Prosthetic Tech

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Contents

Background

What is Prosthetic Technology?

A prosthesis is an artificial replacement of a part of the body that was lost through trauma, disease, or a birth defect. It may include but not limited to a tooth, eye, a hip, a knee or other joints[1]. It can be designed for either or both functional or cosmetic reasons. Ultimately the prosthetic is designed to replicate the original purpose of the body part. It can drastically improve an amputee’s way of life, from allowing them to work, decreasing phantom pain, and reducing secondary health issues such as depression[2]. Prosthetics allow individuals to complete ordinary tasks from walking, to eating, to getting dressed.

History of Prosthetics

The First Prosthetic

Prosthetics have existed for thousands of years. The very first mention of prosthesis predates 3500 BC in a poem[3]. Evidence of ancient prosthetics is slowly being uncovered and dating back further and further than previously thought. While they are rudimentary in comparison to modern devices, it is incredible to see the attempt to assist individuals with disabilities.

BCE

The oldest prosthetic discovered is an artificial eye. It is estimated to be dated between 2900 and 2800 BC[4]. Located in current day Iran, it was found in an ancient burial grave inside the left eye of a woman. The woman wearing it was likely to be of high socioeconomic class. The ocular prosthesis would have been very expensive and was used purely as decoration. The eye served no functional purpose. It was made using bitumen paste, and therefore is very light. It also has a gold lining on the outside with a circle representing the iris. It was designed to look similar to a real eye. Gold thread was threaded through the prosthesis and attached to the eye socket[5].

The oldest functional prosthesis is a toe from 950 to 710 BC. Found on the body of a noblewoman in ancient Egypt, it was made of wood and leather[6]. After bio-mechanical engineers reproduced the prosthetic, they discovered that it allowed her to wear traditional Egyptian sandals and walk barefoot[7]. It was a sign of wealth to be able to wear sandals in ancient Egypt. The use of this prosthetic allowed the individual to still hold that level presentation. The Romans developed the first warfare based prosthetic. Warfare was an avenue for success and prestige in the Roman culture. A general named Marcus Sergius had his hand cut off in battle between 218 and 201 BC[8]. In order to continue fighting, he was later fitted with the first known prosthetic hand. It was made from iron and allowed him to hold his shield during the Punic War. Since it was so heavy it had to be attached to his armour to hold it up[9].

1500-1800

Prosthetics developed specifically for warfare became more prevalent during the middle ages. Prosthetics had not developed much further until Dr Ambroise Paré made significant advances in the field. He was integral to modern day amputation and limb prosthetics. Paré was the first to create a hinged hand and a leg with a locking knee joint[10].

The American Civil War saw a huge rise in the number of amputees and the demand of prosthetics. According to the U.S. National Library of Medicine around 20,000 amputations took place during the four year long war[11]. Surprisingly, lower limb amputation had a mortality rate of 33% and above knee amputations had a 54% mortality rate[12]. Of the amputees that survived, advancements in prosthetics were necessary for assistance in ordinary life. James Hanger, an amputee from the war, invented a prosthetic called the Hanger Limb. It featured barrel staves and metal and was the most advanced prosthetic to date[11]. It hinged on both the knee and ankle allowing for more regular movement. Hanger founded Hanger Inc. which is still operational today and provides care for millions of patients worldwide[13].

World Wars

World War I saw a huge rise in amputees. In Canada, there were approximately 3,461 soldiers with an amputated limb[14]. This sparked the formation of an organization to help educate, train, and provide funding for patients: The War Amps. Founded on September 23, 1918, the group had the mission “to bring their case to the Canadian government; to help amputees with retraining and rehabilitation, and to explore and initiate research into the little-known world of artificial limbs”[15]. With thousands of soldiers coming home with severe physical disabilities, engineers, physicians and politicians had to come up with solutions to enable the soldiers to return to the workforce. In 1918, the Red Cross published a booklet called "Reconstructing the Crippled Soldier" showing pictures of amputees with their prosthetics[16]
An image from "Reconstructing the Crippled Soldier"
.

