GAITS Glossary

An individual who invests personal capital in early-stage companies, typically at the seed or pre-seed stage.

US federal agency that funds high-risk, high-reward health research through milestone-based contracts. Relevant for HealthTech and Digital Medicine teams with ambitious, mission-driven propositions at Seed and Seed+ stage.

Annual Recurring Revenue — the annualized value of subscription or recurring contract revenue.

H-BMC Block 5 — regulatory bodies, payors, specialty boards, and other institutional forces that shape market access.

US federal agency that funds advanced development of medical countermeasures against biological, chemical, nuclear, and pandemic threats. A major non-dilutive funding source for HealthTech companies at Seed+ and Series A stage.

The specific, narrowly defined initial market segment a company targets first to establish a commercial foothold before expanding.

A short-term funding raise designed to extend runway to a defined milestone — typically the next major funding event. Not a standalone funding strategy; the narrative must be explicit about the destination milestone.

Customer Acquisition Cost — the total cost of acquiring a single customer, including sales, marketing, and onboarding expenses.

A spreadsheet or document showing the equity ownership of a company, including all shareholders and their percentage ownership.

The European regulatory approval marking required for medical devices and in vitro diagnostics sold in the European Economic Area, issued under the EU Medical Devices Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR).

H-BMC Block 9 — how the solution reaches stakeholders and what ongoing relationships sustain adoption.

A structured study evaluating the safety and/or efficacy of a medical product in human subjects.

The tendency to weight evidence that confirms prior beliefs and discount evidence that challenges them.

A debt instrument that converts to equity at a future financing round, used for early-stage investment.

H-BMC Block 13 — what it costs to operate the business model at scale.

A standardized code used to describe medical procedures and services for billing purposes.

A structured healthcare innovation program that guides early-stage teams through customer discovery, business model development, and commercialization strategy.

Tier 3 of the Stakeholder Interviewing Rules: violations that reduce the precision and comparability of data collected.

Tier 1 of the Stakeholder Interviewing Rules: violations that collapse the discovery space entirely.

Tier 2 of the Stakeholder Interviewing Rules: violations that systematically skew findings without collapsing the interview.

A defined piece of work at one Innovation Maturity Level in one domain, with its own percent-complete status.

Healthcare solutions delivered primarily through software, including software that diagnoses, monitors, or treats disease and software that supports clinicians in treatment decisions.

Software that delivers an evidence-based therapeutic intervention to prevent, manage, or treat a medical condition.

The reduction in existing shareholders' ownership percentage caused by the issuance of new shares.

Capital provided to a company in exchange for equity or ownership stake — including angel investment, venture capital, and accelerator equity. Contrasts with non-dilutive funding, which does not require giving up ownership.

A structured stakeholder conversation designed to generate unbiased data about problems, behaviors, and needs — before any solution is introduced.

The process of deriving reliable insights from qualitative discovery interview data.

The investigation and verification process conducted by investors before completing an investment.

H-BMC Block 3 — the individuals or institutions that control the budget and make the purchasing decision.

EU funding programme offering blended finance (grant up to €2.5M plus equity up to €15M) for high-potential SMEs with breakthrough innovations. Highly competitive; relevant for EU-based HealthTech and Digital Medicine companies at Seed+ and Series A stage.

The event through which investors realize a return on their investment — typically through acquisition or IPO.

H-BMC Block 4 — clinical champions, KOLs, and other individuals who shape adoption without controlling the budget.

An interview conducted to understand a problem space without any predetermined hypothesis about what the solution should be.

The FDA's authorization for a medical device or drug to be marketed in the US, granted through the PMA or NDA pathway after demonstration of safety and efficacy.

The FDA's authorization for a medical device to be marketed in the US, granted through the 510(k) substantial equivalence pathway.

The rule requiring a deliberate closing sequence at the end of every discovery interview.

The rule requiring questions to focus on past or current behavior rather than hypothetical or future intentions.

The Guidance And Impact Tracking System: software that healthcare innovation teams and the programs that support them use to plan, track, and report project progress from unmet need to standard of care.

The percentage of revenue remaining after subtracting the direct costs of delivering the product or service.

A structured framework for building and testing healthcare innovation business models, organized as 15 blocks across 5 tiers.

The five organizational layers of the H-BMC: Value Foundation, Stakeholder, Economic Model, Operations, and Financial.

The four parallel dimensions tracked at every Innovation Maturity Level: Clinical/Workflow, Market/Business, Regulatory, and Technical/Science.

The framework GAITS implements: ten Innovation Maturity Levels based on Technology Readiness Levels (TRLs), from Need to Standard of Care, tracked across four domains critical to developing a healthcare solution.

Healthcare innovations whose primary regulated component is physical hardware — including medical devices, diagnostics, IVDs, and combination products subject to FDA device regulation. Software-only solutions, including SaMD, are classified as Digital Medicine.

The EU's primary research and innovation funding programme (2021–2027, ~€95.5B budget), covering activities from fundamental research to market-ready innovation through ERC, EIC, and Pillar 2 Health Cluster instruments.

A National Science Foundation program that trains researchers and innovators in customer discovery methodology for technology commercialization.

The team's rating of how impactful a meeting was overall, entered on each Meeting Record.

One of the ten stages of the Healthcare Innovation Cycle, from Need (IML 1) to Standard of Care (IML 10).

