GCMI’s proven process takes a four-phase approach to guide device development and commercialization. We consistently achieve success through our highly interactive approach that begins with innovation, brings in experts for collaborations and iteration that refines and improves the initial medical device concept.

Concept

A new product always begins as a medical device concept; but before it can move forward, it’s necessary to conduct market analysis to determine need and applications. This is supplemented by targeted consultations with regulatory affairs, intellectual property, reimbursement, preclinical, clinical, and other experts to identify potential roadblocks to commercialization.

Design/Build

Once the plan is established, the actual design/build process begins. GCMI’s prototyping capabilities allow the production of 3D models that quickly reveal any design issues and allow effective iteration processes. During this phase, we can begin both non-GLP and GLP preclinical studies with our partner, T3 Labs, and identify other necessary vendor resources.

Plan

While GCMI can move quickly when required, preparation of a plan that identifies engineering requirements, materials, quality systems and evaluation criteria streamlines the process while lowering overall development costs.  In our experience, careful planning upfront with input from relevant experts results in shorter time to market and greater predictability.

Evaluate

Is the concept working as intended? Will it be safe, effective, and cost-efficient? What are the odds it will clear regulatory hurdles and achieve reimbursement? Those questions and many more are examined during this final phase, when grants, investors and industry are investigated to fund continued development and achieve commercialization.