{"href":"http://player.captivate.fm/services/oembed?url=http%3A%2F%2Fplayer.captivate.fm%2Fepisode%2F231aa9c6-aa86-4156-b67c-42b36818a069","version":"1.0","provider_name":"Captivate.FM","provider_url":"https://www.captivate.fm","width":600,"height":200,"type":"rich","html":"","title":"Design History File Ready Ideation: An Innovative Approach to Product Development","description":"As a medical device professional, do you know about Design History File Ready Ideation (DHFRI)? \n\nIt\u2019s 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.\n\nSome of the highlights of the show include:\n \n\u25cf\tAndrew\u2019s definition of DHFRI is holistic view of medical device development through collaboration across multiple functions.\n\u25cf\tDHFRI uses four Canvas tools to gather and brainstorm ideas: \n\u25cb\tDiligence Dashboard: Business risks of medical device development.\n\u25cb\tWaterfall Method: Supports iteration over time for product development.\n\u25cb\tHuman Factors Engineering/Prototyping: Encourages formative work that needs to be done to reduce risk within product being built.\n\u25cb\tRisks and Hazards: Identifying and listing potential problems.\n\u25cf\tCreativity and regulations can coexist; startups and established companies should immediately implement design controls.\n\u25cf\tDesign for Commercialization: Andrew\u2019s industrial designer skillset and mindset produces understanding of manufacturing to meet clinical needs.\n\u25cf\tFDA\u2019s openness has increased regarding creative regulatory, not constraints related to medical device classifications and pathways.","thumbnail_width":300,"thumbnail_height":300,"thumbnail_url":"https://artwork.captivate.fm/53f89c26-6439-414d-b7f7-825b3f5c08a9/6fc3ae8c-9f0c-47a6-9c9f-f85fd831abd1.jpg"}