The Critical Role of Data in Advancing FemTech

by: PQE Group

Women’s needs in health care have historically been overlooked, creating a systemic gap that continues to exist today. Although technology in recent years has allowed us to address some of these challenges and rethink our approach to women’s healthcare, we still have a long way to go in closing the wide gaps that occur in clinical research. The decades-long assumption in clinical trials that research findings based on male physiology were universally applicable to both sexes has led to serious consequences by continuing to under-represent women, while disregarding their unique biological differences and how these factors influence disease progression and treatment responses. Understanding this exclusion not as a recent concern but as a longstanding issue women have been battling with is the first step toward making effective changes that do not overlook women's needs but prioritizes them and understands their unique challenges and needs. Women-specific conditions such as endometriosis, chronic pelvic pain, and Polycystic Ovary Syndrome (PCOS) have been among the most affected areas caused by these gaps, which have consequently made it impossible for millions of women living with these conditions to receive proper care.


The lack of research and attention that women's health and conditions have received over the years has made it almost impossible for women to receive tailored healthcare and access to treatment, not because solutions weren't there but because the data to guide them simply was not available. To really understand what has been missing and what we can do to remedy this situation, we need to look at the situation using data, which will allow us to be more specific. In addition, in the last two decades there has been serious momentum in addressing these challenges by making it easier for women to not just access accurate diagnoses but also participate in clinical research and contribute to the development of personalized treatments and healthcare solutions, largely due to the rapid development of smart personal gadgets, medical devices, and women's health tracking apps. 

Data In FemTech_Blog

How Clinical Data and Medical Devices Are Shaping the Future of FemTech 

As previously highlighted in the introduction, there is no one-size-fits-all approach when it comes to women's health, and when you take a closer look at today's FemTech boom, you will understand how this relatively new industry managed leverage women’s health data to exceed expectations in such a short period of time. Medical devices like bracelets, menstrual trackers, and hormone monitors are just a few of the dozens of tools we now have at our disposal, making a difference in women's lives by making it easier to detect and monitor women-specific conditions and irregularities earlier. These simple and yet sophisticated wearable devices, when paired with diagnostic devices, are making it easier for women to gain insights into their health and know more about their bodies and current health needs than ever before. Women living with incurable conditions like endometriosis, which take time to detect and diagnose accurately with traditional methods, can significantly benefit from this new data-based approach to biomarker identification, as the use of Artificial Intelligence (AI) in data analysis is making it possible to flag abnormalities and symptom patterns that might have gone unnoticed in routine checkups and doctor visits. 

While our main focus has been on the tech side of things thus far, the regulatory and legislative spheres of clinical trials and women's health have also received much needed attention in recent years in both the EU and US. New ICH guidelines and EU clinical trial regulations enforced by the EMA, for example, are now demanding trial populations to have 'reasonable representation' of all patient groups, which is a huge step in ensuring the representation of all groups, including women, in key medical research. However, while this might be the case on paper, there is still a lot of work to be done to ensure that entities conducting these trials follow through and deliver, especially in early-phase drug development and preclinical models. 

The use of AI in FemTech is a game changer that is providing the FemTech industry with a long-awaited solution: AI-powered data analysis. What this means for women's health is that we can now use the data in our hands to predict health outcomes and develop personalized care in ways that we never thought were possible. 

 

The Rise of AI in Women’s Health Monitoring & Tracking Apps 

Women’s healthcare apps have played a role in catapulting consumer FemTech into global success at an unprecedented level, catapulting a once regarded 'niche' industry into a mega industry which is estimated to grow to $117.7 billion, per the latest Statista reports [1]. These AI powered apps, paired with smart wearable technologies, are making it easier for women to understand more about their condition(s) and state of well-being by submitting their health data and allowing the tech to collect and analyze health data in the background. However, despite mainstream FemTech focusing most of its attention on these apps, scientifically, the data collected through these apps, which is often unstructured and inconsistent, cannot yet replace clinical data due to current limitations. This is not to say that these apps are not useful; it just means that these apps are more powerful and helpful when used in combination with clinical-grade diagnostics and devices than on their own. 

 

What’s Next for FemTech, and How Can We Go Further? 

Technology is taking us to a future where women's health needs are met without barriers, and this is slowly becoming a reality in today's digitally driven world. To achieve this, we as players in the FemTech industry, need to go beyond technological innovation alone and promote cross-sector collaboration within the broader life sciences industry. Cooperation with experts and partners in sectors such as biotech, academia, reproductive endocrinology, and gynecology will not only take our industry forward, it will go a long way towards building stronger, evidence-based solutions in the long run and making personalized female healthcare accessible for everyone. Although technology has improved and become more accessible, quality and structured data still remain the key to improving these tools and overcoming current challenges facing the industry and women in accessing personalized healthcare. With structured data, we don't just have an opportunity to improve predictions, we have a real chance to redefine how female health is understood, diagnosed, and treated. 

When it comes to women's health and well-being in general, the truth is we cannot treat what we don't know and can't understand, because attempting to do so would not only be ineffective, it would also be harmful and risky to patients. That is why we must continue to push for more accurate and inclusive trials as well as more accurate and standardized methods of collecting, sorting, and analyzing digital data to ensure that tools and devices at women's disposal are safe and effective. 

 

Sources :  

  1. FemTech Market Size Worldwide 2020–2027. Statista, 2024, https://www.statista.com/statistics/1483460/femtech-market-size-worldwide/
  2. Closing the Data Gaps in Women’s Health. McKinsey & Company, 17 May 2022, https://www.mckinsey.com/industries/life-sciences/our-insights/closing-the-data-gaps-in-womens-health
  3. Why We Know So Little about Women’s Health. Association of American Medical Colleges, 7 June 2022,
     https://www.aamc.org/news/why-we-know-so-little-about-women-s-health. 
 

 

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