Listen to the latest episode of hsDNA, as Michael Quinn, the VP of Design & Engineering for HS Design, joins host Justin Starbird to talk about how being agile and adhering to regulatory constraints is sometimes in conflict.


As everyone knows, the medical device development and manufacturing space is highly regulated. Everything has to have a process. Some people may hear agile and think programming or software, but the truth is you have to apply a process to every aspect of the design, build, and testing of a new product. As a result, it creates an enormous amount of structure that needs to be built. As Mike shares, “There’s conflict between that agile methodology of development and the regulations on how to do development and that’s where we’re really walking a tightrope or a razor’s edge between the two.”


Mike discusses this conflict with Justin to explain how the HS Design Team has turned these areas that were once headaches, into opportunities.