Challenges in Conducting SaMD Clinical Evaluation Trials-Solutions by ProRelix Research

Medical devices encompass simple devices such as tongue depressors, bandages, and syringes to imaging devices (ultrasound and CT scanners), implantable devices (pacemakers), and medical equipment. The emergence and technological advancements in of data analytics, artificial intelligence (AI), and increased internet connectivity and accessibility has led to the widespread use of Software as a Medical Device (SaMD) in diseases prevention, diagnosis, and treatment. Software as a Medical Device (SaMD) refers to a class of medical software intended to be used for medical purposes or that is designed to carry out medical functions without the need for actual hardware. This can comprise of software or applications intended to diagnose, cure, mitigate, or prevent disease. Mobile health apps, wearable devices, imaging software, remote monitoring tools, electronic health record (EHR) systems, virtual and augmented reality (VR and AR) technology, telemedicine platforms, and technology for informed consent, adverse event, and safety reporting systems are some of the SaMDs.

Conducting clinical evaluation trials for SaMD presents unique challenges that require specialized expertise, often provided by a clinical research organization, to navigate regulatory requirements, ensure robust data collection, and manage technological complexities.

As SaMDs are standalone software applications, they should be considered independent medical devices and regulated accordingly by appropriate regulatory authorities. The United States Food and Drug Administration (FDA) and the International Medical Devices Regulators Forum (IMDRF) have released guidance documents that cover risk-based approaches, quality management principles, and the clinical evaluation of SaMDs. According to the FDA guidance, the clinical evaluation for Software as a Medical Device( SaMD) is “the assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety. Performance, and effectiveness of the device when used as intended by the manufacturer”. The clinical evaluation process for SaMDs involves the aspects shown in the figure.

The risk category of the device determines the clinical evaluation plan particularly if independent review and studies are required or previous data and literature can be used to support the SaMD’s use. In general, high-risk devices (category IV) require a more through review and extensive clinical investigation plan whereas low-risk or category I devices can suffice with previous data and do not require a formal independent review.

Although, SaMD use and applicability has grown exponentially, their use and regulatory approval is fraught with challenges. It is necessary for regulatory agencies to develop specific guidelines and regulations for the approval of SaMDs which may be time-consuming and complex. Additionally, the regulatory approval process and requirements for SaMDs differ between countries indicating a lack of harmonization which further adds a layer of complexity when the device is to be marketed globally. Furthermore, and more importantly, the clinical evaluation process for SaMDs relies heavily on thorough clinical investigations and evidence-based approaches that require extensive expertise, knowledge, and adaptability due to the changing nature and upgradation of software. Other challenges with SaMDs include ensuring data integrity (accuracy and reliability) of captured data through real-world sources such as home monitoring systems and wearable sensors, validation of devices, and integration of these devices with other systems. From a clinical evaluation perspective, choosing an adequate end point, patient privacy concerns, and data integrity issues are the main problems that are encountered whilst using SaMDs.

At ProRelix Research, we can help you with bringing your SaMD to market by our expert team of professionals that can assist in navigating the clinical evaluation and regulatory landscape. We provide the following services in the field of SaMD:

• Act as a liaison between regulatory bodies and sponsors/investigators to help understand the applicable local and global regulatory guidelines.
• Help understand the regulatory requirements between different countries and their approval processes to develop and streamline an appropriate regulatory strategy.
• Development of a strong and robust data management plan that ensures the accuracy and reliability of the collected data such that it is traceable throughout the trial.
• Creation of good documentation practices that provide traceability and accountability at every stage of the development program.
• Selection of suitable real-world data sources to support the regulatory approval plan.
• Choose appropriate endpoints for the plan based on previous evidence and collaboration with HCPs and regulatory bodies.
• Development of suitable validation strategies that align with the class of SaMD and regulatory requirement.
• Ensure that patient privacy is protected throughout the clinical evaluation process by design of a robust cybersecurity program and reporting of any security breaches in a timely manner.
• Development of training programs for patients and HCPs to understand information on the safe use and capabilities of SaMDs.
• Programs for collection of post-marketing data to provide feedback on device usage and monitoring of the device functionalities.

References

• Digital Health Terms | FDA
• Final Document: Software as a Medical Device (SaMD): Clinical Evaluation (imdrf.org)
• Regulatory Challenges of Software as a Medical Device (SaMD) (diaglobal.org)
• SaMD Product Development: Addressing Challenges through Early Integration of Regulatory, Quality and Clinical Data Strategies (On-Demand) | RAPS