IntroductionBiodesign innovation processes provide a needs-driven approach to medical innovation, empowering both medical trainees and health care providers to take action in addressing the shortcomings of health care encountered in daily clinical practice. Our objective was to uncover the most pressing unmet clinical needs within a specific clinical setting, pediatric urology at UCLA.MethodsThe biodesign process involves a sequential process of identifying, validating, and prioritizing unmet needs, followed by solution landscaping and prototyping for the most promising needs. Opportunities for medical innovation were first identified through six weeks of clinical immersion, which involved both clinical observation and interview-based insight extraction. Interviews were conducted with 35 stakeholders, including patients, patient families, and health care staff by a medical student participant in Sling Health LA, a program which provides innovation training and incubation for ideas. Follow-up interviews with key stakeholders were performed to validate needs. Priority scores were then assigned to each validated need using a series of pre-determined and weighted criteria. Finally, genealogy maps were constructed and used to guide subsequent solution landscaping for the top three needs.Results33 unmet clinical needs were identified throughout the clinical immersion phase, 27 of which were validated. Following coarse needs prioritization, five needs emerged as top contenders. After fine needs prioritization, three top needs were selected. The first top need arising from this ethnographic study was that “parents and children need a faster (<3 months to resolution) treatment option for resolving nocturnal enuresis that also prevents incontinence during the treatment phase”. Other discovered top needs included “parents and physicians need an accurate method to monitor retractile testes at-home and in the outpatient setting to reduce unnecessary surgical referrals and procedures”, and “a hospital system need to reduce complications and readmissions associated with post-operative catheter obstruction after urologic procedures”. A preliminary solution concept was generated for the top clinical need, nocturnal enuresis treatment.ConclusionBiodesign processes offer a standardized method for identifying pressing unmet clinical needs and informing solution development. The top three needs discovered within pediatric urology through this ethnographic investigation represent promising innovation targets for further solution prototyping and design.

No abstract

Background Nocturnal enuresis (NE) is a frequent diagnosis in pediatric and adolescent populations with an estimated prevalence of around 15% at the age of 6 years. NE can have a substantial impact on multiple health domains. Bedwetting alarms, which typically consist of a sensor and moisture-activated alarm, are a common treatment. Objective This study aimed to determine areas of satisfaction versus dissatisfaction reported by the parents and caregivers of children using current bedwetting alarms. Methods Using the search term “bedwetting alarms” on the Amazon marketplace, products with >300 reviews were included. For each product, the 5 reviews ranked the “most helpful” for each star category were selected for analysis. Meaning extraction method was applied to identify major themes and subthemes. A percent skew was calculated by summing the total number of mentions of each subtheme,+1 for a positive mention, 0 for a neutral mention, and –1 for a negative mention, and dividing this total by the number of reviews in which that particular subtheme was observed. Subanalyses were performed for age and gender. Results Of 136 products identified, 10 were evaluated based on the selection criteria. The main themes identified across products were long-term concerns, marketing, alarm systems, and device mechanics and features. The subthemes identified as future targets for innovation included alarm accuracy, volume variability, durability, user-friendliness, and adaptability to girls. In general, durability, alarm accuracy, and comfort were the most negatively skewed subthemes (with a negative skew of –23.6%, –20.0%, and –12.4% respectively), which are indicative of potential areas for improvement. Effectiveness was the only substantially positively skewed subtheme (16.8%). Alarm sound and device features were positively skewed for older children, whereas ease of use had a negative skew for younger children. Girls and their caretakers reported negative experiences with devices that featured cords, arm bands, and sensor pads. Conclusions This analysis provides an innovation roadmap for future device design to improve patient and caregiver satisfaction and compliance with bedwetting alarms. Our results highlight the need for additional options in alarm sound features, as children of different ages have divergent preferences in this domain. Additionally, girls and their parents and caretakers provided more negative overall reviews regarding the range of current device features compared to boys, indicating a potential focus area for future development. The percent skew showed that subthemes were often more negatively skewed toward girls, with the ease of use being –10.7% skewed for boys versus –20.5% for girls, and comfort being –7.1% skewed for boys versus –29.4% for girls. Put together, this review highlights multiple device features that are targets for innovation to ensure translational efficacy regardless of age, gender, or specific family needs.

BACKGROUND Nocturnal enuresis (NE) is a frequent diagnosis in the pediatric and adolescent populations with an estimated prevalence of around 15% at age 6 years. NE can have a significant impact on multiple domains of health. Bedwetting alarms, which typically consist of a sensor and moisture-activated alarm, are a common treatment. The OBJECTIVE The aim of this study was to determine areas of satisfaction versus dissatisfaction reported by the parents/caregivers of users of current bedwetting alarms. METHODS Using the search term “bedwetting alarms” on Amazon marketplace, products with >300 reviews were included. For each product, the 5 most helpful reviews for each star category were collected for analysis. Meaning extraction method, a natural language processing technique, was applied to identify major themes and subcategories. A percent skew was calculated by summating the total number of mentions of each subtheme: +1 for a positive, 0 for neutral, and -1 for a negative mention and dividing this total by the number of reviews in which that subtheme was observed. Sub-analyses were performed for age and sex. RESULTS Of 136 products identified, 10 were evaluated based on selection criteria. Main themes identified across products were long-term concerns, marketing, alarm system, and device mechanics and features. Subthemes identified as future targets for innovation included alarm accuracy, alarm volume variability, device durability, user friendliness, and adaptability to female children. In general, durability, alarm accuracy, and comfort were the most negatively skewed subthemes indicative of potential areas for improvement, and effectiveness was the only significantly positively skewed subtheme. Alarm sound and device features were positively skewed for older children, while ease of use had a negative skew for younger children. Girls and their caretakers reported negative experiences with devices that featured cords, arm bands, and sensor pads. CONCLUSIONS This analysis provides an innovation roadmap for future device design to improve satisfaction and compliance with bedwetting alarms. Our results highlight the need for additional options in alarm sound features, as children of different ages have divergent preferences in this domain. Additionally, young girls and their parents/caretakers provided more negative reviews overall regarding the range of current device features compared to boys, indicating devices are not adequately developed to meet patient needs regardless of sex. Put together, this review highlights multiple device features that are targets for innovation to ensure translational efficacy regardless of age, sex, or specific family needs.