Design History File Ready Ideation: An Innovative Approach to Product Development

As a medical device professional, do you know about Design History File Ready Ideation (DHFRI)? It’s an innovative and creative approach to product development. In this episode, Andrew DiMeo, Innovation and Design Coach at Trig, joins the show to discuss the reasons why he created DHFRI and its benefits. Some of the highlights of the show include: ● Andrew’s definition of DHFRI is holistic view of medical device development through collaboration across multiple functions. ● DHFRI uses four Canvas tools to gather and brainstorm ideas: ○ Diligence Dashboard: Business risks of medical device development. ○ Waterfall Method: Supports iteration over time for product development. ○ Human Factors Engineering/Prototyping: Encourages formative work that needs to be done to reduce risk within product being built. ○ Risks and Hazards: Identifying and listing potential problems. ● Creativity and regulations can coexist; startups and established companies should immediately implement design controls. ● Design for Commercialization: Andrew’s industrial designer skillset and mindset produces understanding of manufacturing to meet clinical needs. ● FDA’s openness has increased regarding creative regulatory, not constraints related to medical device classifications and pathways.