By: Kimberly Briggs, President of Optimized Regulatory Solutions, LLC
In the midst of the Coronavirus/Covid-19 pandemic many manufacturers have stepped up to supply medical products for the first time. Here are some thoughts on how you might do the same.
How do you start getting involved?
Go to Empire State Development Corporation’s (ESDC) list and sign up your company. ESDC is spearheading medical device needs for New York State. If you think you’d like to make a device, evaluate your core competencies to determine what product is best for your company. Think outside the box, we have seen distilleries switch from gin to producing hand sanitizer in 48 hours! Stop and think if there is something you can do a little differently to help in this time of crisis. Are you producing something that could be useful to the frontline workers or support staff? Currently I’m helping companies through the regulatory process to manufacture and publicly distribute new products outside of their normal offerings such as face shields, hand sanitizer and N95 masks.
How to move forward while many of us are working from home, trying to keep manufacturing lines running, supporting remote Certified Body Audits, with the added anxiety of the looming new Medical Device Regulation (MDR) implementation date?
Identify the critical elements to establish or maintain quality and regulatory compliance, break these elements down into smaller tasks and take one step every day towards completion of these tasks. It may seem daunting, but many manufacturers have done it successfully and the pandemic may open certain doors for you. Can you take advantage of the emergency use authorizations below?
Covid-19 related Guidance Documents: https://www.fda.gov/emergency-preparedness-and-response/coronavirus-disease-2019-covid-19/covid-19-related-guidance-documents-industry-fda-staff-and-other-stakeholders
Emergency Use Authorization: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#2019-ncov
The FDA also plans to hold virtual Town Halls for clinical laboratories and commercial manufacturers to help answer questions on April 29, 2020 from 12:15 pm – 1:15 pm Eastern Time
CDC: https://www.cdc.gov/coronavirus/2019-ncov/hcp/respirators-strategy/crisis-alternate-strategies.html
Niosh: https://www.cdc.gov/niosh/index.htm
Once we return to normal, can this experience help me move my manufacturing company into the medical market? What is usually required?
If you have questions about what you can do to establish or maintain Quality and Regulatory compliance during this critical time OR you have an idea that may aid in the management of the healthcare crisis we are facing, please reach out to your Insyte partner or contact me directly at kimberly@optimizedregulatorysolutions.com.
Most importantly, stay safe and healthy!
Kimberly is the founder of Optimized Regulatory Solutions, LLC and has been in executive Quality & Regulatory roles in start-up, mid-size and Fortune 500 companies. She has over 20 years’ experience including global Executive leadership positions at Greatbatch Medical, Bausch + Lomb and most recently GE Healthcare, with additional regulatory experience from Boston Scientific and St. Jude Medical.
