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Progress from validated concept to trial-ready product

 

FORGE Pathways helps emerging medical device companies navigate the critical next stage of development.

Whether you have a validated concept, early prototype or developing product, FORGE Pathways provides practical support to help you prepare for product validation, manufacturing readiness, quality systems, regulatory planning and future clinical translation.

Our goal is simple: help you avoid costly detours, make informed decisions and progress towards the milestones that matter most.

Who Is FORGE Ideas For?

FORGE Pathways is designed for:

  • Early-stage medical device companies
  • Medtech founders and CEOs

If you’ve moved beyond the initial idea stage and need support preparing for what’s next, FORGE Pathways may be right for you.

What You Can Expect

Every company enters FORGE Pathways at a different stage. Support may include:

Initial Assessment

A rapid review of your product, business and development stage to determine fit and identify priority areas for support.

Gap Analysis

A structured assessment across the critical domains that influence success, including:

  • Product development
  • Manufacturing readiness
  • Quality systems
  • Commercial strategy
  • Regulatory strategy
  • Clinical strategy

Development Roadmap

A practical roadmap outlining key priorities, activities and milestones for the next stage of growth, including what FORGE will deliver and what your team will need to commit.

Tailored Support Program

A coordinated program of activities delivered over up to 12 months, designed to address critical gaps and accelerate progress toward validation, manufacturing readiness and trial readiness.

Access to Capability and Resources

Access residency opportunities within the Factory of the Future, including co-working, collaboration and product assembly space, together with practical tools, templates and frameworks to support product development and quality systems.

Building Your Team and Network

Connections to researchers, engineers, manufacturers, commercial specialists and investors, together with support to establish student internships and access future funding opportunities where appropriate.

Why FORGE Pathways?

Many innovators can get to a prototype.

Far fewer successfully navigate the steps required to prepare for manufacturing, investment, regulatory approval and clinical translation.

FORGE Pathways helps bridge that gap by providing structured support, independent guidance and access to expertise that would otherwise be difficult to assemble.

Rather than trying to navigate these challenges alone, innovators gain a clearer understanding of priorities, risks and opportunities, allowing them to focus effort where it will have the greatest impact.

Our Approach

FORGE Pathways is designed to help emerging medical device companies navigate the complex journey from validated concept to trial-ready product.

Rather than tackling product development, quality, regulatory and manufacturing challenges in isolation, we help identify priorities, address critical gaps and focus effort where it will have the greatest impact.

Our role is to provide independent guidance, connect you with the right expertise and support the activities needed to build a stronger, more investment-ready business.

Building readiness, not dependency

FORGE Pathways combines expert guidance, practical resources and targeted support to help companies develop the capability required for long-term success.

We work alongside your team to establish strong foundations across product development, manufacturing readiness, quality systems, regulatory planning, commercialisation and growth.

Your company. Your product. Your IP.

  • We work under confidential terms.
  • We do not take equity.
  • We do not claim ownership of your intellectual property.
  • We provide independent, objective advice focused on your success.
  • We help build capability within your organisation, not dependence on ours.

Our success is measured by the progress of the companies we support.

Ready for the next stage?

You’ve proven there’s an opportunity. Now it’s time to build the pathway forward.