In the United States, the American Orthotic & Prosthetic Association was formed for a similar purpose. After World War II, more funding and research were provided through veteran and military programs to develop more advanced prosthetics[14]. This research and development led way to the modern more advanced prosthetics we see today. Thanks to advancements in medical fields, more advanced care were administered in World War II[17]. This led to fewer amputees and less of a change in prosthetics needs.

Types of Prosthesis

This section will focus on the types of prosthetics.

Passive Prosthesis

Passive Prosthetics are generally devices that are worn for cosmetic purposes with little functionality.
Custom silicone restoration prosthetics.
The most common are custom silicone restoration devices which are designed to mirror an individual’s natural features including freckles, skin tone, or even hair of the lost limb [18]. These prosthetics are passive because they do not give individuals active movement, however they can provide assistance for an intact limb. This type of prosthetic can help an individual stabilize, apply force, and carry objects in their daily lives [18].

There is an extension that can be combined with a passive prosthetic that offers a little more functionality called multi-positional joints. For example, multi-positional fingers allow the wearer to reposition the finger prosthetics to clasp small objects like a phone, water bottle, or cooking tools [18]. The ability to clasp objects with a life-like looking hand is the most valuable part of this combination.

Body Powered Prosthetics Devices

This type of prosthesis is commonly used among individuals with an upper-limb amputation.
Visual representation of the parts of a body-powered harness.
Body powered prosthetics rely on other parts of the body and use a body harness and cable system to provide movement and functionality to the prosthetic hand or hook [19]. Voluntary movement of the shoulder or residual limb triggers the cables and channels the force to the prosthetic device [19]. These prostheses usually have the capability of opening and closing the prosthetic hand attachment which allows for good grip strength, picking up and releasing objects, or even holding the hand of a loved one [19].

Some key considerations of this type of prosthetic is that the process to move the artificial limb requires a significant amount of energy [19]. Further, the cable system can have technical issues and it looks less natural in comparison to passive prosthetics [19].

Myoelectric Prosthesis

Myoelectric prostheses utilize a battery and electric motors to function.
Diagram of a myoelectric arm prosthetic.
It has electronic sensors that detect muscle movement which then translate the user’s muscle activity into information that its motors use to control the artificial limb’s movements [20]. A control interface on the prosthetic allows users to adjust the strength and speed of the limb’s movements and grip by varying his or her muscle intensity [20]. The small sensors and motorized controls enable greater dexterity [20]. This is helpful, as it can allows the user to handle small items like utensils or coins through functioning fingers. Since it uses a battery and electric motors to function, the myoelectric artificial limb does not require any straps or harnesses which enables a more comfortable fit for the user [20].

A key consideration of this prosthetic device is that it has a steep learning curve. When an individual first starts using it, they have to use muscles they are not accustomed to using to move their arm which takes time to learn and adjust to [20]. It also has a battery that needs to be charged which adds a great deal of weight for users to carry around [20]. However, wearing a skin-like glove covering the prosthesis provides individuals with a natural-looking prosthesis that utilizes existing nerves to function the device [20].

Targeted Muscle Reinnervation

Targeted muscle reinnervation (TMR) is a complicated surgical procedure that takes nerves previously dedicated to a limb and rewires them into adjacent muscles
[21]. Even after amputation, nerves remain active and continue to transmit control signals intended for the missing limb [21]. These signals just don’t have anywhere to go. The TMR procedure gives an individual’s control signals somewhere to go without the need to implant hardware [21].

During TMR, nerves are transferred to nearby target muscles in or near the residual limb [21]. Nerves then reinnervate or grow into this new target muscle. When the person tries to move their missing limb, motor control signals from the brain travel down the transferred nerves, the target muscle contracts and generates EMG (electromyography signal) signals [21]. These signals are used to control a prosthesis.

After the procedure, an individual will have increased range of motion. For example, an above the elbow amputee would be able to [21]:

  1. Flex and extend the elbow of their prosthetic device
  2. Turn the wrist in and out
  3. Open and close the hand

TMR makes prosthesis control more intuitive and easier to operate because neural control signals intended for the missing limb are used to control functions in the prosthesis [21].

