restor3d | Ken Gall, CEO

By combining expertise in 3D printing with advanced biomaterials and artificial intelligence, restor3d is creating patient-specific orthopedic implants to reconstruct and repair the human body.
Speakers
Ken Gall
Ken Gall
CTO, restor3d

Ken Gall  0:00  
Hi everyone, I'm Ken Gall, a professor at Duke University and also the CTO and Founder, co founder of restor3d. At restor3d, our focus is personalized musculoskeletal surgery. If you look at the past, the way orthopedic reconstructions were done, it was really a patient specific need. And it's almost always been a patient specific need. But we've used sort of a brute force solution. I'll give you one example. And this is of a very simple reconstruction in foot and ankle. So if you have flat foot just means that essentially, you need an arch restored in your foot to recover to look at flat foot that usually I get a radiograph or a CT, the doctor then diagnoses you with flat foot, you get that diagnosis, and there's some angle missing from your foot or the arch, then they bring in, they take that CT or that that diagnosis and throw that out. Surgeons don't use that, again, they've just sort of identified the problem with that, then they come in and bring in all of for the surgery, these very large instruments sets that have all kinds of different options for the reconstruction, different angles, different sizes, and that is essentially what is used in the surgery. That results in a reconstruction that's been kind of planned during the surgery. We think at restor3d, the future is going to be different than this. And so I'm going to show you an example of a reconstruction of a very complex reconstruction that has to have pre surgical planning. And you can argue in the case of flatfoot, you don't have to pre surgically plan. But part of our thesis is that pre surgical planning will be a part of all many of these surgeries. So this is an example of a very complex surgery. This is an osteosarcoma or chondrosarcoma of the foot. And this is that you start with a suit CT image of the foot, we then come in and mask that and segment that. So we break down all the bones and figure out where the bones are, where they're positioned, we convert that into a three dimensional model of the anatomy. We identify the, in this case, the chondrosarcoma, and then we realign and reconstruct that and develop a surgical plan. In this case, this revolves a resection of the bone. We do that we plan and 3d print instruments for that case, specific to that patient in that resection. And then we design and 3d printed implant, the entire implant here is printed. And that implant contains both articulating components contains bone attachment points, sometimes soft tissue attachment and things that will osteointegrate to the bone. And this is an example of that complex case. And so this is happening today. 10 years ago, this was not happening. But we believe that part of what we want to do as a business is take this pre surgical planning and take this osseointegrated materials and bring that into more different types of surgeries that can benefit from this.

So that requires a couple of different market approaches. And so for one, prior companies that I've been involved with, and many orthopedic companies have been very channel focused, not clinical solution focused. So they've not projected their clinical solutions over lots of different clinical problems. For example, I had a company called Med shape that was acquired by Colfax Cgo, we were very stuck in the foot and ankle space, because our channel was foot and ankle and it was hard to take our technology and build it out. I founded a company called for Vertera Spine, which is acquired by NuVasive, that that company was also focused in one specific area of the body restor3d, he's taking a very different approach, we are instead of being focused on what is the channel we're going to sell to, we are working directly with the doctors to build products that are in all kinds of areas of medicines, particularly in orthopedics. And then we use that to then define our channel and our selling partners. And that's allowing us to cut across many areas. So we have a very in that sense of very customer centric model. This is a model where we can actually work with the surgeons directly. We still have sales reps, we still require people to help us sell the products in certain situations, and have helped cover cases and do things. But we're not built a building our business because of that we're building it because of the needs the surgeons have. And this is an example of the type of hospitals we're already working with. We get the number one question and this is kind of the last thing I'm going to show you sort of straight to the point, the number one question we get is, that's great. How do you scale? And I think it's a great question, because that's the center of our sort of hypothesis that this is scalable, into other procedures, not just the very complex procedure I showed you. The first thing is you do need materials in sort of a digital design platform. So for example, if you're going to add an osteo integrative material to one of your implants or some type of structure, this osteo integrative material has to be easy to add. So you see a lot of companies and orthopedics they have little miniature trusses and different things that they put in their implants. These are not easy to scale or fabricate or make it in a simple way you can make that truss over and over it's it's the same exact thing, but we've developed materials that have the right type of isotropy and the right type of structures. They're easy to print in any orientation and expose any surface, which allows you to add them quickly to the material. And this is something that's pretty essential, it's been overlooked. You also, and this is a big change for orthopedic manufacturers, you have to have the capabilities in house, you if you don't have the capabilities in house to do the 3d printing, and this includes both instruments and implants, the difficulty you have is that you're going to have troubles with lead times, you're going to have to work with suppliers that will give you eight to month lead times and you're going to have surgeries, sometimes that happen in four to six weeks. And so you have to be able to have a flexible just in time manufacturing schedule, and a quality system that accepts that. And so that's what we've built the restor3d The last three years. And then the last one of the biggest time consuming aspects of of taking this and scaling it from a very large, complex, expensive implant to something that happens more routinely, but could still benefit from the personalization is really the design process. And so when you start to when you do look a case that is a one off, and it's very, you know, you can have an afford to have one engineer to help design that with the surgeon. But when you have cases that happen 10 times 100 times 1000 times, and there's only small differences in what's happening. But the personalization still matters, you do have to start using algorithms and other types of ways to try to bring in the decisions of the past cases, and also bring in the clinical results of the past cases as well. So we've just started printing and developing our first cases that have been designed by an AI program that actually is built off of what our engineers had made decisions off of the last 100 cases. And we think that's some of the future to scale this is that to you have to have these automated tools to do that. So that's all I have for you today. Thank you for coming. I appreciate the time and I think that as far as follow up what we're looking for, we really want to change the face of orthopedics and so we're looking to connect with anyone who shares that vision in any way. So thank you


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