PRODUCT NARRATIVE: PROSTHESES

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A Market Landscape and Strategic Approach to Increasing Access to Prosthetic Devices and Related Services in Low-and-Middle-Income Countries

AT 2030 logo AT scale logo with the text Global partnership for Assistive Technology

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Acknowledgements

This report was delivered by the Clinton Health Access Initiative under the AT2030 programme in support of the ATscale Strategy. The AT2030 programme is funded by UK aid from the UK government and led by the Global Disability Innovation (GDI) Hub. The authors wish to acknowledge and thank prosthetics sector experts, practitioners and users, and the partners from the AT2030 programme and Founding Partners of ATscale, the Global Partnership for Assistive Technology, for their contributions. The Founding Partners are: China Disabled Persons’ Federation, Clinton Health Access Initiative, GDI Hub, Government of Kenya, International Disability Alliance, Norwegian Agency for Development Cooperation, Office of the UN Secretary-General’s Envoy for Financing the Health Millennium Development Goals and for Malaria, UK Department for International Development, UNICEF, United States Agency for International Development, World Health Organization.

The views and opinions expressed within this report are those of the authors and do not necessarily reflect the official policies or position of ATscale Founding Partners, partners of the AT2030 programme, or funders.

Please use the following form: ( https://forms.gle/kQdJTR9uXRj8g5aYA ) to register any comments or questions about the content of this document. Please direct any questions about ATscale, the Global Partnership for Assistive Technology, to info@atscale2030.org or visit atscale2030.org. To learn more about the AT2030 Programme, please visit at2030.org .

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Acronyms

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APDK

Association of Physically Disabled Kenya

AT

Assistive technology

BMVSS

Bhagwan Mahaveer Viklang Sahayata Samiti

CBR

Community-based rehabilitation

CE

CE marking (compliance with EU legislation)

CEPO

Centre of Excellence for Prosthetics and Orthotics

CHAI

Clinton Health Access Initiative, Inc.

CSO

Civil society organisation

CSPO

The Cambodian School of Prosthetics and Orthotics

DPO

Disabled persons’ organisation

EUR

Euro (currency)

FBO

Faith-based organisation

FDA

US Food and Drug Administration

HI

Humanity & Inclusion (formerly Handicap International)

HIC

High-income country

HR

Human Resources

ICRC

International Committee of the Red Cross

ISPO

International Society for Prosthetics and Orthotics

ISO

International Organization for Standardization

LMIC

Low- and middle-income country

NGO

Non-governmental organisation

OADCPH

Organisation Africaine pour le Développement des Centres pour

Personnes Handicapées

OOP

Out-of-pocket

P&O

Prosthetics and orthotics

PPP

Public-private partnership

SOL

Scandinavian Orthopaedic Laboratory (Sweden)

SRA

Stringent Regulatory Authority

TATCOT

Tanzania Training Centre for Orthopaedic Technologists

TF

Transfemoral (prosthesis)

TT

Transtibial (prosthesis)

UK

United Kingdom

US

Unites States of America

USD

United States Dollar

USAID

United States Agency for International Development

WHO

World Health Organization

3D

Three-dimensional (printing)

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Executive Summary

To accelerate access to assistive technology (AT), it is critical to leverage the capabilities and resources of the public, private, and non-profit sectors to harness innovation and break down barriers to affordability and availability. Market-shaping interventions can play a role in enhancing market efficiencies, as well as coordinating and incentivising stakeholders involved in demand- and supply-side activities. This document will address the key barriers and opportunities to increase access to prosthetic services. Since there is a significant overlap in prosthetic and orthotic service delivery, access to orthotic services will also benefit from the proposed interventions.

Globally, an estimated 1.5 million people undergo amputations every year and need to access prosthetic services. The need is growing in low- and middle-income countries (LMICs). However, despite evidence that using a prosthesis can improve quality of life and reduce mortality for amputees, the World Health Organization (WHO) estimates that only 5-15% of amputees who need prosthetic devices in LMICs have access to them.

The market for prosthetic solutions in LMICs is small, because prostheses need to be fitted through a service delivery process that requires specialised infrastructure and personnel, both of which are in short supply in LMICs. Governments have historically not invested in this sector, because they lack data and awareness of the need and economic benefits. In the absence of government investments, non-governmental organisations (NGOs) have developed service capacities, largely in response to emergencies that sometimes operate in parallel to government systems. Without support from governments and donors to integrate provision and expand capacity, prostheses are not accessible to most people that need them. Innovative socket manufacturing technologies, including digital fabrication and direct-casted sockets, have the potential to increase access. However, consensus is needed within the sector on the readiness of these technologies to be deployed in LMIC markets.

A few companies supply most of the prosthetic components worldwide, and these are focused on high-income markets that can bear more expensive and technologically advanced solutions. Alternative suppliers offering affordable products are entering LMICs from emerging markets such as China, Turkey, and India. However, limited transparency on the quality and performance of these components in LMIC contexts inhibit their uptake. Additionally, prosthetic components should be available through a flexible and responsive supply chain, since component selection is made by prosthetists/orthotists based on assessments of users’ needs and use context. While components in high-income countries (HICs) are often ordered individually from the manufacturer, logistics challenges in LMICs may not allow such an approach. An opportunity exists to increase access to affordable, quality, and appropriate prosthetic components, but will require more transparency and a more responsive supply chain.

High prices and poor perception of value of prosthetic services in LMICs, combined with high indirect costs for users to travel, makes prosthetic services unaffordable to many of people who need them. Prosthetic services can be made more affordable by: 1) increasing the number of service units (in particular, by leveraging decentralised service models and the innovative technologies that enable them); 2) establishing reimbursement schemes that encapsulate all costs to the user; and 3) leveraging alternative forms of financing for both capacity-building and user financing.

