Is Remote Human Factors testing an acceptable approach for Human Factors Validation
TimeThursday, April 152:00pm - 3:00pm EDT
LocationEducation and Simulation
DescriptionIn the present landscape of COVID-19 pandemic and the need for social distancing to reduce spread of the coronavirus, laboratory research has decreased in a wide range of disciplines (Servick et al., 2020). Almost all academic institutions (and consultants) have suspended in-person data collection and are not permitting any lab based studies to proceed further. One industry that is heavily impacted is the medical device manufacturers who need to provide human factors validation to receive U.S. Food and Drug Administration (FDA) approval. Furthermore, In the most recent 2020 HFES annual conference, US FDA commented that they were currently “not aware of any data that supports the use of remote HF validation testing or of any consensus scientific guidelines or standards that can inform an acceptable remote HF testing approach. As a result, the Agency is unable to provide a general statement at this time about whether remote HF testing could potentially be an acceptable approach”.
The objective of this study is to replicate the objectives of the original in-person study, which were to evaluate the design, ease of use, intuitiveness, and risks of a 2 stage autoinjector, determine whether the device can be correctly, safely, and effectively used by the intended user population without patterns of preventable use errors that would result in harm to the user, and confirm the device labeling and instructions for use (IFU) to support users in mitigating high risks and use contexts.
We propose to approach the above objectives by replicating a human factors validation study previously conducted using in-person testing and published in Medical Devices journal (Brand- Schieber et al., 2016). This study used 45 migraine patients (30 oral-only medications users; 15 injectable sumatriptan users) who performed one unaided simulated injection. Since sumatriptan injections were not available at the time of in person validation study, anyone who is actually taking sumatriptan injections will be excluded in this study. Additionally, this study will be limited to the self-trained condition (to cater to FDA interest). So the sample size will be 30 in this study.
We intend to use pens that can be modified to have the same injection time as the original sponsor’s medication but modified to remove the needle and have the injected solution captured by an internal absorbent material. The procedures used in the original in-person study will be replicated using a video conferencing tool (e.g. Zoom), and a secondary HD web camera (local or cloud recording capability or via a screen capture software) to capture the user actions in addition to the web camera of the laptop. The moderators will provide the instructions via zoom and instruct participants as and when needed to ensure adherence to study protocols and to make any notes.