Presentation
Advancing Usability Testing for Ingestible Medical Devices: Lessons from the Atmo Gas Capsule System
SessionPoster Session 1
DescriptionThe Atmo® Gas Capsule System is a novel ingestible device designed to measure whole gut and regional transit times (stomach, small bowel, and colon) to aid the evaluation of motility disorders. Transit times are derived from measures of temperature, hydrogen concentration, and carbon dioxide concentration, along with indicators of oxygen level, capsule tumble, and antenna reflectance. The capsule electronically records these data and wirelessly transmits them to the Cloud for aggregation, analysis, and patient reporting. After the study is performed, the gastroenterologist is required to interpret the physiological traces and place four motility markers, which correspond to ingestion, the gastroduodenal and ileocecal junction, and body exit.
Currently the measurement of gastrointestinal transit is largely limited to focusing on single regions in each test with the current standard of care, such as radiopaque marker tests and scintigraphy, involving large radiation doses and repeated clinic visits. Invasive options, such as antroduodenal manometry, provide detailed data but are burdensome, while newer imaging and ingestible technologies remain limited in the type and amount of data they measure. The Atmo Gas Capsule System avoids radiation and allows patients to go home after capsule ingestion under clinical supervision, while data is collected in the background and downloaded after the study. This approach is more convenient for patients, reduces radiation exposure, and clinical resource demands.
A human factors validation was conducted according to IEC 62366-1 and FDA guidance with 17 participants (gastroenterologists, gastroenterology fellows, and internal medicine residents) in a simulated healthcare use environment. After minimal training and a decay period, each participant assessed four studies which including normal and challenging worst-case motility studies. Participants were required to place four motility markers (ingestion, gastroduodenal and ileocecal junctions and body exit) or if data was not conclusive, participants could select “unable to determine”. Placement of each motility marker was assessed 68 times. The evaluation went beyond basic task performance to assess users’ ability to interpret multiple novel physiological traces and accurately place motility markers. Only a few minor use issues were observed during the study, all of which were non-critical and mitigated as low as possible through user interface safeguards, contextual guidance text within the product, labelling, training and clinical oversight.
This study demonstrated that the Atmo® Gas Capsule System is safe and effective for its intended uses, users and use environments. In addition, the study suggests the system is easy to learn and use. It showed that motility markers can be placed consistently, even when novel traces may be unfamiliar to some users. The study further highlighted the value of presenting the minimum number of contextually relevant traces and guidance text to support accurate trace interpretation and marker placement, particularly in more challenging studies.
Currently the measurement of gastrointestinal transit is largely limited to focusing on single regions in each test with the current standard of care, such as radiopaque marker tests and scintigraphy, involving large radiation doses and repeated clinic visits. Invasive options, such as antroduodenal manometry, provide detailed data but are burdensome, while newer imaging and ingestible technologies remain limited in the type and amount of data they measure. The Atmo Gas Capsule System avoids radiation and allows patients to go home after capsule ingestion under clinical supervision, while data is collected in the background and downloaded after the study. This approach is more convenient for patients, reduces radiation exposure, and clinical resource demands.
A human factors validation was conducted according to IEC 62366-1 and FDA guidance with 17 participants (gastroenterologists, gastroenterology fellows, and internal medicine residents) in a simulated healthcare use environment. After minimal training and a decay period, each participant assessed four studies which including normal and challenging worst-case motility studies. Participants were required to place four motility markers (ingestion, gastroduodenal and ileocecal junctions and body exit) or if data was not conclusive, participants could select “unable to determine”. Placement of each motility marker was assessed 68 times. The evaluation went beyond basic task performance to assess users’ ability to interpret multiple novel physiological traces and accurately place motility markers. Only a few minor use issues were observed during the study, all of which were non-critical and mitigated as low as possible through user interface safeguards, contextual guidance text within the product, labelling, training and clinical oversight.
This study demonstrated that the Atmo® Gas Capsule System is safe and effective for its intended uses, users and use environments. In addition, the study suggests the system is easy to learn and use. It showed that motility markers can be placed consistently, even when novel traces may be unfamiliar to some users. The study further highlighted the value of presenting the minimum number of contextually relevant traces and guidance text to support accurate trace interpretation and marker placement, particularly in more challenging studies.
Event Type
Poster Presentation
TimeMonday, March 234:45pm - 6:15pm EDT
LocationRhinelander Gallery
Medical and Drug Delivery Devices