Educating for Industry

During the last two decades, the number of undergraduate programs in BME and bioengineering (BE) has grown exponentially in the United States. In 1992, only 20 programs were accredited by the Accreditation Board for Engineering and Technology (ABET), the nonprofit organization that evaluates engineering programs (see “What the Biomedical Engineer Has to Offer: A Brief Explanation of Engineering Program Accreditation”). Ten years later, 33 programs were accredited, and by 2012, 87 programs were accredited [1]. With this increased program growth, more BE graduates are joining the workforce as well as attending graduate and medical schools.
[accordion title=”What the Biomedical Engineer Has to Offer: A Brief Explanation of Engineering Program Accreditation”]
By John Gassert
Receiving accreditation from the Accreditation Board for Engineering and Technology (ABET) is commonly expected of almost all engineering education programs in the United States and is becoming desirable worldwide. Most employers will only hire a prospective engineer if he or she has graduated from a program that is accredited by the ABET. The reason for this is the minimum level of quality that can be expected of all graduates, which is established by the eight general criteria.
Probably the most pertinent to a prospective employer is “General Criterion 3: Student Outcomes” [S1], often referred to as a–k. The 11 outcomes defined by this criterion are as follows:

• a) an ability to apply knowledge of mathematics, science, and engineering
• b) an ability to design and conduct experiments, as well as to analyze and interpret data
• c) an ability to design a system, component, or process to meet desired needs within realistic constraints such as economic, environmental, social, political, ethical, health and safety, manufacturability, and sustainability
• d) an ability to function on multidisciplinary teams e) an ability to identify, formulate, and solve engineering problems
• f) an understanding of professional and ethical responsibility
• g) an ability to communicate effectively
• h) the broad education necessary to understand the impact of engineering solutions in a global, economic, environmental, and societal context
• i) a recognition of the need for and an ability to engage in lifelong learning
• j) a knowledge of contemporary issues
• k) an ability to use the techniques, skills, and modern engineering tools necessary for engineering practice.

The remaining seven general criteria are far more pertinent to the faculty of an engineering program because they help define the curriculum that helps students achieve the outcomes defined by criterion 3. Additionally, there are 29 program-specific criteria that define program curriculum for specific programs such as “bioengineering (BE) and BME and similarly named engineering programs.” The purpose of program-specific criteria is to help engineering faculty, in this case BE/BME faculty, understand what material must be included in a curriculum for it to qualify as a BE or BME program. It is also intended to help employers understand what makes a graduate of a BE/BME program special.
So why is a BE/BME graduate special? In addition to achieving the a–k outcomes, the BE/BME curriculum must prepare graduates with experience in [1]

• applying principles of engineering, biology, human physiology, chemistry, calculus-based physics, mathematics (through differential equations), and statistics
• solving BE/BME problems, including those associated with the interaction between living and nonliving systems
• analyzing, modeling, designing, and realizing BE/BME devices, systems, components, or processes
• making measurements on and interpreting data from living systems.

The application of engineering principles to human physiology and the understanding of the interaction between living and nonliving systems are unique to BE/BME programs in engineering education. Right now, these qualities are only found in those programs.
Although all BE/BME programs must include the listed BE/BME program-specific topics, employers must be familiar with an educational institution when looking for new engineers. They must know and understand the areas of specialization of BE/BME graduates. The reason for this is that almost every ABET-accredited BE/BME program has its area of specialty. Examples of such specialties include bioinstrumentation [more electrical engineering (EE)], biomechanics [more mechanical engineering (ME)], medical imaging (signals and systems), and systems modeling [could be EE, ME, and chemical engineering (ChemE)]. Employers must match those areas of specialization with their engineering needs.
Another point employers must realize is that some EE or ME graduates could be hired and function as a bioengineer. However, to be successful, they need further education in human physiology and the interaction between living and nonliving systems. Based on their area of specialization, most BE/BME graduates can function as an electrial or mechanical engineer, and they already have the needed additional education.
Communication skills are essential in every engineer. Therefore, new BE/BME graduates must clearly communicate their area of specialty, listing those courses that may include EE, ME, and/or ChemE.

Reference

1. Criteria for Accrediting Engineering Programs, Baltimore, MD: ABET, 2014–2015.

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As recently as November 2013, Money Magazine picked BME as its number one career choice (out of 100 top occupations), with a predicted ten-year job growth of 61.7% [2] (see also Jennifer Berglund’s article in this issue, “The Great Divide”). However, the question remains: Are B.S. BME graduates truly able to find positions in the medical device industry, a natural employer of these graduates?

