What I offer

Who is it for?

• Medical device SMEs whose clinicians ask for a software feature the team cannot assess.
• MedTech start-ups that need to base their technical choices on evidence, including for their investors.
• Medical software SMEs considering a new product.
• Technology transfer offices and incubators deciding whether to invest in a research-born medical software project (see below).

What you get

An independent, reasoned assessment along two axes: scientific and technical feasibility and fit with the clinical need.

• a clinical need checked with several clinicians and written up as functional requirements;
• a state of the art and an analysis of the technical barriers, with several possible solutions for each;
• an analysis of data and integration (imaging, hospital systems, existing code);
• an indicative estimate of the software class (IEC 62304, MDR), which drives the cost of CE marking;
• a prototype estimate in person-days and profiles;
• a written report and an oral debrief.

How it works

1. Pre-assessment (half a day): based on a short questionnaire, we identify together where the project could get stuck, and I quote the scoping as accurately as possible. It is deducted if the scoping is ordered.
2. Functional requirements validated with you halfway through: a milestone, and a possible exit point.
3. State of the art, barriers, data and integration.
4. Report and oral debrief.

If your project is already well specified, the scoping can be lighter and cover only the missing points.

For technology transfer offices and incubators

An independent assessment of the clinical need and feasibility, before the market study, in a format that is comparable from one project to the next. The evaluation criteria are written before the assessment; any follow-up work with the project team only happens with your written agreement.

With a part-time project lead

The scoping can also be carried out within your team, about one day a week: I lead it with your engineers and clinicians, who keep the method afterwards.

Limits

• I give you a precise assessment, not a convenient “go / no-go”: the decision is yours, and nothing follows automatically.
• The class estimate is indicative; it is not a regulatory opinion.
• Hardware is not assessed, only its link with the software.
• Clinicians’ time, if paid, is agreed directly between them and you.

Who is it for?

• Companies that have decided to go ahead after a scoping, mine or one carried out elsewhere, and want to clear the last doubts before starting product development.
• Start-ups whose engineering team, often young, needs to build skills in medical software.
• SMEs that want to test a software feature before hiring.

What you get

• a prototype demonstrating the main functions of the requirements, on test data chosen before starting;
• a demonstration to your clinicians and your team, on a date set from the start, concluded by signed minutes;
• documented and tested code; the code specific to your project belongs to you.

Two ways of working

• On the open-source platform CamiTK: I develop the prototype on my own, or with your engineers while training them.
• On your existing software, as a part-time project lead: your team develops, I lead alongside it, about one day a week (priorities, technical choices, the clinicians’ voice).

If a scientific barrier is still open after the scoping, a capped exploratory phase, with a stop point, comes first.

Training your team

Training in CamiTK and in the method for prototyping medical applications, on your premises, based on the prototype’s code.

Documentation to move on to the product

If the project goes ahead, a transfer file for product development: software requirements, architecture revised after the prototype, software risk analysis, traceability. Documentation structured according to IEC 62304, ISO 14971 and IEC 62366-1, which serves as input to product development and to your technical file. Possible options: test plan, list of third-party components (SOUP), usability evaluation with clinicians.

Limits

• A prototype is not the product: it is used to decide; it is neither maintained nor optimised for performance.
• It assumes prior scoping: mine, or one already carried out elsewhere, which I review before starting.
• CE marking, the ISO 13485 quality system, the full MDR technical file and the relationship with the notified body remain your responsibility; I can refer you to partners.

Who is it for?

• Medical software SMEs that want to launch a new product without having found the right project lead.
• MedTech start-ups that must keep their roadmap without an experienced CTO.

What you get

• well-founded trade-offs and technical choices;
• the link with clinicians and the product priorities;
• a working method handed over to your team, so it can carry on alone.

To launch a product without hiring before you are sure it will be confirmed. This role can accompany the R&D scoping as well as the prototype.

Limits

This is not a salaried position: the assignment has written objectives and a set duration, and the team remains yours.