4 Bold Predictions Shaping Medical Device Quality in 2025
As 2025 approaches, the medical device industry stands on the brink of transformative changes. To help you stay ahead, we asked our CEO and Founder, Kyle Rose, to share his expert insights. From the growing role of AI to shifting regulatory landscapes, here are four bold quality predictions set to redefine the industry in the year ahead.
1. AI Will Be Involved More in Precision Medicine
In 2025, artificial intelligence (AI) will play an increasingly pivotal role in the medical device industry’s shift toward precision medicine. AI is transforming how diagnostic and therapeutic devices adapt to individual patient needs by analyzing large datasets for personalized insights.
The FDA’s guidance on “Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence/ML-Enabled Device Software Functions” (December 2024) emphasizes the importance of maintaining high-quality standards while enabling continuous learning systems. Additionally, the EU’s Medical Device Coordination Group (MDCG) released guidance “MDCG 2023-8: Guidance on Artificial Intelligence and Machine Learning in Medical Devices,” further reinforcing the regulatory focus on quality and adaptability in this field.
2. Prioritization of Trend Accuracy for Wearable Devices
The medical device industry is expected to prioritize trend accuracy over single-point accuracy for wearable devices in 2025. Devices that monitor continuous physiological data, such as heart rate variability or glucose trends, offer more actionable insights for healthcare providers than isolated data points.
The FDA has emphasized this shift, citing the importance of real-world performance and data validation in the agency’s guidance on “Software as a Medical Device: Clinical Evaluation.” Furthermore, the European Commission’s adoption of standards such as “EN 60601-1-11” and “EN ISO 81060-2” underscores the importance of quality metrics for devices used in home healthcare settings, including trend-based analytics.
3. FDA to Improve Regulatory Pathway for Novel and AI-Driven Products
The FDA is expected to enhance regulatory pathways for novel medical devices, particularly those incorporating AI, to meet the unique challenges of adaptive technologies. The agency’s publication of the “Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan” (2021) and subsequent updates reflect a commitment to streamlining processes for innovative products while maintaining rigorous quality and safety standards. Additionally, the agency’s continued focus on the “Breakthrough Devices Program” demonstrates its intention to accelerate the development and review of transformative medical technologies, including AI-driven diagnostics, underpinned by robust validation and quality assurance frameworks.
4. EU to Have Significantly Less Medical Devices Due to MDR Costs and Delays
The implementation of the European Union’s Medical Device Regulation (MDR) has introduced stringent requirements, leading to increased costs and delays in device approvals. Reports indicate that the MDR has become a disincentive against launching medical device innovations in the EU, with a significant reduction in the number of devices transitioning to MDR certification.
Additionally, the complexity and cost associated with MDR compliance have led to a decrease in the availability of medical devices, potentially impacting patient care. As a result, 2025 may witness a notable decline in the number of medical devices available in the EU market, prompting concerns about access to innovative healthcare solutions.
Leverage RookQS Expertise in 2025
As 2025 approaches, navigating the evolving landscape of the medical device industry requires expertise and proactive strategies. At Rook Quality Systems, we specialize in providing top-tier quality and regulatory support to help medical device companies succeed in this dynamic environment. Partner with us in 2025 to leverage our expertise to navigate these transformative changes with confidence and ensure your innovations thrive.