Projected Employment Statistics

According to the U.S. Bureau of Labor Statistics (BLS), 15,700 biomedical engineers were employed in 2010, and that number is predicted to increase by 61.7% in 2020 to 25,400 [3]. But this large projected increase is deceiving for several reasons. First, the BLS counts several types of engineers as biomedical engineers, including all types of engineers at a medical device company, most of whom are electrical and mechanical engineers [4]. More accurately, approximately 25% of biomedical engineers work in the medical device industry [5]. Second, this high growth rate is not equivalent to high numbers of employed biomedical engineers. The BLS counted 15,700 engineers, some of whom were biomedical engineers, in 2010. In the same year, the American Society for Engineering Education (ASEE) counted 3,670 BME B.S. graduates [6]. Even if 15,700 engineers in 2010 were all truly biomedical engineers, the probability that 23% would retire so that new BME graduates could replace them was low.
In January 2014, the BLS updated its employment statistics and projections for 2012–2022. In 2012, the BLS counted 19,400 biomedical engineers. It now only projects an increase of 27% in 2022 to 24,600 biomedical engineers [7]. In 2012, the ASEE recorded 4,374 B.S. BME graduates [8].

The Medical Device Industry’s Hiring Needs

When B.S. BME graduates apply for positions, they hope that their skill sets match employer needs. In a recent survey, medical device managers were asked to rate the importance of various practical skills on a Likert scale of zero (not important) to four (very important) [9]. The 13 respondents were all involved in hiring engineers, with titles that ranged from vice president of product development and director of R&D to research fellow. They had worked an average of 23 ± 9 years in the medical device industry.
These managers’ ratings of nine practical skills are given in Table 1. The practical skills rated either somewhat very important or very important by at least 69% (nine out of 13) of the managers were (in descending order): oral and written communication, business practices, practical experience, project management, and vital signs devices.
[accordion title=”Table 1. Medical device manager ratings (N = 13) of practical skills.”]
Skills were rated on the following scale:

• 0: Not Important
• 1: Somewhat Not Important
• 2: Neutral
• 3: Somewhat Very Important
• 4: Very Important

Skill	0	1	2	3	4
Practical experience (bench familiarity with industry-standard test equipment and/or industry-standard medical devices).	0	1	1	3	8
Oral and written communication (experience with oral discussions and written reports).	0	0	0	2	11
Overall systems perspective (an understanding of how similar medical devices are related by common component—e.g., a pacemaker, deep brain stimulator, and cochlear implant are all implanted electrical stimulators with various stimulation waveforms and energy requirements).	0	1	4	3	5
Engineering standards (knowledge of consensus standards used in premarket submission to the U.S. Food and Drug Administration (FDA),—e.g., pulse oximeters are subject to ISO 9919:2005, Medical Electrical Equipment—Particular Requirements for the Basic Safety and Essential Performance of Pulse Oximeter Equipment for Medical Use).	1	3	2	4	3
Business practices (knowledge of processes involved in the medical device industry’s design and manufacture of medical devices, especially those processes mandated by the FDA; one example process is design control).	0	0	2	7	4
Project management (knowledge of how to plan, organize, and oversee the various tasks involved in a medical device product development project; in this survey we have classified design control as part of “ business practices,” rather than “project management,” because design control is practiced by all engineers, not just engineering managers).	0	2	2	9	1
Vital signs medical devices [knowledge of why the vital signs are important and how these devices work: electrocardiograph, thermometer, respiration monitor (which could be part of a cardiac monitor), pulse oximeter, blood pressure monitor].	2	1	1	7	2
Appropriate physiology (knowledge of the tissue or cell physiology associated with a given medical device).	1	1	4	1	6
Biocompatibility (knowledge of how various materials result in appropriate host responses for a specific device application).	1	1	6	4	1

