ConforMIS has recently received approval from the U.S. Food and Drug Administration for two of its patient-specific implants, the iDuo G2 for partial knee replacements and the iTotal for total knee replacements. The iTotal achieved clearance earlier this year, and now the company is undergoing expansion to meet the market needs for its product.
Here are five points on bringing new orthopedic technology to the market from Raj Sinha, MD, an orthopedic surgeon at JFK Memorial Hospital in La Quinta, Calif., and ConforMIS CEO Philipp Lang.
1. Be prepared to meet tighter FDA approval regulations. Over the past year, the FDA has been tightening regulations for approving medical devices, and the iTotal came to the market just as many of these changes were beginning. "The FDA has significantly heightened their standards, which I think is a good thing," says Mr. Lang. "The line and depth of questioning has been significantly expanded. When we did the original submission, we anticipated 4-6 months for approval and it took twice as long because they went more in-depth with their questions."
He watched the overall documentation grow and the company was able to adapt to the regulation changes for successful approval. "We received the first approval for iDuo at a time when a lot of companies were receiving letters of warning for their patient-specific jigs and there was a lot of turmoil in the industry," he says. "When we received approval for the iTotal CR as well, we were very happy."
Dr. Lang sees several advantages to the more extensive approval process, one being the preparation for achieving the CE Mark in Europe. He says the CE questioning was very similar to the FDA's questions, and the company was able to apply its previous experience to the new process. "The FDA process helped us significantly going through the CE process," he says.
2. Show a differentiation from what already exists. Many orthopedic device companies are struggling to meet the higher standards and complete the testing process before submitting new devices for approval. One of the biggest changes is new devices must prove they are of equal or greater quality and can produce better outcomes than the best product already on the market. "We're taking a very careful and measured approach in that the product is highly differentiated and has many benefits compared to standard total knee replacements," says Dr. Lang. "The implant fits better, is much more bone preserving and maximizes the coverage of the implant to the bone."
The ConforMIS technology is different from other partial and full knee replacement products because it designs every implant based on a three-dimensional image of the patient's anatomy, says Dr. Lang. The individualized implants allow surgeons to fit the implant to the knee without damaging the healthy anatomy. "There are still a few tweaks with the instrumentation, but the implant itself is a homerun," says Dr. Sinha. "I think it's going to be very disruptive to the market in the sense that patients are going to demand its patient specificity."
3. Bring surgeons on board. One of the challenges device companies face is working with surgeons to develop and utilize the technology. When surgeons decide they are interested in learning a new surgical technique or using a different type of implant, the companies, such as ConforMIS, step in to provide the training. The training programs vary from one company to the next, but the most successful programs ensure the surgeons are comfortable with the procedure before performing it alone.
"All of our surgeons have individual trainers and individuals in the room to help them when they start," says Dr. Lang. The company was also able to solicit feedback from surgeons and incorporate suggestions into the final product. "This is a unique position because of the no inventory business model, so we can really listen and adjust to our surgeons in an unprecedented fashion," Dr. Lang says.
In 2011, the company plans to have a significant core number of surgeons across the United States with training and after-training clinical exposure to the implant. Those surgeons form the basis to train subsequent surgeons through 2012. Through this chain of experience, surgeons can offer support to their colleagues at universities, community hospitals or in private practice.
4. Address the economics of orthopedic surgery. Medical devices and implants are a large portion of the overall expense for orthopedic surgery and device companies are beginning to feel industry pressure to lower the cost of care. Companies are beginning to address the economic savings associated with their products, such as a reduced need for revision surgeries or the lower upfront cost per kit. ConforMIS has been able to remain competitive economically because the patient-specific implant, cutting jigs and instrumentation all come sterilized and prepackaged just-in-time to the hospital.
