I read the article titled, Building the Pathway to Successful Use of Real World Evidence. This BoneZone article discusses the potential of using clinical evidence in improving patient safety and product development in orthopedics, highlighting its benefits and challenges, and drawing parallels with its successful application in the pharmaceutical industry.
Sounds great ! Everybody says that they wants more clinical data, but I don’t believe it.
Let’s start with the easy ones. Certainly the FDA and EUMDR want more clinical data. The insurance companies want more clinical data. The national registries want more clinical data.
Outside of the regulatory agencies, my thesis is that the orthopedics industry does not really care about real clinical outcomes evidence.
Let’s look at each cohort individually.
Most surgeons say that they are interested in clinical data but their product purchasing behavior does not support this narrative. Let’s face it. Most surgeons are interested in shinny new objects. They want to be using the latest technology regardless of supporting clinical data. By definition, these newer technology products do not come with clinical data.
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Patients do not understand the art of clinical performance, the controls, the study design, the placebo effects, etc. Also most patients trust the orthopedic specialist when he/she lays out treatment options without delving into clinical evidence, statistics and adverse events reporting.
The device manufacturers do not want more clinical evidence for four reasons:
1/ Money. Building a body of clinical evidence is very expensive. Proof requires significant capital allocation, more full time employees and years of work. For many companies, the cost of conducting rigorous clinical studies may not justify the potential benefits. This is particularly true for smaller companies with limited resources. The substantial investment required for long-term, large-scale clinical trials can be a significant barrier, especially if the company believes that the market will accept the product without this level of evidence.
2/ Time Obsolescence. The pace of technological innovation in orthopedics is rapid. By the time a clinical study is designed, executed, and analyzed, the technology or device in question might already be outdated. This rapid evolution can deter companies from investing in long-term studies, as the results might be irrelevant by the time they are available. Do you want to know what the best total knee product is in the last 20 years? Sorry that product is not on the market any longer.
3/ True Performance. Secretly, many device companies do not want to know how their device compares to the competitors. Clinical performance comparing “apples to apples” may be unwanted. Opacity will win out over transparency every time. In a transparent world of clinical outcomes there will be one product winner that is clinically superior and many losers.
4/ Product Complexity. Orthopedic products used to be hardware – good old fashioned titanium. Creating clinical evidence was more straight forward when a company can compare a titanium implant to a control. But now there is a data component with most new orthopedic products and services. How do you carry out a clinical study when there are new variables such as Robotics, Navigation, Mixed Reality and AI used in the delivery of the implant ?
Post-Market Clinical Studies
For these reasons and more, device manufacturers typically default to post-market clinical studies. They carry out weak post-market surveillance studies to “pretend” that they care about outcomes and satisfy marketing, sales and the surgeon customer. Post-market studies are cheaper to run and post-market studies avoid the time obsolescence problem because the post-market data supports the current device for sale today.