Concepts and processes related to the usability of Sensor-Based Digital Health Technologies (DHTs) have been borrowed from fields such as biomedical engineering, software development, and cognitive/behavioral psychology, resulting in inconsistent terminology and definitions. However, lacking clarity regarding usability best practices means that not all DHTs can be implemented at scale.
The field of digital medicine sits at the intersection of technology and healthcare and must therefore reconcile the differences in terminology within these communities. In addition, regulatory requirements for usability are housed in multiple locations, and they vary by geographical region and by the regulatory status of the product. International standards are similarly disparate.
There is no one-size-fits-all approach to DHT design and usability testing. Consequently, it can be difficult for product developers with limited training on these topics to know what steps to take. It can be challenging for clinicians, investigators, and sponsors to understand whether the usability work undertaken pre-market by a developer is sufficient to meet their specific post-market use case or whether there is a need to proceed with further human factors studies and comparative usability studies.
These challenges give rise to two pressing needs. First, technology developers need help to determine precisely which regulatory guidance and industry standards apply to the usability of their DHT. Second, technology developers, clinicians, investigators, and sponsors need resources to support their product development and scientific strategies specific to DHT usability.
A modular approach to ensuring that sensor-based DHTs are fit for purpose, meaning that the technical, scientific, and clinical performance of the product is suitable for a defined purpose and context of use, is the V3 framework. The framework has become the de facto methodological framework for evaluating DHTs, and it is the logical home for describing usability best practices during the development and evaluation of sensor-based DHTs.
The Digital Medicine Society (DiMe) has assembled a multi-stakeholder team of experts to address the industry challenges and extend the V3 framework to include user-centered design and human factors studies of sensor-based DHTs. The extended framework will consist of clear, actionable recommendations and case studies. It will support those working in the field to meet applicable regulatory requirements while ensuring that their products meet the needs of all users they are designed to help.
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