Perspectives on Post-Pandemic: Use Lessons Learned from EUAs

MPO reached out to members of industry to address the following question:

What do you expect will be one significant change within medtech development and/or manufacturing as a result of the pandemic?

In response, Curtis Hawkins, vice president of the Business Operations Group at Canon Virginia Inc., said:

The COVID-19 pandemic created unique challenges and fostered many significant changes for the medtech industry. One of the most significant changes was with new medical device regulatory emergency use authorizations (EUAs), which allowed new products to be accelerated. As an example, the FDA authorized more than 250 emergency use authorizations (EUAs) since February 2020. The pandemic has created new opportunities for collaboration for companies not traditionally in the medical industry domain to come together to solve supply chain and capacity constraints. Companies that were traditionally risk adverse to share innovation to protect IP had to reconsider restrictive policies to support the pandemic crisis for the good of humanity. My hope is that the regulatory bodies can continue this practice going forward or look hard at what changes can be made to continue open innovation to accelerate pre-market approvals.

Also, manufacturing has to overcome some major changes to keep operations moving while implementing practices to keep employees safe. This includes having flexible work schedules, creating more of a work-life balance for all employees, remote work, and improvements to IT systems. In addition, creating social distancing in production settings, increasing shift configurations to further limit exposure, changing layouts of production lines, frequent cleaning, and creation of smaller work clusters.

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