Poster Q13 - Leveraging Global Target Product Profiles to Guide Design Integration in Biomedical Engineering Core Curriculum

Introduction: Design is a defining hallmark of biomedical engineering education [1]. For several decades, design education has emerged as a high-priority area for curricular reform across engineering disciplines, influenced by priorities outlined in the Educating the Engineer of 2020 Report [2] and ABET program accreditation requirements [3]. In biomedical engineering (BME) education specifically, design skills are viewed as a distinguishing factor compared to other engineering disciplines through the application of interdisciplinary knowledge, engineering standards and regulations, and business implications for medical technology [1]. To continuously strengthen BME students’ design skills, there is a trend toward vertical integration of design experiences across BME curriculum [4], [5], [6], [7].

Despite widespread support, significant barriers remain toward integration of design across BME courses. Put simply, design is difficult to teach, learn, and assess [8]. Additionally, engineering curriculums are densely packed with minimal space for adding design content [9]. In the “middle years” curriculum, integrating design is particularly challenging due to stand-alone courses with discipline-specific content that has remained largely untouched for decades [10]. Lastly, faculty face barriers to identifying design challenges that are open-ended [11], informed by clinicians [1], and situated in alignment with existing course learning outcomes [12].

To reduce these barriers to curricular innovation in BME programs, our purpose is to describe the integration of a project-based learning (PBL) design module in a junior-level required bioinstrumentation course using authentic design challenges outlined by UNICEF & NEST360 Target Product Profiles (TPPs) for pediatric medical devices.

Materials and

Methods: Target Product Profiles (TPPs) are a product planning tool to define and elevate the visibility of unmet health needs. TPPs aim to clearly communicate design requirements for high-priority health needs for which no solutions on the market currently exist [13]. TPPs are typically developed using a Delphi-like process that engages >100 end users, including clinicians, policy makers, and device manufacturers. Informed by this deep stakeholder collaboration, TPPs are a powerful global public good with significant potential to productively steer the development of health technologies.

Underpinned by UNICEF and NEST360 TPPs for pediatric medical devices, we developed a team-based PBL module to integrate design experiences into existing curriculum within a junior-level bioinstrumentation course. We discuss the curricular design and initial implementation, including scaffolded PBL instruction for problem definition, prototyping, and verification testing across the one-semester course. We also provide a detailed overview of the development of rubrics to assess the design experiences, with a focus on assessing ABET student outcomes 2 & 6. Finally, exemplar student design projects are highlighted to illuminate examples of bioinstrumentation design project outcomes in response to the selected TPPs, with opportunities to expand projects into capstone design.

Results, Conclusions, and Discussions: While TPPs have an extensive history of guiding medical device development in industry, we are not aware of prior work that leverages TPPs to guide PBL design projects in biomedical engineering education. Based on implementation in a required bioinstrumentation course, our results suggest TPPs are an appropriate tool for guiding design integration. Across 21 student teams, all projects produced a functioning bioinstrumentation design solution that included a transducer, an active filter, and signal analysis. Example TPPs addressed by students’ design projects included the NEST360 Newborn Respiration Rate/Apnea Newborn Monitor and the UNICEF Height and Length Measurement Device for Pediatric Patients. Course instructors reflected that TPPs provided a significantly strengthened foundation for design project integration in the bioinstrumentation course. Notably, three distinct strengths of TPPs were observed for design integration:

1) Authentic BME design challenges extensively informed by end users
Each TPP is informed by ~100 end users. Underpinning design experiences with TPPs serves as a proxy for end user engagement, enabling students to more holistically understand complex BME design challenges.

2) Clearly defined design requirements with inclusion of global & cultural constraints
In an increasingly globally connected society, it is imperative for BME education to prepare globally-minded engineers. Global health focused TPPs, such as those leveraged in this work, provide a unique opportunity to foster students’ understanding of global, cultural, and environmental design considerations in alignment with ABET program accreditation requirements.

3) Increased time allocated to prototyping and verification testing in a one-semester course:
Given time constraints in a one-semester course, it is challenging for students to engage in the full continuum of the design process. Students often struggle with problem definition and refinement, and little time remains to immerse deeply in prototyping and verification testing. Reflecting these realities, at the 2019 BME Education Summit, verification and validation testing, along with prototyping tinkering experience, were identified as high-priority skillsets to strengthen in BME graduates [1]. By rooting design experiences in TPPs, students have a stronger starting foundation in the early stages of the design process and can devote increased attention to prototyping and verification testing.

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