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Prior to joining the University of Michigan faculty, she worked in the private sector gaining experience in biotech, defense, and medical device testing at large companies and start-ups. Colleen M. Seifert, University of Michigan Colleen M. Seifert is an Arthur F. She received her Ph. Her research interests center on learning, memory, and creativity.

One ideation tool, Design Heuristics, was developed through empirical studies of designs by professional engineers and in award-winning products. While the Design Heuristics strategies were identified and validated in the product design space, their application in biomedical engineering spaces has not been examined. In our study, we implemented a Design Heuristics lesson during one session of a semester-long biomedical engineering design course for upper-level undergraduates.

In this paper, we present an analysis of three design teams from the course to examine the applicability and impact of Design Heuristics within biomedical engineering design problems. Findings revealed that the biomedical engineering students successfully engaged in idea generation using Design Heuristics to build new biomedical engineering concepts. The findings suggest that Design Heuristics can support idea generation in biomedical engineering contexts, demonstrating the value of Design Heuristics outside of the previously-documented mechanical engineering and industrial design contexts.

One idea generation tool, called Design Heuristics, has been shown to be beneficial to student solution processes and outcomes in engineering design courses3,4. The focus of these studies has been on product design in mechanical and multi-disciplinary engineering and industrial design courses. However, there is potential for Design Heuristics to be applied to other engineering disciplines, such as biomedical engineering. Biomedical engineering design courses focus on medical devices, and incorporate a wide variety of expertise and engineering disciplines, including mechanical, electrical, and chemical engineering5.

The breadth of experience represented on a design team can help to generate innovative and diverse ideas. Biomedical engineering design courses focus on the processes of reverse engineering, problem definition and conceptualization, preliminary design, final design selection, prototyping, testing, and marketing, as well as addressing some unique biomedical focus areas such as medical device regulation6,7.

Within the field of biomedical engineering design, there has been limited discussion of how to instruct students about the idea generation process. Instruction on idea generation appears in some biomedical engineering design textbooks with an emphasis on mindset, collaboration, and versatility in idea generation, along with guidelines for facilitation8. However, textbooks in biomedical engineering design provide minimal information about techniques for idea generation.

Biomedical engineering design includes device-oriented designs that require physical interactions with users, and so may benefit from generative heuristics gleaned from end- user products. In this research, we explored the extent to which biomedical engineering students were able to apply Design Heuristics during idea generation, and whether they selected Design Heuristics-driven concepts as practical concepts to take forward in their design projects.

Background The consideration of multiple and diverse concepts during ideation can lead to innovative solutions9, Research indicates that diverse idea generation is difficult for students,11—15 and that limited resources exist for engineering educators on how to generate innovative concepts16— Each of these tools has a unique approach to guiding idea generation, varying in their focus specificity, and usability4.

For example, SCAMPER aids in idea generation by defining general prompts;4 Synectics provides general theme suggestions to define the contextual meaning of product, and brainstorming sets rules to guide a team during idea generation sessions Because of the existing evidence of the applicability of Design Heuristics in product design contexts4,34, we selected this tool for use in a biomedical engineering design course. Design Heuristics are idea generation strategies to prompt designers to explore a wide variety of ideas during idea generation, leading to more diverse and creative design concepts35— They are heuristics rather than algorithms because they provide a suggestion towards a possible solution rather than a deterministic outcome.

A specific set of 77 cognitive heuristics for product design, called Design Heuristics, have been identified in studies of expert and advanced product designers and analysis of innovative products Each of the 77 Design Heuristics provides a different, specific prompt, and is illustrated with a graphic representation and examples of its use in specific products. The heuristics are printed on an index card that can be considered by designers to prompt ideas.

On the front of each Design Heuristic card, there is a title of the strategy, a graphic image, and a description of the heuristic Figure 1. The back of each card provides two example products where the heuristic is evident, demonstrating how the heuristic can be applied to multiple products. One of these example is always a seating device, and the other example is a consumer product, represented by a variety of products throughout the set of 77 cards. Figure 1. Design Heuristic card 50, Provide Sensory Feedback. For example, the Design Heuristic, Provide sensory feedback, prompts the designer to consider how to provide feedback to the user when they interact with the product.

