A Letter from GCMI Interim Executive Director Saylan Lukas – GCMI’s Continuing Commitment to Excellence in Medtech Innovation

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

PULSE Urges FTC, DOJ to Support Pro-Competitive Life Sciences Collaborations and M&A

June 10, 2026
In recent comments to the Department of Justice (DOJ) and Federal Trade Commission (FTC), PULSE highlighted critical reforms to ensure that U.S. competition policies support – and do not impede – the pro-competitive mergers and acquisitions (M&A) and other collaborations that drive American life sciences innovation. PULSE submitted comments in response to two joint DOJ/FTC Requests related to Guidance on Collaborations Among Competitors and Improvements to the Premerger Notification and Report Form (HSR Form). Read below for key takeaways from PULSE’s comment letters: 1. Life Sciences Innovation Depends on Collaboration “At its core, life sciences innovation is overwhelmingly collaborative. The cutting-edge medicines and cures developed by America’s life sciences industry are rarely the result of just one sole actor. Instead, they more often emerge from a calibrated sequence of partnerships… that collectively usher a biomedical breakthrough from early-stage discovery to FDA approval and delivery to patients.” – PULSE, Comments on Guidance on Collaborations Among Competitors 2. Policies that Ignore the Fundamental Role of Life Sciences M&A Risk Chilling Innovation for Patients “Against the significant challenges and pressures inherent to life sciences innovation, such policies that needlessly delay pro-competitive transactions have significant ripple effects: eroded investment incentives, disruptions in the path to launch and, ultimately, slowed or stalled development of new treatments and cures for patients.” – PULSE, Comments on Improvements to the HSR Form 3. Clear, Predictable Standards Can Support Competition and Innovation in America’s Life Sciences Ecosystem “Preserving clear and workable pathways for collaboration is therefore essential to sustain the broader ecosystem that delivers innovation and sustains America’s status as the world leader in life sciences innovation.” – PULSE, Comments on Guidance on Collaborations Among Competitors Leading business and industry organizations echoed and reinforced these priorities. Their comments highlight the unique market dynamics of life sciences innovation and the importance of collaboration and M&A – particularly with respect to early-stage R&D. “Because drug development typically takes over a decade, and the vast majority of drugs in development never make it to market, the antitrust risks associated with R&D collaborations in this space may be less than with other R&D collaborations.” – ABA Antitrust Law Section, Comments on Guidance on Collaborations Among Competitors “In the biopharmaceutical sector, for instance, R&D ventures in the pre-clinical or Phase I stages should be presumed lawful. At these early stages, about 90% of drugs never make it to market, so these collaborations are far too distant from commercialization to pose a meaningful threat to competition.” – U.S. Chamber of Commerce, Comments on Guidance for Collaborations Among Competitors “Healthy M&A activity also aids company formation and capital raising earlier in a business’s life cycle, as entrepreneurs and early-stage investors often depend on M&A for an exit opportunity. Conversely, discouraging business combinations by imposing burdensome one-size-fits-all standards on all transactions, like those imposed by the 2024 amendments, would disincentivize early-stage innovation and slow down economic growth.” – National Association of Manufacturers, Comments on Improvements to the HSR Form The bottom line: A balanced approach to antitrust enforcement policy should support life sciences M&A and other collaborations, ensuring new medicines continue to reach patients, while preserving a diverse and collaborative ecosystem. PULSE urges the agencies to adopt clear, workable and predictable standards that companies can apply with confidence. That includes preserving enforcement safety zones for low-risk, pro-competitive collaborations, as well as ensuring the HSR Form facilitates a timely, focused and fit-for-purpose screening process for life sciences M&A deals. Click below to read PULSE’s full comments: PULSE Comments on Guidelines on Collaborations Among Competitors PULSE Comments on Improvements to the HSR Form Source: PULSE Urges FTC, DOJ to Support Pro-Competitive Life Sciences Collaborations and M&A - Partnership for the U.S. Life Science Ecosystem (PULSE)

