Market Access
& Development

Unlocking commercial pathways for health and medical technology

Getting regulatory approval is only part of the journey. We guide companies from first market entry through to commercial scale, navigating NHS procurement, HTA, reimbursement and global expansion.

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20+

Global markets served

£27bn

UK Medtech sector value

3500+

Medtech companies in the UK

01 - MARKET ACCESS

Understanding the landscape

Key barriers we help you overcome

The UK and global health and medical technology landscape presents complex market access challenges. We help you navigate them with clear, commercially focused strategies.

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Clinical evidence gaps

Insufficient clinical data limits both approval and adoption. We design evidence strategies that satisfy regulators, HTA bodies and investors.

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NHS procurement complexity

Fragmented procurement processes make it difficult to convert pilots into long-term contracts. We align your proposition with NHS evaluation criteria to support commercial adoption.

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Regulatory uncertainty

UK and EU divergence creates complexity for companies targeting multiple markets. We develop aligned strategies across MHRA, FDA and EU frameworks.

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Growth and funding challenges

Companies seeking scale often face barriers when engaging investors. We strengthen regulatory and clinical positioning to support investment readiness.

KEY STATISTICS

The scale of market access challenges

Market access is shaped by complex reimbursement pathways, fragmented data and evolving healthcare systems. These figures highlight the challenges companies face when bringing products to market.

$164bn

Global medical device reimbursement market

97%

of healthcare data goes unused or remains unstructured

2026

EU Joint Clinical Assessments expand to high-risk medical devices

02 - OUR CAPABILITIES

Market access & development services

From first NHS engagement to multi-market commercial launch, we provide end-to-end support tailored to your product and commercial objectives.

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NHS procurement & market entry

We guide clients through NHS procurement, NICE evaluation and Supply Chain approval.

  • NHS Innovation Service navigation

  • NICE MedTech Innovation Briefings

  • Integrated Care System engagement

  • Procurement framework alignment

  • Pilot-to-contract conversion

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HTA & reimbursement

We develop HTA submissions, economic models and clinical effectiveness dossiers for payers across multiple health systems.

  • NICE HTA strategy and submission

  • Health economic modelling

  • QALY and cost-effectiveness analysis

  • Real-world evidence strategy

  • International reimbursement mapping

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International reimbursement mapping

We build regulatory roadmaps for global expansion.

  • UKCA and EU MDR/IVDR strategy

  • FDA 510(k), PMA and De Novo pathways

  • APAC regulatory pathways

  • Notified Body selection and support

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Commercial launch advisory

We support go-to-market strategy and adoption.

  • Market sizing and opportunity analysis

  • KOL engagement strategy

  • Distributor and partner identification

  • Commercial readiness assessment

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Clinical evidence generation

We build evidence frameworks aligned to regulators and payers.

  • Clinical evidence gap analysis

  • PMCF study design

  • CER preparation

  • Literature review

  • Safety and performance evaluation

03 - GLOBAL REACH

Markets we support

United Kingdom

· MHRA
· UKCA
· NHS
· NICE

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European Union

· EU MDR
· CE marking
· CE EUDAMED

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United States

· FDA
· 510(k)
· PMA
· De Novo

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APAC & ROW

· TGA
· ARTG

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· NMPA

· PMDA
· MHLW

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· HSA
· ASEAN

Middle East / Africa

· MOH UAE

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· SAHPRA

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· SFDA

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04 - FOCUS: NHS MARKET ACCESS

Navigating the UK’s complex procurement landscape

The NHS represents one of the largest single-payer healthcare markets in the world — and one of the most complex to access. Clearpath has deep expertise in NHS procurement pathways, ICS structures, and NICE evaluation processes.

Clinical Evaluation Reports (CER)

Comprehensive CERs prepared to MDR Annex XIV and MEDDEV 2.7/1 rev 4 standards - the cornerstone of EU and UK market access for Class IIa, IIb and III devices.

Post-Market Clinical Follow-up (PMCF)

PMCF study design, protocol development and study management to fulfil ongoing regulatory obligations and generate real-world evidence for commercial positioning.

Health economic modelling

Cost-effectiveness and cost-utility analyses that demonstrate value to commissioners, payers and HTA bodies across UK, EU and international markets.

Literature review & state of the art

Systematic literature reviews establishing the current standard of care and demonstrating clinical superiority or equivalence against predicate devices.

Clinical trial design & management

End-to-end support for IDE applications, clinical investigation design, ethics submissions and trial management for devices requiring investigation data.

Real-world evidence strategy

Design of registries, observational studies and real-world data collection frameworks for regulatory compliance, HTA submissions and commercial positioning.

"Navigating the complex landscape of health and medical technology regulation and market access is one of the greatest challenges facing innovators today."

05 - CLINICAL EVIDENCE

Building the evidence that opens markets

Market access and clinical evidence are inseparable. Clearpath designs evidence generation strategies that simultaneously satisfy regulatory requirements, HTA bodies and investor due diligence.

NHS access pathways we navigate:

NHS Innovation Service
The primary entry point for new MedTech products seeking NHS adoption

NICE MedTech Innovation Briefings
Independent assessments that accelerate NHS commissioner confidence

NICE guidance
Formal HTA recommendations that drive commissioning decisions across ICBs

NHS Supply Chain
The commercial framework for scaling from individual trust to national contracts

Integrated Care Board commissioning
Local healthcare system engagement and adoption strategies

Academic Health Science Networks
Partnership opportunities to accelerate adoption across regions

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Get clear, practical guidance on your approval and market access strategy.

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