An opportunity exists to transform access to prosthetic services and products in LMICs, but this will require a coordinated effort between: 1) governments to expand service capacity; 2) global stakeholders to provide guidance on products and technologies; 3) suppliers to expand market presence and offerings; and 4) donors to support these activities. To accelerate access to prosthetic services in LMICs, the following strategic objectives have been defined:

Strategic Objective 1: Develop foundational datasets to inform the investment case for prosthetic services and guide the development of standards.

Strategic Objective 2: Support countries to define appropriate policies and invest in the key requirements of a functioning prosthetic provisioning system.

Strategic Objective 3: Accelerate market validation and adoption of innovative technologies that can simplify, decentralise, and lower the cost of prosthetic service provision.

Strategic Objective 4: Accelerate the uptake of affordable, quality prosthetic components by increasing market transparency to empower buyers to make value-based purchasing decisions.

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Strategic Objective 5: Strengthen regional supply mechanisms to increase affordability and availability of quality prosthetic components.

These strategic objectives are supplemented by initial activities to support access to affordable, high-quality, and appropriate prosthetic devices and services. ATscale, the Global Partnership for Assistive Technology, is currently in the process of developing a prioritisation process to inform which of the market-shaping activities proposed in this document will be incorporated into the Partnership’s action and investment plan in order to guide activities and investments in the short-term. While that is underway, some of these proposed activities will be undertaken in the immediate term by the AT2030 programme, funded by UK aid, in line with its aim to test what works to increase access to affordable and appropriate assistive technology.

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Introduction

1. Assistive Technology and Market Shaping

Assistive technology (AT) is an umbrella term covering the systems and services related to the delivery of assistive products such as wheelchairs, eyeglasses, hearing aids, prostheses, and personal communication devices. Today, well over 1 billion people require assistive technology to achieve their full potential, but 90% do not have access to the assistive technology they need. This unmet need for assistive technology is driven by a lack of awareness of this need, discrimination and stigma, a weak enabling environment, lack of political prioritisation, limited investment, and market barriers on the demand and supply side. Market shortcomings limit availability, affordability, and access to appropriate assistive technology, and market shaping is proposed to address these root causes, as well as serve the wider aim of ensuring improved social, health, and economic outcomes for people who require assistive technology. Increased access to assistive technology is critical to achieve many global commitments, including universal health coverage, the ideals of the United Nations Convention on the Rights of Persons with Disabilities, and the ambitious Sustainable Development Goals. To accelerate access to assistive technology, the global community needs to leverage the capabilities and resources of the public, private, and non-profit sectors to harness innovation and break down market barriers.

Whether by reducing the cost of antiretroviral drugs for HIV by 99% in 10 years, increasing the number of people receiving malaria treatment from 11 million in 2005 to 331 million in 2011, 1 or doubling the number of women receiving contraceptive implants in 4 years while saving donors and governments USD 240 million, 2 market shaping has addressed market barriers at scale. Market-shaping interventions can play a role in enhancing market efficiencies, improving information transparency, and coordinating and incentivising the numerous stakeholders involved in both demand- and supply-side activities. Examples of market-shaping interventions include: pooled procurement, de-risking demand, bringing lower cost and high-quality manufacturers into global markets, developing demand forecasts and market intelligence reports, standardising specifications across markets, establishing differential pricing agreements, and improving service delivery and supply chains.

Market-shaping interventions often require coordinated engagement on the demand and supply side (see Figure 1).

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Successful interventions are tailored to specific markets after robust analysis of barriers and seek to coordinate action on both the demand and supply side. These interventions are catalytic and time-bound, with a focus on sustainability, and are implemented by a coalition of aligned partners providing support where each has comparative advantages.

Figure 1: Engaging both demand and supply side for market shaping

Figure 1: Engaging both demand and supply side for market shaping depicting Demand side engagement and supply side engagement as influencing each other Demand Side Engagement Work with governments, DPOs, CSOs, and others to: - Build and consolidate demand around optimal products in terms of efficacy, specifications, quality, and price - Strengthen procurement processes and programmes to utilise optimal products - Improve financing and service delivery Supply Side Engagement Work with manufacturers and suppliers to: Reduce the costs of production - Enhance competition - Enhance coordination - Encourage adoption of stringent quality standards - Optimise product design - Accelerate entry and uptake of new and better products

Historically, assistive technology has been an under-resourced and fragmented sector and initial analysis indicated that a new approach was required. ATscale, the Global Partnership for Assistive Technology, was launched in 2018 with an ambitious goal to provide 500 million people with the AT that they need by 2030. To achieve this goal, ATscale aims to mobilise global stakeholders to develop an enabling ecosystem for access to AT and to shape markets to overcome supply- and demand-side barriers, in line with a unified strategy ( https://atscale2030.org/strategy ). While the scope of AT is broad, ATscale has focused on identifying interventions needed to overcome supply- and demand-side barriers for five priority products: wheelchairs, hearing aids, eyeglasses, prosthetic devices, and assistive digital devices and software.

Clinton Health Access Initiative (CHAI) is delivering a detailed analysis of the market for each of the priority products under the AT2030 programme ( https://www.disabilityinnovation.com/at2030 ), funded by UK aid from the UK government, in support of the ATscale Strategy. AT2030 is led by the Global Disability Innovation Hub. What follows is a detailed analysis of prosthetic devices, one of the five evaluated priority products.

2. Product Narrative

The product narrative defines the approach, identified by CHAI, to sustainably increase access to high-quality, affordable AT in LMICs. The goals of this narrative are to: 1) propose long-term strategic objectives for a market-shaping approach; and 2) identify immediate opportunities for investments to influence the accessibility, availability, and affordability of prosthetic and orthotic (P&O) services. This document will focus primarily on access to prosthetic services. However, given the overlap between P&O service delivery in infrastructure and personnel, access to orthotic services will also benefit from the proposed interventions.

