The Global Center for Medical Innovation (GCMI) helps verify, validate and accelerate the development and commercialization of new medical technologies that save lives and improve patient care. From our 14th Street facilities adjacent to Georgia Tech in midtown Atlanta, we accelerate medtech commercialization at any point on the pathway from bench to bedside.

GCMI supports medical technology innovators at every step on the commercialization pathway including:

Clinical Needs Identification & Market analysis
IP landscape & Freedom to Operate
Prototyping & 3D printing
FMEA analysis & risk mitigation activities
Verification and validation testing
Regulatory submission management
Manufacturing transfer

Have a clinical partner?

Rigors increase in intensity based on predicate technologies or devices and the relative invasive nature of their use, adjacent to, in contact with, or invasive within the patient.

What we're working on

 

Take a look at a few of your GT peers working with GCMI.

Our history

More than two decades and hundreds of preclinical studies completed, GCMI remains an industry leader in medtech design, development, preclinical testing and bioskills training programs.

Funding support

GCMI has dedicated, annual funding for medtech innovation at Georgia Tech, specifically for projects we believe have high potential for successful commercialization.

Who We Help and How

We help individual clinician innovators, start up companies, engineers and scientists with university supported technologies, large and small medical technology customers including industry partners and health systems. Because medtech innovation is endlessly more rigorous than other types of new technology commercialization or advancement, our milestone driven process helps ensure our customers’ ideas achieve a capital efficient path to market from IP, market assessment, design, prototyping, testing and training.

GT Researchers and Faculty Working with GCMI

 

 

 

Scott Hollister, Patsy and Alan Dorris Endowed Chair in Pediatric Technology, Professor, BME

Hollister and his team of biomedical engineers collaborated with the Global Center for Medical Innovation (GCMI) so that GCMI and Children's Healthcare of Atlanta on Georgia's first 3D printed tracheal implant in a pediatric patient.

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Omer Inan, Linda J. and Mark C. Smith Chair and Associate Professor, ECE

After an IV needle has been inserted into a vein, there are various factors that can cause it to leak, either just beneath the skin or even deeper, into surrounding tissues. This painful process of unintended leakage is called infiltration.

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W. Hong Yeo, Associate Professor, Woodruff Faculty Fellow

Currently available digital stethoscopes are durable but expensive, bulky and heavy for pediatrics, not capable of continuously monitoring sounds and subject to cross contamination. Dr. Yeo'S wireless flexible technology flips the script.

Read more.

Select Georgia Tech / GCMI Collaborations

More from our Georgia Tech news and features category, including Capstone Design course spotlights in which “Students work in teams to design, build, and test prototypes with real world applications.” GCMI has proudly supported Capstone Design teams since 2018.

The Intersection of Design, Engineering and Medicine: Why GCMI is the perfect place for research engineer and GT alum Franco Zapata

Interest and excellence in subjects like biology and mathematics can be precursors to pre-med study initiation or investigation, but it is far from all that is required to succeed. There are also frequently superseding areas of interest and excellence that influence one’s academic and career path.   Franco Zapata, medical device and phase zero research…

“This, this success is the desired result”

With GCMI’s Help, Micron’s Microarray Needle Technology Nearer To Forever Changing the World for the Better Medical device and biotech or medtech innovation doesn’t work like consumer electronics or software. It works more like aerospace. Because lives are literally at stake it needs more than a place for people to work, high speed internet, brilliant…

Insights Article: Market Access for Medical Device Manufacturing

Opportunities and implications for ISO 9001 certified entities to access the lucrative medical device market through ISO 13485 certification.   Researchers estimate the total size of the U.S. medical device market somewhere between $170 billion and $240 billion in 2023. KPMG reports, “The medical device industry is poised for steady growth, with global annual sales…

Medtech Manufacturing for Innovators & Start Ups: What You Most Need to Know

Insights from a deep dive into medical device innovation and production with GCMI’s Saylan Lukas and GaMEP’s Dean Hettenbach   Given the patient safety requirements codified in the United States Code of Federal Regulations overseen and enforced by the Food and Drug Administration, medical device innovation is a challenging enterprise to say the least.  …

It’s About Time: Hub Hygiene Aims to Obliterate CLABSIs

A materials scientist and six GT students take aim at Civil War technology still ubiquitous in clinical care and its implication in 30,000 deaths every year.   The technology that has become Hub Hygiene’s easySCRUB started as a challenge issued to material scientist Jud Ready, PhD, in 2015 by a friend’s spouse, a North Carolina…

What Does Designing for Manufacturability Mean and Why Does It Matter for New Medical Devices?

