Moving Beyond Fear

Thursday, June 16, 2011

I've been struggling a bit with what to say about FDA's new draft RUO guidance. On the one hand, it's an important change for the industry and deserves a lot of thought and analysis.

On the other hand, it also smells like a stimulus bill for consulting groups and lawyers. There are obvious incentives for law firms and companies like ours to have a new set of rules to frighten-up some potential customers. For those who are willing to use these new rules as a club, it could really be a bonanza. I can only imagine how many newly-minted experts we'll see entering the field in the coming years.

Fear has never been a big part of our marketing. I'd like to say that this is due to high principle, but it's chiefly a matter of self-interest. We want to work on the successful projects that advance the state of medicine, and it takes a whole lot more than fear to succeed at that level. The companies who do the best don't act out of fear; they find a way to turn the situation to their advantage. That's the kind of attitude we're talking about when we talk about Enlightened Compliance, and it's still the attitude we will continue to promote.

Even so, it's tough to talk about a big new set of rules without seeming pretty self-interested. So how does Myraqa help industry with this transition without scaring customers into compliance? How do we apply our philosophy of Enlightened Compliance so that we continue to function as trusted advisors and not become just another problem-solver praying for misfortune?

I don't have all the answers yet but a few ideas come to mind. First, we're going to continue providing as much free advice as we can via our blog. We will be as transparent as possible (given the restrictions of client confidentiality) with what we learn along the way as we work with customers to handle this transition.

Next, we will be forming an RUO working group that will meet at Myraqa headquarters (we’re working on a communications tool for those outside the Bay Area). This working group will discuss RUO transition issues as they arise. These meetings will be facilitated by Myraqa, and although the charter and agenda is not yet formed, it will hopefully provide a place to have practical discussions about how to implement these changes as the guidance is finalized and enforcement begins.

These working group meetings will be open to all and free of charge. We may have some space limitations, however, so if you're interested, I'd appreciate if you could send me a quick message ( to say you're interested. It would also be helpful if you'd like to suggest agenda items.

Finally, Myraqa is preparing comments to the Federal Register posting. Although many of these changes are unsurprising, we do have some concerns about implementation we believe we're in a relatively unique position to express. We will post a draft of our comments on the blog and invite comment via email. Our comments will be practical in nature (discussing issues of implementation rather than rants on stifling innovation), but I would appreciate any input our guests are willing to provide.

I’ll be posting more information on the blog over the next few days. If you are interested in the working group idea I’d love to hear from you so that we can decide if it’s feasible. Please send me a note at with your thoughts.

I’m very interested in working with our customers and colleagues to find ways to work through this change and ensure a positive outcome for all – especially the patients that benefit most from our work.

Tags: CDRH, FDA, Policy, RUO, RUO Working Group

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