How Additive Manufacturing Can Bring Prosthetics Care to Millions in Need – Interview with ProsFit CEO Alan Hutchison

Founded in 2013 ProsFit Technologies is a Bulgarian company that leverages digital technology to improve the fitting of prosthetics for people with limb difference. It has developed and successfully built a proven and market-ready platform solution for the industrialised design and additive manufacture of regulated custom-made sockets, at scale. Its solution allows custom-made device design and specification, as well as the configuration and alignment of the full prosthesis. In an interview with 3Druck.com, CEO Alan Hutchison shares his insights into the prosthetics sector and explains how additive manufacturing can help provide prosthetics for millions in need of improved mobility.

Significantly outperforming traditional industry benchmarks ProsFit’s solution provides an alternative to the conventional manner of obtaining a prosthesis, greatly reducing the time and challenges associated with the traditional process, and allowing patients to get fitted anywhere, including at home.

With an increasingly resource-efficient business model, and additive manufacturing partners across the globe, costs are already 25% lower than 5 years ago, and below most traditional benchmarks. Customers, mainly prosthetic clinics, have fitted about 750 amputees in 15 countries.

Architected as an expert system ProsFit’s solution can deploy machine learning approaches, the next stage of development being to populate the solution with a critical mass of data, allowing automation of socket design. This would enable considerable further scale-up of patient care activities, helping the industry to address the current global capacity challenges – only 30% of the World’s amputees have prosthetics, and there’s already a 60% shortage of clinical practitioners.  

Apart from providing a response to the “socket problem” ProsFit’s solution also allows the building of low investment, asset light, digitally enabled, easy to use patient care units, both fixed and mobile, namely PandoPoints. These can be deployed anywhere in both addressed and unaddressed markets, providing outreach to unserved users, even in remote and challenging environments.

Interview with CEO Alan Hutchison

In an interview with 3Druck.com, CEO Alan Hutchison explains how digital methods such as additive manufacturing can bring prosthetics to millions of people in need of better mobility, why establishing industry standards for prosthetics is key to wider adoption, and what the care of amputees and people with limb differences might look like in the future.

In your opinion, what significance does additive manufacturing have for the prosthetics sector and ultimately amputees?

Traditional socket-making is the largest bottleneck in prosthetics provision. It is costly, time-consuming, oftentimes inconvenient and stressful, and the results are variable. It is simply not scalable and economical. Solving this ‘socket problem’ using digital approaches, including additive manufacturing, is key to providing prosthetics and inclusive mobility at scale to millions of people who would otherwise find mobility extremely challenging.

Since 2015 ProsFit’s solution has been successfully deployed to deliver comfortable, robust, reliable and quality medically-regulated 3D printed sockets globally, with a high first-time-fit rate. With certified additive manufacturing partners in most regions, ProsFit is now focusing on global scale-up, including collaborating with partners to provide PandoPoint as a new and alternative market channel.

With limited need for additional capital expenditures, and optimised operating costs, clinics and practitioners adopting ProsFit’s solution and additive manufacturing are delivering improved outcomes, with more convenience for users, enhancing their “Confident Mobility”. Time-to-Comfort (T2C) and Cost-to-Comfort (C2C) are both reduced, and an improved “product-experience” can be delivered in a significantly larger area through accessible and affordable Distributed Care.

To what extent does 3D printing contribute to the availability and affordability of prosthetics?

For prosthetics provision, additive manufacturing is a “transformative technology”, enabling prosthetics provision to be “cheaper, faster, better”. However, adoption of digital approaches, in particular additive manufacturing is constrained by a lack of applicable standards. Although there are research studies showing that 3D printed sockets can perform better than traditional ones, comparative testing needs to be conducted against a standard, giving clinicians confidence to adopt. ProsFit is currently participating in constructing a consortium with the intent to develop such a standard, also allowing sockets to be regulated as medical devices. 