Design control was incorporated into the definition of business practices rather than into the definition of project management. According to the FDA, design control is “an interrelated set of practices and procedures that are incorporated into the [medical device] design and development process” [10].
Business practices were defined as: “knowledge of processes involved in the medical device industry’s design and manufacture of medical devices, especially those processes mandated by the FDA. One example process is design control.”
Project management was defined as: “knowledge of how to plan, organize and oversee the various tasks involved in a medical device product development project.” Practical experience was defined as: “bench familiarity with industry-standard test equipment and/or industry-standard medical devices.”
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Regarding the match between BE/BME curricula and medical device industry needs, medical device executives had differing viewpoints. Stuart Gallant, vice president of product and business development at Pro- Dex, an original equipment manufacturer supplier in Irvine, California, has spent 42 years in the medical device industry working on devices ranging from implantable and noninvasive cardiovascular devices and anesthesia/patient-monitoring devices to kidney dialysis, endocrinology, and orthopedic devices. Gallant began his career at Medtronic and has been hiring B.S. engineers for 35 years, including electrical, mechanical, chemical, and biomedical engineers. He specifically hires B.S. biomedical engineers for “lab work, data analysis, and mathematical modeling.”
When asked to comment on the B.S. BME curriculum, Gallant stated, “I’m not a big fan. The degree does not provide core disciplinary knowledge. Regardless of the school, graduates do not have depth in a specific engineering discipline. The curriculum provides a broad-based background but no specific discipline to solve engineering problems. New graduates can conduct lab analysis but can’t design circuits, software, or algorithms.” He added, “Unless this degree is a stepping stone for grad school, it doesn’t have a lot of value. If you have this degree, you will be limited in companies that can offer you a job.”
Conversely, Judson Laabs prefers to hire biomedical engineers for systems positions. He believes that the undergraduate BME curriculum “breeds the most flexible engineers … who take medical devices seriously.” Other types of engineers, like “electrical engineers, may not have a medical background … and may not realize that the stakes are higher (for patient safety), than in other fields.” His advice to new graduates is to find work in a geographic area known for health care activity. “Once you are integrated and established at a company, it becomes an advantage to have a BME background because you have a unique perspective on how to solve a lot of problems,” he added. Laabs is currently the director of program management at Baxter Healthcare. He has worked 16 years in the medical device industry on devices ranging from critical care monitors and noninvasive continuous cardiac output monitors to large-volume infusion pumps and automated peritoneal dialysis systems. He began his career at GE Medical Systems, worked at CardioDynamics, and has been at Baxter Healthcare for ten years. Two years ago, as senior manager of systems engineering, he managed 30 systems engineers, half of whom were BMEs.