Osseointegration

The term osseointegration refers to a direct connection between human bone and an artificial implant [22]. It involves an expensive two stage surgical procedure
Before and after photos of osseointegration surgery done in a patient's leg.
. In the first stage, a threaded titanium implant is inserted into the marrow space of the bone of the residual limb [23]. The implant is called a fixture, which will become integrated into the bone over time [23].

The second stage happens six months later [23]. A titanium extension called an abutment is attached to the fixture and brought out through the soft tissue and skin [23]. The prosthetic can be directly attached to the abutment [23]. The area where the implant enters the skin, the stoma, has to be cleaned twice daily with soap and water [23]. This is comparable with brushing the teeth. With both stages of surgery, a very strict rehabilitation program is required which lengthens the recovery time [23]. In the first year after implantation, intense muscle pain may be felt [23]. This muscle pain disappears as soon as the stump muscles become fitter and stronger [23].

Patients with an osseointegrated limb have a more intimate and emotional connection to their prosthetic leg or arm, compared to those using a traditional socket prosthesis [22]. This direct skeletal connection eliminates the need for a socket which can be unnatural and uncomfortable for the user [22]. As well, the direct skeletal connection between the prosthesis and the patient’s own natural bone provides superior stability and strength [22]. In particular, patients who have an osseointegrated prosthetic limb have dramatically improved proprioception [22]. This helps patients walk more smoothly, and effectively transfer all of their energy from their residual limb to the prosthesis allowing them to walk longer distances [22].

Summary: Types of Prosthesis

Prosthesis Type Advantages Disadvantages
Passive Prosthetics → Low Maintenance
→ Cosmetic value
→ Minimal Functionality
→ Difficult To Perform Complex Tasks
Body Powered Prosthesis → Increased Functionality
→ More Affordable
→ High Energy Expenditure
→ Uncomfortable Harness
→ Unnatural Cosmetic Appearance
Myoelectric Prosthesis → Increased Dexterity
→ Natural Cosmetic Appearance
→ Comfortable Fit
→ Low Effort Expenditure
→ Expensive
→ Battery Maintenance
→ Increased Weight
Targeted Musle Reinnervation → No Implanted Hardware
→ Easy To Operate
→ Increased Range Of Motion
→ Expensive
→ Requires Additional Surgery
Osseointegration → Emotional Connection To Prosthesis
→ No Socket
→ Greater Stabilization
→ Improves Proprioception
→ Expensive
→ Additional Surgery, Long Recovery
→ Regularly Clean The Interface

Business Aspect

This section will focus on the business functions of prosthetic technology.

The Industry

First, we will focus on the industry as a whole, it's current and growing potential and discuss specific organizational examples.

Market Size and Growth

According to a report by Zion Market Research, in 2018, the global artificial limbs market was valued at approximately $1,970 million USD. It is expected to generate around $2,758 million USD by 2024, at a compound annual growth rate (CAGR) of around 5.8% between 2019 and 2024 [24]. The orthopaedic prosthetics market in North America is expected to cross $1 billion USD by 2026 [25].

The incremental growth of the global market between 2016 and 2021 is $406.5 million USD [25]. Between 2019 and 2024, this figure will grow to $468.88 million USD, bringing the market value to over $2.2 billion USD [25]. 35% of this growth will originate from North America. North America and Europe alone will account for over 50% of the market share. Lower extremity prosthetics are expected to remain the largest and most sold category, accounting for over 60% of the market share [25]
Adoption analysis of the different prosthetics for different parts of the human body.
.

The biggest factor fueling the market is osteoarthritis, the most common form of arthritis occuring when protective cartilage cushions the ends of bones wears down over time [26]. In developed countries with aging populations, this has triggered an increased demand for joint replacement surgeries as osteoarthritis is most common in the elderly. Diabetes, which can lead to a 25 time increased risk of amputation, is expected to affect over 590 million people by 2030 [27]. The greatest increases in numbers seen in low-income and lower middle-income countries. Other major factors include a growing aging population and rising obese population.

Regional Markets

Overall, all regions are expected to witness noticeable growth in the future with regards to their artificial limbs market.

