GCMI’S COVID-19 SAFETY MEASURES AND GUIDELINES
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…
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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.
Service
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.
In our customers' own words
“T3 meets or exceeds all of our mission-critical requirements for medical device training. We would not be as effective in the marketplace if it wasn’t for T3 Labs.” – Margie Sullivan, Training Coordinator, Vista Education & Collaboration Program, Cook Medical. Read more about why Cook Medical relies on our services.
“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, Applied Medical, Clinical Education Manager. Read more, including a video with Applied’s Marc Bolton.
Convenience
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 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.
Critical elements of high quality preclinical study protocols
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…
Webinar: How to design an efficient preclinical protocol
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…
Webinar: The most important things to know before you start a GLP preclinical study
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…
We are on the frontline of the COVID-19 relief effort. And you can help.
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…
Medical Design & Outsourcing: FDA issues FAQ on 3D-printed equipment against coronavirus
Earlier today Medical Design & Outsourcing published the following from the FDA regarding 3D printed equipment intended to supplement PPE needs created by the ongoing…
Breakthrough Initiative Addresses Shortage of Personal Protective Equipment for Nation’s Healthcare Workers in Wake of COVID-19 Pandemic
Research Collaboration to Allow Manufacturers to 3D Print Thousands of Face Shields in the Coming Weeks Atlanta, GA – March 24, 2020 – Global…
GCMI’s COVID-19 Safety Measures, Guidelines and Planned Work
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…
What makes a good preclinical study final report?
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…
Supporting the next generation of biomedical innovators at Georgia Tech – our Capstone Program Support Summary
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.
Aspiring to create a brand new solution for patient aspiration during EGDs – GT Capstone Day at GCMI: Bullseye
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…
Helping clinicians ‘take a load off’ – GT Capstone Day at GCMI: Aprons of Shield
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…
From the CEO: Celebrating 2019 and A Look into 2020
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…
Bridging disciplines to create a new solution for central and arterial line placement – GT Capstone Day at GCMI: S.A.V.A.G.E.
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…
A new, helpful ‘tip’ for surgeons – GT Capstone Day at GCMI: Leading Lap
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…
Attempting to solve a taxing problem in spinal fusion surgery – GT Capstone Day at GCMI: DISCmissed
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…
The most expensive study is one you have to repeat. 10 things to know before you start your GLP study.
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…
Why choose GCMI as your preclinical CRO
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…
Join GCMI as we take a look into the future of spine therapy innovation at NASS 2019
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…
Looking to engage an Industry Leading Preclinical CRO? Connect with T3 Labs at TCT 2019!
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…
Salvage and spike it. What to do when your GLP preclinical study raises questions.
“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…
Need help moving a medtech device through development and regulatory pathways? Connect with T3 Labs at ASAIO 2019.
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…
GCMI and Rambam Medical Center Accelerator Evaluating 12 Israeli Startups for U.S. Commercialization.
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. healthcare market. Earlier this year, Georgia Bio and the Atlanta Chamber of Commerce recognized our work with a 2019 Phoenix Award recognizing leaders who have forged academic and industry relationships…
A few of our favorite insights from SEMDA 2019
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 PitchRounds companies who hailed from AL, AR, GA, FL, KY, MS, NC, SC, TN, TX and VA. Every year, SEMDA is the place to connect with the entirety of…
Exploring the Top Trends and Innovative Technology in Orthopedics at the AAOS Annual Meeting
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 representatives. As a leading preclinical CRO for orthopedic professionals, T3 Labs Orthopedic Program Director, Evan Goldberg attended the 2019 AAOS Meeting earlier this month to keep touch with the pulse…
Are you developing, or have an idea for, a new orthopedic device? If so, make the most of AAOS 2019 by connecting with T3 Labs.
