Every year, worldwide, approximately 23 million procedures are performed with a rod lens arthroscope. These scopes are sterilized after every procedure, yet 71% of endoscopes still contain bacteria after sterilization. Once a typical scope has completed about 30 procedures, it needs to be reprocessed.
These statistics, cited by Pristine Surgical CEO Bryan Lord during his recent presentation at the Musculoskeletal New Ventures Conference in Memphis, highlight the costly, cumbersome nature of legacy arthroscopes, and the risk of contamination and infection that innately come with the reuse of instrumentation.
Such factors motivated Pristine Surgical to develop a single-use rigid endoscope. The imaging system is unique in that it’s a single-use surgical device, as opposed to the in-office diagnostic devices that are currently available.
“We are big fans of what folks are doing in the in-office diagnostics space, because they too are building a similar form factor and championing single-use visualization, but we are focused on the surgical side of the equation,” Lord said. “As opposed to the CT scans and MRIs that are looking to be displaced on the diagnostics side, we want to enhance the form factor of the rod lens scope regime. Basically, we’re looking to be an upgrade path from there.”
Connecting Physical to Digital
The disposable system combines high-quality digital imaging and lighting, advanced software tools and automated delivery mechanisms.
“Everything that’s in the sterile field is contained in the single-use kit,” Lord said. “We use high-performance camera technology and high-performance lighting technology both on the tip of our device to replace the other components that are typically located on the tower, or on other aspects of the rod lens scope.”
The full system contains a custom configured screen, touch keyboard, peristaltic pump and a custom-designed component cart. The single-use scope plugs into an image processing unit outside of the sterile field, which is a reusable box, which then plugs into the screen. Everything is bridged to the Pristine Connect software platform over WiFi.
“We recognized very early on that moving to a single-use regime requires a constant inventory supply. We automated that process,” Lord said. “We know when scopes are used, and therefore when they’re finished with use. We can manage through a connected process and keep inventory at a constant level.”
Once the inventory capability was built, the Pristine Surgical team recognized several functionalities that they could add to the Pristine Connect platform, including patient engagement tools, pre- and post-op communications and training components. Access to the platform is ubiquitous through an app interface and basic web browsers, where information is updated in real time.
The Pristine Difference
The advantages of single-use devices have been well-chronicled, particularly in reference to a reduced risk of infection from cross-contamination or insufficient sterilization. With a visualization tool, the benefits of consistent quality, safety and value are even more pronounced.
“We recognized the ability to be able to perform high-quality visualization in a form factor that was able to deliver a brand new image each time through a single-use system,” Lord said. He compared that with a typical reusable rod lens scope, in which the quality degrades with each use, leading to the need for reprocessing every 30 uses just to achieve a clear image.
Pristine Surgical’s device had to meet three design requirements before it could be considered a viable prospect. First, it needed to be of the highest quality, with top-performance visualization and an uninterrupted feed. Next, it needed to be safe. Biocompatibility was a necessity, as was consistent and repeatable manufacturing. Finally, it needed to be low-cost.
“It doesn’t matter how outstanding the performance or how safe you might be able to fortify; you have to be able to do it in a low-cost form factor,” Lord said. “In our mind, we believe it to be essential that you actually reduce costs also to the overall end-user.”
The company summarizes its value proposition in an alliterative fashion, framing the imaging system as giving customers the Five Cs: a Clear image, Clean scope, Connected device, Cost-effectively in a Convenient form factor.
To solidify the convenient aspect of the Five Cs, Pristine Surgical’s design team went to great lengths to meet the design requirements in a way that would be ergonomically familiar to the surgeon. They adopted an iterative design process that involved surgeons from the start.
“We got a lot of surgeon input through the course of it, and we also paid close attention to the ways that surgeons used the device through human factors testing,” Lord said. “There are some subtle tactile cues in the scope that we use to help a surgeon orient where they are in the screen.”
On the Horizon
The sports medicine market is expected to continue to grow 5% to 6% for the next five years, according to ORTHOWORLD’s estimates. The long-standing trend of procedures moving from hospital outpatient to ambulatory surgery centers will continue, and with it a gain in single-use devices, according to Lord. These factors give an optimistic outlook to further development by Pristine Surgical.
“A lot of tools have moved to single-use, but the technological challenges are very different when you have to also be able to deliver that for visualization,” he said. “A lot of that depends on both investment in the space, and for a company like us to take the risk and engineering effort to make that sort of promise a reality.”
Pristine Surgical and other companies like them also have to rely upon the continued advancement of components available in the marketplace that are able to deliver high-quality visual and lighting capability.
“If it wasn’t for substantial investment in other adjacent spaces, we wouldn’t be able to afford the type of investment to fabricate our own semiconductor chips, camera modules and high brightness LEDs,” Lord said. “We’re the beneficiaries of a tremendous amount of continued advancement in the semiconductor arena that we can really apply to this particular medical device space.”
Pristine Surgical has also leveraged technology mega-trends such as miniature high-performance electronics, SaaS and Cloud computing, and the high-speed distribution economy to make it all happen.
The surgical imaging system for arthroscopic applications from Pristine Surgical is expected to be on the market in the first half of 2020. Similar devices in the pipeline include a single-use laparoscopic system.
“We see rigid endoscopy as our specialty,” Lord said. “We were founded by sports medicine surgeons and as a result, we tackled arthroscopy first, but we are quite confident that after this first entry point we can make some modifications to the scope for a lot of other endoscopy applications.”
The company also offers a green recycling program as an add-on to its device and services. They have identified a solution to reduce the waste stream with a 100% LEED compliant recycling program for the disposable devices.
“We’re excited to finally be in a position to deliver on the promise of our founders and the many people who have worked very hard to see this come to fruition,” Lord said.