Step 1: Confirm your classification early
Decide with specialist advice whether your product is a medical device under MHRA rules and, if you plan to sell in Europe, the EU MDR. The intended purpose you write down drives this, so be careful with claims in marketing and pitch materials.
Step 2: Build an evidence plan and cost it
Lay out each stage of evidence — retrospective validation, prospective studies, real-world deployment — with its cost, time and partners. Put this plan in your financial model. Investors fund milestones, so each round should buy a clear step forward.
- Clinical partners and principal investigators identified.
- Data access agreements with lawful basis and ongoing rights.
- A clinical safety officer and safety case process where required.
Step 3: Find a buyer who can pay now
NHS adoption is valuable but can be slow. Consider a first market that moves faster — private providers, insurers, life sciences companies or overseas health systems — while building the NHS case. Show investors who holds the budget and what it replaces.
Step 4: Stage your fundraising
Healthtech rounds are often staged: a smaller round to reach validation, a larger round after approval or first contracts. Grants and research partnerships can fund early studies. Avoid raising a large round on optimistic approval dates.
Step 5: Prepare for heavy diligence
Expect questions on data protection, cyber security, clinical safety and intellectual property. Having your quality management documents, data protection assessments and security standards organised shortens the process considerably.
Healthtech milestone checklist before each round
| Round | Milestone to reach before raising | What the money buys |
|---|---|---|
| Pre-seed | Clinical need validated with named clinicians | Prototype and retrospective validation |
| Seed | Validation results and classification confirmed | Prospective evidence and regulatory work |
| Series A | Approval or paid deployments | Commercial scale-up |
Questions to prepare before you pitch
- What is your intended purpose statement, and what classification follows?
- What evidence do you need, and what will it cost?
- Who pays in your first market, and from which budget?
- Do you keep long-term rights to the data you trained on?
- What happens if approval takes twice as long as planned?
How KJ Enterprises evaluates healthtech businesses
KJ Enterprises considers healthtech businesses with a realistic regulatory plan, a clear first buyer and AI that saves clinical time or improves outcomes. We prefer founders who stage their funding honestly around milestones.
If that describes your company, you can apply for investment. Related reading: the complete healthtech funding guide and how to raise for a machine learning company.
Frequently asked questions
Can grants fund clinical studies?
Often yes. UK research and innovation funding can support studies, though timelines and eligibility vary, so plan applications well ahead.