User Interface Requirements for Medical Devices

2021 ◽  
Author(s):  
Michael Wiklund ◽  
Erin Davis ◽  
Alexandria Trombley ◽  
Jacqueline Edwards
Keyword(s):  
User Interface ◽  
Medical Devices

scholarly journals Value of Eye-Tracking Data for Classification of Information Processing–Intensive Handling Tasks: Quasi-Experimental Study on Cognition and User Interface Design

10.2196/15581 ◽  
2020 ◽  
Vol 7 (2) ◽  
pp. e15581
Author(s):  
Stephan Wegner ◽  
Quentin Lohmeyer ◽  
Dimitri Wahlen ◽  
Sandra Neumann ◽  
Jean-Claude Groebli ◽  
...  
Keyword(s):  
Information Processing ◽  
Data Analysis ◽  
User Interface ◽  
Home Care ◽  
Eye Tracking ◽  
Medical Device ◽  
Medical Devices ◽  
Interface Design ◽  
Individual User ◽  
Mobile Eye Tracking

Background In order to give a wide range of people the opportunity to ensure and support home care, one approach is to develop medical devices that are as user-friendly as possible. This allows nonexperts to use medical devices that were originally too complicated to use. For a user-centric development of such medical devices, it is essential to understand which user interface design best supports patients, caregivers, and health care professionals. Objective Using the benefits of mobile eye tracking, this work aims to gain a deeper understanding of the challenges of user cognition. As a consequence, its goal is to identify the obstacles to the usability of the features of two different designs of a single medical device user interface. The medical device is a patient assistance device for home use in peritoneal dialysis therapy. Methods A total of 16 participants, with a subset of seniors (8/16, mean age 73.7 years) and young adults (8/16, mean age 25.0 years), were recruited and participated in this study. The handling cycle consisted of seven main tasks. Data analysis started with the analysis of task effectiveness for searching for error-related tasks. Subsequently, the in-depth gaze data analysis focused on these identified critical tasks. In order to understand the challenges of user cognition in critical tasks, gaze data were analyzed with respect to individual user interface features of the medical device system. Therefore, it focused on the two dimensions of dwell time and fixation duration of the gaze. Results In total, 97% of the handling steps for design 1 and 96% for design 2 were performed correctly, with the main challenges being task 1 insert, task 2 connect, and task 6 disconnect for both designs. In order to understand the two analyzed dimensions of the physiological measurements simultaneously, the authors propose a new graphical representation. It distinguishes four different patterns to compare the eye movements associated with the two designs. The patterns identified for the critical tasks are consistent with the results of the task performance. Conclusions This study showed that mobile eye tracking provides insights into information processing in intensive handling tasks related to individual user interface features. The evaluation of each feature of the user interface promises an optimal design by combining the best found features. In this way, manufacturers are able to develop products that can be used by untrained people without prior knowledge. This would allow home care to be provided not only by highly qualified nurses and caregivers, but also by patients themselves, partners, children, or neighbors.

Modular user interface design for integrated surgical workplaces

2016 ◽  
Vol 61 (2) ◽  
Author(s):  
Julia Benzko ◽  
Lisa Krause ◽  
Armin Janß ◽  
Björn Marschollek ◽  
Paul Merz ◽  
...  
Keyword(s):  
User Interface ◽  
Operating Room ◽  
Medical Devices ◽  
User Interfaces ◽  
Interface Design ◽  
User Interface Design ◽  
Hazard Communication ◽  
Work System ◽  
Communication Problems

AbstractSevere bottlenecks in usability and human technology interaction (HTI) of existing surgical workplaces and operating room (OR) equipment can occur today: lack of space, cable as trip hazard, communication problems between sterile and non-sterile staff, and operating errors in the handling of the medical devices. In fact, risks that are caused by poor usability can be critical, and studies show that most are preventable. This issue gets even more challenging in the context of open-OR networks regarding consistent and usable integration of user interfaces (UIs) of independently designed systems in one integrated surgical work system. In this work, a concept of generic UI profiles for the modular integration of a UI has been developed and first prototypes have been implemented. The concept is essentially based on the approach of device profiles developed in the context of the Bundesministerium für Bildung und Forschung project OR.NET (

scholarly journals Verification of User Interface Software: The Example of Use-Related Safety Requirements and Programmable Medical Devices

2017 ◽  
Vol 47 (6) ◽  
pp. 834-846 ◽  
Author(s):  
Michael D. Harrison ◽  
Paolo Masci ◽  
Jose Creissac Campos ◽  
Paul Curzon
Keyword(s):  
User Interface ◽  
Medical Devices ◽  
Safety Requirements

scholarly journals Device- and service profiles for integrated or systems based on open standards

2015 ◽  
Vol 1 (1) ◽  
pp. 538-542 ◽  
Author(s):  
Alexander Mildner ◽  
Armin Janß ◽  
Jasmin Dell’Anna-Pudlik ◽  
Paul Merz ◽  
Martin Leucker ◽  
...  
Keyword(s):  
User Interface ◽  
Medical Devices ◽  
User Interfaces ◽  
Third Party ◽  
Project Work ◽  
Ministry Of Education ◽  
Human Machine Interaction ◽  
Open Standard ◽  
Funded Project ◽  
Integrated Or

