Career Crossover from
High Tech to Medtech:
Medical Devices

If you're now a tech industry refugee wondering how you can cross over to healthcare, because everyone's telling you that's a growth sector, there are a couple of likely bridges: medical informatics (as opposed to bioinformatics, which is not the same thing) and medical devices. This time, we'll look at the latter. It's tough to map the terrain of this parallel universe at first, and the boundaries between biotech, medtech and the pharmaceutical field sometimes look blurry. So here's a rough map to help you get your bearings.

Basic roadmap for medical device territory

The medical device industry has more in common with pharmaceuticals than biotech or medical informatics, because both devices and drugs are regulated by the U.S. Food and Drug Administration (FDA). The FDA Center for Devices and Radiological Health's definition of medical devices states, in part:

"Medical devices range from simple tongue depressors and bedpans to complex programmable pacemakers with microchip technology and laser surgical devices. In addition, medical devices include in vitro diagnostic products, such as general purpose lab equipment, reagents, and test kits, which may include monoclonal antibody technology. Certain electronic radiation emitting products with medical application and claims meet the definition of medical device. Examples include diagnostic ultrasound products, x-ray machines and medical lasers. A device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is:

• intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
• intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of it's primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its primary intended purposes."
  

Even though some devices are implanted in the body, if they’re coated with a drug, the FDA classifies them as drugs, not devices. As they put it: "If the primary intended use of the product is achieved through chemical action or by being metabolized by the body, the product is usually a drug."

The industry classifies devices along a continuum that basically ranges from relatively inexpensive, typically disposable products produced in high volume at low profit margins to those that are expensive and durable, thus produced in low volume but with high profit margins. The Cap Gemini Ernst & Young Perspectives 4 report on Life Sciences puts this in perspective at a glance:

It's also important to understand the developmental and approval phases that medical device companies must follow to comply with FDA regulations. The graphic below gives you the gist of it, and you can find explanations of each phase by clicking on the topics in the original graphic on the Medical Device Consultants site.

Source: Medical Device Consultants, Inc. (MDCI). Copyright 2003 MDCI.
Used by permission.

Industry forecast

According to industry analysts Frost & Sullivan, "The U.S. market for medical devices exceeds $55 billion and continues to grow, thanks to an aging population and technological advances that help improve health and lengthen lifespans." Forrester Research, one of their competitors, agrees, saying in a preview for a forthcoming report, "Medical device firms will thrive on patients' avoidance of nursing homes and hospitals and payers' desire to minimize costly in-patient care. But," they caution, "acceptance, compliance and reimbursement hurdles prevent medical device companies and pharma from capitalizing on these opportunities."

Even some of those roadblocks aren't quite the deterrents they were a year ago, though, says Kirk Walden, Director of Venture Capital Research for PricewaterhouseCoopers (PWC). "The FDA has been increasingly cooperative in getting new drugs approved. Reimbursement is getting enough discussion that, if it continues along this path, a lot of things will qualify for reimbursement with less hassle, and that will stimulate the market."

Just as important for those of us in Silicon Valley, Walden says: "Nationally, biotech will typically get more funding, but that may not be the case in Silicon Valley. Silicon Valley accounts for 40% of all software investments in the US last year, but 29% of all investments for medical devices. Medical devices and biotech are historically solid VC investing categories. Taken together, they're becoming more dominant nationwide. Silicon Valley is ground zero for venture capital. It is going to have the dominant share of any industry, because all the VCs are there."

Walden's firm, PricewaterhouseCoopers, co-issues the quarterly MoneyTree VC funding analysis. There's an interactive version on their site, which you can customize by region, industry and so on. Their 2002 results show that Silicon Valley is home to the most medical device manufacturers, with New England (mainly the Boston area) and San Diego as the next-closest hubs of activity:

Source: PricewaterhouseCoopers/Thomson Venture Economics/National Venture Capital Association MoneyTree™ Survey, Biotechnology Venture Capital Investments by Region, 1998-2002.
Copyright © 2003, all rights reserved. Used by permission.

Even within healthcare technologies, Frost & Sullivan's 2002 report (see Resources) says, "the lines between traditional healthcare technologies are blurring as combination products are launched for the diagnosis and treatment of many different conditions. Image-guided surgery uses medical imaging technologies such as CT and MRI in conjunction with specialized surgical instrumentation. Drug-coated stents combine a medical device with a pharmaceutical formulation. As our analyst says, 'Combination products are expected to drive future market growth and be the key to bringing in revolutionary therapies.'"

