Medical Device
Commercialisation
Pathway

A logic tree for medical device commercialisation, from early-stage research through regulatory approval and market entry.

Decision
Branch point requiring strategic choice
Preferred path
Lower friction, faster timeline
Conditional path
Acceptable with trade-offs
High-friction path
Use only if necessary
Stage output
Required artefact to progress
STAGE 01

Invention Disclosure & Inventorship

▼

Capture the invention before novelty is destroyed; establish ownership before equity is contested.

Decision 1.1
Has the invention been publicly disclosed?
No prior disclosure
Standard provisional pathway. File IP Australia provisional within weeks.
Optimal — full novelty preserved across all jurisdictions.
Disclosed < 12 months ago
Grace period rescue. File provisional urgently in AU + US (both have grace periods).
EU, China, Japan novelty already lost — narrows geographic strategy.
Disclosed > 12 months ago
Patent route closed. Pivot to trade secret + first-mover + design rights.
Reframe commercialisation around know-how licensing or service model.
Decision 1.2
Who owns the IP?
Sole university
Apply standard IP policy. Inventor share per institutional schedule (Go8 averages 30–50% net).
Industry-funded research
Audit funding agreement. Check MTA, CRA, contract research terms for assignment or option clauses.
CRC-P projects have prescribed background/foreground IP rules.
Multi-institutional
Inter-Institutional Agreement (IIA). Negotiate lead institution, cost share, revenue split before filing.
KCA templates available; resolve before PCT to avoid delays.
Output
01
Signed invention disclosure · Ownership map · Filing strategy memo · IIA (if applicable)
STAGE 02

IP Protection Strategy

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Patents are necessary but rarely sufficient for devices — layer in designs, marks, and trade secrets.

Decision 2.1
What patent geography is justified?
Provisional → PCT → Major markets
Standard high-value path. AU provisional (~$110) → PCT at 12mo (~$5K) → US/EU/JP/CN national phase at 30mo ($30–100K).
Default for any device with global market ambition.
Provisional → AU/US direct only
Capital-constrained path. Skip PCT; file direct in AU and US at 12 months.
Cheaper but forecloses EU/Asia. Acceptable for niche devices.
Trade secret only
Defensive secrecy. Document know-how, restrict access, rely on first-mover.
Viable for manufacturing processes; risky for product features.
Decision 2.2
What complementary IP applies?
Distinctive form factor or UI
File registered designs. IP Australia design rights are fast (~6 months) and cheap.
Product name viable
Trade mark filing. AU TM + Madrid Protocol for international.
Software or AI model
Copyright + trade secret layer. Patent only if technical effect is clear (challenging for AI/SaMD).
Output
02
IP portfolio plan · FTO opinion · Filing cost projection · Trade secret register
STAGE 03

Commercialisation Pathway Selection

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License, spin-out, or hybrid — driven by capital intensity, team availability, and market reachability.

Decision 3.1
License or spin-out?
License to incumbent
Lower capital, lower upside. Target AU acquirers (Cochlear, ResMed, Nanosonics, PolyNovo, Compumedics) or international (Medtronic, J&J MedTech, Stryker, B. Braun).
Royalties typically 3–8% finished device; upfronts $50K–$2M; milestones tied to TGA/FDA clearance.
AU strategic partner — domestic supply chain advantages
International MNC — global reach but slower negotiation
Spin-out company
Higher upside, higher capital need. Requires founder CEO, scientific founder retention strategy, board, $2–10M seed.
University takes equity (commonly 5–25% post-investment) in lieu of upfront licence fees.
BTF funds — Brandon Capital, OneVentures, BioScience Managers
Accelerators — MedTech Actuator, Cicada Innovations, ANDHealth+
Strategic angels — sector-specific clinician investors
Hybrid: option + license
Stage-gated. Industry pays option fee, funds development; converts to licence on milestone.
Reduces university risk; common for early-stage devices needing co-development.
Decision 3.2
Non-dilutive capital sequencing?
Pre-clinical / proof of concept
MRFF BioMedTech Horizons + R&D Tax Incentive (43.5% refundable).
Early clinical
MRFF Frontier · NHMRC Development · CRC-P · State funds (NSW MDF, Vic BioMedical).
Scale & market entry
Industry Growth Program · Export Market Development Grants · BTF Series A/B.
Output
03
Commercialisation strategy memo · Term sheet (if licence) or shareholders' agreement (if spin-out) · Funding roadmap
STAGE 04

TGA Regulatory Pathway

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Classification determines everything downstream — evidence burden, timeline, cost, post-market obligations.

