by Elizabeth Hofheinz, M.P.H., M.Ed., September 3, 2019
Roy Sanders, M.D. is an established editor, academician, clinician, administrator and teacher, as well as a long-time designer of trauma implants, with over 40 patents and numerous devices in the marketplace. As such, he is well-positioned to keep abreast of the trends shaping his specialty.
Surgeons are beginning to go it alone when developing their technology.
Dr. Sanders: “In the last 3-5 years I have witnessed a shift in the way that most companies regard new technologies. Increasingly, they are decreasing funding for their in-house technology development due to the expense involved. It is easier to purchase existing technology as there are more and more startups and smaller design companies that utilize engineers and doctors to create their own products. These entrepreneurs use their own funds or venture money and then shop the products around to large, established companies.”
“This method,” says Dr. Sanders, “gives companies added opportunities to see what is out there. While companies might launch a big project such as a redesign of an entire plating system, more than likely these days they are on the lookout for either a completely new technology or a less expensive way to manufacture existing technologies. If someone else does the bulk of the work, then they can acquire it and then add it on to their portfolio. Theoretically it should be a win-win situation.”
“This trend is underway due to the expense of research and development, as well as changes in medicine and reimbursement. In the past, implant manufacturers would work with only a few designers, developing a few good ideas, sometimes at the expense of missing out on many of the good ideas out there. And sometimes all that in-house expense doesn’t pay off. So companies are looking for a way to increase market share, and decrease their opportunity cost. Because of these changes, enterprising surgeons with design ideas based on their clinical practice have begun designing their own products. Unfortunately, this can be quite expensive, and they often run out of money before the product is finished, manufactured and FDA approval has been obtained.”
“More and more you see surgeons obtaining venture funding, or forming a small group with engineers and private funding, and then shopping their product at various stages of development. If they are lucky, they will get traction and a contract with a company that will pay them based on milestones. Using this relatively new method, the larger companies no longer need to have all of their resources committed and are free to explore a variety of product options. However, the companies then find themselves fighting over the best products. This is actually a real win for the designing surgeons, as they control the discussion….if they understand the way to close the game (which is far from easy – but that’s another story).”
There are exceptions, however, says Dr. Sanders. “Take the small company that revolutionized the way to create a lengthening nail. They used rare earth metals and an electromagnetic device to turn the gears for the lengthening process. During this process they started to obtain private funding and grew to the point where they were selling units themselves. Once they had revenue, they developed the same type of implant for pediatric spine where they could lengthen without fusing. Ultimately, they were able to sell this to a large company that ended up buying them. Another small company involving surgeons using minimal funding found an effective way to treat turf toe with a novel technology…and a large manufacturer bought the product.”
Increasing momentum for patients…
On the patient end, this approach to product development means that those needing relief will get it faster, says Dr. Sanders. “This new approach speeds up the availability of products. We are able to get these products to market because the small design shops are doing one or two very specific projects and bringing the technology to the point where it can go to market. Traditionally, things were sequential, i.e., a company manufactured one product, then another, and then another. This approach hindered our ability to get a good idea to market. In the end, the inventiveness and design skill of surgeons will continue to move the market and this time the companies are taking notice.”
Robots marching into trauma.
The other powerful wind blowing into the trauma OR is the use of robotics. “Using robotics in trauma can help significantly with fixation techniques,” states Dr. Sanders. “For example, Stryker initiated the use of robotics in total joint surgery and Smith and Nephew has used computer-assisted intramedullary screw insertion for digital imaging without the need for xrays. ”
Asked why robotics haven’t been used to date in orthopedic trauma, Dr. Sanders notes, “When you do a joint replacement you end up making bone cuts, which have to be precise so that the implant fits on the cut surface. In trauma, you are trying to preserve the anatomy and you still have to reduce the fracture. So you use fluoroscopy, but then visualization and radiation are problematic. The alternative is computer assisted surgery that can help in the more accurate positioning of screws in the femoral head and neck—without the use of radiation or fluoroscopy. But the reduction positioning and fixation logic cannot as yet be performed by artificial intelligence (hopefully not for a really long time!).”
“All of this will become more mainstream as the next generation of residents evolve into attending surgeons. It took a long time for the Mako robot to gain traction in joint arthroplasty, but the cuts are so precise that they are now starting to use saws instead of burrs. Over the next five years we will see robotics increasingly used in screw placement and implant positioning.”
“Taken together, these new directions should translate into more consistent, and thus more efficient, procedures. Patient outcomes will likely see improvements and that would translate to overall cost savings for the healthcare system. This is the shape of things to come.”
