Survey Series: Challenges to implementing the AdvaMed Code

"We're seeing an industry where companies want to do the right thing," but are met by road blocks along the way, Peter Claude, partner in Life Sciences and Advisory Services at PwC, tells Device Regulation Alert. According to Claude, the lack of specific regulatory guidance is forcing companies to make their own judgments about compliance. Inevitably, some companies are more or less conservative or aggressive, creating an uneven playing field and a competitive disadvantage for the more conservative companies.

This competitive disadvantage also extends into companies' relationships with physicians and other customers. According to the survey, 75% of respondents said their companies had received pushback from customers in trying to comply with the AdvaMed Code.

Claude says that physicians often expect companies to still use the "old ways" to try to influence their prescribing decisions, and ask for services that may be unacceptable under the AdvaMed Code. Physicians may point to another company which does not adhere to the Code and choose its products instead.

Finally, management support was cited by respondents as critical to fully implementing the Code. In fact, 61% of respondents said this lack of support or inadequate resources are the biggest challenges to implementing effective monitoring, according to the survey. Claude says that companies also need to invest in training and auditing.

Stay tuned next week when Device Regulation Alert reports the survey's findings about steps for stakeholders to improve compliance with the Code.