“How much is this going to cost , and how long will it take?”

Every new diagnostic idea starts the same way.

A founder walks into the lab with something that works.

There is energy. Momentum. Belief.

And then, usually within minutes, the question comes:

“So… how much is this going to cost, and how long until it’s ready?”

It is a fair question.

But it is also the moment reality starts to bite.

Because no one gets into diagnostics to spend years navigating regulation, clinical trials and documentation.

Yet that is exactly what turns an idea into a product that can be used in the real world.

At Maddison, we see this gap constantly. Not between science and possibility, but between expectation and reality.

Here is what the journey actually looks like in the UK.

1. Early validation is already more expensive than most expect

Before regulators are even involved, your test needs to prove one thing, reliably:

That it works. Every time.

That means analytical validation, repeatability and early clinical relevance.

Even at this stage, costs are not trivial.

The UK government’s own COVID-19 test validation programme showed that laboratory validation alone could cost £89,000 for non-SMEs and £35,000 for SMEs, just for desktop review and lab-based assessment.

And that is before:

• Product design
• Usability testing
• Manufacturing considerations
• Commercial planning

Most teams underestimate this phase because it still feels like “science”.

In reality, it is the first step towards a regulated product.

2. Regulation is not a hurdle , it is the framework

In the UK, an IVD is a regulated medical device. There is no route around that.

The Medicines and Healthcare products Regulatory Agency requires:

• Device registration, currently £261 per application
• Ongoing post-market surveillance fees, expected to be around £300 annually per device category from 2026

On paper, those numbers look manageable.

In practice, they are the smallest part of the cost.

The real investment sits in:

• Quality management systems
• Technical documentation
• Risk management and usability engineering
• Regulatory strategy and consulting

This is where costs quickly move into tens to hundreds of thousands of pounds, depending on complexity.

Regulation is not something you “do at the end”.

It is something you design into the product from the start.

3. Clinical evidence is where programmes succeed or fail

This is the point where theory meets reality.

Regulators, clinicians and buyers all want the same thing:

Proof that the test works in real clinical settings.

That means:

• Patient samples
• Defined study protocols
• Statistically robust data
• Auditable processes

In the UK, properly conducted clinical evaluation typically costs £200,000 to £1 million or more.

Guidance from the University of Glasgow suggests that even basic medical device investigations can reach £0.5 million, with more advanced studies running into £5–6 million.

These costs are not inflated.

They reflect the reality of running controlled, compliant clinical studies.

And critically, this is where poor design shows up:

• If workflows are unclear, results vary
• If usability is poor, data becomes unreliable
• If the product does not fit clinical practice, studies fail

At this stage, redesign is expensive.

4. Time is longer than most teams plan for

Even well-run programmes take time.

Based on UK regulatory and clinical pathways, a realistic timeline looks like:

• Early regulatory planning and quality setup: 3 to 9 months
• Clinical study design and execution: 6 to 18+ months
• Regulatory review and UKCA marking: 12 to 24 months

In total, most SMEs are looking at 2 to 4+ years from working prototype to a regulated product.

And that is before:

• NHS adoption
• Procurement cycles
• Market access

Speed in MedTech is not about moving faster.

It is about avoiding rework.

5. The cost does not stop at launch

One of the most common misconceptions is that costs end at approval.

They do not.

Post-market reality includes:

• Ongoing regulatory compliance
• Surveillance and reporting
• Product updates and iterations
• Commercial team costs

Industry data suggests that once fully operational, internal teams can push annual overheads to £400,000+, particularly if regulatory, clinical and commercial functions are built in-house.

Even baseline compliance now includes recurring MHRA fees.

This is not a one-off investment.

It is an operating model.

6. Funding helps , but only if planned early

The UK does offer support.

Innovation funding programmes have previously provided up to £250,000 to support clinical evidence generation and evaluation.

For early-stage teams, this can be critical.

But these opportunities are competitive and time-bound.

They only work if built into the development plan from the outset.

Where most programmes go wrong

Not because the science fails.

But because:

• Costs are underestimated
• Timelines are unrealistic
• Design is treated as a late-stage activity
• Regulation is approached as a final step

By the time these issues surface, they are expensive to fix.

The Maddison perspective

At Maddison, we work with teams at the point where these risks are still avoidable.

Not to make devices look better.

But to ensure they:

• Work in real clinical environments
• Generate reliable data in studies
• Meet regulatory expectations from day one
• Scale into manufacturable, usable products

Because in IVD development, value is not created in the lab alone.

It is created in the decisions made before the first study begins.

Final thought

When someone asks:

“How much will it cost , and how long will it take?”

The honest answer is:

More than you think. Longer than you hope.

But also this:

Entirely manageable , if you make the right decisions early.