During MD&M West, consultant Phil Triolo discussed the challenges of coated devices and combination products. Specifically he covered meeting both technical and regulatory requirements for these types of products. Triolo had several pieces of advice for achieving such goals. For example, he explained that it is usually better to adapt or use an existing test method instead of trying to develop one from scratch. Validation takes longer with a new method. When it comes to testing, make critical assumptions. For example, always anticipate that a coating will come off the device it is modifying. "Assume worst case scenarios," he said. "And then prove that the outcome is still safe." One of the most interesting moments in the conference was when Triolo discussed biocompatibility of materials. He explained that IAO 10993-1 recommendations, as modified by FDA memo G95-1 can be used, depending on intended patient contact and duration of use. However, for neural tissue contact, there are different rules. To start, device makers can use 10993-4 for blood-contacting devices, but they should be used as a starting point only because FDA does not recognize this as a consensus standard. Ultimately, Triolo's advice is to test, retest, and test again. "Sometimes it is easier to provide test data [to FDA] than rationale."