Human Factors Validation of the Aurie Reusable Catheter System Usability and Operations Procedures
Human Factors Validation of the CathBuddy Cleaning and Sterilizer Operation Procedures
Submitted by Souvik Paul and developed in collaboration with Michelle Zorrilla of IMPACT and Katie Guyot and Kathleen Murphy of the Center on KTDRR
To develop the Aurie Reusable Catheter System Usability and Operations Procedures, the project team conducted formative functional design testing, connecting with catheter users to understand how they use catheters in their daily lives and how the Aurie Reusable Urinary Catheter System (hereafter, Aurie system) can offer functional improvements relative to the current standard of care.
This project validates the operability of the Aurie system by catheter users as a safer, more cost-effective alternative to the currently available single-use, intermittent urinary catheters. Intermittent catheterization is practiced by approximately 600,000 individuals in the United States to manage conditions such as “neurogenic bladder” (when, due to problems with the nervous system, individuals can control urination) and lower urinary tract symptoms. To urinate, these individuals each use 6 to 8 single-use, intermittent catheters a day.
Although this practice enables individuals to reliably empty their bladders, catheter use is associated with a high incidence of urinary tract infections (UTIs) even when single-use catheters are used. It is estimated that catheter users, even those who use single-use catheters, have a 50% risk of UTI. Safer, closed-catheter systems or no-touch catheters help reduce incidence of UTIs by 30%; however, they are cost-prohibitive and rarely covered by insurance. Less than 10% of the Medicare-covered population can access these technologies. Single-use catheters also account for 20 times more plastic waste than single-use plastic straws on an annual basis (Sun, Comiter, and Elliott 2018; Borenstein 2018).
The Aurie system developed by CathBuddy, Inc. is an affordable alternative consisting of a reusable, intermittent, no-touch catheter and a portable catheter carrying case that automates the cleaning, disinfection, and lubrication process with tap water and prepackaged supplies. The system enables users to access the features of no-touch catheters at the cost of standard single-use catheters.
The Cathbuddy, Inc. team recognized that to design a product that has an impact on people’s lives, they needed a nuanced understanding of how people use catheters in everyday contexts. To develop this understanding, the team pursued formative functional design testing with catheter users and participated in a training program for assistive technology tech transfer (ATTT) that the National Institute on Disability, Independent Living, and Rehabilitation Research (NIDILRR)-funded knowledge translation center for technology grantees, the Initiative to Mobilize Partnerships for successful Assistive TeChnology Transfer (IMPACT), offered. These efforts resulted in the Cathbuddy, Inc. team forging stronger connections with catheter users and other stakeholders. These strategies are explored in more detail below. Cathbuddy, Inc. also has hired a Head of Community and User Insights who is herself a catheter user and has provided a user-centered perspective in research and development activities, in part by drawing on other catheter users in her network to provide feedback on product design.
Formative Functional Design Testing
The project team conducted formative functional design testing with 20 catheter users. Users were tasked with simulating catheter insertion, cleaning, and disinfection using Aurie catheters in a laboratory-verified protocol. Researchers evaluated catheter users' ability to understand and implement the protocol instructions, then remotely observed the users, to assess the completeness of the protocol steps and the number of failed steps following protocol completion. A key goal of testing was to understand what “typical use” looks like for catheter users and how this might differ from intended use.
The project’s testing protocol was designed with adherence to Food and Drug Administration (FDA) requirements regarding human factors testing in mind (FDA 2016). FDA guidance is based in part on a study by Faulkner (2003), which suggested that a sample of 15 people is sufficient to find an average of 97% of all problems with a computer software, and that there is little benefit to using samples of more than 15 people for functional design testing. The sample size was higher than 15 due to efforts the team made to ensure gender diversity in the sample: the Cathbuddy, Inc. team recruited 20 users to test the Aurie system, 17 men and 3 women.
The functional design testing protocol entailed a comparative test between three different system architectures for the Aurie system. These architectures used the same basic plumbing for the catheter disinfection process configured in different ways: a bulk device with capacity for an entire day, a single-use device whose components and supplies had to be replaced with every catheter use, and a hybrid desktop/portable device. The team could move forward definitively with one approach as a result of the feedback gathered during this phase of testing.
Business Model Development and Stakeholder Interviews
As part of this project, the CathBuddy, Inc. team participated in a multi-level training program on the ATTT process offered by the IMPACT Center at the University of Pittsburgh. The program is open to grantees in the technology portfolio of the NIDILRR and those seeking NIDILRR funding. As part of this training, the team engaged in business model development through the implementation of the business model canvas. (The business model canvas, used by a vast number of entrepreneurs, is a table or template used to document new or existing business ideas such as the product’s value proposition, customers, and other strategic elements important in technology transfer.)
The team also interviewed stakeholders in the catheter ecosystem, including catheter users living with spina bifida and multiple sclerosis, as well as catheter manufacturers and distributors. The CathBuddy, Inc. team used qualitative information gleaned from these interviews to define product requirements and specifications for the Aurie system.
In addition to shaping certain aspects of the product’s design, interviews with catheter users and health care providers revealed that catheter users have varying points of contact within the health care system depending on their reasons for using a catheter. This information has informed the project’s strategy for communicating with physicians, nurses, and occupational therapists who serve as important sources of information for patients about available catheter products.
As a result of these ATTT strategies, the team could refine the design of the Aurie system and identify important communication channels with catheter users. After the initial testing phase, the project brought on a new team member, who is herself a catheter user, to drive continued engagement with catheter users outside a formal test protocol. The Cathbuddy, Inc. team plans to pursue additional testing to further assure FDA, users, and health care providers of the system’s safety and efficacy.
NIDILRR Grant Name: Human Factors Validation of the CathBuddy Cleaning and Sterilizer Operation Procedures
Organization: CathBuddy, Inc.
Mailing Address: 841 East Fayette St., Syracuse, NY 13210
Key Contact: Souvik Paul, email@example.com
Borenstein, S. (2018). “Science Says: Amount of straws, plastic pollution is huge.” Phys.org. https://phys.org/news/2018-04-science-amount-straws-plastic-pollution.html
Faulkner, L. (2003). Beyond the five-user assumption: Benefits of increased sample sizes in usability testing. Behavior Research Methods, Instruments, and Computers, 35(3), 379–383.
FDA (2016). Applying human factors and usability engineering to medical devices: Guidance for industry and Food and Drug Administration staff (docket number FDA-2011-D-0469). U.S. Department of Health and Human Services. https://www.fda.gov/regulatory-information/search-fda-guidance-documents/applying-human-factors-and-usability-engineering-medical-devices
Sun, A. J., Comiter, C. V., & Elliott, C. S. (2018). The cost of a catheter: An environmental perspective on single use clean intermittent catheterization. Neurourology and Urodynamics, 37(7), 2204–2208. https://doi.org/10.1002/nau.23562
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