Risk Identification and Analysis in the Development of Medical Devices Among Start-Ups: Towards a Broader Risk Management Framework
Omar Kheir, Alexis Jacoby, Stijn Verwulgen Product Development, University of Antwerp, Antwerp, BelgiumCorrespondence: Omar Kheir, Email omar.kheir@student.uantwerpen.beIntroduction: Whilst risk management has become fundamental in the development of medical devices, enforced by regulations and inte...
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| Format: | Article |
| Language: | English |
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Dove Medical Press
2022-09-01
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| Series: | Medical Devices: Evidence and Research |
| Subjects: | |
| Online Access: | https://www.dovepress.com/risk-identification-and-analysis-in-the-development-of-medical-devices-peer-reviewed-fulltext-article-MDER |
| _version_ | 1818021587866091520 |
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| author | Kheir O Jacoby A Verwulgen S |
| author_facet | Kheir O Jacoby A Verwulgen S |
| author_sort | Kheir O |
| collection | DOAJ |
| description | Omar Kheir, Alexis Jacoby, Stijn Verwulgen Product Development, University of Antwerp, Antwerp, BelgiumCorrespondence: Omar Kheir, Email omar.kheir@student.uantwerpen.beIntroduction: Whilst risk management has become fundamental in the development of medical devices, enforced by regulations and international standards, there is still no comprehensive model that explains how risk management in medical devices’ development should be tackled, especially with regard to the type of risks that should be addressed. Risk management in the medical devices’ development field is currently focused on technical risks, comprising product, usability, and development process risks, in alignment with standards’ requirements and regulations, without giving enough attention to non-technical risks, which include business and project risks. Start-ups within this heavily regulated domain have a key role in the innovation process, yet they suffer a structural lack of tangible, such as financial capacity, and intangible resources such as development, risk management, and regulations’ compliance. Nonetheless, they can still optimize their risk identification coverage beyond the enforced requirements to increase their products’ chances of success.Methods: A set of qualitative interviews, serving the adopted grounded theory building research method, with seven start-ups who are involved in the development, commercialization, and quality control of medical devices was accomplished. The purpose was to determine the applied risk management practices and most importantly identify the risk types covered by them. Since every start-up is a project by itself, a sample of project risks, as identified by the project management institute, was utilized to scope the risk coverage and flag missing non-technical risks by the participating start-ups.Results: Un-identified risk types, lack of involvement of the right teams, and other related loopholes were presented.Discussion: A list of requirements was developed and sketched in a user-friendly risk management framework, which is believed to be crucial in helping start-ups attain successful, safe, and regulatory compliant medical devices production, is shared in the discussion and proposed framework section of this paper.Keywords: medical devices, product development, process, risk management, risk identification, risk types, risk framework, start-ups |
| first_indexed | 2024-04-14T08:20:54Z |
| format | Article |
| id | doaj.art-6136610514d94e59a2c340329dd47640 |
| institution | Directory Open Access Journal |
| issn | 1179-1470 |
| language | English |
| last_indexed | 2024-04-14T08:20:54Z |
| publishDate | 2022-09-01 |
| publisher | Dove Medical Press |
| record_format | Article |
| series | Medical Devices: Evidence and Research |
| spelling | doaj.art-6136610514d94e59a2c340329dd476402022-12-22T02:04:13ZengDove Medical PressMedical Devices: Evidence and Research1179-14702022-09-01Volume 1534936378339Risk Identification and Analysis in the Development of Medical Devices Among Start-Ups: Towards a Broader Risk Management FrameworkKheir OJacoby AVerwulgen SOmar Kheir, Alexis Jacoby, Stijn Verwulgen Product Development, University of Antwerp, Antwerp, BelgiumCorrespondence: Omar Kheir, Email omar.kheir@student.uantwerpen.beIntroduction: Whilst risk management has become fundamental in the development of medical devices, enforced by regulations and international standards, there is still no comprehensive model that explains how risk management in medical devices’ development should be tackled, especially with regard to the type of risks that should be addressed. Risk management in the medical devices’ development field is currently focused on technical risks, comprising product, usability, and development process risks, in alignment with standards’ requirements and regulations, without giving enough attention to non-technical risks, which include business and project risks. Start-ups within this heavily regulated domain have a key role in the innovation process, yet they suffer a structural lack of tangible, such as financial capacity, and intangible resources such as development, risk management, and regulations’ compliance. Nonetheless, they can still optimize their risk identification coverage beyond the enforced requirements to increase their products’ chances of success.Methods: A set of qualitative interviews, serving the adopted grounded theory building research method, with seven start-ups who are involved in the development, commercialization, and quality control of medical devices was accomplished. The purpose was to determine the applied risk management practices and most importantly identify the risk types covered by them. Since every start-up is a project by itself, a sample of project risks, as identified by the project management institute, was utilized to scope the risk coverage and flag missing non-technical risks by the participating start-ups.Results: Un-identified risk types, lack of involvement of the right teams, and other related loopholes were presented.Discussion: A list of requirements was developed and sketched in a user-friendly risk management framework, which is believed to be crucial in helping start-ups attain successful, safe, and regulatory compliant medical devices production, is shared in the discussion and proposed framework section of this paper.Keywords: medical devices, product development, process, risk management, risk identification, risk types, risk framework, start-upshttps://www.dovepress.com/risk-identification-and-analysis-in-the-development-of-medical-devices-peer-reviewed-fulltext-article-MDERmedical devices · product development · process· risk management · risk identification · risk types · risk framework · start-ups |
| spellingShingle | Kheir O Jacoby A Verwulgen S Risk Identification and Analysis in the Development of Medical Devices Among Start-Ups: Towards a Broader Risk Management Framework Medical Devices: Evidence and Research medical devices · product development · process· risk management · risk identification · risk types · risk framework · start-ups |
| title | Risk Identification and Analysis in the Development of Medical Devices Among Start-Ups: Towards a Broader Risk Management Framework |
| title_full | Risk Identification and Analysis in the Development of Medical Devices Among Start-Ups: Towards a Broader Risk Management Framework |
| title_fullStr | Risk Identification and Analysis in the Development of Medical Devices Among Start-Ups: Towards a Broader Risk Management Framework |
| title_full_unstemmed | Risk Identification and Analysis in the Development of Medical Devices Among Start-Ups: Towards a Broader Risk Management Framework |
| title_short | Risk Identification and Analysis in the Development of Medical Devices Among Start-Ups: Towards a Broader Risk Management Framework |
| title_sort | risk identification and analysis in the development of medical devices among start ups towards a broader risk management framework |
| topic | medical devices · product development · process· risk management · risk identification · risk types · risk framework · start-ups |
| url | https://www.dovepress.com/risk-identification-and-analysis-in-the-development-of-medical-devices-peer-reviewed-fulltext-article-MDER |
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