Medical Device Manufacturing and COVID-19: Challenges & Opportunities

Medical Device manufacturers are grappling with disruptions to their businesses as a result of the coronavirus pandemic.  Many are experiencing adverse impact to their supply chain and operations,  financial expectations and emergency response plans.  The need for production to be at full capacity remains as manufacturers try to balance employee/family safety, while also meeting unprecedented customer demands.  While many industries have implemented a ‘work from home’ policy and process, production teams are not able to work remotely or exercise social distancing.

But moments of crisis also present opportunity: more sophisticated and flexible use of technology and a rejuvenated appreciation for the outdoors and life’s other simple pleasures. No one knows exactly what will come, but it’s clear that patients and healthcare providers are relying on the MedTech industry.  Consider for example, the vast array of COVID-19-related medical products.  Medical manufacturers are facing an unprecedented demand for supplies of PPE (masks, gloves & sanitizers), diagnostic equipment (test kits) and treatment for COVID-19 (ventilators). These require implementation of rapid response measures ranging from prioritizing customer orders to distributing much-needed medical supplies into the market.

Products and services of this nature are of extreme importance and speed-to-market is critical. Unfortunately, one bottleneck lies with regulatory approval – there is simply not enough of these approved products and manufacturers to add more production capacity to an already strained healthcare supply chain.

Medical device manufacturers work in an essential infrastructure industry – vital technology that helps sustain and save human lives.  But even production rates of 110% cannot keep up with current demand since the safety of their production teams remain a priority.  A potential solution would be to ‘widen’ global production lines by including other medical device manufacturers, especially those with products nearing the completion of their regulatory approval process.

Just this week, the U.S. Food and Drug Administration took significant action to help increase the availability of ventilators and accessories, as well as other respiratory devices, during the COVID-19 pandemic to support patients with respiratory failure or difficulty breathing.  According to the FDA[1],

“Medical device makers can more easily make changes to existing products, such as changes to suppliers or materials, to help address current manufacturing limitations or supply shortages. Other manufacturers, such as auto makers, can more easily re-purpose production lines to help increase supply. Hospitals and other healthcare providers can re-purpose machines they have now to serve as ventilators.”

Acceleration of regulatory approval process for new diagnostics products for SARS-coV-2 and therapies for COVID-19 will increase the supply of essential medical devices to our already stretched healthcare supply chain. As an industry, we must rise to meet the unprecedented demand for medical devices from healthcare providers worldwide fighting the pandemic on the front-line. Along with the FDA’s recent approvals of COVID-19 diagnostic kits, we welcome the EU Commission’s postponement of Medical Device Regulations (MDR) which is expected to relieve pressure for key Medical Device manufacturers.

[1] https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-facilitate-access-crucial-medical-products-including