Career crossover paths

Medical devices also have something in common with hardware and software. As a February 20, 2003 article in the Silicon Valley/San Jose Business Journal said, "Medical devices require the expertise of engineers to build equipment that can be small enough to operate in the human body and perform its function. Software engineers are involved in the design and development of chips that can be used to operate medical devices." Many, however, are biomedical engineers with narrowly defined subspecialties. If you're willing to go back to school for a master's or PhD, that's the direction to explore. You'll find links to academic programs and much more to help you get oriented on the Biomedical Engineering Network's site.

The FDA mandates documentation (more often called “labeling” in the device field, usually overseen by each company's Regulatory and Compliance department), so they need tech writers and editors, too. To control sales costs, device manufacturers are experimenting with online ordering and auctions of both new and used equipment, so that means they also need e-commerce and supply chain experts. And of course, there are opportunities for people with experience in all phases of manufacturing, HR and marketing.

How and where to look for jobs

In the introduction to their February 26, 2003 report on the U.S. Medical Devices Market Outlook, Frost & Sullivan's analysts say, "In this highly competitive industry, increased spending on R&D is a sign of a company's sustained commitment to achieving long-term success." So watch the quarterly MoneyTree VC funding report in the San Jose Mercury News for R&D funding for device companies.

Sometimes, initial phases of research are conducted by contract research organizations (CROs), which put together special teams to do the work commissioned by the device companies. That's sometimes an easier way to break in than working directly for the companies.

To learn more, monitor industry news, join one or two of the leading trade associations (many have lower rates for restricted access first-year membership), attend professional association meetings and conferences, read the trade magazines in the field (including the ads and bylines). You'll find links to good places to start your research in the Resources section that follows.

Note: I wrote the first version of this article for a Silcon Valley, San Francisco Bay area audience, so some of the info below is slanted in that direction. — Judith

Resources

Helpful Web sites

• Medical DeviceLink, comprehensive site with links to trade magazines, books, career resources, discussion forum (requires registration)
• Geocities Medical Device and Equipment Industry Resource Center

Medical device companies

• BioDevices Biz by CanBiotech company directory, searchable by country and types of products (requires registration)
• BioSpace Biotech Bay directory, with links to company profiles, although not all are medical device companies
• California Healthcare Institute, "the advocate for California’s biomedical industry," member directory
• Contract research organizations (CROs)
• Medmart, search under international (more listings) as well as national
• Sales and Marketing Network's annotated directory of medical device companies, with links to their Web sites (follow Medical Devices link from menu at left)
• Websters Online Business Directory

Industry associations

• American Society for Quality (ASQ), Biomedical Division. San Francisco Discussion Group sponsors roundtables and seminars the fourth Wednesday of each month, 7–9 PM in Palo Alto
• Association of Clinical Research Professionals (ACRP), also has a Medical Device Forum
• Association of Medical Diagnostics Manufacturers (AMDM)
• Medical Device Manufacturers Association (MDMA)
• Regulatory Affairs Professionals Society (RAPS)
• Stanford Medical Device Network

Key government sites

• FDA Center for Devices and Radiological Health
  • FDA definition of a medical device
• FDA examples of recently approved devices, what they’re for and who makes them
• Medical Device User Fee and Modernization Act of 2002

• May, Troy. All for innovation: Engineers and biologists work on new health technologies. (February 7, 2003). Silicon Valley/San Jose Business Journal. Accessed April 22, 2003.
  Excerpt: "Frost & Sullivan predicts that in the next decade the most dramatic advances in the medical devices industry will be found in synergies with pharmaceuticals, medical imaging, biotechnology and information technology."
• Frost & Sullivan. U.S. Medical Devices Market Outlook. (February 2003). MedicalDevices.frost.com. See Services by Market -> Healthcare -> Medical Devices ->. On the report page, choose Print Brochure on right. (Requires registration for minimal access, subscription for full report.)
• PricewaterhouseCoopers. Biomedicine: The New Pillar in Northern Cailfornia’s Economy, 2002 Report on Northern California’s R&D Industry. (2002). California Healthcare Institute.
• PricewaterhouseCoopers, Thompson Venture Economics, National Venture Capital Association. MoneyTree Survey. Interactive reports customizable by region, industry and more.
• Stovall, Sam. Medical-device makers look robust. (March 11, 2003). BusinessWeek Online. Accessed April 22, 2003.
  Excerpt: "Promising new products and favorable demographic trends should help this sector stay attractive in an otherwise gloomy market."