Orthopedic device makers are focusing more on the biological differences in patients and producing more anatomically correct options than in the past. However, ConforMIS has been refining its patient-specific process for partial and total knee replacements where individual cutting guides, instrumentation and implants are constructed for every procedure. The one-time use materials arrive at the operating room already sterilized and ready for surgery. Here, Gregory Martin, MD, medical director of the Orthopedics Institute at JFK Medical Center in Florida, discusses the technology and where it's headed in the future.
Q: How have anatomic knee replacements changed over the past few years?
Dr. Gregory Martin: ConforMIS was founded in 2004 and introduced the first of its knee replacements, a partial knee replacement system, in the late 2000s. The interesting thing is they are able to change the technology very quickly and respond to feedback more than the traditional implant company. So the systems they introduced back then have already gone to a second generation, what they call G2, version.
More recently, the iTotal was FDA-cleared at the beginning of last year and was on limited release over the past 18 months. Over that time they have incorporated beneficial changes to the implants and instrumentation and preoperative plan quality in the iView, the personalized planning images that make it simple to visualize joint preparation during surgery. Just a few months ago, they formally launched the G2 version of that system which is just unheard of in orthopedics to go to a second generation in less than two years.
Because of their delivery model, ConforMIS could implement feedback right away. With traditional implants, a company sends out thousands of implants, instrumentation and inventory. If they are going to revise something, it's a huge under taking and something that happens over several years, not 18 months. As we develop the patient-specific implants and the techniques of putting them in, there will always be changes and refinements in surgical technique.
Q: What is unique about the iTotal G2?
GM: Unique is a term perfect to describe the iTotal. It is the only patient-specific implant of its kind on the market — other companies have patient-specific guides, but they are designed to help put in off-the-shelf implants. Both the implant and instrumentation for the iTotal G2 are patient-specific. As we see other implant companies release new implant platforms, they are increasing the number of sizes they offer to fit more patients, but they are not customizing the fit or shape to each individual. We are seeing other companies talk about single-use disposable instrumentation, like ConforMIS, so it's already making an impact on the market.
Q: What are the advantages of this technology?
GM: I think the technology has advantages for all the different players involved. All the stakeholders have benefits as a result of the technology. From the physician's perspective, it's a quick, efficient and refined technique. It inspires confidence as you do it because the instrumentation fits well and design fits well. It doesn't leave any doubt that you are doing it right.
Since the implant fits anatomically, they don't have to make the traditional compromises to fit the knees. It's reassuring for the surgeon. For the patient, the intraoperative advantages are realized because you see a lot less blood loss and swelling. It's pretty dramatic even intraoperatively because they aren't losing blood like in traditional knee replacements. That translates into an earlier return to function. The length of stay at the hospital for my patients has decreased by a day.
Q: How will this technology impact the future of orthopedic surgery?
GM: I think ultimately the delivery model makes the most sense from a technology standpoint because it doesn't make sense to have nine or 10 different trays prepared for every surgery. We are asked to do more surgeries for less reimbursement, so efficiency is important. I think the whole set up is a much easier process from a logistics standpoint.
In addition, I think the single-use instrumentation is important. There has been a major Wall Street Journal report on how the re-sterilization process in hospitals can be contaminated. It just makes sense to have single-use instrumentation for patients; it eliminates one variable that can be a potential source of infection. I think that this is just the start of patient-specific orthopedics. Other fields like dentistry have been doing patient-specific for a long period of time.
Q: Do you see the trend of patient-specific implants in orthopedics continuing in the future?
GM: I think we are going to see this trend continue in medicine because it makes sense to the doctor and patient. Patients get it instantly and size to them is a big issue. They may not have the medical knowledge to know the details but it intuitively makes sense. We are going to see this trend in other prosthetics being made individually as well.
