Chapter 1: Market Landscape

3.1. There are an estimated 65 million people that live with limb amputations globally, with 1.5 million people undergoing amputations – mostly lower limb – each year. Most amputees need access to prosthetic services and this need is expected to double by 2050.

No comprehensive data exists on the global incidence of amputations, but a recent study estimated that 65 million people live with limb amputations globally.³ Amputation is the action taken to surgically remove a part of the body following trauma, disease, or congenital conditions and is the leading reason for the use of prosthetic devices. A prosthetic device is an externally applied device used to replace wholly or in part an absent or deficient limb segment. An orthotic device is an externally applied device used to modify the structural and functional characteristics of the neuro-muscular and skeletal systems.⁴ Both are fitted using common biomechanics, processes, and equipment. WHO groups P&O together since both concern the use of externally applied devices to restore or improve mobility, functioning, and to correct deformities. Although P&O services have overlapping human resource and infrastructure requirements, this document will focus on the market barriers to access for lower-limb prostheses since more than 60% of the 1.5 million amputations every year are lower limb. However, as a result of investing in the scale-up of prosthetic services, access to orthotic services is also expected to also expand due to an increase in the number of service points and trained personnel in LMICs.

An estimated 64% of people living with amputations are in LMICs. Regionally, about half are situated in Asia (see Figure 2). The primary causes for amputation differ between HICs and LMICs. In HICs, around 80% of amputations are caused by complications of blood vessel diseases and diabetes⁵ that restrict blood flow to various parts of the body. Foot ulcers, a common complication of sensory loss due to poorly controlled diabetes, account for the majority of lower-limb amputations among diabetics.⁶ In LMICs, on the other hand, most amputations result from trauma due to road traffic accidents, injury from current or past conflicts, infections of the bone or tissue such as osteomyelitis or sepsis, and untreated birth defects.

The global need for prosthetic devices is expected to double by 2050.⁷ More amputations will take place in LMICs due to a growing population, increasing road traffic accidents due to poor road conditions and urbanisation, and changing demographics that lead to increasing prevalence of non-communicable diseases such as diabetes. For example, diabetic patients are eight times more likely to undergo at least one lower-limb amputation than non-diabetic patients⁸ and WHO estimates that incidence of diabetes will rise from 415 million in 2015 to 642 million in 2040. The global P&O need is estimated to increase from 0.5% of the global population to 1% of the population by 2050.

Source: see footnote ⁹

3.2. Use of prosthetic devices improves quality of life and reduces mortality, but only 5-15% people in LMICs that need one have access.

Appropriate selection of prosthetic devices can improve user quality of life and reduce mortality. Use of prosthetic devices allows amputees to regain mobility and independence. For example, 80% of amputees in Vietnam and India who had received functioning prostheses described themselves as employed.^10,11 This permits reintegration into work and community, raising quality of life measures such as well-being, productivity, intimacy, health, and safety.^12,13 In addition to improvements in their quality of life, a recent study in the US suggests that prosthetic users have greater life expectancy following amputation, and 12-month mortality rates are two times lower compared to non-users with similar disease and demographic profiles, though this study does not control for the prevalence of co-morbidities.¹⁴ From a financial perspective, access to appropriate prosthetic devices decreases the need for hospitalisation and associated acute care, resulting in reduction of health expenditure. In the US Medicare system, the cost of providing prosthetic devices was found to be fully amortised within 12 to 15 months due to a reduction of care in other settings.¹⁵

Although clinical, economic and social benefits of prosthetic use are documented in HICs, there is limited evidence to draw conclusions in LMICs, resulting in low prioritisation and investment by governments. Limited data in LMICs on the number of amputees, need for prostheses, current coverage of prosthetic use, and the clinical benefits and economic returns, make it difficult for policy-makers to ascertain the economic and health burden, and to make appropriate budget allocations. Measuring the cost-effectiveness of prosthetic provisioning through the reduction of the cost of care in other settings or in contribution to the economy over time would drive increased awareness, attention, and urgency.

WHO estimates that prosthetics coverage in LMICs is only 5-15%. Although these numbers are not based on comprehensive data, it indicates the low coverage in LMICs when compared to HICs. In Indonesia, for example, an estimated 4 million people need P&O services, with 146,000 amputees.¹⁶ However, only around 3,000 users (2% of amputees) have been fitted. ¹⁷ In the US, on the other hand, 86% of lower-limb amputees adopt prosthetic devices.¹⁸ Additionally, individuals will need multiple devices in their lifetime.

3.3. Prosthetic devices are available across a spectrum of materials and technologies and are customised based on needs of the user.

