GCMI’s 2024 State of Medtech Innovation Report: Part 1

AI Dominates, But Attention to Manufacturing, Supply Chain and Funding Remain Paramount to Success in Medtech Innovation in 2024 and 2025

AI’s potential and momentum in healthcare and medtech are massive. But the need for safety assurance remains paramount as regulators try to mitigate the risk of a technology that has many waypoints to achieve in the clinical care setting especially for diagnosis.

 

With support for note taking, scheduling, hybrid engagement moderation and reporting or simply your virtual assistant or pinpoint wayfinder; AI has become ubiquitous in our daily lives, professional and personal, with a relatively rapid rate of accuracy and maturity.

 

Though it may feel like it when you are juggling multiple tasks at once, lives are not at stake in those activities. While AI has shown high potential in many healthcare endeavors including drug discovery, engagement moderation and reporting, clinical trial design and enrollment, diagnostics, imaging systems and patient monitoring devices, early disease detection, predictive analytics, and personalized medicine, relatively simple tasks assigned to AI like medical summaries are still prone to errors or “hallucination.”


This month, Medcity News reported, “In the 50 summaries produced by GPT-4o, the researchers identified 327 instances of medical event inconsistencies, 114 instances of incorrect reasoning and three instances of chronological inconsistencies.

 

“The 50 summaries generated by Llama-3 were shorter and less comprehensive than those produced by GPT-4o, [Prathiksha Rumale, one of the study’s authors,] Rumale noted. In these summaries, the research team found 271 instances of medical event inconsistencies, 53 instances of incorrect reasoning and one chronological inconsistency.

 

“‘The most frequent hallucinations were related to symptoms, diagnosis and medicinal instructions, highlighting the fact that medical domain knowledge remains challenging to the state-of-the-art language models,’ Rumale explained.”

 

However, regulators like the US FDA are charged with limiting risk and ensuring patient safety first and foremost. AI, especially generative AI, for diagnostic purposes has some distance to go before it can achieve confidence among regulators that it has sufficiently mitigated certain risks and is safe for substantial clinical utility as its potential suggests it might be able.

 

GCMI Medical Director Emily Blum, MD

The nature of AI and ML will require more substantial investments by innovators for quality systems and post market surveillance

“This field will continue to evolve quickly, and constantly,” said GCMI Medical Director Emily Blum, MD. “Innovators integrating AI technologies into their new devices will need to be nimble. They will need to partner with software engineers with experience managing AI and machine learning (ML) systems long-term, keeping the associated data clean and manageable as regulatory guidance documents change. They will also need a robust quality management system in place to make compliance documents more easily accessible and available to submit to regulatory bodies rather than having to stop what they are doing and scramble to comply.”


“Because the technology is evolving so quickly, and it will continue to do so, innovators need to pay close attention to regulatory news on the topic,” says GCMI Interim Executive Director Saylan Lukas. “Pre-sub calls with the FDA will be a must for new devices with an AI component. They will need to be regulated differently from other medical devices and technologies. Regulatory approvals for these will not be locked in place, approved and frozen once they enter the market and clinical utility. They will require significantly more post market surveillance, which will also impact business models and team investment requirements to support those post market activities and technological evolution inherent in its qualities and nature.”


“If AI by its very nature is constantly evolving, how do we ensure it is not learning the wrong lessons potentially leading to adverse events?” Emily asks.


“The only way to know is to test it,” Saylan says. “But what will be the appropriate post-market interval required by regulators? Is an annual ‘check up’ too burdensome? Is five years too long? Those are questions the industry as a whole, especially regulatory bodies, has to answer.”


“Just like physicians have to take qualification tests and accrue continuing medical education (CME) credits, the FDA is recognizing that AI is trained continuously and needs to be tested at regular intervals just like physicians do,” Emily says. They are establishing standards to do so.”

 

FDA’s AI/ML Regulatory Framework

The FDA is actively working to create a regulatory framework that addresses the unique challenges, including ethics concerns, posed by AI and ML in medical devices. In January 2021, the FDA released an AI/ML Action Plan, which outlines a pathway for the regulation of software as a medical device (SaMD) that utilizes AI and ML. The plan emphasizes the importance of a “total product lifecycle” approach, where AI/ML-based devices are monitored and updated throughout their use to ensure they remain safe and effective.


According to McKinsey & Company, “Innovators should develop protocols for implementing updates to AI/ML algorithms, which will need to be reviewed and potentially re-approved by the FDA depending on the risk level of the changes.​”

 

GCMI Interim Executive Director, Saylan Lukas

In the pre-market stage, innovators need to engage with the agency early in the development process to discuss the regulatory pathway along with data and other evidence for market approval. “Presub” meetings are always of high value for innovators,” Saylan says. “They will be paramount for innovators seeking to successfully commercialize technologies with a critical AI component.”


