03 · Specialist solutions
Defined programmes
Where a problem recurs, we build a way to solve it.
Three programmes developed out of the consultancy, each for a challenge the industry keeps facing. They are specialist services built on MDS experience — not the whole of what we do.
Reimbursement
TariffPath™ · with Real Healthcare Solutions
The rules of Part IX reimbursement are being rewritten.
Navigate change. Protect access. Accelerate growth.
Part IX of the Drug Tariff is the route by which eligible medical devices are prescribed in primary care and reimbursed by the NHS. Reform led by the Department of Health and Social Care is introducing new assessment methods and a far heavier emphasis on value and evidence — the most significant structural change to Part IX in decades.
For manufacturers with listings, that is not a regulatory footnote. It is revenue, market access and patient choice, all of which can be lost at renewal. TariffPath™ was created by James Saunders of Med Dev Services and Richard Shorney of Real Healthcare Solutions to pool commercial and Drug Tariff expertise into one specialist service.
Four situations it is built for
Scenario
New category
Building the strategic case for a new product category, with clinical differentiation mapped against DHSC expectations.
Scenario
New application
Entering an existing category — identifying evidence gaps and benchmarking against the competitive set.
Scenario
Renewals
Early risk profiling to identify delisting exposure across a portfolio, with mitigation planned before the deadline.
Scenario
Appeals
Decision analysis, evidence reframing and modelling of the commercial impact of an adverse outcome.
A structured, three-phase engagement
PHASE 1 · 3 DAYS
Scope & strategy
Project scoping and definition of the strategic position to be argued.
PHASE 2 · 4 DAYS
Feasibility
Assessment against the DHSC Product Evaluation Criteria, with evidence gaps identified.
PHASE 3 · 5 DAYS
Application
Drafting and submission readiness, so the case goes in as strongly as it can.
For UK and international manufacturers with Part IX listings, and the commercial decision-makers carrying the revenue risk.
Real-world evidence
Post Market Insights™ · with Wound Care People
A real-world evidence solution to your PMS challenge.
Post-market surveillance evidence delivered quickly, efficiently and MDR audit-formatted — and useful long after the file is closed.
Under MDR 2017/745, a PSUR must be updated at least every two years for Class IIa and IIb devices, and updated and submitted to the notified body annually for Class III and implantable devices. Meeting that obligation is harder than it looks: distribution channels sit between manufacturers and clinicians, direct engagement is limited, GDPR complicates data collection, and the data that does exist is fragmented across sources.
Med Dev Services partnered with Wound Care People to solve the access problem at source — a database of more than 135,000 active, GDPR-compliant UK healthcare professionals who provide structured feedback on devices they actually use.
What it satisfies
- PMS and PSUR obligations under MDR 2017/745
- Audit-formatted output for notified body submission
- GDPR-compliant data collection
- Structured, documented methodology
What it also tells you
- How the product is genuinely used in practice
- Where it underperforms, and against whom
- Evidence to support access and reimbursement
- Direction for product development and lifecycle decisions
Real-world evidence now supports market access and market retention, not only compliance — as procurement moves toward value and outcomes.
International
Africa–Europe MedTech Bridge
Bridging continents, in both directions.
A strategic gateway for medical device innovation, commercialisation and growth between Europe and Africa.
Med Dev Services, Real Healthcare Solutions and South Africa-based O2 Blue Consult have joined forces to create a route between two MedTech ecosystems that rarely reach each other cleanly. Between them the three consultancies bring decades of market access, commercial strategy, business development and healthcare innovation experience.
For European manufacturers, that means practical insight, local ecosystem engagement and strategic support to establish sustainable commercial pathways into high-potential African markets. For African MedTech innovators, it means a considered route toward European market access — positioning, commercial strategy and the foundations required for international expansion.
Following an invitation to South Africa in April 2026, the collaboration contributed as speakers at GlobalPathways: Scaling Health & Life Sciences, organised by WESGRO in Cape Town.
Partner
Med Dev Services
Commercial strategy, market access and product development across single-use medical devices. United Kingdom.
Partner
Real Healthcare Solutions
Market access and reimbursement specialists. United Kingdom.
Partner
O2 Blue Consult
Healthcare innovation and commercialisation. South Africa.