Many undergraduate educational experiences in biomedical design lack clinical immersion-based needs finding training for students. Convinced of the merits of this type of training for undergraduates, but unable to offer a quarter-long course due to faculty and administrative constraints, we developed an accelerated block-plan course, during which students were dedicated solely to our class for 3 weeks. The course focused on the earliest stages of the health technology innovation process-conducting effective clinical observations and performing comprehensive need research and screening. We grounded the course in experiential learning theory (with hands-on, collaborative, and immersive experiences) and constructivist learning theory (where students integrated prior knowledge with new material on need-driven innovation). This paper describes the design of this intensive block-plan course and the teaching methods intended to support the achievement of five learning objectives. We used pre- and post-course surveys to gather self-reported data about the effect of the course on student learning. Despite the accelerated format, we saw statistically significant gains for all but one sub-measure across the learning objectives. Our experience supports key benefits of the block-plan model, and the results indicate that specific course design choices were effective in achieving positive learning outcomes. These design decisions include (1) opportunities for students to practice observations before entering the clinical setting; (2) a framework for the curriculum that reinforced important concepts iteratively throughout the program; (3) balanced coverage of preparation, clinical immersion, and need research; (4) extensive faculty and peer coaching; and (5) providing hands-on prototyping opportunities while staying focused on need characterization rather than solution development. Based on our experience, we expect that this model is replicable across institutions with limited bandwidth to support clinical immersion opportunities.

UNASSIGNED: Innovation is broadly defined as the act of introducing a new product, idea, or process. The field of surgery is built upon innovation, revolutionizing technology, science, and tools to improve patient care. While most innovative solutions are aimed at problems with a significant patient population, the process can also be used on orphan pathologies without obvious solutions. We present a case of tracheal agenesis, a rare congenital anomaly with an overwhelming mortality and few good treatment options, that benefited from the innovation process and achieved survival with no ventilator dependence at three years of age.
UNASSIGNED: Utilizing the framework of the innovation process akin to the Stanford Biodesign Program, 1) the parameters of the clinical problem were identified, 2) previous solutions and existing technologies were analyzed, newly invented solutions were brainstormed, and value analysis of the possible solutions were carried out using crowd wisdom, and 3) the selected solution was prototyped and tested using 3D modeling, iterative testing on 3D prints of actual-sized patient parts, and eventual implementation in the patient after regulatory clearance.
UNASSIGNED: A 3D-printed external bioresorbable splint was chosen as the solution. Our patient underwent airway reconstruction with \"trachealization of the esophagus\": esophageotracheal fistula resection, esophagotracheoplasty, and placement of a 3D-printed polycaprolactone (PCL) stent for external esophageal airway support at five months of age.
UNASSIGNED: The innovation process provided our team with the guidance and imperative steps necessary to develop an innovative device for the successful management of an infant survivor with Floyd Type I tracheal agenesis.
UNASSIGNED: We present a case of tracheal agenesis, a rare congenital anomaly with an overwhelming mortality and few good treatment options, that benefited from the innovation process and achieved survival with no ventilator dependence at three years of age.The importance of this report is to reveal how the innovation process, which is typically used for problems with significant patient population, can also be used on orphan pathologies without obvious solutions.

There is renewed demand to accelerate innovation in nephrology; public and private sectors are creating programs to support its growth. The Stanford Biodesign innovation process, first developed in 2000, provides a roadmap for health technology and device innovation. There is insufficient published guidance on the application of the Biodesign process in the generation of novel devices to address nephrology- and/or dialysis-related clinical unmet needs. We present \"needs finding,\" the initial part of the identify phase in the Biodesign innovation process and how it may be utilized for nephrology- and/or dialysis-related innovation. We describe here how to apply the Biodesign process to identify unmet dialysis-related needs, with the use of specific case-based examples based on observations within a hemodialysis unit. We then explore how to develop these needs using background research, direct clinical observations, interviews, documentation of observations and interview findings, and development of multiple needs statements. We conclude that there is an opportunity for nephrology innovators to use this methodology broadly in order to identify areas for innovation and initiated the development on novel solutions to be introduced into patient care.

A growing number of Internet sites and mobile applications are being developed intended for use in clinical practice. However, during the development process (e.g., creating features and determining use cases), the needs and interests of providers are often overlooked. We explored providers\' interests using a mixed-methods approach incorporating both qualitative and quantitative research methods. A first study used an interview approach to identify the challenges providers faced, tools they used, and any use of computers and apps specifically. Fifteen providers from both the United States and Canada completed the interview and recordings were transcribed and analyzed using a constructivist grounded theory approach. Four primary themes were identified including challenges, potential tools, access and usability. A second study used a brief survey completed by 132 providers at a large healthcare system to explore current use of and potential interest in Internet and mobile technologies. Although many providers (80.9%) reported recommending some form of technology to patients, this was mostly Internet websites that were predominantly informational/psychoeducational in nature. Overall, these studies combine to suggest a strong interest in websites and apps for use in clinical settings while highlighting potential areas (ease of use, patient security and privacy) that should be considered in the design and deployment of these tools.

Innovation is the process through which new scientific discoveries are developed and promoted from bench to bedside. In an effort to encourage young entrepreneurs in this area, Stanford Biodesign developed a medical device innovation training program focused on need-based innovation. The program focuses on teaching systematic evaluation of healthcare needs, invention, and concept development. This process can be applied to any field of medicine, including Pediatric Surgery. Similar training programs have gained traction throughout the United States and beyond. Equally important to process in the success of these programs is an institutional culture that supports transformative thinking. Key components of this culture include risk tolerance, patience, encouragement of creativity, management of conflict, and networking effects.