AbstractIntegrated OR systems nowadays are closed and proprietary, so that the interconnection of components from third-party vendors is only possible with high time and cost effort. An integrated operating theatre with open interfaces, giving clinical operators the opportunity to choose individual medical devices from different manufacturers, is currently being developed in the framework of the BMBF (Federal Ministry of Education and Research) funded project OR.NET [1]. Actual standards and concepts regarding technical feasibility and accreditation process do not cope with the requirements for modular integration based on an open standard. Therefore, strategies as well as service and device profiles to enable a procedure for risk management and certifiability are in the focus of the project work. Amongst others, a concept for User Interface Profiles (UI-Profiles) has been conceived in order to describe medical device functions and the entire user interface regarding Human-Machine-Interaction (HMI) characteristics with the aim to identify human-induced risks of central user interfaces. The use of standardized device and service profiles shall allow the manufacturers to integrate their medical devices in the OR.NET network, without disclosing the medical devices’ risk analysis and related confidential knowledge or proprietary information.

Research: User Interface Software Errors in Medical Devices: Study of U.S. Recall Data

2019 ◽  
Vol 53 (3) ◽  
pp. 182-194
Author(s):  
Yi Zhang ◽  
Paolo Masci ◽  
Paul Jones ◽  
Harold Thimbleby
Keyword(s):  
User Interface ◽  
Medical Device ◽  
Medical Devices ◽  
Healthcare Providers ◽  
Software Errors ◽  
Recall Data ◽  
Detailed Classification ◽  
Research User ◽  
The Impact

AbstractThe current work assessed U.S. medical device recalls during 2012–15, with the goal of under-standing the impact and nature of user interface (UI) software errors in medical devices. Based on information from the Food and Drug Administration's public and internal recall databases, 423 (~140/year) medical device recalls were identified as resulting from UI software errors, which accounted for nearly one-half of recalls caused by software errors during the same period. A total of 499 UI software errors were identified as the root causes of medical device recalls, and a detailed classification of those errors (into 20 categories) was established. This error classification can be used by device manufacturers, end users (e.g., healthcare providers), and regulatory authorities to raise awareness of the type and impact of UI software errors. The classification also provides stakeholders with an evidence-based challenge to assess and improve the quality of UI software in medical devices.

scholarly journals Value of Eye-Tracking Data for Classification of Information Processing–Intensive Handling Tasks: Quasi-Experimental Study on Cognition and User Interface Design (Preprint)

2019 ◽  
Author(s):  
Stephan Wegner ◽  
Quentin Lohmeyer ◽  
Dimitri Wahlen ◽  
Sandra Neumann ◽  
Jean-Claude Groebli ◽  
...  
Keyword(s):  
Information Processing ◽  
Data Analysis ◽  
User Interface ◽  
Home Care ◽  
Eye Tracking ◽  
Medical Device ◽  
Medical Devices ◽  
Interface Design ◽  
Individual User ◽  
Mobile Eye Tracking

BACKGROUND In order to give a wide range of people the opportunity to ensure and support home care, one approach is to develop medical devices that are as user-friendly as possible. This allows nonexperts to use medical devices that were originally too complicated to use. For a user-centric development of such medical devices, it is essential to understand which user interface design best supports patients, caregivers, and health care professionals. OBJECTIVE Using the benefits of mobile eye tracking, this work aims to gain a deeper understanding of the challenges of user cognition. As a consequence, its goal is to identify the obstacles to the usability of the features of two different designs of a single medical device user interface. The medical device is a patient assistance device for home use in peritoneal dialysis therapy. METHODS A total of 16 participants, with a subset of seniors (8/16, mean age 73.7 years) and young adults (8/16, mean age 25.0 years), were recruited and participated in this study. The handling cycle consisted of seven main tasks. Data analysis started with the analysis of task effectiveness for searching for error-related tasks. Subsequently, the in-depth gaze data analysis focused on these identified critical tasks. In order to understand the challenges of user cognition in critical tasks, gaze data were analyzed with respect to individual user interface features of the medical device system. Therefore, it focused on the two dimensions of dwell time and fixation duration of the gaze. RESULTS In total, 97% of the handling steps for design 1 and 96% for design 2 were performed correctly, with the main challenges being task 1 insert, task 2 connect, and task 6 disconnect for both designs. In order to understand the two analyzed dimensions of the physiological measurements simultaneously, the authors propose a new graphical representation. It distinguishes four different patterns to compare the eye movements associated with the two designs. The patterns identified for the critical tasks are consistent with the results of the task performance. CONCLUSIONS This study showed that mobile eye tracking provides insights into information processing in intensive handling tasks related to individual user interface features. The evaluation of each feature of the user interface promises an optimal design by combining the best found features. In this way, manufacturers are able to develop products that can be used by untrained people without prior knowledge. This would allow home care to be provided not only by highly qualified nurses and caregivers, but also by patients themselves, partners, children, or neighbors.

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