Regulatory        

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.

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. 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.

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. 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. 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.

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.

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.

A lot of what influenced our decision to work with MCRA 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.

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.

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.

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.
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.

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.

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.

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.

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

We seek outside consultants for a couple of reasons:

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.

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.
MCRA’s unique experience with orthopedic devices brings an element of value that, to my knowledge, no other consulting
firm can bring.

The integration of services provided by MCRA 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.

MCRA has consistently delivered quality products in the form of verbal consulting and any written documents – MCRA always delivers.

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.

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.
The people at MCRA 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.

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.

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.

MCRA is not a law firm and neither provides legal advice to its clients nor can affirm the legal or regulatory validity of the materials of which it provides. MCRA recommends that its clients consult an attorney to discuss any legal issues that relate to its business and/or MCRA services