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GCMI Design & Development has moved to gcmiatl.org
For medical device and pharmaceutical manufacturers of all sizes, we provide high quality, high-value medical device testing, bioskills training, and translational facilities. Our facility provides physicians, sales staff, students and allied healthcare professionals what they need and when they need it with the highest quality service designed with your bioskills training needs in mind.
We provide medical device testing and bioskills training for more than 2,000 physicians, medical device sales force members, students and other allied healthcare professionals every year. Our commitment to the highest quality service ensures our bioskills training customers come back to us time after time. Whether your product is approved and on the market entering clinical trials, or are at the very early stage of device development seeking customer feedback, our team can help you translate rapidly through device testing, regulatory approval, and education & training. We have a portfolio of repeat customers who chose to return time and time again to take advantage of the expertise and quality partner within us. Our bioskills training team provides a turnkey, team-wide, top-tier, flexible scheduling service. We provide a real-world environment and experience for your bioskills needs.
We are conveniently located in midtown Atlanta, just 15 minutes from the world’s busiest airport, Hartsfield Johnson. Our facilities are AAALAC accredited, USDA licensed, and GLP compliant. We operate 32,000 sq ft of operating room, lab, office and vivarium space. Our operating rooms are dedicated to research in 12 therapeutic areas. We have a total of four (4) operating rooms, including one fixed cathlab.
Our operating rooms are flexible and can be set up for a surgical, endoscopic, orthopedic, or interventional case for both animate and human cadaveric models. Each operating room is equipped with a room camera and surgical light camera that is available for recording or viewing in the convenience of a conference room. Along with our surgical and imaging equipment, our operating rooms are a one-stop shop for all of your preclinical testing and bioskills training needs.
“Having credentialed professionals managing the study, board-certified veterinarians on staff and a team who cared about the project as if it was their own, is a distinguishing feature for GCMI/T3 Labs.”
Tyler Wanke, Co-Founder and CEO
“Our mission is to bring down the cost of healthcare and provide better patient outcomes at the same time. Effectively reducing OR time is one key way we accomplish our mission. When our physicians train at T3 Labs, they walk into an environment that is very familiar, and that enables us to complete our training with great proficiency and efficiency.”
Marc Bolton, Clinical Education Manager
The Transcatheter Cardiovascular Therapeutics (TCT) meeting is the world’s largest educational meeting specializing in interventional cardiovascular medicine. This year, it will take place on October…
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GCMI and our preclinical arm also known as T3 Labs is a trusted, proven industry-leading preclinical CRO for medical devices and other medical products. We’re…
GCMI’s Spring 2023 Capstone Spotlight on Team LifeSTEM “Gliomas are brain tumors that come in multiple forms ranging from low-grade, benign tumors to high-grade, malignant…
2023 Capstone Team Phantom Lead: a leadless pacing device that utilizes transcatheter delivery for placement in an unconventional location within the heart.
