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. It turned out that the 90-minute conversation was dominated by the topic of reprocessing and storing devices and instruments. Questions posed to the panel ranged from ways to reduce the cost of delivery of care to reduction of the real concern of employee burnout and turnover in healthcare to procedures moving to ambulatory surgery centers (ASCs). A phrase continually repeated was, “We need to address the real problem.” To them, the problem is delivery of care. Current instrument options, according to them, 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. (You may read their brief bios here.)
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
and 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 to 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 to accomodate just-in-time manufacturing.
What did the surgeons think about current instrument ideas developed to solve this problem?
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.
“Innovation and standardization are not opposites; standardization is the foundation for which the next innovation can occur. Every time you standardize, you allow for a baseline against which you can innovate up to the next plateau. People have a misperception that you’re either standardizing or innovating. You’ve got to do both, sequentially and in relation to one another so that you can do them both effectively.”
–Dr. Froimson on innovation
Dr. Sweeney: As a spine surgeon, I can’t count the number of cannulated instruments that I’ve found with old bone in it. 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.
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?
“When you consider the increasing access to healthcare throughout the world and the increasing shortage of trained surgeons to do the work, I don’t think we have any choice. I think big data, artificial intelligence has to help in the decision-making process, and I think that the technical advances that are in the O.R. that I can use as a multiplier—particularly, I love image guidance—make me more efficient, reduce my stress and improve my outcomes. All of those things add up to make the whole healthcare force more efficient, and I don’t think we have any choice.”
–Dr. Sweeney on software and analytics to improve manpower
Dr. Althausen: I agree, 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?
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.