ReviewTherapeutic innovation & regulatory science2020
Impact of Design on Medical Device Safety.
Review in Therapeutic innovation & regulatory science, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
13 citing papers in PubMed.
- Organizational Tensions in the Implementation of Modifiable Off-the-Shelf Technologies in a University Hospital: Qualitative Multimethod Study.JMIR human factors · 2026Article
- Investigating the Feasibility, Usability, and Efficacy of a Mobile App to Reduce Anxiety and Depression in Families of Critical Care Cancer Patients: A Quasi-Experimental Pilot Study.Healthcare (Basel, Switzerland) · 2026Article
- Usability Evaluation of an Electrically Powered Orthopedic Exerciser: Focus Group Interview and Satisfaction Survey Study.JMIR human factors · 2025Article
- Psychological consultation apps in Saudi Arabia: A study for experts' evaluation and users' points of view.PloS one · 2025Article
- A comprehensive review of catheter dislodgement: prevalence, clinical impact, and innovations in securement devices.npj biomedical innovations · 2025Review
- Article
- From intra- to extra-uterine: early phase design of a transfer to extra-uterine life support through medical simulation.Frontiers in medical technology · 2024Article
- Development of Smart Clothing to Prevent Pressure Injuries in Bedridden Persons and/or with Severely Impaired Mobility: 4NoPressure Research Protocol.Healthcare (Basel, Switzerland) · 2023Article
- Quality analysis of manufacturer's incident reports regarding medical devices.Journal of pharmaceutical policy and practice · 2023Article
- The evolution of technical prerequisites and local boundary conditions for optimization of mitral valve interventions-Emphasis on skills development and institutional risk performance.Frontiers in cardiovascular medicine · 2023Review
- Chest Drainage Therapy: What Comes out of Pandora's Box Can Affect Patient Outcomes.Journal of clinical medicine · 2022Article
- Evolution of anodised titanium for implant applications.Heliyon · 2021Review
- Heuristics used for evaluating the usability of mobile health applications: A systematic literature review.Digital healthReview
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
The growing number of emerging medical technologies and sophistication of modern medical devices (MDs) that improve both survival and quality of life indexes are often challenged by alarming cases of vigilance data cover-up and lack of sufficient pre- and post-authorization controls. Combining Quality with Risk Management processes and implementing them as early as possible in the design of MDs has proven to be an effective strategy to minimize residual risk. This article aims to discuss how the design of MDs interacts with their safety profile and how this dipole of intended performance and safety may be supported by Human Factors Engineering (HFE) throughout the Total Product Life-Cycle (TPLC) of an MD in order to capitalize on medical technologies without exposing users and patients to unnecessary risks.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.