“X-rays supporting our testing at GCMI and T3 Labs clearly showed where the device engaged and the tip aligned at the bone level. This kind…
Evaluating your new artificial organ technology’s readiness for preclinical work or just want to get together to talk about the latest in preclinical testing, bioskills…
The National Center for Biotechnology Information describes mechanical circulatory assist devices as, “commonly used in the treatment of severe heart failure as bridges to cardiac…
“Founded in 1917, the American Association for Thoracic Surgery (AATS), along with its philanthropic arm, the AATS Foundation, has sought to advance the field of…
Image credit: Clinical Imaging Systems GCMI, the U.S. proving ground for medtech innovation, has recently acquired a GE LightSpeed VCT 64 Slice CT Scanner with…
“Because we followed a solid pathway, we had a lot more latitude to make positive changes that should increase the likelihood of clinical utility and…
Quick Insights Aligned in Acceleration: Indeed, the Most Expensive Preclinical Study is the One You Have to Do Twice As mentioned in a post last…
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As we shared recently, our colleagues at Within3 are using technology to accelerate pharma and medtech innovation in some very interesting ways. Their platform improves…
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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…
Join GCMI’s Dr. Emily Blum, Evan Goldberg, PhD and John Tipton for an ORS Innovation Network Webinar August 31, 2022 “For over 60 years,…
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,…
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…
“The failure of existing products on the market to successfully accomplish the needs of patients and clinicians made this a problem we addressed with enthusiasm…
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…
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…
Congratulations are in order! GCMI Chief Executive Officer, Sherry Farrugia, and Director for Product Development Mike Fisher, were among those recently awarded the Presidents’ Award…
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…
Learn from our experience to streamline your regulatory pathway and set your new medical device or technology up for commercialization success. Investigational Device Exemptions…
Meet Georgia Tech BME Fall 2021 Capstone Team Five of Hearts The Unmet Need Heart disease, Viral infections, autoimmune diseases, and cancer can all…
“Our confidence in data generated by our in vivo studies with T3 Labs cannot be greater.” – Dr. Hee Cheol Cho The Preclinical Challenge…
Preclinical proficiency and Georgia ‘medtech’ ecosystem assets yield data needed for follow-on, translational funding The Problem – When Nature Doesn’t Give Us the ‘Pacemaking’…
If you’re attending ORS 2022 and have a new orthopedic technology in development, including preclinical work that may be on your product development horizon, you…
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…
In 2014, a Children’s Healthcare of Atlanta nurse, Lynn Pogue, approached an engineer, Leanne West from Georgia Tech, to discuss the burden of IV monitoring.…
Since the first quarter of 2020 the demand for virtual bioskills training and education programs for medical technologies has skyrocketed . Teams leaned on virtual…
According to the American Red Cross, every two seconds someone in the United States needs a blood transfusion. That fails to take into account injuries…
In 2018, GCMI chronicled one Georgia Tech Capstone team’s effort to end complications from epidural misplacement. Fast forward more than three years and the…
Our lives, personal and professional, bear little resemblance to those we led at the beginning of 2020. Remarkably, in February 2021, U.S. FDA announced the…
The Fluid Fighters Capstone team needed to test their prototype for draining rates and tissue adherence or occlusion avoidance. GCMI’s preclinical testing and bioskills training…
Yoel Alperin, Parth Gami, Sindhu Kannappan and Kelly Qiu comprise the Georgia Tech Spring 2021 Capstone Design Team ScolAlign. Their technology seeks to objectively improve…
“Our validation work would not have been possible without GCMI’s support and T3 Labs’ facility and equipment. Being ‘radio-opaque’ is a critical design input for…
“We needed to validate whether or not our device could create the appropriate pressures needed to restore esophageal function in tissue that closely mimics live…
We know preclinical testing is a substantial commitment of time and treasure for medtech and life science innovators. We also know the most expensive study…
At GCMI and our preclinical testing arm T3 Labs, we take great pride in our scientific acumen. After all, the organization was conceived and designed…
At GCMI, we strive to provide the highest quality data for our preclinical sponsors and customers. GCMI is committed to working with innovators to…
In this era of consolidation, the dwindling number of preclinical CROs often aren’t interested in developing new models or venturing outside of their well established…
As the preclinical CRO industry consolidates, creativity and flexibility suffer. GCMI and our preclinical arm, T3 Labs, works around your needs, around you and your…
In the context of GCMI’s phase-gated product development, the “Design and Development” phase (also called “Phase 2” at GCMI) typically follows a Project Planning phase…
There are approximately 292,000 cases of in-hospital cardiac arrest every year for which the survival rate is less than 24 percent. Resuscitative efforts and supporting…
How can medtech, life science and biopharma innovators know their product is ready for preclinical testing? GCMI Design and Development Director Mike Fisher and Preclinical…
Where does preclinical work find its way into project planning for new medical technologies? What are the top considerations for preclinical work in this early…
Georgia Tech recently completed its Fall 2020 (virtual) Capstone Design Expo. From the project’s website, “The Capstone Design Expo showcases Georgia Tech’s graduating seniors as…
How does medtech design verification and validation “translate” to preclinical testing? GCMI’s Director of Scientific Affairs explains.
