It says because organizations are taking digital clinical measures and products to scale, digital health technologies (DHTs) must meet the needs of larger audiences.
The existing framework is considered a go-to guide for evaluating whether sensor-based DHTs are fit for purpose from a technical, scientific, and clinical performance of the product perspective.
The purpose of the new V3+ project is to add evidence-based components ensuring users’ needs are met through best-practice in usability, human factors, and human-centred design.
AARDEX Group is representing an ecosystem of a partnership of companies, Medmix, Schreiner MediPharm, and Westrock, on the project group.
Bernard Vrijens, chief executive officer at AARDEX Group, said: “This is a great team and a fast-moving project which we are delighted to be part of. Medication adherence packaging is already very high in terms of usability compared to other approaches such as video directly observed therapy (VDOT). AARDEX Group looks forward to bringing its extensive experience in usability and human factor studies to the V3+ Framework Project.”
He said the V3+ project will help ensure DHTs meet the necessary industry and regulatory standards for usability, while drawing on the principles of diversity, equality, and inclusion.
Jessie Bakker, program director at DiMe added: "Since we published V3 in 2020, the framework has emerged as the go-to guide for evaluating whether sensor data is accurate and precise, true, and informative. It has been accessed over 30,000 times, used by over 130 teams including national and international government agencies, and cited over 150 times in the scientific literature.
“We’re now seeking to build on this incredible success by evaluating and defining best practices for user-centered design, usability, and human factors engineering of digital medicine technologies, ensuring scalability while meeting the needs of all users they are designed to help."
The first project launched in 2019 with the manuscript being published the following year and DiMe said this proved it was able to deliver clinical work on a tech timeline.
With three components, it combined software and clinical development practices to carve out a shared foundation for evaluating whether digital clinical measures were fit for purpose.
