The Medtech industry stands at a crossroads. As artificial intelligence (AI) transforms all aspects of the tech world, Medtech executives are grappling with a high-stakes dilemma: adapt quickly or become irrelevant. But this transformation isn’t without risks – these trends may spell as much trouble for Medtechs as they do promise. While I won’t pretend to predict the future with certainty, here are four bold thoughts on the evolution of safety-critical software.

1. AI Becomes Standard, Not Just a Novelty

By the end of 2025, all major Medtech companies will have AI-enabled products. What was once a cutting-edge novelty is becoming table stakes, driven by intensifying competition and the pressure to innovate. AI will no longer be reserved for startups, experimental products, or niche applications; it will be embedded into devices across diagnostics, treatment planning, and patient monitoring.

But the rush to integrate AI comes with strings attached. Manufacturers aren’t just racing to develop these tools—they’re under immense pressure to ensure AI systems are safe, effective, secure, and compliant with increasingly complex regulations. Companies that fail to address these foundational challenges first will never be able to harness the power of AI in medicine.

2. Clinical AI Software Releases on a Weekly or Monthly Basis

AI development is accelerating beyond anything the Medtech industry has seen before, taking a page from industry leaders such as Google, Amazon, and Netflix. In 2025, expect to see some Medtech leaders adopting rapid release cycles, pushing updates weekly or monthly. This change marks a dramatic departure from the slow, methodical release cycles the industry has traditionally relied on. Embracing continuous delivery could make today’s development pipelines look like a relic of the past. The ability to release monthly isn’t just a business goal, it is a regulatory requirement based on the 2023 Patch Act.

While faster updates allow companies to refine algorithms, fix bugs, and respond to market demands, the speed of change raises critical questions about quality assurance. The stakes in Medtech are uniquely high—rushed updates could compromise patient safety in ways that are simply unacceptable. Can we stabilize the recent rash of recalls, or are we facing a future where the risk of safety-related software recalls is always on the horizon? Striking a balance between agility and reliability will be one of the industry’s defining challenges.

3. A Surge in Software Recalls

The combination of AI and faster release cycles can result in some unintended consequences: more recalls. Given the recent headlines and 50% increase from 2023 to 2024, 2025 will see a notable increase in recalls stemming from safety-critical issues in AI-driven devices. This won’t be a failure of technology, but rather the inevitable consequence of innovation outpacing regulatory processes.

Regulators, already playing catch-up with AI advancements, will likely struggle to provide clear guidance in real time. As a result, medical device manufacturers will need to self-police, investing heavily in pre-release validation and post-market monitoring tools and processes to automate these efforts. Unfortunately, recalls could become an accepted cost of doing business. As noted previously, the key question is whether the industry can stabilize this trend—or if the rising pace of recalls signals a deeper systemic problem.

4. Generative AI Won’t See the Light of Day in Medtech

Generative AI may be making waves in other industries, but it’s not ready for prime time in Medtech. The statistical nature of generative AI presents challenges for safety-critical environments where predictability and reliability are paramount. 

While generative AI might eventually play a role in administrative functions or patient education, we’re not ready to deploy it in clinical or life-or-death scenarios in 2025. For now, the risks far outweigh the potential rewards. Simply put – we don’t know how to “safely” control generative AI in life and death situations – and won’t for some time. 

Medtech companies should focus on refining deterministic AI models before venturing into the murkier waters of generative AI. 

The High-Stakes Balancing Act

The widespread adoption of AI and faster release cycles promise incredible innovation, but they also pose threats to the Medtech industry’s traditional pillars of safety and reliability.

For Medtech executives, the stakes couldn’t be higher. Companies that embrace these changes without a clear strategy may find themselves facing not just recalls and regulatory scrutiny but also the erosion of trust among healthcare providers and patients and, even worse, patient harm.

2025 will Separate the Innovators From the Imitators 

Those who succeed will be the ones who can navigate this era of AI-powered disruption. For the rest, the question isn’t if they’ll stumble—it’s how hard.