Medical device market access & commercial strategy
Approval is only half the journey.
What gets a therapy approved isn’t the same as what gets it paid for. I help medical device companies work out reimbursement, coding and adoption early, while there’s still time to shape the trial and the device around them.
Planning a first-in-human or pivotal study? That’s the best time to talk.
THE JOURNEY TO PATIENTS
Clinical and access work, side by side.
Clinical & regulatory
Access & reimbursement
First-in-human
Safety and feasibility
Coding route
Codes and payment mapped
Pivotal trial
Efficacy evidence
Payer evidence
Built into the trial
Approval
CE mark or FDA
Adoption plan
Centres that can afford it
Patients treated
Most companies start on reimbursement once the trial is finished. By then it’s usually too late to change what the trial measured.
The trial.
Collect the cost and outcome data payers will ask for while the study is still being designed.
The code.
Know which code your device will use, and what it pays, before the design is fixed.
The buyer.
Acquirers want to see it will be paid for and fit their business, as well as the clinical data.
Previous clients
Epiminder
Nocionix
01
The problem
Approval doesn’t mean anyone will pay for it.
New device procedures rarely fit existing codes or tariffs, and small design decisions matter more than most founders expect. Something as simple as how a lead connects to the implant can change which code applies and roughly halve what the procedure pays. Found after approval, that’s slow and expensive to fix.
US
median time from FDA authorisation to any Medicare coverage for novel devices and diagnostics.¹
US
of 64 novel technologies reached a Medicare coverage milestone during the study’s follow-up.¹
UK
estimated average time for a new device to go from successful clinical trial to mainstream NHS adoption.²
¹ Sexton ZA et al. JAMA Health Forum. 2023;4(8):e232260. Technologies authorised 2016–2019. ² NHS Improvement estimate, cited in the House of Commons, Westminster Hall debate on Innovation in the NHS, 3 March 2020.
The hurdles, by market
Each country values different things, and it all takes longer than you’d think.
Coding
AMA CPT
A new procedure needs the right code, and the evidence bar for each code category is different.
Coverage
CMS & payers
Coverage decisions turn on whether your trial answers the questions payers actually ask.
Payment
Facility economics
Physician and surgery-centre economics drive adoption. If they don’t make a reasonable margin, they won’t use it, however good the data.
02
Where to start
The two-minute readiness check
0 of 5 answered
Five questions every medical device board should be able to answer before the pivotal protocol is locked.
1. Does your pivotal protocol collect health-economic and resource-use data?
2. Do you know which procedure code you will use in each target market?
3. Have you modelled hospital payment against your device and procedure cost?
4. Have payers, not just regulators, accepted endpoints like yours before?
5. Has your board seen a timeline from approval to first reimbursed sale?
Start with a Readiness Review.
Most of what I find in these reviews is cheap to fix before the protocol is locked. A year later, much of it can’t be fixed at all.
Where most clients start
I look at your protocol, device design, evidence plan and target markets, and tell you where reimbursement is likely to get stuck and what to change. You get a written report your board can act on.
Timing
Planned around your protocol deadline
Fee
Fixed, agreed up front
Markets
UK · EU · US
You leave with
Coding route for the UK and US, with the risks in each
Evidence-gap analysis of your pivotal protocol against what payers will ask
Access plan and timeline from approval to first reimbursed sale
Board and investor summary you can share as it is
See an example scorecard from a review
Need more than a review? Some clients keep me on afterwards for ongoing access support, scoped and agreed with you.
Limited availability. I take a small number of engagements alongside my current role, and never with directly competing technologies.
Specialist input. If a project needs health economics or regulatory expertise, I’ll tell you and can introduce people I trust.
03
For investors and acquirers
What I’d want to know before investing.
I’ve spent years on the company side of the table, raising money, presenting to VCs and talking to strategic acquirers, including selling a company as CEO. One thing I see missed again and again is US physician economics: if the surgeon or the surgery centre doesn’t make a reasonable margin, they won’t adopt it, however good the data. I can give you a practical view of a therapy’s reimbursement and adoption path, alongside your formal diligence.
