Goldberg, Jay R.

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epublications@Marquette

Marquette Universitye-Publications@MarquetteBiomedical Engineering Faculty Research andPublications Biomedical Engineering, Department of9-1-2013How Industry Benefits from Student DesignJay R. GoldbergMarquette University, jay.goldberg@marquette.eduPublished Version. Medical Device and Diagnostic Industry (MD+DI), Vol. 35, No. 9 (September2013): 28-35. Permalink. © 2013 UBM Canon.How Industry Benefits from Student Design | MDDI Medical Device and Diagnostic Industry News Products and SuppliersMarquette students Ethan Pedretti (left) and Brian Korveswork on a prototype of a second-generation assistivefeeding device. Learn more about working with academiato help innovate at MDM Chicago, September 11, 2013. Industry/StudentMedical DesignProjectsGet the scoop on threereal-life collaborationsbetween MarquetteUniversity students andMedtronic, 3M, and GEHealthcare. NewsHome - > Design Services - > How Industry Benefits from Student DesignHow Industry Benefits from Student DesignPosted in Design Services by Heather Thompson on August 19, 2013Sponsoring student design projects can free up companies' resources, but challenges remain.   Medical device companies often lack the engineering staff for new product development projects. One way to solvethis problem is to sponsor a senior design project at an accredited undergraduate engineering program. This optionprovides the sponsoring company with a team of engineering students dedicated to the project for up to twosemesters, depending on the school. Students benefit from the opportunity to work on real-world problems. Theygain exposure to project management and product development processes, as well as familiarity with economic,legal, and regulatory design constraints.How Senior Design Courses WorkCapstone design courses around the country differ inthe duration of the course, required deliverables,engineering disciplines, number of credit hours, andlevel of industry involvement. A description of thecapstone design course taught by the author atMarquette University is presented here as an example.The two-semester design course at MarquetteUniversity includes biomedical, electrical, computer, andmechanical engineering students. Students meet withfaculty twice a week as well as separately to discussdiscipline-specific topics such as FDA requirements,packaging and sterilization, and standards.During a typical semester there are 12 projects thatinvolve medical devices. Project teams consisting ofthree to five students from a mix of engineeringdisciplines are formed based on the required expertise and skills. Typically, medical device companies sponsor threeor four of these projects. The remaining projects involving medical devices are proposed by students, faculty, orexternal stakeholders on behalf of clients with disabilities.The course schedule and required team deliverables are based on the design control requirements of ISO 9001 and13485 and reflect the design process used in industry. During the fall semester, students working on industry-sponsored projects meet with sponsors as early as possible to define the project. Students and sponsors discuss howthe problem is currently solved (prior art and other competitive solutions), why a new approach is needed, and how anew product should perform better than what exists (e.g., lower cost, improved performance, or easier to use). Asappropriate, teams are encouraged to investigate who might benefit from a new design and estimate potential marketsize. These activities result in a written project definition. Teams then work with sponsors (and potential customers, ifappropriate) to define customer needs and performance requirements to generate the customer needs/target productspecifications document. Next, teams generate potential design concepts and determine the best concept, resultingin the generated/final concepts document. At the end of the fall semester, teams submit a written formal proposaldescribing the design they plan to pursue. Teams are required to justify technical feasibility through appropriatemathematical modeling methods (free-body diagrams, heat transfer calculations, finite element analysis, etc.).During the spring semester, teams create a detailed project schedule and riskanalysis document. This includes risk mitigation plans to minimize threats to projectschedules. Schedules and risk status are updated periodically. Teams fine-tunetheir design concepts, and construct and test functional prototypes. Informal designreviews occur during meetings with the team, faculty advisors, and sponsors.Designs are revised, and prototypes modified and retested until the design isfinalized. The experimental verification document describes testing of the prototypeto prove that it performs per the required performance specifications. The prototypeis shown to the sponsor for final approval and design validation. A final reportdocumenting the project, including all design inputs, outputs, and verification andvalidation results, is presented to the class (if not prevented by a nondisclosureagreement). Throughout both semesters, teams compile project notebooks thatcontain original designs, test procedures and results, meeting minutes, and otherproject-management-related items. These serve as design history files for theprojects. At the end of the course, prototypes, project notebooks, and final reports are transferred to the industrysponsors.How Industry is InvolvedThe most common form of industry involvement in capstone design courses is through sponsorship of design            How Industry Benefits from Student Design | MDDI Medical Device and Diagnostic Industry News Products and SuppliersBiomedical engineering student Jamie Solum works to builda defibrillator testing device for Engineering World Health.projects, which includes mentorship and funding of projects. According to a 2005 study of capstone design courses inthe United States, 71% of the courses included industry-sponsored projects.1 The average level of industry fundingper project from industrial sponsors varied within individual programs. Forty-eight percent of projects received lessthan $500 per project, and 12% received more than $5000 for at least one project.Industry sponsors are required to identify a company representative to serve as an advisor to the project. Theindustry advisor acts as the company contact for the team and is asked to be available to advise teams on issuesinvolving customer needs, provide technical expertise and advice, and approve design concepts and prototypes.Faculty advisors are responsible for administrative issues (grading, monitoring progress of teams, and dealing withteam issues) and providing guidance to the team. Communication between the team and the industry advisor can bein person or by telephone, e-mail, or video conferencing. The industry advisor determines the frequency ofcommunication with the team as well as the need for travel. Teams are required to construct and test prototypes to verify that their design solves the sponsors’ problems andmeets the sponsors’ needs. Students typically have access to the