Women’s Health in MedTech Is A Trillion-Dollar Frontier Startups Need to Navigate Now

For decades, medical innovation left women behind. Even as they make up over half the global population and account for 80% of healthcare decisions, women have been excluded from clinical trials, overlooked in product design, and underserved by regulatory frameworks. That neglect is slowly being corrected. Women’s health is no longer a niche—it’s a growth market projected to reach over $1 trillion globally in the coming years, according to the World Economic Forum. Yet, despite its promise, regulatory and compliance hurdles still prevent many women-focused MedTech startups from scaling effectively.

As the sector evolves, regulatory pathways are maturing—but slowly. From digital contraception and menopause care to pelvic floor diagnostics and reproductive wearables, innovators must proactively address how their products are classified, validated, and monitored under increasingly scrutinized global frameworks. Startups that embed regulatory foresight into their product strategy are more likely to survive post-market surveillance, investor due diligence, and data privacy scrutiny.

Where FemTech Devices Fit into the EU MDR and FDA Landscape

Many FemTech startups develop apps, sensors, or wearable devices to address menstrual, reproductive, and menopausal health issues. However, classification under regulatory systems such as the EU Medical Device Regulation (EU MDR 2017/745) or the FDA's classification codes isn't always intuitive.

Under the EU MDR, devices used for the diagnosis, prediction, or monitoring of physiological conditions—including menstrual tracking, fertility prediction, or relief of menopausal symptoms—may qualify as medical devices if their intended purpose meets the regulatory definition. This includes software-only products, such as cycle-tracking apps that make contraceptive claims. These products must comply with essential safety and performance requirements and undergo conformity assessment. Yet, many FemTech developers list their tools under non-medical categories, such as "wellness" or "entertainment," enabling them to bypass medical-grade scrutiny—a loophole that regulators are increasingly working to close.

The UK Medicines and Healthcare products Regulatory Agency (MHRA) echoes this challenge, emphasizing that classification depends on how the manufacturer describes the intended purpose. Their guidance on stand-alone medical device software notes that apps labeled for contraception, disease management, or diagnostic functions are squarely within regulatory scope.

In the U.S., the FDA has been more conservative—many digital health tools skirt classification by claiming general wellness use. However, suppose a product is intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, or affects the structure or function of the body. In that case, it is considered a medical device under the Federal Food, Drug, and Cosmetic Act. Digital contraception tools and AI-driven diagnostic apps are increasingly landing within this territory.

Fertility, Menopause, and Wearables Pose Unique Compliance Questions

FemTech doesn’t stop at period tracking. Device developers working in reproductive planning, menopause symptom relief, and postpartum health must also contend with emerging guidance and data protection requirements.

Fertility apps and devices, especially those used for digital contraception, face growing scrutiny due to user-reported failures and unclear risk disclosure. UK-based researchers note that without uniform standards, the burden of failure often falls to the user, rather than the manufacturer. That ambiguity exposes startups to reputational and legal risk.

In the menopause space, devices like Ru Medical's "Unpause," which provides automated relief from hot flashes, demonstrate the convergence of consumer technology and regulated medical devices. Their utility across primary and specialized care environments underscores the importance of rigorous usability testing and human factors validation, requirements under both the FDA and EU MDR frameworks.

Meanwhile, wearables and AI-powered tools for pelvic floor health, like FemTherapeutics' 3D-printed vaginal devices, raise classification challenges around invasiveness, biocompatibility, and software safety. Startups must determine whether their software functions are standalone or accessory to the device, which influences the conformity route and risk classification.

The Regulatory Grey Zone Around Data Privacy and AI in FemTech

FemTech products handle extraordinarily sensitive data—from biometric fertility signals and sexual health information to AI-analyzed menstrual patterns. Yet few data protection frameworks directly address the risks. Researchers have found that many FemTech apps lack proper consent mechanisms, use excessive third-party trackers, or mislabel the app category to avoid regulation.

In the EU, this data often falls under the GDPR’s “special category data”—requiring explicit consent, impact assessments, and documented safeguards. Switzerland’s new Federal Act on Data Protection (nFADP) and the UK Data Protection Act 2018 reflect similar principles. U.S. HIPAA laws, however, often don’t apply to direct-to-consumer apps not affiliated with a covered healthcare entity.

Startups should conduct Data Protection Impact Assessments (DPIAs) and ensure alignment with standards like ISO 13485 for medical devices and ISO 27701 for privacy information management.

Fast-Tracking Women’s Health Innovations Through Strategic Pathways

While the regulatory environment remains complex, there are targeted pathways that can accelerate access to market for high-need women’s health technologies.

In the U.S., the FDA’s Breakthrough Devices Program has supported the development of digital tools for pelvic floor health and contraception. The De Novo pathway also provides a route for novel, low-to-moderate risk devices that lack a predicate. Daré Bioscience, for instance, has used these frameworks to advance women’s health drug-device combinations.

In the EU, Notified Bodies are gradually developing specialized expertise in digital reproductive health, and there is growing pressure to create guidance tailored to FemTech, particularly as demand surges following the U.S. Roe v. Wade reversal.

Public-private initiatives are also providing momentum. The Biden administration’s $100 million Women’s Health Research initiative through ARPA-H is attracting investor and policy attention to the field, while CMS is introducing reimbursement pilots for maternal and postpartum care through Medicaid models.

Build Boldly, But Build With Compliance in Mind

MedTech startups working in women’s health can improve their odds of success by embedding regulatory and privacy considerations early:

• Classify your product correctly: Determine whether your app, wearable, or software falls under medical device regulations in your target markets. Align your intended use with regulatory definitions.

• Map your data ecosystem: Identify what sensitive data you collect, how it is stored, shared, and used. Ensure consent is valid and transparent, especially in jurisdictions with strict data protection laws.

• Design for usability and clinical validity: Conduct human factors studies and integrate real-world evidence to meet regulatory expectations for safety and performance.

• Plan for post-market obligations: Develop a Quality Management System (QMS) aligned with ISO 13485, and define your Post-Market Surveillance (PMS) and Vigilance procedures to track performance.

• Engage early with regulators: For novel products, consider pre-submission meetings with the FDA or early engagement with Notified Bodies to validate classification and evidence requirements.

• Leverage funding and policy tailwinds: Stay informed about public initiatives and potential reimbursement pilots that could support the adoption of your product.

Ready to Lead in Women’s Health? Let’s Talk

FemTech is stepping out of the regulatory shadows. With women's health now a global priority, the standards for compliance are rising. Startups that prioritize data privacy, clinical evidence, and risk-based classification in their innovations are more likely to scale successfully and maintain their growth. For those prepared to seize the moment, the opportunities are not only significant but long overdue.

If you are developing the next breakthrough in women’s health, don't navigate this journey alone. Let’s collaborate to create a regulatory strategy tailored to your product, market, and growth objectives.

Contact us today to discover how we can support you in delivering safe, effective, and innovative technologies to patients worldwide—quickly and with confidence.