The Funding Readiness Guide

Teams working through the GAITS framework build a progressively detailed picture of their project's maturity — what has been validated, what gaps remain, and where they stand relative to each stage of the innovation journey. This guide gives those teams a direct way to translate that picture into a funding strategy: identify the funding level that best matches the current evidence position, use the criteria to understand what it would take to compete credibly at the next level, and plan accordingly.

For teams approaching this guide without that foundation, the same principle holds. The most effective teams do not pick up this framework when they start preparing for a funding conversation. They pick it up when they start planning their work. The GAITS Funding Readiness Framework gives teams a clear picture of what funders will evaluate — so that picture shapes the work from the start, not after the fact.

The framework is built on four foundations:

Healthcare innovation funding follows a progression from early research grants through increasingly commercial investment stages. This framework begins where research funding ends — at the point where teams move from scientific exploration to structured development with a defined path to clinical and commercial adoption.

The five levels covered here represent the funding journey from first translational grant to institutional Series A. Their structure reflects the same de-risking logic at the heart of the GAITS programme. GAITS guides teams through a sequence of Deliverables focused on progressively validating and accelerating an innovation toward practice adoption — each Deliverable pushing the project to a lower-risk position and clearer path to clinical use. The funding levels here follow that same general sequence: each stage targets a distinct primary risk, requires a corresponding body of evidence, and has a distinct funder profile. The alignment between GAITS Deliverables and funding levels is not one-to-one — GAITS covers many Solution Types, each with its own Deliverable structure — but the sequences map well together, and teams progressing through the GAITS framework will find that Deliverable completion is a reliable indicator of funding stage readiness. The criteria apply across both US and EU contexts; where regulatory pathways or funding instruments differ by geography, this is called out at the relevant criteria level.

The five levels are not mandatory checkpoints — a team that raises enough capital in a single round to meet the evidence threshold for multiple stages can move directly to the level that matches their actual position. The framework describes where you stand, not a fixed sequence you must follow in order. Each level also includes typical raise size guidance: non-dilutive and dilutive capital ranges, ticket sizes, and funder counts for both the US and EU. And where the commercial path, regulatory requirements, or funder landscape differ meaningfully between HealthTech solutions — devices, diagnostics, and hardware — and Digital Medicine — software, AI, and SaMD — the framework treats them separately rather than forcing a single set of criteria onto both.

The Funding Readiness framework defines what funders actually evaluate at each stage of the funding ladder. It does not describe what funders say they evaluate — it describes what they act on. For each stage, criteria are separated into two categories and assessed across two independent dimensions.

Two aspects of the framework deserve particular attention before you work through the criteria.

Project readiness is largely objective. The evidence either exists or it does not. Following the GAITS framework systematically will build the project dimension — it is a process with a clear path.

Team readiness is different. There are objective attributes — role coverage, domain expertise, execution history, time commitment — that can be built and documented. But funders also bring their own judgment about fit, relationships, and conviction. Those factors vary from funder to funder and cannot be fully controlled. The implication is not to ignore the subjective dimension, but to focus your energy on what you can control, and enter funding conversations knowing exactly where your objective team strengths are and where genuine gaps remain.

Funders assess Project and Team independently because a weakness in either dimension represents a different kind of risk that requires a different response. A strong project with a weak team signals execution risk — the opportunity may be real but the people needed to realise it are not yet in place. A strong team with a weak project signals that effort and capability are being applied to an insufficiently validated opportunity. Conflating the two masks these distinctions and produces misleading readiness assessments.

At every stage, criteria are divided into two tiers. Must-Have criteria are gating: a team that cannot demonstrate them is not fundable at that stage regardless of other strengths. Should-Have criteria increase confidence and competitiveness, but they do not compensate for a Must-Have gap.

Both dimensions — project and team — must meet the readiness threshold independently. A strong project with a weak team signals execution risk. A strong team with a weak project signals an underdeveloped opportunity. Both must be addressed.

Must-Have criteria are assessed independently for Project and Team. Both dimensions must meet the threshold — a strong project with a weak team, or vice versa, does not produce a ready result.

