The Lumina Pathway

Lumina Medtech supports innovators across the full Australian market journey. Our pathway is designed to reduce risk early, align regulatory and commercial decisions, and build sustainable growth.

Opportunity → Readiness → Approval → Launch → Growth

Regulatory, quality and clinical rigor underpin every stage — enabling confidence, credibility and long-term adoption.

Pathway Stages

Opportunity

We start by understanding whether Australia is the right market.

- Market size and growth potential
- Clinical need and unmet demand
- Competitive and reimbursement landscape
- Strategic fit with your broader growth plan

Readiness

Before committing to approval and launch, we assess what’s required.

- Regulatory pathway and timing considerations
- Quality system and clinical evidence readiness
- Resource, cost and risk assessment
- Go / no-go decision support

Approval

We support regulatory execution where appropriate.

- TGA registration strategy and coordination
- Australian Sponsor responsibilities
- Clinical evaluation and investigation support
- Quality system alignment and documentation

Launch

Approval becomes the starting point, not the finish line.

- Launch and go-to-market planning
- Distribution strategy
- Stakeholder engagement and early adoption
- Regulatory and quality integration into launch activities

Growth

We help build momentum and scale responsibly.

- Market development and expansion
- Ongoing sponsor and post-market obligations
- Change management and lifecycle support
- Portfolio growth planning

WHAT MAKES LUMINA DIFFERENT

· Early involvement before distribution

are locked in

· Honest advice on readiness and timing

· Direct access to senior expertise

· Flexible engagement models for smaller innovators