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 academics seeking the latest in injury prevention and disease treatment of the musculoskeletal system. AAOS 2019 will once again bring the top names in orthopedics together in Las Vegas March…
Commercializing Research to Reengineer Healthcare as We Know It
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 tangibly advanced our mission of accelerating the development, testing, training and commercialization of innovative medical products that improve quality based outcomes and delivery of healthcare for patients. 2018 Highlights Leading…
Evaluating or Ready to Engage an Industry Leading Preclinical CRO? Connect with T3 Labs at TCT 2018, Booth 334!
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 21-25, 2018 in San Diego, California. GCMI and T3 Labs will be attending as an exhibitor at TCT again this year. Our booth number is 334. We’re excited to spend…
GCMI Provides Hands-On Learning to High School Students through Project Engages
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 are doing with students in six inner-city Atlanta high schools. This year, GCMI had the opportunity to host the fifth Project Engages cohort for an introduction to the medical product…
[video] Protecting Your Medical Device Idea
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 series recommending you consider how invested you are in your medtech idea and then get input to find out if your idea really fulfills an unmet clinical need. In the…
[video] Does Your Idea Address an Unmet Clinical Need?
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 good candidate for commercialization. It’s not just your idea that matters, but also others’ need for your idea because you’re not the only person that’s going to be using your product.…
Vesalio Finds an Unprecedented Preclinical Partner in T3 Labs
“We have not once veered from our relationship with T3 Labs and have no intentions of doing so. I wish I could bring the T3 staff to Europe for research programs that must be done there. The T3 staff handle everything required with the utmost professionalism and consideration.” – Vesalio CEO Steve Rybka Dr. Arthur…
HRS 2018 Insights: Read about future technologies and how T3 Labs can be your partner in emerging EP research.
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 edition was no exception and included a few variations on atrial fibrillation (AF) ablations. Catheter Ablation vs/ Antiarrhythmic Drug Therapy The big news from the show was the dissemination of…
[video] How Invested Are You in Your New Medtech Idea?
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 moment. The possibility of solving a real unmet clinical need can seem so promising that you may overlook the myriad process challenges that go along with bringing this idea to…
Is one young Georgia Tech company about to end complications from epidural misplacement? Read about their experience at T3 Labs.
“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 and regional medtech ecosystem, that is exactly what is happening here.” Among the approximately 4 million births in the United States each year, 2.4 million of those mothers elect to…
Let’s talk the latest in AF innovation at HRS 2018
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 of electrophysiology experts year after year. With that being said, we can’t wait for HRS 2018, May 9-12, in Boston! When it comes to atrial fibrillation, ablation catheters, mapping catheters,…
T3 Labs sets gold standard in preclinical testing for CorAmi: a medtech company revolutionizing drug delivery for Atrial Fibrillation
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. With preclinical help from T3 Labs and the support of experts within the Atlanta medtech ecosystem, Dr. Rebecca Levit aims to change that. Dr. Rebecca Levit Dr. Levit is Assistant…
See you at SIR 2018, Booth 833
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 Angeles, CA. This is a great opportunity to learn about the latest clinical and scientific contributions as well as current treatments, needs and future trends in interventional radiology. We look…
Time again to connect with orthopedic experts and expand our knowledge of musculoskeletal therapies at AAOS 2018!