Teams working through the GAITS framework build a progressively detailed picture of their project's maturity — what has been validated, what gaps remain, and where they stand relative to each stage of the innovation journey. This guide gives those teams a direct way to translate that picture into a funding strategy: identify the funding level that best matches the current evidence position, use the criteria to understand what it would take to compete credibly at the next level, and plan accordingly.

For teams approaching this guide without that foundation, the same principle holds. The most effective teams do not pick up this framework when they start preparing for a funding conversation. They pick it up when they start planning their work. The GAITS Funding Readiness Framework gives teams a clear picture of what funders will evaluate — so that picture shapes the work from the start, not after the fact.

The framework is built on four foundations:

Healthcare innovation funding follows a progression from early research grants through increasingly commercial investment stages. This framework begins where research funding ends — at the point where teams move from scientific exploration to structured development with a defined path to clinical and commercial adoption.

The five levels covered here represent the funding journey from first translational grant to institutional Series A. Their structure reflects the same de-risking logic at the heart of the GAITS programme. GAITS guides teams through a sequence of Deliverables focused on progressively validating and accelerating an innovation toward practice adoption — each Deliverable pushing the project to a lower-risk position and clearer path to clinical use. The funding levels here follow that same general sequence: each stage targets a distinct primary risk, requires a corresponding body of evidence, and has a distinct funder profile. The alignment between GAITS Deliverables and funding levels is not one-to-one — GAITS covers many Solution Types, each with its own Deliverable structure — but the sequences map well together, and teams progressing through the GAITS framework will find that Deliverable completion is a reliable indicator of funding stage readiness. The criteria apply across both US and EU contexts; where regulatory pathways or funding instruments differ by geography, this is called out at the relevant criteria level.

The five levels are not mandatory checkpoints — a team that raises enough capital in a single round to meet the evidence threshold for multiple stages can move directly to the level that matches their actual position. The framework describes where you stand, not a fixed sequence you must follow in order. Each level also includes typical raise size guidance: non-dilutive and dilutive capital ranges, ticket sizes, and funder counts for both the US and EU. And where the commercial path, regulatory requirements, or funder landscape differ meaningfully between HealthTech solutions — devices, diagnostics, and hardware — and Digital Medicine — software, AI, and SaMD — the framework treats them separately rather than forcing a single set of criteria onto both.

The Funding Readiness framework defines what funders actually evaluate at each stage of the funding ladder. It does not describe what funders say they evaluate — it describes what they act on. For each stage, criteria are separated into two categories and assessed across two independent dimensions.

Two aspects of the framework deserve particular attention before you work through the criteria.

Project readiness is largely objective. The evidence either exists or it does not. Following the GAITS framework systematically will build the project dimension — it is a process with a clear path.

Team readiness is different. There are objective attributes — role coverage, domain expertise, execution history, time commitment — that can be built and documented. But funders also bring their own judgment about fit, relationships, and conviction. Those factors vary from funder to funder and cannot be fully controlled. The implication is not to ignore the subjective dimension, but to focus your energy on what you can control, and enter funding conversations knowing exactly where your objective team strengths are and where genuine gaps remain.

Funders assess Project and Team independently because a weakness in either dimension represents a different kind of risk that requires a different response. A strong project with a weak team signals execution risk — the opportunity may be real but the people needed to realise it are not yet in place. A strong team with a weak project signals that effort and capability are being applied to an insufficiently validated opportunity. Conflating the two masks these distinctions and produces misleading readiness assessments.

At every stage, criteria are divided into two tiers. Must-Have criteria are gating: a team that cannot demonstrate them is not fundable at that stage regardless of other strengths. Should-Have criteria increase confidence and competitiveness, but they do not compensate for a Must-Have gap.

Both dimensions — project and team — must meet the readiness threshold independently. A strong project with a weak team signals execution risk. A strong team with a weak project signals an underdeveloped opportunity. Both must be addressed.

Must-Have criteria are assessed independently for Project and Team. Both dimensions must meet the threshold — a strong project with a weak team, or vice versa, does not produce a ready result.