This report has been informed by desk research, market analysis, key informant interviews, and site visits with relevant partners and governments to develop a robust understanding of the market landscape and the viability of the proposed interventions. A list of all individuals interviewed or consulted during the development process can be found in Annex A. This document is divided into two chapters:

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Chapter 1: Market Landscape

3. Market Context

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 diabetes 5 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 patients 8 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.

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Figure 2: Regional Distribution of people living with amputation

Figure 2: Regional distribution of people living with amputation (2017) Number of people living with amputations per region East-Central Asia: 17 million; 62% lower limp, 38% upper limb Europe: 14 million; 71% lower limb, 29% upper limb South Asia: 11 million; 66% lower limb, 34% upper limb Africa: 5 million; 75% lower limb, 25% upper limb North America: 5 million; 59% lower limb, 41% upper limb Middle East: 5 million; 74% lower limb, 26% upper limb Central-South America: 4 million; 60% lower limb, 40% upper limb South East Asia: 3 million; 70% lower limb, 30% upper limb Australia: 1 million; 66% lower limb, 34% upper limb

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,

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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.

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Table 1: Types of prosthetic devices

Type of prosthetic device

Upper or lower limb type

Body part(s) replaced

Shoulder

Upper limb

Shoulder, elbow, forearm, wrist, hand

Transhumeral (TH) (above elbow)

Upper limb

Elbow, forearm, wrist, hand

Transradial (TR) (below elbow)

Upper limb

Wrist, hand

Transfemoral (TF) (above knee)

Lower limb

Knee, shin, ankle, foot

Transtibial (TT) (below knee)

Lower limb

Ankle, foot

Partial foot (PF)

Lower limb

Part of the foot

Table 2: Components of modular (endoskeletal) lower limb prosthetic devices

Illustration of a transtibial and a transfemoral prosthesis Both consist of: liner, sock (worn under the liner), socket, pylon and foot. The transfemoral prosthesis also has a rotator and a knee joint.

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.

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Component

Description

Range of Raw Materials

Liner, sleeves, socks

Soft interface materials that ensure fit, comfort, and that the prosthesis stays attached to residual limb. Certain suspension systems require use of liners. When used properly, they provide a cushioning effect within the socket, help to minimise friction forces, and provide even pressure distribution.

Socks can be used to adapt to changes in the volume of the residual limb.

Ethylene-vinyl acetate (EVA) foam, silicone, gel, urethane, thermoplastic elastomer (TPE), pelite, wool, cotton.

Socket

Where the prosthetic device attaches to the residual limb. Because the residual limb is not meant to bear body weight, sockets must be individually moulded and meticulously fitted to ensure pressure is distributed, and to avoid damage to skin and tissue.

Polypropylene, thermoplastic elastomer (TPE), wood, aluminium, glass-reinforced plastic (GRP), resin, carbon fibre.

Knee joint

Mimics the function of a natural knee by providing safety, symmetry, and smooth movement while walking. High variations exist in activity level, functionality, technology, and materials.

Titanium, aluminium, polypropylene, nylon, wood.

Pylon

Connects the socket to the foot. Lightweight and absorbs shock.

Wood, titanium, aluminium, steel, carbon fibre, glass-reinforced plastic (GRP), polypropylene.

Foot

Designed to be the point of contact between prosthesis and contact surface, with different foot designs optimised for different functions or terrains.

Polypropylene, polyurethane, wood, rubber, carbon-fibre.

Cosmesis

Limb covering to mimic appearance of real limb. Can be readymade or custom-designed or made from locally sourced materials.

Silicone, local fabrics, Ethylene-vinyl acetate (EVA) foam.

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.

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Figure 3: Examples of lower-limb prosthetic devices

Figure 3: Examples of Lower-limb prosthetic devices shows photos of 3 devices Conventional (exoskeletal) are made from one type of raw material, with limited customisation or variation of components (ICRC TF prosthesis shown, made from polypropylene). Basic Modular (endoskeletal) are made of mechanical user-powered components made from aluminium, steel, or rubber, amongst others. Modular design permits customisation and selection of components to suit user needs. Advanced Modular - includes hydraulic, pneumatic, microprocessor controls - has advanced functional components made from lightweight materials designed for comfort and activity (carbon fibre, titanium). Some advanced joints employ hydraulic or pneumatic joints for smooth gait control. Others utilise microprocessors equipped with intelligent controls and sensors that respond to the user and environment. Though designed to be durable, most advanced components often have limited lifespans in LMIC environments.

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:

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.

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Figure 4: 4-Step prosthetic service delivery process

Figure 4: 4-Step prosthetic service delivery process Figure showing the four steps with arrows. 1. Assessment: The prosthetist evaluates patient health, lifestyle, environment, and amputation to prescribe an appropriate prosthetic solution (including selection of appropriate components and materials to match user needs). 2. Fabrication & Fitting: The prosthetist takes measurements and casts impressions of residual limb. The cast of the stump is modified by the clinician to take into account individual biomechanics and attributes. The prosthetist, in collaboration with prosthetic technicians, fabricates the socket and assembles components. Finally, the prosthetist fits and customises the prosthesis to the user’s needs. 3. User Training: User undergoes physical therapy and functional training to maximise benefits, ensure safety, and continued use. Physical therapist coaches user in gait training, and provides education on appropriate maintenance and care after the device is provided. 4. Product Delivery & Follow-up: When the prosthesis is optimally fitted, the prosthetist conducts requisite quality and functionality checks, and delivers the prosthesis. Follow-ups with the patient tracks outcomes and troubleshoots issues that may arise after a period of use and are an important feedback loop. For new amputees, regular socket fit assessment is needed as changes can occur as stump consolidation takes place.

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 200,000 24 up to USD 400,000, 25 with machinery accounting for 50-80% of the cost.