Connect with T3 Labs at AAOS 2018 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 academics seeking the latest in injury prevention and disease treatment of the musculoskeletal system. AAOS 2018 will bring the top names in…
How to design an efficient preclinical testing study
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 prides itself in delivering value-based excellence in what we consider phase 2 of this process, preclinical testing. We are often asked by prospective sponsors for in vivo preclinical studies that…
T3 Labs 2017 Year In Review
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 continues to ensure physicians and surgeons develop the skills required to fully realize the value of the medtech innovations. As we put a bow on a remarkable year, we want…
How T3 Labs Can Assist With Your Grant Application Process
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 of planning. We at GCMI-T3 get dozens of requests every year to be collaborators on the preclinical portion of the grant application, often times the night before the grant is…
Selecting the right preclinical partner: Why Cell Constructs utilizes T3 Labs as their trusted Preclinical CRO
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 class and type of submission, not every medical product requires preclinical studies, however, completing preclinical studies is advantageous for proof of concept, when raising capital, applying for reimbursement, and…
The latest in transcatheter cardiovascular therapeutics and innovation from TCT 2017
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 wide spectrum of transcatheter therapies. The 2017 edition was no exception. This was the second year that GCMI and T3 Labs has had a booth during TCT, and we stand…
Learning about the latest transcatheter cardiovascular innovation at TCT 2017 – Connect with T3 Labs booth #6001
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 largest educational meeting specializing in interventional cardiovascular medicine. For over 25 years, TCT has been the center for transcatheter innovation and education. The goal? As always, to improve patient care.…
Learning about the latest advances in medical technologies and life sciences
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 to commercialization is an intimidating, complex and expensive process which often stifles innovation instead of encouraging it. What will the future of innovation mean for the healthcare industry as a…
Coming together at ACG 2017 to advance care for patients with GI disorders
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 public about digestive disorders. Starting Thursday, October 12 in Orlando, Florida, industry leaders across the spectrum of gastroenterology and GI will gather at ACG 2017, the American College of Gastroenterology…
ALung Receives IDE Approval to Conduct VENT-AVOID Trial of the Hemolung RAS for the US Market
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 conduct a VENT-AVOID trial of the Hemolung RAS for the US Market. The device, which achieved its CE mark in 2013, permitting sales throughout the EU, is the world’s first…
An Evening of Medical Device Development: The FDA and Pediatric Medical Devices
“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 Officer of the Pediatric Technology Center, and Director of Children’s Healthcare of Atlanta Partnership. “When adult devices are used it can often cause safety concerns in surgery, orthopedics – really…
Influencing future medical device innovators and biomedical industry leaders
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 to bedside. On July 12th, GCMI and its subsidiary T3 Labs, hosted 30 high school students who are a part of Project ENGAGES- a year long program for high school…
T3 Labs sets gold standard in preclinical testing for CorAmi: a medtech company revolutionizing drug delivery for Atrial Fibrillation
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 delivery for Atrial Fibrillation. Dr. Rebecca Levit Dr. Levit is Assistant Professor of Cardiology at Emory University in Atlanta, GA and adjunct faculty in the Department of Biomedical Engineering at…
Talking bioskills training and medical device development with Georgia’s top surgeons
Connect with GCMI and T3 Labs at GSACS 2017! The Georgia Society of the American College of Surgeons (GSACS) promotes elevation in standards of surgical care. Each year, the society meets for an annual meeting aimed at further educating surgeons for the benefit of the healthcare system. GCMI and its subsidiary T3 Labs is…
Fostering Medical Innovation in the Clinical Setting: Piedmont Innovations & GCMI
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 subsidiary of GCMI, embark on a journey to create a self-sustaining innovation enterprise: concept to commercialization. All I.J. was trying to do was celebrate a friend’s wedding at the beach.…
Talking Good Lab Practices(GLP) with FDA Representatives and Industry Leaders at SQA 2017
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 annual meeting, held March 26-31, boasted attendance of over 800. Located in National Harbor, Maryland, the conference was in close proximity to Washington DC, posing a unique opportunity for more…
Infection prevention in orthopedic medical devices, rigorous FDA regulations, & more: our AAOS 2017 takeaways
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 leaders, and academics seeking the latest advancements and learnings in orthopaedic surgery. Leaders gathered together in San Diego from March 14th to the 18th. The new T3 Labs booth (a…
Connecting with orthopedic experts and expanding our knowledge of musculoskeletal therapies: Why T3 is eager to attend AAOS 2017!
