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Cardinal Maturity Determination of Technology Development: Medical Device Development Case Study

Published online by Cambridge University Press:  26 May 2022

S. R. Mishra  and
K. Behdinan
S. R. Mishra*
Affiliation:
University of Toronto, Canada
K. Behdinan
Affiliation:
University of Toronto, Canada
*
[email protected]

Abstract

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A novel application of Best Worst Method (BWM) enables one to incorporate the complexity of specific sub-criteria of technological development to assess its maturity with the pre-established Technology Readiness Level (TRL) framework. It utilizes the concept of Multi-Criteria Decision Making (MCDM) methods to determine the cardinality of endpoint quantitative processes. The model is used to determine the maturity of Class II Ventilators and to detect the consistency aspects for their selection.

Keywords

medical device developmentsystems engineering (SE)technology developmentintegrated product development
Type
Article
Information
Proceedings of the Design Society , Volume 2: DESIGN2022 , May 2022 , pp. 1313 - 1322
Creative Commons
Creative Common License - CCCreative Common License - BYCreative Common License - NCCreative Common License - ND
This is an Open Access article, distributed under the terms of the Creative Commons Attribution-NonCommercial-NoDerivatives licence (http://creativecommons.org/licenses/by-nc-nd/4.0/), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is unaltered and is properly cited. The written permission of Cambridge University Press must be obtained for commercial re-use or in order to create a derivative work.
Copyright
The Author(s), 2022.