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Figure 5: Prosthetics and orthotics service unit requirements

Space requirements

A Prosthetics and orthotics unit has 4 main areas:

Reception/waiting Area

Clinical area

Workshop area (typically multiple rooms and workbenches)

Personnel area

Types of equipment & machinery

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/orthotists 27 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 occupations 28 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 LMICs 29 (see Case Study 1).

Table 3: Designations in prosthetic and orthotic professions according to 2018 education standards (see Annex B for detailed descriptions),

Professional designation

Responsibilities

Training

Recommended number

Prosthetist/Orthotist

Formerly: Category I Prosthetist/ Orthotist

Clinician

Clinical: assessment, prescription, fitting, design, fabrication, monitoring outcomes.

Non-clinical: leadership of clinical team, management of service unit, training, education, community demonstrations, awareness-building.

4 years full-time at university level.

5-10 clinicians per million population.

Each service point should have at least one Prosthetist/Orthotist or experienced Associate Prosthetist/Orthotist.

Associate Prosthetist/ Orthotist

Formerly: Category II Orthopedic Technologist

Clinician

Clinical: clinical assessment, prescription, technical design, fabrication, fitting of device, monitoring outcomes.

3 years formal structured.

5-10 clinicians per million population.

Each service point should have at least one Prosthetist/Orthotist or experienced Associate Prosthetist/Orthotist.

Prosthetist/Orthotist Technician

Formerly: Category III Prosthetic/Orthotic Technician/Bench Worker

Non-clinician

Non-clinical: support (Associate) Prosthetist/Orthotist in device fabrication, assembly, maintenance, repair. Not involved in direct services to the user.

2 years formal structured or 4 years on the job/in-house training.

2 non-clinicians per clinician.

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

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integrated with health services. In some settings, rehabilitation clinicians are also trained to provide device maintenance or repairs.

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Case Study 1: Prosthetist/Orthotist training centres in Southeast Asia and East Africa

Southeast Asia: Cambodia n School of Prosthetics and Orthotics (CSPO)

CSPO was established in 1994 in collaboration with the Cambodian Ministry of Social Affairs to address the shortage of trained prosthetists/orthotists in Cambodia and across Southeast Asia. CSPO is currently upgrading its accreditation by ISPO to provide prosthetist/orthotist degree training and has been accredited since 1998 for Associate Prosthetist/Orthotist diploma and Prosthetics/Orthotic Technician training. It was the first ISPO-accredited school to receive ISO 9001 Quality Management System accreditation, exhibiting international levels of production quality control. Since establishment, 327 individuals from 27 countries across the region and beyond have graduated from the school and entered the profession.

The establishment of the school led to quality improvements in P&O services across Southeast Asia. Having local training capacity led to the expansion of services and developed a cadre of professionals and leaders who rapidly transformed the quality of P&O services in the region. CSPO curriculum and graduates have been used worldwide by Exceed to seed P&O training institutes in Sri Lanka, Indonesia, the Philippines, and Myanmar. CSPO has developed the domestic capacity of prosthetists/orthotists, enabling workforce nationalisation (instead of reliance on expatriate practitioners) across numerous countries, and established professional associations who advocate for recognition of the profession and policy changes to improve service capacity.

Anchored by CSPO, a P&O ecosystem has evolved in Cambodia. The ecosystem includes a social enterprise that provides differentiated services for users at different income levels, and is part of a regional component manufacturing and distribution company which also operates using a social enterprise model.

Despite this progress, the impact is limited by poor referral rates and awareness of prosthetic services. Limited professional development and recognition of the prosthetist/orthotist profession also leads to attrition and inequity for users outside urban areas.

East Africa: Tanzania Training Centre for Orthopaedic Technologists (TATCOT)

TATCOT was founded in 1981 with the support of German Technical Cooperation (now Gesellschaft für Internationale Zusammenarbeit) and operates under the Directorate of Human Resources Development for the Ministry of Health of Tanzania. TATCOT offers ISPO-accredited degrees and diplomas. As of December 2017, 752 students have graduated: 134 Prosthetists/Orthotists and 370 Associate Prosthetists/Orthotists, the remainder being specialised technicians. Graduates stem from 43 countries, including 32 in Africa.

Prosthetist/Orthotist and Associate Prosthetist/Orthotist degrees at TATCOT cost USD 44,500 and USD 25,725 respectively. 32 TATCOT offers a Blended Learning Education programme that can allow Associate Prosthetist/Orthotist diploma holders to upgrade to a Prosthetist/Orthotist degree while continuing to work on the job. The curriculum combines online lectures with on-site practical teaching. TATCOT is continuing to experiment with blended learning to provide continuing education as well as specialisation training.

A 2012 USAID-funded assessment showed that TATCOT graduates have had lasting impact across East Africa. In Tanzania, Kenya, and Uganda, graduates have improved quality of care, established outreach services and mentorship, and established professional communities that enable professional development.

In addition to being a leading training institute, TATCOT is a provider of P&O services in Tanzania. A barrier to providing affordable services is the high cost of materials and components, most of which need to be imported. To address this, TATCOT has worked with professional associations in Tanzania to advocate for the inclusion of P&O components in central procurement processes by the Ministry of Health for the national Medical Store.

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.

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4. Market Assessment

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

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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.

Table 4: Capacity gap of P&O service units and personnel in select LMICs

Country (population)

Number of P&O service units: Need

Number of prosthetic service units: Actual

P&O personnel: Need

P&O personnel: Actual

Status of in-country training institution

Kenya

(50 million)

50-150

40 35

250-500

200 trained personnel, very few ISPO-accredited.

Not ISPO-Accredited.

Rwanda

(12 million)

12-36

14
(both public and private sector)

120-240

67 ISPO-accredited clinicians: 53 Associate Prosthetists/Orthotists and 14 Prosthetists/Orthotists.

Accredited by ISPO.

Indonesia

(260 million)

260-780

24 in general hospitals 36

1,300-2,600

243 accredited clinicians.

