04 May The Need for Approval
What do cosmetics, bio-pharmaceuticals, and medical devices all have in common? No matter how seemingly novel or fool-proof, most eventually leap through hoops like Chihuahuas in a traveling circus. Fortunately, I bring good news from the most reliable source this side of Y2K! The Onion News reports that a shining new age of industry leaders are standing up, drying their eyes, not eating their vegetables, and adopting a staunch “FDA who?” mentality…
All kidding aside, this satirical Onion article is a lighthearted reminder that the FDA approval process can be a time-consuming and complex process. But remember also that it is an exceedingly necessary process given the nature of our work. At Key Tech and elsewhere, engineers, biologists, and researchers are lucky to be developing products that affect peoples’ lives. But the reality then is that we are developing products that have the power to affect peoples’ lives! I find it reassuring that our industries are subject to the measures the FDA puts in place if it means safe and efficacious end-results for the consumer. In a 1940’s comic strip entitled Pogo by cartoonist Walter Kelly, the title character exclaims, “We have met the enemy and he is us”. I would say that Kelly – who died of complications of diabetes in 1973 – would agree that his words could also be applied to any field involving human health and safety as, “We have met the end-user and he is us”.
- Ep 33 Design as a Platform for Future Assay Tests - March 27, 2024
- Benefits of Consumable and Instrument Development by One Partner - March 5, 2024
- Ep 32 Where to Focus De-Risking - February 5, 2024