One year in, and incorporating

7 Apr

It's been a year since I went fully self-employed, and I'm proud to say I'm now incorporating a GmbH in Switzerland. Founder of what, you might ask — the new entity will serve two projects at once.

Two ventures, one edge

Edge Compliance is the boutique healthtech compliance agency this blog lives under — a tailored, tech-forward approach to quality, regulatory, and clinical affairs for companies navigating the boundary between medtech and wellness, with a particular focus on femtech startups.

Onya Health is the newer, earlier-stage idea: improving childbirth experiences through early profiling of the woman, not just the baby. When women and obstetric professionals can make data-informed plans for labour, it can lower the incidence of tragic complications, as well as the physical and psychological trauma that follows some births — trauma with costs that can last a lifetime.

That last point isn't rhetorical. Recent research estimates that childbirth-related PTSD affects roughly 6.6 million mothers and 1.7 million fathers or co-parents worldwide every year. A 2026 UK study found that 40.6% of women experience childbirth as at least moderately traumatic, with 5.9% going on to develop diagnosable childbirth-related PTSD. These aren't rare edge cases in obstetric care — they're a substantial, under-addressed slice of what happens after "it's a boy" or "it's a girl." Better profiling and planning before labour won't eliminate that burden, but even a modest reduction matters at that scale.

Why founders — and birthing, founding women especially — have to be heroes

I'm ever more convinced that health startup founders, and women founders in particular, have to be genuinely heroic to make it in this world. The data backs up why that word isn't hyperbole: all-women founding teams received just 2.3% of global venture capital in 2024 and 2025, a figure that hasn't meaningfully moved in over a decade. When it does move, it moves the wrong way — UK data shows investment in female-led startups actually dropped from 21.6% to 18.6% between 2023 and 2024. Women-founded companies also, by several accounts, generate more revenue per dollar invested than male-founded ones — the "heroism" isn't sentiment, it's founders consistently outperforming on less capital, less room for error, and less benefit of the doubt.

My admiration goes to all of them, and my hope is that the work I do — Edge Compliance's regulatory strategy, and now Onya Health's earlier bet — can do a little bit to help.

The first year, in numbers

Some honest bookkeeping on what year one actually looked like:

6 ongoing client projects — 2 IVD, 2 SaMD, 1 AIMD, 1 cosmetic
2 fractional roles with companies I genuinely love working with
3 partnerships with providers of complementary services
7 subcontractors who extend what I can personally cover
4 conferences attended, 1 as a panel speaker
2 mentoring roles with early-stage startups
20 blog posts published on edgecompliance.co
A 40-week streak of LinkedIn thought-leadership, as of today
A 20:80 split of non-billable to billable consulting time

That last ratio is one I'm still calibrating — enough non-billable time to build the pipeline, content, and relationships that got me here, without it eating into the work that actually pays.

How do you scale a consultancy without losing what makes it work?

This is the one I'd genuinely value input on. Two constraints, in tension with each other:

First, maintaining consistent quality and approach beyond my own direct involvement. Regulatory consulting is trust-heavy work — clients hire you, specifically, for judgment built over years. Scaling that past a single expert, without diluting it into generic templated output, is a genuinely hard people-and-process problem, not just a hiring one.

Second, keeping internationally attractive rates while staying profitable from a Swiss cost base. Switzerland's cost structure is real; clients evaluating consultants globally aren't necessarily pricing that in. Finding the model that lets a Swiss-based boutique compete on rate with lower-cost-base consultancies, without racing to the bottom on margin, is the puzzle.

If you've navigated this — scaling a specialist consultancy past founder-dependency while holding both quality and rate discipline — I'd love to hear how. This is the open question I'm carrying into year two.

Gratitude

I can't count, or even fully list, the like-minded people I've met or reconnected with this year who've supported this in ways big and small. Thank you — genuinely.

I feel fully alive and fully in for whatever comes next. If you see synergies with anything above — Edge Compliance's regulatory work, Onya Health's early concept, or just the BD question I'm chewing on — reach out. Let's talk.

References

Chan, S. J. et al. (2024). Childbirth-related posttraumatic stress disorder: definition, risk factors, pathophysiology, diagnosis, prevention, and treatment. American Journal of Obstetrics & Gynecology.
Webb, S. et al. (2026). Risk factors for birth trauma and postpartum posttraumatic stress in the United Kingdom. Acta Obstetricia et Gynecologica Scandinavica.
PitchBook / Forbes, The Funding Gap For Women Founders Isn't Closing, 2026 data on all-female-team VC funding share
The Gender Index 2025 Report, UK female-led startup investment trends

Methodology note: This article is based on my original LinkedIn post (link), reflecting my personal and professional reflections on my first year of self-employment and the incorporation of my Swiss GmbH. AI assisted in elaborating the topic into a broader article by integrating background research on maternal health outcomes and the startup funding landscape for women founders. All analysis, numbers about my own business, and perspectives are my own, and all content has been reviewed by me for accuracy.

Giulia Paggiola