TY - JOUR
T1 - Biomedical device innovation methodology
T2 - Applications in biophotonics
AU - Beswick, Daniel M.
AU - Kaushik, Arjun
AU - Beinart, Dylan
AU - McGarry, Sarah
AU - Yew, Ming Khoon
AU - Kennedy, Brendan F.
AU - Santa Maria, Peter Luke
PY - 2018/2/1
Y1 - 2018/2/1
N2 - 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.
AB - 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.
KW - Biodesign
KW - Biophotonics
KW - Innovation
KW - Medical device
UR - http://www.scopus.com/inward/record.url?scp=85040520855&partnerID=8YFLogxK
U2 - 10.1117/1.JBO.23.2.021102
DO - 10.1117/1.JBO.23.2.021102
M3 - Article
C2 - 29243414
AN - SCOPUS:85040520855
VL - 23
JO - Journal of Biomedical Optics
JF - Journal of Biomedical Optics
SN - 1083-3668
IS - 2
M1 - 021102
ER -