In the realm of medical devices quality is systemic, mandatory, codified and highly regulated because lives are literally at stake. It considers a device’s complexity, but it never, ever exempts it from safety standards and good manufacturing practices.
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…
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…
2023 Capstone Team Phantom Lead: a leadless pacing device that utilizes transcatheter delivery for placement in an unconventional location within the heart.
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…
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…
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…
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…
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…
“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,…