Great that your product works fine. But what about the data?
Last week at AdvaMed in D.C., an overriding theme was data – big data, who owns the data, how do we collect data, what data do we collect to inform our economic story? How do we do it safely? What about The Sunshine Act and reportable interactions? There were lawyers and other regulatory experts everywhere, opining on the current sad state of governmental affairs or offering carefully crafted
service packages designed to help medtech firms and their customers keep compliant.
And the hunt for all things data isn’t just about devices. At a session on
in vitro diagnostics, 1 panelist stated that the biggest need for innovation in IVD isn’t new tests, it’s IT. That’s partly due to the rise of molecular testing and the growing need for labs to educate physicians on when it makes the most clinical and economic sense to order a test. You need data to do that, and it needs to be data that doesn’t run afoul of HIPAA. The rub is that, as personalized medicine is actually, finallybecoming more personalized, there is a greater need to de-personalize the data while still keeping it relevant.
Here on Day 2 of the government shutdown, it’s hard to know whether government enforcement of The Sunshine Act will be eclipsed by a delayed implementation of the entire health care reform package. But what is becoming clearer – and this too was a topic in the corridors at AdvaMed – is that medtech manufacturers will need to be able to tell their customers not only how well their products work, but how they will help customers deal with government’s hunger for data and transparency requirements.
For sales reps, it might sound something like this: “Yes, doctor, of course I’d like to tell you about our new product. But I’d also like to share with you how our company is handling The Sunshine Act.” Here’s how we’re handling post-market surveillance. Here’s how we’re doing everything we can to help you focus on your patient and your practice of medicine. We understand your burden and we’re doing something about it.
Even that old standby, the printed sales brochure, could and perhaps should address these issues. Compliance is part of the conversation. If the customer knows your data’s okay, and that theirs will be, too, then everyone’s okay. An idea so old it’s new.