Biomedical device innovation methodology: applications in biophotonics

Daniel M. Beswick; Arjun Kaushik; Dylan Beinart; Sarah McGarry; Ming Khoon Yew; Brendan F. Kennedy; Peter Luke Santa Maria

doi:10.1117/1.JBO.23.2.021102

14 December 2017 Biomedical device innovation methodology: applications in biophotonics

Daniel M. Beswick, Arjun Kaushik, Dylan Beinart, Sarah McGarry, Ming Khoon Yew, Brendan F. Kennedy, Peter Luke Santa Maria

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Journal of Biomedical Optics, Vol. 23, Issue 2, 021102 (December 2017). https://doi.org/10.1117/1.JBO.23.2.021102

Abstract

The process of medical device innovation involves an iterative method that focuses on designing innovative, device-oriented solutions that address unmet clinical needs. This process has been applied to the field of biophotonics with many notable successes. Device innovation begins with identifying an unmet clinical need and evaluating this need through a variety of lenses, including currently existing solutions for the need, stakeholders who are interested in the need, and the market that will support an innovative solution. Only once the clinical need is understood in detail can the invention process begin. The ideation phase often involves multiple levels of brainstorming and prototyping with the aim of addressing technical and clinical questions early and in a cost-efficient manner. Once potential solutions are found, they are tested against a number of known translational factors, including intellectual property, regulatory, and reimbursement landscapes. Only when the solution matches the clinical need, the next phase of building a “to market” strategy should begin. Most aspects of the innovation process can be conducted relatively quickly and without significant capital expense. This white paper focuses on key points of the medical device innovation method and how the field of biophotonics has been applied within this framework to generate clinical and commercial success.

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Daniel M. Beswick, Arjun Kaushik, Dylan Beinart, Sarah McGarry, Ming Khoon Yew, Brendan F. Kennedy, and Peter Luke Santa Maria "Biomedical device innovation methodology: applications in biophotonics," Journal of Biomedical Optics 23(2), 021102 (14 December 2017). https://doi.org/10.1117/1.JBO.23.2.021102

Received: 12 July 2017; Accepted: 16 November 2017; Published: 14 December 2017

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