By Sean Fenske, Editor-in-Chief

For years, orthopedic implants were developed with a “one size fits all” type of mentality. While a range of sizes was provided, they weren’t specific to each patient and case. However, with the advent of newer technologies and digital tools, more sophisticated solutions could be offered. Known as patient-specific, these products help with pre-planning, recovery, and the procedure itself.

Since patient-specific options are relatively new, there are questions surrounding them. Orthopedic device makers are not intimately familiar with the technologies needed to develop these types of offerings, such as software solutions. As a result, they may be hesitant to explore them as options for their surgical customers and their patients.

Fortunately, several organizations have been working with patient-specific devices and technologies for some time. To help address questions around these solutions for orthopedics, Michael Lawrenchuk, Sr. Business Development Manager at Materialise, took part in the following Q&A. He explains patient-specific technologies, the advantages they offer, and how OEMs and their surgical customers use them.

Sean Fenske: From your perspective, what are the drivers of patient-specific solutions in the orthopedic space?

Michael Lawrenchuk: I think what it comes down to is the market has recognized the value of pre-operative planning. Most of the patient-specific solutions out there—whether it’s CT-based robotics, patient-specific instrumentation, or custom implants—the common theme is everyone involved with the treatment has a better understanding of the situation before getting in the operating room, and can more accurately execute a procedure for a specific patient. It’s a win for all stakeholders involved (OEM, hospital, patient), and it’s only natural that this area is seeing growth and will continue to see growth.

Fenske: Are patient-specific solutions more expensive than traditional offerings? Is the reimbursement for patient-specific options appropriate, or is more progress needed?

Lawrenchuk: As compared to a traditional treatment plan, there is a lot more that goes into preparing a patient-specific solution. You typically need to get imaging done according to a specific protocol, reconstruct that imaging data accurately, design a unique device, and coordinate sign-off on the specific treatment plan. In parallel, you are also ensuring the data is securely transferred between the different stakeholders. The holy grail that everyone is striving for is to make that process as automated as possible; for the foreseeable future, that extra friction is creating cost and overhead for each case. That said, in our decades-long history with patient-specific solutions, we see this effort/cost is easily offset by the value realized. The benefits include more confidence in the operating room, more efficient inventory management, and, most importantly, a better outcome for the patient.

Fenske: Why do device makers need a patient-specific case planning solution? Isn’t this more for the clinician?

Lawrenchuk: Something we’ve found is that a lot of the challenge in orchestrating a new patient-specific solution isn’t necessarily in the individual workflow steps (i.e., reconstructing the images, preparing a plan, designing a device, etc.). Especially in recent years, with AI-driven image segmentation, workflow scripting, and other developments, those steps are getting increasingly efficient or even automated in some cases. The most recurring challenge we hear from groups who are quickly scaling in case volumes is how to efficiently and effectively manage the communication and overall case flow with the clinical site. It’s critical to have a secure, robust, and intuitive platform to ensure nothing falls through the cracks. A single case can have several communication touchpoints; extrapolating that out to hundreds or thousands of cases a month, it only makes sense to have everything organized and traceable in a comprehensive online platform. This is exactly what we developed more than 15 years ago under the Surgicase brand to support our own patient-specific device processes and have now adapted it to make it available to any orthopedic OEM as part of the Mimics Flow platform.

Fenske: Is this system used by the device manufacturer and clinician in tandem? Does it serve as a way to enhance communication?

Lawrenchuk: Mimics Flow is an off-the-shelf, cloud-based platform that can be configured to the specific needs of the device manufacturer. Indeed, the overall goal is streamlining communication and case flow with the clinical site. Ongoing cases are managed and promoted through the platform by designers and engineers within the device manufacturer. Once a plan has been prepared by the OEM and is ready to share, the surgeon gets an automated email prompt to review. They click a link in the email, and it takes them to a cloud-based interface to review and sign off. The platform aims to improve the overall experience for both the device manufacturer and the clinical site.

Fenske: Can a clinician provide feedback to the manufacturer through the platform, or is it directed from the company to the clinician only? Can the patient be involved?

Lawrenchuk: Yes, there is a feedback mechanism if changes or inputs are requested by the surgeon. The sign-off approval is also tracked and logged into the system. It doesn’t happen all the time, but we do hear from groups that use the platform to involve the patient in the treatment plan, particularly for more complex treatments. I think most patients appreciate getting more detailed insight into their surgery and seeing the level of attention and sophistication that goes into planning their specific treatment.

Fenske: What unexpected benefits have device manufacturers gained from implementing a case planning platform like this? What advantages were realized they didn’t know would be achieved?

Lawrenchuk: We hear from groups that it creates a more interactive and enjoyable user experience for their surgeon customers. Clinicians who are accustomed to paper case reports appreciate looking at a 3D plan on their iPad or phone, rotating it around, sending comments, etc. Where the platform may have been initially implemented as a practical way to streamline their cases, it often adds significant value to the surgeon’s experience and improves their engagement.

Another unexpected benefit is the value of the data collected in Mimics Flow. As groups process clinical cases, they also accumulate a substantial amount of well-structured historical data that can be leveraged to improve various aspects of their operations. By understanding surgeons’ preferences, identifying workflow bottlenecks, and delivering key insights to their sales teams, our partners can be very creative in how they use the data through our APIs to deliver more value to the clinical staff and the patients they serve.

Fenske: Do you have any additional comments you’d like to share based on any of the topics we discussed or something you’d like to tell orthopedic device manufacturers?

Lawrenchuk: While on the surface such a platform seems straightforward, experience shows that building it is a tough challenge in our highly regulated environments. Mastering data privacy and security while being compliant with the various applicable requirements is not a simple task, especially when trying to keep the whole user experience smooth and enjoyable. In short, this is our message to device manufacturers: don’t underestimate the development and maintenance efforts involved in this aspect of your patient-specific planning workflow. We are happy to be able to leverage our years of experience in these activities to make this platform available out-of-the-box.

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