Preclinical evaluations are often the best way to assess a medical product’s performance, and regulatory bodies often require preclinical data in product submissions. But this…
Watch, listen and learn. Our 2020 AdvanSE session can help you know, and fix, the ways medtech innovators burn cash unnecessarily. Too many promising…
A long-time customer of GCMI and T3 Labs, ALung Technologies, has recently announced that they have received FDA Emergency Use Authorization (EUA) for their Hemolung®…
GCMI’s Facilities Director Hugh Lambert has spent 11 years ensuring the efficiency of building operations and equipment, maintenance, and facilities management. He uses his 40+…
Gross and histopathology are very important aspects of preclinical research. They can be crucial endpoints for safety and toxicity studies. Oftentimes, they help determine whether…
The timely review of your GLP preclinical final report is very important. However, timelines are tight, and yours is not the only study that a…
All preclinical study estimates are not created equal: they may or may not include line items that can widely influence the total fee. We know…
Here are some of the most common cost types you should consider when planning your preclinical study to give your product the best chance of…
As the global COVID-19 pandemic continues to force all of us to find safe paths forward, GCMI continues to remain operational across all service lines…
When a medical product innovator has reached the point at which preclinical research is necessary to achieve the next milestone, they have already surmounted significant…
Preclinical work, especially GLP studies, are costly and critical to the product’s successful regulatory submission. Efficiency and quality in preclinical work begins with a robust…
Curious about the most important things to know BEFORE starting a GLP preclinical study? Now would be the perfect time to attend a webinar! The…
To our GCMI clients, experts, and friends – From the beginning of the COVID-19 crisis, my team and I have been focused on how GCMI…
Earlier today Medical Design & Outsourcing published the following from the FDA regarding 3D printed equipment intended to supplement PPE needs created by the ongoing…
Research Collaboration to Allow Manufacturers to 3D Print Thousands of Face Shields in the Coming Weeks Atlanta, GA – March 24, 2020 – Global…
WE ARE HERE FOR YOU – Here’s what we are doing during this time to keep business moving forward GCMI remains focused on the health…
Based on decades of collective experience conducting preclinical studies and writing preclinical final reports (both GLP and Non-GLP), our team of subject matter experts has…
In mid-November 2019, six student-led Georgia Tech Capstone teams put their medical device ideas to the test at GCMI. These are five of their stories.
Georgia Tech biomedical engineering students Oscar Gutierrez, Ahmed Alnamos, Nishani Kanthasamy and Sondos Alnamos make up the team ‘Bullseye’ for the Fall 2019 edition of…
Aprons of Shield set out to design a device that achieves full-body shielding from radiation for clinicians while still giving them the ability to use…
As the year comes to a close and many of us look forward to a holiday respite, I find myself full of enthusiasm having recently…
Georgia Tech Biomedical Engineering students Robert Bridenhagen, Gabriel Cruz, and Annika Clawson teamed up with Computer Engineering student Matthew Aspinwall and Electrical Engineering student Matthew…
Leading Lap has redesigned the trocar’s tip to prevent puncturing or injuring organs upon insertion. Georgia Tech biomedical engineering students Hailey Avis, Cameron Bennett, Will…
Thanks to GCMI’s Capstone Day, the team was able to use their device in a highly clinical, practical situation. “Being able to test the device…
Good laboratory practice (GLP) studies are an essential component to medical product development and regulatory submissions. They are highly rigorous, are conducted in compliance with…
Finding a trustworthy CRO for preclinical studies is a top priority for medical product innovators. It is always more cost-effective for companies to get it…
The North American Spine Society (NASS) Annual Meeting is the gathering with arguably the greatest ability to influence the global market for spinal implants and…
The Transcatheter Cardiovascular Therapeutics (TCT) meeting is the world’s largest educational meeting specializing in interventional cardiovascular medicine. This year, it will take place on September…
