Part 4: Showing Traction & Preparing for the Fundraise

Use this as a common language with investors. You should adapt the wording to your domain.

Further notes on TRLs

• Often times your innovation will be the lowest TRL part of a more mature system. Make sure you investors understand where the technology risk resides (i.e. what is the lowest TRL part of the system)
• The bigger and easier your market opportunity is, the more technology risk the investor can afford to take. If the end market is energy generation you can support a lower TRL than if your application is in Defense.

• Define your null hypothesis at every stage - Before you begin, articulate clear criteria for what would make you stop or pivot at each TRL. Too many founders push forward on sunk cost rather than evidence. What specific technical, clinical, or market signals would definitively prove your approach wrong?
• Regulatory strategy shapes everything, start early - Your regulatory pathway fundamentally determines your development timeline, clinical strategy, and capital requirements. Engage regulatory consultants at TRL 3-4, not TRL 6. A Class III device requiring PMA versus a Class II 510(k) represents vastly different risk profiles and funding needs.
• Quality thinking begins on day one - ISO 13485 and design controls aren't compliance boxes to tick later - they're fundamental frameworks that shape how you collect data, manage changes, and build evidence packages. Starting this discipline early prevents costly redesigns and lost data.
• Clinical evidence is your most expensive risk - Plan your clinical strategy before you freeze your technology. Every design change after TRL 5 potentially invalidates clinical work. Map your evidence generation requirements early and design your technology development to support efficient clinical validation.
• Commercial viability matters as much as technical feasibility - Regulatory approval gets you permission to sell, not customers who will buy. Market access, health economics, and adoption barriers often prove harder than the technical challenges. Validate your commercial assumptions throughout development, not just at the end.

Investor Notes: Spin-outs most commonly occur at TRL 3-4, when proof-of-concept is established but significant engineering and clinical validation remains. This timing maximises the university's IP value whilst leaving substantial value creation for the commercial entity - but beware that most founders underestimate the capital and time required to reach TRL 7 which is typically where strategic investors (i.e. medical device companies) look to invest.