Plain and simple. Medical device product development depends on input and feedback from physicians, nurses, and others in the healthcare industry. But the “rules” medical device developers must follow when working with physicians has been changing. One segment of the medical device industry is orthopedics. Here is an article with feedback from CEOs from the some larger orthopedics companies: Zimmer, Biomet, DePuy, Stryker, and Smith & Nephew.

The rules have certainly changed for the orthopedics industry, requiring stringent code of ethics and scrutiny. Here is one of the questions asked:

AAOS Now: The DOJ compliance requirements state that payments for consulting arrangements with orthopaedic surgeons must be based on “fair market value.” How are you determining fair market value, and has your need for consultant surgeons changed?

Some of the responses:

“. . . works with outside consultants and healthcare compliance lawyers who specialize in this area.”

“. . . has obtained independent third-party analysis on fair market value ranges for hourly consulting services as well as for intellectual property contributions resulting in royalties paid.”

“We identified a basic range for hourly rates and royalty compensation. We will depend on periodic—most likely annual—revalidation to ensure that we stay in step with what is deemed fair market value.”