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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.

Introduction The COVID-19 pandemic significantly increased the usage of various types of face masks. In addition, it triggered the rapid manufacture of new production lines of masks to cope with the unprecedented demand to overcome worldwide shortages. Such masks, which were previously used mostly by the health care personnel, became a daily necessity to the greater mainstream population. This rapid and sudden increase in their usage and the fact that new masks’ innovations are progressively emerging to meet the growing global shortage requires an ongoing analysis on the factors associated with the fit and comfort while using these masks. Methods This paper presents the first translation and validation of the R-COMFI questionnaire to evaluate the comfort of a newly developed filtering face-piece respirator by the research team at the University of Antwerp. The questionnaire, which consists of 3 sections: Discomfort, General wearing experience, and Function, was translated from English to Arabic and involved 43 participants in the Lebanese Red Cross healthcare field based in Lebanon. Results The results showed discomfort factors that are mostly related to breathability and sweating caused by mask usage. Additionally, the results revealed that female respondents found the mask significantly less comfortable than male respondents (p-value with the two-tailed test is 0.0319), which confirmed that future validations should consider the concerns of both genders, and validated the R-COMFI translation exercise detailed in this paper. Discussion The contribution of this paper can be pinned down into three findings. The first finding is related to the discomfort issues. The second finding highlighted a significant difference in comfort experience between females and males. The last finding is the translation validation of the R-COMFI instrument, which confirmed that the questionnaire can be applied among wider geographical locations.

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Start-ups that are involved in the development of medical devices play a key role in innovation, yet among the several limitations they encounter, they suffer a lack of knowledge in quality management. This lack may create a challenge that could hinder or limit their success. This paper seeks to present an overview and act as a guideline for the required documentation to establish a quality management system for start-ups in medical devices development, based on a case-studied start-up, in accordance with ISO 13485. Using this case study along with the actual ISO 13485 standard document, can support medical devices start-ups in their ISO compliance and certification journey.