In part 1 of our 2023 State of Medtech Design and Development Report we discussed sensors, AI and the paradigm shift in regulatory strategy. Here in part 2, we dive into a persistent need for gap analysis, the importance of focusing on the unmet clinical need, the challenges of manufacturing at scale and investigate…
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…
So many engineers probably wanted to be an astronaut as kids at some point or another. Saylan Lukas wanted to design roller coasters. Fortunately for GCMI, our clients and patients benefiting from novel medical technologies, Saylan’s elective in Biomedical Engineering taught by Dr. Sam Hulbert at Rose-Hulman Institute of Technology shifted his career course…
“In partnership with Georgia CTSA (Clinical and Translational Science Alliance), the I3 (Imagine, Innovate, and Impact) GCMI Research Awards are intended to spark synergistic interactions among investigators from the Emory School of Medicine (SOM) with Georgia Tech affiliate the Global Center for Medical Innovation (GCMI). Proposals are envisioned to improve patient care by more effectively…
The team’s work to date, from concept to the technology’s current state, had primed it to seize the opportunity presented by the January 2022 Centers for Medicare and Medicaid Services (CMS) announcement of five new remote therapeutic monitoring CPT codes.
“When your ‘north star’ is doing what’s right for the patient and the user, everything else can follow. The best way to accelerate clinical adoption and utility is to prove your early hypotheses, generate data and gather clinical input.”
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…
Our colleagues at Health Connect South are in the final stages of preparing for their 2022 Gathering on September 22nd at the Georgia Aquarium. “Though the Southeast is home to world-class health assets, there is surprisingly little interdisciplinary clarity around areas of focus, impact, needs and capacity within and among our health assets. We…
Our colleagues at Southeast Life Sciences are now accepting applications for Pitchrounds at AdvanSE 2022. They’re seeking the southeast’s most promising life science innovators across multiple life science categories including biopharma, medtech, diagnostic, digital health and agriculture biotechnology technologies. Along with Southeast Life Sciences, we encourage those seeking early rounds of six figures…
Learn from our experience to streamline your regulatory pathway and set your new medical device or technology up for commercialization success. Investigational Device Exemptions are required by the U.S. FDA for devices or technologies that require clinical use before regulatory approval or general market release. Examples of devices that may require an IDE study…