"Reprocessing metal trays, depending on the institution, could be anywhere from $60-$100 per tray with 6-10 trays required for each orthopedic procedure," says Dr. Lang. "With ConforMIS, all you need to do is wrap up the instrumentation in the drape and dispose of it in biohazard waste. Everyone is watching the dollars in the hospital setting, aside from the clinical benefits for the patient, and they should theoretically be able to do more cases for less money with iTotal."
The economic benefits of these products for hospitals also make them attractive for surgeons performing their cases in ambulatory surgery centers. "Everything is easily disposable and you don't have to worry about reprocessing or storing the instrumentation," says Dr. Sinha. ConforMIS is currently starting clinical trials to show the economic benefit of using its products.
5. Show advantages for patient care. While temporarily it may seem as though the industry is more focused on economics than outcomes, successful surgeries and patient satisfaction are still the most important factors in long-term care. When developing new technology, companies must be able to show new procedures are able to have better outcomes.
"Many surgeons say standard TKR is excellent and they have 90 percent or more success rates for these surgeries," says Dr. Lang. "But then you ask them how their patient is doing, if they are still able to remain active. Many patients complain of persistent pain, impingement or unnatural feeling knees. That's where the opportunity comes in for us because we address the shortcomings of the fixed prosthetic design."
The real challenge is creating a product that addresses the needs of the patient, surgeon and hospital with room to continue developing in the future. "In the short term, we have a great economic proposition for the hospital and great clinical value for the surgeons and patients," says Dr. Lang. "In the midterm, I'm very hopeful we can establish clinical superiority of the implant."
Dr. Sinha estimates that when given the option to receive the standard or personalized implant, approximately 90 percent of the patients in his practice choose the patient-specific technology. One of the drawbacks for the other 10 percent is waiting while the personalized implants are manufactured before undergoing the procedure. However, the wait doesn't hinder most patients. "Patients are often willing to wait for the extra time it takes to manufacture the implant because of the potential long-term advantages, such as the feel of a natural knee," he says.
Learn more about ConforMIS.
Related Articles on the Orthopedic Device Market:
Staying Competitive in the Orthopedic Device Market: Q&A With Stryker Orthopaedics
7 Critical Orthopedic and Spine Device Industry Trends
Orthopedic and Spine Device Industry Post-Reform: 6 Challenges
Here are five points on bringing new orthopedic technology to the market from Raj Sinha, MD, an orthopedic surgeon at JFK Memorial Hospital in La Quinta, Calif., and ConforMIS CEO Philipp Lang.
1. Be prepared to meet tighter FDA approval regulations. Over the past year, the FDA has been tightening regulations for approving medical devices, and the iTotal came to the market just as many of these changes were beginning. "The FDA has significantly heightened their standards, which I think is a good thing," says Mr. Lang. "The line and depth of questioning has been significantly expanded. When we did the original submission, we anticipated 4-6 months for approval and it took twice as long because they went more in-depth with their questions."
He watched the overall documentation grow and the company was able to adapt to the regulation changes for successful approval. "We received the first approval for iDuo at a time when a lot of companies were receiving letters of warning for their patient-specific jigs and there was a lot of turmoil in the industry," he says. "When we received approval for the iTotal CR as well, we were very happy."
Dr. Lang sees several advantages to the more extensive approval process, one being the preparation for achieving the CE Mark in Europe. He says the CE questioning was very similar to the FDA's questions, and the company was able to apply its previous experience to the new process. "The FDA process helped us significantly going through the CE process," he says.
2. Show a differentiation from what already exists. Many orthopedic device companies are struggling to meet the higher standards and complete the testing process before submitting new devices for approval. One of the biggest changes is new devices must prove they are of equal or greater quality and can produce better outcomes than the best product already on the market. "We're taking a very careful and measured approach in that the product is highly differentiated and has many benefits compared to standard total knee replacements," says Dr. Lang. "The implant fits better, is much more bone preserving and maximizes the coverage of the implant to the bone."