Accredited by ISPO.

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.

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Table 5: Insurance and reimbursement rates for amputees for lower-limb prosthetic devices

Country

Financing for users

Eligibility criteria

Price (USD)

Kenya

National Health Insurance Fund: provides reimbursement, up to a job-dependent annual maximum.

Must be civil or public servants. Pre-approval is required.

TT: USD 500

TF: USD 1,000

Rwanda

Community-Based Health Insurance: used by 85% of Rwandans; does not generally cover prosthetic devices except at 2 university teaching hospitals.

Beneficiaries can access up to RWF 175,000 (USD 175) at university teaching hospitals in Rwanda, which typically covers the cost of a prosthetic foot.

TT: USD 360-1,000

TF: USD 600-1,000

Rwanda

Rwanda Social Security Board: covers 85% of cost of device and services.

Only civil servants; requires 15% employee salary contribution.

TT: USD 360-1,000

TF: USD 600-1,000

Rwanda

Military Medical Insurance: covers 85% of cost of device and services.

Only members of Rwanda Defence Force and police staff.

TT: USD 360-1,000

TF: USD 600-1,000

Indonesia

National Health Insurance: covers services, but prosthetic device coverage is Rp 2.5 million (USD 180) every 5 years.

Requires a prescription; can only be accessed through a government secondary healthcare facility.

TT: USD 920

TF: USD 1,700

Indonesia

Other financial coverage is available for people under social welfare from certain provinces.

TT: USD 920

TF: USD 1,700

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

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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.

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Case Study 2: Public-private partnership in Thailand

Mahidol University is a public-sector institution that hosted the first ISPO Category I-accredited school in Southeast Asia. Scandinavian Orthopaedic Laboratory (SOL) is a private sector enterprise in Sweden. Together, the two partners collaborated in 2017 to create the Centre of Excellence for Prosthetics and Orthotics (CEPO) to pilot PPPs as a new way to co-invest in P&O services.

In the past, public service units offered basic services and products free of charge, covered by national insurance schemes. Issues in this public system included low quality of services and devices, and long wait times. At a price premium, private providers offered a higher level of service and higher-priced component options in well-equipped facilities with well-trained staff. To provide an alternative to the public and private sector service levels, CEPO was established to serve a middle class who want to access government reimbursement for prosthetic services, but also have a desire for faster access to services and better quality components, and can afford to supplement public insurance funding. CEPO also provides clinical training for P&O staff and other rehabilitation professions.

Partners share investments and costs, and assume profits and losses equally. Mahidol University invested in the construction of the site, employs all local staff, and offers existing hospital administration systems for patient records and payments. SOL invested in the equipment, furniture, and machinery required to achieve high level of service. SOL also employs management staff and manages procurements, since procurement restrictions prevent the government entity from selecting from a range of appropriate products.

CEPO has set a new standard for quality of P&O services through improved service unit management and leadership, and increased quality of components. As a result, clinicians and users have begun to request access to better-quality products and services in other public sector service units. While profitability has not yet been achieved after 3 years, CEPO anticipates it will soon be profitable as volumes increase through broader awareness and improved referrals. Moving forward, access to a lower cost of capital for establishment could encourage additional private sector investments in service expansion and to shorten the time to reach financial sustainability.

Case Study 3: Exceed social enterprise

Exceed Worldwide is a UK-based non-profit that has established five P&O schools in Southeast Asia and supports the capacity development to train prosthetists/orthotists in the region. Exceed also supports local prosthetic services and runs a social enterprise which provides differentiated services to users of different income levels. By applying a government-recognised poverty assessment tool in Cambodia, clients with suitable financial means are offered services and products which command a higher price and profit, while low-income users are able to access quality services free of charge and products at cost-recovery price. The services for low-income users are supported by the government and by the People with Disability Foundation.

The social enterprise also operates a regional distribution company, which procures materials and components from international and local suppliers in order to supply service providers across Southeast Asia. All profits support philanthropic activities such as subsidised products and services for low-income users and scholarships for training prosthetists/orthotists. Since its initial launch in Cambodia, Exceed has expanded this model to Sri Lanka and the Philippines. The social enterprise is currently supported by Innovate UK and researching similar models in Myanmar.

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.

Case Study 4: Amputee Screening through Cellphone Networking (ASCENT) in the Philippines

The ASCENT project was developed in 2010 to address the challenge of reaching under-served communities on the islands of the Philippines. Health workers use mobile phones to record the medical history and transmit data to a centralised web-based database with photographs and videos.

Utilising ASCENT has initiated the creation of a registry of amputees from remote communities and vulnerable populations that were previously not visible to policy-makers. This data, along with other advocacy efforts, led to the creation and implementation of the Philippine Health Insurance Z Mobility, Orthosis, Rehabilitation and Prosthesis Help (MORPH) benefits package, which was launched in 2013. The package allows users to access 15,000 pesos (about USD 300) for each lower-limb prosthesis. This coverage was expanded in 2016 to 75,000 pesos (about USD 1,500) for TF prostheses.

ASCENT has not been scaled nationally or beyond the Philippines, but such tools represent potential models for countries to consider when initiating user registries and data collection efforts.

Case Study 5: National Quality Registry for Amputation and Prostheses (SwedeAmp) in Sweden

SwedeAmp was developed in Sweden in 2010 in response to the lack of data on amputees and patient outcomes from different treatment regimes in different regions and clinics. Utilising existing government health registry platforms, SwedeAmp collects patient-level data, including pre-amputation situation, amputation (level, technique used), prosthetic-fitting (device, personnel) and post-fitting (activity level achieved, and whether the patient is able to return home and resume activities). Patient outcomes are tracked until death.

