Clinician Insight Series 2, Episode 2
Welcome back to our conversation with Jeff Erenstone, CPO, owner at Mountain Orthotic and Prosthetic Services, and Andrea Cutti, CPO, Applied Research Manager at Centro Protesi INAIL, experts in O&P digital workflows.
If this is the first time you’ve heard about Clinician Insights, welcome to our conversation with trusted O&P experts to get their perspective on the trends, developments and research happening in clinics across the globe to provide patients with better fit, more comfort and the best possible experience.
This episode is a primer on the AOPA Socket Working Group. The group came together in 2020 to develop evidence-based best practice for the O&P community, with a focus on prosthetic socket structural analysis.
With the potential for positive change created by emerging digital technologies, we’ve asked Andrea and Jeff to share why the workgroup was formed, and how O&P professionals might expect the aims of the group to support their clinical practice.
Today’s conversation should prove interesting to anyone who’s curious about how leaders in our field are collaborating to ensure that new technology can be sustainably deployed and sensibly scaled in clinics, and some of the questions to ask ourselves as we adapt to innovation.
Andrea - Our first motivation is to be able to provide patients with a custom-made product. I want to be confident so when a patient tells us ‘I want to do weight lifting, can you make me a socket?’, I should have an understanding of how I should make the socket for him to be safe weightlifting or training every day for six months, and for going to the Olympics.
The second motivation is to establish simple guidelines for internal production. So, we want to find a way to make sockets that can be simple for the operator, also saving materials and in doing so, respecting the environment.
The third motivation is that we want to have a better understanding of how to introduce new production methods and new technologies. Let’s say I want to introduce 3D printing, and maybe I want to introduce a new thermoplastic material to do sockets and I want to set a benchmark to then compare new technologies and this comes from a very practical story- So every time we try to engage in discussion about new materials and manufacturing technologies, companies providing materials and technologies always ask: exactly what do you want to do? What mechanical strength? What is the cyclic strength? What are the forces that should be applied? So the idea was really to say, shall we make the effort to agree on the methodology that we can all apply to test worst case conditions to have a baseline?
The final motivation was to say, the law is basically telling you that, at least in Europe, that even for custom made products, you need to have an understanding of what might be the ultimate strength and the cyclic strength of the product that you are trying to develop. It is very important to establish this methodology.
We were very glad to hear about the interest of many other people in these motivations, and we are grateful to AOPA to really consider this as an interesting topic and to really engage in starting this guidance group to have an open discussion with all stakeholders, from patients to prosthetists, to companies to clinical providers to researchers.
Jeff - It's been recognized for quite a while that there is actually no socket strength standard. It hasn't necessarily been a problem in quite a while, because the general design of sockets is a methodology of making either vacuum forming thermoplastics or laminating carbon fiber or fiberglass.
We went through a trial and error process years and years ago to figure out how strong those carbon fiber and fiberglass sockets needed to be and more or less we've been making them the same way for quite a while.
In recent years there's been two different advents. One is 3D printing, which is a new way to lay down material and can be much more controlled in how the sockets can be engineered. At the same time, you can't control it unless you know how strong the socket needs to be, so there's an opportunity and an advantage in 3D printing that can't be utilized without some form of understanding in the standard methodology of how a socket should be made.
There's also some of these frame style adjustable sockets that have strength members and flexible members built into them. Well, that's more that we don't know; how strong those strength members need to be, and how much can be adjustable in the sockets. So those are two different things that have come forth in the last say 10 years or so that are very much being hampered by the lack of understanding of how strong the socket needs to be.
For those reasons, It was just very obviously clear that we needed to figure out some way to help practitioners know if that 3D printed socket is strong enough. So that was sort of the motivation behind the creation of the Socket Guidance Committee and it turns out there were quite a few researchers who have been quite interested in this for a while, and we're excited to kind of jump in and see if we could figure out all the individual factors that we need to take into account to create a standard.
Now we’re calling it the Socket Guidance Committee because we don't feel like we're in a position to create standards; that's much more of an ISO thing. Not only that, there is a concern that needs to be addressed before you could create a standard, which is that most standards have a device test that generally requires expensive machinery, and frequently requires taking a device to destruction testing to figure out its strength. Well, we can't.
It is not feasible to require that every individual socket that's custom made for a patient gets tested like that. It's not feasible to require every clinical orthotic and prosthetic practice to have this expensive testing equipment nor take everything they make to destruction to test. So in some ways, I think what the standard would need to be is more of a range guideline. That's why I'm saying it as much more of a guidance than a standard, even though I do believe that a standard could be written kind of like a guidance.
Andrea - I expect patients to receive better products and be more comfortable. Their sockets will require less effort to use, respecting their skin and soft tissues more, decreasing pain and improving their quality of life. Our patients should really be confident in what we do even when we propose new technologies, new methods, and new ways of providing our services. They should be confident and be able to carry out their daily activities, whatever they are, from sport to walking, to climbing mountains and running.
For the innovators, I think it's a very important piece of information that is coming up because you have a way to test your state-of-the-art and then prove that you can actually give an improvement and respect the quality of product that we can provide.
So we can talk numbers and not just qualitative opinions. We have a solid base to then pave the way for future developments in technologies, materials, and really completely new ways of thinking about sockets.
I also think there is a benefit for companies to embrace that because they can prove that they do things right, and that they have all the paperwork done properly.
Jeff - For the patients and the clinicians the benefits are that there's new innovations out there that could benefit the care that's being provided to the patients. There are also new workflows that make the practitioners’ care more efficient and more streamlined, and give the desired results more often with less iteration.
At the moment there's this roadblock preventing a certain amount of people from moving forward into these new technologies because there's such an unknown.
There's also other stakeholders. For researchers, how do you conduct research until you understand what you're researching, what you're trying to accomplish? So that's another group of stakeholders that would greatly benefit from this. You know, there's very interesting research that can be done that has been limited because we don't have this piece of information.
Then there's also regulators, associations and governing bodies who see this technology, understand that there may be some benefits to it, but don't know how to regulate it and how to make sure that these things are safe enough or that the benefits are clear enough. It would be hugely negative to the field if a regulator decided well, because we don't have enough information, we're just going to disallow this innovation or apply unnecessary regulations. So in some ways, the more that we know and could self-regulate, the less that the regulators need to use their sledgehammer approach.
And that’s where we’ll pause our conversation for today. I’m sure you’ll share our thanks to Jeff and Andrea for such an insightful explanation of the considerations researchers and clinicians are collaborating on, all to bring innovation to patients in the safest and most-suitable way possible.
Recently published discussion on mechanical testing of transtibial prosthetic sockets has proved to be an enormously rewarding collaboration featuring Radii Devices’ Joshua Steer and Alex Dickinson together with Andrea, Jeff and other colleagues from the Socket Guidance Working Group.
If, like us, this conversation has left you wanting to find out more, you can join us back in conversation with Jeff and Andrea next time. For our final installment of this series we’ll turn the talk to the role of data in socket design and patient experience.
Clinician Insights is an ongoing conversation; we’d love to bring more colleagues in to share their insights. You can join the discussion, comment or tell us your thoughts by getting in touch:
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Until next time!