Where the Jobs Are

Based on this small, sample-sized survey and set of interviews, the current undergraduate BE/BME curricula may not be meeting medical device industry needs. This is not the first time this mismatch has been identified. In a 2012 IEEE Institute article titled “What It Takes to Be a Bioengineer,” IEEE Life Fellow Kenneth Foster stated, “if you intend to work in industry, you should pick up traditional engineering skills such as signal and image processing and software design so you can compete for entry-level design jobs” [11]. Similarly, in ASEE Prism, James Tien, dean of engineering at the University of Miami in Florida, advised interested students to “major in electrical [engineering] for your undergraduate; it’s very easy at the master’s level then to pick up the [biology] and be as effective as anybody” [12].
In the ABET Criteria for Accrediting Engineering Programs, “an ability to communicate effectively” is one of the student outcomes of General Criterion 3. However, the BE/BME program criteria do not specifically call out any of the other practical skills that were highly rated in the survey. While capstone design projects were not specifically part of the survey, design projects give students a first experience in engineering design, and this experience is the foundation upon which graduates conduct design in industry positions. Historically, many BE/BME programs have had difficulty fulfilling this part of “General Criterion 5: Curriculum.” Often, this occurs because programs have students conduct research projects rather than complete design projects. To address this mismatch, in 2008, John Gassert and John Enderle, who were then both members of the Biomedical Engineering Society (BMES) Accreditation Activities Committee (AAC), identified the differences between design and research projects in IEEE Engineering in Medicine and Biology Magazine [13], which is now known as IEEE Pulse. BMES AAC oversees the annual evaluation of BE/BME programs for the ABET.
Ultimately, students reading this may wonder if they should major in BE/BME. It is important to reiterate that the undergraduate BE/BME curricula provide a strong foundation for graduate BE/BME programs. Undergraduate students are exposed to a breadth of BME topics, enabling them to effectively choose a specialty for their Ph.D. or M.S. degree work. For those students wishing to work in industry immediately after graduation, students are advised to consider attending a B.S. and/or M.S. BME degree program that emphasizes the elements of design control, which may be taught within a capstone design course.
In addition, after graduation from an ABET-accredited undergraduate program, biomedical engineers are well suited to become quality engineers in the medical device industry. As defined by the FDA, quality systems are established by manufacturers “to help ensure that their products consistently meet applicable requirements and specifications” [14]. (Yes, applicable requirements and standards can be found in the engineering standards that are called out in ABET Criterion 5.) A quality engineer conducts testing and/or risk analysis before a medical device is cleared or approved by the FDA to ensure that manufacturer requirements are met. Because BME graduates are capable of “solving BE/BME problems, including those associated with the interaction between living and nonliving systems,” as described in the program criteria, they have experience in testing, which can range from bench testing to animal testing. Other types of engineering graduates do not possess the physiologic knowledge necessary for animal testing.
It can be argued that quality engineering is more important than product development (design) engineering, as quality engineers are the last line of safety between a newly market-released device and patients. In the widely reviled Guidant implantable cardioverter defibrillator (ICD) design defect case that caused an FDA recall, quality engineers first discovered the short circuit that caused ICDs to malfunction when their patients needed an electrical countershock to survive. Guidant ignored its quality engineers’ advice and continued selling defective inventory, which resulted in the largest U.S. Department of Justice medical device settlement to date of US$296 million [15], [16]. Vice president of quality is a common medical device industry position.
As noted by Laabs, biomedical engineers are also well suited to become systems engineers in the medical device industry because of their cross-disciplinary experience. System engineers focus “on defining customer needs and required functionality early in the development cycle, documenting requirements, and then proceeding with design synthesis and system validation while considering the complete problem: operations, cost and schedule, performance, training and support, test, manufacturing, and disposal” [17]. This type of engineering activity, while not specifically mandated by design control, is becoming increasingly emphasized by the FDA as it moves to minimize the annual number of medical device recalls [18], [19]. The International Council on Systems Engineering recently created a Biomedical and Healthcare Working Group to identify, develop, and tailor biomedical best practices [20].
However, if students want to design medical devices immediately after graduation, they may consider taking extra electrical engineering (EE) or mechanical engineering (ME) courses, or even double majoring in EE or ME as well as BME. These extra engineering courses may enable graduates to design, rather than just qualify, electrical or mechanical medical devices. There are substantially more FDA-approved and FDA-cleared EE and ME medical devices than tissue medical devices.
Exposure to the medical device industry through a summer internship or an industry-sponsored capstone design project may also differentiate a graduating senior during a job interview. Another option may be to graduate with a general engineering degree, which may provide engineering depth through system theory and engineering design courses and the opportunity for a few elective courses in specialties such as BME. The curricula for a general engineering degree, which is also known as engineering science or engineering physics, vary widely. General engineering degrees, with emphasis on system theory and engineering design, can be found at schools such as Harvey Mudd College and Olin College.
BME seniors should also be open to working in other industries. Other industries that may hire graduates include regulatory companies (such as UL), pharmaceutical and biotechnology companies, and consulting companies (such as Accenture). BME’s broad-based curriculum, which includes “the application of engineering principles to human physiology,” is attractive to these employers. Since these industries may not interview on campus, BME seniors may need to contact these employers directly about open positions.

What Academia Can Do

As BME professors, we can assist our students in career planning. Our students are very talented and frequently enter as freshmen with the highest mean SAT scores compared to students from other engineering departments. We can discuss the variety of interesting medical device positions for which they can apply, which include quality engineering and systems engineering as well as product development.
We can also assist our students by reevaluating our curricula. Curriculum reevaluation activities would be consistent with ABET “General Criterion 2: Program Educational Objectives.” From 2009 to 2010, the American Society of Mechanical Engineers (ASME) conducted surveys of ME department heads (n = 79), industry supervisors (n = 381), and early career mechanical engineers (n = 635) to better understand what topics should be taught to their undergraduate students in preparation for industry positions. This multipart study was called ASME Vision 2030 [21]. Undergraduate curricula study recommendations included “offering more authentic practice-based engineering experiences, developing students’ professional skills to a higher standard, and increased faculty expertise in professional practice” [22]. A similar survey of medical device supervisors and early career medical device engineers could provide useful inputs for enhancements to the BE/BME curricula, which could enable our graduates to design medical devices.
A decade ago, the American Institute for Medical and Biological Engineering (AIMBE) conducted BE/BME program surveys to determine where B.S., M.S., and Ph.D. graduates were employed. In 2002, 30 institutions, with 445 B.S. graduates, reported that 30% had industry positions, 54% went on to graduate school, and 16% were still seeking employment [23]. In 2007, 35 institutions, with 1,389 B.S. graduates, reported that 33% obtained a job, 41% continued their education, 7% were still seeking employment, 3% were not looking, and 16% were unknown [24]. It may be time to survey institutions again to determine the percentages of B.S. graduates seeking further education or employment. In January 2015, the BMES Accreditation Activities Committee recommended to the Academic Council of AIMBE that the Academic Council survey where their graduates go.
In summary, although BE/BME undergraduate programs may not realize the job forecasts that the media has predicted, graduates of ABET-accredited programs who do not plan to attend graduate school are well suited to become quality engineers and systems engineers in the medical device industry and may also find opportunities in regulatory companies, pharmaceutical and biotechnology companies, and consulting companies. Looking forward, ABET-accredited programs should continue to engage with medical device supervisors and early career medical device engineers to determine how best the BME curricula can be enhanced so graduates are better prepared for product design in the medical device industry.
We invite academic and industry readers to join our discussion by contributing comments.

