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Pediatric medical devices lag behind adult devices due to economic barriers, smaller patient populations, changing anatomy and physiology of patients, regulatory hurdles, and especially difficulties in executing clinical trials. We investigated the requirements, challenges, associated timeline, and costs of conducting a multi-site pivotal clinical trial for a Class II pediatric physiologic monitoring device. This case study focused on the negotiation of clinical trial agreements (CTAs), budgets, and Institutional Review Board (IRB) processing times for a pediatric device trial. We identified key factors contributing to delays in clinical trial execution and potential best practices to expedite the process while maintaining safety, ethics, and efficacy. The total time from site contact to first patient enrollment averaged 14 months. CTA and budget negotiations were the most time-consuming processes, averaging nearly 10 and 9 months, respectively. Reliance and local IRB processing also contributed significantly to the timeline, overall adding an average of 6.5 months across institutions. Nearly half of all costs were devoted to regulatory oversight. The COVID-19 pandemic caused significant slowdowns and delays at multiple institutions during study enrollment. Despite these pandemic-induced delays, it is important to note that the issues and themes highlighted remain relevant and have post-pandemic applicability. Our case study results underscore the importance of establishing efficient and standardized processing of CTAs, budget negotiations, and use of reliance IRBs to expedite clinical trial execution for pediatric devices. The findings also highlight the need for a national clinical trials network to streamline the clinical trial process.

A multidisciplinary team at Rice University transformed the Texas Medical Center (TMC) Library’s collection of rare anatomy atlases into a physical-digital, human-sized atlas-of-atlases. The Electronic Vesalius installation gives these old books new life, informed by contemporary media theory and the centuries of medical and aesthetic criticism provoked by these multimedia image-texts.

The flipped class is a buzzword in education circles. This transformative approach inverts the traditional workflow of each lesson, and places the listening to lectures out of class and the doing of work inside the class. The flipped model reflects a drive toward more student-centered, active classrooms and also supports meeting the students halfway in their pervasive use of technology by bringing it into the instruction. Introduction to Engineering Design is a one-semester, multidisciplinary, elective design course available for all first-year students at Rice University. Teams of students work for an entire semester on an authentic, open-ended design challenge and produce a physical prototype for their client. The instructional materials the authors developed are free and accessible to other educators; they welcome faculty to add materials to expand the library

Design programs frequently employ physical prototyping as a method of problem solving or to produce functional solutions. A popular approach is to begin with low-fidelity prototyping by using readily-available materials to produce physical artifacts. These materials engage problem solvers of all ages and educational levels because successful application of the method rests upon latent creativity rather than tool usage skills or availability of machines. However, experiencing success in low-fidelity prototyping does not correlate with success when moving to medium-fidelity prototypes, and this is a consistent source of struggle for teams and individuals. Low-fidelity prototypes may be made from simple materials like cardboard, tape, popsicle sticks, and rubber bands, but the same idea remade as medium-fidelity prototype may necessitate the use of wood, fasteners, a dowel, and actual springs. Effective transition to medium-fidelity requires more extensive training and resources, and student designers lose momentum when the prototyping process shifts from using simple analogous materials to functional materials. In this pilot study, we introduced the use of the 3Doodler 3D printing pen in an established engineering design course hoping the tool could bridge the gap between low- and medium-fidelity prototypes. Freshman teams created prototypes of solutions to their design challenges as normal; some teams did so using only standard available materials (control), while others used these materials with the addition of the 3Doodler pen (experimental). Students in the experimental group were trained to use the 3Doodler pen and were shown several construction techniques for applying the tool. Prototype photos, surveys, and a prototype evaluation compare the usage and the groups.

Engineering design teams are most successful when members possess a broad range of skills to tackle a project. Instructors of design courses are challenged to select and teach the most important skills they believe will be useful for students now and in the future. Some skills, including teaming and engineering design process skills, can be acquired in a short period of time by applying evidence based training models. But in terms of prototyping, since there are so many tools and machines available, the question arises of which are truly critical to student success. In first-year design at Rice University, a course that has existed for almost ten years, we aim to teach students only the prototyping skills needed to complete their projects. Students participate in just three workshops that are prototyping related, two of which are required (hand tools and electronics) and an optional third (CAD). By recording student prototyping and measuring experience gains, we have investigated how skills contribute to project completion. The results illustrate that the question for first-year design education is not how many prototyping skills can be taught, but how few an instructor can get away with.

Effective engineering curricula are sparse at the secondary level, and often revolve around projects for-a-grade instead of implementing solutions to real-world challenges. The upfront cost of the existing curricula can be cost prohibitive to low-income schools. The authors adapted and implemented Rice University’s Freshman Design class, ENGI 120, a university-level, client-focused engineering design curriculum at Yes Prep Brays Oaks, a public charter school that serves primarily low-income, minority students. By adapting an existing model to secondary education, it is possible to ensure high-quality materials regardless of budgetary constraints. This paper explores the impact of this course on the students at YES Prep as a case study for possible partnerships between future universities and pre-college programs.