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 year: hosting thousands of thought leaders, physicians, scientists and academics seeking the latest in injury prevention and disease treatment of the musculoskeletal system. AAOS 2017 will bring the top names…
T3 Labs 2016 Year In Review
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 been excitingly marked by growth. As we put a bow on a remarkable year, we want to share the advancements made by T3 in 2016, as well as the goals…
Improving patient outcomes through research and medtech innovation with confidence: Dr. Robert Matheny’s T3 narrative
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 the original team of T3 recognized the need and saw to it that it was met. Dr. Robert Matheny, MD, Chief Scientific Officer of CorMatrix Cardiovascular Inc. The change in…
Meeting the top needs in preclinical studies for orthopedic devices: the first structural, completely porous bioactive glass
Janet Krevolin, Ph.D. Chief Technical Officer of Bio2 Technologies 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 Technologies reached the second stage in the process from concept to cure to commercialization – preclinical – they entrusted T3 Labs…
Influencing future innovators: T3 Labs speaks to the Georgia Tech Masters of Biomedical Innovation and Development class
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 extraordinary resources and reputation of the Wallace H. Coulter Department of Biomedical Engineering: a joint department of the Georgia Tech College of Engineering and the Emory University School of Medicine.…
Aortic & mitral valves galore plus bioresorbable scaffold results: T3 Labs’ insights from TCT 2016
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 wide spectrum of transcatheter therapies and the 2016 edition was no exception. In addition to catching up with existing and prospective sponsors and FDA regulators, here are a few of…
Connecting on preclinical testing at the 2016 World Stem Cell Summit
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 is the premier opportunity to keep up with state of the art advancements in stem cell research, translation and application. We are confident the 2016 edition will meet this high…
Building bridges and learning about the latest in interventional neurovascular technology at the SVIN 2016
T3 Labs will be present at the Society of Vascular and Interventional Neurology (SVIN) annual meeting, which will be held November 16 – 19, 2016 in Brooklyn, New York. This is a great opportunity to learn about the latest clinical and scientific contributions in endovascular technologies and innovative approaches in the management of stroke and…
Breakthroughs in preventing and treating GI disorders: What we learned at ACG 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 of GI disorders and the 2016 edition was no exception. The ACG’s mission is to advance world-class care for patients with gastrointestinal disorders using innovative methods in prevention and treatment.…
Meet us at TCT 2016
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 – November 2nd in Washington D.C. The transcatheter cardiovascular innovation space is ever evolving which makes this conference valuable to the T3 Labs team- but we are particularly excited about TCT…
Grab insights on development paths for spine therapy innovation including preclinical testing in the $15 billion global market. Connect onsite with T3 Labs at NASS 2016.
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 with arguably the greatest ability to influence that market, its innovation and growth is the North American Spine Society (NASS) Annual Meeting. T3 Labs’ Orthopaedic and Spine Program Director Dr.…
Meeting the top needs in preclinical cardiology. Understanding the interaction of next generation bioresorbable platforms with underlying vascular tissue.
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 Tech lead by Dr. Hanjoong Jo, generate and utilize observations from a very long-term translational study toward the understanding of very late vasomotor responses and gene expression profiles in arteries…
Breakthroughs in preventing and treating GI disorders: what to look forward to at ACG 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 of GI disorders. The ACG’s mission is to advance world-class care for patients with gastrointestinal disorders using innovative methods in prevention and treatment. As an industry leading preclinical CRO for…
Gearing up to network with cardiothoracic thought leaders in Barcelona at EACTS 2016!