The FDA is collaborating with international bodies to develop standards and best practices for AI/ML development (Good Machine Learning Practices – GMLP), ensuring consistency in how these technologies are validated and implemented. The agency’s 10 “Guiding Principles of Good Machine Learning Practice for Medical Device Development” can be found here.


Like Good Manufacturing Practices (GMP) and Good Laboratory Practices (GLP), regulators will look closely at adherence to GMLP guidelines. How are you controlling the code? Who can make changes? What does your post market analysis look like?

 

EU Regulatory Landscape

In Europe, the regulatory environment for AI and ML in medical devices is shaped by the Medical Device Regulation (MDR), which took effect in May 2021. The MDR places a strong emphasis on the clinical evaluation of AI-based devices, requiring robust evidence of safety and performance before they can be marketed. Additionally, the European Commission is developing the Artificial Intelligence Act, which will impose further requirements on high-risk AI applications, including medical devices. This Act is expected to introduce strict compliance obligations related to transparency, risk management, and human oversight of AI systems​ (AlphaSense)​.


In fact, CNBC reported, “The European Union’s landmark artificial intelligence law officially enters into force [August 1st, 2024] — and it means tough changes for American technology giants.


“The AI Act, a landmark rule that aims to govern the way companies develop, use and apply AI, was given final approval by EU member states, lawmakers, and the European Commission — the executive body of the EU — in May.”

 

Will the US FDA follow suit? Time will tell, but some level of agreement and alignment is likely.

“The FDA is compelled to do everything in its power to ensure patient safety first and foremost,” Emily says. “Imagine this summer’s Crowdstrike event affecting the healthcare system in many more orders of magnitude than it did.”


AI and ML advancements for healthcare and medtech, along with new and nascent regulatory guidelines reflect a growing recognition of the potential and risks associated with AI and ML in healthcare. As these technologies continue to evolve, regulatory bodies are working to strike a balance between fostering innovation and ensuring patient safety.


Medtech innovators who’s new technologies have critical AI or ML components will need to proactively engage with regulatory bodies early and often to make the approval process as smooth as possible regardless of the disease state or therapeutic area of interest. Gathering clean, quality data to support product development (and improvements) along with strong quality and post-market monitoring systems is paramount throughout the product’s design, development and commercialization lifecycle.

 

Cybersecurity Regulations

As cybersecurity threats have increased, so have regulatory requirements. As previously mentioned, the Crowdstrike episode wrought havoc on hospitals and health systems. Imagine what it could do to medical technologies reliant upon AI and ML.


The FDA has added Section 524B to the Federal Food, Drug, and Cosmetic Act, which mandates that all new medical device applications include a cybersecurity plan. This plan must detail how manufacturers will monitor, identify, and address potential cybersecurity risks.


Devices, especially those connected to the internet, must have robust security features, and innovators should integrate these considerations from the design phase. Plante Moran succinctly stated, “Detailed cybersecurity documentation must now be a part of regulatory submissions, requiring collaboration between product developers and cybersecurity experts​.”


In conclusion, the latest advancements in AI, ML, and other medical technologies offer significant opportunities for innovators in specific therapeutic areas. However, navigating the regulatory landscape and addressing the unique challenges of each application will be crucial for bringing these innovations to market successfully.


Thanks for reading! Stay tuned for part 2 in which we unpack US / EU regulatory alignment, wearable tech, 3D printing, funding and the supply chain should lead medtech innovators’ awareness for the balance of 2024 and 2025.

