Male: This product really got started in about in 2008 when the Jaipur Foot Organization approached a class at Stanford and asked them to help redesign a better knee joint from what they had been using before. Which was this guy right here. It's a very simple device very low cost, very cost effective but it performs pretty poorly. It's very mechanically unstable and pretty simple and so the results of that class project was a poly centric knee as their called. which is shown right here installed in the full And the nice thing about this is that it's just a little bit more stable.
but we were able to do it still in a low cost way. And the first patient started being fit with this in 2008. And shortly after that myself and a few of the students from the original class decided to form the Remotion Project. And the goal of that was to take it from, just having impact with the Jaipur Foot Organization to something that could scale globally and really meet the true need all around the world. Krista Donaldson: So, this is...this is the original one leg venture that the knee that they were using, and it's a single axis. So, just think about how the knee is rotating around the axis like a door hinge And then you have this, which, the students did, which is a poly centric mechanism, which is just a four bar mechanism and, this mechanism has been around for a long time.
Do you know how long? Male: About 15 years. Krista Donaldson: Yeah. So it's been around for a long time and I think the key innovations jump in. Is that they were really thinking about like how do you produce it, how do you mass produce it in a high quality way out of plastic. Male: Yeah. So most of the knee joints that have been, used this mechanism before were either made out of titanium or stainless steel. they're very strong but they're also not the best for the kind of context that you have in developing world. a lot of heat, a lot of moisture, and especially. Krista Donaldson: Dust. Male: Dust. You can see that one's kind of dirty right here.
But most importantly titanium is really expensive. And so the big innovation of the class was figuring out well, how can we make this same kind of mechanism but do it out of plastic. That might be a little more low cost and easier to manufacture. Krista Donaldson: This is a knee in the leg system. So, you have the foot which attaches to a pylon, which attaches to the knee. And then this attaches to a socket. Male: Mm-hmm. Krista Donaldson: and the knee is the most complex and expensive component of this whole system. Male: Mm-hmm. The knee is a really tricky component, because if you think about a knee you need it to do two very different things.
You need it to be stable while you're putting your weight on it and not bend. But then when you want it to swing it needs to then bend very quickly. And so you kind of have to ask it to do two very different things in a very short poeriod of time. But the biggest thing about a polycentric actually is that. It's sort of, so a single axis knee just kind of rotates about one point. A poly-centric knee almost slides as it rotates, so it kind of, we can see it moves backwards and then slides, or and then rotates, which is actually how the anatomical human knee, how your knee and my knee works.
not quite with having a bunch of bars like this, it gets it in a different way but it has the same kind of motion. Krista Donaldson: And so, one of the things that we know from early field work, though, is that clinics already were using some of these knees but they were used. The challenge, of course, with used components is a process wouldn't get all of the same kind of knees and also they wear unpredictably. So it's a bit of a challenge being reliant on these used products that come in, that are in various stages of disrepair or refurbishment.
and then weren't originally designed for that environment anyway. Male: Version One was launched with us in 2008. and since then about 4,800 patients have been fit with the Version One. And we've been really happy with sort of the stability and the performance of the knee. And, going into it, we thought that a lot of the feedback would be related to those kind of performance. You know, people saying I can't walk up stairs, it's real easy to walk down, or maybe like a hill is okay but this is not. But in actuality, all of the feedback was almost related to how it looked and how it made them look as an amputee.
And so, we found that there was a pretty big, in India there's a pretty big social stigma. And this is common in many places in the developing world. there's a social stigma on being an amputee. And so, not for everybody, but a lot of people's goals was just to sort of not be have attention called to themselves as an amputee. And so one of the big things we saw is that this sort of blocky design at first, while it was really nice for manufacturing because it was very easy to produce, It produces these, sharp corners that kind of stick out from your pants if you were wearing or a skirt or a dress over it.
And that's not, you know, the most natural-looking thing. The other one, and this is probably the most consistent feedback we've heard, is that when you're walking along, (NOISE) it has this really loud clicking sound, which kind of just. Krista Donaldson: Even without the echo of the, the socket. Male: Even without the echo on top, yeah, with your stump in it. It's, it's softer but still pretty, pretty jarring. And it serves just this kind of, like, a warning noise. Or, serves to call attention to the fact that you are an amputee or something else is going wrong. And so when we went to version two, those were principle among the things that we wanted to change.
And so not much changed with the kinematics or the mechanism that we were using. But we implemented sort of a curved front, to make it look a little more natural while you're wearing it under pants. And then also, a noise bumper, just to sort of cut down a little bit on the amount of noise it's making while you walk. Which, a lot of people really appreciated. Krista Donaldson: And we have, we have user images of people trying to do noi-, home-made noise bumpers in the knee. Male: Mm-hm. Krista Donaldson: And also we've had a lot of amputees who, you can see, have put padding around their knee.
To kind of mask the fact that they have a prosthesis. Male: Mm-hmm. And as a, when you're trying to design a product like this that's sort of, that's the most, that's the best feedback you can get is when people are modifying their own device. Like that's a clear signal that that's something that they care about. And that's something we never would have found out at a gate lab here in the US. You know, we had to get it into. the hands of the patients that were actually cared about and were trying to help, and in order to get that type of feedback. and as designers we have to prioritize that, even though on paper it may not seem like the biggest user requirement, especially if I personally, as the person doing engineering was not the one to hear from the patient, just how important this is.
If I just saw that as a requirement on paper I might think it's more important that they can walk up stairs. That's a secondary thing. But when you go out and talk to users, you see, no, this is a number one. Like, this is the primary thing we need to work on. And if people don't like it, then all of the engineering I do on the kinematics is not going to matter. Because they're not going to wear it. Krista Donaldson: So for example people are sitting or squatting, and the range on this knee is much greater than most other knees. Male: It gets to about 165 degrees.