SwedeAmp can show trends and predict expected outcomes of a patient, given their age, diagnosis, and location. Clinicians in the public and private sectors are mandated to manually input patient data, but progress is underway to link certain data points from other registries and electronic records. Healthcare professionals can access this dataset. Annual aggregated reports are made available to suppliers and private sector partners.

Implementing the registry has improved quality of care by allowing policymakers to identify issues in patient care and develop interventions to improve quality, based on comparing amputee outcomes across cities or facilities. 39 As a result, local guidelines for amputee and prosthetic user care have been published and strictly implemented to ensure consistency of high-quality practice.

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

20

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-

21

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.

Table 6: Decentralisation models for integration of P&O services in lower levels of health systems

Model

Description

Services Provided

Community-based rehabilitation (CBR) and outreach

Mobile clinics

Satellite services

Tele-rehabilitation

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Case Study 6: Association of Physically Disabled Kenya (APDK) community-based rehabilitation and mobile P&O clinic programme

APDK is the oldest non-profit organisation for persons with disabilities in Kenya. It operates a network of 10 branches, each with comprehensive orthopaedic rehabilitation service, including prosthetic and orthotic services, wheelchairs, and physical rehabilitation.

To reach vulnerable populations, APDK employs a mix of CBR programmes and mobile clinics that identify and refer people with disabilities.

APDK is currently assessing the potential to integrate direct-casted sockets to the offerings available through the mobile clinic. If proven successful and cost-effective, this model would permit users to be fitted on the same day and closer to their home.

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

23

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

24

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.

Figure 6: Quality and regulatory guidance for prosthetic components

Prosthetic limb components are categorised as medical devices by SRAs such as the FDA and the European Commission (CE marking). In addition to SRA approval, some LMICs have regulatory processes for registration of medical devices which may or may not include prosthetics. Prosthetic components fall under the category of medical devices, which permits suppliers to declare self-conformity under US FDA (Class II, 510(K) exempt) and CE (Class I).

There are numerous quality standards for prosthetics available from the International Organization for Standardization (ISO), including: ISO 10328:2016 Prosthetics – Structural testing of lower limb prostheses – requirements and test methods and ISO 22523:2006 External limb prostheses and external orthoses — Requirements and test methods. These standards focus on the durability of the components and delineate requirements for structural testing of a prosthetic component in a laboratory setting. To indicate that products conform to these standards, suppliers can either invest in their own testing equipment or submit their components to a third party with specialised equipment to test prosthetic limbs, which can cost up to USD 50,000 for each set of components. Due to the high cost, some suppliers may opt to test only a few components instead of its entire product line.

ISO standards do not stipulate how components should function in LMIC settings, which can be marked by harsher environmental conditions and user lifestyles (i.e. agricultural or physical labour use cases). WHO recommends that clinical user field tests are carried out to determine the strength, durability, functionality, safety, and effectiveness of components. However, this is not a requirement under FDA or CE as prosthetic components fall under the category of medical devices, which exempts suppliers from clinical trials.

These gaps – 1) limited SRA oversight; 2) lack of LMIC considerations in standards; and 3) the high cost of testing to standards – lead to a lack of visibility on the quality of components in the market for LMIC providers. Without further quality guidance, prosthetists rely on anecdotal experience to evaluate quality.

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.

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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.

Case Study 7: Organisation Africaine pour le Développement des Centres pour Personnes Handicapées (OADCPH)

OADCPH is a Togo-based non-profit regional distributor that links international manufacturers with providers in Africa. OADCPH serves a network of 80 members in more than 30 African countries, which includes public and private rehabilitation centres, individual prosthetists/orthotists, NGOs, FBOs, and governments.

The annual membership fee is USD 80 and members must agree to abide by a code of ethics for setting sustainable and affordable margins. OADCPH’s members benefit from negotiated pricing from bulk orders placed annually from a range of international suppliers. OADCPH has a 600m 2 warehouse for storing inventory and can deliver components in a number of countries in as quickly as 24 hours.

Because of its reputation and access to prosthetists/orthotists in Africa, OADCPH has been able to negotiate working capital financing with suppliers and in turn offers extended payment terms to buyers. OADCPH also disseminates product information from suppliers to its members to better inform product selection and purchasing decisions. OADCPH is currently piloting a 3D printing orthotics project with HI to supply orthotic components to regional members from a 3D printer centrally housed at its warehouse. OADCPH has also developed a regional training centre that offers a roster of training programmes for prosthetists/orthotists and other rehabilitation professionals, covering technical skills, service unit management, and administration and professional development.

Looking ahead, OADCPH is planning to expand warehousing capacity and its presence to East and Central Africa. It hopes to access increased working capital financing to offer better payment terms to more providers. It also hopes to strengthen its educational and training programmes, and sets ambitions on setting up a regional component testing centre to evaluate the quality and performance of components that passes through its distribution channels.

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

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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.

Table 7: Opportunities to expand and extend HR capacity

Model

Description

Impact on Access

Blended online-offline P&O training

Virtual learning modules and online lectures, combined with practical technical skills through a short period of on-site learning at a regional school or through mentorship in their current P&O workplace and role.

Video- or phone-based rehabilitation and gait training

Mobile applications use motion sensors on the user to provide coaching prompts to facilitate gait training without a physical therapist.

Video conferencing for physical therapists to provide training advice and answer user questions during rehabilitation after the user has left the service centre.

Task-shifting

Utilising digital scanning technologies, and under the supervision of rehabilitation clinicians (i.e. physical therapists, prosthetists/orthotists, rehabilitation therapists), the assessment and measurement step in the fitting process could be task-shifted to primary and community-level health workers.

5. Market Challenges

LMIC markets for prosthetic services have been limited by the lack of service capacity, with a need to rally political prioritisation and funding to invest in expansion, and to support users to access prosthetic services. The key demand and supply dynamics that have presented challenges to user access and sustainability of the market are summarised in this section.

