When the future of the medical device and implant industry is discussed, a common concern is the uncertainty in supply of new workers with solid scientific or engineering training. A steady supply of well-trained young people is crucial to the continued development of the U.S. medical device industry. Universities have taken heed and are adjusting school programs to respond. They are beginning to embark on educational ventures that directly address practical applications to provide engineering and science students with the skills industry requires. One such program is the Bison Microventure (Bμv).

Bμv is a focused learning experience at North Dakota State University. It is an innovation team that brings together students from various bioscience and engineering disciplines to learn together about design, development, manufacture, and testing of bone implants. Motivated students from other disciplines are also welcome.

This program goals are to provide an opportunity for students to learn entrepreneurial and intrapreneurial skills and to create an environment that encourages innovation and invention, while pursuing the cutting edges of technology. Although the learning process is the dominant purpose, assistance is also provided in filing patents and other intellectual property protection. Likewise, a desirable, though not necessary, outcome would be the forming of new enterprises by innovative and entrepreneurial students. Encouragement and assistance in venture formation and development are provided to those innovative groups who evolve to that state.

The Bμv is multidisciplinary and multilevel, and it is now completing its sixth year. Almost 70 students from seventeen majors have enrolled for one or more semesters. Enrollment is open to students in suitable majors from sophomore through graduate status, although a highly motivated freshman is occasionally admitted. The Spring 2013 team is the largest to date, with twenty-three engineering and bioscience majors now working on the project. A manufacturing engineering professor and a manufacturing engineering laboratory technician mentor the team, with support from a number of other faculty members in cellular biology, biochemistry, microbiology, mechanical engineering, and biomedical engineering.

Ceramic Implant Project

The current Bμv project began as the development of a hydrophilic porous ceramic dental implant. There are three main research hypotheses for this project. One is that ceramic is a more natural material than metal and would therefore lead to more natural healing from surgery. Students are also researching whether native bone cells can infiltrate into a porous implant, rather than simply adhere to the surface of a solid, to lead to more thorough healing. The final hypothesis is that osteoblasts will migrate more readily to a hydrophilic surface to speed healing. An additional hypothesis suggests that an implant that intrinsically resists infection will provide safer healing.

The Mechanics of Bμv

Bμv students enroll in a one-credit elective course that meets for two hours once a week. The majority of work occurs outside of formal class hours. Course learning objectives are to develop skills and competencies in translation of laboratory research into commercial products or processes, to create and maintain intellectual property, and to apply microtechnologies in medical and dental devices. Class meetings are modeled after product development meetings that occur in industry, including reports of what each person has accomplished during the preceding week, team-wide discussion of these items, and establishment of specific tasking for each team member for the following week. Students document their work in intellectual property journals, by occasional special reporting, and through end-of-term summary reports.

Team meetings also include guest speakers and field trips. Common guest topics include primers on orthopedic surgical procedures, manufacturing of dental prostheses, advanced imaging technology, bacteriology, new venture formation, and intellectual property documentation. Field trips have included travel to the Medical Device Manufacturing Exhibition in Minneapolis and visits to companies and laboratories engaged in research in biomaterials and biomechanics, in manufacture of dental implants, cardiovascular surgical tools, stents and pacemakers, and in production of advanced instrumentation.

The primary student activity is pursuing the laboratory studies, product and process design work, testing and experimental evaluation, market assessment, and business planning to create a commercially viable product concept. That is, students learn about innovation by being innovative. The team is cognizant of requirements for FDA approvals and certification, but at this point, the status is strictly pre-clinical. Concentration is on product definition, manufacturing process development, and in vitro laboratory evaluation.

Project work builds on accomplishments done in the preceding years and veteran students mentor new students. As the work has advanced, manufacturing techniques have become more refined and significant experimental biological evaluation has been launched. It has become clear that the product concept has a wider application; it may well be usable for a broad range of orthopedic surgeries. At the current stage of development, active studies are underway in testing the hydrophilicity and porosity hypotheses, quantitative imaging, development of synthetic bone-like materials for implants, antimicrobial mixtures, measurement techniques, and methods for more closely emulating the in vivo environment in the laboratory.

Each of the hypotheses is tested both directly and indirectly through experimental work conducted by groups of two to five students. There are eight task groups for the total of twenty-three students, and all groups work in relationship with other sub-teams. Thus, a natural collaborative environment is created in which bioscience students learn about the engineering needed to produce medical devices and engineers learn the biological and biochemical requirements for such devices.

To my knowledge there are no other universities attempting to further undergraduate learning in this way. In its small way, the Bison Microventure is a steady contributor to the supply of new college graduates with high-grade skill sets for the medical device and implant industry.

David L. Wells PhD, CMfgE, has been professor of Industrial and Manufacturing Engineering at North Dakota State University since January 2000. He teaches undergraduate and graduate courses in process engineering and production engineering systems design for conventional manufacturing, electronics assembly, biomedical products and micro-manufacturing. His active research lies in orthopedics, micro-assembly, micro-machining, PCB process engineering, printed electronics, applications of RFID technologies and manufacturing engineering pedagogy. He is active in SME, ASEE, SMTA, IEEE and ABET. Prior to joining NDSU, he held manufacturing engineering and management positions in aerospace, commercial sheet metal and automotive industries for twenty-six years. He also held a faculty position at University of Cincinnati for fifteen years. He is a certified manufacturing engineer and earned the BS and MS in Mechanical Engineering from Stanford University and the PhD in Engineering Management from University of Missouri-Rolla.

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