North America dominated the global market in 2018 and is expected to continue to do so [24]. The United States leads the continent’s artificial limb market and is expected to register the highest CAGR in the future [24]. This is attributed to its

  • Well-established medical devices industry,
  • A rising number of research activities for the development of novel devices,
  • The growing prevalence of chronic disorders, and
  • Continuous technological advancements.

This is all amongst the growing health issues in its population related to obesity and an overall more senior population.

Europe has the second largest regional market [24]. It is expected to witness noticeable growth in the future along with the Asia and Asia-Pacific region. Within the Asian region, China, South Korea, India and Japan are the greatest contributors. Again, with a growing senior population and also a high prevalence of chronic diseases, rising accidental incidences, and growing expenditure related to research and development activities. The Asian Diabetes Prevention Initiative states that Asia accounts for 60% of the global diabetic population. By 2030, China and India are expected to house nearly half a million diabetic people [25].

The Middle East, Africa and Latin America are anticipated to register growth that’s mainly attributed to the high burden of diseases [24].

Key Players

This section lists the top 5 vendors in the global artificial limbs market from 2017 to 2021 based on a report done by Technavio, a leading market research and advisory company. All five companies have strong distribution channels globally, thus leading to an increased sales volume in comparison to others [28].

Business Description
Blatchford Blatchford offers prosthetics, wheelchairs, orthotics, and special seating along with advanced microprocessor artificial limbs. It also provides exclusive clinical services to the National Health Service (NHS) and the military.

In 2018, the company grew its revenues by nearly 15% to around $79 million USD last year, with 7% of the sales increase coming from clinical contracts with the NHS, which it won in 2016 and began operating in 2018 [29].

Össur Össur manufactures, develops, and sells non-invasive orthopedic equipment such as braces, support products, compression therapy, and prosthetics.

The company generated a revenue of $686 million USD in 2019, a sales growth of 12% from the previous year. This amounted to a net profit of $439 million USD and gross profit margin of 64% in 2019 [30].

Ottobock Ottobock Healthcare is a subsidiary of the Ottobock Group. It has four divisions, including orthotics, prosthetics, mobility solutions, and medical care. Ottobock has a presence in over 50 countries.

Sales grew to over $1.1 billion USD in 2020. The O&P segment, which includes the prosthetics, orthotics and component business, grew by 6% to $1.19 billion USD. A key success factor is the increased number of patients receiving treatment with technologically sophisticated microprocessor-controlled prostheses [31].

Ohio Willow Wood (WillowWood) Ohio Willow Wood manufactures, designs, and distributes prosthetics and solutions for amputation surgeries. It offers transfemoral, transtibial, upper extremity liners, and low, moderate, high activity prosthetics.

In 2020, its annual revenue was $25 million USD. The company found itself in a legal battle in 2013 when one of its star products, its Alpha® Classic and Hybrid Liners and sleeves was blocked from the market because a key ingredient infringed on a competitor’s patent. DW Management Services LLC bought a majority stake in the company in 2019 [32].

Fillauer LLC Fillauer manufactures, designs, and customizes 3200 products locally and internationally for pediatrics and adults. It is known for its prosthetic suspension lock system. In 2020, its annual revenue was $7.65 million USD [33].

Other key players include Johnson & Johnson, RSL Steeper Group Ltd., PROTEOR, Blatchford Group, Spinal Technology, Inc., and Optimus Prosthetics, among others.

COVID-19 Impact

The coronavirus’s impact is expected to be short-term and relatively small [25]. While the pandemic restricted patient hospital visits to get treated for orthopaedic prosthetics, thereafter, the market is expected to return with extra safety and health precautions put into place while visiting hospitals.

Many clinics reduced attendance and closed buildings on days when no essential client visits were scheduled [34]. Video conference consultations were implemented to replace face-to-face interactions that did not require hands-on or technical work.

Helping Those In Need

The business of prostheses for many companies if usually not first and foremost, capitalistic. Many owners and organizational leaders often start off in the industry after having experienced an amputation themselves and from there, fostered a desire to help others so as a team, we also wanted to mention those who currently need the most help.

