6 Cornerstone Truths for Medtech Innovators (Researchers or Clinicians) in the Hospital Setting
By: Marty Jacobson with Paul Snyder Because clinicians have such an intimate knowledge of unmet clinical needs, hospitals are…
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.
By: Marty Jacobson with Paul Snyder Because clinicians have such an intimate knowledge of unmet clinical needs, hospitals are…
Prologue – Eliminating a Surgical Never Event that Should not Exist Surgical instruments that emit high-intensity light coupled with human…
First, the news. “On January 31, 2024, the FDA issued a final rule amending the device current good manufacturing…