Clarifying the unmet clinical need during medical device innovation in women's health - A narrative review.

IF 1.2 4区医学 Q4 PUBLIC, ENVIRONMENTAL & OCCUPATIONAL HEALTH

Health Care for Women International Pub Date : 2024-01-01 Epub Date: 2023-03-31 DOI:10.1080/07399332.2023.2190983

Ritesh Rikain Warty, Vinayak Smith, Malitha Patabendige, Deborah Fox, Ben Mol

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Abstract

Medical technologies are pervasive across women's health, spanning across obstetric and gynecological care. FemTech, the sector responsible for developing these technologies, is growing at 15.6% per annum. However, there are concerns of disconnects between new product development (NPD) and the care afforded to women in consequence of implementing these innovations. The most crucial stage of NPD involves understanding the clinical need. Without a clear need and clinical use case, innovators risk developing solutions which do not address the issues women and caregivers experience. Thus, the product will miss the market and experience limited uptake. Tools for performing clinical needs assessments and defining the use case are being developed. This review provides an analysis of their strengths and weaknesses to inform FemTech innovators of the available resources. We further discuss concepts for creating a unified approach to assessing unmet needs such that technologies have a higher chance of improving women's healthcare.

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明确妇女健康医疗器械创新过程中未满足的临床需求--叙事性综述。

医疗技术在妇女健康领域无处不在，横跨产科和妇科护理。FemTech 是负责开发这些技术的部门，年增长率为 15.6%。然而，新产品开发（NPD）与实施这些创新后为妇女提供的护理之间的脱节令人担忧。新产品开发最关键的阶段是了解临床需求。如果没有明确的需求和临床用例，创新者就有可能开发出无法解决妇女和护理人员遇到的问题的解决方案。因此，产品将无法进入市场，其使用率也将十分有限。目前正在开发用于进行临床需求评估和定义用例的工具。本综述分析了这些工具的优缺点，让女性科技创新者了解现有的资源。我们还将进一步讨论创建统一方法的概念，以评估未满足的需求，从而使技术有更大的机会改善妇女的医疗保健。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Health Care for Women International Multiple-

CiteScore

3.30

自引率

7.10%

发文量

期刊介绍： Health Care for Women International is a critically acclaimed, international publication that provides a unique interdisciplinary approach to health care and related topics that concern women around the globe. Published twelve times a year, Health Care for Women International includes the newest research, theories, and issues in the fields of public health, social science, health care practice, and health care policy. Scholars and practitioners address topics such as cultural differences, alternative lifestyles, domestic violence, public health issues associated with the aging of the population, maternal morbidity and mortality, infectious diseases, and a host of other gender-based ethical issues. The editor also encourages discussion topics, inviting readers to comment on articles that focus on specific aspects of health issue for women.