In developing countries, the World Health Organization estimates that, out of the 40 million amputees, only 5% of them have access to any form of prosthetic care [35]. As the amount of people who require prosthesis continues to increase, it is important that proper systems are in place to support those in need.

Individuals in these countries not only suffer from a lack of proper healthcare but also from humanitarian crises including wars, famines and natural disasters. Examples such as the earthquake in Haiti or the civil war in Sierra Leone can result in large numbers of individuals requiring amputations in difficult environments with limited accessibility [35].

Organizations in these areas often run into systemic issues such as funding and delivery issues [36]. The required expertise and infrastructure are frequently nonexistent in the developing world and the costs are far beyond the reach of most, whose incomes can be less than $300 USD a year [36]. Travelling distances for those living in rural areas also make it difficult to provide proper follow-up care and rehabilitation.

In the photo here, we have Daniel Omar, now 14, was fitted with a 3D-printed prosthetic arm after losing both arms during an aerial attack in Sudan [37]. He received it from a Red Cross team who has also helped others in his situation.
Daniel fitted with a 3D-printed arm.

Types of Organizations

This section will discuss the types of organizations that can provide access to prosthesis technology beyond a state’s healthcare program or specific government aid programs. These prostheses are often provided either at no or low cost. Comparisons will be made based on developed and developing nations based on how effective and useful the provided prosthetics from the organizations.

The information provide with regards to how well an organization performs in a developing nation was provided by a report written in 2015 by the Global Humanitarian Technology Conference (GHTC). These are generalizations meant to give the audience an idea of the level of care provided. Exceptions exist within each category. Not mentioned are hospitals, prosthetic/orthopedic centers, and trained professionals.

Nonprofit Organizations

The purpose of nonprofit organizations is to create social value rather than to generate a profit. This definition will also include non-government organizations (NGOs). Most nonprofits that provide prosthetic devices receive funding through partner organizations, private funding, grants and personal donations. Those that distribute prostheses will accept donations of prosthetic devices, which may include materials and funds. The funding is also used to cover administrative and material, and training costs [35].

Nonprofit organizations in developed nations help individuals secure funding needed to obtain a prosthesis and the care required before and after. Individuals may ask for aid through their healthcare provider or on their own without a representative.

In regards to developing nations, the devices that international nonprofits provide to patients in said area are often not suitable, either locally made and donated or western made and donated [35]. They perform poorly in the rugged terrain and are expensive to maintain. Clinics may also be too far from patient residences to provide proper maintenance and rehabilitation after they receive a prosthetic device. It also affects continued maintenance and refitting sessions.

Faith-Based Organizations (FBOs)

FBOs are commonly known as religious organizations that are doing work and providing help on the basis of faith. Their approach is similar to that of NPs where both receive monetary donations and thus have the same funding challenge. They are often trusted and important healthcare providers for the poor in both developed and developing nations.

Data regarding the exact amount of assistance that FBOs have provided in high-income countries is lacking [38]. Reasons for this data gap include historical neglect of research and policy focused on faith-based institutions, and data availability. Many are also reluctant to share financial data with local or international partners.

In developing nations, FBOs have superior distribution in rural areas where they are highly prevalent.
The distribution of prostheses between manufacturers, fbos, nonprofits and hospitals to amputees.
In fact, in any given African country, FBOs make up 30% to 70% of healthcare services [35]. Due to their prevalence and close relations with rural areas, they are able to provide maintenance and repair and ensure continued usage of the device. They represent a key pathway to this population of amputees.

For-Profit and Hybrid for-Profit/Nonprofit Organizations

Hybrid organizations merges the social philosophy of a nonprofit and the monetary cash generation of a for-profit business. Cash may be generated to conduct philanthropic activities and meet goals that were not previously attainable without the extra funds.

Both for-profits and hybrids are able to design more unique and personalized prostheses that can be more applicable and suited for each patient [35]. Many strategically locate themselves and their manufacturing facilities to help their target patient base.

