1–3: Problem, user and payer
First ask what decision or workflow the product changes. Second, identify the daily user. Third, identify who pays. These may be three different people: a veterinarian uses the product, a practice group signs the contract, and an owner ultimately funds the service.
If the company cannot describe today’s alternative—including doing nothing—the claimed market may be more theoretical than real.
4–6: Evidence, regulation and claims
What evidence supports the core claim? What regulatory category is likely to apply in the United States? What exact wording will the company use to market the product? These questions are connected.
A wellness product, a diagnostic, a veterinary device and a new animal drug can face very different paths. Founders do not need every answer on day one, but they should understand which uncertainties can change cost and timing.
7–9: Workflow, economics and distribution
How does the product fit into clinic operations? What economic benefit does the customer receive? How will the company reach customers at a sustainable acquisition cost?
A product that saves two minutes in a rare workflow may be less valuable than a modest tool used fifty times per day. Distribution through veterinary groups, laboratories, distributors, manufacturers or direct sales each changes margins and speed.
10–12: Defensibility, team and milestones
What becomes harder to copy as the company grows? Does the team combine scientific or clinical credibility with commercial execution? What milestone will materially reduce risk before the next financing round?
Good milestones are specific: complete a pivotal study, obtain an FDA technical-section completion, reach a defined number of active clinics with target retention, or demonstrate a reproducible diagnostic performance threshold.
Primary resources
- FDA – Development & Approval Process
- USDA APHIS – Veterinary Biologics