References

Olechowski, A. L., Eppinger, S. D., Joglekar, N., and Tomaschek, K., “Technology readiness levels: Shortcomings and improvement opportunities,” Syst. Eng., vol. 23, no. 4, pp. 395–408, 2020, doi: 10.1002/sys.21533.CrossRefGoogle Scholar
Petsiuk, A., Tanikella, N. G., Dertinger, S., Pringle, A., Oberloier, S., and Pearce, J. M., “Partially RepRapable automated open source bag valve mask-based ventilator,” HardwareX, vol. 8, 2020, doi: 10.1016/j.ohx.2020.e00131.Google ScholarPubMed
AAMI, “AAMI COVID-19,” 2020. https://www.aami.org/news-resources/covid-19-updates/coronavirus-resources-for-the-field. (Accessed: 23rd Oct, 2020).Google Scholar
ANSI, “ANSI - COVID19,” 2020. https://www.ansi.org/news_publications/news_story?menuid=7&articleid=27ba33a0-7482-47c5-b3a7-faa8a55518eb. (Accessed: 23rd Oct, 2020).Google Scholar
ASTM International, “ASTM Standards & COVID-19,” ASTM International, 2020. https://www.astm.org/COVID-19/. (Accessed: 23rd Oct, 2020).Google Scholar
Sauser, B., Ramirez-marquez, J. E., and Tan, W., “A Systems Approach to Expanding the Technology Readiness Level within Defense Acquisition,” International Journal of Defense Acquisition Management, 2008.Google Scholar
BSI, “COVID-19 Response – Ventilator,” 2020. https://www.bsigroup.com/en-GB/topics/novel-coronavirus-covid-19/ventilators/. (Accessed: 23rd Oct, 2020).Google Scholar
Wells, C. R. et al. ., “Projecting the demand for ventilators at the peak of the COVID-19 outbreak in the USA,” Lancet Infect. Dis., vol. 20, no. 10, pp. 1123–1125, 2020, doi: 10.1016/S1473-3099(20)30315-7.Google ScholarPubMed
CSA, “COVID-19 Response Standards & Handbooks,” 2020, [Online]. Available: https://www.csagroup.org/news/covid-19-response-standards-handbooks/. (Accessed: 23rd Oct, 2020).Google Scholar
Department of Defense, Readiness Assessment (TRA) Guidance. Washington, D.C.: Assistant Secretary of Defense for Research and Engineering (ASD(R&E)), 2011. (Accessed: 23rd Oct, 2020).Google Scholar
Commission, E., “Ventilators Regulatory Requirements,” 2020. https://ec.europa.eu/health/sites/health/files/md_sector/docs/md_mdcg_2020-9_regulatory_requirements_ventilators_en.pdf. (Accessed: 23rd Oct, 2020).Google Scholar
Conrow, E. H., “Estimating technology readiness level coefficients,” J. Spacecr. Rockets, vol. 48, no. 1, pp. 146–152, 2011, doi: 10.2514/1.46753.CrossRefGoogle Scholar
Kujawski, E., “Analysis and critique of the system readiness level,” IEEE Trans. Syst. Man, Cybern. Part ASystems Humans, vol. 43, no. 4, pp. 979–987, 2013, doi: 10.1109/TSMCA.2012.2209868.Google Scholar
FDA, “Emergency Use Authorization | FDA,” Food Drug Adm., 2020, [Online]. Available: https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization#covidinvitrodev. (Accessed: 23rd Oct, 2020).Google Scholar
FDA, “Enforcement Policy,” Food & Drug Administration, 2020. https://www.fda.gov/media/136318/download. (Accessed: 23rd Oct, 2020).Google Scholar
FDA, “Ventilators and Ventilator Accessories for COVID-19 | FDA https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical…,” 2020. https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/ventilators-and-ventilator-accessories-covid-19. (Accessed: 23rd Oct, 2020).Google Scholar
Food and Drug Administration, “Classify Your Medical Device,” 2016. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/.Google Scholar
Van Norman, G. A., “Drugs, Devices, and the FDA: Part 2,” JACC Basic to Transl. Sci., vol. 1, no. 4, pp. 277–287, 2016, doi: 10.1016/j.jacbts.2016.03.009.Google ScholarPubMed
Canada, H., “GUIDANCE DOCUMENT Guidance on the Risk-based Classification System for Non-In Vitro Diagnostic Devices (non-IVDDs) Health Products and Food Branch,” 2015.Google Scholar
Health Canada, “Interim Order respecting clinical trials for medical devices and drugs relating to COVID-19: Notice - Canada.ca,” Health Canada, 2020. https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/interim-order-respecting-clinical-trials-medical-devices-drugs/notice-interim-order.html#a2. (Accessed: 23rd Oct, 2020).Google Scholar
Homeland Security Institute, “Department of Homeland Security Science and Technology Readiness Level Calculator (ver 1.1) Final Report and User's Manual,” 2009. [Online]. Available: https://web.archive.org/web/20100826124930/http://www.homelandsecurity.org/hsireports/DHS_ST_RL_Calculator_report20091020.pdf. (Accessed: 23rd Oct, 2020).Google Scholar
Hook-Barnard, I., et al. , “Technology Readiness Levels in the Department of Defense,” 2013.Google Scholar
