Medical Device & Diagnostic Industry Magazine
MDDI Article Index

Originally Published MDDI July 2005

NEWSTRENDS

Maria Fontanazza

Device companies must thoroughly train employees, especially the sales force, about a product's intended use, according to a legal expert. Companies need to make sure that every single person involved in promoting its products is aware of what uses can and can't be promoted, said Lisa Acevedo, a partner at Foley & Lardner LLP (Chicago).

She advised manufacturers to make time to specifically explain how each product works to all relevant employees. However, she said, companies can find resistance when trying to educate a sales force about the nuances of promotion if they are not properly compensated. Acevedo explained that sales staff “often see [training] as a roadblock.” In their eyes, they're not getting paid for the training time. So, if the sales force is paid by commission, it's important to let them know that the company recognizes this situation, too.

Before starting a new training project, reevaluate and revise existing training policies to ensure that all the right processes are in place. “Get down into the trenches to develop a standard operating procedure,” said Acevedo. There should be a method for reviewing and approving any training materials to make sure the materials get the point across, while keeping the intended audience in mind. Every device is different, so avoid the one-size-fits-all approach, especially when high-risk devices are concerned. It's especially important to educate anyone new to regulated industry, she said.

Acevedo also suggested that companies practice role-playing and mock depositions to demonstrate how to handle different situations. Follow-up evaluations should measure the training's effectiveness. And penalties must be levied against employees who violate these policies.

Acevedo spoke at The Center for Business Intelligence (Woburn, MA) marketing compliance forum in Washington, DC, in April.

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