5.1. Demand

5.3. Enablers

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Chapter 2: Strategic Approach to Market Shaping

6. Strategic Approach to Market Shaping and Market Building

Increasing access to prosthetic services to address the unmet need of users in LMICs will require a multi-faceted approach that leads to long-term, sustainable access. Interventions that address global barriers to market access, encourage political prioritisation to increase prosthetic service capacity, accelerate the scale-up of innovative fitting technologies, and ensure local availability of affordable high-quality components are foundational to market access. This section proposes five strategic objectives and long-term desired outcomes that will build and strengthen the market for prosthetics services.

Strategic Objective 1: Develop foundational datasets to inform the investment case for prosthetic services and guide the development of standards.

Strategic Objective 2: Support countries to define appropriate policies and invest in the key requirements of a functioning prosthetic provisioning system.

Strategic Objective 3: Accelerate market validation and adoption of innovative technologies that can simplify, decentralise, and lower the cost of prosthetic service provision.

Strategic Objective 4: Accelerate uptake of affordable, quality prosthetic components by increasing market transparency to empower buyers to make value-based purchasing decisions.

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7. Next Steps

This document was developed to support the identification of activities that will support increased and sustainable access to appropriate and affordable AT. As an overall investment and implementation strategy is developed, some of these proposed activities will be undertaken in the immediate term by the AT2030 programme, which is funded by UK aid and led by the Global Disability Innovation Hub, to test what works to increase access to affordable AT. Others will be complementary early investments that ATscale will take on or will become foundational to ATscale’s long-term investment in the space.

As interventions are shown to be effective, the investment case outlining the magnitude and types of investment needed will be further refined and developed. It is expected that different large-scale investments and financial instruments will be needed to achieve long-term outcomes. For example, system-strengthening grants may be needed to support the integration into the health system, while match funding or co-investments may catalyse government procurement and investment. On the supply side, donor investment may be leveraged to de-risk private investment in cost-effective supply mechanisms.

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Annexes

Annex A: List of Consultations for Product Narrative Development

35 36

Organisation

Name

500 Miles

Austin Mazinga

Amparo

Lucas Paes de Melo

Association of Physically Disabled of Kenya (APDK)

Benson Kiptum

Joseph Gakunga

Gladys Koech

Beijing JingBo P&O

Qing Hong An

Beijing P&O Technique Centre

Linda Zhu

Bhagwan Mahaveer Viklang Sahayata Samiti (BMVSS)

D.R. Mehta

V.R. Mehta

Blatchford/Endolite

John Ross

Cambodian School of Prosthetics and Orthotics (CSPO)

Sisary Kheng

Click Medical

Jimmy Capra

Clinton Health Access Initiative (CHAI)

Jean Bosco Uwikirebera

CURE Hospital

Seith Simiyu

Nelson Muoki

Michael Mbote

Exceed

Carson Harte

Fujian Guozi Prosthetics

Jianwei Pan

Humanity and Inclusion (HI) (formerly Handicap International)

Isabelle Urseau

Abderrahmane Banoune

Jérôme Canicave

International Confederation of Amputee Associations (IC2A)

Dr. Nils-Odd Tonneyold

Dieter Juptner

Jean-Pascal Hons-Olivier

Sandra Sexton

International Committee of the Red Cross (ICRC)

Marc Zlot

Jess Markt

International Society of Prosthetics and Orthotics (ISPO)

Friedbert Kohler

Claude Tardif

Jaipur Foot, Nairobi

Kundan Doshi

Francis Asiema

Kenya Ministry of Health

Alex Kisyanga

LegWorks

Emily Lutyens

Metiz

Elena Morozova

Mohamed Bassiouny

MiracleFeet

Chesca Colloredo-Mansfeld

Nia Technologies

Jerry Evans

Matt Rato

Organisation Africaine pour le Développement des Centres pour Personnes Handicapées (OADCPH)

Masse Niang (also of FATO)

Anarème Kpandressi

Ottobock

Berit Hamer

Prosfit

Alan Hutchison

Christopher Hutchison

Prosthetist/orthotist, Fiji

Dean Clarke

Proteor

Frederic Desprez

Puspadi Bali

Ni Nengah Latra

Regal Prosthesis

Oriana Ng

Rehab Impulse/Alfaset

Roger Ayer

South Africa P&O / physical therapist

Liezen Ennion

Johann Snyder

ST&G Corporation

Glenn Choi

SwedeAmp/CEPO

Bengt Soderberg

Tanzania Training Centre for Orthopaedic Technologists (TATCOT)

Longini Mtalo

Teh Lin Prosthetics

Brian Chen

James Chen

University Don Bosco, El Savador

Monica Castaneda

University of Global Health Equity

Claudine Humure

University of Melbourne

Wesley Pryor

United States Agency for International Development (USAID)

Michael Allen

Kirsten Lentz

Vorum

Nam Vo

World Health Organization (WHO)

Chapal Khanabis

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Annex B: Designations in Prosthetist/Orthotist professions according to 2018 Education Standards (detailed)

38

Designation

Responsibilities

Requisite training

Recommended Number

Prosthetist/Orthotist

Clinician

Formerly: Category I Prosthetist/ Orthotist

Clinical Services: clinical assessment, prescription, technical design, fabrication, and fitting of devices; monitoring outcomes.

Leadership: management of service units; advance models and/or methods of service delivery by integrating best available evidence, or new technologies; supervising and training clinical and non-clinical personnel; participation in community-based rehabilitation; advocacy for P&O services and professionals in professional organisations and government agencies.

Training, education, community demonstrations, awareness-building.

4 years of full-time study at university level. Curriculum includes: practical techniques for fitting/fabrication techniques across a wide range of prosthetic-orthotic device types.

Theoretical topics: clinical conditions, anatomy, physiology, pathologies, biomechanics, materials technology.

Clinic management: leading clinical teams, inventory management, budget management, training and supervision, occupational hazards, ethical code, research methods.

