Women’s health is a specialist field. Treat it like one.

Fractional executive and strategic advisor for FemTech, medical device and women’s health companies - and the investors who back them.

I was working in women's health before it had a name. My PhD investigated why women tear their ACL so much more often than men — and what the menstrual cycle has to do with it. I then spent a decade leading research and evidence-generation strategy at the intersection of nutrition and physiology, building high-performing teams and developing a reputation as being someone who questions everything, while building at the same time.

I came back to women's health deliberately. Partly because as you go through life in a female body, the gaps in innovation and care become glaringly obvious. Partly because if you chat with me at a cocktail party, I will talk your ear off about data disaggregation, reference man bias, and why most health solutions weren’t (and still aren't) built for women's bodies.

I work across science, product, and regulatory because in this space, those things don't separate cleanly. Neither do I.

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Girl in front of brick wall painted with FOR WOMEN. FemTech consulting research development regulatory

How I can help

  • Early-stage women's health companies face a specific problem: the decisions that shape whether a device succeeds - classification strategy, clinical evidence design, product development priorities - all happen at the intersection of science, regulatory, and product. That intersection rarely has a dedicated owner.

    I embed as a fractional CXO to cover it. Not as an advisor you brief once a month, but as a working member of your team: in the weeds when it matters, in the room for the decisions that count, accountable for outcomes.

    What this typically includes:

    • Ongoing involvement across strategy and execution, not one-off deliverables

    • Tailored support across device development, clinical validation, and/or regulatory readiness

    • Multi-market experience: EU, US, Canada

    • Bilingual delivery in English and French

  • Regulatory clarity early, so you can build it once and build right.

    I help founders get the strategy right before the paperwork starts. This includes an assessment of device classification and risk profile, a realistic view of your fastest credible pathway to market, and an action plan that survices investor or notified body scrutiny.

    • Regulatory strategy and pathway: EU-MDR, FDA 510(k), wellness devices and enforcement discretion

    • Device classification and risk assessment

    • CE marking and notified body selection

    • QMS and ISO 13485 gap analysis

    • Clinical evaluation strategy and CER/PMCF planning

    • IEC 62304, ISO 14971, ISO 14155 compliance

    • Multi-market expansion strategy

    • FSA/HSA reimbursement strategy

    • Crisis management and regulatory remediation

  • Regulatory and clinical risk can derail even the best ideas and founding teams.

    I provide independent, expert assessment of where a company actually stands: whether their regulatory pathway is realistic, whether their clinical evidence strategy is likely to hold up under scrutiny, and whether the timeline they've presented to you is grounded in how these processes actually work.

    I've been on the operator side of these decisions. I know what a credible plan looks like, and I know how to spot one that's been optimistically packaged.

    • Regulatory pathway feasibility: EU-MDR, FDA 510(k), De Novo, PMA

    • Device classification review and risk profile assessment

    • Clinical evidence strategy and CER/PMCF plan evaluation

    • QMS maturity and ISO 13485 readiness

    • Timeline and milestone realism

    • Multi-market regulatory sequencing

    • Identification of hidden regulatory or clinical risks pre-investment

    Engagement format:

    Project-scoped DD reports, delivered on investor timelines. For portfolio companies that need operational leadership post-investment, fractional executive support is also available.

What People are Saying

“At a critical stage in our journey, Erica immediately grasped the challenges we were facing and brought clarity and direction. Her ability to apply her experience to deliver bespoke, highly relevant advice was invaluable.”
— Nigel Denby, CEO, Your Menopause
“Most remarkable are her human skills: a leader you wish to follow due to her empathy and impactful communication skills.”
— Executive Director, Life Sciences Trade Association
“When Erica highlights something that could be done better, it is never for the sake of criticizing but keeping the growth of the company at heart. She is a force for change, for the better.”
— Chief Marketing Officer, Medical Device sector
“She has the rare capacity to make science accessible.”
— International Regulatory Director, Nutrition sector
“I have had the pleasure of discovering your multiple talents, scientific obviously, but also strategic thinking, storytelling, panel facilitation... I have truly enjoyed all our discussions as I always learned something.”
— SVP, FMCG sector
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Let’s build something amazing together.

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