Standards, processes, tests and tons of data are crucial to any medical device manufacturer seeking regulatory approval.
But Katie Brinkman, who recently joined Hohenstein Medical as Biocompatibility Program Manager, argues that storytelling should also be a big consideration.
Medical Design & Development recently spoke with Brinkman about how she got her start in regulatory compliance, how have recent medical device trends changed the way manufacturers need to approach biocompatibility plans, why it's important to boil medical device data down to easier-to-digest stories, and how manufacturers can best ensure that their medical device submissions will connect with regulators.
