The Challenge
Where international companies get it wrong
he UK digital health market operates on its own regulatory framework, procurement logic, and clinical safety standards. What qualifies a product for market in the US, EU, or GCC does not automatically transfer. International companies routinely underestimate the compliance burden, misjudge how NHS commissioners evaluate products, and arrive at procurement conversations without the evidence stack those conversations require.
Our Deliverables
What we help international companies with
Market Assessment
Understanding what the UK market requires before you commit resources.
- UK regulatory landscape mapping
- DTAC and clinical safety gap analysis
- NHS procurement entry route assessment
Compliance Build
Constructing the evidence stack UK commissioners need to see.
- DTAC self-assessment and submission
- DCB0129 clinical safety documentation
- MHRA classification and pathway strategy
Market Entry
Supporting first commissioner engagements and ongoing UK presence.
- Commissioner meeting preparation
- UK market entry roadmap
- Ongoing regulatory advisory
Automation examples
See what's possible
Full UK Market Entry Programme
- UK compliant. First NHS conversations opened.
GCC Investor Due Diligence
- Investment decision supported. Risks identified early.
MHRA Regulatory Strategy
- MHRA pathway confirmed. UK launch de-risked.
Typical outcomes
The impact of entering the UK market properly
faster
time
to first NHS commissioner engagement when UK compliance is built before the sales cycle begins
reduction in
procurement
rejection risk when DTAC and clinical safety are addressed before submission
“International companies that enter the NHS market without specialist advisory do not just lose time. They damage relationships with the commissioners they most need to impress.”
Dr Jide Idowu, Founder, SDHA
- Full Market Entry
End-to-end UK market entry programme for a US-based remote monitoring company. DTAC submission, DCB0129 safety case, and MHRA pathway all completed within twelve weeks. First NHS commissioner meeting booked before programme close.
- GCC Advisory
Regulatory due diligence and UK market assessment for a GCC health technology investor evaluating a UK digital health acquisition. Full regulatory position report produced in three weeks.
- MHRA Pathway
SaMD classification and MHRA regulatory strategy for an EU AI diagnostic tool entering the UK post-Brexit. Classification confirmed, UKCA pathway mapped, and investor-ready regulatory strategy document produced.