References

1. ABET. (2014, May 1). Accredited Program Search. [Online].
2. ABET. (2013). Best Jobs in America, Money Mag. [Online].
3. C. B. Lockard and M. Wolf, “Employment outlook: 2010-2020: Occupational employment projections to 2020,” Monthly Labor Rev., pp. 84–108, Jan. 2012.
4. U.S. Bureau of Labor Statistics, personal communication, Jan. 2010.
5. U.S. Bureau of Labor Statistics. (2014, 1 May). Biomedical Engineers: Work Environment, Occupational Outlook Handbook. [Online].
6. M. T. Gibbons, Engineering by the Numbers. Washington, D.C.: ASEE, 2010.
7. U.S. Bureau of Labor Statistics. (2014, May 1). Biomedical Engineers: Summary, Occupational Outlook Handbook. [Online].
8. M. T. Gibbons, Engineering by the Numbers. Washington, D.C. ASEE, 2012.
9. G. D. Baura and T. Berry, “Comprehensive teaching of medical devices,” in Proc. American Society of Engineering Education Annual Conf., Vancouver, 2011, AC2011-1920.
10. FDA Center for Devices and Radiologic Health, Design Control Guidance for Medical Device Manufacturers. Silver Spring, MD: FDA, Mar. 11, 1997.
11. A. Monaco, “What it takes to be a bioengineer,” Institute, Dec. 2012.
12. B. L. Benderly, “Extra Strength: Engineering offers new insights into diseases and tools to treat them,” ASEE Prism, Oct. 2010.
13. J. Gassert and J. Enderle, “Design versus research in BME accreditation,” IEEE EMB Mag., vol. 27, no. 2, pp. 80–85, 2008.
14. J. Gassert and J. Enderle. (2014, July 13). Quality system (QS) regulation/medical device good manufacturing practices. [Online].
15. Bloomberg News, “Judge accepts guilty plea by Guidant,” The NY Times, Jan. 13, 2011.
16. G. D. Baura, “FDA case study: Guidant FDA recall,” in Medical Device Technologies: A Systems Based Overview Using Engineering Standards. Waltham, MA: Elsevier, 2011, pp. 115–117.
17. Systems Engineering Handbook: A Guide for System Life Cycle Processes and Activities, v.3.2.2, SE Handbook Working Group, INCOSE, San Diego, CA, 2011, p. 17.
18. H. Ghods. (2014, Nov. 21). Batteries in Medical Devices: A Systems Engineering Perspective. [Online].
19. H. Ghods. (2014, Nov. 21). Electrical and software engineering. [Online].
20. INCOSE. (2014, Nov. 21). Healthcare Working Group. [Online].
21. A. Kirkpatrick, “ASME Vision 2030: Designing the future of mechanical engineering education,” in Proc. ASEE College Industry Education Conf., Phoenix, AZ, Feb. 6–8, 2013.
22. A. Kirkpatrick, S. Danielson, and T. Perry, “ASME Vision 2030’s recommendations for mechanical engineering education,” in Proc. American Society of Engineering Education Annual Conf., San Antonio, TX, 2012, AC2012-4805.
23. S. Schreiner, “Placement of bioengineering and biomedical engineering graduates,” in Proc. American Society of Engineering Education Annual Conf., Portland, OR, 2005, AC2005-906.
24. American Institute for Medical and Biological Engineering, “2006–2007 Placement Survey,” Washington, D.C., AIMBE, 2007.