COVID-19 has brought into stark reality the dangers of medical device shortages and supply chain disruptions. From a lack of personal protective equipment for frontline workers to a critical shortage in ventilators needed by COVID-19 sufferers, this pandemic is a grim reminder. Since then, governments have put in place safeguards to preserve the critical manufacturing supply chain as it can be crucial during emergency situations.
FDA and Veterans Health Administration have formed a new partnership aimed to reduce medical device shortages via the creation of digital stocks. James Coburn, who is the lead of the FDA Office of Counterterrorism and Emerging Threats’ advanced manufacturing team, said that the memorandum of understand between the two organizations was born of the shortages of essential medical products during the pandemic.
The pilot is focused on medical devices and accessories manufactured using advanced and distributed manufacturing techniques. When companies, for example, use new, developing, or established technologies to advance their product development. Manufacturing technologies include 3D-printing, artificial intelligence (AI), machines learning, virtual modeling, and simulation.
The digital storehouse, which would allow civilians and veterans to access medical products more quickly in an emergency, would include electronic plans, methods, and instructions for the manufacture and testing of medical products. The digital stockpile also contains distributed manufacturing technologies that would enable products like nasal swabs and PPE to be manufactured near the point-of-care to minimize disruptions.
Coburn noting that the partnership “will help to identify the types of systematic controls, scientific data, and certifications that may be necessary to institute trusted manufacturing networks during emergencies.”
Safety and effectiveness are also important when making and printing these products. During the height of COVId-19 shortages, “people realized they were out of face masks, so they began making and 3D printing them,” said Beth Ann Ripley, acting director of the VHA Office of Healthcare Innovation and Learning, in an interview for the Regulatory Affairs Professionals Society. “And that’s exciting. But as it turns out, if you make something that looks like a face mask, it may or may not actually act like a face mask,” Ripley said in an interview. “You still must come back to, is it safe and effective? Is it doing what it’s supposed to be doing? Because if you make a mask and you think you’re protected, but you’re not, that’s not good.”
That’s where the stockpile comes in. The stockpile provides users with approved and tested blueprints, designs and instructions instead of relying on unknown alternatives that may cause harm.
The agencies are currently focusing their efforts on compiling the list of devices that will be most in demand in the event of a pandemic or other major event. The agencies will test which devices can be produced in certain circumstances, such as using a home 3D printer, and then rank them.
It appears that large organizations, like VHA or FDA, are now adopting advanced manufacturing concepts. They have both been pushing it for many years. Medical Device Innovation Consortium, MDIC, has opened an online clearinghouse called Advanced Manufacturing Clearing House to help avoid product shortages. Companies that plan to use advanced manufacturing tools can apply for project funding through the consortium — up to 30% of overall project costs, not to exceed $300,000 — but if they take the funding, the companies must be willing to share their experiences through the clearing house portal.