Clinical Needs Discovery in Pediatric Urology: Utilizing the Biodesign Process

Abstract

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.

Identifying Targets for Innovation in Amazon Reviews of Bedwetting Alarms: Thematic Analysis

“…Our study was developed following a recent qualitative study performed by our group. Through 6 weeks of clinical immersion, which involved both clinical observation and interview-based insight extraction across all members of the treatment and patient care team in the pediatric urology clinic, we identified challenges with current bedwetting alarms as the top unmet need [10]. Consistent with our single-center needs mapping, the cause of bedwetting alarm inefficacy and dissatisfaction across a range of products was dissatisfaction with and challenges presented by certain device features as identified in Amazon reviews.…”

“…This study arose from a recent partnership between a medical student innovation program and a capstone engineering course at a research university. First, a stepwise biomedical innovation needs-mapping process was performed as part of a formal medical innovations program, Sling Health [10]. During this program, perspectives were obtained from various stakeholders, including patients and their families as well as health care staff through clinical observation [10].…”

“…First, a stepwise biomedical innovation needs-mapping process was performed as part of a formal medical innovations program, Sling Health [10]. During this program, perspectives were obtained from various stakeholders, including patients and their families as well as health care staff through clinical observation [10]. The need for more efficient treatments for NE was identified as the top unmet need in pediatric urology [10].…”

“…During this program, perspectives were obtained from various stakeholders, including patients and their families as well as health care staff through clinical observation [10]. The need for more efficient treatments for NE was identified as the top unmet need in pediatric urology [10]. Based on this finding, a team with backgrounds in bioengineering and medicine was assembled to create a prototype to meet this need.…”

A Framework for Social Needs-Based Medical Biodesign Innovation

“…The innovation biodesign process is a systematic approach for user-centered medical innovation that involves identifying unmet health care needs through clinical observation, followed by solution mapping and prototyping for commercialization. 7 This needs-based approach empowers health care providers to address health care system shortcomings and disparities patients encounter. The biodesign process differs from the traditional linear bench-to-bedside model through which researchers seek meaningful clinical applications for newly developed technologies.…”