Contextual Intelligence: Getting to the “Issues Behind the Issues” on the Value of Medicines
September 17, 2017
For healthcare companies, talk of “being customer-centric” is all the rage – especially when it comes to placing a value on their products. In the pharmaceutical and device arenas specifically, the term “customer” refers to more than just the patient; it refers to all stakeholders – the diverse set of…
How to Maximize Your Early Interactions with FDA and Improve Your Chances of Medical Device Approval: Perspectives from a Former CDRH Reviewer and Project Manager
September 6, 2017
As someone who spent the last seven years working at the Center for Devices and Radiological Health (CDRH), I can tell you that the underlying relationship between your company and its review division really matters – from submission, through a potential Advisory Committee meeting and beyond to your medical device…
The Art of Moderating and Lion Taming
August 14, 2017
My first time moderating an advisory board, I had the distinct feeling of being a lion tamer in a cage without a chair or whip for protection. The panel of 15 KOLs had three who loved the sound of their own voices and assumed everyone else would as well. Some other participants may have been shy – but almost all were unwilling to compete, disagree, or offer alternative opinions. I thought there had to be a better way of managing a group like this. Through talking to others who excel at moderating, some Internet research, and my own evolving experience, I have landed on these 10 tips as particularly useful.
The Danger of Company Groupthink in FDA Advisory Committee Preparations
June 6, 2017
It might seem obvious that one person alone cannot drive successful FDA advisory committee (ADCOM) preparations. What’s less obvious is that one unchallenged thought process could also result in failure. But that’s the unfortunate outcome of company groupthink.