CNS trials · Brain imaging

Medical-device
rigour for
brain-imaging
trial endpoints

Quantitative brain-imaging endpoints are software-generated measurements. Making them robust can require an additional layer of medical-device science — verification, validation and controlled change. I bring that layer into drug-trial evidence.

Imaging vendors work from the technology and device side; clinical teams from drug development. I translate between them independently — so your endpoint holds up from scan to therapeutic conclusion.

PhD

Neuroscientist

EIT Health

Certified · Digital medical devices

NdDB

Framework author

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A light on the whole chain The LuMMiens candle at the centre lights up, one by one, the five steps behind a brain biomarker: clinical question, image acquisition, processing, quality control and trial endpoint. Each step is owned by a different team, and the handovers between them are where risk hides. Clinical question CLINICAL TEAM Acquisition TRIAL SITES Processing IMAGING VENDOR Quality control CORE LAB Trial endpoint BIOSTATISTICS A light on the whole chain — from scan to conclusion. Five steps, five owners. The claim can break at any handover.

Who This Is For

Which side are you coming from?

Brain-imaging endpoints sit between two worlds. I work on either side, translating a claim into the evidence it needs.

Drug-development side

I bring device science — verification, validation and controlled change — to your endpoint and evidence plan.

CNS biotech

You plan to use a brain-imaging measurement in a trial, without in-house imaging or device expertise. You need to know if it can carry the endpoint before the protocol is fixed.

Pharma clinical & biomarker teams

You have imaging experts and vendors, but need an independent view: does the measurement chain support the claim your trial must make?

Claim → evidence

Technology & device side

I bring the disease and clinical perspective: which brain changes matter, when, and in whom.

Quantitative imaging startups

Your tool measures the brain well. To serve as a trial endpoint, it must also show what changes across the disease course, in whom, and what that change means.

Academic spin-offs & research groups

Your imaging method works in the lab. Clinical use requires showing it captures what matters in the disease, robustly, beyond your own data.

If your team speaks only one of these languages, this is the right conversation.

Independence rule · On any given programme, I work for one party only.

How to Work Together

Three ways to work together.
Pick the one that matches where you are.

Every engagement follows the same reasoning: from claim, to evidence, to a defensible decision.

The goal is not more evidence, but enough for the claim and decision at hand. Start small; go further only if useful.

Clarity is how we work. Better-informed decisions are what we aim to enable.

01 · Entry

Scientific Readiness Scan

A quick, honest first look: can your measurement support the claim you want to make?

Come when

An imaging biomarker is heading for a drug trial, or an imaging tool for clinical validation, and you need to know if the claim is realistic.

You receive

Claim Brief

  • →The claim your measurement must support, stated precisely
  • →The main risks, explained in plain terms
  • →A clear recommendation: go further, adjust, or stop

02 · Core

NdDB Readiness Review

A full check of your evidence plan before the study design is fixed.

Come when

Your trial protocol and analysis plan, or your clinical validation plan, are not yet final.

You receive

Evidence Gap Report

  • →Your programme scored on the six dimensions of the NdDB Readiness Map
  • →A ranked list of evidence gaps, and the smallest sufficient way to close each one
  • →Written to be shared across your clinical, imaging and statistics teams

03 · Advisory

Embedded Scientific Advisor

An independent senior scientist alongside your team, as decisions come up.

Come when

You need ongoing imaging-biomarker and evidence expertise, without building a new internal function.

You receive

Decision Notes

  • →At each key decision: what was decided, on what evidence, and what remains open
  • →Independent review of protocols, analysis and validation plans, and vendor documents as they evolve
  • →A senior scientific voice in team discussions

Not sure which one fits? Describe your situation and I will tell you.

Free resources

Explore on your own, at your own pace.

Learn the reasoning

Clinical Evidence in SaMD Development

A free, self-paced course: from a clinical claim to the evidence it needs and the smallest sufficient investigation. Hosted on K-space Studio.

Open the Course ↗

Check your programme

Self-assessment

18 questions · about 5 minutes. See where your biomarker programme stands, on your own.

Start the Check →

The framework behind the work

NdDB Readiness Map

NdDB = neuroimaging-derived digital biomarker: a brain measurement from imaging, used in a clinical trial. Six areas to check, from image acquisition to regulatory questions.

Explore the Framework →

Why LuMMiens

When complexity becomes a blind spot, clarity becomes an innovation.

Brain-imaging programmes can produce sophisticated technology, abundant data and specialised teams — and still lack an integrated view of the evidence behind a decision. The missing step is not always another technology. Sometimes it’s seeing what is already there, and how the pieces connect.

That is the idea behind the candle: technology serves human judgement, not the other way round.

Luciana Bonnot, PhD

About

Where brain research meets device science

I am Luciana Bonnot, a neuroscientist with a background in brain imaging across neurology, psychiatry and neurodevelopment, including multisite research and AI-based imaging projects.

Through EIT Health’s programme in digital medical devices, I added device-science thinking to that clinical perspective. LuMMiens brings the two together through a claim-to-evidence approach: define the claim, identify the gaps, and find a proportionate path to a defensible decision. I also teach this reasoning in a free course on clinical evidence in SaMD development.

Based in France · English, French, Portuguese

Full profile and publications ↗

Contact

Let’s talk about your claim

Tell me what you want your measurement to show, where it comes from, and where the uncertainty sits.

  • ✓ Confidentiality assured
  • ✓ NDA available on request
  • ✓ Response within 48 hours
linkedin.com/in/bonnot-luciana