Prosthetic devices are classified by the body part(s) they replace (Table 1) and their construction. Lower-limb prosthetic devices are divided into several types, including: transfemoral (TF) or above-knee prostheses, transtibial (TT) or below-knee prostheses, and partial foot and toe prostheses that are used for amputations of the toe and foot. Exoskeletal (also referred to as conventional) prostheses have external walls that provide shape to the device and also perform the weight-bearing function. They are usually manufactured from one piece of raw material and have limited adjustability and customisability. In endoskeletal (also referred to as modular) prostheses, weight is transmitted through a central shank from socket to foot and to the ground.¹⁹ These are composed of multiple components, each of which serve different functions, and can be mass-produced and then selected, assembled, and adjusted to adapt to a user’s lifestyle (Table 2).

Prosthetic devices are customised and fitted based on the needs of each user. Prosthetic sockets have a high level of customisation since they serve as the interface between the prosthesis and the user. They are individually fabricated after patient assessment and measurement, and take into consideration the amputation, anatomy, and any underlying medical conditions to ensure comfort and fit. Prosthetic components are also selected and customised to account for the measurements and lifestyle of the user. Users in LMICs often require their P&O devices to function for a range of environmental and lifestyle factors, such as activity (agricultural or labouring livelihoods), temperature, humidity (requiring waterproof or anti-rust features), culture (being able to sit cross-legged or to squat; colouring of limb coverings or cosmesis), and affordability. Poorly-fitted or low-functionality prosthetic solutions that do not meet users’ needs often lead to abandonment.

A prosthesis is typically assembled from the following components: 1) liners: soft material that ensure fit and comfort; 2) socket: interface between the residual limb and the prosthesis; 3) terminal device: the foot; 4) joints: knee, ankle; 5) pylon: allows adjustment of the length of the prosthesis. The device is attached to the body using a suspension system: these range from straps or leather to pin and lock. In a modular prosthetic device, the socket is usually made to order from raw materials while the other components can be manufactured centrally and then customised, based on selection of size or adjustments to fit the users.

Prosthetic components can be made from a wide range of materials which affect the durability, functionality, and price of the device. Materials that are commonly used in LMICs, because of price and availability, include wood, leather, rubber, aluminium, and polypropylene. These materials create affordable devices, albeit with limited flexibility and suitability for different use cases. Advanced materials such as carbon fibre and titanium are more expensive, but offer increased functionality, flexibility, and durability and are typically lighter in weight. Material and component selection may impact whether the user is able to participate fully in their desired daily activities, and whether the user continues to wear the device over time.

Prosthetic components are available in a range of basic to advanced technologies that affect functionality and control. Prostheses built with basic mechanical components, which usually cost up to USD 2,000, are user-controlled and have a limited range of movement and functionality, particularly in the knee and ankle. More advanced components, which cost up to USD 15,000, allow for a wider range of motion and incorporate pneumatic or hydraulic control systems, resulting in a more natural gait. Devices that use microprocessors and other intelligent response controls that can sense the users’ activity level, gait, and environmental changes to control the limb can cost up to USD 70,000. These high-technology prostheses are usually customised to the user’s desired lifestyle and are comfortable, lightweight, and feel like a real limb to users. On the other hand, exoskeletal prostheses that are typically manufactured from one raw material can be priced as low as USD 100-USD 500. See Figure 3 for examples of lower-limb prosthetic devices.

For sources for the Conventional (exoskeletal) device consult footnote ²⁰, for Basic Modular (endoskeletal) device consult footnote ²¹ and for Advanced Modular device consult footnote ²².

3.4. WHO and the International Society for Prosthetics and Orthotics (ISPO) have issued standards for the provision of appropriate prosthetic and orthotic services, which requires specialised health professionals, infrastructure, equipment, and supply chains.

In 2017, WHO, in partnership with ISPO and the United States Agency for International Development (USAID), published Standards for Prosthetics and Orthotics, a two-part standards and implementation manual for health systems providing P&O services.²³ The standards outline recommendations to countries on appropriate policy, products, personnel, and service provision in establishing a P&O services system (Figure 4). Regarding the selection of prosthetic components, the standards highlight the following key considerations:

• User: level of amputation, clinical presentation of the residual limb, age, general health, weight, strength, desired mobility level, type of work, and lifestyle.

• Context: environment (terrain, temperature, humidity), proximity to service providers for maintenance, availability of local or imported materials and components, types of fabrication equipment, and component supply available to the service provider.

• Financing: availability of reimbursements and eligibility of various component types, price of components, longevity of components, and need for replacement.

