Upping the game: focus on the process My course’s focus needs to be on the process, not the product. Therefore, a surrogate product was selected for the course — one that uses standards, business models, intellectual property, safety testing, similar equipment (laser cutters, 3D printers, software, casting, etc.), and similar overall processes — board games . It doesn’t matter what product you have. All products out there have specifications. Bioengineering has design controls — what the rest of the world calls standards. For example, in board games, playing card size is standardized via ISO 216. Medical design is standardized through patents; blood glucose is under ISO 15197-2013. Blood glucose meters require 34 seconds to obtain a reading, require a small volume of blood (0.5 uL), have a dynamic range of 40 mg/dL to 600 mg/ dL, and maintain a shelf life of three months after purchase. In the same way, board games have specifications. The board game allows me to take the product out of the limelight and stay fixated on the process. The zombies on the game cover take your attention away from the fact that it’s not a pacemaker or blood glucose meter. Cards with cartoon hazmat suits make you forget that you’re helping doctors and nurses retain the CDC’s protocol for Ebola treatment and prevention. Throughout the entire course, connections to medical product design are made so that students learn the two have a similar process. This also helps students recognize the process when in senior design. I broke the course up into seven different design tasks, as shown in Figure 3 at right . The design tasks allow me to focus on student development. I’ve improved the course by transitioning from solely problem-based learning (PBL) to incorporate entrepreneurially minded learning (EML). Through PBL, students attack a problem and identify a unique way to solve it. With EML, students are encouraged to reframe the problem and consider opportunities and issues that may have been absent in the original construct. Because EML promotes a different type of thinking, the focus is not on a homework problem that will soon be forgotten, but is really on the students themselves. EML focuses on developing a mindset. Students get their hands dirty immediately. After students form teams during the first week of class, they play various games to become more familiar with different game designs — think tabletop, card, and dice. In class, they learn more about financials and business development, customer research, and design specifications.​ By the end of the second week, teams select a category for their game design. The game needs to be related to the medical field, address a current issue in the news, or fit an identified game genre. Teams go through weeks of research, alternative design creation, and verification before they even begin to prototype. This is where most EML takes place. Often, if students develop a prototype too soon, they become tied to one component of their game just because it’s unique. More often than not, they create better concepts after exploring alternatives and talking to customers and other students. It’s not until Design Task 4 that students are ready to create the alpha prototype. During this week, they finalize game specifications and a bill of materials in preparation for their beta design. They think about the financials, including whether they’ll build or buy game pieces, and how much the game and the individual pieces will cost. From a practical standpoint, they consider tradeoffs. For instance, if game components are over budget or if the game’s weight increases the cost of shipping, there are likely better alternatives. During Design Tasks 5 and 6, students focus on beta and gamma designs. They develop surveys so other teams can test the games and provide feedback. I keep my lectures minimal so that they have time to work during class. The last three weeks of the course are reserved for students to complete their games and practice communicating their design and ideas. During the last week of class, teams present their game ideas. They give a five-minute elevator pitch to a panel of over 20 validators. Game producers and developers from across the spectrum show up to play and evaluate the games alongside representatives from medical organizations like Mayo, Banner, W.L. Gore, and Medtronic. They review the games from an engineering standpoint: how well are they constructed? Then they consider the gaming standpoint: is it fun? Bingo! Credits (ASU, ASU Now, Scott Seckel) GAME LAB! The next step is computational prototyping and modeling. Things to consider are Michaelis- Menten kinetics and the conversion of the moles of electrons of glucose oxidase to current — ultimately, figuring out how to get a voltage reading and convert it to mg/dl ( see Figure 2, at left ). Prototyping a blood glucose meter uses the iterative prototyping pathway. Each iteration provides an opportunity for feedback and the addition of new requirements, such as regulatory standards. It’s Professor LaBelle, in the laboratory, with a pacemaker, and no one is Sorry! So why is BME 382 — officially called Biomedical Engineering Product Design and Development III, aka Physical Prototyping — sometimes just called zombie class — as popular as Park Place on Fridays when other classes are as deserted as Baltic Avenue? Need a Clue? It’s my creative approach to captivating students. As a result, I enjoy 100 percent attendance Friday mornings at 8:00 a.m. (yes, you read that correctly). Students learn that engineering education is not just about learning the technicalities. It’s about being able to create value. Figure 2: Michaelis-MentenCurve The end game of my bioengineering class is to teach engineers how to make prototypes of medical devices like pacemakers. That one word has defined the entire course. It’s essential that students consider the purpose of prototyping during a product development cycle. Prototypes can be used to test a concept or showcase a solution to a potential customer. Our prototyping process is not as well defined as an FDAWaterfall or Regulatory Pathway, but it is iterative and has some cool-sounding steps like alpha, beta, and gamma designs ( See Figure 1, at right ). Envision sketching a paper and pencil version of a blood glucose meter. What does the display show the user? Where are the buttons? Where does the test strip go? These questions are all informed by human-centered design, but they don’t tell us how the product will function. Hospitals are told to treat patients suspected of Ebola by following steps on the CDCwebsite. A student-designed card game helps doctors and nurses rememberwhat to dowhen things don’t go according to plan. Figure 1: Prototyping Pathway Process INTERNAL REVIEW (VERIFICATION) #3 REVIEW PROTOTYPE #2 BUILD PROTOTYPE #1 IDENTIFY NEED EXTERNAL REVIEW (VALIDATION) #4 FREEZE DESIGN Figure 3: Students complete a series of design tasks throughout the course A COURSE DESIGNED TO PLAY WITH PROCESS [S] (mM) K m 1/2V max V 0 (uM/min) V 0 = V max [S] K m V 0 = V max Design Task 1: Teamselection and product specification Design Task 2: Concept generation Design Task 3: Verification DesignTask 4: Verificationcontinues Design Task 5: Improve beta Design Task 6: Develop gamma Design Task 7: Final presentation By Jeff LaBelle, Assistant Professor of Biomedical Engineering at Arizona State University 37 36