Our lives, personal and professional, bear little resemblance to those we led at the beginning of 2020. Remarkably, in February 2021, U.S. FDA announced the agency “approved, cleared, or authorized a record high of 132 novel medical devices in 2020, surpassing the 40-year high mark we set in 2018 and capping off 10 years of…
How we walk is a key indicator of any injury, recovery pathway and overall health. Clinicians’ analysis for assessment of gait is still done in a highly subjective way with the naked eye. As such, physical therapists struggle to track patients’ recovery and therapeutic process without a technical, objective yet visual solution for gait assessment.…
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…
The 2021 Women@SLS Conference recently took place on June 24, exploring the growth and changes that the industry has seen over the past year while still acknowledging the opportunities for improvement.
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.”