understanding of the crucial intersections where device design and packaging can meet with adverse outcomes, and the know-how to avoid them," said Roy E. Morgan, general manager of Eagle Medical Sterilization Packaging, a...