“We needed to conduct the study perfectly to prove to the FDA that our technology really was safe and effective; we learned that we needed…
At GCMI, medtech and medical device innovation are at the core of our efforts including our work within our industry leading preclinical CRO. While our…
In October 2018, GCMI and Rambam Medical Center announced the formation of a partnership to help Israeli medtech innovators commercialize their products in the U.S.…
Yet another edition of the SEMDA Medtech Conference has come and gone. The 2019 edition saw colleagues from 26 states attend and significant diversity among…
The American Academy of Orthopaedic Surgeons (AAOS) Annual Meeting is the world’s largest orthopedic conference with over 30,000 attendees annually that include physicians and industry…
The American Academy of Orthopaedic Surgeons’ Annual Meeting (AAOS) is the premier ortho event of the year: hosting thousands of thought leaders, physicians, scientists and…
GCMI’s 2018 year end review and 2019 look ahead Thanks to our staff, customers, sponsors and fellow industry, academic and philanthropic visionaries, GCMI has…
The Transcatheter Cardiovascular Therapeutics (TCT) meeting is the world’s largest educational meeting specializing in interventional cardiovascular medicine. This year, it will take place on September…
GCMI hosts the fifth cohort of Project Engages Last year, we wrote about the amazing work Georgia Tech Professor Emeritus Dr. Robert Nerem and others…
Welcome to the third episode in our series about what it takes to get from an idea to a new medical device. We started the…
Your innovative medtech or medical device idea may solve a problem that you face on a regular basis, but that doesn’t always make it a…
“We have not once veered from our relationship with T3 Labs and have no intentions of doing so. I wish I could bring the…
As the leading annual electrophysiology event, HRS will always bring the latest advancements in pacing, ablation and mapping to the society’s annual meeting. The 2018…
So you have an idea for a new medical device. Now what? Coming up with a concept for a new medical device is an exciting…
“It is exceedingly rare for student medtech projects to become companies,” Rains said. “But in a very intentional way, and thanks to a robust local…
Having attended the annual Heart Rhythm Society Scientific Sessions for the past seven years, we can attest to its industry leading role in the gathering…
An estimated 10 million Americans suffer from atrial fibrillation (AF). The current medications to treat AF have low success rates and potentially toxic side effects.…
GCMI-T3 Labs will be exhibiting at the Society of Interventional Radiology annual meeting (Booth 833), which will be held March 17-22, 2018 in sunny Los…
Connect with T3 Labs at AAOS 2018 The American Academy of Orthopaedic Surgeons’ Annual Meeting (AAOS) is the premier ortho event of the year:…
A new medical device’s or product’s pathway from concept to cure to commercialization is fraught with pitfalls, setbacks and usually significant financial investment. T3 Labs…
2017 was a year for the books! Our sponsors continue to receive regulatory approvals maximizing their investment in preclinical research, and our bioskills training program…
Grants season is coming up again! Let’s face it, preparing and submitting a biomedical research grant application is a tedious task that requires a lot…
For medical product innovators large and small, T3 Labs prides itself on delivering the highest value preclinical testing and bioskills training services available. Depending on…
The Cardiovascular Research Foundation’s annual TCT conference serves as the premier cardiovascular event of the year: delivering the latest clinical and preclinical updates on a…
Starting Sunday, October 29, industry leaders in transcatheter cardiovascular innovation will convene in Denver, Colorado for TCT 2017. Transcatheter Cardiovascular Therapeutics (TCT) is the world’s…
Connect with GCMI and T3 Labs during the 2017 edition of the Georgia Bio Innovation Summit Bringing a new medical device from concept to cure…
Connect with T3 Labs during ACG 2017- Booth #526 The American College of Gastroenterology is a recognized leader in educating GI professionals and the general…
We wish to extend a huge congratulations to our sponsor ALung Technologies! Just last week, it was announced that ALung has received IDE approval to…
