A study of the challenges faced by FDA-regulated early-stage medical device startups and how to approach them
Name
1262989968-MIT.pdf
Size
3.63 MB
Format
Adobe PDF
Checksum (MD5)
c5ab621bb36535aa11b57f6eace2f1e3
Author(s)
Bui, Chinh
(Chinh Thi Diem)
Advisor(s)
Matthew Kressy.
Date Issued
2020
Publisher
Massachusetts Institute of Technology
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.
Description
Thesis: S.M. in Engineering and Management, Massachusetts Institute of Technology, System Design and Management Program, May, 2020
Cataloged from the official version of thesis.
Includes bibliographical references (pages 69-74).
Subjects
Integrated Design and Management Program.
Engineering and Management Program.
System Design and Management Program.
MIT Department
Massachusetts Institute of Technology. Integrated Design and Management Program
Massachusetts Institute of Technology. Engineering and Management Program
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