Facet Solutions
Geoff PARdo
President & CEO
october 2008

Have you worked with other consultants in the past?
At Facet Solutions, we have our own internal clinical and regulatory staff, but we use outside reviewers to help us with protocol issues and get a different perspective on moving our submissions through the FDA. We chose MCRA because we wanted to have some different opinions. Glenn Stiegman used to be one of our reviewers during our pilot IDE process and so we decided to give MCRA a try.

Can you give us an example of your experience with MCRA?
We had recently submitted our IDE to the FDA and had received some feedback on our protocol, which had some outstanding issues with the agency. Glenn was able to provide a good assessment of what the issues were – he gave us a very pragmatic perspective on these issues. While we are still working through some of the questions, he gave us some sound advice and brought others to closure.

How critical of a time was it to get your device to market?
Time is definitely of the essence and the way the FDA works, they use all the time that is allotted to them. Going through the IDE process cleanly is really important to getting a timely start to the study, so bringing some expert resources to bear can have a significant effect on the timing.

Reimbursement and regulatory issues are paramount in our industry, so having someone bring expertise on both items is really important since they tend to overlap in a lot of respects. It’s smart that outside advisers like MCRA focus on both. We definitely face a double approval process in the US – from the regulatory aspect and from the different payors – and there are a lot of common themes that we can use MCRA for.

How does MCRA interact with your current team?
I think we’ve developed a good relationship with Glenn and we trust his counsel and perspective. MCRA is part adviser, part sounding board – someone who can help think through some of the different questions from FDA. Someone who has the experience level and direct background at the FDA helps us understand what the agency may be getting at and what our chances are in moving the agency closer to our end goals.

Has MCRA delivered on its promises and commitments?
We’ve been really satisfied with Glenn’s performance. One of our biggest concerns with consultants in general is that their relationship with the agency is more important than their relationship with the company. Glenn has really pragmatic feedback where he tries to look at things from a company’s perspective, which, given his background, is pretty unique. He is able to bring the FDA perspective, but at the same time, he can work with the company to negotiate some of the issues. MCRA works well on behalf of the company.