Medical Device Development Process, and Associated Risks and Legislative Aspects-Systematic Review
| Autor: | Ali Selamat, Wan Nur Hidayah Ibrahim, Blanka Klimova, Petra Maresova, Jan Honegr, Kamil Kuca |
|---|---|
| Rok vydání: | 2020 |
| Předmět: |
Process management
Process (engineering) Computer science Scopus Session (web analytics) medical devices 03 medical and health sciences Consistency (database systems) 0302 clinical medicine Health care stages 030212 general & internal medicine Product (category theory) development Reimbursement legislations business.industry lcsh:Public aspects of medicine 030503 health policy & services Public Health Environmental and Occupational Health lcsh:RA1-1270 Transparency (graphic) Public Health Systematic Review 0305 other medical science business risks |
| Zdroj: | Frontiers in Public Health, Vol 8 (2020) Frontiers in Public Health |
| ISSN: | 2296-2565 |
| DOI: | 10.3389/fpubh.2020.00308 |
| Popis: | Medical device development, from the product's conception to release to market, is very complex and relies significantly on the application of exact processes. This paper aims to provide an analysis and summary of current research in the field of medical device development methodologies; discuss its phases; and evaluate the associated legislative and risk aspects.The literature search was conducted to detect peer-reviewed studies in Scopus, Web of Science, and Science Direct, on content published between 2007 and November 2019. Based on exclusion and inclusion criteria, 13 papers were included in the first session, and 11 in the second session. Thus, a total of 24 papers were analysed. Most of the publications originated in the United States (7 out of 24).The medical device development process comprises one to seven stages. Six studies also contain a model of the medical device development process for all stages or for just some of the stages. These studies specifically describe the concept stage during which all uncertainties, such as the clinical need definition, customer requirements/needs, finances, reimbursement strategy, team selection, and legal aspects, must be considered.The crucial factor in healthcare safety is the stability of factors over a long production time.Good manufacturing practices cannot be tested on individual batches of products; they must be inherently built into the manufacturing process. The key issues that must be addressed in the future are the consistency in the classification of devices throughout the EU and globally, and the transparency of approval processes.Key words: medical devices, development, stages, risks, legislations• This review presents in-depth specifications of the stages of the medical device development process and the associated risks, which are not described in organisational or managerial research. It provides a general point of view as opposed to large numbers of case studies.• Research findings are strategically important for healthcare development, because they clearly state the requirements for medical device development and offer a way for researchers to apply this specific process in general managerial research.• This study is limited in the sense that it cannot cover all consequences of changes in legislative aspects. |
| Databáze: | OpenAIRE |
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