New and Developing Technologies

Small Initiatives

Small organizations and businesses across the world are looking at creating more affordable, personalized and environmentally friendly prostheses. Advancements in prosthetic technology, 3D printing and open source prosthesis templates, organizations such as RePurpose For Good and Form5 are able to focus efforts on designing and manufacturing reusable prosthetics from recycled plastic.

While not meant to replicate the thousand dollar myoelectric appendages, they are meant for simpler muscle-actuated ones that retail between $6,000 USD and $10,000 USD. The raw materials typically cost less than $50 [39]. Adding the cost of the 3D printer in, and it is only a few thousand. Kickstarters can be created to obtain funding.

Typically, such initiatives are only limited to the maker’s attention to detail and mechanical know-how. e-NABLE, an open-source community that shares templates with prosthesis makers across the globe, estimates to have helped over 8,000 people [40].

A great example includes Form5’s founder Aaron Westbrook and kids who’ve been fitted with prosthetics made by him and his team
Westbrook with a young patient.
. Westbrook, born with only one hand, started off making his own prosthetics, after his first try-on with a one bought for him. It fit poorly and cost about $40,000 even though he would eventually outgrow it. At 18, he decided to make his own, using the 3D printer in his school and launched Form5. Form5 is a nonprofit that customizes mostly open-sourced artificial limb designs in an eco-friendly way [41]. He collects his own recyclable material, and, eventually, hopes to repurpose outdated hands into other devices, which would close the loop on any waste.

Prosthetic Technology with the Internet: Open-Source Communities

To expand on the previous section, this one will focus on open-source communities and their pros and cons.

Open-source communities allow for developmental build-up of models. Earlier efforts are constantly remodeled and improved, reducing the amount of time needed for research and, thus, resulting in a faster market release [42]. Open-source projects can also help academics and businesses cooperate more efficiently. And due to their low costs, even students and hobbyists are able to develop prosthetics on their own. The overall reduced costs of prosthetics made with templates provided by open-source communities heavily outweighs the lack of medical certifications. The uniqueness of each patient combined with material costs can often offset patients tens of thousands of dollars, but with the development of openly-sourced templates, prototypes can be made for a tenth of the cost.

There have been two significant developments in the last decade that have further enhanced the advantages of openly-sourced prosthetics. The first is the development of single-board microcontrollers, which are essentially a small computer on a chip that provides all the circuitry needed and are immediately useful to developers without requiring them to spend time and effort developing the hardware [42]. Costing less than $50 apiece, the use of multiple controllers together can still make for a highly functional, low-cost device despite their limited functionality

Just as important are 3D printers. In the last decade, their costs have decreased significantly. As late as 2014, most quality 3D printers went for over $2000. Today, numerous high-quality options exist for under $1000 [43]. This has allowed unprecedented design and production of materials. 3D printers have rapidly decreased the time between research and development because both modifications and replacement parts can be made in a matter of hours.

Players in the Field

Openly-sourced prosthetics are currently being developed by amateurs, academics, and companies. Often, amateurs such as students and hobbyists will contribute resources and design modifications for the public’s general use while academics are more involved in the business aspects.

One of the first, most influential academic centers for open-source prosthetics is the Yale OpenHand Project
Model Q, one of the many hand designs the OpenHand Project has created.
. It has been working “to advance the design and use of robotic hands designed and built through rapid-prototyping techniques in order to encourage more variation and innovation in mechanical hardware” [44]. They currently have seven designs created for hand prosthetics and also developed means of attaching them to wrists or arms. Their designs have inspired other open source devices, both with and without modifications.

Another example is e-NABLE, an online global community of “Digital Humanitarians.” There are approximately 20,000 e-NABLE volunteers in over 100 countries who have delivered free prosthetics to an estimated 8,000 recipients in underserved communities who have little to no access to medical care [40]. They have an interactive map on their website that lists and shows their global community.

There is also Open Prosthetics (OP), a web-based education and collaboration initiative of the Shared Design Alliance, a 501(c)3 non-profit corporation. It is dedicated to the facilitation of curating crowd-sourced information and collaboration in the field of prosthetics [45]. A forum of collaboration, the creations on their website are available for anyone to use and build upon.

