Edin Deljkic is founder and CEO of Klika.getty​Endometriosis takes an average of 7.4 years to diagnose. That number comes from the EU Women’s Health Manifesto. The biology has been understood for decades. A March 2024 WHO/Europe report confirmed that digital health tools can genuinely improve access, maternal health outcomes and women’s autonomy over their own health decisions.That report also states what is undeniably a problem: barriers in access, digital literacy gaps and the persistent difficulty of deploying and scaling solutions in practice. We can clearly see that technology is advancing, but the infrastructure and compliance environment in which it operates is the harder problem.Femtech, as a category, has matured quickly. Startups like Red Drop Lab, which is exploring menstrual blood as a clinical biomarker, and Clue, a cycle-tracking company known for its partnerships with universities on research into women's health, are building products that treat women’s health data as a serious clinical resource. They represent a broader shift in what femtech can actually do. But between a promising product and one that operates at scale across regulated markets, there is almost always an engineering-and-compliance gap. Science tends to run ahead of the infrastructure that supports it.The Data ProblemWomen remain underrepresented in clinical trials across Europe. Women-specific conditions have historically generated far less structured data than those taken from men. Doctor Konstantina Davaki’s 2025 European Parliament study, “Gender Inequalities in Medical Research, Drug Development and Access to Care,” focuses on gender inequalities in medical research.Unfortunately, the longstanding bias continues, producing worse outcomes for women. AI usage further complicates this, with diagnostic tools trained on insufficient female-specific data giving confident wrong answers.Women’s health applications collect highly sensitive personal data, which is regulated under several laws. Under GDPR, this is treated as special category data. In Switzerland, under its revised Federal Act on Data Protection, in force since September 2023, it falls under particularly sensitive personal data.The Swiss nFADP was explicitly designed to align with EU data protection standards, so companies treating Swiss expansion as a simplified version of EU expansion often find otherwise when they reach the compliance specifics.Processing requires explicit consent or another valid legal basis. The process is handled under robust security measures, with careful handling of cross-border transfers. These obligations have to be resolved before a product can credibly enter any new regulated market.Early-stage femtech companies routinely underestimate this.When a company builds a genuinely useful product, reaches the point of international expansion and then discovers that its entire cloud infrastructure is under someone else’s control, that company cannot make credible compliance representations to regulators in any new market. The expansion stalls. In a market where trust is the product, that recovery is slow and expensive.Femtech And AIApplied carefully (and this can’t be overstated), AI addresses real clinical problems in women’s health that previously had no good technical solution. Anomaly detection, pattern recognition and risk stratification for pregnancy complications are all tractable applications when the underlying data quality is there, and the design keeps a clinician in the decision loop.That last part is not optional under European law. The EU AI Act (Regulation (EU) 2024/1689), whose obligations are being phased in through 2026 and into 2027, classifies AI systems that influence diagnosis or clinical triage as “high-risk.” This means: data governance, explainability requirements, continuous monitoring and human oversight must be built into the product architecture before launch, not added afterward.The mistake that costs companies the most time is treating regulatory requirements as a legal layer applied to a finished product. Companies that get this right tend to move faster in the long run because they are not stopping to re-architect every time they enter a new market.The Good EngineeringIf there are no useful decisions made around it, technology is useless. It doesn’t close the women’s health gap just by existing. What it actually can do is reduce friction and enable clinicians, researchers and patients to obtain better data and make more informed decisions. That is only possible when the infrastructure is sovereign, compliance is embedded from the start and the AI is designed to support clinical judgment rather than replace it.Our team learned early that bringing infrastructure and compliance into the conversation before the first line of code is written prevents rework that can stop market expansion cold. Femtech companies that scale successfully in European markets (or any markets globally, for that matter) are the ones that treated regulatory requirements as a given from day one and built their data architecture accordingly. In this market, the companies that treated compliance as an engineering input from day one are the ones that actually reached new markets. The ones that didn't are still retrofitting.Forbes Technology Council is an invitation-only community for world-class CIOs, CTOs and technology executives. Do I qualify?