Prosthetic service units that provide prosthetic services can be expensive to set up, and require specialised infrastructure and equipment. Different types of equipment and machinery, such as an oven, vacuum suction and drills, are utilised to fabricate the socket that is moulded to the residual limb of the patient and to assemble the prosthesis. In addition, other workshop areas are also required to ensure appropriate services (see Figure 5). The estimated cost of establishing a prosthetic service unit in a LMIC ranges from USD 200,000²⁴ up to USD 400,000,²⁵ with machinery accounting for 50-80% of the cost.

3.5. Trained and accredited prosthetists/orthotists are critical to the service delivery process.

Prosthetists/orthotists assess, fabricate, and fit users with P&O devices. They undergo specialised education and training which equip them to assess and educate the user, prescribe the appropriate device, fabricate the custom-fitted components, and to fit the final device. ISPO and WHO have developed guidelines for the training of prosthetists/orthotists²⁷ which include the delineation of tasks of the various personnel and guidelines for their training. In 2018, ISPO published the new ISPO Education standards for prosthetics/orthotics occupations²⁸ and updated the three levels of professional designations (see Table 3): Prosthetists/Orthotists, Associate Prosthetists/Orthotists and Prosthetics/Orthotics Technicians. Prosthetists/Orthotists and Associate Prosthetists/Orthotists are referred to as clinicians, who mainly perform clinical work, while Prosthetics/Orthotics Technicians are referred to as non-clinicians. Over the years, ISPO has implemented an accreditation process for training programmes to professionalise the role of the prosthetist/orthotist internationally. Among the worldwide training institutions, there are 17 P&O schools which offer ISPO-accredited training in LMICs, of which 5 offer training at Prosthetist/Orthotist level, 13 at Associate Prosthetist/Orthotist level and 1 at Prosthetic/Orthotic Technician level. There are also a number of non-ISPO-accredited training institutes in operation in LMICs, with varying levels of effectiveness in graduating practitioners with adequate skills to deliver quality services. Training prosthetists to ISPO standards has shown to positively impact developing new service capacity, appropriateness of prosthetic and orthotic service delivery, clinical leadership, and driving development in professional communities in both HICs and LMICs²⁹ (see Case Study 1).

Besides prosthetists and orthotists, multidisciplinary teams that include physical therapists and occupational therapists are critical for pre-fitting and post-fitting rehabilitation. Without rehabilitation and physical therapy, users may abandon their prosthesis due to discomfort or safety issues. These auxiliary rehabilitation clinicians also offer opportunities to provide gait training or physical therapy outside a service unit setting, since they are often integrated with health services. In some settings, rehabilitation clinicians are also trained to provide device maintenance or repairs.

3.6. Donor funding is limited, with support mainly focused on training prosthetists/orthotists and establishing service provision capacity.

Donor funding in the prosthetics sector has historically been prioritised for the training of prosthetists/orthotists to ISPO-accredited levels. Nippon Foundation and USAID have been the leading donors to support the establishment of ISPO-accredited schools. Building on the success of CSPO, between 2003-2020, Nippon Foundation invested around USD 55 million for the expansion and establishment of schools in the Philippines, Indonesia, Thailand, and Myanmar in collaboration with their governments and implemented by Exceed Worldwide. These schools have graduated 600 practitioners as of December 2018. While some training institutes are established and staffed by international organisations, and transitioned to local practitioners over time (see CSPO in Case Study 1), others, such as the Sirindhorn School of Prosthetics and Orthotics, are founded with government ownership and local workforce from the start. Training institutes in LMICs are typically established with funding from donor organisations. Since the mid-1990s, USAID has supported the development of the prosthetist/orthotist workforce by funding the development of regional ISPO-accredited schools and scholarships for training personnel from 34 different countries. Additionally, through the Leahy War Victims Fund, USAID has invested in the development of the WHO Standard for Prosthetics and Orthotics Services, and established P&O services and service units in LMICs since 1989.

Other large contributors operate primarily in the humanitarian response field, such as the International Committee of the Red Cross (ICRC), Humanity & Inclusion (HI) and Bhagwan Mahaveer Viklang Sahayata Samiti (BMVSS). These organisations primarily focus on supporting the expansion of service provision capacity and also run large rehabilitation programmes, and will therefore be discussed in detail later in this document.

4.1. The global prosthetics component market is estimated at USD 1.3 billion and dominated by a few companies that primarily focus on HIC markets; however, lower-cost suppliers are emerging.

The global prosthetics market is valued at USD 1.3 billion and growing +3% every year.³³ The US and Germany are the largest markets in the world by value. China is the largest market by volume, followed by the US and India. HIC markets can be characterised as high-value and low-volume, which is primarily driven by higher pricing of components and the selection of more advanced technologies. Regarding component type, microprocessor joints are estimated to account for more than 50% of global market value, while mechanical feet account for 60% of global volume. India and Brazil are the fastest-growing markets. The highest growth segments are high-tech components, including myoelectric hands and microprocessor feet.

