Medical Device Link.

Originally Published MX January/February 2001

In a market filled with new and emerging technologies, medical device companies face continual challenges in sourcing, attracting, and retaining skilled personnel.

Joseph Mullings

In the United States, the national unemployment rate is currently at a record low of 3.9%—the lowest it's been, in fact, since the mid-1970s. Couple this with the strength of today's economy, the stock market rising to record levels, higher per-capita income, and a higher GDP than in years past, and employers find themselves having to offer more than just a competitive wage to attract and retain employees.

Such challenges are especially problematic for medical device companies, where access to specialized skills is increasingly important if a company is to keep pace with constantly changing and continually emerging new technologies. The demand for software developers, for example, has created a highly competitive market. In this area, medical device companies are facing real difficulties in gaining access to software engineers who have not made the jump to a dot-com.

For the leaders of such medtech companies, sourcing talented personnel with the skills essential to the successful development of today's emerging medical technologies is a significant concern. Companies face the difficulties of retaining employees in a highly competitive market while sourcing talent for growth—growth that is fueled by advances in technology.

An Understanding of Technology

To understand why today's employment market is so tight for medical device companies, one need only look at how technologically sophisticated the industry has become. As applied in the medical device field, the term technology can be construed in two ways: industry-specific application technologies and business-enabling technologies. This distinction is not a new one, but it has become increasingly profound as specific embodiments of these technologies have evolved. To be competitive in today's marketplace, companies in the medical device industry must be proficient in both forms of technology. Depending upon their job function, individual employees may also need to have expertise in one or both forms of technology.

Medical-application technologies are essentially those that contribute directly to the functional features of a medical product. The development of such technologies has made it possible to create more-precise means to diagnose, treat, or prevent an increasingly wide range of highly complex diseases and medical conditions. For example, low-dose radiation technology, along with the ability to deliver it to a specific site, has enabled the treatment of conditions such as benign prostate hyperplasia (BPH) and vascular stenosis. In another example, laser technology has provided treatment solutions both to revascularize the heart (transmyocardial revascularization) and to restore near-perfect vision by altering the topography of the cornea. In the human resources field, such advances in technology translate into increased demand for scientists and engineers who can apply such technologies in developing devices to treat complex diseases (see Table I).

Table I. Top medical-application technologies for which scientists and engineers are in demand by medical device manufacturers, with related job titles and representative types of applications. Source: The Mullings Group.

Business-enabling technologies, on the other hand, are those that provide companies with the means to develop products, manage their business, and communicate more effectively. One example of such technologies is that of computer-aided design (CAD) systems, which have enabled the development of more-complex and sophisticated devices. Manufacturing resource planning (MRP) and enterprise resource planning (ERP) systems have enabled companies to plan and manage materials and resources more effectively throughout their organizations. And the Internet has provided a platform for communication that has exponentially enhanced business decision making. From a human resources point of view, advances in business-enabling technologies raise the minimum standard required to compete in the device market (see Table II). Because the use of such technologies is not unique to the medical device industry, other companies that design, manufacture, and distribute products and services represent a competing demand on the available talent pool of skilled employees.

Table II. Key business-enabling technologies being adopted by medical device manufacturers, with functional areas most affected. Source: The Mullings Group.

Although the adoption of business-enabling technologies has elevated the skill levels that medical device manufacturers must ask for in their employees—and thereby made it more difficult to locate qualified employees—it has also had some beneficial effects on the development of employee skills. By automating many of the traditional business functions involved in the development and commercialization of medical devices, such systems free up resources that can then be dedicated to helping employees develop industry-specific knowledge and skills and to stimulating greater attention to the creation of new medical technologies. At the same time, employees are also able to gain a more thorough understanding of the market conditions and competition affecting the commercialization of new medical-application technologies, and an intimate knowledge of both the therapeutic benefits and limits of those technologies.

Medical technology companies have already benefited from these trends, especially in such areas as business planning and accounting. Manufacturers that have taken the steps toward automation with sophisticated resource planning tools and accounting software now require fewer employees to perform those job functions than they did in years past. As a result, they have been able to shift precious resources to the task of developing new technologies, which is the lifeblood of their existence (see sidebar, below).

Competing demands for those skilled in medical-application and business-enabling technologies, coupled with advances in those technologies, have created a challenging atmosphere in which to attract talented employees. Today, employees with those skills have far more career and employment opportunities to consider than ever before. And this factor in itself has exacerbated the problem of recruiting specialized talent.

