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The Use of a Medical Device Surrogate for Cooperative Product Development Learning of Engineering Design

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2017 ASEE Annual Conference & Exposition


Columbus, Ohio

Publication Date

June 24, 2017

Start Date

June 24, 2017

End Date

June 28, 2017

Conference Session

Design in BME

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Jeffrey Thomas La Belle Arizona State University

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Jeffrey T La Belle is currently an Assistant Professor in the School of Biological Health and Systems Engineering and the Biodesign Institute at Arizona State University. He holds adjunct status in the School of Energy and Matter Transport (Mechanical Engineering) as well as the College of Medicine at Mayo Clinic. He has a Ph.D. and Masters in Biomedical Engineering from ASU and a MS and BS in Electrical Engineering from Western New England University in Springfield Massachusetts. In the La Belle Group, we are currently developing electrochemical sensors for noninvasive glucose sensing, the novelty of our design is to obtain tear fluid for tear to blood glucose correlation in a noninvasive means to increase patient compliance. The next leap in technology for diabetes care is a multiplexed sensor that will add more depth of information for a self-monitoring blood glucose devices, here five accepted markers for DM care and management, including glucose, HbA1c, among others are simultaneously monitored on a single strip sensor. This technology we are developing could also allow for continuous and single use stress/trauma sensing technologies. Other applications of the sensing technologies include small molecule, DNA, protein, and whole cell detection to address changing climate in point-of-care technologies and medicine. On the activation side of our research, we are fabricating nitinol staggered muscle arrays that mimic skeletal muscle and we have recently demonstrated over 30% compression in our SMA’s similar to muscle bundles. Our approach to design is simple, following FDA guidelines and suggestions from the start, look at what the user needs and/or wants and apply a unique solution. We have a well-diversified group to tackle the challenges in health care today, staff and students come from biomedical engineering, electrical engineering, mechanical engineering, chemical engineering, computer science engineering, as well as biology and chemistry programs at ASU. BME at ASU teaches a 8 semester wide medical device design tract that initiates the students in design, regulations, standards, IP and other aspects from day 1. Dr. La Belle has develop and courses and taught at the freshman, junior, senior and graduate level on these topics.

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Aldin Malkoc Arizona State University

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Aldin Malkoc, MS is a student in the School of Biological and Health Systems Engineering at Arizona State University. Aldin is enrolled in the 4+1 program to receive his Masters of Science in Biomedical Engineering from Arizona State University in 2017 and will pursue a doctoral degree in Biomedical Engineering from Arizona State University in 2017. The primary focus in his master's thesis will pertain to the study of a point-of-care insulin sensor in biosensor development. Currently, Aldin is a graduate teaching assistant at the Fulton Schools of Engineering and wishes to develop effective engineering education strategies.

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Mackenzie Honikel Arizona State University, Biological and Health Systems Engineering

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Mackenzie Honikel, a current PhD student in the School of Biological and Health Systems Engineering at Arizona State University. Mackenzie graduated from SUNY Binghamton in May 2016 with a Bachelor's degree in biomedical engineering, concentrating in biomedical devices and biomaterials. Her background is in point-of-care diagnostic sensors, and she aims to continue this work during her time at Arizona State University. Her dissertation focuses on the development towards implantable cardiovascular sensors for continuous patient monitoring and reduced embolism formation at the site of implantation.

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While many core engineering classes prepare students’ technical ability, there are few classes that strictly enforce development of key concepts. The work presented is a project-based learning experience that teaches and enforces three key concepts: (1) innovation, (2) prototyping strategies, and (3) design processes crucial for engineering design. While it is important for students to learn the presented key concepts, it is imperative to ensure that upon completion of the course, each student is at an equal proficiency. The focus of this study is on translatability between professors and times a course is offered. Such that, no matter when and by whom the course is instructed, the students will effectively learn and show improvements in innovation, prototyping, and design. Our research poses the question: how will a project-based learning experience translate between different professors and times a course is offered when trying to enhance and develop concepts of innovation, prototyping, and design?

A hands-on, project-based cooperative learning lab was designed where students are placed into teams to design and develop a final prototype. The course uses the development of a board game as a surrogate for a medical device to enhance students’ skills in innovation, prototyping, and design. The use of the board game allows students to focus on the process versus the development of a final specific device. Additionally, the board game requires consideration in all aspects of medical device design: innovation, prototyping, standards consideration, regulatory pathway, intellectual property, and design of an experiment.

The course has three main components that enforce and teach innovation, prototyping, and design. The students begin by taking a survey for self-assessment evaluation, a pre- and post design challenge for instructor assessment, and expert validation of a final project prototype. From the study, the design challenges and student surveys showed significant differences between pre- and post scores. This was evident in all three key concepts. Some of the key findings were, the spring 2014 semester, 76% showed improvement in innovation, fall 2015 Wednesday section showing a 73% increase in the innovation category for the student survey, and spring 2014 showing a 143% score increase in the design category of the design challenge. However, at this time, there are no reported statistical differences in validator scores for the final product prototype.

The study here hopes to address two concepts. The first being teaching and retention of concepts that are important in design, specifically senior year design. Second, it offers promise into the transferability of content and learning between professors, semesters, and time a class is offered. While this study was performed on a junior year course, a project-based learning experience is perfect for the freshmen year experience, to ensure that students are taught these skills early on in their academic careers. In addition, the methodology used in this course is applicable to any grade level. While implemented junior year, this form of teaching could greatly benefit FYE.

La Belle, J. T., & Malkoc, A., & Honikel, M. (2017, June), The Use of a Medical Device Surrogate for Cooperative Product Development Learning of Engineering Design Paper presented at 2017 ASEE Annual Conference & Exposition, Columbus, Ohio. 10.18260/1-2--29016

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