A few companies dominate the global market, with varying presence in LMICs (see Annex C). Ottobock (Germany) is the leading global supplier of modular components. Founded post-World War I, the company has achieved a strong market position by leading innovation and establishing networks of prosthetics clinics. Ottobock is present in LMICs through distributors and service providers, as well as through acquisitions or technology transfer partnerships. Össur (Iceland) is the second-largest leading supplier, estimated to be half the size of Ottobock. Össur has regional presence in Europe, the Middle East, Southern Africa, and the Americas, with sales growing fastest in the Asia-Pacific region. Proteor (France) and Blatchford (UK) are long-standing companies who focus on HIC markets, but have also developed low-cost, basic solutions targeted towards LMICs. Proteor components are commonly found in Francophone Africa, partially through partnerships with HI, with whom they have developed an emergency prosthetic kit. Blatchford has formed the Endolite subsidiary and line of prosthetics, which targets large LMIC markets such as China and India.

Prices for different prosthetic devices can vary considerably, depending on the brand, country of origin, technology, and materials. Basic mechanical TF limbs are typically sold by the leading companies for between USD 1,000 and USD 3,000. Manufacturers from China, India, Turkey, Russia, and Taiwan have emerged offering lower-priced limbs, ranging from USD 100 to USD 500. In addition, some start-up companies have developed specific components suited for a LMIC context, such as D-Rev’s ReMotion Knee (USD 80) as well as the LegWorks All-Terrain Knee (USD 200). Select prosthetic solutions can be found in Annex D. Many of these alternative suppliers have obtained internationally-recognised certificates of quality, such as approval by the US Food and Drug Administration (FDA) and the European Commission (CE marking), report conformity to ISO standards, and operate in LMICs.

4.2. LMIC markets for prosthetic devices are small as they lack capacity for provision.

Lack of prioritisation of investment and coordination by LMIC governments limits the provision of prosthetics and growth of a market. LMIC governments have largely not prioritised investments because they lack awareness of the unmet need and value of providing prosthetic services. Further investigations to quantify the return on investment of providing prosthetic services is needed to advocate for prioritisation and investment. Additionally, prosthetic services and rehabilitation often fall within the responsibility of multiple ministries, requiring coordination of investments between various groups, such as the Ministries of Health, Social Welfare, Labour, Education and Veteran Affairs, which is often lacking.

Developing sustainable markets for prosthetic services requires long-term planning and investment in developing service capacity. In LMICs, the high cost of establishing and operating a prosthetic service unit has limited the number of access points, which are often only found in tertiary-level teaching hospitals in capital cities or urban centres. The lack of service points presents a logistical and financial barrier to many users who must travel long distances. Expansion of service points requires an increased capacity of accredited prosthetists/orthotists. Training for ISPO-accredited professional designations often requires sponsorship and travel to a regional school. Once trained, it is proving challenging to retain prosthetists/orthotists in the country due to poor working conditions, lack of professional recognition, and the ability for accredited personnel to seek employment in the private sector or abroad. Due to the shortage of required capacity in LMICs, personnel will sometimes take on responsibilities above their level of training.

Though government financing may exist in some LMICs, current reimbursements for prosthetic services and devices are largely insufficient. Table 5 compares reimbursements available and the associated prices of prosthetics in select LMICs. The prices do not consider indirect costs typically incurred by the user relating to travel or accommodation, etc. In addition, amputees may have already spent available financial resources on upstream medical treatments that led to and include the amputation, particularly if those services are also not covered through the public health system. To build upon the efforts countries have made to date to offer coverage, additional analysis of the cost to users and the value of providing prosthetic services is needed to build momentum for increased support.

Novel financing mechanism for users, such as micro-loans and leases from financial institutions, could increase affordability of prosthetic services, but have not yet been demonstrated or piloted. Since prosthetic devices enable many users to return to work, there is an economic argument to be made for lenders. No such options exist in LMICs today. Establishing funds to provide loans to amputees or assisting financial institutions to understand the risk profile of lending to amputees can unlock user ability to afford prosthetic devices.

4.3. Lack of LMIC government investments has left a gap that has been filled by non-governmental (NGOs) and faith-based organisations (FBOs).

NGOs and FBOs provide and support prosthetic services in LMICs. These organisations primarily initiate programmes in response to conflict, natural disasters, or humanitarian crises. They provide technical assistance, train clinicians, and establish supply channels. While NGOs and FBOs typically work in partnership with governments, their individual deployment models result in parallel systems for provisioning, procurement, supply, and user engagement. Governments become reliant on the funds and technical inputs. Ownership and operations have been transferred to the local governments with varying levels of success.

