Medical device usability: literature review, current status, and challenges

Roma, Marylene Sousa Guimarães; Garcia, EA

doi:10.1007/s42600-019-00037-8

Cited by 5 publications

(1 citation statement)

References 37 publications

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“…Thus, assessing the readiness of the technology developed through TRL and clinical validation through an RCT are fundamental steps in ensuring the effectiveness, clinical performance, and safety of a medical device. Carrying out a clinical investigation plan that foresees specific endpoints for each of these components is a regulatory requirement that must be met for the medical device to be approved and made available to patients [110][111][112].…”

Section: Discussionmentioning

confidence: 99%

Development of Smart Clothing to Prevent Pressure Injuries in Bedridden Persons and/or with Severely Impaired Mobility: 4NoPressure Research Protocol

et al. 2023

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Pressure injuries (PIs) are a major public health problem and can be used as quality-of-care indicators. An incipient development in the field of medical devices takes the form of Smart Health Textiles, which can possess innovative properties such as thermoregulation, sensing, and antibacterial control. This protocol aims to describe the process for the development of a new type of smart clothing for individuals with reduced mobility and/or who are bedridden in order to prevent PIs. This paper’s main purpose is to present the eight phases of the project, each consisting of tasks in specific phases: (i) product and process requirements and specifications; (ii and iii) study of the fibrous structure technology, textiles, and design; (iv and v) investigation of the sensor technology with respect to pressure, temperature, humidity, and bioactive properties; (vi and vii) production layout and adaptations in the manufacturing process; (viii) clinical trial. This project will introduce a new structural system and design for smart clothing to prevent PIs. New materials and architectures will be studied that provide better pressure relief, thermo-physiological control of the cutaneous microclimate, and personalisation of care.

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Section: Discussionmentioning

confidence: 99%