Saylan Lukas headshot

Medtech and life science innovation is 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 outcomes within a capital efficient pathway. The organization originated with support from the Office of Innovation and Entrepreneurship, part of the U.S. Department of Commerce’s Economic Development Administration, and an i6 Challenge Grant.

In 2016 GCMI, a Georgia Tech affiliate, acquired responsibility for T3 Labs – an industry leading preclinical CRO – making GCMI truly an end-to-end medtech innovation center. More than six years on, the institutions determined that demand for costly preclinical work, especially good laboratory practices (GLP) studies required by regulatory submissions, is driven too far downstream in the product development process for optimal operational efficiency. GCMI therefore chose to focus on core design and development pathways in a more concentrated fashion leading to the November 2023 sale of T3 Labs to Veranex.

No, GCMI has not been “taken private.”

GCMI’s Continuing Commitment to Excellence in Medtech Innovation

GCMI remains a non-profit affiliate of Georgia Tech. As we have for more than a decade, we help clinician innovators, start up companies, engineers and scientists with university supported technologies, industry partners, hospitals and health systems realize and commercialize new medical technologies. We maintain ISO 13485 compliant quality management systems and possess expertise in all relevant subject matter critical to successful medtech innovation and commercialization. That expertise includes the imperative clinician’s perspective via our Medical Director and pediatric urologist, Emily Blum, MD. We can also serve as manufacturer of record for novel medical technologies including those used in compassionate use provisions and investigational studies.

Saylan Lukas demonstrating with a prototype

Our work in support of Georgia’s life science innovation ecosystem specifically includes Hong Yeo’s flexible wireless stethoscope, multiple projects in collaboration with Children’s Healthcare of Atlanta, Piedmont Healthcare physicians and clinical teams, NFant Labs, OXOS Medical and GloShield by Jackson Medical among others. GCMI also plays a pivotal role in the Center for Medtech Excellence (CMTE), which is focused on catalyzing the development and commercialization of breakthrough biotechnology, medical devices, life science and therapeutic innovations. Within CMTE, we have supported Dr. Noze Best and it’s NozeBot Baby Nasal Aspirator and Hub Hygiene’s easySCRUB device.

Georgia’s medtech innovation ecosystem has all of the assets needed for success with high quality of life and lower cost of living compared to locales like Boston and the Bay Area with more august reputations in the discipline. Our ecosystem of clinicians, hospitals, patients, universities, engineers, entrepreneurs, investors, solutions providers and supporting state and municipal resources is robust. Atlanta specifically has additional biomarkers for medtech innovation like grant funding including the Georgia Research Alliance, startups spun out in the past, a mature funding ecosystem and patents issued. Our foundation is strong. Our growth potential is high and GCMI intends to actively foster that growth.

At the end of the day, GCMI is fully committed to successful medtech commercialization that improves outcomes. We welcome you to contact us at any point in a medical technology’s pathway from the ‘back of the napkin’ to the bench, manufacturing, bedside and beyond.

I invite you to take a moment to follow our new organizational profile on LinkedIn and take a look at our new web presence https://gcmiatl.org

Sincerely,

Saylan Lukas

Interim Executive Director, Global Center for Medical Innovation

Georgia Life Sciences Designates City of Atlanta as Newest BioReady® Community

By Sheran Brown • February 21, 2025
Georgia Life Sciences Designates City of Atlanta as Newest BioReady® Community

Bipartisan PBM Reform Back in Focus as House Committee Plans Hearing

By Sheran Brown • February 20, 2025
A renewed push for prescription drug cost reform is gaining momentum in Congress, with the House Energy and Commerce Committee's health subcommittee planning a hearing on pharmacy benefit manager (PBM) reform for late February. The hearing, to be led by Rep. Buddy Carter (R-Ga.), signals a revival of bipartisan efforts to regulate these pharmaceutical intermediaries. PBMs, which negotiate drug prices for insurers and employers, have become a focal point in the broader discussion of healthcare costs. A previous bipartisan agreement to regulate these entities was crafted by Carter and Rep. Diana DeGette (D-Colo.) in the last Congress, though it ultimately stalled when the larger spending bill it was attached to faced opposition. The reform efforts enjoy broad support from both parties and the president, making it one of the few areas with potential for bipartisan cooperation. However, new complications have emerged as Republicans consider using PBM regulations to generate savings for their broader policy agenda, potentially requiring up to $880 billion in cost reductions. The path forward remains uncertain, with ongoing debates about whether such reforms would qualify for budget reconciliation and whether using PBM regulations as a funding mechanism could derail bipartisan cooperation. Meanwhile, stakeholders continue to disagree on the impact of additional PBM regulation, with pharmaceutical companies arguing that PBMs inflate drug costs while PBMs contend that new regulations would increase prices.

Council on State Biotechnology Associations says NIH funds are a critical component of innovation ecosystem

By Sheran Brown • February 20, 2025
The Council of State Biotechnology Associations (CSBA) has issued a strong warning about proposed cuts to National Institutes of Health (NIH) funding, emphasizing the critical role these grants play in America's biotech innovation ecosystem. The statement, below , comes amid concerns over recent guidance that would reduce NIH funding to key research institutions. ----------------------- “Today, the US biotech industry employs nearly 2.3 million people across the US and is making positive contributions to economic impact and national security across all 50 states. In fact, for every dollar the National Institutes of Health (NIH) contributes to a successful drug, the private sector invests over $65, underscoring the agency’s unparalleled return on investment. As the associations representing the bioscience industry across the nation, the Council on State Biotechnology Associations (CSBA) is concerned by recent guidance that would cut funding provided by the NIH to universities, hospitals, and other institutions that perform critical early-stage research. NIH grant funds are a critical component of our innovation ecosystem. Grants for basic research are the spark that leads to university-driven discoveries, with public-private partnerships and tech transfers that bridge early-stage research to industry-sponsored drug development and ultimately to FDA approved medical advances for hundreds of diseases. While the administration looks for greater efficiency in the use of taxpayer dollars, it cannot be overstated - once scientific innovation moves abroad, it may never return. In the race for scientific innovation around the world, as our adversaries continue to increase government investments in research, we encourage President Trump to follow suit and ensure that we maintain our global leadership in an industry that was created and thrives across the US.”
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