Ten years ago, it was logistically very difficult to produce patient-specific implants, but the ConforMIS headquarters is extremely impressive. It's interesting to see how the manufacturing technology has adapted to allow the company to do this in an efficient manner.
More Articles on Orthopedic Devices:
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Q: How have anatomic knee replacements changed over the past few years?
Dr. Gregory Martin: ConforMIS was founded in 2004 and introduced the first of its knee replacements, a partial knee replacement system, in the late 2000s. The interesting thing is they are able to change the technology very quickly and respond to feedback more than the traditional implant company. So the systems they introduced back then have already gone to a second generation, what they call G2, version.
More recently, the iTotal was FDA-cleared at the beginning of last year and was on limited release over the past 18 months. Over that time they have incorporated beneficial changes to the implants and instrumentation and preoperative plan quality in the iView, the personalized planning images that make it simple to visualize joint preparation during surgery. Just a few months ago, they formally launched the G2 version of that system which is just unheard of in orthopedics to go to a second generation in less than two years.
Because of their delivery model, ConforMIS could implement feedback right away. With traditional implants, a company sends out thousands of implants, instrumentation and inventory. If they are going to revise something, it's a huge under taking and something that happens over several years, not 18 months. As we develop the patient-specific implants and the techniques of putting them in, there will always be changes and refinements in surgical technique.
Q: What is unique about the iTotal G2?
GM: Unique is a term perfect to describe the iTotal. It is the only patient-specific implant of its kind on the market — other companies have patient-specific guides, but they are designed to help put in off-the-shelf implants. Both the implant and instrumentation for the iTotal G2 are patient-specific. As we see other implant companies release new implant platforms, they are increasing the number of sizes they offer to fit more patients, but they are not customizing the fit or shape to each individual. We are seeing other companies talk about single-use disposable instrumentation, like ConforMIS, so it's already making an impact on the market.
Q: What are the advantages of this technology?
GM: I think the technology has advantages for all the different players involved. All the stakeholders have benefits as a result of the technology. From the physician's perspective, it's a quick, efficient and refined technique. It inspires confidence as you do it because the instrumentation fits well and design fits well. It doesn't leave any doubt that you are doing it right.
Since the implant fits anatomically, they don't have to make the traditional compromises to fit the knees. It's reassuring for the surgeon. For the patient, the intraoperative advantages are realized because you see a lot less blood loss and swelling. It's pretty dramatic even intraoperatively because they aren't losing blood like in traditional knee replacements. That translates into an earlier return to function. The length of stay at the hospital for my patients has decreased by a day.
Q: How will this technology impact the future of orthopedic surgery?
GM: I think ultimately the delivery model makes the most sense from a technology standpoint because it doesn't make sense to have nine or 10 different trays prepared for every surgery. We are asked to do more surgeries for less reimbursement, so efficiency is important. I think the whole set up is a much easier process from a logistics standpoint.
In addition, I think the single-use instrumentation is important. There has been a major Wall Street Journal report on how the re-sterilization process in hospitals can be contaminated. It just makes sense to have single-use instrumentation for patients; it eliminates one variable that can be a potential source of infection. I think that this is just the start of patient-specific orthopedics. Other fields like dentistry have been doing patient-specific for a long period of time.
Q: Do you see the trend of patient-specific implants in orthopedics continuing in the future?
GM: I think we are going to see this trend continue in medicine because it makes sense to the doctor and patient. Patients get it instantly and size to them is a big issue. They may not have the medical knowledge to know the details but it intuitively makes sense. We are going to see this trend in other prosthetics being made individually as well.
Ten years ago, it was logistically very difficult to produce patient-specific implants, but the ConforMIS headquarters is extremely impressive. It's interesting to see how the manufacturing technology has adapted to allow the company to do this in an efficient manner.
More Articles on Orthopedic Devices:
15 Orthopedic Device Company Financial Reports
12 Orthopedic Surgeries for Professional Athletes
10 Key Trends in Spine Surgery for 2013