Questions I can help you answer
How long until it is actually paid for?
Coding, coverage and payment in the markets that matter, and whether the plan’s timing is realistic.
Will doctors and centres adopt it?
Who implants it, how it fits their day, and whether the economics work for the physician and the hospital or surgery centre.
Would a strategic buyer want it?
Acquirers want more than clinical data. They need to see it will be paid for, fit their existing business and make a real difference to patients.
How it works: most investors start with a one-hour call about a specific company. If that’s useful, we can agree a short written view or help on particular questions.
Confidential and conflict-checked. I’m happy to sign an NDA before we talk, and I don’t advise on companies with competing technologies or connected to my current employer.
04
Experience
Situations I’ve worked through.
Every company is different, but most of these will sound familiar.
2021–22
CEO, Palion Medical
Took an early-stage injectable headache therapy through development and grant funding to acquisition.
2014–18
Autonomic Technologies
Part of the team launching a new headache therapy in countries with no reimbursement route. Each country wanted something different, patient groups mattered more than we expected, and everything took longer than planned.
2008–13
St. Jude Medical (now Abbott)
Ran the UK neuromodulation business and launched deep brain and occipital nerve stimulation in the UK.
Since 2018
Mercian Medical
Market access and commercial projects for clients including Nyxoah, Spark Biomedical and Monash University.
05
What clients say
“
Founder, PD Neurotechnology
“Mercian Medical investigated the EU market in a way that helped shape our decision to pursue CE approval. We now have a clear understanding of what needs to be achieved and when.”
Former CEO, Spark Biomedical
“The key to access and reimbursement is knowing not only the processes but also the stakeholders. Mercian Medical's network has been key to us starting to build a presence and awareness that will prove invaluable as we further expand our therapy..”
Former COO, Nalu Medical
Latest thinking · November 2026
A short guide for medical device founders and boards, to share before your protocol is locked.
06
About
Started in the NHS. Grew neuromodulation businesses. Led a start-up to acquisition.
I started as a cardiac technician in the NHS, moved into device sales and clinical research, and spent two decades building medical device businesses, from UK P&L leadership at St. Jude Medical to opening new European markets for an emerging therapy. Most of my career has been in cardiology and neuromodulation, but the same principles apply across novel implantable medical devices.
I set up Mercian Medical in 2018 to advise companies without a UK presence. The work has since moved towards what I enjoy most: early-stage companies around first-in-human, when a simple decision can change where they are three to five years later. At events like LSX Europe I’m still struck by how little many founders have been told about reimbursement, coding and adoption. That’s the gap I try to fill.
Education & credentials
BMedSci (Hons), University of Birmingham
PgCert Neuromodulation & Pain Management, Queen Mary (2024)
EEPIN, City University London
Professional Diploma in Marketing, CIM
ICH GCP E6(R3) · ISO 14155:2020
Career
1995
Cardiac Technician
City Hospital NHS Trust
2000
Sales & Clinical Research
Biotronik UK and Medtronic
2008
BU Manager, Neuromodulation
St. Jude Medical UK
2014
Senior Regional Sales Director
Autonomic Technologies
2018
Founded Mercian Medical
Independent consultancy
2021
CEO, Palion Medical
Acquired by MAN & SCIENCE
Now
Global Head, Marketing & Commercialisation
MAN & SCIENCE
07
Questions
What founders and investors ask first.
What does a Readiness Review cost?
Will you sign an NDA?
How do you handle conflicts of interest?
Do you work remotely?
Can you help on a live deal?
How do you handle confidentiality and conflicts?
How quickly can you start?
We’re pre-first-in-human. Is it too early?
Whether you’re planning a first study, approved but not yet paid for, or looking at an investment, tell me where you are and what you’re working on. If I can help, I’ll say how. If I can’t, I’ll try to point you to someone who can.
Or email dbarnes@mercianmedical.com.