January 2019

Orthotic and Prosthetic Innovation: Tempering Enthusiasm with Caution

By Louise Puli, BPO, MPH

My perspective comes from 2 roles: Professional Standards Officer for the Australian Orthotic Prosthetic Association (AOPA) and international lecturer with Human Study e.V., a non-profit organization that delivers and establishes prosthetic and orthotic education in regions and countries where formal and internationally recognized education in this field of medical practice does not exist. Working as an educator and regulator has me considering the impressive potential of 3-dimensional (3D) printing technology, while also recognizing considerations that are required before global implementation.

Technology, innovation, and the professional agility required to adopt change are accelerating at an unprecedented rate across industries. The orthotics/prosthetics industry is experiencing this with new products coming to market at a rate previously unseen. Rapid advancements are occurring at both ends of the technology scale. High-tech, high-cost computerized orthoses and prostheses are becoming increasingly predominant, while lower-cost 3D-printed devices are also emerging at the low end of the market.

In this Editorial, I’ll discuss the application of emerging low-cost technology—in particular, 3D printing.

The Conversation

Throughout the media internationally, excitement and momentum regarding 3D printing in orthotics and prosthetics is captivating audiences. Community members are more exposed to the wonder of this industry along with the amazing career path as an orthotist/prosthetist. One result of media and community hype is consumer demand—and the challenge of managing consumer expectations—along with recognizing the risks associated in the application of this new technology.1 Celebrating community engagement in our industry is essential however, as we are given the opportunity and platform to present the breadth of our clinical capability in support of the provision of safe and effective orthoses and prostheses.

The Challenge

Consumers expect their practitioners to be aware of, test (in clinical trials), and use the newest, most technology, such as 3D printing. As practitioners, we balance this demand by harnessing innovation safely, ensuring that evidence-based practice is maintained.

Today, however, our profession is challenged by a paradox: The base of evidence cannot keep up with innovation.2 An example is the diffusion of low-quality, “home-made” 3D-printed prosthetic hands into the market, despite limited evidence of their safety. In fact, the best available evidence presents them, in many cases, as a suboptimal treatment option.3 Demand for these novel devices has gone so far as to drive supply around the world by “makers,” as opposed to qualified health professionals—a trend that might expose the community of patients to risk. We must now consider if it is reasonable for us to expect consumers to wait for the evidence base to catch up.

Regulation (and the Hazards of Nonregulation)

In most countries (including Australia, where I reside), orthoses and prostheses are considered medical devices and are therefore regulated in regard to quality and safety, as a measure of public protection. Further regulations are in place in regard to the certification of practitioners who are able to provide orthoses and prostheses under national funding schemes. Such certification ensures delivery of safe and effective services, through which  patients are assessed, presented with a range of treatment options, and participate in shared decision-making to establish the resulting prescription. Currently, with some 3D-printing innovations, when they are provided in isolation, there are limited options from which to choose. This can mean that consumers are severely limited in their ability to receive the most suitable orthosis or prosthesis to meet their participatory goals.

The emergence of one-size-fits-all printable prosthetic sockets and hands that can be mailed to patients internationally is concerning, and leaves the regulator in me wondering what happens when things go wrong:

  • What protections are in place for consumers?
  • Does this business model undermine local services?
  • Does this practice remove pressure from governments to invest in training orthotist/prosthetists and develop local services?
  • What ethical considerations are needed to provide products in the absence of on-the-ground follow-up services?

In contrast, the international educator in me is excited: I anticipate getting this technology into the hands of trained practitioners in settings where resources are fewer, such that orthotic and prosthetic services can be dramatically scaled up to meet the needs of more people around the world.

Considering the above, we should also recognize that the global situation regarding access to assistive technology is dire. The World Health Organization estimated that more than 1 billion people who need assistive technology are unable to access it. It is also estimated that as many as 80% of nations are without accredited tertiary training programs for the orthotic/prosthetic professions. Considering the massive estimated need, paired with a global lack of practitioners; it is not surprising that altruists feel compelled to begin filling this gap, with treatments that cannot yet be considered evidence-based, in questionable models of care.

Keeping Expectations Clear and Realistic

It is important to widely acknowledge and communicate that 3D printing is, right now, a technical solution— not a clinical one. While 3D printing simplifies orthotic/prosthetic fabrication process in some cases, it does not simplify the patient, his/her needs, or the myriad of considerations that are taken into account before an orthosis or prosthesis is prescribed. I believe it is also very important to consider the ethics of this scenario—for both us, as practitioners, and for “makers” or untrained altruists in the provision of any non-evidence-based treatment across international borders, particularly where no local practitioners are involved.

Engaging with, critically evaluating, and embracing innovation is simply part of being an orthotist/prosthetist, as is communicating our way around community demand for the newest fad or untested technology. As orthotists/prosthetists, we recognize that, first, providing devices to patients remote from complete services should not occur, and, second, the day a client receives an orthosis or prosthesis is just the beginning, not the end, of the orthotic/prosthetic treatment plan.

This is an exciting time to be working in orthotics/prosthetics, and I am grateful to be able to contribute to the discussion.

Louise Puli is a practicing orthotist/prosthetist in Melbourne, Australia. She has worked with the AOPA (www.aopa.org.au) since 2015, serving as its Professional Standards Officer since 2016. She is also a lecturer for Human Study e.V (www.human-study.org). You can find her on Twitter @LouisePuli.

REFERENCES
  1. Omer T. Empowered citizen ‘health hackers’ who are not waiting. BMC Med. 2016;14(1):118.
  2. Diment LE, Thompson MS, Bergmann JH. Three-dimensional printed upper-limb prostheses lack randomised controlled trials: A systematic review. Prosthet Orthot Int. 2018;42(1):7-13.
  3. Gretsch KF, Lather HD, Peddada KV, Deeken CR, Wall LB, Goldfarb CA. Development of novel 3D-printed robotic prosthetic for transradial amputees. Prosthet Orthot Int. 2016;40(3):400-403.
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