Non-COVID-19 Device...WAITING in the FDA beeline...I GOT YA!
The COVID-19 pandemic, or as I like to call it “the psycho virus”, promises to change nearly every aspect of our lives from social distancing, remote working, face masking, and these likely will be part of our new norm for years to come.
The medical device industry and its regulation are no exception!
Exhibit A, the Food and Drug Administration (FDA) has largely fixed its focus on swiping right on Emergency Use Authorizations (EUAs) for COVID-19, as they should!
Leaving more typical device approvals waiting on the beeline. Get it ;P
In fact, analysts predict that the slowdown in new non-coronavirus device approvals could even stretch into 2021, considering how busy the FDA will be with COVID-19 diagnostic testing oversight, not to mention trials for COVID-19 treatments and vaccines.
There is no question that medical innovation to end this pandemic threat once and for all must be our priority.
At the same time, pre-pandemic there was already a tremendous need for medical solutions to fight a bunch of other nasty illnesses.
A few examples are heart conditions, diabetes, and chronic respiratory disease. These are very serious conditions, not easy to postpone, and requiring lifesaving procedures and medical technologies.
Thus, even though it is expected to take longer to flirt with the FDA, the need for medical innovation is 100% there and will not go away!
Hence, to all my Biomedical Innovation Fanatics out there with genius lifesaving medical solutions:
#RiseUP!
FDA officially SLOWING DOWN non-COVID-19 device approvals equals OPPORTUNITY!
You have been granted the rare gift of time to increase your chance of success by making your innovation of the HIGHEST QUALITY.
Because at Genius Shield we care so much about patient safety and love our innovators, I will be sharing in a series of articles
the TOP Shielding Actions from the Product Design, Risk Management, Quality Management System, and Investment perspectives that you could be doing to reduce risks, and build quality into your product from day one to become
Quality and Regulatory sexy and irresistible to FDA clearance/approval!
Get them HERE
#ShieldYourself #ShieldToSavePatients
If you know a visionary innovator whose brilliant invention has the potential to save patients, please forward this email.
And if YOU ARE that visionary innovator, click the BOOK A CALL button below to learn more about how Genius Shield can help you bring your invention to market like only the Genius Shield team can!
May the innovation force be with you