Track: Formulation and Delivery - Chemical - Drug Delivery, Devices, and Drug Device - Software
Category: Late Breaking Poster Abstract
Evolution of a Software as Medical Device from Concept to Reality
Purpose: As technology continues to advance all facets of health care, software has become an important part of all products, integrated widely into digital platforms that serve both medical and non-medical purposes. Software, which on its own is a medical device, Software as a Medical Device (SaMD), is one of three types of software related to medical devices. The other two types of software related to medical devices include software that is integral to a medical device (Software in a medical device) and software used in the manufacture or maintenance of a medical device. The International Medical Device Regulators Forum (IMDRF) define SaMD as, “a software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device. While software in medical devices refers to the applications being used by the medical device to diagnose, treat or mitigate a particular disorder or medical condition, Software as a Medical Device (SaMD) is independent of any hardware or medical device, functions on any computing platform and aims at diagnosing, treating or mitigating a disorder or medical condition. Hence, there came a need to classify SaMD distinctly and propose regulations that are at par with the regulations of drugs and devices. Methods: Medical devices have become increasingly sophisticated due to software capabilities and applications becoming increasingly important. Failure in software functionality can have a fatal consequence or cause serious injury to patients. Therefore, the software development process is of vital importance and regulating this across medical devices is considered a fundamental core element of medical device manufacturing. To regulate the software development process, IEC 62304 deﬁnes the software development and veriﬁcation activities which medical device manufacturers must comply with. Such activities include software development planning, requirement analysis, architectural design, software design, unit implementation and veriﬁcation, software integration and integration testing, system testing and, ﬁnally, software release. The software development life cycle includes risk management, conﬁguration management and problem resolution processes which are guided by IEC 62304 at each stage of the software development process.
We examined how Connected Health encompasses terms such as wireless, digital, electronic, mobile and tele-health and refers to a conceptual model for health management where devices, services or interventions are designed around the patient’s needs. Considering the broad and emerging nature of Connected Health, demystifying the regulatory environment to identify which regulations apply to Connected Health technologies is a complex task. Results: SaMD may leverage connectivity between devices, and people to continuously monitor the safety, effectiveness and performance of the SaMD. A SaMD manufacturer may have future functionality and intended use of a SaMD that may be informed by continuously collecting and analyzing data on use of the SaMD in a post-market setting. Monitoring real world performance data can help the SaMD functionality and intended use evolve after initial introduction into the market. Such data may include post-market information such as safety data, results from performance studies, on-going clinical evidence generation for medical devices, new research publications and results that support or strengthen the clinical association of the SaMD output to a clinical condition, or direct end-user feedback, that can help the SaMD manufacturer understand the real world performance of the SaMD. Conclusion: SaMD tools help accelerate the discovery, management and treatment of a wide range of medical issues, automating certain aspects of care to save time. By being able to collect large amounts of data, and doing so quickly, SaMD can also solicit user feedback through its availability on multiple devices. Advantages include improved health outcomes through more accurate data as well as quicker production and feedback, leading to faster innovation. Companies using or developing SaMD can use this fast feedback loop to enable faster product iterations, drive faster innovation and get to market quicker. It also makes collecting data quick and simple, providing high-quality data leading to better health outcomes. Some of the applications of SaMD platforms can be Screening and diagnosis, Monitoring and alerting Chronic condition and disease management and Digital therapeutics.
References: 1) Food and Drug Administration. General Principles of Software Validation; Final Guidance for Industry and FDA Staff; Issued January 11, 2002 2) Jonas PA. Fundamentals of Medical Device Regulation. 2nd ed. Regulatory Affairs Professionals Society (RAPS); 2019 3) Jonas PA. Fundamentals of US Regulatory Affairs. 11th ed. Regulatory Affairs Professionals Society (RAPS); 2019 4) International medical device regulatory forum - SaMD N10: Software as a Medical Device (SaMD): Key Definitions 5) International medical device regulatory forum, SaMD N12: Software as a Medical Device (SaMD): Possible Framework for Risk Categorization and Corresponding Considerations