“Children aren’t little adults, yet we expect our physicians to retrofit adult devices to fit a pediatric patient,” says Sherry Farrugia, Chief Operating and Strategy…
Through Project ENGAGES, a select group of high school students experience the biomedical community and the full view of the medical product pathway: from bench…
With preclinical help from T3 Labs and the support of experts within the Atlanta medtech ecosystem, Dr. Rebecca Levit and her team is revolutionizing drug…
Connect with GCMI and T3 Labs at GSACS 2017! The Georgia Society of the American College of Surgeons (GSACS) promotes elevation in standards of…
Who better to address unmet clinical needs and life-changing improvements to medical devices of all types than clinicians themselves? Piedmont Healthcare and T3 Labs’ a…
The Society of Quality Assurance is dedicated to promoting quality in the regulated research community, including clinical settings, laboratories, and manufacturing facilities. This year the…
The American Academy of Orthopaedic Surgeons’ Annual Meeting (AAOS) is the premier ortho event of the year: hosting thousands of surgeons, medical device companies, thought…
Connect with T3 Labs at AAOS 2017- Booth #1956 The American Academy of Orthopaedic Surgeons’ Annual Meeting (AAOS) is the premier ortho event of the…
Between the collaborative efforts of the robust medical ecosystem in the Southeast, and the sponsors who have helped us tell our story, this year has…
Having a facility like T3 to test novel and breakthrough applications’ ability to save lives is crucial for battling diseases and disorders. Dr. Matheny and…
For medical product innovators large and small, T3 Labs prides itself on delivering the highest value preclinical testing and bioskills training services available. Once Bio2…
The Masters of Biomedical Innovation and Development program (BioID program) is a collaborative academic experience in Biomedical technology and a hands-on clinical experience built upon…
The Cardiovascular Research Foundation’s annual TCT conference serves as the premier cardiovascular event of the year: delivering the latest clinical and preclinical updates on a…
The World Stem Cell Summit (WSCS) will convene its 12th annual meeting from December 6-9, 2016 in West Palm Beach, Florida. The WSCS Annual Meeting…
T3 Labs will be present at the Society of Vascular and Interventional Neurology (SVIN) annual meeting, which will be held November 16 – 19, 2016…
The American College of Gastroenterology annual conference serves as the premier gastrointestinal event of the year: delivering the latest clinical updates on a wide spectrum…
Transcatheter Cardiovascular Therapeutics (TCT) is the world’s foremost educational meeting specializing in interventional cardiovascular medicine. This year, TCT 2016 will be hosted October 29th –…
According to Markets and Markets Research, the global market for spinal implants and devices will top $15 billion by 2020. In North America, the gathering…
How T3 Labs helped Abbott Vascular, Dr. Bill Gogas, Dr. Sandeep Kumar, the core teams of Emory University lead by Dr. Habib Samady, and Georgia…
The American College of Gastroenterology annual conference serves as the premier gastrointestinal event of the year: delivering the latest clinical updates on a wide spectrum…
The European Association for Cardio-Thoracic Surgery (EACTS) is holding their annual meeting from October 1-5 in Barcelona, Spain. T3 Labs was originally founded as a…
For more than 14 years, Georgia Bio has presented Georgia’s premier bioscience and medtech conference welcoming more than 600 CEOs, senior executives, scientists and public…
T3 Labs and GCMI always stand ready to help new medical devices and their innovators advance from ‘back of the napkin’ ideas often generated in…
Over 2,000 physicians and allied health professionals participate in bioskills training programs at T3 Labs every year. Among them is Dr. Keith Delman, director of…
Medical device innovators need trustworthy CROs for preclinical studies to help speed the process from concept to cure to commercialization. Here are a few must…
Late last week, T3 Labs, GCMI, Georgia Tech and Emory announced that GCMI signed a letter of intent to acquire ownership interest in T3 Labs…
We would like to thank Jeremy Kimmel and ALung Technologies for recommending such a wonderful and productive conference: ASAIO 2016. The ASAIO (the American Society…
T3 Labs Training Program Director Kelley Bennett joined SEMDA Executive Director Jason Rupp and GCMI Executive Director Tiffany Wilson on Health Connect South Radio last…
