Biotechnology/Medical Devices Research

Discovery research, perhaps the most direct route from academic training into industrial research/biotechnology, offers career tracks throughout research and management. Unlike governmental research, which serves to drive policy, industrial research is motivated by enterprise to develop useful products for the marketplace, or the creation of entirely new markets based on an innovative technology.

Building on basic science, biotechnology companies use applied research to develop and commercialize cutting-edge products and technologies. Within therapeutic biotechnology, product development tends to move from discovery research to preclinical studies, into clinical development and regulatory affairs, and finally on to commercial operations (marketing, sales, and technical support). The process from conception to production can be a lengthy one, and legal and regulatory pressures, along with the public's perception of emerging technologies, can influence the development and marketability of products and services.

Product development of instruments, reagents, diagnostics and platform technologies in nontherapeutic biotechnology is often a faster and less expensive process, as clinical trials are not required. The motivation behind product innovation may be driven by market research, the expansion of an existing product, or extant technical gaps. Components of the nontherapeutic development process include research/product development; manufacturing; and marketing, sales, and technical support. Research within industry tends to be largely collaborative, and project leaders often manage the process to completion.

The closely related and broad field of medical devices includes development of healthcare products and procedures that diagnose, treat, cure, or prevent disease by means other than—or in addition to—pharmaceuticals or biologics. This relatively new field is an exciting place for researchers and biomedical engineers interested in bridging knowledge from many technical sources, as they conduct research or develop new medical products and procedures. Product development within the medical-device field typically begins with engineering and product design, undergoes clinical development/trials and regulatory affairs, and moves to sales and marketing following a successful product launch.

In addition to scientific skills and training, it may be helpful to have an understanding of regulatory issues, safety standards, and project management. Medical-device researchers may work within a single setting or among multiple diverse settings, including hospitals, laboratories, manufacturing, and business.