And that was really important because in a lot of these settings people are having to use pit toilets, they need to spot to go to the bathroom, or even just as part of prayer or other cultural activities that may not be as normal here or the norm for a posture that you would use. And so we had to use, or had to make it bend to high degree, about 165. which, coincidentally also let's people bike, which was not something that we intended, but a really great side-effect of, of sort of designing for squatting.
Now people are able to ride a bike, which is pretty, pretty popular and predominant in, India and China, and other places in the developing world. We started out with CNC and that was by far the best choice while we were prototyping because you can make changes very quickly. CNC is basically just taking, CNC machining is you take a hunk of plastic. And instead of building it up, you cut away the parts, until you have what you need. which is why it was really nice to have this sort of blocky design at first. Because you know, that's a simple cut. You just swoop it once there and then once in the back and you're done.
Long term though, that wasn't the best option, in order to scale up with CNC machining. We would need either thousands of machines, or have them in many different locations which the ability to control quality across many machines at many locations that's impossible, really difficult, or expensive at the very least. Krista Donaldson: Well least expensive any way because your removing material to get to really what you want. Male: Yeah it's a low volume processing so each, there's no real set-up cost involved, but the unit costs are very high.
Once we have a design that we know will work long term, the, the goal is then to switch to injection molding, which gives us a lot of advantages. You can, and so that's sort of the main difference that we have in, now in our version three design. is that it's produced by injection molding rather than TDC and so the biggest benefit is that you can produce a high volume of parts. They are very consistent and so you can manage quality fairly easily. They can be produced all in one central location and the cost is very low in volume per unit.
The setup cost though is quite high. You have to design a set of metal molds that. when they come together, they form a cavity that forms the shape of the knee and then molten plastic is basically injected in there, then it cools and then pops back open. So, cutting those molds is very expensive, but then once you're at a finalized design, you can pay that up front cost because you know that will be producing a huge volume of parts. And so we could incorporate a lot more, or a lot more advanced design aesthetics. We good have curve services and, you know, thin flowing lines as opposed to these sort of blocky structures we have in the version one.
Krista Donaldson: And we can useless material, too. Because you can build it structurally a different way. I think another thing that is actually key about this kind of manufacturing, is this may not have been possible ten years ago, in terms of getting the product to users. So, the shift from making products locally still makes sense in some places but now that we live in a more globalized world and we can get products really to any part of the world. The priority really is this high volume, high quality and that's the key thing high quality and affordable price. I think the affordability and quality aspect are from the very beginning.
Like, we believe that you can design high quality, high performance products at a price. And, in some ways, it doesn't really start with the knee design, it starts with users, and what the users can afford to pay, because if they can't, if the clinics can't afford to purchase these knees, nobody's going to wear the knee, no matter what the quality is. So, understanding what the price point is. And then using that moving backwards to, to design a product. Male: And I think a lot of it is just making sure that having a high design aesthetic or something that's desired is a priority on your requirements.
And so not that it's secondary. It has to be just as important as making a well engineered product or something that lasts long. because again if someone doesn't want the product or doesn't feel like it's a quality device, they're not as likely to buy it and then. Put it's sort of impact to work. Krista Donaldson: I think one of our core tenets is we believe that you can have something that's beautifully designed that doesn't cost extra. It doesn't cost extra from a retail standpoint, to actually design for a beautiful, to have a beautiful thing. Male: Which is why processes like injection moulding are really nice, because it lets us incorporate that high design aesthetic but not actually drive up the unit price.
Krista Donaldson: And you can see we learned a lot of lessons going from here to here to here. And I would say one other lesson we learned from V2 to V3 is we got feedback about the weight of the knee and also the width of the knee. And some users didn't notice at all, then we had some users who were like this might be fine for you Westerners, but we're a little bit smaller here. So this knee is I think, about, it's 26% narrower? Male: Yeah. Krista Donaldson: Narrower, yeah, so there's a noticeable difference when you're holding them.
Male: So, we just did our first and sort of high volume run of injection moulded parts creating the version three design. And now at the phase we're at, we're trialing those designs with a few different clinics around the world, making sure that everything's going well before we make any design tweaks, do the final testing, and then go to full production. Krista Donaldson: And then they give you an idea where we're with all of any of the knees this knee is worn by over 4800 amputees right now. We're hoping 5000 soon.
and fans in nine - ten countries, the list's on the back. (LAUGH) and this is to our partnership to the Jaipur Food Organization. And they are able to use this version of the knee with all of their clinics. And then this was this version Tuni was tested with a small sample in Ecuador and really what we were trying to do was understand the features and how well they worked. And now this knee is being fit and it's scaling up right now with the trials. Male: When we're thinking about our design approach for impact, we factor in not just the design of the product but the design of the business model and our choice in that distribution model from a very early stage.
And so when we were looking at the knee, I can give you an example of that. We sort of had, the field was wide open and types of which models we could choose to scale up the knee but we knew pretty early on that we weren't going to choose a model such as you know, us going in and setting up prosthetic clinics in individual countries. Because if we were, to do that you know, it'd probably be five years before we were out of you know, one neighbourhood. Rather, let alone into global scaling. And so we made a conscious decision to work with prosthetic clinics that are already existing and have the capacity to and the ability to fit patients locally and deploy these sort of on the, the very final leg of the last mile.
And so that really influences how we set up our distribution model, knowing yes, we can produce things centrally because we have to get them and ship them to individual clinics rather than individual customers when we're in scale. Krista Donaldson: So where we are now is that this is starting in field trials, and we will learn some lessons about, it is a product. We'll learn about how users are using it, and then the next step is. Male: Next step is we hope to be on the market with our final version and full production set-up by the end of 2014.