The Top 5 Challenges for Founders Developing SaMD and Connected Device Software

Compliance with regulatory frameworks is important for SaMD and connected device development. Agencies such as the FDA, EMA, and their international counterparts impose rigorous standards to safeguard patient safety and efficacy.

• Proactive Regulatory Engagement: Cultivating early and ongoing dialogue with regulatory authorities is essential to gain clarity on evolving requirements, minimize delays, and align development strategies with regulatory expectations.
• Robust Risk Management and Quality Systems: Implementing comprehensive risk management frameworks, such as ISO 14971, and establishing robust quality management systems based on ISO 13485 are fundamental to demonstrating device safety and effectiveness.
• Data Privacy and Cybersecurity: Given the sensitive nature of medical data, founders must prioritize data privacy and cybersecurity by adhering to regulations like GDPR and implementing robust security measures.

Ensuring patient safety in a software-centric medical device environment demands a holistic approach that extends beyond traditional hardware considerations.

• Human-Centered Design: Integrating patient needs and preferences into the design process is crucial to developing intuitive and user-friendly devices.
• Cybersecurity Resilience: Protecting medical devices from cyberattacks is imperative. Implementing robust cybersecurity measures, such as vulnerability assessments and threat modeling, is essential to safeguarding patient data and device integrity.
• Post-Market Surveillance and Real-World Evidence: Establishing robust post-market surveillance systems and leveraging real-world evidence to continuously monitor device performance and identify potential safety issues is vital.

A cornerstone of successful SaMD and connected device adoption is an intuitive and user-centric experience. Healthcare professionals operate in fast-paced environments and require tools that seamlessly integrate into their workflows.

• User-Centered Design Philosophy: As emphasized by the foundational text exploring the complex interaction between human thought and the technology it creates, The Design of Everyday Things by Don Norman, involving end-users in the design process is crucial for creating products that align with user needs and expectations.
• Human Factors Engineering: Applying human factors engineering principles, as outlined in the ISO 9241 standard, can optimize interface design, reduce cognitive load, and minimize the potential for errors, thereby enhancing patient safety.
• Comprehensive Training and Support: Effective training programs and ongoing support resources are essential for empowering users to fully leverage the capabilities of the device. Studies have found that health information technology can improve the quality and efficiency of care delivery through better decision support, as cited by the Health Renaissance research on The impact of training on the use of electronic health records. This highlights the importance of this factor in user satisfaction and device adoption.

The ability to seamlessly integrate with existing healthcare infrastructure is critical for the successful deployment of SaMD and connected devices. Interoperability challenges can hinder adoption, while successful integration can optimize workflows and improve data exchange.

• Adherence to Interoperability Standards: Compliance with industry standards such as HL7, FHIR, and DICOM is essential for facilitating data exchange and ensuring compatibility with a wide range of healthcare systems. As highlighted in the Office of the National Coordinator for Health Information Technology’s (ONC) Interoperability Roadmap, these standards have become increasingly important for the successful implementation of health IT systems.
• Robust Application Programming Interfaces (APIs): Developing well-documented and secure APIs enables seamless integration with EHRs, HIS, and other medical devices, promoting data flow and system efficiency. Examples of successful API integrations in healthcare include the use of FHIR-based APIs by Epic and Cerner to enable data exchange between their EHR systems and third-party applications.
• Rigorous Interoperability Testing: Comprehensive testing is crucial to identify and address integration challenges, ensuring that the device functions as intended within the complex healthcare ecosystem. The Interoperability Standards Advisory Committee (ISAC) provides guidelines and frameworks for conducting effective interoperability evaluations.

The rapid evolution of software engineering, artificial intelligence, and machine learning presents both significant opportunities and challenges for SaMD and connected device developers. To maintain a competitive edge, founders must adeptly balance innovation with regulatory compliance and product stability.

• Continuous Learning and Adaptation: Fostering a culture of innovation requires a dedicated commitment to staying abreast of emerging technologies and regulatory shifts. Implementing robust knowledge management systems and encouraging employee development can help organizations adapt to the evolving landscape.
• Strategic Technology Adoption: Careful evaluation of new technologies is essential to determine their alignment with product goals and regulatory requirements. A phased approach to adoption, coupled with rigorous testing and validation, can mitigate risks and maximize benefits.
• Legacy System Modernization: Many medical device companies operate with legacy systems that can hinder innovation. Developing a strategic plan for modernizing these systems while ensuring uninterrupted operations is crucial for long-term success.

Developing SaMD and connected devices is a complex endeavor that demands a multifaceted approach. Founders navigating this landscape must prioritize regulatory compliance, patient safety, usability, system integration, and technological advancement. By establishing a strong foundation of robust processes, fostering a culture of innovation, and cultivating strategic partnerships, companies can overcome challenges and deliver life-changing medical solutions.

Navigating the complexities of developing SaMD and connected devices requires a partner with deep expertise in both technology and healthcare. HTD specializes in designing and developing physician-centric digital health solutions that address the critical challenges outlined in this article. Our focus on user experience (UX) and user interface (UI) design ensures that our solutions are not only effective but also intuitive and user-friendly.

With a proven track record of delivering successful digital health projects for leading healthcare organizations, HTD can help you overcome regulatory hurdles, prioritize patient safety, enhance usability, achieve seamless integration, and stay ahead of technological advancements. Let HTD be your partner in transforming your healthcare organization and delivering exceptional patient care. Contact us today to learn more about how we can help you achieve your digital health goals.