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Software as Medical Device (SaMD) Challenges and Opportunities for 2021 and Beyond Webinar

This webinar was hosted by Andrew Wu, Branch Manager | Software Consultant at Rook Quality Systems.

On December 9th, 2020, an online webinar regarding the SaMD challengers and opportunities for 2021 and beyond was hosted through Greenlight Guru. Andrew Wu, the software consultant from Rook Quality Systems, gave a presentation regarding the recent Emergency Use Authorization (EUA) for SaMD products, updates from the FDA on Digital Health initiatives, validation challenges for SaMD manufacturers, and best practices for leveraging agile method for SaMD development.

In the presentation, Wu started with how the medical technology industry has been influenced by COVID-19, which has accelerated the development of safer, scalable, and more extended digital health technologies. Several SaMD EUAs have been approved by the FDA in order to promote more efficient and safer clinical flow for the front-line workers. In particular, a document that was recently revised by the FDA, Clinical Decision Support Guidance, was recommended by Wu to developers seeking EUAs for their SaMD products.

As of the updates from the FDA on Digital Health initiatives, FDA has recently established the Digital Health Center of Excellence (DHCoE) which is a new evolution of the Digital Health Program under the Center for Devices and Radiological Health (CDRH). The DHCoE is intended to serve as a resource for digital health technologies and policy in order to provide technology developers and stakeholders guidance to rapidly deliver high-quality digital health technologies to patients. The ultimate goal is to empower stakeholders to advance health care by fostering responsible and high-quality digital health innovation. The FDA has hosted two listening sessions collecting feedback and suggestions from the stakeholders (See this post).

Wu described the agile practices that can be leveraged by the SaMD developers in order to enhance an efficient software development process as well as conform to the FDA requirements. Some of the common validation challenges can be addressed by taking advantage of the best practices of the agile method. Wu concluded with a forecast that the digital health industry will continue to grow, specifically in preventative care, early disease identification, and clinical workflow streamline. He also pointed out that more potential vulnerabilities will come into view, particularly from a cybersecurity perspective, such as data breaching.

In the Q&A session, several questions were raised regarding the agile practice in terms of how much documentation is adequate to display conformity. Wu suggested starting with the requirements definition and keeping a standardized output repository. Regular review meetings will then identify gaps and allow the team to prioritize new tasks. Another question that was raised was about the best practice of using open-source software for SaMD. Wu advised ensuring the open-source software was developed and is maintained in a standardized manner. From a regulatory perspective, it is recommended to establish a risk assessment and propose risk mitigation at least at the system level when any failure events happen.

Overall, the webinar is an informative discussion as to synchronizing the agile practice with the requirement conformance and briefing the development trend in the digital health industry. More information can be found on


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