ICRC, BMVSS and HI are the largest international organisation and NGO providers in LMICs. ICRC and HI support a broad network of rehabilitation service points in over 40 LMICs, and BMVSS is primarily focused on India. ICRC and BMVSS each deliver around 25,000 prosthetic devices every year, while HI delivers around 6,000 devices. They play a critical role in helping to fill the gap in prosthetic services in LMICs. More information can be found in Annex E on these providers.

ICRC and BMVSS have developed products for low-resource settings. These products are consistent in design and fabrication, which allows for streamlined centralised manufacturing to achieve lower costs and simplified provisioning. The availability of these products has been impactful, particularly in conflict and emergency situations. However, these products provide limited customisability for different user lifestyles and activity levels. ICRC’s polypropylene prosthetic technology is widely accepted and recognised because of its suitability for deployment in LMIC contexts. Since 2019, ICRC has switched to Alfaset, a non-profit arm of Swiss-based manufacturer Rehab Impulse. In contrast, studies suggest that BMVSS’s Jaipur solutions are poorly accepted due to high failure rates and low durability, resulting in low adherence and lack of technical and clinical acceptability.³⁷

Beyond these three international organisations, additional NGO and FBOs are listed in Annex F.

4.4. Collaborations between the public sector and for-profit organisations may have the potential to mobilise cross-sector investments to expand access.

Coordinating investments between the public and for-profit sector could drive expansion of services. In the absence of government-funded services, a for-profit sector has emerged which caters mostly to populations who can afford to pay out of pocket. Private providers offer a variety of prosthetic solutions, varying in functionality, quality, and pricing. Quality can be a challenge in the private sector because of a lack of regulatory oversight or frameworks. Private-public partnerships (PPP) and other mechanisms that integrate the public sector and for-profit models can allow governments and private sector providers to collaborate, co-invest, and integrate resources to jointly expand services while ensuring quality. Demonstration and pilot projects are underway in LMICs, including in Thailand (see Case Study 2 and 3). These models rely on willing government partners, appropriate policies (i.e. reimbursement, quality control) that regulate and enable private-sector investments, and could be further expanded through enabling the private sector to achieve financial sustainability.

4.5. Collecting amputee data supports improved advocacy to drive investment in prosthetic services and improvements to quality of care.

Amputee data is the starting point to drive awareness and prioritisation in prosthetic services; however, very limited data is currently collected in LMICs. Investments in collecting such data and developing registries help to illuminate the full need and monitor amputee outcomes. Data initiatives in LMICs include examples such as ASCENT (see Case Study 4) and ICRC’s Patient Management System. Such initiatives hold the potential to drive increased availability of prosthetic user data to motivate government resource mobilisation for prosthetic services.

In order to accelerate data collection and the development of registries, global investments can be made to develop foundational research and parameters for data collection. For example, defining the core dataset of amputee data and outcome measures will underpin the efforts of countries to implement registries. Creation of a global platform and governance for aggregation of country-level data will enable consolidated insights. ISPO’s Industry Advisory Group has launched an initiative to outline the core datasets and develop a framework for a global registry, but lacks resources to accelerate development and implementation and could benefit from additional support. Following the development of a global framework for data collection, investments in implementation and data collection efforts are needed to underpin national and sub-national planning for service expansion. See Case Study 5 for an example of the establishment of a user registry to collect such data.

4.6. The starting point for prosthetic services is a link between amputation and rehabilitation, but poor referral pathways lead to patient drop-off.

The care pathway for prosthetic users starts with the surgical amputation of the limb. Amputees consult with a rehabilitation specialist to be referred to prosthetic services. Amputees are then discharged for healing and recovery, before arranging to visit a service provisioning unit. The prosthetics service delivery process is then carried out. This consists of the user being assessed and measured by a prosthetist, who then prescribes and fabricates a prosthesis. The user will thereafter be fitted and undergo gait training to learn to use and care for the prosthesis. Following the initial fitting, users often need to return to the service unit for repairs, maintenance, and to make adjustments as their residual limb or lifestyle changes.

Many amputees never enter rehabilitation, with poor linkage, low awareness of services, and lack of post-discharge follow-up as common gaps to successful referral. Lack of awareness of availability of prosthetic services from surgeons and other health workers can impact the amputation procedure, sometimes leading to requirements for revision surgery. After amputation, WHO recommends that patients should be assessed for eligibility by a medical or rehabilitation clinician and referred to prosthetic services,⁴⁰ but this often does not happen in LMICs due to low awareness of services by health workers or lack of rehabilitation staff. Patients are typically discharged from the hospital to heal after surgery, which can last up to six months. There is often no post-discharge follow-up with amputees to ensure the patient has sought rehabilitative care. Better integration and improved awareness of prosthetic services and benefits of prosthetic use in healthcare workers at primary, secondary, and tertiary levels of the health system can improve referral.

