The 2024 DIA Europe Conference brought together industry experts to explore the rapidly evolving medical device software and connected devices landscape. Key sessions focused on the critical role of digital health technologies in improving patient outcomes, particularly in diabetes management, while addressing the regulatory challenges and cybersecurity concerns accompanying these innovations. The conference also highlighted real-world applications and the complex pathways for reimbursement and commercialization, offering a comprehensive overview of digital health solutions’ current state and future potential.

Digital Health: Bridging the Gap in Diabetes Management

Laura Pastor Sanz from Novo Nordisk opened the session with a stark statistic: only about 6% of people with diabetes achieve desirable health outcomes. Sanz emphasized the need for innovative treatments and support for treatment behavior. Digital health technologies, including medical device software and connected devices, were identified as pivotal in bridging the gap between clinical trials and real-world patient outcomes. Sanz highlighted the growing importance of these technologies, especially considering that the number of people with diabetes is expected to increase by 50% by 2045.

Sanz presented two use cases demonstrating the impact of connected devices. The first involved durable pen injectors for insulin, which record and transmit dosage information to a mobile app. This data can be shared with healthcare professionals to optimize insulin treatment, ensuring patients receive the correct dosage at the right time. For example, these injectors can log the timing and amount of each dose, providing a comprehensive history that helps doctors adjust treatment plans more accurately. The second example was a dose guidance solution for insulin, where a mobile app calculates the next dose based on patient-entered data, significantly enhancing treatment precision and adherence. This solution provides real-time feedback and personalized dosing recommendations, reducing the risk of incorrect dosing and improving overall diabetes management.

Regulatory Challenges: Clarifying Medical Device Classifications

A significant portion of the discussion focused on regulatory challenges, particularly the classification of medical devices. Laura Pastor Sanz highlighted the complexities of implementing Rule 33 in the Medical Device Regulation (MDR), which classifies software that drives or influences device use. For instance, ambiguity around what constitutes “driving” or “influencing” leads to inconsistent classifications across similar products. A practical example discussed was the classification of caps for pen injectors, which vary widely depending on interpretation, resulting in classifications from low-risk Class I to higher-risk Class 2B.

Sebastian Fischer, Regulatory Strategist at TÜV SÜD, emphasized the need for clearer definitions and examples from regulatory bodies to streamline the classification process. Fischer pointed out that Rule 11 within the MDR, which affects the classification of software used in clinical decision support and other low-risk applications, also lacks clarity. This has led to lengthy and often contentious discussions with notified bodies about the appropriate classification of these products. Fischer advocated for more detailed guidance and specific examples to ensure consistency and predictability in the regulatory process, ultimately facilitating smoother market entry for innovative medical device software.

Cybersecurity and Artificial Intelligence: Ensuring Patient Safety

Cybersecurity emerged as a critical concern for connected medical devices. Sebastian Fischer stressed the importance of robust cybersecurity controls to prevent unauthorized access and data breaches, which could compromise patient safety. He highlighted the need for adherence to international and EU regulations, including the Medical Device Coordination Group (MDCG) guidelines, to ensure comprehensive protection of patient data and device functionality.

The session also explored the integration of artificial intelligence (AI) in medical devices. Fischer discussed the proposed Artificial Intelligence Act, which introduces new requirements for AI systems in medical devices. This Act ensures that AI-driven devices are safe and effective, mandating stringent conformity assessments by notified bodies. The new regulations are designed to address the unique challenges posed by AI technologies, ensuring they meet high standards of reliability and performance in medical applications.

Real-World Applications: Connected Devices in Clinical Practice

Yury Rozenman, Senior Vice President at Ada Health, shared practical examples of connected devices in clinical practice. He highlighted wearable technologies, such as Fitbit and Apple devices, for identifying atrial fibrillation and monitoring conditions like sleep apnea. These devices provide continuous monitoring, crucial for conditions outside clinical settings. For instance, wearable devices can detect irregular heartbeats that may indicate atrial fibrillation or track oxygen levels and heart rate to identify sleep apnea events at night.

Rozenman also discussed the challenges of medication adherence and the role of AI in addressing these issues. AI can identify patterns and intervene to improve adherence and treatment outcomes by analyzing data from connected devices and patient-reported outcomes. For example, AI algorithms can detect when patients are missing doses or experiencing side effects, allowing healthcare providers to intervene with reminders, education, or adjustments to the treatment plan, ultimately enhancing patient compliance and health outcomes.

Reimbursement and Commercialization: Navigating the Financial Landscape

The session concluded with a discussion on reimbursement pathways for digital medical devices. Yury Rozenman noted that payers are often reluctant to cover connectivity costs within devices, especially for inexpensive pharmaceuticals. However, pharmaceutical companies may bear the cost of ensuring patient adherence and optimizing outcomes for high-cost biologics and other expensive treatments. This financial support is critical for maintaining consistent usage and maximizing the therapeutic benefits of these costly medications.

Rozenman emphasized the importance of aligning business and commercial models with reimbursement realities. He advised considering who will pay for the device and under what conditions, as reimbursement remains a significant challenge even for cleared devices. Companies must strategically plan their market approach, ensuring that the added value of connectivity and digital health features is demonstrated to payers to secure funding and support widespread adoption.

Key Takeaways: Advancing Digital Health Technologies

The 2024 DIA Europe Conference highlighted the transformative potential of digital health technologies and medical device software in improving patient care. However, it also emphasized the need for clearer regulatory guidelines and robust cybersecurity measures in medical device software. As the industry moves forward, collaboration between stakeholders, including manufacturers, regulators, and healthcare professionals, will be essential in navigating these challenges and maximizing the benefits of digital health solutions.

Moe Alsumidaie
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Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.