Nelson Laboratories President and CEO Jeffery Nelson recently met with MDTmag’s Sean Fenske to discuss the future of the MedTech industry. The following is an excerpt from that interview in which Nelson highlights the state of medical device testing in light of the novel and innovative products coming to market.
What are some significant changes you’ve seen in the medical device development industry since your start in this market?
Nelson: I’ve watched as our industry has gradually matured. I remember in the early years of the company, we were often working directly with founders of smaller companies. Even larger manufacturers were represented by an engineer or quality assurance person. Over time, this has changed, and we are now interacting with more buyers, purchasing agents, and outsourcing coordinators, many of whom are managing multiple sites or divisions. This can result in some efficiency, like shared audits, and centralized communication, but definitely changes the interaction and communication with our customers. In some cases, we are beginning to see the use of electronic bidding processes. These auction type approaches can definitely drive down price, but don’t always consider the significant costs that can accrue beyond price if quality is compromised.
…. I see more opportunity than ever before in our space. Today, professionals in our industry can follow any number of development paths in building a successful, long-term career. It is a great time to be working in this industry.
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It’s also exciting to see how innovative our industry is. There are so many new and novel products. We see more hybridization of products, incorporating pharmaceutical, technology, and even tissue elements. Our industry has amazing engineers and technologists who are pushing the frontier of medical science. Although exciting, this does create new challenges. How do you sterilize a medical device that now has a heat labile pharmaceutical component? How do you apply the tried and true consensus standard to a novel product like this? These challenges require more flexibility in the standards that govern testing and more creativity by the manufacturers and laboratories that produce and test these products. It’s more important than ever that manufacturers receive timely advice about how to proceed and carefully document their decisions and justifications. We are consistently seeing more demand for help in this area. Companies who contact us don’t just need tests performed, they need a partner who can help them make decisions, justify and document these decisions, and be there for them when they have to defend the decisions in the courts of regulatory scrutiny.
