Commentary

Balance innovation and patient care

Improved understanding of orthopedic conditions combined with advances challenge orthopedic surgeons to use the newest technology. Combined with the rapid development of new concepts is the influence of industry and patient demands that encourage the early adoption of technology that has not stood the test of time.

Anthony A. Romeo

Projections of value of these ideas are often supported with assumptions and calculations biased toward the new intervention’s efficacy. It may diminish potential risks and complications, only focusing on outcomes valuable to patients if the technology fulfills its promise. However, as with any new technology, the expectation of value often leads to overuse and poor adherence to original indications, driven either by financial or reputation enhancement biases.

FDA’s strict premarket approval process is based on clinical evidence that takes years to collect. From January 1982 to December 2014, FDA approved 70 orthopedic devices through this process, according to data from Samuel and colleagues. Even after a rigorous approval process, FDA recalled 12 of the devices. High-risk devices cleared by FDA likely undergo changes from the originally approved device, especially soon after approval. Additionally, some devices will be removed from the market due to safety concerns.

Most devices are FDA approved via a 510(k) pathway, which requires “substantial equivalence” to an already cleared device. FDA accepts the manufacturer’s claim that a device is similar to another approved product on the market. Unfortunately, if an argument can be made on equivalence, clinical trials and rigorous testing are not performed and patients may be subjected to an “experiment” to confirm the device is truly equivalent to one cleared via PMA.

The opinions of key opinion leaders (kol), industry and early clinical successes can lead to a rapid increase in use of a new device. The personality of many orthopedic surgeons, especially those who have not seen the lifecycles of devices that did not meet expectations, leads to early adoption of innovation. Inflated expectations are often disrupted by poor outcomes, leading to a decrease in use. Indications are further refined so the right technology and procedure bring promised outcomes, but in a smaller population than was projected.

Technology use reaches a steady state in the market until newer versions or competitive products share the market. Known as the “hype cycle,” this is played out daily in orthopedics. With the hype, the personality of users plays a role in how the new products are adopted.

Rogers Adoption Curve includes technology acceptance stages, such as innovators and early adopters. Many surgeons deem themselves early adopters. After the hype has settled and indications are more clearly defined, they don’t wait to adopt new innovations.

To be an innovation leader, early technology adoption is critical. We must routinely evaluate ourselves so we do not place our priorities above those of patients. Innovators and early adopters should focus on the process of data collection and analysis of early results to identify issues that occur with promising, but unproven, new technology and communicate these problems to peers. Putting balance among innovation, early technology adoption and patient care and safety at the top of the priority list develops true KOLs.

Disclosure: Romeo reports he receives royalties, is on the speakers bureau, is a consultant and does contracted research for Arthrex; receives institutional grants from MLB; and receives institutional research support from Arthrex, Ossur, Smith & Nephew, ConMed Linvatec, Athletico and Wright Medical.

Improved understanding of orthopedic conditions combined with advances challenge orthopedic surgeons to use the newest technology. Combined with the rapid development of new concepts is the influence of industry and patient demands that encourage the early adoption of technology that has not stood the test of time.

Anthony A. Romeo

Projections of value of these ideas are often supported with assumptions and calculations biased toward the new intervention’s efficacy. It may diminish potential risks and complications, only focusing on outcomes valuable to patients if the technology fulfills its promise. However, as with any new technology, the expectation of value often leads to overuse and poor adherence to original indications, driven either by financial or reputation enhancement biases.

FDA’s strict premarket approval process is based on clinical evidence that takes years to collect. From January 1982 to December 2014, FDA approved 70 orthopedic devices through this process, according to data from Samuel and colleagues. Even after a rigorous approval process, FDA recalled 12 of the devices. High-risk devices cleared by FDA likely undergo changes from the originally approved device, especially soon after approval. Additionally, some devices will be removed from the market due to safety concerns.

Most devices are FDA approved via a 510(k) pathway, which requires “substantial equivalence” to an already cleared device. FDA accepts the manufacturer’s claim that a device is similar to another approved product on the market. Unfortunately, if an argument can be made on equivalence, clinical trials and rigorous testing are not performed and patients may be subjected to an “experiment” to confirm the device is truly equivalent to one cleared via PMA.

The opinions of key opinion leaders (kol), industry and early clinical successes can lead to a rapid increase in use of a new device. The personality of many orthopedic surgeons, especially those who have not seen the lifecycles of devices that did not meet expectations, leads to early adoption of innovation. Inflated expectations are often disrupted by poor outcomes, leading to a decrease in use. Indications are further refined so the right technology and procedure bring promised outcomes, but in a smaller population than was projected.

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Technology use reaches a steady state in the market until newer versions or competitive products share the market. Known as the “hype cycle,” this is played out daily in orthopedics. With the hype, the personality of users plays a role in how the new products are adopted.

Rogers Adoption Curve includes technology acceptance stages, such as innovators and early adopters. Many surgeons deem themselves early adopters. After the hype has settled and indications are more clearly defined, they don’t wait to adopt new innovations.

To be an innovation leader, early technology adoption is critical. We must routinely evaluate ourselves so we do not place our priorities above those of patients. Innovators and early adopters should focus on the process of data collection and analysis of early results to identify issues that occur with promising, but unproven, new technology and communicate these problems to peers. Putting balance among innovation, early technology adoption and patient care and safety at the top of the priority list develops true KOLs.

Disclosure: Romeo reports he receives royalties, is on the speakers bureau, is a consultant and does contracted research for Arthrex; receives institutional grants from MLB; and receives institutional research support from Arthrex, Ossur, Smith & Nephew, ConMed Linvatec, Athletico and Wright Medical.