Importance of Life Sciences M&A Amid Rising Interest Rates

November 6, 2026
Increasingly high bond rates are having important implications for the U.S. life sciences ecosystem – and underscore the role of mergers and acquisitions (M&A) and other pro-competitive partnerships in advancing innovation. The upshot. Developing a new medicine requires significant and sustained investment over many years. This makes the life sciences industry especially sensitive to changes in the cost and availability of capital. With financial conditions tightening, a predictable environment for life sciences M&A is critical to sustaining investment in the next generation of cutting-edge treatments and cures. Why bond rates matter. It can cost billions and take more than a decade to bring a new treatment or cure to patients. Often, these companies operate without a profit and rely on outside investment (such as venture capital) to finance this high-stakes journey. When relatively low-risk investments like U.S. Treasury bonds offer stronger returns, investors need significantly greater potential returns to justify betting on riskier, long-term investments, such as drug development. The cost to early-stage life sciences investment. For emerging life sciences companies, less available capital can mean fewer resources to advance promising science and fewer new cures reaching patients. Research from NBER estimated that an unexpected one-percentage-point increase in interest rates reduces R&D spending across industries by approximately 1–3% and venture investment by roughly 25% over the following one to three years. M&A as an investment incentive. A healthy M&A environment provides a critical incentive for investors to support high-risk science by offering a potential exit. The prospect of an acquisition allows investors to realize returns from financing early-stage research – and reinvest that capital in the next generation of treatments and cures. M&A helps advance promising innovation. M&A is similarly vital to turning the promising science that attracted investment into approved medicines for patients. Emerging companies contribute specialized scientific knowledge and innovative drug candidates – but often depend on partnerships with larger, more established companies to access the clinical-development expertise, regulatory capabilities and infrastructure needed to bring medicines to patients. The evidence reinforces this complementary relationship. Findings from Cornerstone Research show that drug projects acquired from smaller companies by firms with prior launch experience were three times more likely to launch – and five times more likely to launch as novel drugs – than projects acquired by another small firm. A predictable pathway forward. When higher bond rates raise the bar for investing in innovation, policymakers should avoid adding unnecessary barriers to an already challenging investment environment. A predictable and balanced approach to merger enforcement can help preserve life sciences M&A as a vital pathway for transforming promising scientific discoveries into new medicines for patients. Source: Importance of Life Sciences M&A Amid Rising Interest Rates - Partnership for the U.S. Life Science Ecosystem (PULSE)

Georgia's Political Landscape Has Changed. Our Mission Hasn't.

November 4, 2026
CEO Note: A New Political Landscape, A Continued Commitment to Georgia Life Sciences Georgia's 2026 election results mark a historic shift in the state's political landscape, setting the stage for a new administration, new statewide leadership, and a potentially changed balance of power in the General Assembly as we approach the 2027 legislative session. At the national level, Democrats won control of both chambers of Congress , creating a new dynamic for federal policymaking. With the presidency remaining under Republican leadership, the coming years will require bipartisan cooperation to advance legislation. Changes in congressional leadership and committee oversight could significantly affect healthcare, federal research funding, FDA policy, drug pricing, and patient access. The most significant changes for our industry, however, are happening here in Georgia. Keisha Lance Bottoms' victory in the gubernatorial race marks a historic transition in state leadership, ending more than two decades of Republican control of the Governor's Office. She will also become the first Black woman elected governor in U.S. history. Democrats also swept Georgia's statewide executive offices , including lieutenant governor, attorney general, secretary of state, and the commissioners responsible for agriculture, labor, and insurance. These leadership changes create new opportunities for engagement on the policies and investments that shape Georgia's economy. In the General Assembly, Democrats made substantial gains and appear positioned to take control of the Georgia House of Representatives , pending final results in several close races. Republicans retained a narrowed majority in the State Senate. This potentially divided legislative environment will require thoughtful engagement and collaboration across party lines. We can also expect considerable turnover in the General Assembly, with dozens of new legislators beginning their terms in January. Along with a new Governor and incoming administration, this creates an important opportunity to introduce policymakers to Georgia's life sciences industry, its economic contributions, and its potential for future growth. What Does This Mean for Georgia's Life Sciences Industry? Life sciences is an economic development priority that should transcend party lines. Our industry's growth depends on a combination of sound public policy, private investment, research, workforce development, infrastructure, and a business environment that encourages innovation and commercialization. As Georgia establishes its new leadership priorities, several areas will be particularly important: Economic Development and Manufacturing: Positioning Georgia to attract and retain biopharmaceutical, biotechnology, and MedTech companies while advancing the infrastructure and capabilities needed to support scale-up manufacturing. Research and Commercialization: Strengthening connections between Georgia's research institutions, emerging companies, investors, and industry partners to move discoveries from the laboratory into commercial applications. Workforce Development: Expanding investment in technical education, apprenticeships, and industry-aligned training to prepare Georgians for the growing range of life sciences careers. Capital and Investment: Improving access to capital and supporting programs that help Georgia-based companies grow, commercialize technologies, and remain competitive. Healthcare Innovation and Patient Access: Supporting an environment that encourages medical innovation, advances research, and improves patient access to new treatments and technologies. These priorities align directly with Pathways & Partnerships: A Roadmap for Georgia's Life Sciences Sector , our ten-year strategy to position Georgia as a leading scale-up manufacturing hub in the Southeast. Georgia enters this transition with both an opportunity and a clear need to strengthen its competitiveness in life sciences. The recently released BIO/TEConomy report highlights the industry's significant contributions, including more than 42,600 jobs across over 4,200 establishments, while reinforcing the opportunity for Georgia to accelerate growth relative to other states. Our Roadmap provides a foundation for working with policymakers to turn these opportunities into sustained investment, stronger industry partnerships, and high-quality jobs throughout Georgia. GLS's Role Moving Forward For Georgia Life Sciences, this transition reinforces the importance of our role as the industry's statewide voice and convener. We will be intentional about building relationships with the incoming administration, new legislative leadership, returning legislators, and state agencies. We must ensure that policymakers understand not only the healthcare implications of our industry, but also its broader economic impact: high-quality jobs, significant research investment, advanced manufacturing, innovation, and opportunities for communities across Georgia. At the federal level, we will continue working with our national partners and Georgia's congressional delegation to advocate for policies that sustain research and innovation, support a predictable regulatory environment, strengthen American biomanufacturing, and advance patient access. With a new administration and many new legislators, we have an opportunity to establish a stronger understanding of what it takes to build and sustain a competitive life sciences ecosystem. That means bringing industry leaders to the table, communicating our priorities, identifying areas of bipartisan alignment, and advocating for policies that support long-term growth. Our industry's success requires a long-term commitment that extends beyond any election cycle or administration. The political landscape may change, but our commitment to advancing Georgia's life sciences industry remains constant. We look forward to working with leaders on both sides of the aisle to ensure Georgia continues to be a place where life sciences companies can innovate, invest, manufacture, and grow.

