This past week the FDA issued patient engagement guidance for medical devices . This guidance is in keeping with PFDD but, nonetheless, is still a draft – both encouraging AND frustrating. My assessment is that until PFDD and any related guidance is FINAL the drug or medical device industry will not take the value of patient engagement seriously. The industry is mired in access only, not realizing the value of engaging with patients, with people, more fully. I have seen this, so unfortunately, play out over and over. Even as I present strategies to support better patient engagement to companies, proving out potential revenue and impact on health outcomes, there is ALWAYS someone in the room who asks “Is the draft guidance final yet?”. The question alone is not an issue, it is the ensuing conversation – “if the guidance is not yet final we don’t have to comply”. Industry, if you wait until the guidance is final you will be too late. You will find that you are not prepared to comply. More importantly, you are missing a huge opportunity to improve your bottom line along with health outcomes. In my experience, I know you don’t see this right now but, also in my experience, once you DO see the value it is impossible to unsee the value.

AND, trust me, some of your competitors are paying attention. Those companies that are paying attention are working to get outcomes included in their labeling thus creating an advantage over you with payers. They are capturing real world data giving them insights into how their drug or device works in the real world – an advantage over you, again, with payers and regulators.

So, again, here is the link to the latest draft guidance and, to refresh your memory, here is the original PFDD draft guidance. And, for those of you who work globally (these days who does not work globally?) here is the EU effort towards Patient Focused Medicines Development (PFMD), recognizing that there needs to be a change in our own thinking to execute on the opportunity that PFDD/PFMD presents. I always call it “breaking the brain” after how I felt after realizing I, too, needed to think differently in order to execute true patient engagement.

Till next time,

Dyan Bryson

Patient Engagement Strategist

“It’s not about marketing, it is about changing behavior”

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