Open Bionics is a company that started off as an open-source community. Its CEO, Joel Gibbard, launched the Open Hand Project in 2013 to produce 3D printed robotic hands that can be reliably controlled via EMG sensors [46]. He released his designs with an open-source licence and in 2014, started Open Bionics to commercial the project’s research. Based in the United Kingdom, it currently develops low-cost bionic hands. In 2015, they partnered with Disney to create superhero-themed prosthetics for young amputees [47]
A promotional image for Open Bionics' and Disney's collaboration featuring an Iron Man hand and Star Wars lightsaber hand.
.

Open Source in the Long Term

The success of companies like Open Bionics and communities such as e-NABLE and Open Prosthetics would make one believe that cheap, 3D-printed, open-source technology is the future for biomedical device production.

However, an industry based on philanthropy, grants, crowdsourcing and volunteerism will not suffice in the long term. Individuals such as advanced prosthesis expert Hubert Egger of the University for Applied Sciences of Linz, Austria, believes that the proper quality checks and regulatory affairs that prosthetics should go through to ensure user safety “may need the support of public or private organisations” [42]. Valentino Megale of the Open BioMedical Initiative also mimics this by stating, “Open source means easy information access, but to assure this information is valid and safe you need major investment” [42].

AI Prosthetic Technology

According to György Lévay, Research Manager at Infinite Biomedical Technologies, artificial intelligence is the future of prosthetics. Traditional prosthetics effectively replicate movements repeatedly. This is effective in controlled and limited scenarios, however everyday life provides many variables for our limbs. In order to fully rehabilitate and instil ordinary life back into amputees lifes, they need to overcome varying circumstances. For example, only three percent of India’s buildings are accessible for disabled individuals [48]. Individuals with prosthetics will have difficulties in accessing 97 percent of the country’s buildings.

To combat this, we have adaptive artificial intelligence which allows the prosthetic to learn how to move in the moment to complete a task. This allows patients to do activities and go places they could not get to with ordinary prosthetics with smoother and more intuitive movement. These prosthetics are currently not in the market yet for a broader and less wealthy patient base, but with how rapidly advancements are being made, they could be available in the near future.

Lévay states that "In one way or another A.I. will be a part of advanced prostheses in the future. Processing the amount of data running between our brain and limbs will require “smarter and smarter” algorithms as the technology advances” [49]. With advancements in technology, we have succeeded in replicating human dexterity with the Modular Prosthetic Limb and recently, in 2020, patients became able to touch and feel objects with their prosthetic arms [49]. Prior to this, in 2008, developments allowed even monkeys to feed themselves with a mechanized arm using their brain activity [50].

The future for AI is bright. As developments continue, material costs will decrease as the ubiquity of the technology will increase. The developments we see now are incremental changes that will add up to truly change the market for AI-limbs.

Issues with R&D: Are we doing the right thing?

What is important to address in relation to R&D is device abandonment. In a study done by the International Society for Prosthetics and Orthotics, they found that the rate of device abandonment (a person discontinuing use of a device after obtaining it) has remained relatively the same with the past 25 years despite recent, large gains in prosthetic technology [51]. To date, the rate of abandonment is 35 percent and 45 percent for body-powered and electric prosthetic devices, respectively [51].

The current mentality surrounding research and development can be summarized by Justin Tyler, a researcher at the Functional Neural Interface Lab at Case Western Reserve University: "Without sensation, no matter how good the hand is, you can’t perform at a human level" [52]. Today's goal in the lab is to design devices that are as similar to the biological as possible; the best and only way to perform at a human level is to replicate the human form.

However, this has come at a cost. A study done by the International Society for Prosthetics and Orthotics has shown that advanced technological pursuit has stated that the overwhelming desire to create more sophisticated designs have been put before the needs and desires of the end user [53]. The pursuit of technology that imitates human form and function with increasing accuracy is hurting a critical component of prosthetic adoption: how easy it is to use [51]. Not surprisingly, the technology to enable a prosthetic device to move and feel precisely like a biological hand introduces increased complexity to the device. A typical high-tech devices may be controlled by the activation of residual muscles in the arm or some other external control feature. Thus, adding a feature on the prosthetic like independent control of individual fingers may require significant focus or attention from a user. From a practical perspective, this adds a level of inconvenience for everyday use.

