Medtech

We help turn smart ideas into validated, investable device concepts ready for clinical success and market traction. We can:

• Support rapid prototyping through CAD, 3D printing, and engineering workshops via Griffith’s Australian Centre for Precision Health and Technology (PRECISE)
• Facilitate co-design with clinicians, engineers, and end users to ensure usability and clinical fit
• Provide testing platforms for motion analysis, materials assessment, and early risk evaluation
• Assist with regulatory strategy, device classification, and early TGA/FDA engagement
• Connect you with research and clinical advisors to assess workflow fit and integration pathways
• Enable IP and commercial feasibility checks via Griffith Enterprise
• Support business model validation through programs like NextGen, LuminaX, and AmplifyTech
• Provide access to seed funding and proof-of-concept grants
• Offer human factors guidance and usability insights to inform design
• Conduct unmet needs analysis and market research for competitive positioning

We help you design smarter, validate faster, and move confidently toward commercialisation.

We help MedTech innovators move from prototype to validated device with confidence. We can:

• Enable iterative prototyping and mechanical testing via Griffith PRECISE
• Facilitate simulated use-case validation at the Clinical Education & Simulation Centre
• Support usability studies aligned with ISO 62366 and FDA expectations
• Provide preclinical testing options, including cadaveric simulation, motion capture, and biomaterials analysis
• Assist with design for manufacturability, sterilisation, labelling, and packaging planning
• Guide software validation for AI-enabled or connected devices, including IEC 62304 and cybersecurity compliance
• Connect you with clinical advisors to refine functionality, safety, and product differentiation
• Support quality and risk management planning, including hazard analysis and documentation
• Provide access to pilot funding, testing partners, and benchmarking tools
• Ensure early alignment with regulatory requirements for preclinical and usability evidence

With this integrated support, we help transform promising prototypes into compliant, test-ready devices.

We support MedTech companies to generate high-quality clinical evidence for market access and adoption. We can:

• Guide clinical trial design, ethics submission, and governance approvals via a nationally accredited HREC with multi-site capabilities
• Enable in-hospital and outpatient device evaluations through the Gold Coast Clinical Trials Unit and Clinical Research Facility at GCUH
• Support investigator-led or sponsor-backed studies aligned to device class, user group, and regulatory needs
• Provide access to real-world workflows and patient cohorts across surgical, rehab, allied health, and chronic care settings
• Assist with clinical endpoints, data protocols, and usability validation (ISO 14155)
• Connect you with biostatistical and regulatory experts for submission support
• Support human factors testing and safety usability reporting
• Advise on PMCF strategies and evidence generation
• Guide preparation for TGA, FDA, and CE regulatory engagements
• Integrate clinical data into pricing, reimbursement, and commercial strategies

With trial-ready infrastructure and expert support, we help accelerate your clinical validation journey.

We help MedTech ventures embed quality and scale-readiness into manufacturing for a successful market launch. We can:

• Provide access to Griffith PRECISE for precision engineering, prototyping, and device assembly refinement
• Support GMP-readiness and ISO 13485-aligned quality systems for pilot-scale production
• Facilitate design for manufacturability (DFM) and design transfer to bridge R&D and production
• Offer support for packaging, labelling, sterilisation validation, and shelf-life testing
• Connect you with QA and regulatory experts for QMS development and audit prep for TGA, FDA, or CE
• Assist with formulation characterisation, batch testing, and stability analysis via Griffith’s Analytical & Formulation Lab
• Advise on materials, sourcing, and supply chain strategy
• Enable usability and risk validation of commercial-ready devices
• Support pilot runs and documentation, including DHF, DMR, and technical files
• Prepare teams for inspections and post-market quality management

We help ensure your product is ready to scale, comply, and succeed.

We help MedTech companies scale through strategic engagement with health systems and market integration. We can:

• Connect you with clinicians, procurement teams, and health leaders via the Gold Coast Health Innovation Office
• Support real-world evaluations through embedded hospital and community testbeds to generate outcomes data
• Provide health economics expertise and reimbursement support for government and private payers
• Link you to export assistance, trade missions, and investment via Trade & Investment Queensland and INVEST Gold Coast
• Offer access to funding, investor networks, and accelerator programs through LSQ and MTPConnect
• Assist with go-to-market strategies across hospital, private, and consumer health channels
• Connect you to partners across digital health, distribution, and integrated care
• Support post-market surveillance and compliance to maintain regulatory standing
• Guide branding and communication strategies tailored to health audiences
• Facilitate licensing, partnerships, and service contracts for long-term success

We help you embed, expand, and thrive – locally and globally.