Research platform for medical device development to simplify translation to the market

Somerlik-Fuchs, Karin H.; Uecker, Florian C.; Reich, Uta; Kogut, Andreas; Schiemer, Jonas F; Rupp, Rüdiger; Kneist, W.; Hoffmann, Klaus‐Peter; Krueger, Thilo B.

doi:10.1109/embc.2019.8857935

Cited by 1 publication

(2 citation statements)

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“…Obstacles to the emergence of new medical devices from research are numerous [1], [2], [3]. One of the main difficulties of technology transfer is the time and effort required to achieve compliance with regulations.…”

Section: Introductionmentioning

confidence: 99%

“…As many medical devices are associated with or incorporate software, our study focuses on assessing the maturity *This work was supported by the French National Research Agency, as a project of the laboratory of excellence CAMI -ANR-11-LABX-0004-01 1 Univ. Grenoble Alpes, CNRS, UMR 5525, VetAgro Sup, Grenoble INP, TIMC, 38000 Grenoble, France 2 CHU Brest, LaTIM, Inserm, UMR 1101, SFR IBSAM, 29200 Brest, France of what we call "Software-driven Medical Technologies" (SdMT).…”

Section: Introductionmentioning

confidence: 99%

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Maturity assessment of software-driven medical technologies: a quantitative score derived from a quality standard for the research phase ^*

Haberbusch,

Dardenne,

Promayon

2023

2023 45th Annual International Conference of the IEEE Engineering in Medicine &Amp; Biology Society (EMBC)

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Quantitatively assessing the level of readiness of medical technology improves its chance of successfully transfer from research to industry but remains a challenge. As many innovative medical devices are associated with or incorporate software, this article presents a methodology for evaluating the software maturity of a "Software-driven Medical Technology" (SdMT) during the research phase. A technological maturity model is developed by methodologically extracting relevant terms from the ISO/IEC 62304 standard, the main industry standard for medical device software, and results in a list of required software engineering artifacts. This list and the relative weight of the artifacts are used to establish a software maturity score for SdMT and the corresponding assessment questionnaire. The consistency of the model is demonstrated by analyzing the obtained score system relatively with the standard. The maturity score of a SdMT can be assessed during the research phase and depends on the number and importance of the artifacts already present at the time of evaluation. Clinical relevance-The proposed quantitative maturity score can help the medical technology innovation actors (clinicians, researchers and industrials) to better identify, improve and fasten the readiness of technology for clinical investigation and technology transfer.

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Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Maturity assessment of software-driven medical technologies: a quantitative score derived from a quality standard for the research phase ^*

Haberbusch,

Dardenne,

Promayon

2023

2023 45th Annual International Conference of the IEEE Engineering in Medicine &Amp; Biology Society (EMBC)

View full text Add to dashboard Cite

show abstract

Research platform for medical device development to simplify translation to the market

Cited by 1 publication

References 6 publications

Maturity assessment of software-driven medical technologies: a quantitative score derived from a quality standard for the research phase ^*

Maturity assessment of software-driven medical technologies: a quantitative score derived from a quality standard for the research phase ^*

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Research platform for medical device development to simplify translation to the market

Cited by 1 publication

References 6 publications

Maturity assessment of software-driven medical technologies: a quantitative score derived from a quality standard for the research phase *

Maturity assessment of software-driven medical technologies: a quantitative score derived from a quality standard for the research phase *

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Maturity assessment of software-driven medical technologies: a quantitative score derived from a quality standard for the research phase ^*

Maturity assessment of software-driven medical technologies: a quantitative score derived from a quality standard for the research phase ^*