What Does it Mean to be "Clinically Proven" in FemTech?

If you've spent any time in FemTech, you've seen the terms everywhere: "clinically validated," "clinically proven," "evidence-based." But what do they actually mean? And how do you get there?

For FemTech founders, clinical credibility isn't just nice to have; it's increasingly the difference between traction and obscurity. For investors, it's a key indicator of long-term viability.

According to Precedence Research, the global FemTech market is projected to reach USD 60.89 billion in 2025,¹ but with over 400 new products launched in the past decade, the space is crowded. Clinical validation is now the sharpest differentiator.

For Users: Women are tired of apps making big promises without proof. Clinical validation means your product actually works.

For Healthcare Providers: Doctors won't recommend products they don't trust. Clinical evidence builds that trust.

For Payers and Partners: Insurance companies and health systems increasingly require clinical evidence before reimbursement or integration. In 2024, 23% of FemTech partnerships involved healthcare providers, surpassing pharma partnerships for the first time.

For Investors: Capital now flows towards companies with strong clinical validation. Europe, which leads in validation strength, saw 157% year-on-year growth in FemTech investment in 2024.

Not every FemTech product needs the same validation level. Your path depends on what your product does and the claims you make.

Wellness Products—don't make medical claims; think menstrual cycle trackers or educational platforms. You need user satisfaction data, basic usability testing, and data privacy compliance. No FDA approval is required, but you still need evidence your product works safely, and you should work as though you’ll be needing FDA approval soon.

Software as a Medical Device (SaMD) makes specific medical claims, like diagnosing conditions, treating diseases, or managing health conditions. Examples include apps detecting endometriosis, digital therapeutics for PCOS, or AI-powered breast cancer screening tools. These require FDA 510(k) clearance (Class II) or full approval (Class III), demonstrating safety and efficacy through clinical studies.

The Gray Area: Many products sit in between. A period tracker logging dates might classify as a wellness product, but if the same tracker predicts ovulation for fertility planning, you're entering medical territory.

Clinical validation means you have evidence from rigorous studies that your product works as intended, produces claimed outcomes, is safe, and performs as well as or better than existing alternatives.

Randomized Controlled Trials (RCTs): are the gold standard. You randomly assign participants to use your product or a control, then measure outcomes. RCTs minimize bias and demonstrate causation. 

Limitation: they're expensive and time-consuming (six months to two years).

Observational Studies: track real-world usage and measure outcomes. They're cheaper and faster than RCTs and generate valuable real-world evidence increasingly accepted by regulators. 

Limitation: they can't definitively prove causation.

Peer-Reviewed Publications: add massive credibility. Independent experts evaluate your methodology and findings. Target journals specific to women's health or digital health to signal validation to investors and partners.

Stage 1: Proof of Concept (Months 0-6)

Work with clinicians from day one, conduct pilot studies with 20-50 users, gather initial safety data, and identify clinical outcomes you'll measure. 

Stage 2: Clinical Study (Months 6-18)

Design a rigorous study, recruit 100-500 participants, partner with academic medical centers, and use validated clinical endpoints. 

Stage 3: Publication and Regulatory (Months 18-36)

Submit findings to peer-reviewed journals, prepare FDA submissions if needed, and continue collecting real-world evidence. 

Plan to spend at least two years building credibility properly. Yes, it feels like forever when you're eager to scale, but it pays off.

Collaborate with Academic Institutions: Partner with university research departments that have grant funding and research infrastructure.

Leverage Existing Validation: If you're building on established science (like CBT for menstrual pain), you don't need to reprove that the underlying therapy works, just that your digital delivery is effective.

Use Real-World Data: If your product is already in the market, systematically collect and analyze user data. One FemTech company validated its predictions through analysis of data from over 22,000 women.

Start with Observational Studies: Before investing in expensive RCTs, run observational studies that are faster, cheaper, and increasingly accepted.

Build an Advisory Board: Recruit respected clinicians and researchers as active advisors. Their involvement lends credibility even before published studies.

Class I (Low Risk)

Class II (Moderate Risk)

Class III (High Risk)

Clinical credibility isn't about checking boxes; it's about genuinely proving your product improves women's health. The path takes time and money, but it's increasingly non-negotiable for serious players.

Start building credibility from day one by involving clinical experts, planning your validation strategy early, and being honest about your evidence. The companies winning in FemTech today baked clinical validation into their development process from the beginning.

For investors, look for founders who understand this journey with realistic timelines. Be wary of bold medical claims without corresponding evidence. In a crowded market, clinical credibility separates future category leaders from apps that disappear after a funding round.

The FemTech revolution will only reach its full potential when products move beyond hype and deliver evidence-based solutions that genuinely improve women's health outcomes. 

That starts with clinical credibility.

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Are you (or someone you know) building a FemTech brand and want to make claims you can actually back up? I help brands translate clinical evidence into content that builds trust with their users and investors.