From Concept to Commercialization

The medical device industry differs from other industries in that the structure in which technologies are developed and commercialized is highly regulated. FDA mandates strict adherence to federal codes and regulations affecting medical devices. Working in the medical device industry therefore requires an intimate knowledge of the regulations and standards that affect the development of medical technologies.

Within any given medical device company, employees at all levels may need to understand the underlying science of the technologies that the company is developing. The depth of the required knowledge, of course, may vary according to the functions that the employee is required to perform. An R&D engineer, for example, may need to possess a scientific understanding of the technology, the challenges involved in its development, and its limitations with respect to its medical application and effectiveness. A manufacturing engineer, on the other hand, may need to understand and be able to validate the effects that various manufacturing processes will have on the technology's performance.

In order to understand the therapeutic benefits and limitations of any medical technology, those charged with the development of the technology must be capable of thinking like the physician who will use the device. Thus, for medical device companies, an inventory of employee skills must include knowledge of human physiology (see sidebar, above).

With the exception of the medical profession itself, in no other industry does the understanding of human physiology play such a vital role in the development and commercialization of emerging technologies. But physiology is only one area in which medical device employees may need to become experts. Employees working to develop new devices from pending technologies, for example, must often have a background in engineering in addition to a thorough understanding of physiology. Even those responsible for the commercialization of the technology may need to have an industry-specific background in order to understand its customers.

The Sourcing Dilemma

When employers find it difficult to attract individuals with industry-specific experience—as is likely in today's tight labor market—it can be wise to consider candidates with experience in other medical industries, such as pharmaceutical manufacturing, biotechnology, or the medical profession itself. The relevance of any such experience will be predicated upon the nature of the tasks and functions the individual will be charged with carrying out (see sidebar, above).

Individuals handling regulatory and clinical affairs for medical technology companies are perhaps the best examples of employees who may be able to use their experience in other medical industries as leverage. Those involved with regulatory and clinical affairs deal mainly with compliance with FDA regulations and validation of the safety and effectiveness of their companies' products. Nearly identical sets of regulations must be adhered to in the biotech and pharmaceutical industries. As such, the experience that an employee has gained in one of those industries may be transferable to the medical device industry. Other similarities exist for those involved in sales, marketing, and operations. In fact, with the exception of R&D, most other company functions in pharmaceutical and biotech firms offer experience that prospective employers may find applicable to the medical device industry.

Although related industries are the device manufacturer's logical first stop for sourcing talented employees, companies should not overlook those with experience in nonmedical industries—especially if that experience is directly related to the job to be performed. A candidate with nonmedical experience and a thorough understanding of how to perform a support function, for instance, could be a good fit for a support position that does not require industry-specific knowledge. Areas where such candidates could be appropriate include purchasing, manufacturing, and quality functions, where prior experience may be relevant even if the candidate's primary job functions were not specific to the medical device industry.

There are limitations to the transferability of such experience. Manufacturers should expect, for instance, that those involved in the training or mentoring of employees possess relevant, industry-specific experience. In this case, such experience is important, since it is the role of trainers to provide the necessary supplemental instruction to bring those from other industries up to speed with the medical device industry.

Conclusion

The success of an employee who is transferring into the medical device industry is often determined by the employee's knowledge of the primary job functions and degree of previous accomplishment in performing those functions. Such knowledge and accomplishment are generally not independently sufficient; both must exist in order for the employee to make a successful transition. For the purposes of employee recruitment, individuals who demonstrate a thorough understanding of the medical device industry and a track record of accomplishment within that industry should be viewed as the gold standard.

However, the primary functions that the individual employee will be charged with carrying out are also of fundamental importance. Individuals with functional experience and proven accomplishment can also enhance the value of the organization. It is the amalgamation of knowledge, experience, and accomplishment that is ultimately the measure of an employee's success.

To begin recruiting successfully, companies should take an overall inventory of the skills available among their employees. Matching those available against those needed permits an understanding of gaps in core competencies that will affect a company's competitiveness. For medical technology companies, establishing a baseline of the skills required for success and identifying the gaps that could prevent success are essential tasks for developing a human capital strategy that responds to today's tight labor market.

Joseph Mullings is president and CEO of The Mullings Group (Norwalk, CT, and Del Rey Beach, FL), an executive search firm specializing in the pharmaceutical, biotech, and medical device industries.

Copyright ©2001 MX