Once a new medical technology or device is ready to go from prototype to product, following a defined process and generating appropriate documentation is crucial. Regulatory bodies require specific documentation as evidence to determine the safety and efficacy of the product. These documents range from design input requirements to outputs like design specifications, manufacturing processes…
A medtech or life science project’s success is dependent on the careful consideration of several intersecting components: technological, clinical, commercial and legal. GCMI follows a structured, phase-gated process that allows for a disciplined, capital efficient medical device design and product development approach.
When it comes to medtech innovation, our client’s success is always our top priority. We help find the right people for the task at any point on the commercialization pathway.
The Fluid Fighters Capstone team needed to test their prototype for draining rates and tissue adherence or occlusion avoidance. GCMI’s preclinical testing and bioskills training arm T3 Labs provided the facility and resources the team needed to complete the task.
Yoel Alperin, Parth Gami, Sindhu Kannappan and Kelly Qiu comprise the Georgia Tech Spring 2021 Capstone Design Team ScolAlign. Their technology seeks to objectively improve the standard of care for intraoperative spinal alignment during scoliosis correction surgery.
GCMI is now pleased to offer you a deep-dive, behind-the-scenes look at what we do and how we do it in our comprehensive Book of Knowledge.
“Our validation work would not have been possible without GCMI’s support and T3 Labs’ facility and equipment. Being ‘radio-opaque’ is a critical design input for this tool. That type of feedback is impossible without a proper operating room environment.”
“We needed to validate whether or not our device could create the appropriate pressures needed to restore esophageal function in tissue that closely mimics live human tissue… in a safe environment for live tissue where sanitation would not be a concern. The GCMI and T3 Labs team helped prepare the space, tools, and specimen we needed for the validation testing event.”
Georgia Bio, the state’s life science trade association, named GCMI, the Saldana Research Group and Georgia Tech 2021 Golden Helix Innovation Award recipients. The Innovation Award recognizes the department, institution, company or individuals who are forging new ground by thinking outside traditional paradigms to create some unique technology. In early 2020, U.S. frontline healthcare…
In the context of GCMI’s phase-gated product development, the “Design and Development” phase (also called “Phase 2” at GCMI) typically follows a Project Planning phase (called “Phase 1” at GCMI). At the completion of project planning, innovators have determined what work is required to take the technology from prototype to product. The Design and Development…