PERSONALIZATION AT SCALE

Cambre Kelly is the co-founder and Chief Technology Officer at restor3d, a provider of 3D printed personalized surgical solutions.

On a recent episode of the Additive Insight Podcast, Cambre shared her insights on additive manufacturing in the healthcare sector, including the product range restor3d offers, its vision for scaled personalization, and working with the FDA.

TCT: Alongside the recent announcement of the Kinos Total Ankle System, there was the launch of the r3id Personalized Surgery Platform. What does this platform offer to medical professionals?

CK: So, the platform enables our surgeon collaborators to work directly with our engineering team to facilitate that patientspecific design process.

Before the launch of r3id, that was conducted in what I call an offline process and what we've brought to the table with the launch of r3id, which is both a web and now a mobile companion app for both iOS and Android, is the ability for the surgeon to collaborate with the engineering team at restor3d directly.

So, upload CT scans of the patient preoperatively, provide us some information about the case and the patient that we need to go ahead and start our design process, and then facilitate the patient specific process through the portal all the way through, getting ready for manufacturing, and then ultimately shipping the products out for surgery.

The other kind of great benefit of the system is that it acts as a repository for an individual surgeon's case library and so they can go back and access their past cases on the fly. And remember, ‘oh, I did this case with restor3d a couple months ago, I have a patient that might be a candidate for something similar,’ and refresh their memory on what's going on, or if they're preparing for a podium presentation or a series, they can aggregate all that data together. And that's been a really exciting feature of what we've rolled out that surgeons have been very positive on.

TCT: Earlier in our conversation, you mentioned the concept of scaled personalization. Can you provide some insight into the infrastructure required to enable that?

CK: One of the more common objections that we might see from people in the market saying, 'this is great for personalization at this level, it’s great for some really complex reconstructions, but it's not something that can be applied to every case in orthopedics,' and our team feels very strongly that that's not the case. Our vision is to make this a scalable operation. So, that includes scaling both the front end design aspects as well as the manufacturing operations as well.

I mentioned [earlier] we are moving into a new facility. And the intention there is to bring scale to our manufacturing asset to unlock that vision. Then the other component is to bring more digital aspects to the front end of the process.

Our first step into that space is the launch of r3id to make the process streamlined and frictionless for the surgeons and our team, as well as trying to bring some more automation and streamlining the design aspects of what our team does. So, the more that we can bring automatic segmentation, automatic design, these sorts of aspects to what we're doing on that business, we'll be able to truly unlock the vision of scaled personalized orthopedics.

TCT: How much of a hurdle does FDA clearance, for example, become when you’re doing scaled personalization?

CK: I think there's been a lot of great collaboration and conversation in the last year or two around point of care printing and what that looks like and FDA has laid out some really interesting framework, from their perspective and solicited some feedback from industry and others.

And so, we've been very fortunate to collaborate with FDA. Really try to understand from their perspective, how can we do this at scale and be compliant in the regulation? So, that looks like designing envelopes that encompass some of the patient specific aspects and features of what we might want to do for a given device and being really thoughtful and collaborative, like I said, with the agency to be able to do this.