Medisphere AX
The single source of truth for surgical device performance
We are building the definitive real-world evidence layer for the $400 billion global surgical consumables and implants market.
PROBLEM:
Every Class IIb/III surgical device sold in the UK and EU must continuously collect structured post-market clinical evidence under MDR 2017/745. Today, 97 % of manufacturers still rely on one-page paper forms that surgeons lose or delay in 40–60 % of cases.
Scale of the problem
•400,000+ major surgical procedures per year in the UK alone use haemostats/sealants/implants
•Across the EU27 + UK: >12 million procedures annually
•Global market value of these devices: £400 billion (McKinsey/EvaluateMedTech 2025)
•Estimated annual cost of lost/incomplete data: £2–3 billion in manual chasing, delayed reimbursement, and regulatory risk
Consequences if unaddressed
1.Regulatory non-compliance: Notified Bodies are already rejecting CERs and delaying CE renewals for insufficient PMCF data (BSI/TÜV Süd 2024 reports).
2.Delayed or denied reimbursement: NHS England and EU payers now demand real-world evidence before listing new devices.
3.Lost competitive advantage: manufacturers remain blind to how their product actually performs in real theatres versus competitors.
4.Wasted NHS resource: clinical teams spend thousands of hours chasing paper forms instead of treating patients.
Evidence
•Innovate UK Biomedical Catalyst reports (2024): “>50 % of UK MedTech firms cite post-market data collection as their biggest regulatory bottleneck.”
•MHRA 2025 guidance: “Paper-based systems no longer meet the proactive, continuous requirements of MDR Article 83.”
Solution:
Medisphere AX is the only solution that digitises the exact existing form, achieves >98 % same-day capture, and creates the first blinded benchmark pool—turning a £400 billion compliance burden into the strongest competitive moat in surgical devices.
- Digitises the exact paper form surgeons and reps already use → >98 % same-day capture
- Delivers instant, regulator-grade PSUR/PMCF data.
- Creates the only blinded benchmark pool that shows every manufacturer precisely how they perform against the entire market in real OR.
- Multi centre trials across all territories with analytics and AI
Surgeons request for PROMS:
How MAX Can Own PROMS (Patient-Reported Outcome Measures) for Surgical Devices
The paper evaluation form is purely surgeon-reported. True PROMS = Patient Reported Outcome Measures — the holy grail for MDR Article 61 (clinical evaluation) and NHS Value-Based Procurement.
Why this is a £10B+ adjacency:
Manufacturers currently have zero structured patient feedback at scale for surgical consumables. They rely on sporadic complaints or 6-month follow-up clinics → weak evidence, slow sales cycles.
MAX’s PROMS Play – Zero Extra Effort
We already have the surgeon’s phone in theatre (magic-link). After submission we send one follow-up SMS to the patient (with surgeon and patient consent):
Day 7 post-op “Hi, how are you feeling after your procedure? 30-second survey”
No competitor offers zero-friction adoption + real-time head-to-head comparison + multi-centre trial capability in one platform.
The Sky Is The Limit:
Mandatory Pull = “Pay-to-Play” via NHS Theatre Access (Exactly like MIA credentialing today)
How it works
NHS Trust policy: “All reps bringing new Class IIb/III devices into theatre must use Medisphere AX for post-market evaluation forms.” (Same way MIA is mandatory for reps to even enter the building.)
Manufacturers subscribe to trial new products – reps will only get the opportunity to trial new products with an evidence-based platform – MAX. Clinical evidence. Surgical confidence.
Result: Manufacturers must subscribe or their reps can’t trial devices in that Trust. Once 20–30 Trusts adopt this policy, it becomes de facto mandatory across the NHS.
No legal mandate needed – just Trusts choosing the tool surgeons love – real world evidence, PROMS and the best medical devices for their patients. Same model as MIA/IntelliCentrics, but for evidence instead of credentials.
That’s the “compliance gate” – and it’s how MAX becomes unavoidable
Traction
- MAX prototype completion end of Dec 25
- First potential contract with a Medical Device manufacturer
- NED on board
- High calibre medical advisory team; relationships map exactly to early sales targets and pilot sites.
- Experienced Philips Healthcare CTO-level engineer managing development, reducing execution risk versus a
founder with no technical access.
Financials
Year 3: £10.6 million ARR, £4 million EBITDA
Year 7: £120 million+ ARR, £6–12 billion exit path
Blinded pool launches 2027 → £100 million+ valuation overnight
Medisphere AX will be the single source of truth for post-market clinical evidence in Europe: every Class IIb/III surgical device will be evaluated through our platform, delivering >98 % capture and blinded benchmarking as standard. Surgeons will never see another paper form, manufacturers will turn compliance into their strongest sales weapon, and MAX will power the largest anonymised surgical outcomes dataset on the continent, driving better devices, faster adoption, safer surgery and better patient care.
Conclusion / Recommendation
Founder brings domain expertise, surgeon-level trust, a credible lighthouse customer and early
clinical governance that together make Medisphere AX a compelling Explore-stage opportunity.
If the pilot converts and the pricing / capture metrics hold, this product has a clear path to a multi-million ARR
business with the network effects necessary to reach the £10M+ outcome investors target.