Synthes, Inc.
John Walsh
Director, Director of Regulatory and Clinical Affairs
August 2007

1. What device categories has MCRA been involved in your business?
MCRA predominantly has been involved in three different device categories. That is: innovative general orthopedics, spine products, and biologics products.

2. Why did you seek outside consultants?
We seek outside consultants for a couple of reasons. (1) The business model that I employ at Synthes is to staff at a minimum resource requirement, so whenever there is an increase in demand for regulatory resources beyond that which I am normally staffed to, I will seek to augment my internal resources by using available outside resources in the form of consultants. (2) MCRA’s expertise in orthopedics, which other organizations do not have, coupled with the recent experience at FDA by Glenn Stiegman as well as others within MCRA, uniquely positions MCRA to support the orthopedic device community.

3. How does MCRA compare to your experience to other outside consultants? Do you still work with other consultants?
I do not work with other outside consultants on regulatory issues relating to device applications. As far as how MCRA compares to other consultant organization, I’ll reiterate that MCRA’s unique experience with orthopedic devices brings an element of value that, to my knowledge, no other consulting firm can bring.

4. Do you feel that MCRA’s integration of services is helpful?
The integration is critical to the success of MCRA and to the success of programs that I have here at Synthes. The ability to gather input  from a regulatory point of view, from a product development point of view, as well as a reimbursement point of view, adds value to the entire enterprise.

5. Has MCRA delivered on its promises and commitments? Does MCRA add value?
MCRA has consistently delivered quality products in the form of verbal consulting and any written documents – MCRA always delivers.

6. Please give an example of your experience with MCRA?
We use MCRA in 2 ways. First, we have used MCRA in the past to do complete application writing on specific product applications. In that role, they almost become an integral member of our regulatory team by working closely with our product development and marketing departments in order to put these applications together. Second, MCRA serves a more traditional consulting role. When I have questions where I am seeking expert input, I turn to MCRA’s professionals to help me develop my strategy regarding regulatory questions or reimbursement questions.

7. Can you comment on how MCRA interacts with your in-house regulatory team?
We treat MCRA as an integral member of our regulatory and reimbursement team. In other words, they are involved in team meetings with product development and with marketing. So they really do, on any given project, for the most part assume the same role as if they were staff regulatory professionals.

8. Can you comment on MCRA’s ethics?
I have no question about MCRA’s ethics or integrity in any aspect or in any regard.

9. What are the people at MCRA like?
They are delightful to work with. It is a result of a combination of several things. It is their specific expertise in the areas that are of interest to me, in combination with their energy and enthusiasm for the projects we work with them on. It’s one thing to hand something over to a consultant and ask them to do it; it’s another thing to know that that consultant is really going to go the extra mile to make sure that it gets done as well as it possibly can be done and not just to provide the run of the mill consulting service.

The individuals at MCRA are different than every other consulting firm I’ve ever worked with. They are uniquely interested in bringing projects to a successful outcome and by success I mean in some regard even more successful than how we may have originally envisioned it. They are turning over every stone in order to make sure that we have the best possible information upon which to make a decision.

10. What do you see as the future of product development in the face of the current regulatory and reimbursement challenges?
I think the following applies to all orthopedic companies as far as orthopedic challenges are concerned. While the industry is ever-changing, I think that the direction in which it is changing is rather predictable. One must understand that in all well-developed markets around the world, you have an aging population. That aging population, to an increasing extent, will rely more and more on the public sector to support their healthcare needs, without that population specifically supporting the funding requirements for those public sectors. In other words they are leaving the workforce but they are still relying on Medicare and Medicaid to take care of their healthcare needs. This population is going to live longer so it is going to have an increased need for orthopedic products.

It is no longer enough to develop the best product. It used to be 10 years ago that if you develop the best product you can control the market. And 5 years ago, I would have said that regulatory was the most important aspect of product development cycle because it was the gating item as to whether or not you were ever going to see the value of what you have developed. Now I would put reimbursement first, regulatory second and product development as third in line. If you can develop the best product but you can’t get the regulatory or reimbursement approvals to bring that product to market, you essentially have no product. It is no longer enough to develop the best product. It is no longer enough to get that product on the market. You have to ensure that when you get the technology on the market, that it is placed in a value position for which you can receive payment from both public and private payors to ensure that surgeons have access to your product and are going to be paid appropriately for its utilization.

11. Is there anything else you would like to add?
When it was first announced that MCRA was going to be formed, I was delighted by the news in that they had taken the first step by bringing Glenn Stiegman, a past Orthopedics Branch Chief on board. I am especially pleased with the way they have continued to develop the organization and I look forward to working with them now and in the foreseeable future.