IEEE, “IEEE - COVID19,” 2020. https://standards.ieee.org/covid-19/index.html. (Accessed: 23rd Oct, 2020).Google Scholar
ISO, “COVID-19 Response: Freely Available ISO Standards,” 2020. (Accessed: 23rd Oct, 2020) https://www.iso.org/covid19. (Accessed: 23rd Oct, 2020).Google Scholar
Pietzsch, J. B., Aquino, L. M., Yock, P. G., Paté-Cornell, M. E., and Linehan, J. H., “Review of U.S. medical device regulation,” J. Med. Devices, Trans. ASME, vol. 1, no. 4, pp. 283–292, 2007, doi: 10.1115/1.2812429.Google Scholar
Mankins, J. C., “Technology readiness and risk assessments: A new approach,” Acta Astronaut., vol. 65, no. 9–10, pp. 1208–1215, 2009, doi: 10.1016/j.actaastro.2009.03.059.CrossRefGoogle Scholar
Rezaei, J., “Best-worst multi-criteria decision-making method,” Omega (United Kingdom), vol. 53, pp. 49–57, 2015, doi: 10.1016/j.omega.2014.11.009.Google Scholar
Rezaei, J., “BWM Solver Excel Sheet,” 2015. (Accessed: 23rd Oct, 2020).Google Scholar
Speer, J., “State of Medical Device - Product Development & Quality Management,” 2020. https://www.greenlight.guru/state-of-medical-device.Google Scholar
Ocampo, J. U. and Kaminski, P. C., “Medical device development, from technical design to integrated product development,” J. Med. Eng. Technol., vol. 43, no. 5, pp. 287–304, 2019, doi: 10.1080/03091902.2019.1653393.CrossRefGoogle ScholarPubMed
Mankins, J.C., “Technology Readiness Levels,” A White Paper. Office of Space Access and Technology, 1995.Google Scholar
Fahimian, M. and Behdinan, K., “On characterization of technology readiness level coefficients for design,” in Proceedings of the International Conference on Engineering Design, ICED, 2017, vol. 2, no. DS87-2, pp. 309–316.Google Scholar
MHRA, “Exemptions from Devices regulations during the coronavirus (COVID-19) outbreak,” Gov.Uk, 2020, [Online]. Available: https://www.gov.uk/guidance/exemptions-from-devices-regulations-during-the-coronavirus-covid-19-outbreak. (Accessed: 23rd Oct, 2020).Google Scholar
Mico Medicals, “Product Info: CoroVent,” 2020. https://www.micomedical.cz/product-info-corovent#detail-info. (Accessed: 23rd Oct, 2020).Google Scholar
MIT, “MIT Em ergency Ventilator Project,” AcademiaThemes, 2020. https://emergency-vent.mit.edu/?fbclid=IwAR3JvScS-93DOpQoc827UFI2F0ygICChQA_FXwZ6THtexZM71xrtDcMFCc4. (Accessed: 23rd Oct, 2020).Google Scholar
D, R.. (DRD) Director, Office, and D. R. and E. (DDR&E) T. Office of the Director, “Technology Readiness Assessment ( TRA ) Deskbook,” Technology, no. July, pp. 1-H1, 2009, [Online]. Available: http://www.dod.mil/ddre/doc/DoD_TRA_July_2009_Read_Version.pdf. (Accessed: 23rd Oct, 2020).Google Scholar
Read, R., “COVID-19 Ventilator Projects and Resources and FAQ,” 2020. https://github.com/PubInv/covid19-vent-list. (Accessed: 23rd Oct, 2020).Google Scholar
Rice University and Technologies, Metric, “OEDK - Rice University - ApolloBVM,” 2020, [Online]. Available: http://oedk.rice.edu/apollobvm/. (Accessed: 23rd Oct, 2020).Google Scholar
Blanchette, S. and Garcia-Miller, S., “Beyond Technology Readiness Levels for Software: U.S. Army Workshop Report,” 2010. Available: http://www.dtic.mil/cgi-bin/GetTRDoc?AD=ADA535517&Location=U2&doc=GetTRDoc.pdf. (Accessed: 23rd Oct, 2020).Google Scholar
Revfi, S., Wilwer, J., Behdinan, K., and Albers, A., “Design Readiness of Multi-Material Concepts: Manufacturing and Joining Technology Integrated Evaluation of Concept Maturity Levels Using Cardinal Coefficients,” in Proceedings of the Design Society: DESIGN Conference, 2020, vol. 1, pp. 1067–1076, doi: 10.1017/dsd.2020.274.Google Scholar
Saaty, T. L., “How to Make a Decision: The Analytic Hierarchy Process,” Interfaces (Providence)., vol. 24, no. 6, pp. 19–43, 1994, doi: 10.1287/inte.24.6.19.CrossRefGoogle Scholar
Therapeutic Goods Administration, “Ventilators and other devices intended for respiratory support for COVID-19,” TGA, 2020. https://www.tga.gov.au/behind-news/ventilators-and-other-devices-intended-respiratory-support-covid-19#alternatives. (Accessed: 23rd Oct, 2020).Google Scholar
Via Global Health, “Adult Life Pro – Product Specification,” 2020. https://viaglobalhealth.com/wp-content/uploads/2020/09/Neonatal-Rescue-AdultLife-Pro-Product-Guide.pdf. Accessed 23rd October 2020. (Accessed: 23rd Oct, 2020).Google Scholar
World Vent Foundation, “WorldVentTM Ventilator Overview,” 2020. https://www.worldvent.org/worldvent-overview. (Accessed: 23rd Oct, 2020).Google Scholar