All medical devices, including prosthetic sockets, must by definition be designed to be safe for the user, and there is no reason that this should be avoided in the case of sockets. If anything, the custom-made nature of a socket should increase the legitimate level of control required for safety, as there is more scope for variation to contend with. It’s unusual that one important and life-determining medical device is currently treated as “not regulable”, with little explanation as to why. The very reasons given for why it is “exempt” are indeed the very reasons why it should be regulated. By introducing industry standards and measuring against them, we could turn the tide around. 

There is of course resistance to standards and regulation for sockets. This is driven primarily by a fear of change by skilled practitioners, who have been educated/trained in traditional artisanal approaches. They are concerned that the creation of a standard and comparative testing, may well show that only a small proportion of traditionally fabricated sockets would meet the requirements, further driving attention to additive manufacturing.

And, standards can provide a structured framework within which creative and technological advancements and innovations can thrive. 

Additive manufacturing has continuously developed in recent years. Which innovations or technological breakthroughs do you consider to be particularly important when looking at prosthetics?

There is now a range of proven technologies for the manufacture of custom-made prosthetic sockets, and more than ever, it is imperative that these sockets are regulated as medical devices, with their performance, and ability to meet user needs. It should allow the consistent delivery of high-quality, low-risk devices that maximise user outcomes.

In addition to strength testing a standard should also address factors such as the ability to incorporate user specific designs and features, user outcomes, traceability, and environmental impact, all possible with additive manufacturing.

From an environmental perspective, to fit a definitive socket using traditional processes, including the use of interim diagnostic sockets, requires 20-25 times of the weight of the final socket in plaster, thermoplastics and other forms of material waste for shape capture and fabrication. With plaster mining, transportation, high temperature processes, dust extraction, and the inability to recycle, this results in a significant carbon footprint. If each prosthetic requires 8 to 10 kg of plaster, and with increasing numbers of amputees to be fitted, this really will lead to “moving mountains.” Continuing to use costly, slow, inefficient, and environmentally damaging artisanal methods, is simply not justifiable in today’s world.

Additive manufacturing offers an alternative, not only with significantly improved outcomes, but also much better for all “3Ps” – “People, Planet and Profits”. With scanning for shape capture, and additive manufacturing, with high reusability materials, sockets generate only half their weight in waste. Being significantly lighter, that’s up to 100 times difference.

Equally, 3D printed sockets require 90% less energy, and generate 90% less carbon. As a manufacturing process additive manufacturing/3D printing is ISO 14040/44 compliant, energy efficient, and meets the life cycle-based sustainability standards.

What impact do you think additive manufacturing will have on the prosthetic sector and possibly society as a whole in the coming years?

Disruptive, scalable end-to-end digital platform solutions such as that offered by ProsFit radically improve prosthetic provision, allowing the needs of amputees to be met differently in future.

ProsFit’s proprietary, user-proven and cost-effective software solution for socket design and prosthetic configuration, brings significant benefits – both qualitative and quantitative – relative to incumbent solutions. With radically improved productivity for clinicians, it unlocks the critical bottleneck caused by current socket fabrication methods, enabling accessible and affordable prosthetics provision and inclusive mobility anywhere.

There is a good consensus that amputee care services will increasingly be delivered through digitally enabled Distributed Care Networks (DCNs), each comprising a “Principal Clinical Centre”, with a network of linked “Satellite Centres”, mainly in urban areas. These will be complemented in more remote areas by “Community Service Points” and “Mobile Units”. Equally, approved Home Visits will increasingly be adopted where local healthcare professionals and rehabilitation specialists see this to be the best course of action.

How service providers configure their DCN will depend on population dispersion, and how they can most effectively serve the needs of amputees using available expertise, resources, infrastructure and technologies. As professionals put more and more focus on patient-centred care, additive manufacturing will be outsourced to owned or sub-contracted external fabrication hubs. Additional efficiency will be gained through use of telehealth and telerehab approaches to facilitate patient-specialist communication, and improved clinical decision-making.

Here you can find further information on ProsFit.