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论创新。

On Innovation.

机构信息

National Administration of Drugs, Food and Medical Technology, Buenos Aires, Argentina.

出版信息

Ther Innov Regul Sci. 2020 Sep;54(5):1068-1075. doi: 10.1007/s43441-020-00125-3. Epub 2020 Feb 5.

Abstract

Innovation has become an increasingly common topic in healthcare. Private companies, developers, payers, and regulators are devoting attention toward innovative products and processes as a crucial component of their interests in and occupation with healthcare services. Even when there is no consensus as to its definition, "innovation" -as opposed to "invention"- is broadly understood to refer turning a good idea into a practical solution. Adoption and applicability are key components of implementation that are sustained not only on innovation's attributes themselves but also in the characteristics of providers, users, and implementing organizations, as well as the external environment. Regulatory agencies often face the need to make decisions about proposed innovations with obsolete or inadequate normative frameworks and with a high degree of uncertainty about its eventual performance or its risks. Early interaction between developers and dedicated multidisciplinary teams at regulatory agencies may prove instrumental for speeding up the time required for proper evaluation and product registration, as well as the establishment of quality validation mechanisms. Community involvement both in the adoption and vigilance on innovative products and processes is crucial for completing the process of defining their roles and uses.

摘要

创新已成为医疗保健领域日益常见的话题。私营公司、开发商、支付方和监管机构都将创新产品和流程视为其关注和涉足医疗服务的重要组成部分。即使人们对其定义尚未达成共识,“创新”——与“发明”相对——通常被理解为将好的想法转化为实际的解决方案。采用和适用性是实施的关键组成部分,不仅取决于创新本身的属性,还取决于提供者、用户和实施组织的特征,以及外部环境。监管机构经常需要在规范性框架过时或不足的情况下,对拟议的创新做出决策,并对其最终表现或风险存在高度的不确定性。开发者与监管机构专门的多学科团队之间尽早进行互动,可能有助于加快适当评估和产品注册所需的时间,并建立质量验证机制。社区的参与对于确定创新产品和流程的作用和用途至关重要。

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