As surgical teams increasingly adopt innovative digital technologies and many medtech companies develop these technologies, the question of how to assess their value becomes paramount. In recent years, various health technology assessment (HTA) bodies have published frameworks for evaluating the value of digital technologies, although many of them are still evolving and being refined. To learn more about the challenges and opportunities related to the assessment of digital surgical technologies, we spoke to Jamie Erskine, Senior Consultant, Medtech Market Access and Commercial Strategy at Alira Health and one of the authors of our recent global review, Robotic-Assisted Surgery (RAS) in Orthopedic Procedures.

What is the state of digital surgical technologies today?

The use of digital surgical technologies is growing rapidly, and they are deployed across the whole surgical pathway. One of the strengths of digital surgical technologies is that many are not limited to specific therapeutic areas. Any type of surgery in any therapeutic area has the potential for enhancement by digital technologies. The sky is really the limit. Surgeons can use digital tools to plan surgeries; for example, using virtual reality headsets to visualize the patient’s anatomy before surgery and to execute practice runs on the robotic platform. Then there’s intrasurgical guidance, such as using augmented reality during surgery to help surgeons through the operation. The surgical team can also receive analytics that can detect if something is going wrong or recommend a different approach. Post-surgical analytics can inform the surgical team on what they could do differently in future. Reviewing video and data can indicate if, for example, the surgeon should have moved more slowly or used less pressure at a particular point. Even very experienced surgeons can use this technology to continuously improve. And some technologies focus on linking with the patient in the days and weeks after surgery so that they can report on how they’re doing, whether they’re experiencing any adverse events, and if they need further support.

What commercial strategies are medtech companies pursuing with digital surgical technologies?

With all the potential for digital technologies to improve surgery, many companies have entered the market or are looking at how to do so. There are two main commercial strategies. First, market-leading companies with robotic platforms are developing a wide variety of complementary digital technologies to increase the platforms’ value. Second, many smaller companies are developing digital technologies surgical teams can use across a wide variety of robotic platforms, or even without a robotic platform. These smaller companies may look to potential acquisitions by large companies and/or mergers with other small companies to take full advantage of the market opportunity.

What do HTAs currently consider when assessing the value of digital surgical technologies?

Assessing the value of digital surgical technologies is challenging. I was the lead author on a recent paper, An international consensus panel on the potential value of digital surgery, and we explored two key considerations. HTA bodies are concerned with the clinical and economic value of an intervention. But it is difficult to assess a digital surgical technology because its value comes from working in combination with other technologies. Our expert panel recommended looking at the value of the entire surgical ecosystem holistically. The other consideration is domains of value that are not captured by clinical and economic outcomes, such as social value. Digital surgical technologies have the potential to provide access to more patients, particularly in rural areas where clinicians may lack surgical expertise. Facilitated by these technologies, surgeons can plan and prepare for surgeries, receive guidance and feedback and link directly to other surgeons for support during surgery, and easily follow up with patients. This could reduce health inequalities. There are even potential sustainability benefits if healthcare systems can reduce the number of patients who must travel for surgery. While HTAs in a few countries, such as the Netherlands, already consider these types of value, most do not. Because the standard framework for assessing value doesn’t apply, what does that mean for HTA bodies and for medtech companies developing digital surgical technologies? For HTA bodies that need to evaluate digital surgical technologies, there is currently no straightforward answer on how to assess their value. They could find The World Bank framework for assessing digital technologies useful. They could also consider assessing the holistic value of all the technologies that work together through the surgical pathway and incorporate the impact on the surgical team and their workflow. Other keys to assessing the value of a digital surgical technology include the use of real-world evidence (RWE), which should encompass understanding the patient perspective through patient-reported outcomes and patient satisfaction measures. From the medtech company perspective, in addition to creating robust, secure technology, interoperability is key. Developers need to ensure that systems can not only communicate and share information but also link to other systems containing vital data, including electronic health records. Digital technologies and robotic platforms generate enormous amounts of useful data that companies and clinicians can harness as a potential opportunity to improve clinical outcomes as well as to generate RWE.

What role does RWE play in the digital surgical technologies value assessment?

Throughout the surgical pathway, digital technologies gather and respond to data constantly, and surgical teams react to that data. The enormous amount of automatically generated information creates a significant opportunity for companies to more rapidly and easily develop RWE. RWE doesn’t replace randomized control trials, which provide the best understanding of the level of effect from implementing an intervention. But RWE from digital surgical technologies can provide a system-level understanding of the impact. Again, interoperability is crucial and plays a vital role in the quality of evidence. If the data from different systems is not in the same format, it’s difficult and time-consuming to manually merge data sets. The adoption of digital surgical technologies is not yet widespread; many medtech companies are still in development and gathering early clinical evidence. But we do recommend that companies start thinking about an RWE strategy as soon as possible because it will play a key role in the product value assessment.

How will the assessment of digital surgical technologies’ value evolve over the next few years?

From the HTA perspective, some bodies, such as the National Institute of Health and Care Excellence in the UK, are already doing early value assessments into soft tissue and orthopedic robotic assisted surgery, which include some digital aspects. But most digital surgical technologies will not reach the assessment stage for several years yet. Digital surgical technologies will change the overall value proposition of a robotic platform, and of robotic surgery in general, because in combination, they can improve clinical outcomes. And hopefully, this will also mean better access for patients and reduced health inequities. While widespread adoption is still to come, we expect these technologies to benefit clinicians, patients, and indeed, the healthcare ecosystem in the future.