Sophie McGrath, partner at Goodwin, considers whether the regulatory environment surrounding women’s health and femtech devices are fit for purpose.
Goodwin
The women’s health and wellness industry has expanded exponentially in recent years and is expected to be worth $65 billion by 2027. Driving this growth are companies focussed on developing technology aimed at addressing women’s health and wellbeing across a range of areas, including reproductive, sexual, and mental health. These companies are often aimed at bridging the gender gap in women’s healthcare, resulting from, among other things, the underrepresentation of women in clinical trials and research and the design of healthcare systems.
While the issues presented by the gender gap are not new, they have become a focal point because of the intersection of several economic, demographic and market factors. Demand has increased for products and services from women who are looking for optionality in their healthcare and demanding alternatives. This has coupled with a commercial awareness of the market size and its purchasing power, with women directing 83% of all consumption in the USA. As a result, venture capital investment has increased. In August 2021, following a $110 million series D funding round, Maven became the first women’s health start-up to reach a valuation of over $1 billion. Women’s healthcare is also increasingly a focus of government attention; earlier this year, the Department of Health and Social Care announced its intention to develop a new women’s health strategy, requesting input from women to help create a set of priorities to put women back at the centre of their own health and wellbeing.
This shift in focus has intersected with a changing healthcare landscape increasingly concentrated on personalisation and digital healthcare solutions, exemplified by the growth and development of wearable technologies and the establishment of departments such as NHSX in 2019. COVID-19 has accelerated this progression towards digital, which necessitated a move towards remote healthcare through web-based applications during national lockdowns. The expansion of digital services has fuelled the growth of women’s healthcare platforms and applications, which are often focussed on the provision of remote healthcare.
One critical factor to consider in the continued expansion of the women’s health and wellness industry is the legal and regulatory framework in which these technologies are being developed. There is no separate regulatory regime for female-focussed technology and these developments therefore fall within frameworks applicable to remote access healthcare and medtech more generally. This raises the question of whether the existing regulatory environment can achieve the right balance between ensuring that women receive products and services that are safe and fit for purpose, while eliminating unnecessary or disproportionate obstacles to continued innovation in an underserved space.
In the USA, the growth of remote healthcare has faced regulatory obstacles resulting from restrictive and conflicting state laws in crucial areas. These restrictions have temporarily been waived because of the COVID-19 pandemic and the declaration of a public health emergency (“PHE”) on 31 January 2020. This waiver has increased access to remote healthcare, which can be provided to new and existing patients via third party applications and has incentivised healthcare professionals participating in Medicare who can be reimbursed for remote services at the same rate as in-person visits. Alongside state-wide relaxations, remote health utilisation in the US has risen to levels 38 times higher than before the pandemic, allowing female-focussed companies in the remote healthcare space to grow and broaden their audience. While the PHE is a temporary measure and it is unclear if more permanent relaxations of existing regulation will be put in place, developments in this area will impact continued innovation and access in women’s healthcare.
Innovation in Britain faces different legal challenges because of regulations that do not clearly reflect the new application-based digital environment. For example, the MHRA regulates technologies which are classified as a “medical device,” which also covers web-based applications. The regulatory framework maintains a distinction between regulated devices or software that is intended to provide a diagnosis, control conception and/or which is used to administer medication and unregulated applications intended to monitor health and wellbeing or provide general advice. New female-focussed technologies may test the validity of these distinctions; for example, it is unclear whether an application that tracks a person’s basal body temperature and is intended to facilitate conception will be subject to existing medical device regulation.
These are some of the potential pitfalls in existing legal and regulatory regimes and how these interact with the development of technology centred on women’s healthcare solutions. A continued focus by lawmakers and regulators on women’s health strategies in connection with increased collaboration with innovators and investors will ensure the industry’s potential is maximised in the years to come.