Decision 4.1
What TGA classification applies?
Class I (low risk)
Self-assessment. Sponsor declares conformity; minimal TGA involvement.
Non-sterile, non-measuring devices. ~weeks to ARTG inclusion.
Class IIa / IIb (moderate risk)
Conformity assessment by TGA or Notified Body. ISO 13485 QMS mandatory.
Most diagnostic and many therapeutic devices. ~6–18 months.
Class III / AIMD (high risk)
Full TGA conformity assessment. Clinical investigation typically required; pre-submission meeting strongly advised.
Implantables, life-supporting. 18–36 months from submission.
Software as Medical Device
Apply TGA SaMD classification rules. Risk-based; AI/ML adaptive software has additional guidance.
Boundary/exclusion rules updated periodically — confirm currency.
Decision 4.2
Can overseas evidence be leveraged?
FDA clearance or CE certificate held
Comparable Overseas Regulator pathway. TGA accepts evidence with abridged assessment.
Single fastest route to ARTG; typical for AU subsidiaries of global companies.
MDSAP audit in hand
QMS evidence accepted. Reduces TGA on-site audit burden.
No overseas evidence
Full TGA pathway. Build technical file, clinical evaluation, QMS from scratch.
Plan parallel FDA/CE filings to capture downstream economies.
Output
04
Classification rationale · Conformity assessment plan · Technical file structure · ARTG sponsor strategy
STAGE 05

Clinical Evidence Strategy

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A clinical evaluation is mandatory; a clinical investigation may not be — choose carefully.

Decision 5.1
Is a new clinical investigation needed?
Substantial equivalence demonstrable
Literature-based clinical evaluation. No new trial; build CER from published data on predicate.
Common for Class I/IIa devices with established precedents.
Novel mechanism or claim
Feasibility study + pivotal study. Two-stage clinical investigation under ISO 14155.
Standard for Class IIb with new indication.
First-in-human or implantable
Pre-submission meeting + staged trials. Engage TGA before protocol finalisation.
Class III default — clinical investigation almost always required.
Decision 5.2
CTN or CTA scheme?
CTN — Clinical Trial Notification
Default fast path. HREC approves; sponsor notifies TGA; trial starts.
~95% of AU device trials use CTN. Days to weeks from HREC approval.
CTA — Clinical Trial Approval
TGA reviews and approves. Required when HREC requests TGA opinion on high-risk unapproved device.
Months to approval; rare for devices but used for first-in-human implants.
Output
05
Clinical Evaluation Plan · Clinical Investigation Plan (ISO 14155) · Investigator's Brochure · Statistical Analysis Plan
STAGE 06

Trial Setup — Ethics & Governance

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Where most academic device trials lose 3–6 months. Plan ethics and governance in parallel, not sequence.

Decision 6.1
Single-site or multi-site?
Single-site feasibility
One HREC submission. Use sponsor institution's HREC; fastest path.
Appropriate for first-in-human or small device validation studies.
Multi-site (NMA-eligible)
National Mutual Acceptance. Single lead HREC reviews; other public sites accept.
Lead HREC choice matters — Alfred, Melbourne Health, RPA, RBWH, SA Health all have device experience.
Multi-site (mixed public/private)
Hybrid pathway. NMA for public sites; separate HREC for private hospitals.
Bellberry HREC commonly used for private/commercial trials.
Decision 6.2
Site Specific Assessment (SSA / RGO) approach?
Parallel submission
Submit SSA in parallel with ethics. Saves 4–8 weeks per site.
Sequential submission
Wait for ethics first. Default but slower; only acceptable when ethics outcome uncertain.
Output
06
HREC approval letter · RGO authorisations · Site indemnity & insurance · Clinical Trial Research Agreements · Investigator initiation packs
STAGE 07

Patient Recruitment

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The silent killer of Australian device trials. Population is small, dispersed, and competed-for at specialist centres.

