An Executive Reflection on 30 Years in the Spine Market

This year marks a three-decade career in the spine industry for Randy Roof.

His experience ranges from sales rep to Agent Principal to product development, product commercialization, sales pipeline development, operations management, founder and CEO. He spent time in the 1990s at AcroMed (bought by DePuy) as a territory sales rep, started his own sales agency in 1998 (nuSpine Medical Technologies) and spent time as an executive board member for Altiva (bought by Exactech). Mr. Roof also founded several other companies along the way: Eden Spine (OUS assets acquired by Spineart), Band-Lok (acquired by OrthoPediatrics) and Cutting Edge Spine (CES).

Mr. Roof’s entrepreneurial drive comes from identifying and seeking to close clinical gaps in the spine space while providing optimal fiscal value to the healthcare community. With Cutting Edge Spine, where he’s served as President and CEO since its founding in 2009, his goal is to focus on novel materials and manufacturing processes.

“I started Cutting Edge Spine with the concept of aligning strategically with a direct-to-manufacturing concept, allowing us to eliminate the risks associated with the capital and fixed cost burdens of owning our manufacturing facility, while at the same time affording us lower volume manufacturing at preferred rates with quick turnaround time and associated engineering assistance. At the same time, we realized the importance of looking at organic product development within a robust quality system, investing in novel materials that could potentially lead to better clinical outcomes, and the value of data collection from the onset,” he said. “We have a very strong focus on development and distribution of what I call ‘passively smart’ implant technologies. Our core competency has been within the interbody and sacroiliac (SI) fixation spaces. But we hold an intellectual property position relative to what I call futuristic fixation in the entire orthopedic arena, whether it be spine, foot and ankle, craniomaxillofacial, dental, sports or general orthopedics.”

Cutting Edge Spine’s focus on R&D and IP has led to the recent FDA 510(k) clearance of its first product within this novel class of technology, the T-FIX®3DSI Joint Fusion System.

We sat down with Mr. Roof to cover a wide range of topics, including technology and market forces in the spine industry’s past, present and future.

What initially attracted you to the spine market?

Mr. Roof: I looked at transitioning from other sales capacities to medical devices. I looked at total joints and sports med, and it was the subject matter of spine that ultimately was the difference maker. I found it to be very complex and challenging, and I was also excited about the opportunity to jump into what was a relatively new market segment at the time. It was the early 1990s. We, literally, were tasked with educating our customers on the benefit of using long bone screws in the spine, essentially creating an entirely new orthopedic market opportunity in addition to helping progress patient care in exponential form. Wow, I loved the early- to mid-1990s, and I am so proud of what we all accomplished.

In your opinion, what have been the most significant clinical advancements in spine?

Mr. Roof: There have been quite a few, and I’ll speak on them categorically. While Dr. [Art] Steffee was utilizing and validating pedicle screws (long bone screws) in the ’80s, there were so many challenges with FDA that the pedicle screw market never took off on a broad scale until they were down-classified in ’96. That was the first major paradigm shift in creating the industry as we know it today.

A few other things were transpiring around the same time in the ’90s. Synthes came out with the first unicortical ventral cervical plating system, the CSLP. This was really the genesis for what modern plating systems are today. It had some flaws, but was the template for future technologies. Whether semi-dynamic, dynamic or rigid in form, Synthes changed the game in that regard. Once again, it added another layer to revenue opportunities and treating patients with certain pathologies in a more clinically sound manner than we had previously.

Around the same time, interbody fusions took off. Interbody fusions is still a substantial financial part of the marketplace. It’s a multi-billion-dollar segment. Regardless of the approach, categorically, I think the materials that are utilized today and the science behind interbodies have progressed exponentially over several decades, and the results prove that.

In addition, and also around the same time, we saw the first demineralized bone matrix (Grafton) being offered on a broad scale. This is the genesis of the biologics industry we have today; it comprises all types of products, from “low-level” DBMs to “high-Level” cellular technologies. This has become one of the largest financial revenue segments in the orthopedic space and a huge financial drain on the healthcare system. I am very concerned that, while these technologies are of great importance in certain situations, they are being utilized too aggressively and on a broad scale.

I look at artificial discs, where they are today versus when I was first educated on them in the 1990s. AcroMed was one of the first companies to talk about artificial discs in the United States. Its AcroFlex TDR was a major evolution versus what was previously available in the form of the Fernstrom sphere. The technology was way ahead of its time, but had a lot of issues. The concept was genius and a total evolution relative to said devices. Now, many years later, and through the hands of numerous caregivers over time, we are finally going to see an evolved version of that product used on a broad scale. Twenty-plus years later the timing, and technology, just might be right! I’m super excited about this particular product, as well as where artificial discs are going as a whole.

