Artificial intelligence is rapidly transforming healthcare, creating new opportunities to improve clinical decision-making, enhance patient monitoring, and drive more personalized care. As AI technologies evolve, companies face increasing challenges in generating evidence, navigating regulatory requirements, and demonstrating long-term value to patients, providers, and payers.

Few professionals have had the opportunity to shape AI regulation from both the regulatory and industry perspectives. With a background in biomedical engineering, neuroengineering research, digital health, and AI-enabled medical devices, Alex Cadotte has spent his career helping define how emerging technologies can safely and effectively reach patients. Following his work at the FDA, where he contributed to the agency's evolving approach to AI and Software as a Medical Device (SaMD), Alex now partners with innovators across the MedTech ecosystem to develop regulatory strategies for next-generation digital health solutions.

Q: You've had a unique career path from biomedical engineering and neuroengineering research to leading AI and digital health regulatory strategy at both the FDA and industry. What were the most pivotal experiences that prepared you for this role?

The most pivotal decision I made was joining the FDA. It allowed me to combine my background in software development, algorithms, and engineering with exposure to a broad range of medical technologies and regulatory challenges.

At FDA, I had the opportunity to evaluate emerging AI-enabled devices while contributing to the agency's evolving thinking around AI regulation. That experience provided a unique perspective on both the technologies themselves and the frameworks needed to assess them safely and effectively. It continues to shape how I approach regulatory strategy today.

Q: Many digital health companies are eager to incorporate AI into their products. What separates the AI-enabled solutions most likely to succeed over the next several years?

Not all AI applications create meaningful clinical value. The most successful companies focus on solving real healthcare challenges rather than incorporating AI simply for the sake of innovation.

Success ultimately comes down to evidence and product strategy. The value of your evidence is directly tied to the quality of your data. Companies that think early about both reimbursement and regulatory requirements are typically better positioned for long-term success because they are building products that address market needs and regulatory expectations from the outset.

Q: As generative AI becomes embedded across healthcare workflows, where do you see the greatest opportunities and regulatory challenges?

Generative AI enables capabilities that were previously difficult to achieve with traditional software systems and has the potential to improve efficiency, decision-making, and workflow automation across healthcare.

At the same time, regulatory oversight will remain focused on patient safety. FDA expects manufacturers to identify and mitigate risks before products reach the market rather than learning about those risks after deployment. The challenge over the next several years will be striking the right balance between enabling innovation and maintaining confidence in the safety and effectiveness of these technologies.

Q: You contributed to foundational FDA thinking around AI/ML-based Software as a Medical Device. How do you see regulatory approaches evolving?

Historically, regulatory frameworks have moved more deliberately than technology development in order to better understand potential risks and establish appropriate safeguards.

The challenge today is that AI innovation is accelerating rapidly. Over time, regulators may need increasingly automated approaches to evaluating and monitoring continuously learning systems. Regardless of how those frameworks evolve, confidence in performance monitoring and ongoing oversight will remain essential to maintaining patient safety and public trust.

Q: Wearable technologies continue to evolve rapidly. Where do you see the market heading over the next few years?

Wearables are becoming increasingly sophisticated and capable of generating data with meaningful clinical value in a growing number of applications.

The greatest opportunity lies in transforming continuous streams of data into actionable insights that support earlier intervention and better disease management. As more validated clinical grade solutions become available, these technologies will help move healthcare from a reactive model toward a more proactive and preventive approach to patient care.

Q: If you were advising a startup developing an AI-enabled medical device today, what is the one mistake you would encourage them to avoid?

Do not assume that AI can replace regulatory expertise.

AI can be an incredibly powerful tool, and many organizations are already using it to support regulatory activities. However, successful regulatory strategy still requires experience, judgment, and subject matter expertise. Organizations need to understand both the strengths and limitations of AI-generated recommendations to prevent costly delays. Working with experts from the beginning ensures you get the right answers, the first time.

Technology can help accelerate processes, but it does not eliminate the need for expert oversight. Companies that recognize this distinction are often better positioned to avoid costly delays, reduce risk, and navigate regulatory complexity more effectively.

Conclusion

Alex Cadotte's career reflects the rapid evolution of digital health, artificial intelligence, and software-enabled medical technologies. As he notes, successful innovation requires more than advanced algorithms. Organizations must combine high-quality data, strong evidence generation, thoughtful regulatory strategy, and a clear understanding of patient and market needs. By bringing together expertise across AI, digital health, software regulation, and commercialization, IQVIA MedTech helps innovators navigate complexity and bring transformative technologies to market with confidence.