The ConforMIS technology is different from other partial and full knee replacement products because it designs every implant based on a three-dimensional image of the patient's anatomy, says Dr. Lang. The individualized implants allow surgeons to fit the implant to the knee without damaging the healthy anatomy. "There are still a few tweaks with the instrumentation, but the implant itself is a homerun," says Dr. Sinha. "I think it's going to be very disruptive to the market in the sense that patients are going to demand its patient specificity."
3. Bring surgeons on board. One of the challenges device companies face is working with surgeons to develop and utilize the technology. When surgeons decide they are interested in learning a new surgical technique or using a different type of implant, the companies, such as ConforMIS, step in to provide the training. The training programs vary from one company to the next, but the most successful programs ensure the surgeons are comfortable with the procedure before performing it alone.
"All of our surgeons have individual trainers and individuals in the room to help them when they start," says Dr. Lang. The company was also able to solicit feedback from surgeons and incorporate suggestions into the final product. "This is a unique position because of the no inventory business model, so we can really listen and adjust to our surgeons in an unprecedented fashion," Dr. Lang says.
In 2011, the company plans to have a significant core number of surgeons across the United States with training and after-training clinical exposure to the implant. Those surgeons form the basis to train subsequent surgeons through 2012. Through this chain of experience, surgeons can offer support to their colleagues at universities, community hospitals or in private practice.
4. Address the economics of orthopedic surgery. Medical devices and implants are a large portion of the overall expense for orthopedic surgery and device companies are beginning to feel industry pressure to lower the cost of care. Companies are beginning to address the economic savings associated with their products, such as a reduced need for revision surgeries or the lower upfront cost per kit. ConforMIS has been able to remain competitive economically because the patient-specific implant, cutting jigs and instrumentation all come sterilized and prepackaged just-in-time to the hospital.
"Reprocessing metal trays, depending on the institution, could be anywhere from $60-$100 per tray with 6-10 trays required for each orthopedic procedure," says Dr. Lang. "With ConforMIS, all you need to do is wrap up the instrumentation in the drape and dispose of it in biohazard waste. Everyone is watching the dollars in the hospital setting, aside from the clinical benefits for the patient, and they should theoretically be able to do more cases for less money with iTotal."
The economic benefits of these products for hospitals also make them attractive for surgeons performing their cases in ambulatory surgery centers. "Everything is easily disposable and you don't have to worry about reprocessing or storing the instrumentation," says Dr. Sinha. ConforMIS is currently starting clinical trials to show the economic benefit of using its products.
5. Show advantages for patient care. While temporarily it may seem as though the industry is more focused on economics than outcomes, successful surgeries and patient satisfaction are still the most important factors in long-term care. When developing new technology, companies must be able to show new procedures are able to have better outcomes.
"Many surgeons say standard TKR is excellent and they have 90 percent or more success rates for these surgeries," says Dr. Lang. "But then you ask them how their patient is doing, if they are still able to remain active. Many patients complain of persistent pain, impingement or unnatural feeling knees. That's where the opportunity comes in for us because we address the shortcomings of the fixed prosthetic design."
The real challenge is creating a product that addresses the needs of the patient, surgeon and hospital with room to continue developing in the future. "In the short term, we have a great economic proposition for the hospital and great clinical value for the surgeons and patients," says Dr. Lang. "In the midterm, I'm very hopeful we can establish clinical superiority of the implant."
Dr. Sinha estimates that when given the option to receive the standard or personalized implant, approximately 90 percent of the patients in his practice choose the patient-specific technology. One of the drawbacks for the other 10 percent is waiting while the personalized implants are manufactured before undergoing the procedure. However, the wait doesn't hinder most patients. "Patients are often willing to wait for the extra time it takes to manufacture the implant because of the potential long-term advantages, such as the feel of a natural knee," he says.
Learn more about ConforMIS.
Related Articles on the Orthopedic Device Market:
Staying Competitive in the Orthopedic Device Market: Q&A With Stryker Orthopaedics
7 Critical Orthopedic and Spine Device Industry Trends
Orthopedic and Spine Device Industry Post-Reform: 6 Challenges