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We convened a panel of three surgeons, working in different clinical environments and different market segments, for a diverse perspective on innovation gaps in orthopaedics. The 90-minute conversation returned to the topic of reprocessing and storing devices and instruments while discussing multiple subjects.
Questions posed to the panel ranged from ways to reduce the cost of delivery of care to reduction of employee burnout and turnover to procedures moving to ambulatory surgery centers (ASCs). A phrase continually repeated was, “We need to address the real problem.” To the surgeons, the problem is delivery of care. Current instrument options, both mainstream and niche, can lead to changes in surgical planning, downtime between surgeries, significant cost assumed by the hospital or surgery center and inventory management conundrums.
The surgeons were asked their thoughts on single-use and patient-specific instruments. We’ll recap those. First, we provide their perspective.
The surgeons from the OMTEC 2018® Closing Keynote:
- John B. Pracyk, M.D., Ph.D., Integrated Leader, Medical Affairs & Clinical Research, DePuy Synthes Spine
- Peter Althausen, M.D., Chairman and Treasurer, Orthopaedic Implant Company; Trauma Surgeon, Reno Orthopaedic Clinic
- Mark I. Froimson, M.D., Immediate Past President, American Association of Hip and Knee Surgeons, and Principal, Riverside Health Advisors
- Patrick Sweeney, M.D., Spine Surgeon, Founder, Center for Minimally Invasive Surgery, Flow-Fx and ConnectSx
As Dr. Althausen puts it, with more total joint procedures moving out of the hospital, ASCs will face real constraints from storage and reprocessing standpoints. He thinks the answer to the problem is innovation on the product development side to decrease inventory and increase technology to track that inventory. Additionally, his ASC, a participant in Medicare’s Bundled Payments for Care Improvement (BPCI) Initiative, has reinvested the money it saved through BPCI to develop a position for a super rep whose job is essentially know what cases are taking place, know enough about the implants being used and make sure all needed products are available for surgery.
Dr. Sweeney, inventor of his own supply chain software, says that technology advancements in the next five years need to revamp the archaic distribution system. And big data will need to be utilized to decrease overproduction and lost inventory, and increase cost savings and efficiencies. A portion of the problem can be solved by each link in the supply chain adopting more adaptive models in order for device companies to provide just-in-time manufacturing benefits.
What did the surgeons think about current instrument ideas developed to solve this problem?
Single-Use Devices
Single-use, sterilized devices will become a mandate in Europe, and device companies of all sizes are introducing the concept in the U.S., primarily in the spine and trauma space. Dr. Pracyk asked the surgeon panel whether they thought the technology would eventually be rolled out as the main option in the U.S., and asked if the concept is worth it—even if it raises costs.
Dr. Sweeney: As a spine surgeon, I can’t count the number of cannulated instruments that I’ve found with old bone in them. Our current cleaning and sterilization systems aren’t good. Walking around the exhibit hall and talking with people about single-use devices, there are a lot of issues that I wasn’t aware of. There are a lot of advantages to single-use devices for repetitive procedures that don’t have a lot of variability. There is certainly savings in the supply chain; you can get premium prices because the hospital personnel just throw it away. I have questions about medical waste, and I don’t know if the single-use instruments can apply to the vast majority of procedures. I’m more excited about how we can improve the biggest problem, which is sterilization.
Dr. Althausen: As a trauma surgeon, I hate the idea. I love speed and efficiency and I think some of the studies that we’ve done at our institution, having all of the instruments in the same tray and all of the devices, reduces having to open each box individually. As physicians and scientists we’ve looked at infection on a huge scale; what matters is surgical time and getting a dose of pre-op antibiotics. Anything that increases surgical time may put that patient at risk for infection, and that I worry about. I love the idea of packaging for an ASC because it addresses the space issue, but it may not be a good long-term solution for the patient.
Dr. Froimson: I agree. If the problem is that the sterilization is challenging and we have debris, we need to solve that problem. I don’t think we solve it by increasing waste and expense. To me, my gut feeling is that there may be some role for it, but it shouldn’t be the default.
