Listen to the newest episode in our podcast series, "PARADIGM PERCEPTION SHIFT in Medical Device Development: the INNOVATION ROADMAP™."
In our previous episode, Chris Montalbano provided an overview of the INNOVATION ROADMAP™ as applied to medical device development in addition to describing the 1st Stop which was Market Exploration & Discovering Opportunities. In this new episode, Principal and Chief Creative Officer, Gregory Montalbano discusses the INNOVATION ROADMAP™ 2nd Stop, which is Technology Innovation and the R&D Process.
As discussed in prior episodes, the FDA-QSR & ISO 13485 guidance recognizes both Stop 1 Market Exploration & Discovering Opportunities as well as Stop 2 Technology Innovation and the R&D Process are essential formative exercises for any business to implement while at the same time making it known that regulatory controls such as Design Controls & Risk Management do not have to be implemented at this point. The FDA recognizes the importance for an organization to explore development opportunities, methodologies and technologies first.
Learn more about how MIDI's INNOVATION ROADMAP™ yields innovation and competitive differentiation in the medical device market.