The medical device innovation process

Research output: Chapter in Book/Report/Conference proceedingChapter

2 Scopus citations


Developing a new medical device requires more than a good idea and good engineering. This chapter presents a structured method and best practices to guide innovators through the steps of medical device development. Practical suggestions are offered for screening an innovative medical device based on its technical, market, and financial feasibility, how to cost effectively test new medical devices for safety and efficacy, and how to protect intellectual property and navigate the patent process. The complexities of regulation, reimbursement, and financing of medical devices are discussed as well. Following best practices for new medical device development does not guarantee success, but it does minimize the risk of developing the product.

Original languageEnglish (US)
Title of host publicationEngineering in Medicine
Subtitle of host publicationAdvances and Challenges
Number of pages15
ISBN (Electronic)9780128130681
ISBN (Print)9780128135143
StatePublished - Jan 1 2018

Bibliographical note

Publisher Copyright:
© 2019 Elsevier Inc. All rights reserved.


  • Financing
  • Innovation
  • Intellectual property
  • Market feasibility
  • Medical device development
  • Medical device regulation
  • Patent
  • Prototyping
  • Reimbursement


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