Marešová Petra, Klímová Blanka, Honegr Jan, Kuča Kamil, Ibrahim Wan Nur Hidayah, Selamat Ali
Faculty of Informatics and Management, University of Hradec Kralove, Hradec Kralove, Czechia.
Biomedical Research Centrum, University Hospital Hradec Kralove, Hradec Kralove, Czechia.
Front Public Health. 2020 Jul 30;8:308. doi: 10.3389/fpubh.2020.00308. eCollection 2020.
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 were included in the second session. Thus, a total of 24 papers were analyzed. 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.
从产品概念构思到投放市场，医疗设备的开发过程非常复杂，且在很大程度上依赖于精确流程的应用。本文旨在对医疗设备开发方法领域的当前研究进行分析和总结，讨论其各个阶段，并评估相关的立法和风险方面。通过在Scopus、科学网和科学Direct数据库中检索2007年至2019年11月期间发表的同行评审研究文献。根据排除和纳入标准，第一轮纳入13篇论文，第二轮纳入11篇论文。因此，共分析了24篇论文。大多数出版物来自美国（24篇中的7篇）。医疗设备开发过程包括一到七个阶段。六项研究还包含了医疗设备开发全过程或部分阶段的模型。这些研究具体描述了概念阶段，在此阶段必须考虑所有不确定性因素，如临床需求定义、客户要求/需求、财务状况、报销策略、团队选择和法律方面。医疗保健安全的关键因素是长期生产过程中各因素的稳定性。良好生产规范不能在个别批次产品上进行测试；它们必须内在地融入生产过程中。未来必须解决的关键问题是欧盟乃至全球范围内设备分类的一致性以及审批流程的透明度。
