A study of the challenges faced by FDA-regulated early-stage medical device startups and how to approach them

Abstract

It is never easy to start a company with a novel product, let alone building hardware that will be rigorously regulated by the United States Food and Drug Administrations (FDA). This thesis explores the difficulties faced by startups and proposes a step-by-step guide for the founders to navigate this challenge. The guide seeks information from the regulations database, and from interviews with stakeholders involved in medical product developments. First, the device requirements by the FDA and the device application process are presented in the style of a submission guide. The different costs to the startups are then discussed followed by guidelines to founders to steer their startup ship. The guideline focuses on 1) explaining the personas and challenges faced by the stakeholders in medical device development, 2) presenting the best practices in medical product development, 3) recommendations to adopt an electronic Quality Management System with software and tools and finally 4) pointers to useful resources those founders may have to spend months to collate. This thesis is a starting point for anyone thinking of creating medical devices regulated by the FDA, regardless of background and experience.