Evaluating the readiness of your artificial heart, ventricular or respiratory assist device for preclinical testing, need valuable feedback from clinicians, or the very best in…
“DDW is the largest annual gathering of surgeons, hepatologists, and gastroenterologists from around the world. The breadth of content covered — from liver to pancreas…
Over 1,300 of the world’s foremost cardiothoracic surgeons comprise The American Association of Thoracic Surgery. It is the definition of an industry leading organization in…
If you are an early stage medtech innovator and want to talk about your device’s or product’s path to regulatory approval, including preclinical studies, or…
T3 Labs is committed to excellence in translational research including preclinical cardiovascular research. After all, our program leaders are scientists, too. This is most recently…
If you are attending the Wound Healing Society 2016 Annual Meeting in Atlanta, odds are you are less than a mile or 5 minutes away…
“I’ve gotten more out of these eight hours than I have in any other training facility.” “This is as close as you can come to…
Remaining on the forefront of FDA requirements and learning from our peers’ experience is why we invest in the SQA Conference every year including SQA…
“At the conclusion of every program, we depart with a great brand name.”
At T3 Labs, we take great pride in our scientific acumen. Afterall, the organization was conceived and designed by translational researchers for medical product developers.…
In any medical device training program the stakes are high. The investment in time and money, the relationships with your physicians and the overarching reputation…
The data driving R&D and commercialization decisions in medtech innovation, like histology, can be underpowered and don’t expound the entire product efficacy story. The processing…
ALung recently raised $12 million to support the U.S. regulatory approval process for the Hemolung RAS, the world’s first fully integrated respiratory dialysis system.
At T3 Labs we love to connect with our colleagues at industry leading events year-round. Event engagement not only quenches our thirst for new scientific…
Preclinical testing and training industry leader T3 Labs and imaging and image analysis experts ImageIQ use advanced quantitative imaging to accelerate preclinical research for medical…
A surgeon, a product director and a preclinical study director bump into each other at the Omni Shoreham lobby… Well, not exactly, but that’s the…
“Our experience with T3 Labs for the CardioMEMS device created new knowledge and refinements to the device that resulted in a product that was highly…
ALung Technologies continues to rely on T3 Labs for preclinical research for the Hemolung RAS (Respiratory Assist System) as GLP study for FDA IDE application…
At T3 Labs, we are always eager to meet the collective medtech minds at every conference we attend. What projects are ongoing, where are they…
“At the preclinical stage of medical device product development, there is an important opportunity to identify and implement significant improvements before first clinical use.…
ALung Technologies needed a CRO with great flexibility and responsiveness in order to maximize limited resources and accelerate the timeline associated with preclinical trials. “T3’s recommendation…
The past few months at T3 Labs have been immensely productive. Along with our preclinical sponsors we continue to produce ground-breaking data. Our sponsors continue…
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment in preclinical?
Atlanta is a hidden gem in the national medical device innovation ecosystem. We recently detailed the top reasons why on the T3 blog. Last week,…
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment in preclinical?
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment in preclinical?
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment in preclinical?
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment in preclinical?
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment in preclinical?
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment in preclinical?
Surefire Medical achieves FDA 510(k) clearance for direct-to-tumor embolization device Surefire Precision in just 76 days with the help of T3 Labs.
Characterizing nerve response post renal denervation is the most critical aspect of any preclinical renal denervation study. Nerve atrophy, healing changes (fibrosis), condition of the…