Doctors Research Group, Inc.
Richard J. Deslauriers, MD
President and CEO
April 2010

1. How would you best describe the quality of work and expertise that MCRA provides to your company? Does MCRA add value?

We develop novel devices for which there is very little regulatory precedent. MCRA’s knowledge of the predicate landscape and FDA expectations led to the successful clearance of our first product. We spent more than five years working to secure FDA marketing authorization for KRYPTONITE™ Bone Cement. MCRA put us on a systematic pathway to obtain clearance, as well as to position the device for future clearances with expanded technologies and indications. MCRA’s added value has impacted our fundamental mission to legally market safe and effective devices to treat orthopedic patients.

2. Have you worked with other consultants in the past? If so, how does MCRA compare to your experience to other outside consultants?

Yes, we have worked with a number of consultants. The biggest difference between MCRA and other consultants is the depth of orthopedic-specific knowledge. This was critical in our FDA submission process, where many of the FDA discussions required very specific knowledge that you just can’t get from a Guidance Document or knowledge of the Regulations.

3. Considering the current challenges that are affecting the orthopedic industry, how does MCRA help you mitigate those risks?

The orthopedic industry has been going through changes in regulatory policies. Given the more conservative FDA review policies we have experienced, there are considerably more opportunities for a company to “burn bridges” with FDA. MCRA has been instrumental in correctly positioning our device within the predicate landscape to ensure we do not confuse or accidentally mislead FDA.

4. Can you comment on how MCRA interacts with your in-house team?

MCRA regularly interacts with our in-house regulatory and engineering departments. We leave it up to MCRA and our product development team to develop test protocols, test batteries, regulatory strategies, and regulatory submissions. This dynamic interaction has been very fluid and essential to the success of our product development process.

5. Has MCRA delivered on its promises and commitments? Can you comment on the quality of the consultant’s expertise? Can you comment on MCRA’s ethics?

MCRA consultants are very responsive and manage to meet our stringent deadlines. We are a very driven company so we strive to expeditiously put forth the best product. MCRA’s attitude parallels our own, so it has been a healthy relationship. The consultants have always displayed the most ethical behavior; otherwise, we would not be working with them.

6. Is there anything else you would like to add?

We enjoy our regular interactions with MCRA and rely on them for our regulatory processes. Their extensive knowledge has become an invaluable asset to our decision-making process.