In the absence of referral pathways, user associations help to fill the gap and empower amputees to access prosthetic services. Through a network of peers, these groups provide counselling and information, even if formal referrals are not obtained through the health system. For example, the International Confederation of Amputee Associations (IC2A) is a non-profit organisation dedicated to improving the quality of life for amputees through strengthening and sharing best practices between its 15 national amputee associations. Objectives include developing peer support and mentorship models, and disseminating these models across country-based user groups. IC2A national amputee associations advocate for users to be included in government policy- and priority-setting. The IC2A champions policy changes such as setting best practices in rehabilitation and prosthetic services, and the inclusion of P&O services and products in government budgets and health insurance schemes.

4.7. When patients are referred, the service point can be costly and difficult for amputees to reach.

As discussed in Section 4.2, amputees often face significant financial and logistical barriers to access services, including high indirect costs. Prosthetic service units are commonly situated in urban areas. For example, among Indonesia’s archipelago of 17,000 islands, there are only 24 prosthetic service units; in Kenya, some prosthetic users in rural counties need to travel over 500 kilometres to access services. Amputees are already at a greater risk of poverty,⁴¹ and the cost of travel for the individual and family members or personal assistants can be prohibitive. Additionally, wait times for fitting and fabrication, delays in supply of components, and physical rehabilitation add to overnight accommodation costs.

Beyond the initial fitting, the clinical pathway continues with rehabilitation and patient management occurring through multiple touchpoints during the first 1-2 years. Physical therapy is needed for numerous weeks post-fitting to ensure the user mobility using the device. Changes in activity from adopting a prosthesis will typically cause the residual limb to change in volume, which then requires prosthetists to adjust the device to ensure continued comfort and fit. Repairs and maintenance in response to wear and tear throughout the useful life of the device also require technical skills of the prosthetist. To ensure the successful fitting, adoption and continued use of the prosthesis, users need to be able to regularly access prosthetists and service units, which can incur significant indirect costs.

At present, most government reimbursement or insurance schemes do not account for these indirect costs. Some NGOs assist users with costs of travel through free overnight accommodations or reimbursement of travel expenses. One such example is 500 Miles in Malawi, where users are either provided with funds for transport or transported directly to the central provisioning facility in Lilongwe, the capital city. However, these schemes are few and far between. In their absence, users are largely left to raise funding from donations or loans from friends and family.

4.8. Decentralisation can overcome these barriers, but presently focuses on pre- and post-fitting activities in service provision and further investigation on cost-effectiveness is needed.

WHO’s Standards for Prosthetics and Orthotics recommend a tiered approach to delivering prosthetic services that is integrated with various levels of the health system. Specialised services are available at the tertiary level, with standard services available at the secondary level. Decentralised services should be available in the primary and community levels of the health system to ensure the widest range of services can be provided as close as possible to users. Integration of prosthetic services to the lowest levels ensures appropriate patient identification, referral, and follow-up can be conducted.

A number of promising models of decentralisation have been observed in LMICs, which include satellite service centres, and patient outreach and referral through linkages with other community health programme initiatives (see Table 6). Mobile clinics have also been deployed, but face challenges with quality control of services and product delivery. Numerous challenges currently exist to scale these models.

Specialised human resources are needed throughout the process, which are limited in capacity and are thus mostly found in central facilities to serve the highest volume of patients. The cost-effectiveness of offering decentralised services needs to be further investigated: it typically requires significant additional investment by the provider, while generating considerable savings for users. Additionally, the current models for decentralisation focus on: 1) pre-fitting activities – providing referral, conducting the initial measurement and patient assessment; and 2) post-fitting activities – providing follow-ups, maintenance of devices, reassessment, and physical rehabilitation. These models do not yet permit the full decentralisation of the end-to-end fitting and fabrication process. However, integration of digital and other innovative technologies can potentially transform the process to enable full decentralisation in the future.

4.9. Innovative socket fabrication techniques can expand prosthetic services, but adoption is limited by product maturity, lack of clinical and economic evidence, and implementation guidance.

While some pre-fitting and post-fitting activities have been successfully decentralised, the socket fabrication step has remained largely tethered to a full-service prosthetic service unit. Traditional socket fabrication follows a multi-step process (see Annex G), which is difficult to de-link from personnel and infrastructure requirements. The prosthetist/orthotist’s expertise is required to shape the socket so that weight is distributed in pressure-tolerant areas, which is specific to the patient’s residual limb. Socket fitting is critical to the final comfort, mobility, and safety of the patient, and impacts adoption and adherence.

