Techniques for Usability Risk Assessment during Medical Device Design

Ravizza, Alice; Lantada, Andrés Díaz; Sánchez, Luis Ignacio Ballesteros; Sternini, Federico; Bignardi, Cristina

doi:10.5220/0007483102070214

Cited by 8 publications

(3 citation statements)

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“…The reference standard is IEC 62366 (International Electrotechnical Commission, 2015) that proposes various methods for usability verification. We proposed in the past the choice of the most adequate methods according to the device kind and the step in the device design process (Ravizza, Lantada, Sánchez, Sternini, & Bignardi, 2019).…”

Section: Usability Verificationmentioning

confidence: 99%

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Methods for Preclinical Validation of Software as a Medical Device

Ravizza,

Sternini,

Giannini

et al. 2020

Proceedings of the 13th International Joint Conference on Biomedical Engineering Systems and Technologies

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Software as a medical device is subject to dedicated regulatory requirements before it can be used on human beings. The certification process in Europe requires that sufficient data on clinical benefits are available before the device is CE marked. This position paper describes our proposal of a risk-based approach to technical and preclinical validation of software as medical devices. This approach ensures that all technical solutions for safety are implemented in the software and that all information for safe use is consistent before the software can be made available to patients. This approach is compliant to the main international standards ISO 13485 on quality systems and ISO 14971 on risk management and therefore ensures regulatory compliance as well as patient protection. This integrated approach allows the designers of the software to integrate regulatory and safety testing in the technical testing of the candidate release version of the device. This approach ensures patient safety and regulatory compliance at the same time as technical functionality.

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Section: Usability Verificationmentioning

confidence: 99%

“…Analysis of user errors and of critical errors as observed leads to the approval of the user interface or to the identification of non-acceptable use risks, that would lead to device interface re-design (Ravizza, Lantada, et al, 2019;Zhang, Johnson, Patel, Paige, & Kubose, 2003).…”

Section: Usability Verificationmentioning

confidence: 99%

Methods for Preclinical Validation of Software as a Medical Device

Ravizza,

Sternini,

Giannini

et al. 2020

Proceedings of the 13th International Joint Conference on Biomedical Engineering Systems and Technologies

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show abstract

“…In usability evaluations, different methodologies are applied depending on the purpose of the evaluation and the stage at which it is performed. Therefore, it is important to employ appropriate evaluation methodologies at each stage [8]. Formative evaluations are performed repeatedly from the device-design stage to manage the risks associated with convenience of use and usability.…”

Section: Introduction Backgroundmentioning

confidence: 99%

Formative Evaluation of an Electrically-Powered Orthopedic Exerciser: A Focus Group Interview Study (Preprint)

Hong,

Choi,

Kweon

2024

Preprint

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BACKGROUND Errors while using medical devices, owing to flaws in the user interface design and implementation, can be a risk for users. Accordingly, increasing emphasis is being placed on usability evaluations by actual users in the design and development stages of medical devices to minimize the risk factors that may cause usage errors. Moreover, a usability evaluation is a mandatory requirement for medical device regulations in countries that follow the IEC 60601-1 standard. OBJECTIVE This study aimed to conduct a formative evaluation using focus group interviews (FGIs) and satisfaction surveys with healthcare professionals in the field of rehabilitation medicine to identify areas for improvement to enhance the safety and convenience of an electrically-powered orthopedic exerciser, a lower-extremity medical rehabilitation device, in the prototype stage. METHODS Quantitative and qualitative data were collected through formative evaluation conducted using FGIs and satisfaction surveys with participants; participants consisted of rehabilitation doctors (n=5) and physical therapists (n=5) with experience in using similar medical devices. RESULTS During the formative evaluation, the following three categories were derived to reduce exerciser usage errors: 1) product upgrades to ensure safety, 2) hardware and software improvements for convenience of use, and 3) improvement of the manual for better identifiability and understanding of the product and instructions. CONCLUSIONS Improvement areas to ensure safety, convenience of use, and clarity of instructions were identified through a formative evaluation based on FGIs and satisfaction surveys with healthcare professionals with experience in using similar medical devices. The factors derived from this formative evaluation are expected to contribute to the development of an improved electrically-powered orthopedic exerciser, and repeated formative and summative evaluations of the improved version will eventually lead to the development of a safe medical device.

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