Evidence
What we have tested, and what the first trial will measure.
Orwyn has no results to publish yet, and will not claim any until an evaluation is complete and has been reviewed. This page says exactly what exists today, what has been tested and how, and what the first trial will measure. Where work is unfinished, it says so.
Status on 1 October 2026
| Area | Status | What that means |
|---|---|---|
| Clinical rules | Done for evaluation | Written and signed off by a named consultant knee surgeon, Dr Arj Imbuldeniya. Every rule carries a version, a date and a source that can be opened and read. Orwyn's knee safety rules are written and signed by its Clinical Safety Officer (version 0.17, October 2026). They are approved for demonstration and evaluation with made-up patients, not for live clinical use. |
| Software | Working demo | A working demo with example patients, covering a demonstration look-up of example patients by NHS number, the safety questions, the most likely diagnosis with its reasons, tests, what to do today, review and escalation, and the letters. Automated tests run on every change to the software. Returning outcomes to the clinician, stored records and connection to a real record system are planned. |
| Clinical safety | In progress | Clinical risk management follows DCB0129. The Clinical Safety Officer was appointed on 19 August 2026. A hazard log and a clinical risk management plan are in place. The clinical safety case report is in progress. Independent clinical review is planned before first deployment and is not yet in place. |
| Regulation | Not yet held | Orwyn is health technology built to the engineering and documentation standards expected of regulated clinical software under UK medical device regulation, with specialist regulatory advice taken before any classification commitment, and the intention to certify. Certification is not yet held. |
| NHS assessment | In progress | Orwyn is being mapped against every criterion of the NHS Digital Technology Assessment Criteria (DTAC) as it is built. Cyber Essentials certification and the NHS Data Security and Protection Toolkit are planned ahead of first deployment. |
| Trial | Being assessed | Orwyn is currently being assessed for an NHS pilot. The first trial will measure process, decisions in both directions, the pathway, user experience and safety. |
What has been tested, and how
The software is tested automatically every time it changes, so that a change in one place cannot quietly alter an answer somewhere else. The clinical rules are written by the surgeon who governs them, each linked to the evidence behind it, and the safety rules have been approved for evaluation by the Clinical Safety Officer. Orwyn is currently being assessed for an NHS pilot to test its safety, clinical effectiveness and cost effectiveness.
An independent review of past knee referrals at two hospitals is under way, by two consultant surgeons working separately to written criteria. It sets the starting point that any trial will be measured against.
What the first trial will measure
- The right first step. The share of patients whose first decision was the right one, in both directions, judged by two consultant surgeons against written criteria. This is the main measure.
- Time to a surgical opinion. For the patients who needed one.
- Specialist visits that did not change the plan. Appointments that ended where they began.
- Whether patients improved. On a recognised knee or musculoskeletal score, where one is recorded.
- Safety. Urgent problems missed at first contact, which must not rise, and every safety rule that applied.
- Use. How often clinicians followed Orwyn or overrode it, and why. Clinicians are never required to follow it, and every disagreement is recorded.
Whether a patient went on to have surgery is reported as background, never as a target.
How a first evaluation would be set up with a service is on the page for NHS service leads and commissioners. Where each standard stands is on our standards page, and how the tool is built to be safe is on safety and how it is built.
Surgeon-governed decision support for first-contact MSK clinicians.