Socket fabrication in LMIC is affordable, but time-consuming and creates waste. Sockets in LMICs are fabricated from polypropylene or resin, through lamination of fibres. Both materials are affordable and durable. The socket fabrication and fitting process usually takes one to three days, depending on the need for adjustments. Negative environmental impact is caused by wasteful intermediary outputs that are disposed of, such as the cast of the residual limb and the plaster positive mould. With traditional casting, information is lost in the process; meaning some changes require the process to be repeated.

Innovative technologies can potentially decentralise socket fitting and fabrication, and enable full end-to-end decentralisation of the prosthetic fitting process. Two different types of technologies exist: 1) direct casting; and 2) digital fabrication. Direct casting technology forms the socket material directly on residual limbs to create a socket, without the need of plaster casting or heavy machines. Fewer steps are required compared to traditional socket fabrication and the process takes one to two hours. All equipment and materials needed can be mobile. The current leading developers of direct casting technology are Amparo’s Confidence socket and Össur’s IceCast. While direct casting technologies look promising, further investigation into the cost-effectiveness and clinical acceptability in LMIC contexts is needed to drive adoption.

Digital fabrication utilises digital scanning to capture the shape of the limb, and software to make virtual rectifications combined with fabrication of the final socket (or the intermediary mould) from the digital file. This method replaces heavy machinery and equipment with digital tools, such as a scanner, mobile phone, laptop, and 3D printer, thereby making it potentially more cost-effective to offer in more clinics. Several companies are active in digital fabrication, with varying software, materials, and fabrication methods. Some companies, such as Prosfit and Nia, print sockets with 3D printers, albeit through different fulfilment models (the process of production, shipping, and delivery). Prosfit relies on centralised printers, which offers the benefit of centralised quality control, but requires additional shipping considerations. Nia deploys on-site, lower-priced 3D printers. Rodin, Vorum, and Proteor combine digital scanning with fabricating the positive mould of the socket using a centralised milling machine, which enables digital scans to be captured and sent to a central service which can fabricate the final socket without requiring the user to travel. In terms of market readiness in LMICs, Prosfit and Nia are the most advanced since they have conducted trials in LMICs, though further evidence generation is needed to demonstrate acceptability. Rodin, Vorum, and Proteor are commercially available in HICs, where they have focused their deployment, and currently have limited presence in LMICs.

Some 3D-printed sockets have experienced failures in laboratory testing, which differs from the slower breakage or tearing observed in sockets fabricated through other methods. These failures, which may be linked to the printing technology, could potentially cause injury or harm to users. Further research and investigation into the root causes and mitigation strategies is needed.⁴² See Annex H for profiles of the main developers of novel fitting technologies currently making progress in LMICs.

While most of these technologies are commercially available in HICs, they have yet to be widely adopted in LMICs, driven by a lack of consensus on acceptability and financial implications due to insufficient clinical, operational, and economic evidence. There is potential for digital fabrication to deliver and decentralise prosthetic services more cost-effectively. Some technologies have undergone field testing in LMICs, but a lack of research standards to govern the set up and control of these trials often lead to inconclusive results that are not generalisable to other settings. For buyers and implementers to have clarity on the use of these technologies, establishing research standards, analysing cost-effectiveness, and implementation guidance is needed to drive transparency and adoption.

Prosthetic liners are an important component to the use and comfort of prosthetic devices, and are critical to the adoption of some novel socket technologies; but modern liners are cost-prohibitive in LMICs. Liners act as the interface between the skin and the socket, and are used to secure the prosthetic device, reduce slippage, ensure fit, adjust to volume change, and regulate temperature.

Over 70 types of liners are commercially available and fabricated from a number of materials. Silicone liners are most common in HICs as the material balances comfort and durability. However, since liners need to be replaced annually and are priced at USD 200 to USD 500, they are cost-prohibitive to most users in LMICs. Socket socks, bandages, or foam are commonly used instead, but such alternatives have short useful lives and often cause discomfort, which may lead to user abandonment of the entire device. Modern liners decrease dependence on walking aids, improve suspension, improve weight distribution, decrease pain, and increase comfort.⁴³ Field evaluation to validate whether emerging affordable liners are suitable in LMICs would enable wider adoption. Numerous innovative socket fabrication technologies require modern liners in order to be attached to the residual limb safely and comfortably. Uptake of silicone liners would enable wider adoption of these innovations.

4.10. Cost is a barrier to affordability for users and is mainly driven by the cost of prosthetic components. Prosthetists lack the market intelligence and transparency on quality of lower-cost components, which limits the penetration of these components in LMICs.