I still think that arthroplasty presents its own challenges, and there is a need for more understanding which will occur over time. Thus, utilization of these devices should be closely scrutinized relative to patient selection. Cervical arthroplasty, in my opinion, is way ahead of lumbar arthroplasty. I have seen overutilization of certain technologies happen too many times over the past three decades, and it is always the patient who pays the price. For instance, one-level cervical fusions — interbody fusions with ventral cervical plating — have excellent proven clinical efficacy results over a long period of time. Artificial disc results for one-level cervical fusions are excellent as well. In the event of a revision surgery, the challenges are entirely different, in my opinion. It is challenging to revise an artificial disc and maintain structural integrity if done ventrally; therefore revisions, are often done via a posterior approach which is much more complex than a ventral procedure. So, we need to be somewhat cautious with patient selection with arthroplasty and not just turn to discs automatically for primary procedures.

Having said the aforementioned, I am a huge advocate of motion preservation for select patients. In time, I think we will see more and more young patients opting for arthroplasty over fusion. Our challenge, as an industry, is not to let it be marketing driven but instead be analytics driven.

Another paradigm shift is navigation and artificial intelligence. It’s not quite there yet, in my opinion, but there is a growing demand for it in the marketplace. Some systems are far better than others, and some really cool things are hitting the market now. Based on cost-benefit analysis, I don’t think it’s fiscally feasible on a broad scale yet. Still, I think it provides a degree of value relative to safety of placing implants in certain regions of the spine and as a marketing tool. As pricing decreases and the technology improves, it will become a standard part of care in spine surgery.

Cutting Edge Spine is primarily focused on passively smart implant technologies. Why materials?

Mr. Roof: I sincerely think that materials are everything. The marketplace is saturated with a bunch of commodity technologies, and the broad scale utilization of biologics is unnecessary if better materials are considered when developing implant technologies. Not to mention far better fixation and fusion results achieved through materials. A major economic strain on the healthcare system is the over-utilization of biologics. With better designed implant technologies, which I call “passively smart” implant technologies, we can easily decrease the amount and form of biologics used and, in time, eliminate the fiscal burden imposed upon the system. That could potentially save the system billions of dollars per annum.

CES is already here, and we plan on being at the forefront of this paradigm shift in spine. Our challenge will be access so as to better educate potential supporters relative to the optimal fiscal value associated with our products. There are many who will be steadfastly resistant to this shift.

You mentioned navigation. Have you thought about entering the navigation space?

Mr. Roof: Given our strong IP position, our existing 510(k)-cleared portfolio, and our projected growth in the SI fixation arena, we would be a great partner for a company already focused on navigation and robotics — especially in the ASC setting. We have had several discussions to date in said regard.

We think medium and small spine companies would probably have more of an advantage in partnering with companies for these technologies, instead of investing in them independently.

Mr. Roof: We’re fighting a lot of issues at the market level as a collective group, many of which have become extreme. This includes hospital system mergers, GPO preferred vendor agreements and associated rebate fees, difficulty in deriving sufficient sales profit to stay afloat due to pricing degradation that has hit “rock bottom” in my opinion, and inability to get truly novel technologies approved at the hospital level even though surgeons request them.

Small companies had better look to strategic alliances to preserve their position within the industry and afford themselves the ability to scale, or I fear that many of us will go away. The big are getting bigger and stronger, and the only way I feel that we can compete is through synergistic relationships that make both fiscal and clinical sense for both companies.

Spine has a lot of players. It’s recovering from COVID. How would you describe today’s spine market?

Mr. Roof: I think it’s saturated with commodity products and too many companies that offer no additional clinical and/or fiscal value. We’ve seen pricing degradation each and every year over the last decade. That’s a huge challenge for everyone. Coming out of COVID, our pricing increased by at least 20% with our manufacturers and material suppliers. Yet we can’t pass those pricing increases and inflation on to our customers like we used to. This is not sustainable.

It’s very difficult to show a profit in our industry today. Between the cost of goods, the cost of sales, developing and getting products through FDA, and the pricing degradation and GPO mandatory rebate fees, many companies are actually losing money per annum, even if their revenues are increasing. If you look at the earnings reports, it is concerning. They’re not making money.

Our free-market economy within the medical device industry has seen far better days, and one could argue it no longer exists, with a few exceptions. With hospital consolidation and GPO-preferred vendor contracts, I fear that our free market has vanished. My concerns relative to that are that patients are not getting better technologies and better patient care, while at the same time we know that fair competition is what keeps pricing down and wages up.

I feel that, ultimately, companies on contract will set new policy, and salespeople, many of whom are clinically brilliant, will be forced to work with these few big companies that get on contract status, even if they don’t want to — there just won’t be many options. They will have to do the same job for far less and with fewer incentives to do well.