Patient-Specific Instruments
Large and medium-sized device companies have rolled out patient-specific instruments in order to streamline procedures. One question suggested that these instruments do not add much cost, and with additive manufacturing they’ve become more cost effective, so why they haven’t caught on?
Dr. Althausen: I agree with you, and I’m a trauma guy. I say to my joint partners, ‘Why wouldn’t you do that, it seems like a no brainer.’ They are always worried about what happens if the instrument doesn’t really fit. How do I convert it and what if something goes wrong? Our first goal as doctors is to never hurt the patient and to put their care first. In talking about standardizations, if that was going to work in 98% of the people, you should do that 98% of the time and have a bailout for the 2% where it won’t work.
Dr. Froimson: I’m going to answer this in two ways. The first is, people don’t change easily. We tend to do things the same way. So when we go to change surgeon’s behavior, we’re surprised that a guy who has been doing it for 18 or 23 years and has a certain level of success, that it’s hard to get him to change. The first thing is we should disavow ourselves that once we bring something new to the table, everyone is going to think it’s a great success. The burden of proof is on you to tell me why there is a problem and why I need to change. Frankly, for most surgeons, inventory management in the O.R. is not his problem. It may be indirectly his problem because of turnover. That goes to the second point I want to make. We don’t do a great job in our conversations connecting the dots when we want people to change. Most surgeons aren’t as enlightened to understand that if they did adopt PSI, their O.R. rep could work more efficiently, and we could save money and buy other things that you want. There’s a cascade. We throw it out there under the guise that it’s a better clinical outcome. My clinical outcome is not the problem here. You’re selling it in a way that isn’t going to work, and that’s why it didn’t get adopted.
The biggest challenge with innovation is getting people to adopt it and understanding the complexity of the work flows that need to change when they do go ahead and adopt it. There’s going to be a learning curve, a painful time of change. I have to send this patient to the CT scanner; I have to call the radiology department; I have to set up a relationship; I have to set up a protocol; I have to get the scans back; I have to send it to the company; I have to change the way I plan surgery; then I have to make sure I have the inventory; I have the device; now, who is going to check to make sure I have it; do I have a backup—there are a lot of steps I have to take to in order to adopt patient specific instrumentation. Now, I think PSI is great. When I use it, I love it. But it’s not just my behavior that has to change; I have to change my entire team’s behavior. Am I going to invest the emotional and political capital to do that when I don’t really know how my outcomes are going to be improved?
How Will Surgical Procedures Change?
In response to the surgeon panel’s directive to focus innovation on actual problems, an audience member asked how surgical techniques will change over the next five to 10 years, and what might that mean for new products?
Dr. Sweeney: The most difficult challenge that orthopaedics faces will be answered by precision delivery of biologics or medication. Personally, I’m committed to the concept of orthopaedic implants becoming a medication delivery device. …When you look at the advances in biologics that we’ve had and the medications that have been available for a long time, delivering those in a precise fashion has the potential to change surgical techniques.
Dr. Althausen: We need to look at the real problem. If you look at trauma or total joint, over the next five year period, I don’t think we can perform the surgery any faster. The 20 operations that I do, I do them within the same time frame—a hip nail takes seven and half minutes every time, unless something is horribly wrong. The inefficiency of what happens between the surgeries is the problem we’re looking at now. Until our problems are solved by the superbiologic, how do we make the implant delivery easier, how do we decrease time in processing and storing? How do we make it easier on our staff so that they get burned out less?
Dr. Froimson: Biologics are going to be key. Think of total joint replacement; there are two problems that plague us. One, infection rate is still real—1% to 2%—and it’s a devastating problem. If you get an infected total joint, your mortality rate within five years is higher than most cancers. The implants we put in people haven’t changed and we need biologically augmented implants coated with certain agents that will deter infection. Two, some people develop early or late instability around a primary total knee that, despite our best efforts with robotics or sensors or alignment techniques, there are still people with whom the kinematics are off. It would be nice to make adjustments in vivo so that we could correct the kinematics after an implant has been implanted. There are areas of innovation if you look at the existing problems.
The end conclusion was simply a plea from the surgeons for manufacturers to focus more on delivery of care than tinkering with current implants on the market.
