This article is reproduced with permission from
the Whitaker Foundation 1999 Annual Report.

Biomedical Engineering and Industry

Three years ago Microsoft's Bill Gates told the New York Times, "I expect to see breathtaking advances in medicine over the next two decades, and biotechnology researchers and companies will be at the center of that progress."

Indeed, the medical technology sector-the industry with the highest demand for biomedical engineers-is already one of the fastest growing commercial sectors in the world.

The Health Industry Manufacturers Association and Merrill Lynch estimate that the medical device industry is a $146-billion enterprise worldwide. The United States accounts for $62.3 billion, almost half of the total. In this country, optimism about medical device sales has reached a six-year high.

Pharmaceutical companies are entering a new era of drug development spurred by the rapid pace of discoveries in basic biology, genetics and gene sequencing, while the biotechnology industry is on the rebound from a lull in the early 1990s.

In 1999 the Nasdaq Biotech Index rose 102 percent, outperforming the Nasdaq Composite Index, which climbed by 86 percent during the same period. Meanwhile, biotech companies raised nearly $12 billion in public and private financing.

"There's a whole new momentum in the recent performance of the biotech sector, sparked by the genomics and chip companies," Dennis Purcell, managing director of the investment bank Chase H&Q, told the Biotechnology Industry Organization. "There are great investment opportunities in biotechnology for new investors."

The optimism is also visible in the executive offices of the medical device industry. Sixty percent of company leaders surveyed for Medical Device & Diagnostic Industry magazine rated the overall business climate as excellent or good, the highest mark in six years. Only 6 percent viewed conditions as poor.

"This year's numbers are even stronger for large companies, with good or excellent conditions reported by 80 percent of firms with more than $50 million in 1998 sales volume," says editor Jon Katz. Fifty-two percent of survey respondents said their companies' sales had increased from 1997 to 1998. Eighty-two percent of the biggest companies reported rising sales.
 

Ongoing Revolutions

The ongoing revolutions in biology and microelectronics continue to produce a dizzying array of new health care technologies, from imaging and gene-based diagnostics and therapies, to cell and tissue engineering, to new drug delivery methods and more effective medical implants.

At the intersection of these two revolutions is the growing field of biomedical engineering. But finding the best corporate fit for a biomedical engineering graduate is not always straightforward. Many corporate leaders are unaware of the expertise that a degree in biomedical engineering represents and the high quality of students studying biomedical engineering.

"A lot of them are like me," says Robert Morff, manager of technology development for Sentron Medical Ventures. "I did not go through a biomedical engineering program; none of my degrees say 'biomedical engineering.' I was in electrical engineering and then went into physiology and biology-oriented training. People who are doing the hiring tend to look for people who have training similar to theirs."

But Morff, an adviser to The Whitaker Foundation's Special Opportunity and Industrial Internship programs, says things are changing: "For one thing, companies are building a history of experience with people who have biomedical engineering degrees, a history of positive experience. Also this bias is more prevalent among people who had their educational training quite a number of years ago, before there were many biomedical engineering programs."

One good way to make companies aware of the talents and training of biomedical engineers is through internship programs and cooperative education programs. The Whitaker Foundation recognizes the importance of these programs and supports them through its Industrial Internship program. (See page 34.)

So far, the foundation has approved a total of $3.2 million in grants to 21 institutions to begin or enhance industrial internship programs or cooperative education programs, many of which lead to permanent job placements for participating students. One of the biggest strengths they demonstrate as interns is their breadth of knowledge, combined with the ability to be flexible and think quickly.

Most biomedical engineers in industry work in a team whose members have diverse backgrounds and areas of expertise. In the medical device industry, teamwork begins at the conception of a product and continues through development. It may involve engineers, scientists, business managers, sales and marketing representatives, lawyers and regulatory experts.

It is critical that someone understands and is able to work effectively in that multidisciplinary environment, building knowledge across disciplinary barriers. This is exactly what biomedical engineers are trained to do.

