Alignment and Impact: What the new FDA Quality Management System Regulation final rule means for GCMI and our medtech design and development customers.

First, the news.   “On January 31, 2024, the FDA issued a final rule amending the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation under 21 CFR 820 to align more closely with the international consensus standard for Quality Management Systems for medical devices used by many other regulatory authorities…

The GCMI 2023 State of Medtech Design and Development Report: Part 1

Innovation in medical technologies is something of a paradox. On one hand, new technologies that drive innovation can manifest at breakneck speed. On the other hand, the pace at which those technologies breed innovations that reach full commercialization and patient impact can be glacial by comparison.   What have been the most significant changes with…

Beware the Unfamiliar Approach: Preclinical Implications for Novel Cell & Gene Therapies

Roughly one decade ago, scientists made significant improvements in viral vectors’ ability to deliver genetic therapeutics. Those therapies use genetic material like DNA to manipulate a patients’ own cells. Cellular (cell) therapies transfer cells into the patient whether they are the patients’ own cells or cells derived from another location or donor cells.    Because…

Preclinical Implications for 3D Printed and Bioresorbable Medical Technologies

The phrase “personalized medicine” has been thrown about by so many for so long in healthcare as to defy definition: or require post graduate work in any one of dozens of specific clinical or technological fields.   For the sake of brevity, 3D printing and bioresorbable material technologies are actively realizing personalized medicine in the…

The 2022 State of Medtech Design and Development Landscape

Medical technology innovation and critical supporting service providers are not only working through pent up demand for delayed projects from 2020 and 2021, but also striving to advance technologies that reduce cost and improve patient outcomes developed much more recently. The U.S. FDA is striving to support innovation with new programs and guidelines that improve…

Rooted in Cardiology: Let’s talk preclinical and cardio innovation at TCT 2022

Founded by Cardiologists In the late 1990s, Dr. Robert Matheny, Chief Scientific Officer of CorMatrix Cardiovascular Inc., was looking for accessible resources, including preclinical support, needed to support innovation in care for cardiovascular physicians and their patients.   In 1999, his collaboration with other Atlanta area interventional cardiologists and cardiothoracic surgeons resulted in the development…

High Demand, Regulatory Support and Importance of Advance Planning Highlight the 2022 State of the Preclinical Ecosystem

As industries of all shapes and sizes continue to evolve embracing remote work models and various levels of return to travel for business, medical technology innovation and critical supporting service providers are not only working through pent up demand for delayed projects from 2020 and 2021, but also striving to advance technologies that reduce cost…

Phase Zero and Phase One Services Accelerating Wearable Pediatric Stethoscope Path to Commercialization

“I can say with confidence our journey toward commercialization of our new [wearable pediatric stethoscope] medical technology would have taken years longer without GCMI’s Phase Zero and Phase One services.”   As the winner of the 2021 GCMI Baby Sharq Tank competition for their innovative wearable pediatric stethoscope, the interdisciplinary team of Dr. Hong Yeo,…

When clinical relevance calls for on-the-fly preclinical protocol deviation

How GCMI and T3 Labs is supporting Dr. Lindon Young’s novel therapy to significantly reduce cardiovascular reperfusion injuries.    During events such as myocardial infarction (heart attack) and surgical procedures involving angioplasty, bypass surgery, or heart transplantation, reactive oxygen species (ROS) can be generated, which cause organ and blood vessel damage. ROS is generated from…