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 cardiovascular research institute, and boasts a decade long track-record in preclinical cardiovascular studies. “The facilities [at T3 Labs] are top tier. They are designed to make it easy to move…
A few features of the 2016 Georgia Bio Innovation Summit that have us counting down the days
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 policy officials from across the nation. 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,…
From the back of the napkin through preclinical and commercialization for cardiology interventions
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 clinical practice from concept to commercialization and eventually, to cure. Deepal Panchal – Program Director at T3 Labs Recently T3 Labs’ Deepal Panchal joined Health Connect South Radio Host CW…
Bioskills educators & facilities: teaching the next generation of surgeons their craft
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 the Carlos and Davis Center for Surgical Anatomy and Technique at the Emory University School of Medicine. Board certified by the American Board of Surgery as well, Dr. Delman shared…
Five questions to ask when selecting a CRO for preclinical studies
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 ask questions for medtech innovations selecting a CRO to perform your preclinical studies: Are they GLP compliant and/or have a thorough knowledge of regulations? Time and again, FDA guidance documents…
T3 Labs Joins Forces with GCMI, the Global Center for Medical Innovation
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 from Emory / St. Joseph’s Hospital, Inc. We are happy to convey that it’s business as usual for our existing preclinical testing and bioskills training sponsors. You can expect to…
ASAIO 2016: Our Discoveries and Takeaways
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 for Artificial Internal Organs) event provided us with new insight into new pre-clinical models for heart and respiratory devices. Some of our insights and takeaways from this conference included: During…
Update: State of Medtech Innovation in the Southeast
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 week. Give a listen to the current state of medtech innovation in the southeast and how T3 Labs supports our vibrant medtech ecosystem. Via our colleagues Jay Schaffer and CW…
“Saving lives one medical device at a time.” Getting to know ASAIO 2016.
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…
Talking device innovation for gastro, GI and more at DDW 2016
“DDW is the largest annual gathering of surgeons, hepatologists, and gastroenterologists from around the world. The breadth of content covered — from liver to pancreas to colorectal — ensures that every attendee, no matter their specialty, type of practice, or level of experience will benefit from the program. For trainees as well as practicing surgeons,…
Cardiothoracic connections at AATS 2016
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 thoracic surgery. “Other than visiting a surgeon in his or her own operating room, there is no opportunity like [AATS] in education in thoracic surgery,” according to Charles D. Fraser,…
Top 3 things we’re looking forward to at SEMDA 2016: the southeast’s premier medtech conference
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 if you just want to talk about what we are seeing in medtech innovation in the southeast and beyond, we want to connect with you at SEMDA 2016. SEMDA is…
Meeting the top bio-skills training needs: why Cook Medical relies on T3 Labs
“T3 meets or exceeds all of our mission critical requirements for medical device training. We would not be as effective in the marketplace if it…
JACC-CI study & ACC Distinguished Award winner evidence T3 leads the way in preclinical cardiovascular research
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 evident in the journal article “Vasomotor Function Comparative Assessment at 1 and 2 Years Following Implantation of the Absorb Everolimus-Eluting Bioresorbable Vascular Scaffold and the Xience V Everolimus-Eluting Metallic Stent…
Just 1 mile from WHS 2016 in Atlanta, tour an industry leading preclinical CRO.
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 from one of the top preclinical CRO and surgical training facilities in America. Located near Georgia Tech in midtown Atlanta, just 1 mile from the WHS 2016 venue, the Georgia…
Get more out of your medical product training programs
“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 a real OR experience.” At T3 Labs, our commitment to preclinical testing and training excellence is readily apparent to all of our sponsors. But don’t take our word for it.…
Keeping the tip of the GLP spear sharp: SQA 2016
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…
Why Applied Medical relies on T3 Labs for med device training programs
“At the conclusion of every program, we depart with a great brand name.”
A Partner That Understands Your Science & Your Product Development Needs
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. Thirst for science: it’s in our DNA. Our preclinical testing and training program leaders are trained scientists themselves, interested in understanding and participating in the science and methods behind innovations…
Delivering a familiar medical device training environment for surgeons
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 of your company’s brand are all on the line. Founded in 1987 and headquartered in Orange County, California, Applied Medical is a rapidly growing, global organization with over 3,000 team…
Advanced medical imaging and analysis enters FDA guidance, accelerates preclinical trials
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 of those images and the associated analysis can be painfully slow and in many cases subject to detrimental observer-based bias and variability – a simple issue of the human eye…
ALung raises $12M for its U.S. regulatory path. Congratulations!