Three key considerations and solutions related to the challenges of manufacturing at scale; but the Golden Rule here is design for manufacturability from day one.

Avoiding pitfalls and implementing strategies early for success in medtech manufacturing

A webinar with GCMI and the Georgia Manufacturing Extension Partnership, June 25, 2024 at 10:30 a.m. EDST When – at long last – it comes time to build your new medical device, be that for verification and validation testing, show and tell or educational examples, clinical trials or “full scale,” you will always wish you…

6 Cornerstone Truths for Medtech Innovators (Researchers or Clinicians) in the Hospital Setting

By: Marty Jacobson with Paul Snyder   Because clinicians have such an intimate knowledge of unmet clinical needs, hospitals are fertile ground for medtech innovations that improve value and outcomes. But bringing a technology or device to bear in clinical use, especially at any scale, works in much different, much more rigorous ways and paths…

From Phase Zero to Full on Sales Mode: GCMI Continues to Proudly Support Jackson Medical’s Mission to Eliminate “Never Events” in the OR

Prologue – Eliminating a Surgical Never Event that Should not Exist Surgical instruments that emit high-intensity light coupled with human error are a leading cause of intraoperative fires and patient burns. The healthcare system refers to incidents like these as “never events” so they should never happen, right? But, survey results published in the Joint…

GCMI’s History

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 of a preclinical CRO called American Cardiovascular Research Institute which later became Translational Testing and Training Laboratories, Inc. or T3 Labs.

GCMI was founded in 2012 by Tiffany Wilson, now CEO of the Philadelphia Science Center. In 2016 GCMI became a Georgia Tech affiliate and acquired responsibility for T3 Labs making GCMI an end-to-end medtech innovation center.

More than two decades and hundreds of preclinical studies completed, GCMI remains an industry leader in medtech design, development, preclinical testing and bioskills training programs. We have helped more than 50 new medical technologies achieve regulatory approval.

In early 2024, T3 Labs, the preclinical testing arm of GCMI, was sold to Veranex. Veranex did not acquire GCMI. They acquired the preclinical testing arm, T3 Labs, only. GCMI has not been “taken private.”

Following the transaction, Saylan Lukas was named GCMI Interim Executive Director.

“Our mission is to help direct the development, testing, and commercialization of innovative medical devices that improve quality based outcomes and delivery of healthcare for patients,” GCMI Interim Executive Director Saylan Lukas wrote in January. “Helping to produce powerful, positive impacts on patients’ lives involves translating research from the lab to the clinic, including clinical trials, first in human studies and other required activities for FDA approval. We do this in support of Georgia Tech faculty, students and the ecosystem at large, and we do it every single day.”

On Funding and Clinical Partners

 

We've got some funding for promising medical technologies.

GCMI has dedicated, annual funding for medtech innovation at Georgia Tech, specifically for projects we believe have high potential for successful commercialization, follow-on funding and improved patient outcomes. Funded projects are selected by GCMI leadership inclusive of consultation with the board of directors. 

Learn more.

 

You've found a clinical partner. Now what?

New medical technologies are subject to the significant, necessary rigors applied by regulatory bodies and, ultimately, market forces. Those rigors increase in intensity based on predicate technologies or devices and the relative invasive nature of their use, adjacent to, in contact with, or invasive within the patient.

Learn more.

Get in touch. It's never too early.

If you want to know more about medtech innovation at Georgia Tech including who we are, what we do and how we do it, contact Saylan Lukas via email saylan.lukas@devices.net.

More To Know

 

 

Phase Zero: The place to start for your new medical technology or idea.

 

Doing the right things early and following a rigorous phase gated process can substantially increase the likelihood of milestone achievement at any point in a technology’s commercialization pathway. 

Learn more.