We have a significant product selection issue at the hospital level in that products approved and not approved are done so and not always for the right reasons. Because of this, big companies are in a much stronger position, and truly novel technologies are denied patients even if they come with surgeon support. Small companies are fighting for a very small percent of the market share, which we’ve always done. We have fought traditionally by offering better clinical options than made available by others. But now, we’re blocked at most major hospital systems, even if you have novel technology. That creates a significant challenge. Ultimately, many will pay the price, especially the patient. We must see reform soon.

Do you see hospitals further limiting products by type of implant?

Mr. Roof: We are. Here in our backyard, for example, two big systems control healthcare. As they continue to expand their respective bandwidth(s), we are finding it more and more difficult to get products approved at the hospital level, even with surgeon support and novel technology(s). One of the big systems is trying to merge with another huge system. Further consolidation of vendors will likely occur as is happening on a national scale, as hospital systems are allowed to grow in tremendous form.

One thing that each of us is aware of on our side of the fence is that there’s no one company, regardless of size, that has the best of everything per patient. Contrary to these “limited vendor” GPO strategies, the only strategy that I have seen that facilitates the needs of all involved other than a truly free market is a capitated pricing structure. Such a structure protects the free market to a degree, protects surgeon choice, provides better products for the patient and addresses the hospital systems’ fiscal concerns. It allows small companies to innovate and still have a place within the market, and it helps make sure that big companies pursue market share for all the right reasons.

Once the big companies get deeply seated within one, two or three vendor systems, we all know what will happen. Pricing will go up, policy will change on many levels, and patient care will diminish at some point due to lack of innovation. I think all of these should be concerns for CMS, and the government should take a deep look at what’s going on within our industry.

How do small companies and the market as a whole move forward under these conditions?

Mr. Roof: It’s challenging. This is where I think strategic alliances come into play for the smaller companies. There’s not a whole lot of incentive for small companies to innovate if they don’t have a home for their products, and there’s no incentive for big companies to buy small companies if they already have preferred vendor status. So that is a paradigm. I think the advantages in the marketplace are for companies that bring products to the market based on solid science. We must truly get back to developing products based on solid science and applications. That’s what we’re trying to do.

Going back to Cutting Edge Spine, what market advantages do you think you provide?

Mr. Roof: While being able to provide an optimal value proposition to any institution, I think we are the perfect supplier for ASCs because of our broad 510(k)-cleared portfolio of “passively smart” implant technologies and the fact that we can provide them with an optimal fiscal value proposition. We have a broad spectrum of interbody options. Following the recent 510(k) clearance of the T-FIX® 3DSI Joint Fusion System, which will be added to our already successful EVOL®-SI system, we have arguably the most comprehensive and novel SI fixation system in the world right now. We also have a degree of protection given our proprietary position in said regard. The T-FIX® 3DSI Joint Fusion System offers an array of proprietary trabecular, fully-threaded screws for SI fixation. It is 510(k)-cleared for four approaches: Lateral, S2AI (S2 Alar Iliac), Open posterior bridging and Transgluteal lateral. We feel that utilization of this particular screw, furthermore, can potentially eliminate the need for biologics in SI fixation procedures. If we can align with the right company, we could have a dominant position within the SI fixation segment of the industry within a relatively short period of time and an overall solid market position within the ASC market space within three to five years.

Our IP position in trabecular technology and dual screw technology is a tremendous opportunity for Cutting Edge Spine. Whether it’s bringing spine implant technologies to market on our own or licensing the IP to others for other applications, I think we have the constitution to offer the entire orthopedic marketplace better fixation options than are currently available for certain procedures.

This will be your first trabecular product, right?

Mr. Roof: Yes, we are the first company in the world, to my knowledge, to get such a clearance for this exact type of technology. Developing a fully-threaded trabecular screw is not obvious by any means. Our Manager of R&D, Kyle Kuntz, did an exceptional job in getting us over many hurdles along the way. As did our Manager of Operations & Supply, Brad Roof. We went through many iterations of failures over many years just to get it to work biomechanically. Manufacturing was an extreme challenge for some time. Now that we have received a 510(k) clearance with the technology, we are entering into a new phase at CES; one whereby we incorporate the IP into numerous systems forthcoming. For lack of a better word, we are quickly becoming a futuristic screw development company.

What advice do you have for other CEOs in the industry?

Mr. Roof: The world doesn’t need another commodity-focused spine company. Patient outcomes should always matter the most. Data collection matters, so collect it. Science first, product development second. Much better products will come from that approach.

It’s time to think about strategic alliances for all of us small- to mid-size companies. If you are not already doing so, you are falling behind!

The way I’ve always tried to run my business and my life is to do things the right way each time, all of the time, and for all of the right reasons. Ethics and morals matter! In business, it means that a lot of times you’re going to have to pass on business opportunities, which we do every day.