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Date of this Version

9-30-2019

Document Type

Book Chapters

Summary

  • The regulatory burden for medical device innovation varies based on the specific Food and Drug Administration (FDA) pathway required, and early strategic planning for this regu­latory burden is critical.

  • The regulatory strategy and milestones must be integrated with other key components of the innovation process and informed by an understanding of and/or direct communication with all the stakeholders involved, including the customer, engineering/manufacturing team, research and development team, safety/regulatory bodies, the potential payers, and investors.

  • While it is almost never too early to initiate contact with the FDA, inquiries through 513(g) petitions or pre-submission meetings should be focused on specific questions and goals to make the most of these engagements.

  • Regulatory assessments and consultation with experts require upfront costs, but saving time and money in the long term by designing an efficient regulatory strategy can be the difference between success and failure for the academic entrepreneur.

  • Fundraising (private and public) must be considered in the regulatory strategy, as approx­imately 90% of fundraising is based on claims tied to regulatory milestones.

Creative Commons License

Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License
This work is licensed under a Creative Commons Attribution-Noncommercial-No Derivative Works 4.0 License.

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