Prosthetics are only as good as their usefulness to real patients in everyday life. It's time for more collaboration between scientists and patients.

Barriers

Proofs of Concept

Many of the more advanced developments in the field are simple proofs of concept [49]. Advanced prosthesis prototypes that require wiring to a computer software to translate nerve signals into fine movements are stuck in the lab. Once prototypes leave the lab, it will also take time for approvals to be given from regulators such as the United States Food and Drug Administration (FDA).

The Science Itself

A limited understanding of the brain and its connection to our limbs is another struggle. György Lévay, Research Manager at Infinite Biomedical Technologies, says, “The quality and complexity of the data; our lack of understanding of how exactly feedback mechanisms work in the human nervous system; and the uniqueness of individual neurological systems make it very difficult to predict human intent” [49].

Financial Issues

The Prosthesis Itself and Associated Physical Therapy

The cost of a prosthesis can be expensive. It’s based on factors that vary from patient to patient, including but not limited to the:

  1. Level of amputation,
  2. Activity level of the patient,
  3. Components and materials required,
  4. Overall complexity of the design and the time required to fabricate and fit the device [54].

The cost can range from $5,000 to over $50,000 for myoelectric apparatuses [55]. Replacements are recommended every three to five years from wear and tear. Models that require electronic components can cost over $100,000. This is a high price to pay, especially for individuals in developing nations.

For families with young, growing children, the financial burdening can be suffocating. Here’s the math for an eight-year old child with limb loss who needs to replace their prosthetic limb on every two years until age 18:

Given the cost range earlier:

  • Minimum burden on families: $5000 x 5 = $25,000
  • Maximum burden on families: $50,000 x 5 = $250,000

This also does not include any hospital fees or physical therapy costs, including rehabilitation [55]. For individuals who lose their limbs in an accident, many can expect to go through weeks, months or years worth of physical therapy.

Insurance Structures

At the core of it all are insurance structures.

For patients, depending on their area of residence, general healthcare plans often do not cover prosthetic devices or have an annual limit on how much a patient can spend on devices [54]. It is usually not enough to cover the full cost. Patients and their families will often have to look towards charitable organizations, other government assistance or specific funding agencies (for children, veterans, workers compensation, etc.).

For companies developing the technology, they have to demonstrate the value proposition of their devices to expand access to them. Insurance companies are often reluctant to accept more devices; they are very expensive and come with a high degree of abandonment. Robert Armiger, project manager for amputee research at Johns Hopkins University’s Applied Physics Lab, says, “Insurance companies say, ‘we’re spending this much money on this device and people don’t wear it, and now you’re asking us to spend more money on a more advanced technology” [49].

Personal Experiences

Prosthetic technology can greatly add value to a persons life. Check out the video below to gain insight into an individuals personal experience with prosthetics.

So What?

Although an amputee can survive without a limb, it is very challenging for them to learn how to adapt and manage many ordinary tasks. According to the American Medical Association’s Guide to the Evaluation of Permanent Impairment, the loss of a thumb alone leads to a 22% impairment of the whole person[56]. People undervalue how much they use their limbs on a daily basis. A loss of one would have significant effects on their mental and overall health, in addition to the loss of function. Prosthetics change people's lives for the better. No one can predict when they may need a prosthetic. Therefore, everyone must take their part in progressing the field. A prosthetic is extremely important for someone to complete activities and everyday tasks. Ultimately, it regains an individuals independence.

References

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Authors

Graham Pinkerton Matteo Botteselle Teresa Y. Wu
Beedie School of Business
Simon Fraser University
Burnaby, BC, Canada
Beedie School of Business
Simon Fraser University
Burnaby, BC, Canada
Beedie School of Business
Simon Fraser University
Burnaby, BC, Canada
gpinkert@sfu.ca Matteo_Botteselle@sfu.ca tyw8@sfu.ca
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