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

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.