With prices ranging from USD 700 to USD 3,000,⁴⁴ prosthetic solutions from leading suppliers are not affordable to many that need them, particularly the lowest-income users. Components for a basic mechanical prosthesis – including the socket, knee joint, pylon, foot, and connectors – account for as much as 50-75% of the total cost. Contributing to the high cost of devices are the high custom duties and taxes to import components into many countries. Reducing the price of components is an opportunity to reduce overall service cost. In LMICs, there are typically limited options of components available for purchase locally. Instead, prosthetists or health administrators either hold stock of components – but have difficulties in predicting the needs of users who seek care – or place individual orders directly from overseas suppliers after patient assessment, leading to long lead times, inefficient and costly procurements, and logistical challenges.

There are a number of suppliers emerging in Asia offering affordable component options but prosthetists in LMICs have little awareness that these options are available, leading to low market penetration. LMIC practitioners are generally only aware of a few suppliers: Ottobock has earned a reputation for offering high-quality and expensive components; the ICRC and Jaipur have developed low-cost technology with decades of presence in market. Prosthetists have little knowledge of other suppliers and if they do, they often do not know how these compare in terms of quality or performance. Although international standards exist and Stringent Regulatory Authorities (SRA) regulate prosthetic components, SRA approval processes generally allow for self-declaration of conformance instead of evaluation of a regulatory dossier. This can lead to variability in quality and performance (see Figure 6 for further details). When existing standards are insufficient to guide product evaluation, brand reputation, supplier marketing efforts and user’s ability to pay drive the selection criteria. Market transparency is needed on the various supply options and their comparative quality and performance in LMIC contexts. This can also help lower the barriers to entry for more competitors in LMIC markets.

4.11. Responsive supply channels are needed in LMICs and could be met via regional distributors.

Because patient assessment is required before components can be selected, an assortment of solutions needs to be locally available. Unfortunately, this is rarely found in LMICs since service providers often lack access to the working capital needed to maintain a large volume of components. Additionally, it is difficult to anticipate the needs of patients when making aggregate volume orders. See Annex I for limitations of common supply channels observed in LMICs. Flexible ordering from local sources and supply channels which can responsively supply tailored components to the individual users are needed.

Regional distributors aggregate volumes across buyers to purchase in bulk from international suppliers and maintain a wider range of inventory that can effectively meet various user needs. Purchasing currently occurs through disorganised, ad-hoc patterns with individual purchasers each choosing their own channels, which includes placing individual orders directly with international suppliers. This leads to high delivery costs and long lead times. Organisation and aggregation of ordering can improve quality and affordability through expanded product options, reduction of delivery lead time, and logistical costs. Distributors that focus on prosthetic components operate successfully in some LMIC markets (see Case Study 7) and help drive efficiency and affordability by aggregating orders, negotiating volume-based pricing, offering extended payment terms to buyers, and delivering responsively to providers. With additional support, they can improve upon their capacity as an intermediary between buyers and suppliers and organise efficient markets. Such support can help these distributors increase access to working capital financing, enable geographic expansion, and expand warehouse capacity.

4.12. Irrespective of the delivery approach, human resource (HR) capacity is a limitation, and novel ways of expansion and extending HR need to be considered.

To support the adoption and scale-up of innovative fitting technologies, consideration needs to be made for shifts in HR requirements. The traditional fitting process relies heavily on the skill level of the prosthetist/orthotist in order to control quality, which also limits how quickly services can be expanded and whether services can be decentralised. For novel technologies, certain steps such as digital scanning could potentially be task-shifted to lower-level or non-P&O healthcare workers. Conversely, direct fitting or digital rectification requires prosthetists/orthotists to be trained in new techniques and skills. Thus, the scale-up of these technologies is highly dependent on adequate investment in training P&O and other clinicians to successfully integrate these tools into their workflow.

Investing in capacity expansion of prosthetists/orthotists and leveraging models of HR extension are critical to address the gap of prosthetists/orthotists in LMICs. Trained prosthetists/orthotists are central to ensuring high-quality, well-fitted prosthetic solutions, regardless of the provisioning approach selected. Sufficient capacity of prosthetists/orthotists is a key pillar of any functioning prosthetic services system. Investment is needed to increase the number of prosthetists/orthotists, and to upskill and retain existing practitioners by investing in training, developing career pathways, and adequate job benefits. Novel models are emerging which use digital technologies to cost-effectively expand training and extend the reach of clinicians to reach more patients, thereby lowering barriers to access. These models need further validation and support in order to reach wider adoption and achieve impact.

5.1. Demand

5.2. Supply

5.3. Enablers