Healthtech Readiness Check

1. Do you have clinical data from your product in its intended-use population?

2. Is your evidence prospective, retrospective, or both, with a registered or pre-specified protocol?

3. Which performance metrics have you measured, and against what comparator?

Examples: sensitivity, specificity, PPV/NPV, time-to-decision, AUROC.

4. Have you measured a change in patient or clinician outcomes, not just accuracy?

5. What is your primary protection?

6. Have you filed for IP protection on any part of the product or program?

Discuss the IP options that can enhance your valuation with our team. Protection does not have to wait for a groundbreaking invention.

7. Do you hold rights to your training data, with patient consent and de-identification documented?

8. Has a freedom-to-operate review covered your core software, AI components, and open-source licences?

9. Can you name your three closest competitors and what each has cleared or launched?

10. Do you have a predicate device or clear comparator for your regulatory submission?

11. What would make a hospital or payer switch from the incumbent to you, and can you quantify it?

12. Have well-funded entrants appeared in your indication in the last 12 months?

13. Which adjacent fields could make your approach obsolete or stronger within three years?

14. Do published academic studies support or challenge your core mechanism?

15. Does your product depend on a third-party model, sensor, or platform, and is continuity assessed?

16. Have you assessed cybersecurity and interoperability standards (for example HL7 FHIR, IEC 62304, ISO 14971)?

17. Which comes first for your product: revenue or regulatory clearance?

18. Which regulatory path do you intend to take, and have you held a pre-submission meeting?

19. Do you have a billing code (CPT/HCPCS) or a planned coverage pathway for your product?

20. Pilots: signed agreements, conversion terms, and references