The operational budget lines that healthtech founders leave out of every grant application

QMS Development

Quality management system development is a legitimate project cost, not overhead

If your healthtech product needs ISO 13485 (medical devices) or ISO 27001 (information security), the work of building that system — documentation, process design, internal audits, gap analysis — is a fundable project activity. It’s not overhead. It’s a deliverable that directly enables your product to reach its regulated market. The cost depends heavily on scope and whether you already have someone who knows regulation well enough to drive it. If you do, this can be very lean. If you need to hire someone, costs rise — but that hire is itself a fundable project cost. Present it as a dedicated work package with clear milestones: “Month 3: Gap analysis complete. Month 6: Documentation framework established. Month 9: Internal audit conducted.”

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Regulatory Prep

Regulatory pathway preparation belongs in your Gantt chart, not your overheads

MHRA classification work, DTAC preparation, clinical safety case development (DCB0129), CE/UKCA marking preparation — these are project activities with defined deliverables. A highly experienced regulatory consultant at £800–£1,200 per day for 10–15 days across a 24-month project is £8,000–£18,000 — and it’s the difference between a project that ends with a validated prototype and one that ends with a prototype that’s actually ready for its regulated market.

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Operational Leadership

Fundable — and it signals maturity to assessors

A budget line for operational oversight, compliance management, and board reporting is legitimate in most NIHR and Innovate UK competitions. Present it as “Project Lead” or “Operations” — language that assessors recognise. It tells the assessor you understand the project needs more than technical execution. A lot of founders skip this line entirely because nobody told them they could include it. But experienced founders will tell you they learned the hard way that separating operational delivery from the founding team’s commercial work is what keeps the project on track. Assessors tend to agree: evidence that someone is managing delivery, compliance, and governance — without pulling the founder away from fundraising and sales — is usually favoured.

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Hiring Plan

Where most founders under-budget — always better to over-anticipate

A common mistake is not thinking far enough ahead about the team you’ll need. It’s always better to over-anticipate and end the project with funds left over than to discover mid-project that you missed a crucial hire. If your project includes bringing on 2–3 people, budget for onboarding, contracts, and the team infrastructure that determines whether those hires actually deliver. It’s a fraction of the salary costs and it prevents the most common operational failure in grant-funded startups: brilliant people with no structure around them.

The principle: every operational cost that makes your project more likely to produce a real-world, market-ready outcome is a cost your funder should see in your budget. Hiding these in overheads or leaving them out doesn’t make you look better value — it makes your project look less realistically deliverable. Put them in, name them clearly, and let the assessor see that you’re building a company, not just running a research project.