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MedTech Product Development Framework for Post-Pandemic Era

Published online by Cambridge University Press:  26 May 2022

N. Glazkova
Affiliation:
Skolkovo Institute of Science and Technology, Russia
Y. Menshenin*
Affiliation:
Skolkovo Institute of Science and Technology, Russia
D. Vasilev
Affiliation:
Karfidov Lab, Russia
C. Fortin
Affiliation:
Skolkovo Institute of Science and Technology, Russia

Abstract

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A case study during pandemic revealed the major drawbacks of the traditional product development process for MedTech industry. Disruption of conventional manufacturing, urgent need for accelerated design and production, faster regulatory approval have challenged the industry. In this paper the conventional medical product development process is explored based on the intramuscular injector case study. The study revealed core areas for improvement of the medical devices development process. The paper proposes the Lean-Agile methodology with the incorporated elements of Concurrent Engineering.

Type
Article
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

Cortex-Design. [online] cortex-design website. Available at: https://cortex-design.com/work/raytheon-technologies-c-fast-rapid-covid-19-diagnostic/ (accessed 09.11.2021)Google Scholar
Eckert, C., Isaksson, O. and Earl, C. (2019), “Design margins: a hidden issue in industry”, Design Science, 5.Google Scholar
Eisenhart, S. (2017), Emergo Study: FDA 510(k) Submissions from US Companies on the Decline. [online] Emergobyul website. Available at: https://www.emergobyul.com/blog/2017/03/emergo-study-fda-510k-submissions-us-companies-decline (accessed 11.11.2021).Google Scholar
Eppinger, S.D. and Browning, T.R. (2012), Design structure matrix methods and applications, MIT press.CrossRefGoogle Scholar
FDA (2021a), Coronavirus Disease 2019 (COVID-19) Emergency Use Authorizations for Medical Devices. [online] FDA website. Available at: https://www.fda.gov/medical-devices/emergency-use-authorizations-medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices (accessed 11.11.2021).Google Scholar
FDA (2021b), FDA COVID-19 Pandemic Recovery and Preparedness Plan (PREPP) Initiative: Summary Report. [online] FDA website. Available at: https://www.fda.gov/media/145129/download (accessed 11.11.2021).Google Scholar
FDA (1997), Design Control Guidance for Medical Device Manufacturers Guidance for Industry. [online] FDA website. Available at: https://www.fda.gov/media/116573/download (accessed 11.11.2021).Google Scholar
FDA 510(k), Clearance Process. [online] FDA website. Available at: https://www.drugwatch.com/fda/510k-clearance/ (accessed 11.11. 2021).Google Scholar
Glazkova, N., Fortin, C. and Podladchikova, T. (2019), “Application of Lean-Agile Approach for Medical Wearable Device Development”, 14th Annual Conference System of Systems Engineering (SoSE), pp. 7580. https://dx.doi.org/10.1109/SYSOSE.2019.8753825Google Scholar
Gottlieb, S. (2019), Breaking Down Barriers Between Clinical Trials and Clinical Care: Incorporating Real World Evidence into Regulatory Decision Making. [online] FDA website. Available at: https://www.fda.gov/news-events/speeches-fda-officials/breaking-down-barriers-between-clinical-trials-and-clinical-care-incorporating-real-world-evidence (accessed 09.11.2021).Google Scholar
Kim, H.J., Park, S.K. and Park, S.H. (2017), “Upper limb nerve injuries caused by intramuscular injection or routine venipuncture”, Anesthesia and Pain Medicine, 12(2), pp. 103110.Google Scholar
Materialise (2020), COVID-19: new 3D printed device could address shortage of ventilators. [online] 3Dnatives website. Available at: https://www.3dnatives.com/en/3d-printed-device-shortage-of-ventilators-070420205/#! (accessed 15.11.2021).Google Scholar
Medina, L. A., Kremer, G., Wysk, R. (2012), “Supporting medical device development: A standard product design process model”, Journal of Engineering Design, Vol. 24, pp. 137. 10.1080/09544828.2012.676635Google Scholar
Medina, L.A., Jankovic, M., Kremer, G. E. O. (2013), “An investigation of critical factors in medical device development through Bayesian networks”, Experts Systems with Applications, Elsevier, 2013, 40 (17), pp. 70347045.CrossRefGoogle Scholar
Meisenzahl, M. (2020), This 3D-printed oxygen mask was designed to help with a lack of ventilators for coronavirus patients. [online] Businessinsider website. Available at: https://www.businessinsider.com/3d-printed-oxygen-mask-ventilators-covid-19-2020-4 (accessed 11.11.2021).Google Scholar
Menshenin, Y. and Crawley, E. (2020), “A system concept representation framework and its testing on patents, urban architectural patterns, and software patterns”, Systems Engineering, 23(4), pp. 492515.Google Scholar
Molitch-Hou, M. (2020), 3D Printing for COVID-19, Part Two: Spare Valves for Oxygen Masks. [online] 3Dprint website. Available at: https://3dprint.com/265022/3d-printing-for-covid-19-part-two-spare-valves-for-oxygen-masks/ (accessed 15.11.2021).Google Scholar
O2IN. [online] O2IN website. Available at: https://o2in.ru/ (accessed 09.11.2021).Google Scholar
Pathfinder (2013), Agile in an FDA Regulated Environment.Google Scholar
Pharmaphorum (2021), COVID-19 has propelled the regulatory industry years ahead. [online] Pharmophorum website. Available at: https://pharmaphorum.com/views-and-analysis/covid-19-has-propelled-the-regulatory-industry-years-ahead/ (accessed 15.11.2021).Google Scholar
Presley, A. and Liles, D.H. (1995), “The use of IDEF0 for the design and specification of methodologies”, In Proceedings of the 4th Industrial Engineering Research Conference, Nashville, Tennessee.Google Scholar
Shepherd, E. (2018), “Injection technique 1: administering drugs via the intramuscular route”, Nursing Times, 114(8), pp. 2325.Google Scholar
Shuren, J. and Maizel, W. (2021), A Year Into the Pandemic: How the FDA's Center for Devices and Radiological Health is Prioritizing its Workload and Looking Ahead. [online] FDA website. Available at: https://www.fda.gov/news-events/fda-voices/year-pandemic-how-fdas-center-devices-and-radiological-health-prioritizing-its-workload-and-looking (accessed 09.11.2021).Google Scholar
Sean (2020), Xiaomi Youpin releases F95 mask for children, easy to breathe and better fit for Asians. [online] Gizmochina website. Available at: https://www.gizmochina.com/2020/02/05/xiaomi-youpin-released-f95-mask-for-children-easy-to-breathe-and-better-fit-for-asians/ (accessed 15.11.2021).Google Scholar
Simonsen, L., Kane, A., Lloyd, J., Zaffran, M. and Kane, M. (1999), “Unsafe injections in the developing world and transmission of bloodborne pathogens: a review”, Bulletin of the World Health Organization, 77(10), p.789.Google ScholarPubMed
Sisson, H. (2015), “Aspirating during the intramuscular injection procedure: a systematic literature review”, Journal of Clinical Nursing, 24(17-18), pp. 23682375.CrossRefGoogle ScholarPubMed
StarFish Medical, “Health Canada certifies Winnipeg Ventilator 2.0 to support the needs of Covid-19 patients. [online] StarFish Medical website. Available at: https://starfishmedical.com/news/health-canada-certifies-winnipeg-ventilator-2-0/ (accessed 09.11.2021).Google Scholar