Koneksa’s Usability Testing Case Study: Alignment with DiMe’s V3+ Framework

Koneksa contributed to the new Digital Medicine Society (DiMe) V3+ framework, which adds usability to the process of validating digital health technologies (DHTs). Usability is an important aspect of successful DHT deployment and also highlights why DHTs are inherently patient-centric.

The FDA finalized guidance for Digital Health Technologies (DHT) for Remote Data Acquisition in Clinical Investigations in December 2023, following dissemination of the draft guidance for public comments in December of 2021. This was much-needed and anticipated guidance to clarify many questions around the use of DHTs in clinical trials, resulting in vigorous discussion and comments from the scientific community. The response from the FDA was thorough and thoughtful, resulting in a number of changes including expansion of the language pertinent to usability testing which is key for successful implementation of DHTs. Usability testing is not new to the pharmaceutical industry; however, prior to the broad deployment of DHTs it was largely limited to medicinal products approved in conjunction with drug injection devices. DHT adoption in clinical trials necessitated deeper considerations and appropriate adjustments of the concept of usability testing in the context of DHT deployment.

DiMe is a non-profit organization providing an educational and collaboration platform for stakeholders in the field of digital medicine. Through the Digital Health Measurement Collaborative Community (DATAcc) with the FDA’s Center for Devices and Radiological Health, DiMe launched a pre-competitive initiative to create a framework around usability testing, expanding on the original V3 framework which focused on best practices to determine if a DHT is fit for purpose by evaluating sensor verification, analytical validation, and clinical validation steps. The newly expanded framework is called V3+, and identifies key elements for usability validation of sensor-based DHTs and provides different scenarios for conducting these experiments; e.g., for technologies under development and off-the-shelf solutions.

Development and implementation of DHTs is fundamental to our work at Koneksa: our company is committed to developing and validating novel digital measures for use in clinical trials with the ultimate goal of improving patient lives. Koneksa contributed to the development of the V3+ framework and pressure-tested it with our own usability case study focussed on the next generation of Koneksa’s Neuroscience Toolkit and its usability by patients with early-stage Parkinson’s disease. The Toolkit comprises a variety of digital mobile assessments capturing both motor and non-motor disease features to give a holistic picture of patients’ signs and symptoms. The toolkit updates included a new patient-facing app, new tasks to be performed by patients, an updated assessment schedule, and changes in hardware and firmware. 

All elements of the usability validation component of V3+ were deployed in the Koneksa usability study. The case study highlights the decision-making process that went into (1) conducting additional formative human-factor testing on a well-established clinical measurement tool, (2) the evaluation strategy used to assess usability and risks of the DHTs, and (3) the process for modifying the Toolkit design and implementation based on the learnings from the formative testing.

The case study can be accessed on the DiMe’s resource page and within their Digital Medicine’s Academy online learning module, “Building Fit-for-Purpose Sensor-based Digital Health Technologies: A Crash Course”.

Koneksa and DiMe are long-term collaborators, fully aligned in their mission to develop a comprehensive strategy toward DHT innovation, development, and validation. These types of best practices will ensure safer and more effective health technology for patients, which will contribute to better health outcomes.

Resources: 

1. Digital Health Technologies for Remote Data Acquisition in Clinical Investigations: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/digital-health-technologies-remote-data-acquisition-clinical-investigations

2. V3 Nature Published Article: https://www.nature.com/articles/s41746-020-0260-4

3. V3+ Extended Framework Presentation: https://www.youtube.com/watch?v=HQ0i311_ZqQ

4. V3+ Extended Framework DiME Resources: https://datacc.dimesociety.org/v3/?__r=3186&__i=1144165&R6wF9AvbqY=100D43249A5B7153B8ADF3995FB9C695

5. Koneksa Case Study: https://dimesociety.org/wp-content/uploads/Koneska-Case-Study-V3.pdf

6. DiME’s Resource Page: V3+ Framework with sensor based digital health technology: https://datacc.dimesociety.org/v3/extending-v3/

7. Building Fit-for-Purpose Sensor-based Digital Health Technologies: A Crash Course: https://dimesociety.org/courses/building-fit-for-purpose-sensor-based-digital-health-technologies/