Tissue engineered scaffolds are often considered \"black boxes.\" Post implantation, they are solely expected to provide temporary mechanical support and foster tissue ingrowth while de novo tissue forms around its matrix. This is rarely the case however, as the post implantation interaction between this foreign body and the host biological system is largely uncontrolled. A growing body of concrete results is overwriting previous holistic knowledge to provide firm and hierarchical guidelines for successful scaffold design. Two areas have recently demonstrated fertile ground for progress: (1) the mechanical strength of architecture and (2) the fluid flow properties of that architecture, both of which act on different void phases. Mechanical properties are controlled by the solid phase of the matrix, while the void space determines fluid flow characteristics. The objective of this dissertation was to demonstrate the benefits of an analysis of the structural properties of tissue engineered scaffolds combined with the specific design potentials of computer-aided tissue engineering (CATE) for orthopaedic applications. Two overarching goals directed this research. The first was focused on antipodal properties and addressed solutions which included an interplay between opposing poles while matching biological properties and secondly, to apply that knowledge towards the design of patient specific implants. Two antipodal properties were studied; (1) modification of the solid phase was addressed with respect to structural mechanical properties and (2) modification of the void phase was studied to determine fluid flow characteristics of porous architectures. These concepts were then applied in real applications using CATE towards the goal of tissue engineered scaffolds for bone repair and drug regimen.

Teaching Freshman Design Using a Flipped Classroom ModelA team of faculty at XXXX University and other institutions are creating instructional resourcesto support a flipped classroom for first-year engineering design. The traditional ‘class’ in whichfaculty lecture on the design process has been replaced by in-class exercises and additional teamtime. Since the flipped classroom model shifts course content with low cognitive load to videos,students learn this material outside of the classroom. Now, students spend significant amounts oftime during class applying the design process to their projects. For example, teams developappropriate design criteria, brainstorm and select a design solution, and build a physicalprototype during class.The first objective of this project is to create educational materials to flip the first-yearmultidisciplinary engineering design classroom. To date, we have completed: Fifty web-based videos (3-7 min in length) featuring student teams and faculty at XXXX University and other institutions that focus on steps of the engineering design process. Topics include understanding customer needs, research on a design problem, framing design criteria, thorough solution development using brainstorming, using morphological charts to assemble complete solutions, selecting solutions with Pugh matrices, and project planning using Gantt charts. Ten online quizzes that cover information discussed in the videos. The quizzes are multiple choice and test students’ knowledge and application of the technical content in the videos. Thirty in-class exercises that support active learning in the classroom. The in-class exercises range from applying knowledge to a new problem to evaluating a completed design scenario to applying the design process to their team’s specific project.The second objective of this project is to answer the engineering education research question:Are there differences in student performance in executing the engineering design process whencomparing delivery of engineering design process knowledge using a lecture format versus aflipped classroom model? This research question will be tackled by assessing studentperformance in two ways:1) Pre- and post-testing of students’ application of the design process as measured by their critiques of a Gantt chart laying out a 14-week design process.2) Team technical memos in the steps of establishing design criteria, brainstorming solution ideas, and applying Pugh matrices for evaluation.The team has collected and assessed data on student performance for courses taught using alecture format for FY 2012-2014. During the FY 2014-2015 year, the team is collecting data forcourses taught using the flipped classroom format. Analysis of the data is in progress.These materials are available for others to use. The team is seeking feedback on developingmaterials that will be helpful for the academic community teaching engineering design. Thiswork is supported by an NSF DUE grant (#1244928).

This paper describes kits that were deployed in a freshman engineering design course and used to enhance understanding of the engineering design process. In a first-year engineering design course student teams were given instructions and a kit of physical materials to work with. The instructions present a design challenge that can be solved through the creative assembly of the materials. The instructions outline rules, timing and scoring of the challenge. Each activity can be completed in as little as one hour. Brevity of the assignment forces student teams to think quickly and rapidly functionalize ideas. Student teams use the time to complete the challenge and then compete against each other with their finished product. An example of one of these challenges is tasking the teams to develop a launcher capable of transporting a ping pong ball the furthest using a collection of low fidelity materials. Scoring is based on a strength to weight ratio. The activities are designed such that student teams are most successful when they allocate time in the challenge and methodically proceed through the design process. The steps that each of these kits focus on are planning, defining the design criteria or success criteria, brainstorming, prototyping, testing, and iterating. Before and after the activity students take a survey that assesses their understanding of the engineering design process and queries how they would allocate time in a similar challenge based on the steps of the design process. We detail the student and faculty experiences and provide preliminary data from our pilot deployment of these kits. We will provide sample kits for other faculty to take home and solicit suggestions for adoption in other programs.