Update on the Software as a Medical Device (SaMD) Industry

The Software as a Medical Device (SaMD) industry is revolutionizing healthcare with innovations that enable real-time patient monitoring, advanced diagnostics, and personalized treatment plans. As we enter 2025, the SaMD market continues to evolve rapidly, shaped by technological advancements, regulatory changes, and increasing global demand.

For medical device companies, staying competitive in this dynamic landscape requires robust data management solutions that are secure, scalable, and compliant with stringent global regulations. This article provides a comprehensive update on the state of the SaMD industry, examining regulatory shifts, market trends, and the challenges and opportunities on the horizon.

Regulatory Landscape

Regulations for SaMD are evolving to keep pace with the industry’s growth and technological sophistication. In 2025, key regulatory updates include expanded guidance from the FDA and international bodies like the International Medical Device Regulators Forum (IMDRF). These frameworks aim to address emerging challenges such as the integration of artificial intelligence and machine learning (AI/ML) technologies in SaMD applications.

Key areas of focus for regulators include:

AI/ML Guidance: The FDA has introduced a new regulatory framework for medical device software development related to AI/ML-enabled SaMD, emphasizing transparency, risk management, and real-world performance monitoring. These regulations aim to ensure that AI-driven solutions remain safe and effective over time.

Real-World Evidence (RWE): There is an increased emphasis on using RWE in SaMD validation, allowing companies to leverage data from actual patient experiences to demonstrate safety and efficacy.

Global Harmonization: Initiatives to standardize regulatory requirements across regions are gaining momentum, enabling companies developing SaMD companies to streamline their compliance processes.

Market Trends for SaMD

The SaMD industry is experiencing steady growth as it transforms healthcare delivery. The global SaMD market size is expected to be worth around USD 5.0 Billion by 2033 from USD 1.4 Billion in 2023, growing at a CAGR of 13.6% during the forecast period from 2024 to 2033.

Source: Market.US

Several trends are shaping its trajectory:

AI/ML Integration

Artificial intelligence and machine learning are revolutionizing SaMD applications. From predictive analytics to personalized treatment recommendations, these technologies enable advanced capabilities that were previously unimaginable. Regulatory bodies are responding by setting clearer guidelines for their use, further driving adoption.

Cloud-Based Solutions

The demand for secure, scalable, and compliant cloud platforms has surged. Medical device companies increasingly turn to cloud-based solutions like the Galen Cloud to efficiently manage and analyze patient and device data while ensuring adherence to regulatory standards.

Global Expansion

Emerging markets are embracing SaMD solutions as healthcare infrastructure improves. This presents an opportunity for SaMD companies to reach new populations, though it requires navigating diverse regulatory landscapes and tailoring products to meet local needs.

A Closer Look at Two Leading Trends for SaMDs

Cybersecurity and patient experience are top priorities for the entire tech industry, and SaMD manufacturers are not exception. Let’s look at these two trends in more detail.

Cybersecurity and Privacy

As the healthcare industry becomes more digital, protecting sensitive patient data has become a top priority for SaMD developers. Cybersecurity threats, data breaches, and evolving privacy regulations like HIPAA and GDPR demand robust security measures to safeguard data integrity and patient trust. Key considerations for the SaMD industry include:

Proactive Risk Management: Cyberattacks are increasing, with hackers targeting medical devices and their associated data. To mitigate risks, SaMD companies must adopt proactive measures like regular vulnerability assessments, secure software updates, and encryption.

Compliance with Global Standards: Staying compliant with diverse regulatory requirements across regions ensures patient safety and trust. Secure cloud platforms like Galen Cloud offer a compliant infrastructure that meets the strictest global standards.

Building Trust: Privacy concerns remain a significant barrier to adoption. SaMD companies can foster trust among healthcare providers and patients by demonstrating a commitment to data security and transparency.

Galen Data understands the critical importance of cybersecurity and privacy in the SaMD industry. Their cloud platform meets rigorous compliance standards and provides tools to help SaMD companies manage data securely and confidently in an increasingly complex environment.

Patient-Centricity and User Experience

The SaMD industry is increasingly focusing on patient-centric solutions to enhance engagement, improve outcomes, and build long-term trust. A user-friendly experience is no longer optional but a key differentiator in a competitive market.Key developments include:

Personalized Interfaces: SaMD applications are integrating intuitive designs and customizable interfaces to cater to diverse patient needs. This approach ensures accessibility for patients with varying levels of technical expertise.

Real-Time Monitoring: Patients now expect real-time feedback on their health status. This requires SaMD companies to deliver reliable, instantaneous data updates while maintaining compliance with security standards.

Increased Patient Autonomy: Empowering patients to actively participate in their healthcare journey is a growing trend. By enabling better understanding and control of their health data, SaMD companies can foster a stronger patient-provider relationship.

By prioritizing user-centric design and functionality, SaMD solutions can bridge the gap between innovative technology and patient adoption. Galen Data’s cloud platform supports this evolution by providing seamless data management that prioritizes both usability and compliance.

Challenges and Opportunities

As SaMD continues to grow, the industry faces a dual landscape of challenges and opportunities.

Challenges

Regulatory Complexity: Navigating multiple regional requirements is a major hurdle for SaMD companies looking to expand globally.

Interoperability Issues: Ensuring that SaMD applications integrate with other medical devices and healthcare systems can be technically demanding.

Cost of Development: Developing and maintaining compliant, secure, and innovative solutions often requires significant financial investment.

Opportunities

AI Advancements: The ongoing development of AI and machine learning presents opportunities to create more intelligent and efficient SaMD applications.

Global Market Expansion: The increasing adoption of digital health solutions in emerging markets opens new avenues for growth.

Strategic Partnerships: Collaborating with cloud and data management experts like Galen Data allows companies to focus on innovation while mitigating operational complexities.

By proactively addressing challenges and leveraging emerging opportunities, SaMD companies can position themselves for sustainable growth in 2025 and beyond.

Moving Ahead

The Software as a Medical Device (SaMD) industry is entering a transformative era, marked by advancements in technology, evolving regulations, and a growing emphasis on patient-centric care. Companies that succeed in this dynamic landscape will be those that embrace innovation while navigating the complexities of compliance, cybersecurity, and user experience.

At Galen Data, we understand the unique challenges faced by the medical device industry and SaMD companies. Our secure and scalable cloud platform provides the infrastructure needed to manage data efficiently and in full compliance with global standards.

Partner with Galen Data today to:

• Develop a secure and scalable data management plan.
• Leverage our expertise in medical device data and compliance.
• Focus on innovation while we handle the infrastructure.

Schedule a call with us today to discuss your specific needs and see how Galen Data can help you store, manage, and secure your medical device data at scale.