It is critical that someone understands and is able to work effectively in that multidisciplinary environment, building knowledge across disciplinary barriers. This is exactly what biomedical engineers are trained to do.This ability is increasingly important in industry because more and more products require a multidisciplinary approach. Tissue engineering is a good example. The ability to manipulate or manufacture human tissue for medical purposes draws on biomaterials, mechanical engineering, cell and molecular biology, chemistry and chemical engineering, and other areas of engineering, biology and physiology.
 

A Fast-Paced Business

Another factor in industry is the pace at which projects come and go. In academia a biomedical engineer could spend an entire career on one narrow area of research, becoming the world's expert in that area. In industry, work on a product may last for a year or 18 months; then that product is out the door and the team moves on to something new.

Burke Mays, president of Mays and Associates Inc., a small medical services firm, says a major reason his company benefited from the work of biomedical engineering intern Ryan O'Toole of Vanderbilt University was that O'Toole was already up to speed.

"He quickly grasped our needs," Mays says. "He had to understand the electrical engineering and the medical aspects of things. We did have to do some outside-the-class education with him, but it was not as hard as it could have been. He had a good grasp of the medical concepts."

O'Toole helped the company develop a strategy for using custom software to operate a single machine for two purposes: as an electroencephalograph for studying brain wave activity, and as a polysomnograph to study sleep disorders.

"I'd do it again in a New York minute," Mays says of the internship program. "It worked out very well, and I have a couple of other projects that I might go back to [the university] for."

At Marquette University, as many as 65 percent of biomedical engineering students take a company job, according to Lisa Waples, associate chair of the department. "We're no different than any other biomedical engineering department. Five or six years ago there were few jobs in biomedical engineering. We weren't connected with industry. Now we are.

"Today the market is such that students really need to have some engineering experience before they graduate. The ones that get the good, competitive jobs are the ones that have the experience," she says.

• Research and development testing of medical devices and components.
   
• Engineering support for developing and launching new products.
   
• Preparation of standard operating procedures for testing and manufacturing processes.
   
• Conducting engineering studies, completing manu- facturing manuals and summarizing manuals into a process control/quality control sheet.
   
• Preparing documentation for the Food and Drug Administration (FDA).
   
• Dealing with vendors about component parts, working on quotes, sending out quotes, and assisting with functional issues of medical device products.
   
• Performing failure modes and effects analyses.
   
• Assisting with the design of biomedical devices and products.
   
• Assisting with technical marketing materials.
   
• Working with research sites and original equipment manufacturers to ensure that designs can be manufactured.
   

Companies Large and Small

Biomedical engineers are not confined to the research and development departments of large companies. Well-trained biomedical engineers usually have a strong background in engineering, biology and medicine, combined with a specific area of expertise, so they can interact effectively with doctors and health care providers, who may be the company's primary customers. Biomedical engineers can form an effective marketing bridge between the MBAs and the customers. Biomedical engineers can also interact effectively with clinical physicians, regulatory personnel, intellectual property staff, research and development staff, and traditionally trained engineers.

In a small company, biomedical engineers can fill knowledge gaps created by the lack of a large work force. It is not unusual for an intern at a small company to be involved in biomedical laboratory work, engineering, research, and business applications. This could involve laboratory animals, drug preparation, surgical procedures, cell culturing, documenting research results, the interpretation of results, the application of electrical bioinstrumentation, experimental design, researching new applications for existing drugs, and interactions with the FDA.

For companies, the internship experience does more than identify potential employees. For about 15 years, the National Science Foundation has sponsored collaborative research between industry and academia. The goal is to improve engineering research and to better prepare students for careers in industry. In a recent survey industrial partners who were in the program for eight or more years said the biggest benefit to them was access to new ideas, know-how, and technologies. These are followed in order by direct technical assistance, networking, company enhancements, and hiring graduates.

As biomedical engineering graduates work their way through the corporate hierarchy, companies will become more acquainted with the value of biomedical engineering graduates, and more biomedical engineers will contribute to the health care industry. At that time a major goal of The Whitaker Foundation will have been achieved.

Copyright 1999 The Whitaker Foundation