I'm sure it's the most important ones are red. I'm a founder of a startup company as listed there. So I wanted to talk a little bit about the innovation cycle. So when I think about innovation in medicine and orthopedics in particular, I think that we start with our standard of care. We do studies as Rick just talked about, where we look at how are we performing that standard of care and what are the results there? And we can take that information and then use it to invent or discover new ways to maybe do things better. But that idea is not enough. You have to take that idea then through proof of principle, things like proof of value, products and services, and then figure out from your different things that you test in product and services, what might be the best practice, and then introduce that back into clinical practice for your idea to make an impact. So in orthopedic innovation, we try to do this all the time. So we often start with basic science and prototyping. And we usually can get through this phase in the academic world. And we did this with the Bayer procedure. And I thought, oh, great, we've got a prototype. We're good to go. Industry should be here and they should be super excited about this idea. Somebody's gonna come and take it through the preclinical assays and the FDA work and the usability and then commercialization. But what really happened, what we found, was that industry was really over here. And so we were stuck in what has been referred to earlier today as the valley of death. So how do you bridge that? So we looked at how other places who do great innovation do it. And one of the things that came to mind was NASA. I mean, who else does totally impossible things? And so they have this wonderful system that they call the technological readiness levels. And it's a way that they systematically approach innovation and how to get innovation from an idea to a planet. And I really liked how they brought this, how they divided this up into these phases. Now in each phase, there were some key parts. So at the beginning of the phase, they identified what they wanted to do. They identified a team that they needed to be successful. And they pre-identified what success would look like before they even ran an experiment. Then they would go through that process and decide at the end, did the data justify going to the next level? If it did, they went on. If it didn't, they repeated the level. Or sometimes they abandoned the project. So in orthopedic innovation, I think about it this way. Traditional orthopedic research really embodies looking at basic principles and possible solutions and even sometimes getting to proof of concept of an idea. Industry is down at the technological readiness levels eight and nine, where you manufacture a proven product and then the products used routinely. And so what we wanted to understand was, could we, in academics, do the middle four steps, the optimization, the testing in the model, the prototyping? So bridge-enhanced ACL repair is a technique that we worked on for a bit of time, where instead of replacing a torn ACL with a graft of tendon, which is an ACL reconstruction, we wondered, could we somehow use a scaffold to support ACL healing? And at the time, we considered that we were at TRL three, proof of concept. So our next phase that we wanted to go to is technological readiness level four, or optimization. And we had some different elements of the technique that we wanted to optimize. So we wanted to optimize the scaffold. We wanted to optimize how we fixed the knee to allow healing to occur in the early stages. And we wanted to identify what biologic element should we put in the scaffold to stimulate healing. And so we did a series of experiments to optimize these three different parts and came up with the construct that's noted here. So once we had that, we then went to testing in the model environment, or level five. We wanted to develop a model that was as close to the human condition as possible. And we elected to use the porcine mini pig. And we wanted to measure key outcomes in that model with our technique. And the things that we thought were most important were the mechanical strength of the healed ligament and whether the animals developed osteoarthritis or not. When we had success in that area, then we had to build a prototype. So in our case, we had to go from something that we were making under kind of laboratory conditions that we could use in the porcine model to something that could actually be used in a human trial. And so to do this, we set up a lab that was under GLP conditions. And we conducted multiple different types of safety assays for the FDA and then prepared and submitted our IDE application, which you can see here in the top right picture. And so once we were able to do that and get FDA approval for our first in human studies, we were ready for technological readiness level seven, which is testing in the model environment. And so this is where, for orthopedics, this is where we want to test things in clinical trials. So we designed these trials with the approval of the FDA, starting with a small study for safety and then moving to a pivotal study for efficacy with patient reported outcomes and structural measures included. So with this project, we were able to get through those middle four phases of technological readiness to get to where the actual system was built and the system could be used routinely. And we were able to successfully translate this idea now into industry where they're taking it forward for building the system and using it routinely. So in summary, bench to bedside, I think going from an idea to routine clinical use can be done in a fairly systematic fashion. And even though industry may be way over here and we're more used to just getting through the in vivo models and face this valley of death, I do think that we should be able to build this translational pipeline where we can do in vivo modeling, preclinical assays, and really get through early clinical trials in academia. And hopefully we can work with other people to do this for other projects now, now that we've been through it once and make this something that is more routine so we can get more things out of the lab and into actual practice. So thank you very much for your attention. Thank you.

Dr. Heather Roberts

innovation cycle

medical field

orthopedics

technological readiness levels