university’s computer network, libraries, machineshops, and laboratories. Construction of functional prototypes can be costly, and testing them may require specializedtest equipment or software not available to students. Depending on the complexity of the design and therequirements of the sponsoring company, some prototypes can be made of parts obtained from local hardware storesand easily assembled in a dormitory room. Others may use materials that require casting, molding, or otherprocesses that might not be available to students in an academic setting. In these situations, industry sponsors areasked to provide the necessary resources (prototyping facilities or personnel, laboratories, and test equipment) forthe team to complete its projects.Benefits of Industry InvolvementIndustry sponsors benefit from their involvement in thecapstone design course by receiving additionaltechnical resources dedicated to solving a technicalproblem at a lower cost. They were recently asked,“How did you or your company benefit from sponsorshipof a senior design project (at Marquette University)?”Industry representatives pointed out the additionalresources the projects gave their companies, which ledto faster time to market. They also noted the opportunityto assess the quality of students for prospective hiring.Others noted the fresh perspective teams brought todesign projects.These responses indicate that industry sponsorship canbenefit companies with limited technical resources andallow companies to make progress on lower priorityprojects without diluting their in-house resourcesallocated to higher priority projects. Working withengineering students can provide companies with a newway of looking at and solving problems. Projectsponsorship allows companies to participate in thetraining of new engineers, advertise their companies oncampus, and gain access to a pool of graduatingengineers for recruitment.Challenges with SponsorshipIndustry-sponsored projects present challengesregarding intellectual property. Intellectual propertypolicies vary greatly between institutions. At MarquetteUniversity, for example, students own their intellectualproperty and can voluntarily sign nondisclosure andpatent assignment agreements with sponsoring companies as a condition of sponsorship. Each year, a few of oursponsoring companies do not allow any public disclosures (e.g., classroom presentations) of the results of theprojects they sponsor. These requests for confidentiality are accommodated through private team presentations to thecourse instructor and the faculty project advisor, both of whom have signed nondisclosure agreements with thesponsor.Typical problems with industry-sponsored projects include company contacts not being available to teams when theyare needed, industry sponsors changing scope of the project once the project is defined (scope creep), unrealisticexpectations as to the amount of work and level of quality that a project team is capable of delivering in twosemesters, and sponsor expectations that do not match the course requirements (time, scope of projects, and orderof steps in design process, among other activities).Overcoming ChallengesExperience with the two-semester multidisciplinarycapstone design course at Marquette University hasshown that certain types of projects are suited forindustry sponsorship. The following types of projectstypically meet the needs of industry sponsors andstudents, as well as the requirements of the capstonedesign course:Lower priority projects for which the companylacks resources. This can be attractive to start-upcompanies with fewer technical resources.How Industry Benefits from Student Design | MDDI Medical Device and Diagnostic Industry News Products and Suppliershttp://www.mddionline.com/article/how-industry-benefits-student-design[11/7/2014 11:04:20 AM]Left to right: Kevin Vincent, Michael Stojanovic, and AndrewWeingart collaborate on testing of a component to be usedin a medical device.Projects that can be completed in eight monthsor less (required for a two-semester designcourse sequence).Projects involving the development of new-to-the-world products (may be difficult to completein two semesters but could be appropriate if aproof-of-concept prototype is acceptable),improvements to existing products (new features,revised packaging, new materials, etc.), or process improvements.Projects requiring the development of test procedures and the design of test equipment.Recommendations for project sponsors include the following:Agree on funding expectations with the school. Will you reimburse for team expenses or pay a fee upfront topay for needed items?Discuss goals, timetable, and required deliverables of the course. Sponsors need to understand the desiredlearning outcomes of the course, what the course deliverables are, and when they are due.Sponsors need to understand their roles in the project. They need to be available to students for backgroundinformation, guidance, and design feedback when students need them to be able to meet course deadlines.Sponsors must be aware of students’ time commitments to other courses. Sponsors and students shouldagree on the frequency of meetings and decide if travel is necessary.Manage expectations. Try to avoid scope changes (scope creep) that will require additional time and possiblydelay completion of the project beyond the end of the course. Don’t request additional deliverables beyondwhat is required by the course. And don’t expect students to complete the project prior to the end of thecourse.SummaryIndustry involvement in capstone design courses can provide many benefits to participating companies and students.Project sponsors benefit from their involvement by receiving additional technical resources dedicated to solving atechnical problem at a lower cost. Sponsorship allows companies to participate in the training of new engineers,advertise their companies on campus, and gain access to a pool of graduating engineers for recruitment. Industry-sponsored projects provide students with experience in solving real-world problems of interest to industry and helpprepare them for careers in engineering.References1. Susannah Howe, "Where Are We Now? Statistics on Capstone Courses Nationwide," in Advances inEngineering Education [online] Spring 2010 (Washington, DC: American Society for Engineering Education,2010); available from Internet: http://advances.asee.org/vol02/issue01/papers/aee-vol02-issue01-p03.pdf.To sponsor a senior capstone design project, contact the capstone design instructor at anyaccredited undergraduate engineering program. Jay R. Goldberg , PhD, PE, is director of the healthcare technologies management program at Marquette Universityand the Medical College of Wisconsin (Milwaukee). Goldberg is a member of the Biomedical Engineering Society, theNational Society of Professional Engineers, and AAMI, as well as a consultant to the gastroenterology and urologytherapy device panel of FDA’s Medical Device Advisory Committee. He is the cocreator of the BiomedicalEngineering Innovation, Design, and Entrepreneurship Award.

How Industry Benefits from Student Design

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