A quick note before today's piece:
I'm hosting a virtual conversation on FemTech and Africa for International Women's Day, exploring what FemTech really is, what it can offer African women, and how we move forward responsibly without hype or borrowed models that don't fit our realities.
If women's health matters globally, then African women must be part of the conversation, not catching up to it.
Learn more and get involved here or send an email for further details.
Now, to today's critical topic: knowing where to draw the line between product innovation and clinical boundaries.
Every FemTech product makes clinical decisions, whether the team realizes it or not.
Each time your app labels a symptom as “normal,” suggests an action, or reassures a user, it’s encoding a medical judgment into software. Not through diagnosis or prescriptions, but through normalization, omission, and tone.
Most credibility failures in FemTech don’t come from false data or broken algorithms. They come from products that quietly crossed a line they didn’t know existed.
FemTech sits in an uncomfortable middle ground.
Too medical to be dismissed as wellness. Too consumer-facing to follow traditional clinical workflows. As a result, many products operate in a gray zone where responsibility is implied but not clearly defined.
Clinicians manage this gray zone through referrals. It’s how medicine acknowledges uncertainty, limits scope, and protects patients. Products, however, are rarely built with the same escalation logic.
That gap between how clinicians think and how products behave is where credibility breaks.
Referral intelligence isn’t about slowing innovation or deferring to doctors at every turn. It’s about translating real clinical decision-making into product boundaries, alerts, and pathways. When done well, it strengthens trust with users, clinicians, investors, and regulators alike.
If you’re building in FemTech, understanding where your product should step back is not a constraint. It’s a strategic advantage.
The Credibility Break You Didn't See Coming
A cycle-tracking app positions itself as a PCOS management tool. It offers symptom tracking, lifestyle recommendations, and dietary guidance. Users love it. Investors are impressed. Then a woman using the app for irregular bleeding is suddenly diagnosed with endometrial hyperplasia (a precancerous condition her app may have been tracking as "normal cycle variation" for eight months).
The problem isn't the technology. The app tracked bleeding patterns accurately. The problem is that the builders don't understand what clinicians know instinctively: certain patterns aren't lifestyle issues to be managed; they're red flags requiring immediate medical evaluation.
This is where product intelligence and clinical intelligence must intersect. And most FemTech founders are building in the dark.
Scope of Practice Meets Scope of Product
In clinical medicine, knowing when to refer is as important as knowing what to treat. Clinicians operate with two invisible lines in mind:
what they're legally allowed to do (scope of practice) and
what they're competent to manage safely (scope of competence).
When either line is crossed, the correct action isn't to push harder; it's to refer.
Products, however, don't have that instinct.
Your product is making clinical distinctions whether you realize it or not. Every time you categorize a symptom as "track it," every time your algorithm suggests a lifestyle change, and every time you normalize a pattern, you're making a clinical judgment.
The question is, are you making it with the right knowledge?
This matters because the real cost of missed referral signals compounds quickly. For patients, it's delayed diagnosis and worsened outcomes. For your product, it's regulatory scrutiny, liability exposure, and destroyed credibility.
The Framework You Need: Green, Yellow, Red
Think of your product scope in three zones:
Green Zone: where FemTech thrives.
Tracking and pattern recognition
Education and awareness
Lifestyle optimization
Wellness and behavior support
Here, you're empowering users with information and tools they can act on independently.
A period tracker that helps users identify their cycle patterns—Green zone.
An app that educates about nutrition for hormonal health—Green zone.
If you stayed here forever, regulators would mostly leave you alone, and clinicians would thank you.
Yellow Zone: requires collaboration, not replacement.
This is where credibility is earned or lost:
Symptom assessment that suggests clinical evaluation
Data sharing with healthcare providers
Treatment adherence support
Guided self-management with medical oversight
Yellow-zone products need clinician input baked into the design, not as an afterthought. You're the bridge, not the destination.
Red Zone: demands immediate clinical handoff.
Diagnostic conclusions
Prescribing or treatment decisions
Medical decision-making
Urgent or emergency situations
If your product is operating here without appropriate medical oversight, you're not just risking credibility; you're risking lives.

What Clinicians Actually Refer For (and What Your Product Should Do)
Understanding referral triggers is where theory becomes product design.
When an OB/GYN sees a patient with irregular cycles, they're running through a mental checklist:
Is this heavy bleeding (more than 80 ml per cycle)?
Is she bleeding longer than seven days?
Is there intermenstrual bleeding?
Postmenopausal bleeding?
Each answer determines whether this is a "let's track this" situation or a "we need to investigate this now" situation.
For menstrual irregularities: Your product should flag patterns like heavy bleeding, prolonged bleeding, or intermenstrual bleeding, then explain why they matter and prompt medical consultation. Avoid normalizing concerning patterns as "just stress" or "hormonal fluctuations."
For PCOS symptoms: Clinicians refer when they see metabolic risk factors, fertility concerns, or significant insulin resistance. Your product should identify symptom constellations and explain when specialist evaluation is needed. Avoid the mistake of "diagnosing" PCOS based on symptoms alone or suggesting supplements as a substitute for proper evaluation.
For fertility concerns: Clinicians typically refer for fertility evaluation when someone under 35 has been trying for 12 months, or over 35 for 6 months, or even earlier if there are risk factors or cycle abnormalities. Your product should support cycle tracking and timing while clearly communicating when evaluation is needed.
Avoid over-promising conception likelihood or delaying appropriate specialist care.
Building Credibility Through Boundaries
Your product becomes more credible when you clearly define what it won't do.
When a menstrual tracking app flags bleeding patterns and says, "This could indicate a condition that needs medical evaluation; here's what to discuss with your doctor," it builds trust. When a fertility app says, "If you're over 35 and haven't conceived in six months, it's time to see a specialist," it demonstrates clinical intelligence.
So what are the market opportunities here?
Long specialist wait times create opportunities for interim support tools.
Poor communication between primary care and specialists needs coordination technology.
Patients don't understand when symptoms warrant specialist care, and that's an education gap your product can fill.
Your Clinical Boundary Audit
Ask yourself:
Does your product make diagnostic claims?
Does it recommend treatment without medical oversight?
Does it normalize symptoms that should prompt medical evaluation?
Does it track data that could identify red flags, and if yes, do you alert users?
Can users distinguish between wellness support and medical advice?
If you're uncertain about any answer, you have a credibility gap to address.
The best FemTech products are the ones that know exactly where they fit in the care continuum and build credibility by respecting those boundaries while delivering exceptional value within them.
That's not limiting your product. That's defining your competitive advantage.
Dr. Ayomide Owodunni is a FemTech Credibility Advisor helping FemTech founders build products that can withstand regulatory scrutiny and investor due diligence.
Brand Spotlight — Elvie
Founded in 2013 by Tania Boler, Elvie creates smart, beautifully designed hardware for women’s intimate health. From pelvic floor training to its silent wearable breast pump, the company helped modernize overlooked care. Curious how that pivot changed everything? Click here to read the full Elvie story.
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