Arepo Medtech Pty Ltd · Australia

Healthcare needs a new safety layer.

Mākoha is governance infrastructure for safe AI-enabled clinical care. Working demo live. Pharmacy wedge. Platform ambition.

demo.makoha.ai · session-gated · synthetic data only · no clinical use

Why now

The safety gap is on the public record.

Every Australian jurisdiction is expanding what a pharmacist may prescribe. In August 2026, two independent reports — from the Grattan Institute and the Sax Institute — identified significant gaps in the evidence base for pharmacist-led prescribing. The RACGP's submission to the Pharmacy Board sets out nine scenarios in which patients are harmed despite prescribing that fully complied with protocol, because protocols alone do not account for diagnostic uncertainty, follow-up, or accountability over time.

Diagnostic harm is often delayed, diffuse, and invisible to complaints-based systems.

The absence of reported harm is not the same as evidence a system is safe.

— Dr Michael Wright, RACGP President, August 2026

An industry being told it cannot prove its own safety is an industry that needs an evidence layer. That is the company.

Source: RACGP, Safety gaps exposed in pharmacy prescribing protocols, 10 August 2026.

The remedy is already specified

The critics have written the requirements document.

The RACGP's own prescription for safe pharmacist prescribing:

Continuity

Care connected across episodes and sites, not one-off transactions.

Shared records

A clinical history that travels with the patient.

Clear accountability

A named professional on the record for each decision.

Structured reassessment

Diagnostic uncertainty recognised and revisited over time.

Escalation pathways

Defined routes out when the presentation exceeds scope.

Established clinical governance

Evidence that the pathway was followed, not just that a medicine was supplied.

Every item on that list is a software problem. None of them is solved by a scribe, a dispensing system, or a protocol PDF.

What Mākoha does

AI prepares, checks and evidences. Clinicians decide.

Accountability by design — the registered professional is never removed from the loop. Every recommendation is grounded in verifiable evidence, every output is checked before it is trusted, and every decision leaves a versioned, auditable record.

01

Capture

Structured history and workflow context.

02

Check

Evidence, exclusions and red flags.

03

Sign

Human review and clinical accountability.

04

Record

Longitudinal memory and audit trail.

Fail-closed — stops on missing evidence, identity mismatch or unsafe uncertainty, at every stage.

Differentiation

Not a scribe. Infrastructure.

The scribe market proves the appetite

Australian clinicians adopt clinical AI at speed — the country's AI-scribe companies have reached tens of thousands of consultations a day and nine-figure valuations. Nobody in that cohort is solving assurance.

Why assurance is the durable position

Note quality is matched in a release cycle. Regulatory evidence, clinical trust and cross-site audit history compound — and cannot be copied.

6,000+
community pharmacies in Australia
18
pharmacy visits per person per year — more than any other part of primary care
80,500
pharmacist-delivered UTI consultations in 2025
90%
of Australians support expanded in-pharmacy care

Source: Pharmacy Guild of Australia / Westpac, Community Pharmacy Industry Insights Report 2026. Figures dated at publication and subject to change.

Regulation-native

Built for the regulation that arrived in February 2026.

The TGA's guidance on AI-enabled medical device software applies from 5 February 2026: regulation is triggered by intended purpose, not technology; software as a medical device is an enforcement priority; synthetic data supplements but never replaces clinical evidence; and change control is scrutinised.

Our posture

Synthetic-only development. No patient-facing release. Formal classification counsel-attested before clinical supply. Fail-closed architecture and versioned audit evidence from the first line of code.

The timing advantage

Competitors will retrofit this. We started here — an advantage measured in years, not features.

Source: TGA, Artificial intelligence and medical device software regulation, February 2026.

Working demo · live today

Not a mockup. Not a roadmap slide.

The consultation surfaces run end to end at demo.makoha.ai.

It exists

The surfaces run end to end — this is working software, not a concept.

It is gated

Session-controlled access, explicit prototype notice, no real patient data accepted.

It is honest

The disclaimer is on the front door: educational information, not medical advice.

demo.makoha.ai · synthetic data only · no clinical use

Team

Clinician-led, governance-ready.

Dr Ken Lee

Founder · Clinician-founder · Director, Arepo Medtech Pty Ltd

Mission, product thesis and executive leadership. A practising clinician with direct experience of the Western Australian primary care, telehealth and community pharmacy landscape the product is built for.

Regulated clinical authority cannot rest on one founder. Independent authority roles are a planned milestone, gated before any live clinical activity:

Medical authority — appointment planned Pharmacy lead — appointment planned Regulatory / QMS — appointment planned Clinical safety committee — planned

Contact

Talk to us.

Design partnership, evidence collaboration, or investment — we would like to hear from you.

Compliance and regulatory matters: compliance@arepo-tech.ai