Why PDUFA Reauthorization Matters for Georgia’s Patients and Economy

October 30, 2026
For Georgians living with serious and rare diseases, how quickly and predictably a new treatment moves through U.S. Food and Drug Administration (FDA) review can make a real difference. That predictability also matters to the researchers and businesses that make up Georgia’s growing life sciences sector. Both depend in large part on the Prescription Drug User Fee Act (PDUFA), a longstanding bipartisan program that Congress needs to reauthorize by 2027. How PDUFA Works Since 1992, PDUFA has allowed the FDA to collect user fees from biopharmaceutical companies to supplement the agency’s resources for reviewing new medicines. In exchange, the FDA commits to clear, predictable review timelines. The agency’s standards for safety and efficacy remain unchanged. By providing additional resources and establishing clear performance goals, PDUFA helps ensure patients can access new treatments in a more timely and predictable manner. The result of PDUFA have been significant. Before PDUFA, FDA reviews often took more than two years. Today, the median review time is 10 months for standard applications and 8 months for priority applications. In 2025, nearly 70% of new medicines were approved in the U.S. before any other country. What’s at Stake in 2027 Congress reauthorizes PDUFA every five years. The current agreement, PDUFA VII, expires September 30, 2027. Timely reauthorization is critical to maintaining the FDA’s review capacity, preserving regulatory predictability, and ensuring patients continue to benefit from medical innovation. Georgia stakeholders recently came together to talk through what that means here at home. On October 28, Georgia Life Sciences, the MTS Sickle Cell Foundation, and Georgia First hosted “PDUFA: How Medicines Reach People,” a lunch-and-learn at Brookhaven City Centre. Patient advocates, congressional staff, and business and academic leaders heard from Nick Magallanes of Todd Strategy Group, Natalie Crawford of Georgia First, Maria Thacker-Goethe of Georgia Life Sciences, and Mapillar Dahn of the MTS Sickle Cell Foundation. What We Heard At the event, speakers came at PDUFA from different angles, but the common thread was how the program affects Georgians. Mapillar Dahn of the MTS Sickle Cell Foundation stressed that patients need to remain at the center of conversations. As a mother of three daughters with Sickle Cell Disease, Mapillar stressed that she wants the FDA to have what it needs to carry out a thorough review without unnecessary delays. The confidence families place in a treatment depends in part on confidence in that process. Natalie Crawford with Georgia First and Mended Hearts spoke about the need for a fully resourced FDA so that Georgia patients have access to innovative treatments and also for a healthy Georgia economy. Additionally, Maria Thacker-Goethe spoke to what PDUFA reauthorization means for Georgia’s booming life sciences sector. She warned that without PDUFA reauthorization, research across the board will be stifled – ranging from devastating impacts to small startups to significant delays in investments and research. Part of a National Conversation As Congress prepares for the 2027 reauthorization, conversations like these help bring together patients, advocates, and community leaders to highlight the real-world importance of the program. Decisions made in this reauthorization cycle will shape FDA resources and review timelines nationwide. By reauthorizing PDUFA on time, Congress can make sure the FDA can keep reviewing new medicines efficiently and patients in Georgia and across the country can get the treatments they need. 
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