Adherence specialists AARDEX Group are proud to announce its partnership with other industry leaders on DiMe’s new Extending the Verification, Analytical Validation, and Clinical Validation (V3+) Framework project.
Organizations are taking digital clinical measures and products to scale, meaning digital health technologies (DHTs) must meet the needs of larger audiences. DiMe’s existing V3 Framework is the 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 goal of the new V3+ project is to build on this success by adding evidence-based components that ensure DHTs meet the needs of all users through the application of best practices 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 & Scientific Lead, 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.”
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. It will also ensure data generated by DHTs in the real-world conditions of decentralized clinical trials and healthcare delivery is trustworthy for clinical, regulator, and payer decision-making.
“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”, said Jessie Bakker, Program Director at DiMe. “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.”