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.
The pulse of orthopaedic innovation and preclinical: let’s connect at AAOS and ORS 2016.
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 knowledge to the benefit of our organization, our sponsors and our team members, it also fosters what’s next for our organization. Because preclinical orthopaedic device testing and training is an…
Q: Can advanced medical imaging like microCT accelerate preclinical trials? A: Yes.
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 device and pharmaceutical innovators, bring welcome evolution to regulatory processes and data quality. The challenge – speeding up the medtech development cycle Medical device and biologic innovators, especially in the…
CRT 2016 Collisions – Good Ones
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 way the annual CRT conference feels. Like a well designed meeting hub, the event generates “productive collisions” that foster innovation and learning throughout the cardiovascular research technologies ecosystem. Why we…
Preclinical Trials Generate Critical Improvements to St. Jude Medical’s CardioMEMS HF System
“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…
Hemolung RAS Nearer FDA Approval Through Preclinical Research at T3 Labs
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 draws near. ALung’s relationship with T3 began in 2013 for preclinical studies supporting U.S. regulatory approval for the first fully-integrated respiratory dialysis system, Hemolung RAS. Early in the engagement, T3…
Top things in medtech innovation we’re looking forward to at STS 2016
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 in the development lifecycle and what do they mean clinically? Who is driving new milestones? Where is the value? What resources are needed? We focus on events where breakthrough medical…
Preclinical Case Study: St. Jude Medical & T3 Labs for CardioMEMS HF System
“At the preclinical stage of medical device product development, there is an important opportunity to identify and implement significant improvements before first clinical use. T3 Labs provides extensive expertise and capabilities in the critical preclinical stage of medical device product development.” – Jason White, Senior Director of Product Development, St. Jude Medical The challenge:…
Case Study: Selecting a New Preclinical Trials Partner – T3 Labs & ALung’s Hemolung RAS in a Calf Model
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 has accelerated our product refinement testing and preclinical trials saving ALung time and money at every step along the way.” – Jeremy Kimmel, PhD Director of New Technology for ALung Technologies…
The Latest In Preclinical: T3 Labs’ Q4 2015 Quarterly Snapshot
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 to receive regulatory approvals maximizing their investment in preclinical. And our medical device training program continues to ensure physicians and surgeons develop the skills required to fully realize the value…
Top Factors Enabling Swift GLP Turnaround Under Tight Preclinical Timelines
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment in preclinical?
T3 Labs and GCMI Talk Medical Device Innovation Ecosystems with Health Connect South Radio
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, Tif Wilson, executive director of the Global Center for Medical Innovation and T3 Labs advisory board chair, along with Andrew Stevenson, executive director of T3 Labs spoke at length about…
3 reasons Atlanta is a hidden gem for medical technology innovation and investment
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment in preclinical?
Medical device training and testing for gastro and GI: top 3 things we’re looking forward to at ACG 2015
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment in preclinical?
Development paths for spine therapy devices in the $15 billion global market. Connect onsite with T3 Labs at NASS 2015.
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment in preclinical?
TCT 2015: Connecting with industry leaders in transcatheter cardiovascular innovation and beyond.
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment in preclinical?
3 Things to Look for at AdvaMed 2015
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment in preclinical?
From Concept To Cure, How To Secure FDA Approvals on Preclinical Medical Device Testing.
Preclinical medical device testing: how do you know you are ready and how do you make the most efficient investment in preclinical?
Surefire Precision gains FDA 510(k) clearance twice as fast as the industry average with T3 Labs
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.
Nerve Response Post Renal Denervation: Preclinical Testing Generates First Of Its Kind Documentation
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 perineurium, neuromatous regeneration; all of these aspects determine the success or failure of the denervation treatment. We are honored to present our most recent publication: “Neuromatous Regeneration as a Nerve…