Corrections dept.: The feature article about 3D-printed prosthetics in Amplitude‘s current print edition includes an unforced error. We misspelled Chris Hutchison’s name as “Hutchinson,” with an extra “n” before “son.” The web version of the article now reflects the correct spelling; Chris was extremely gracious about the mistake, but we’re still red-faced about it. Shouldn’t have happened.
It’s a name you may be seeing more often, because Hutchison’s pioneering company, ProsFit, is poised to start doing business in the US before long—maybe as soon as this year. The Bulgarian company has spent the last half-decade rolling out its innovative scan-design-print socket solution at partner clinics in Europe, Africa, and Asia, along with a Canadian affiliate or three. Based on early returns, ProsFit’s model has shown the ability not only to improve socket fit but also to bring prosthetic care to people who previously had none at all. “We’re trying to completely remove the barriers to getting prosthetics as an amputee,” says Hutchison, a bilateral amputee and certified prosthetist who owns the company with his father, Alan.
But the US healthcare system is its own special beast, a regulatory and financial obstacle course that must be navigated with great care. “It’s more important for us to do it correctly than to do it quickly,” Hutchison says. In addition to taking all proper legal and corporate steps, the Hutchisons are going out of their way to enter an unsettled marketplace with as much finesse as possible. They hope clinicians will embrace the ProsFit solution as an opportunity to eliminate bottlenecks, serve more patients, improve amputees’ mobility, and establish a sustainable business model for the 21st century. The danger is that potential partners will regard ProsFit with suspicion, viewing it as yet another wildcard in an industry that’s already full of uncertainty.
The conversation below is a mashup of two interviews conducted a few months apart. Learn more about ProsFit at their website, prosfit.com.
What’s the current timeline for launching ProsFit within the US?
We’re lucky in the sense that we’re an international company, and we’re operating in many different markets right now. We’re learning a lot from different places and experiencing some interesting market developments elsewhere in the world. The US is obviously is a key market, but it’s a complicated market.
The order of operations is slightly different in the US than in Europe. As a European medical device, company, we have a very strong responsibility to know where our devices going, that they’re being used in a way that is appropriate to the local market regulation, and so forth. If we were to allow a professional in the United States to start ordering devices in an area where we’re not regulated, we could be held responsible by European authorities. We’ve prepared all of our FDA paperwork. Everything’s basically ready to submit. From our perspective, though, the earlier you do that, the earlier you also tell the world about some of the details of what you’re doing. So we’re prepared to sit on that until we know all the other pieces are in place and everything’s ready to flow according to plan.
The company is actually celebrating its 10-year anniversary this year, is that correct?
The idea for ProsFit and our initial work to get to get a solution up and running began in 2013. But I’d like to back up a bit before that. I was in an accident in Switzerland in 2009, when I was 17 years old. I was leaning against a train, and when it pulled off I fell between the train and the platform. And that very quickly made me a double amputee.
Our subsequent experience was that it was very difficult to get comfortable prosthetics. And this was in Switzerland, which is supposed to be somewhere near the top as far as access to health care. We thought, “There has to be a better way to do this.” And we were having the best experience possible. There are people all over the world, 20 million or 30 million amputees, who don’t have access to any kind of service at all. So we began thinking about it from the perspective of a globally scalable solution that can be rolled out effectively.
We put our focus on socket comfort because, based on experience, that was really the critical bottleneck in the process—but also the most important piece of prosthetic care for any amputee. And our focus from the beginning was on digital technologies and solutions. We established the company in 2014, and in 2015 we ran a clinical investigation in the UK through the NHS. In early 2016 we introduced the first fully implemented and regulated commercial solution for 3d-printed socket manufacturing. So we’ve been in this game for a few years.
How did you happen to choose Bulgaria for a base of operations?
We had visited Bulgaria even before my accident. After I lost my legs, it was kind of a tough time, and some friends there called and said, “You look like you need a holiday. Come and visit us.” We just fell in love with the place very quickly, and we ended up moving three months later as a family to Sofia, the capital. And that’s now more than 10 years ago, in 2012.
If we hadn’t come to Bulgaria, I don’t think we’d be doing what we’re doing. It turned out to be the perfect ground to start a business. We were in an environment that was very thriving and entrepreneurial. Historically it’s a very scientific country, and the cost of doing business here was about a fifth of what we were used to in Switzerland. So when we put together the business plan, we realized: This is doable here. So why don’t we just do it?
3D-printed prosthetics almost completely untested at that time, at least in a clinical sense. What was the reception like?
We realized that we had to go out and find the early adopters, especially at the beginning. So we looked for people who were already doing innovative things—individuals who are more entrepreneurial, risk takers who are willing to say “This works, I’m gonna go and go and do it.”
At a certain point we set ourselves the challenge of who would be the ideal partner to help us scale up to serve a larger share of the market. We started working with HP on the 3D-printing side, before they even came into the industry. We started working with BASF on material development, Oracle on machine learning. In 2019 we were invited by the World Health Organization to participate in a global conference on assistive technology. We were actually the only company from the prosthetics industry that was invited to participate, and we were able to give a presentation on the health economics and return on investment of our model. In low-middle-income countries, we were showing very easily a nine times return on investment. In high-income countries, the return is quite easily 30 times.
Do you feel as though the 3D-printed sockets are still in the proof-of-concept phase? Or is the industry ready to take the next step?
The challenge is to open up the model and make the whole system more flexible so that it’s better for the amputees in receiving care, but also provides better opportunities for professionals to do things that are more entrepreneurial, more hands-on. If we shift out of using only the traditional footprint of clinics and move toward what we call distributed care, that enables much greater flexibility. We have mobile points of care in Bulgaria where we can fit patients with a very high success rate, and the whole transaction happens very rapidly. A prosthetist can show up to do the scanning, take some measures, and collect some data. Five days later, he can come back with the sockets. And we’re fitting people who’ve been off prosthetics for years and have given up all hope. It doesn’t take multiple trips into a clinic and weeks of waiting around.
What seem like relatively small changes can have very highly leveraged impacts on the final result. That’s what I hope will come from this. If you make sure someone doesn’t drop out of the system, you make sure that they’re actually seen and provide them with a solution, these things actually have really big impacts downstream.