H-BMC Block 15 — the gross margin, unit economics, capital requirements, and return potential of the business model.

Intellectual Property — legally protected creations including patents, trade secrets, copyrights, and trademarks.

H-BMC Block 11 — the critical activities the company must perform to deliver its value promise and execute its business model.

H-BMC Block 10 — external relationships and organizations that make the business model possible.

H-BMC Block 12 — the assets that make the business model defensible and operational.

Key Opinion Leader — a clinician or researcher whose expertise and reputation significantly influence clinical practice and adoption of new technologies.

Lifetime Value — the total revenue a company expects to generate from a single customer over the duration of the relationship.

H-BMC Block 7 — the volume of potential use cases, expressed as addressable patients, procedures, or episodes.

The GAITS feature a team uses to record its meetings, such as mentor, stakeholder, regulatory, and investor meetings.

Gating criteria in the GAITS Funding Readiness Framework. A team that cannot demonstrate these is not fundable at that stage regardless of other strengths. Must-Have gaps should be addressed before submitting.

The rule requiring narrative questions rather than yes/no questions.

The rule requiring each question to address only one construct.

The rule prohibiting interviewers from correcting factually incorrect statements made by interviewees.

The rule prohibiting questions that could be answered through basic pre-interview research.

The rule prohibiting questions about desirability without revealing the associated tradeoffs.

The rule prohibiting summarizing, paraphrasing, or validating interviewee responses during an interview.

The rule prohibiting questions that embed assumptions or suggest expected answers.

Capital provided to a company that does not require the company to give up equity or ownership.

The rule requiring interviewers to follow stakeholder-driven threads rather than forcing the conversation back to a prepared script.

The rule prohibiting any framing of the interview context before questioning begins.

The rule prohibiting any introduction of a solution, product, or technology during a discovery interview.

A limited, time-bound implementation of a product at a customer site to evaluate performance and fit before a full commercial commitment.

Premarket Approval: the FDA review process for Class III medical devices, which requires evidence of safety and effectiveness, usually from clinical trials.

A GAITS site that groups Solution Sites so a program can manage access and monitor progress across its teams.

The second funding level in the GAITS Funding Readiness Framework — early-stage investment to validate a proof of concept and define the path to a Seed round, where the primary risk is technical and clinical feasibility.

The route a product must follow to gain authorization for sale in a given market, set by the product's classification and the jurisdiction.

The mechanism by which healthcare providers are paid by insurers or government payors for using a medical product or service.

H-BMC Block 14 — the revenue the business model generates at scale, derived from market size and transaction model.

A qualitative threshold suggesting that a pattern heard from approximately seven independent sources is likely to reflect a real market signal.

Simple Agreement for Future Equity — an instrument that grants the right to equity at a future priced round without accruing interest.

Software as a Medical Device — software that performs a medical function independent of any hardware device it runs on.

Small Business Innovation Research — a US federal grant program funding early-stage research and development at small businesses.

A bridge or extension round targeted at a specific Series A-ready milestone, requiring proof that Seed investment produced its intended results and demonstrating repeatability beyond the initial pilot context.

The third funding level in the GAITS Funding Readiness Framework: structured investment against defined milestones, where the primary risk is execution under real-world conditions and the team must present a coherent business case alongside technical progress.

Early-stage equity investment used to fund initial product development, team building, and early validation.

The distortion introduced when the people interviewed are not representative of the target population.

The fifth and final funding level in the GAITS Funding Readiness Framework — institutional venture funding to scale a de-risked asset, where the investment thesis must be financially defensible on its own terms.

A venture capital round used to scale commercial operations following initial market validation.

Strengthening criteria in the GAITS Funding Readiness Framework. These increase confidence and competitiveness but do not override a Must-Have failure. Teams with strong Should-Have evidence stand out from the field.

Tier 4 of the Stakeholder Interviewing Rules: missed opportunities that leave insight unretrieved and stakeholder access unexploited.

A private GAITS site where one team plans and tracks one project, built on one Solution Type.

The template a Solution Site is built on, which sets its Deliverables for a class of healthcare products.

A set of 12 rules for conducting exploratory stakeholder interviews that generate valid, unbiased discovery data.

Investment from a corporation — typically a healthcare system, device company, pharma company, or payor — with both financial and strategic motivations.

Small Business Technology Transfer — a federal grant program requiring collaboration between a small business and a research institution.

The full addressable population of potential customers a company could ultimately serve with its solution.

A non-binding document outlining the key terms and conditions of a proposed investment.

H-BMC Block 8 — how each use of the solution converts to revenue.

The first funding level in the GAITS Funding Readiness Framework — mission-driven funding for teams with a defined unmet need and a plausible technical approach, where the primary risk is scientific and translational feasibility.

H-BMC Block 2 — the individuals who directly use the solution in clinical or operational practice.

The estimated worth of a company at a given point in time, used to determine the price of equity in a financing round.

A hospital committee responsible for evaluating new products and technologies for clinical value, safety, and economic impact before approving them for institutional use.

H-BMC Block 1 — the core unmet need, why it matters, and why the solution is the right answer.

H-BMC Block 6 — the economic case for institutional buyers, translating clinical value into measurable financial impact.

Institutional equity investment in high-growth potential companies in exchange for ownership stake.

A planned unit of work that groups related Deliverables, with a Responsible Person, schedule, budget, and status.