Success Factors Impacting Nowadays Technologically Driven Medical Devices

Kheir, Omar; Jacoby, Alexis; Verwulgen, Stijn

doi:10.1007/978-3-030-51981-0_34

Cited by 2 publications

(2 citation statements)

References 12 publications

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“…It provides assistance to those responsible for the development of medical devices by assisting them in ensuring that their products are reliable, perform as intended, and do not pose a risk to either patients, operators, or the environment. To put it another way, the primary goal of the risk management cycle is to lessen the likelihood of an error occurring in the product by taking various preventative measures [1,2].…”

Section: Introductionmentioning

confidence: 99%

Risk Management in Medical Device Industry

Khinvasara,

Ness,

Tzenios

2023

JERR

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In spite of the fact that risk management has developed into an essential component of the process of developing medical devices, as mandated by both domestic and international regulations and standards, there is still no all-encompassing model that describes how risk management in the development of medical devices ought to be approached, particularly in terms of the types of risks that ought to be addressed. This is due to the fact that risk management has developed into an essential component of the process, which is mandated by both domestic and international regulations and standards. The present focus of risk management in the industry of developing medical devices is on technical risks, such as product, usability, and development process hazards. This is done in compliance with the norms and laws of standards. On the other hand, non-technical risks, such as those associated with businesses and projects, are not given nearly enough consideration. This review focuses on the risk management in medical device industry.

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Section: Introductionmentioning

confidence: 99%

Risk Management in Medical Device Industry

Khinvasara,

Ness,

Tzenios

2023

JERR

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“…Risk management (RM) has been recently confirmed as a new success factor in the medical devices development (MDD) industry with a growing importance that previous studies on MDD success factors did not emphasize on. 1 The trending digitization of medical devices imposes a new horizon of risks that may have not been thoroughly considered before. Security risks resulting from intentional threats have only recently been confirmed, as medical devices increasingly use newer information and communication technologies (ICT) such as wireless communication and Internet access.…”

Section: Introductionmentioning

confidence: 99%

Risk Identification and Analysis in the Development of Medical Devices Among Start-Ups: Towards a Broader Risk Management Framework

Kheir¹,

Jacoby²,

Verwulgen³

2022

MDER

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Introduction: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.

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Success Factors Impacting Nowadays Technologically Driven Medical Devices

Cited by 2 publications

References 12 publications

Risk Management in Medical Device Industry

Risk Management in Medical Device Industry

Risk Identification and Analysis in the Development of Medical Devices Among Start-Ups: Towards a Broader Risk Management Framework

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