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For example, in designing a prosthetic, this Design Heuristic could be applied by adding vibrating sensations for the user whenever their prosthetic touches a surface. By pushing the designer to consider aspects of designs noted by other designers, Design Heuristics can help novice engineers broaden their conceptions of the design space, consider non-obvious ideas, and generate multiple, diverse concepts4. In a series of studies, the Design Heuristics cards have been empirically validated as effective in helping students generate conceptual solutions to address design problems39— Designs developed with the cards were non-obvious and distinct, and led to diverse and creative ideas in later stages of the design process3.

In studies with first-year mechanical engineering students4,39, design concepts generated with Design Heuristics were more original than those generated without Design Heuristics, which were often replications of known ideas or simply minor changes to existing products3.

Biodesign : the process of innovating medical technologies

Another study engaged first-year engineering students by teaching Design Heuristics as 1 a concept generation technique and 2 a concept transformation technique More variety of solution concepts was observed in design concepts generated with the Design Heuristics In a study with upper-level engineering students working in teams, concepts generated using Design Heuristics were observed as more practical, and were maintained from initial ideation through the final project design3.

In this study of teams working on different design projects, Design Heuristics were found to be applicable across a diverse range of problems.

Inventing Medical Devices

In sum, Design Heuristics have been established as a beneficial tool to assist mechanical engineers in generating diverse and create ideas3,4,41,42,44, In the present study, we sought to determine whether this instructional method would also benefit students in the domain of biomedical engineering design. Research Methods Research Questions The focus of this study was to investigate whether and how Design Heuristics may assist students in generating design ideas in the context of biomedical engineering problems.

We were also interested in how students developed their initial ideas as they refined and developed their concepts. To what extent are heuristic-driven ideas present in concepts considered worthwhile and selected to take forward in the design processes? Course Context and Participants The goal of the biomedical engineering design course at a large Midwestern university was to design, test, and build medical devices for stakeholders such as university departments, clinicians, and industry.

Skills developed through the course included problem definition, concept generation, detailed design, fabrication and evaluation, project management, and technical communication. Projects spanned from a wide range of topics including medical device creation, research equipment development, and usability of medical devices. All students work in teams of four or five students as part of a year-long upper-level biomedical engineering course.

Since we implemented a new pedagogical method in the class, we did not have a comparison group. For this study, coursework from three teams was examined to explore the application and practicality of the Design Heuristics-driven concepts. The three project teams selected represented a broad range of project types in the context of biomedical engineering product design: Project Team A: Creating a New Device The project team was composed of five students three males and two females. One male student opted out of the study and was not included in the analysis. Project Team B: Research Application The project team was composed of five students three males and two females.

One male student opted out of the study and his ideas were not included in the analysis.

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Data Collection Prior to the session, a Google forms survey was distributed to the students to gather background information on their experience in design and past projects. We then collected data during the idea generation phase of the course. Students spent one classroom session minutes learning and then applying Design Heuristics in a concept generation session for their project. Students were first asked to individually generate 4 concepts for their design problem in 20 minutes. Then, they were given instruction on Design Heuristics as an idea generation technique and practice on an unrelated problem.

The detailed instruction video can be found on www.

Biodesign : the process of innovating medical technologies (Book, ) []

Then, the students were asked to apply Design Heuristics to generate 4 new concepts in 20 minutes. We selected several cards that encouraged user interactions and product modifications. Each team was given either set A or B to ensure that every member within the same group had the same set of cards.

Table 1. Adjust Functions for Design the functions of the product with target user Specific Users characteristics in mind e. Create System Identify the core product functions and define a multi- stage process to achieve the overall goal.

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Set A Incorporate User Input Identify product functions that are adjustable and allow users to make those changes through an interface control, using buttons, sliders, levers, dials, touch screens, etc. Offer Optional Provide extra components for the user to swap. Components Mimic Natural Imitate naturally occurring processes, mechanisms, or Mechanisms systems. Set B Provide Sensory Return perceptual e.

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