- The challenge
- DHSC reform of Part IX of the Drug Tariff introduced new assessment methods and a heavier emphasis on value and evidence — the most significant structural change to this reimbursement route in decades. Manufacturers faced delisting exposure at renewal, uncertainty over new applications, and no established playbook for responding.
- What we did
- Rather than treat each client's exposure as a one-off, we built a defined service. TariffPath™ was created with Richard Shorney of Real Healthcare Solutions, combining Drug Tariff expertise with commercial strategy, and structured as a three-phase engagement: scoping and strategy, feasibility assessment against the DHSC Product Evaluation Criteria, then application drafting and submission readiness.
- The outcome
- A repeatable route through Part IX covering the four situations manufacturers actually face — creating a new category, applying within an existing one, protecting a listing at renewal, and appealing an adverse decision — with policy developments tracked continuously from DHSC, NHS bodies and reimbursement authorities.
- Why it mattered
- Part IX listings carry revenue, market access and patient choice. Losing one is not a compliance event; it is a commercial one, and it is usually irreversible within the same product cycle.
04 · Experience
Selected work
Thirty years of doing it, not advising on it.
Brands launched, transformed and revitalised. Markets entered. Partnerships built. More than £100m in sales generated across more than thirty countries. Below is a selection of the work that can be described publicly.
30
Years
Commercial roles and consultancy across single-use medical devices.
£100m+
Sales generated
From brands launched, transformed or revitalised.
30+
Countries
Across four continents, with European and UK markets at the core.
Selected engagements
Four pieces of work, described in full.
Each of these began as a commercial problem that had no obvious owner.
- The challenge
- MDR 2017/745 obliges manufacturers to keep PSURs current — every two years for Class IIa and IIb devices, annually for Class III and implantable. But complex distribution channels obscure clinician feedback, direct manufacturer–clinician engagement is limited, GDPR complicates collection, and the available data sits in fragments across sources.
- What we did
- Med Dev Services partnered with Wound Care People, whose database reaches more than 135,000 active, GDPR-compliant UK healthcare professionals. Post Market Insights™ uses that reach to run structured research directly with clinicians who use the devices in question, and returns the evidence MDR audit-formatted.
- The outcome
- Surveillance evidence delivered quickly and in submission-ready form — and, from the same exercise, real-world insight into how products are used, where they underperform, and what would make clinicians switch.
- Why it mattered
- As procurement moves toward value and outcomes, real-world evidence has stopped being purely a compliance cost and started supporting market access and market retention. Manufacturers who generate it once and use it twice are simply ahead.
- The challenge
- European manufacturers see African markets as high-potential but hard to read, and rarely have the local ecosystem engagement required to enter them credibly. African MedTech innovators face the reverse problem: promising technology, no clear commercial route into Europe.
- What we did
- Med Dev Services formed a three-way collaboration with Real Healthcare Solutions and South Africa-based O2 Blue Consult, combining market access, commercial strategy, business development and healthcare innovation expertise. We engage directly with MedTech ecosystems across Africa to identify companies and technologies with genuine potential, then work on positioning, commercial strategy and the foundations for international expansion.
- The outcome
- A working cross-border platform aligned with regional MedTech growth priorities, and an invitation to South Africa in April 2026 to contribute as speakers at GlobalPathways: Scaling Health & Life Sciences, organised by WESGRO in Cape Town. The presentation is available on request.
- Why it mattered
- Most international expansion advice stops at the report. This is an operating connection between innovators, manufacturers, healthcare stakeholders and commercial partners on two continents.
- The challenge
- Clients kept asking a version of the same question after an engagement ended: how do we do this ourselves next time? Capable product managers were being asked to navigate the NHS, pricing, clinical evidence and tender management without ever having been taught any of it in a structured way.
- What we did
- We built the Med Device Academy: fourteen modules for product managers across commercial mastery, market access and stakeholder management, plus UK MedTech Essentials for sales support and customer service teams. The programme pairs on-demand learning with the Spotlight Performance psychometric and one-to-one coaching to apply it to live situations.
- The outcome
- A structured route for clients to develop their own teams, available as individual seats, team access or a custom academy built around a company's own portfolio and priorities.
- Why it mattered
- Consultancy that leaves nothing behind is an expensive habit. Capability built inside the business compounds.
Under NDA
Most of the work isn't on this page.
NDAs are put in place at the outset of an engagement as standard, and we proactively avoid competitive conflicts of interest. That is the point of working with a limited number of clients — but it does mean the majority of engagements cannot be described publicly.
If you would like to understand how a comparable problem has been approached in your category, ask. Most of it can be discussed in conversation, in the appropriate detail, without breaching anyone's confidence.
Where the experience sits
- Categories
- Wound care, ostomy, continence, skin health, nutrition and related medical consumables.
- Types of work
- Market entry, distributor development, portfolio development, reimbursement and Drug Tariff, product development, market research, post-market insight, international expansion.
- Types of organisation
- International manufacturers, brand owners, IP holders, distributors and entrepreneurial MedTech businesses.
- Geography
- United Kingdom and Europe principally; work delivered across more than thirty countries and four continents.
Client experience
In their words.
Your guidance, insight, and support help us learn, grow, and navigate this complex world better.
James Saunders' input and support to our organisation have been consistently high quality, focused and exceptionally well-informed.
James is a true expert in medical device marketing, bringing strategic insight and deep industry experience to every project.