Enter at any point and find a straighter path

GCMI’s medical product lifecycle advisory services facilitate medical product development through all phases – from initial concept generation through transfer to production manufacturing and physician training.

Our customers enter at multiple points on their commercialization pathway from pure back of the napkin ideas to late-stage preclinical work, regulatory submission and post-market training. We bring the right resources to bear at the right time.

While it may be advantageous to bounce between GCMI teams, capabilities and services, we guide and execute along a strategic pathway. Our team works with a variety of innovators; individual physicians, researchers and engineers, startup companies and publicly traded industry leaders.

We can help straighten your path from concept to commercialization. Tell us where you are.

Globally, medical product developers work in a highly regulated and uniquely constrained environment. Our team works with you to realize your product in a capital efficient way while considering regulatory compliance, clinical practices, intellectual property and healthcare economics. Our team, including multiple biomedical engineers, contributes development expertise, clinical insights, design skills, project management and an ecosystem of experts to minimize risk and streamline the overall development process.

Our process including design and development

Project success is dependent on careful consideration of several intersecting aspects: technological, clinical, commercial and legal. We follow a structured, phase-gated process that allows for a disciplined product development approach. Our process encourages an early focus on clear problem definition and de-risking a wide variety of potential solutions.

From the 30,000 foot level, the phases can be reasonably defined as:

  • Feasibility
  • Planning
  • Development
  • Verification
  • Validation
  • Manufacturing transfer

By later phases, the funnel of design options narrows significantly, converging on a final product that has been thoroughly shown to meet the customer needs and is ready for commercialization.

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Preclinical testing and bioskills training

GCMI is home to a trusted, proven industry-leading preclinical CRO for medical devices and other medical products. We’re an AAALAC accredited facility that conducts feasibility, proof of concept, safety, and GLP medical device testing for studies in any therapeutic area and in small and large models. Since January 2012, we have archived more than 50 GLP studies for leading medical device manufacturers of which more than 25 products have received regulatory approvals.

Post-market entry, we can support your next-gen device and bioskills training needs.

Vesalio’s NeVa thrombectomy platform is intended for retrieving clots in the cerebral vasculature to minimize the damage caused by stroke.

Vesalio has partnered with T3 Labs through multiple GLP and Non-GLP preclinical studies, since 2016 to develop their family of devices in an effort reduce the amount of “passes” or attempts required to remove a variety of clot types while reducing fragmentation that can result in clots migrating to more difficult or impossible to reach areas of the brain.

As a direct result of GLP preclinical studies performed at T3 Labs, Vesalio received a CE mark in October 2017.

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