Amedica
Robert Wolfarth
Director of Regulatory Affairs and Quality Assurance
october 2008

Amedica started in 1996, and is the brain child of our CEO – Ashok Khandkar – and he and Aaron Hoffman, MD are the co-founders of the company. The focus on the company is on bringing advanced ceramics to the orthopedics market. There certainly are other ceramics available, but they are not widely used. There have been concerns about some ceramics in the past being brittle. Dr. Khandkar is a specialist in advanced ceramics, and he wanted to bring silicon nitride to the market given its bio-compatibility and also its strong properties. That’s what the company is based on as a concept. It has been growing steadily as a concept and in the last four years has started to grow rapidly in size. We have approximately 80 employees with about half in the manufacturing group. Our first devices have been brought to market this year, and within days anticipate having CE Mark on several devices.

1. Have you worked with consultants in the past? If so, how does MCRA compare to your experience to other outside consultants?
   Amedica has worked with consultants in the past on various projects. Our choice of consultants involves a rigorous examination of a candidate’s experience, aptitude, philosophy, and other criteria. MCRA rose to the top tier of choices due to its depth of experience directly related to our areas of interest. We continue to use other consultants for certain functions. MCRA compares very favorably with other consultants, on par with the most knowledgeable firms that I am aware of in the regulatory consulting business.
   
   
2. How critical was time in terms of getting your device to market? Did that influence your decision to choose MCRA?
   
   A lot of it was time to market and depth of experience. As an emerging leader in the orthopedic industry, time to market was critical for Amedica. The probability of success for young companies often hinges, in part at least, on how quickly their first innovative products can be cleared by the FDA. Knowing this, I was highly selective in choosing who our regulatory counsel would be. MCRA was vetted thoroughly during this selection process, as were other candidates. MCRA emerged as the leader and has been at our side ever since.
   
   
3. Please give an example of your experience with MCRA.
   
   As I mentioned, Amedica designs and manufactures spinal and orthopedic implants with a revolutionary technology that, in my opinion, has the potential to alter the landscape of our industry. Ours are not “me too” devices, so they understandably elicit careful attention by the FDA. Bringing such novel devices to market is no easy task.
   
   So to prepare for this level of scrutiny, I worked closely with MCRA to craft first a high-level regulatory strategy prior to implementation. MCRA then helped us to draft the actual submissions with the goal of presenting our new technology to the FDA in a way that would help them get comfortable with the technology and our risk mitigations. Development of the strategy and development of the submissions is a team effort.
   
   
4. Can you comment on how MCRA interacts with your in-house team?
   
   I have dialog with MCRA staff on a regular basis, both on specific projects and general consulting with new ideas and strategies. We exchange e-mail and hold teleconferences, and MCRA is dependably quick to respond to enquiries, provide written proposals and research, and to discuss ideas informally. Indeed, it becomes easy for me to consider Glenn, Justin, Adam, and others at MCRA as a part of the Amedica team, even when they are across the country. A quick phone call brings their expertise into our office.
   
   
5. Has MCRA delivered on its promises and commitments? Does MCRA add value?
   
   MCRA has consistently delivered on its promises and commitments, and most definitely adds value, without question. Most consulting firms can add some value, but MCRA is greatly positioned to add value in a way that is critical to Amedica, largely based on their experience of working within the FDA, the breadth of experience and people with different perspectives.
   
   
6. How much time has MCRA saved you? How much cost?
   
   MCRA’s counsel on crafting regulatory submissions has almost certainly helped us avoid rounds of questions from FDA reviewers and that has been of obvious importance for us. Using their knowledge from direct FDA experience, MCRA uses tried and true methods of formatting and presenting data in a way that the FDA expects to see in regulatory submissions. Tabulating total cost savings is difficult, but MCRA has certainly assisted our negotiations with the FDA in ways that have helped us meet our time-to-market goals. And that equates to very valuable cost savings.
   
   
7. Has MCRA’s integration of services been helpful?
   
   We have not had the opportunity to take advantage of MCRA’s full range of services. But I believe categorically that it is helpful. It is a plus knowing that should the need arise, MCRA’s expert staff is ready to provide various services.
   
   
8. What are the people at MCRA like?
   
   They’re great. MCRA staff is knowledgeable, creative, and professional, while also being personable. One staff member does not hesitate to call upon another for a second opinion and that speaks well to how they work together as a team. Individually, they have unique perspectives that often help us see a new angle we may not have considered. They also share my philosophy that integrity is paramount, and this is very important. Building a relationship of trust with the FDA benefits all involved, and MCRA helps us do that.
   
   
9. In the face of the current regulatory and reimbursement challenges that are plaguing the orthopedic industry, how can MCRA help you mitigate those risks?
   
   In the US, I foresee increased post-market scrutiny, more attention to reimbursement issues, and greater burden on device companies to meet the growing requirements of proving safety and effectiveness. MCRA can help us by staying in touch with FDA insiders and providing insights into FDA current thinking which has been tremendously valuable to us. Knowing where the FDA is heading helps industry plan for future product requirements.
   
   
   10. Is there anything else you would like to add?
   
   On behalf of Amedica, thanks for the dedication and creative thinking that they have provided. Our company is far better for it. I foresee a long partnership because MCRA has been of great value for us.