Decision 7.1
What recruitment channels fit the indication?
Specialist clinic flow
Embed in existing referral pathway. Highest yield for specialty devices (cardiac, oncology, orthopaedic).
Target LHDs with high patient volume + research-friendly directors.
Patient registry partnership
Engage disease registries early. AOA NJRR (orthopaedic), ANZICS (ICU), ANZDATA (renal), Cancer Registries.
Registry-embedded trials accelerate recruitment dramatically.
GP / primary care referral
Engage PHN networks + research-active practices. Slower per-site yield; useful for chronic disease devices.
Consumer / community recruitment
Partner with disease foundations. Heart Foundation, Diabetes Australia, Lung Foundation, Stroke Foundation research networks.
Social media / direct-to-consumer
HREC-approved digital campaigns. Requires pre-approved creative; strict targeting rules.
High variance in conversion; useful for awareness-driven indications.
Decision 7.2
Special population considerations?
Aboriginal & Torres Strait Islander participants
Engage AH&MRC (NSW) / AHCSA (SA) / state equivalents. Co-design from protocol stage; specific ethics review.
Paediatric population
Quaternary centre strategy. RCH Melbourne, SCH Sydney, QCH Brisbane, WCH Adelaide, PCH Perth.
Rare disease
Registry-first; international site augmentation. Australia alone often insufficient; plan ANZ + Asia-Pacific recruitment.
Decision 7.3
If recruitment lags benchmark?
Drop-off at eligibility screening
Protocol amendment to broaden criteria. Re-submit minor amendment to HREC.
Drop-off at consent
Revise PICF, consumer co-design. Often a comprehension or trust issue.
Site under-performing
Add sites; consider international expansion. Activating new sites takes 3–6 months — plan early.
Output
07
Recruited cohort meeting sample size · Screening log · Protocol deviation register · Adverse event log
STAGE 08

Market Access & Reimbursement

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TGA approval is permission to sell. Reimbursement is permission to actually have a business.

Decision 8.1
What reimbursement pathway applies?
Procedure-based device (used by clinician)
MBS listing via MSAC. Submit application; typically 18–36 months to listing decision.
Requires health economic evaluation, comparator analysis, clinical outcomes.
Implantable device
Prescribed List (formerly Prostheses List) via PLAC. Benefit category and pricing assessed.
Critical for private hospital uptake; pricing benchmarked against comparators.
Capital equipment / consumable
Direct hospital procurement. HealthShare NSW, HSV, Health Support Qld tenders + private group purchasing (Ramsay, Healthscope).
Direct-to-consumer / wellness
Private pay or private health insurance ancillary. Engage Bupa, Medibank, HCF, nib innovation teams.
Decision 8.2
Post-market surveillance approach?
Active surveillance via registry
Register device data in disease registry. Enables real-world evidence; satisfies TGA PMS obligations.
Standard PSUR + DAEN monitoring
Sponsor-led Post-Market Surveillance Plan. Periodic Safety Update Reports; monitor TGA DAEN for signals.
Output
08
ARTG inclusion · Reimbursement listing (MBS / PL / hospital formulary) · PMS Plan · Real-world evidence collection
Practitioner's Note

The three stages where Australian academic medical device projects most commonly stall are Stage 4 (regulatory classification surprise), Stage 6 (HREC/governance timeline), and Stage 8 (reimbursement afterthought). Strong TTOs front-load these decisions to Stage 3 — choosing a commercialisation pathway with regulatory class, evidence burden, and reimbursement route already mapped — rather than discovering them as constraints later. The R&D Tax Incentive runs continuously across all eight stages and is often the single largest funding source for spin-outs; structure financial records to capture eligible activities from day one.