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Estimated Cost of Developing a Therapeutic Complex Medical Device in the US

The US medical device market is the world’s largest, but estimates of the cost to bring a medical device to market are not available to help inform policy making and regulatory efforts to enhance device safety and innovation. In this economic evaluation study, the cost of therapeutic complex medical device development from proof of concept through postapproval stages was assessed accounting for the cost of failures and the cost of capital. Existing estimates did not account for all stages of development, capitalization, or failure costs, which this study suggests were substantial.

September 2022

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Resource Type:

Database
Journal Article
Journal Article
Resource

Citation:

The US medical device market is the world’s largest, but estimates of the cost to bring a medical device to market are not available to help inform policy making and regulatory efforts to enhance device safety and innovation. In this economic evaluation study, the cost of therapeutic complex medical device development from proof of concept through postapproval stages was assessed accounting for the cost of failures and the cost of capital. Existing estimates did not account for all stages of development, capitalization, or failure costs, which this study suggests were substantial.

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Authors: Sertkaya, A., DeVries, R., Jessup, A. and Beleche, T.

Health Risks(s):

  • Other

Product type(s):

  • Other

Topic(s):

  • Development

Region(s)

  • United States

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