Pre-launch mode. Planned launch: 2027.
Pre-launch mode. Planned launch: 2027.
The Red Team Consultancy for Pharma and MedTech
We attack your assumptions before reality does. Biologically, clinically, ethically. Not cyber: human.
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The approval bar is moving
FDA's new Quality Management System Regulation takes effect in February 2026. The FDORA statute requires diversity action plans for pivotal clinical trials. FDA's patient-focused guidance series now includes a final methodology for clinical outcome assessments. None of this asks for better slides. It asks for proof that your product works for real bodies. That proof is hard to generate from inside your own organization. We generate it from the outside, with people who live the conditions your product touches.
We build that proof. Our reports are structured the way FDA's patient-focused guidances describe and the way quality systems can absorb: clear evidence, clear severity, clear direction.
What we do
We do not replace your R&D, regulatory, or strategy teams. We are the independent layer that stress-tests their work against three realities:
Patient reality.
Does it hold up under non-ideal, real-world use?Precision standards.
Does it meet the tolerances Swiss engineering expects?Ethical integrity.
Does it protect dignity and avoid trust-washing?
Think of us as quality assurance for your quality assurance.
Why survivor-led
Survivors are not symbols. They are risk-mitigation experts who understand where systems fail because they have lived through those failures. Our Survivor-Strategists are employed professionals, not volunteers. They are compensated at premium rates, protected by strict dignity rules, and they never have to tell their story to be heard. We sell their analysis, never their person. We don't round away the 1%.
Here is what that means in practice. A strategist who has worn a maxillofacial prosthesis for twenty years can tell you in one working session where your design will abrade soft tissue. No model gives you that. We bring twenty years of that knowledge to your prototype review.
Who we work with
Biopharma and MedTech
We test devices, protocols, and patient-facing materials against real-world bodies and real-world behavior. Standards test for perfection. We test for reality.
Consulting firms
You build the framework. We verify the tolerances. We plug into your mandate as the independent reality layer your clients will ask for by name.
WHY SURVIVOR-LED?
BECAUSE SURVIVAL IS DATA:
People living with chronic conditions do not trust systems that have failed them. They trust survivors who have forensically analysed why those failures occurred.
At Ethos Fidelis, Lived Experience is not a narrative; it is Operational Intelligence.
A New Forensic Discipline:
We are building a consultancy where survivors contribute biological, behavioural, and navigational data, translating the realities of long‑term survival into practical red‑team strategies for R&D, Clinical Trials, and Regulatory Affairs.
Survivor-Informed, Not Just Academic:
We bridge the gap between the raw, non‑ideal patient journey and the sterile rigor of Swiss regulatory and engineering standards. This creates a level of realism that academic models cannot replicate.
Anatomical, Not Political:
Our focus is strictly on biological reality phenotypes, genetics, biomechanics, and physical access.
We ensure your innovation works for the full diversity of human anatomy, moving beyond “Standard Reference” models to achieve true Bio‑Fidelity.
The Operational Advantage:
By integrating survivor‑strategists into your processes, we identify Cantilever Effects, Silence Gaps, and other failure points that academic, corporate, or standards‑based models are structurally unable to detect.
Swiss precision meets patient reality
Our founder, Fidel Strub, trained as a watchmaker, working at tolerances of 0.01 millimeters, before surviving noma and 28 reconstructive surgeries. He now advises global health institutions and was named a TIME100 Health Honoree. Ethos Fidelis applies the same intolerance for error to patient reality.
Preparing a trial, a device, or a market launch in 2027? Get notified when we open our doors, or talk to us about a Foundational Partnership today.