Georgia Life Sciences Promotes Stacey Bowlin to Executive Vice President

June 5, 2026
 June 5, 2026 - Georgia Life Sciences is pleased to announce the promotion of Stacey Bowlin to Executive Vice President . Since joining Georgia Life Sciences in 2024, Stacey has played a central role in advancing the organization’s strategic visibility, industry partnerships, membership growth, and statewide engagement. Her leadership has helped strengthen Georgia Life Sciences’ position as a leading voice for Georgia’s biotechnology, pharmaceutical, medical device, diagnostics, and digital health sectors. “Stacey has made an extraordinary impact on Georgia Life Sciences in a very short period of time,” said Maria Thacker Goethe, President & CEO of Georgia Life Sciences . “She successfully led our transformation from Georgia Bio to Georgia Life Sciences, helping modernize our brand and better reflect the full breadth of Georgia’s life sciences industry. She has also strengthened our member recruitment and retention strategy, deepened engagement across the ecosystem, and brought a level of operational discipline that has helped position the organization for continued growth. I am thrilled to recognize Stacey’s leadership and contributions with this well-deserved promotion to Executive Vice President.” In her expanded role, Stacey will continue to lead key areas of organizational strategy, operational execution, member engagement, and long-term growth. She will work closely with the CEO to support financial and organizational performance, oversee key initiatives, and help translate Georgia Life Sciences’ long-term vision into actionable strategies that strengthen the state’s life sciences ecosystem. With more than two decades of experience in strategic engagement, marketing, operations, and industry development, Stacey brings a collaborative, mission-driven approach to leadership that aligns closely with Georgia Life Sciences’ vision for the future.

Governor Kemp Calls Special Session

June 4, 2026
June 4, 2026 - Governor Brian Kemp has issued a formal proclamation convening the Georgia General Assembly in a special session, signaling the need for legislative action outside the regular session calendar. Under the Georgia Constitution, the Governor is empowered to call a special session and define the scope of issues lawmakers may consider. In this instance, the proclamation outlines the specific subject matter to be addressed, effectively limiting legislative activity to those enumerated items. The proclamation underscores the urgency and importance the administration places on the identified issues, which may include time-sensitive fiscal matters, policy priorities, or emergent statewide concerns that cannot reasonably wait until the next regular session. By setting the agenda, the Governor not only accelerates legislative consideration but also shapes the policy framework within which the General Assembly must operate. From a practical standpoint, the special session compresses the legislative timeline, requiring stakeholders to quickly mobilize, engage decision-makers, and adapt strategies in a fast-moving environment. For clients and partners, this means heightened attention to committee activity, leadership negotiations, and potential amendments, as outcomes are often determined on an expedited basis. Topspin Strategies will continue to monitor developments closely, provide real-time updates, and engage with key policymakers to ensure our clients’ priorities are effectively represented throughout the duration of the special session. Details About the Code Sections Being Discussed: Code Section 21-2-379.23 This law applies to Georgia’s electronic ballot marking devices. Key requirements: Ballots must include standard info like: “OFFICIAL BALLOT” Election date Candidates, offices, and questions Ballots must be printed on secure paper with features like a watermark. The text on the paper ballot is the official vote The human-readable text (what you can read on the ballot) = the legally binding vote This applies to: Vote tabulation Recounts Audits What S.B. 189 changed The 2024 law (Act 697 / S.B. 189) made a major shift: It prohibits relying on QR codes or machine-readable codes to count votes Instead, only the printed text must be counted The key changes to this section are scheduled to take effect July 1, 2026 This code section is at the center of current election debates because: Georgia’s existing voting system relies on QR codes for tabulation The law forces a transition to text-based counting State and local officials have warned this creates: Logistical challenges Potential funding gaps Uncertainty before elections Code Section 48-8-109.52 This section (added by S.B. 33) deals with a specific type of local sales tax authority. From the bill text, it ties to: Local governments that levy certain property taxes (ad valorem taxes) And allows or governs how they can adopt an additional local sales tax via local legislation It creates a framework for certain local governments to pass a new or modified local sales tax, but they must do it through a local Act. If a county/city wants to use this new tax authority The legislature must pass a local bill (local Act) following the rules in that code section S.B. 33 (Act 461, 2026) This is the law that: Created or updated this tax mechanism Set the rules + process for how locals can implement it
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