GCMI Supports the global medtech ecosystem through the Department of State’s Young Leaders of the Americas Initiative (YLAI).
The Epitome of a “Physician Innovator,” Driven by Unmet Clinical Needs Every day the dedicated team of engineers and…
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.
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:
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.
The Epitome of a “Physician Innovator,” Driven by Unmet Clinical Needs Every day the dedicated team of engineers and…
A materials scientist and six GT students take aim at Civil War technology still ubiquitous in clinical care and its…
In the realm of medical devices quality is systemic, mandatory, codified and highly regulated because lives are literally at stake.…