EMBS- Educating for Industry: A CALL TO ACTION FOR BIO-/BIOMEDICAL ENGINEERING PROFESSORS AND STUDENTS

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.

What the Biomedical Engineer Has to Offer: A Brief Explanation of Engineering Program Accreditation

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.

Table 1. Medical device manager ratings (N = 13) of practical skills.

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.

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