i'm an executive for a large medical device commercialization consultancy. we do it all from pure r&d, development/engineering, software/firmware (including SaMD), quality/regulatory, commercial strategy, preclinical, precision medicine, manufacturing, etc.
what i see most often from "digital health startups" is 1) a severe lack of knowledge of the device development process (generally due to immaturity) 2) under appreciation of the importance of a true regulatory strategy 3) poor product generational planning (boil the ocean).
this generally results in startups not understanding why development costs are what they are.
what i see most often from "digital health startups" is 1) a severe lack of knowledge of the device development process (generally due to immaturity) 2) under appreciation of the importance of a true regulatory strategy 3) poor product generational planning (boil the ocean).
this generally results in startups not understanding why development costs are what they are.