UC-San Diego Program Focuses on Designing Medical Devices

SAN DIEGO — UC-San Diego’s Jacobs School of Engineering is enrolling its second class for its Master of Advanced Study Program in Medical Device Engineering. The multidisciplinary curriculum has been developed specifically for working engineers who have at least two years of job experience, with the goal of preparing students for a career in the medical device industry, one of San Diego’s fastest-growing technology sectors.

The program is unusual in terms of the broad education it provides, school officials said. Half of the classes are in bioengineering and the other half in mechanical engineering, according to Faye Kurpanek, director of executive education at UC-San Diego’s School of Engineering.

Courses include clinical needs assessment, mechanics and transport, anatomy and physiology, modern life science technologies, biomaterials, wireless embedded controls and computer-aided design. Students also attend seminars on health care economics, biomedical informatics, project management and leadership skills. By the end of the two-year executive program, students are expected to have created a working prototype of a medical device.

The medical device industry is evolving and incorporating new technologies, such as computer chips and mobile applications, which are becoming an integral part of product development. Companies increasingly need engineers with interdisciplinary experience, and perhaps just as important, a broader understanding of the regulatory and financial environment that the devices they build will enter.

As a result, product launching, regulatory and payment issues and FDA regulatory oversight are also integrated into the program’s curriculum.

“It’s really the regulatory environment and the quality systems that you have to have in place,” said Jorge Valdes, chief technology officer of DexCom, a San Diego-based maker of continuous glucose monitoring technology.

Another unusual aspect of the program, according to Kurpanek, is students’ ability to audit courses in different but related disciplines that may be of interest to them. If a student’s prototype project, for example, deals with cardiology, the school will connect the student with experts from UCSD’s School of Medicine.

Responding to Industry Demand

The Master of Advanced Study Program in Medical Device Engineering was built in direct response to an industry need and input from many San Diego-based medical device companies that expressed an interest in helping professionals currently working for them to broaden their engineering expertise.

“We went out to company after company in the area … and said we’re thinking about doing this. What do you think? Would you send people? What do you want to see?” Kurpanek said.

Consistently, the feedback included praise for broadening students’ engineering background. But most important to companies, according to Kurpanek, was that students would leave the program understanding issues around reimbursement, regulatory concerns and design control.

This broader education, companies reported, would better help students move into senior level positions not just as technical leaders, but as professionals who understand the business side of the medical device industry as well.

This program will also prove valuable for engineers interested in becoming entrepreneurs, said David Nexon, senior executive vice president of the Advanced Medical Technology Association, a Washington D.C.-based trade group representing medical device manufacturers. 

“The ideal model in our industry — and also true for many start-up companies — is the doctor and engineer getting together in their garage to develop a new invention,” he said.

And perhaps no other market is closer to that industry ideal than San Diego. Most medical device companies here tend to be earlier stage and entrepreneurial ventures with an average of four employees, according to Joleen Schultz, principal at the medical branding and marketing agency 321 Medical Launch, as well as chair of BIOCOM’s Medical Device Committee. 

“Those four individuals have to wear a lot of hats. Employees need to have broad understanding of the different disciplines to get products through the FDA and to market,” Schultz said.

Growth Industry in San Diego and Beyond

San Diego is one of the country’s largest medical device industry hubs. According to BIOCOM, the San Diego-based life sciences trade group, there are 240 medical device companies based in San Diego County and 715 companies throughout the region, making it one of the area’s largest employment sectors.

And it’s growing. Between 2009 and 2011, the medical device industry added more than 2,300 new jobs throughout the region, representing a growth rate of 7%.

Beyond San Diego, the prospects for the industry’s expansion are also good, Nexon said. He cites three primary reasons for the industry’s growth:

  • An explosion in new scientific knowledge. Developments in the understanding of basic biology, as well as in material and computer sciences, have all contributed to the development of new products. “That means the industry is going to grow and it’s going to need new people,” Nexon said. A survey of member companies conducted by AdvaMed in 2010 found that one-third had difficulty in recruiting enough scientists, and 40% had difficulty recruiting qualified engineers. 
  • Aging of the population. In the next two decades, the elderly population is expected to grow by 80%, or an additional 32 million people. Worldwide, projections are for 1.2 billion people over age 65 by 2025. This suggests a future high demand for medical devices, which are disproportionately used by the elderly, according to Nexon.
  • Growth of emerging markets. Current predictions are that by 2015, there will be more middle-class people in China than in the total U.S. population. India is expecting 600 million people in the middle class by 2025. “So you can just see what’s happening worldwide as these developing countries with very large populations develop a large middle class,” Nexon said.

Increasingly, the middle class in emerging economies will have the ability to pay for medical devices and other health care products and services that both lengthen and add quality to their lives.

A Current Slowdown

Despite optimism for the future, the medical device industry is in a cost-cutting mode right now. “So immediate job prospects might not be as good this year as they will be in future years,” Nexon said.

The recession has been one cause for a slowdown in purchasing by hospitals, the medical device industry’s main customer.

Also weighing heavily on the industry is a new tax included in the health reform law. Going into effect next year, manufacturers and importers of medical devices will pay a 2.3% excise tax on sales of taxable medical devices, representing a $30 billion cost over 10 years for the industry.

Over the past couple of months, Schultz said, large medical device companies have reduced their workforces in anticipation of the additional costs. “They are all trying to prepare their bottom line for this medical tax,” she said.

Ironically, that may be good news long term for the San Diego market, which is dominated by small companies hoping either to be acquired or to license rather than sell their products.

“There is a great marriage right now between small companies that are developing technology and the bigger medical device companies that are looking for technology. I think over the next couple of years [large companies] will be looking to acquire earlier stage technology to fill their development pipeline,” Schultz said.

In the end, Nexon said of UCSD’s program, “I think the direction they’re taking is really focusing on what is both a current need and a need that’s going to grow over time.”

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