GCMI Remains Your Resource for Capital Efficient Medtech Design and Development

Medtech and life science innovation is intensely rigorous. It requires high levels of acumen and proficiency in multiple disciplines. It can also be immensely capital intensive.    Tiffany Wilson founded Atlanta’s Global Center for Medical Innovation (GCMI) in 2012 to help medtech innovators de-risk their technologies, increasing their odds of successful commercialization and positive patient…

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…

Early, consistent focus on the unmet need keeps Augment Health on a solid commercialization pathway

“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.”

Are you a life science innovator seeking funding in the next 12 months? Applications are open for PitchRounds at AdvanSE 2022.

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…

Faculty Researchers and Innovators: What you need to know about IRBs and the medtech innovation process – Insights & Recording

New medical technologies or devices cannot enter stages of research or clinical trials in humans without certain authorizations required by regulatory agencies responsible for safety and efficacy. As far as those regulatory bodies are concerned, the path to clinical trials in humans is the same whether it’s research or commercial driven. Failing to walk that…

StrideLink Walks Quickly Into the Future of Physical Therapy Through CREATE-X and GCMI

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.…

Commercialization During the COVID-19 Crisis: Lessons Learned in a 60 Minute Webcast.

The vast majority of novel ideas from academia never make it into clinical use. Together we can change that. Innovative medical technologies start with a great idea, novel science and an identified unmet clinical need. The process by which these technologies enter clinical care is as complicated as the science behind it. On October 7th,…

Global Center for Medical Innovation Joins Alira Health in Strategic Partnership to Accelerate Innovation Globally

Atlanta, GA & Framingham, MA – June 24, 2020   In response to the unprecedented need for continuous innovation and improving patient outcomes, GCMI (www.gcmiatl.org) the leading accelerator and incubator in the Southeastern United States and Alira Health a leading international healthcare and life sciences advisory firm are pleased to announce their new partnership. With this…

What is a 510(k)? Medtech regulatory expert Grace Powers answers some frequently asked questions about the common, but tricky, regulatory submission and clearance for new medical technologies.

A significant number of innovative medical technologies fall into FDA’s Class II classification, the vast majority of which require an FDA 510(k) submission. What exactly is a 510(k)? What types of products fall into the Class II, 510(k) category?   Grace Powers, principal consultant with Powers Regulatory Consulting, has 20 years of industry experience in…

What does the Project Planning process for medtech innovation look like?

Where does Medtech Project Planning fit in with Product Development and why is it important? Let’s review the basic steps for successful Project Planning.   What is Project Planning? Project planning, also referred to as “Phase 1” at GCMI, follows directly after the feasibility phase, “Phase Zero.”  Phase 1 is the beginning of the formal…