5-10 prosthetist/orthotist clinicians per million; though in HICs, it is usually 15-20 per million.

Each service point should have at least one qualified clinician, ideally Category I Prosthetist/Orthotist or an experienced Associate Prosthetist/Orthotist).

Each clinician can be expected to provide complete services to 300-600 users per year.

Associate Prosthetist/ Orthotist

Clinician

Formerly: Category II Orthopedic Technologist

and

Category II “Specialised” (according to their area of training (i.e. prosthetics, lower-limb orthotics, etc.) Technologists

Clinical Services: clinical assessment, prescription; technical design, fabrication, and fitting of devices; monitoring outcomes.

Associate Prosthetists/Orthotists are capable of carrying out all tasks allocated to orthopedic technologists, but only in one speciality branch.

3 years of formal structured education which covers many of the topic areas of the Prosthetist/Orthotist curriculum but to a lesser depth, and with a greater focus on clinical services and fabrication.

Associate training in one single discipline usually takes 12-18 months. Thereafter, they are named according to their area of expertise (i.e. Associate Prosthetist, Associate Lower Limb Orthotist)

5-10 prosthetist/orthotist clinicians per million; though in HICs, it is usually 15-20 per million.

Each service point should have at least one qualified clinician, ideally Category I Prosthetist/Orthotist or an experienced Associate Prosthetist/Orthotist).

Each clinician can be expected to provide complete services to 300-600 users per year.

Prosthetist/Orthotist Technician

Non-Clinician

Formerly: Category III Prosthetic/Orthotic Technician/Bench Worker

Non-clinical services: Support (Associate) Prosthetists/Orthotists in device fabrication, assembly, maintenance, and repair. Expertise in material science, technical procedures, and safe practices, but does not have clinical contact with users (i.e. making fitting adjustments or alignments).

Not involved in direct services to the user. However, in LMICs, lack of capacity often means Prosthetist/Orthotist Technicians are also directly working with patients, typically under the guidance of a Prosthetist/Orthotist / Associate Prosthetist/Orthotist.

2 years of formal structured or 4 years of on the job/in-house training.

Curriculum includes practical technical training and basic understanding of material science and safety procedures.

Each clinician should be supported by 2 non-clinicians; thus 10-20 non-clinicians are needed per million.

In decentralised units with a shortage of clinicians, increasing the ratio of non-clinicians can effectively extend the service team.

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Annex C: Global Component Supply Landscape

Supplier

Country

Mechanical TF prosthetic *

Website

Quality certification

LMIC availability

Beijing Jingbo

China

USD 250-500

www.en.jingbo-po.com

ISO, CE

Asia, Southern Africa

Blatchford/Endolite

UK/ India

over USD 1,000

www.endoliteindia.com

ISO, CE

South and Southeast Asia

Fujian Guozi Rehabilitation

China

under USD 250

www.fpcfoot.com

ISO, CE, FDA

East Asia

Metiz

Russia

USD 500-1,000

www.metiz-ltd.com

ISO, CE

Asia

Nobel Prosthetics

Hong Kong/China

USD 500-1,000

www.nobel.hk

ISO, CE

Latin America, Asia, Middle East, Africa

Ortotek

Turkey

www.ortotek.com

ISO, CE

Asia, Latin America, Middle East, Africa

Össur

Iceland

over USD 1,000

www.ossur.com

ISO, CE, FDA

Southeast Asia, Southern Africa

Ottobock

Germany

over USD 1,000

www.ottobock.com

ISO, CE, FDA

Asia, Africa, Latin America

Proactive Technical Orthopedic

India

under USD 250

www.protechortho.com

ISO, CE

50+ countries

Proted

Turkey

USD 500-1,000

www.protedglobal.com

ISO, CE

46 countries

Proteor

France

over USD 1,000

www.proteor.com

ISO, CE, FDA

French-speaking Africa

Teh Lin

Taiwan

USD 500-1,000

www.tehlin.com

ISO, CE, FDA

Asia, South and North Africa

* knee, pylon, ankle, foot, connectors.

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Annex D: Select prosthetic components developed for LMIC context

Technology

Provid er

Price

Description

Availability

Agilis Prosthetic Foot

ICRC

Switzerland

www.blogs.icrc.org/inspired/2019/05/05/affordable-feet-icrc-agilis-prostheses

under USD 100

Designing a low-cost carbon foot with increased comfort and mobility.

Under development

Alice Limb

Blatchford/Endolite

UK/India

www.endoliteindia.com

USD 500-1,000

Low-cost modular prosthetic components.

Predominantly India

All-Terrain Knee

LegWorks

USA

www.legworks.com

USD 200
(in LMICs)

Mechanical knee that gives a natural swing without hydraulic or pneumatic technology. Waterproof, can be used in dusty, hot environments. Can be fitted for active and low-mobility amputees.

~30 countries

Emergency Limb

Proteor

France

www.proteor.com

USD 500-1,000

Temporary prosthetic limb with partially-fitted socket, that can be strapped and adjusted to amputees to provide temporary mobility in emergency settings.

Available through HI

‘ICRC’ Polypropylene System

ICRC

Switzerland

www.icrc.org/en/doc/assets/files/other/icrc-002-0913.pdf

USD 200-800

Launched in 1993, ICRC has developed prosthetic devices composed of polypropylene components that are produced in high volumes in Switzerland.

Available throughout LMICs

ReMotion Knee

D-Rev

US

www.d-rev.org

USD 80
(in LMICs)

Mechanical, polycentric knee, water-resistant and durable; developed through Jaipur.

~30 countries

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Annex E: Overview of prominent international organisations providing prosthetic services 45

42

Organisation

International Committee of the Red Cross (ICRC)

Bhagwan Mahaveer Viklang Sahayata Samiti (BMVSS)

Humanity & Inclusion (HI)

W ebsite

www.icrc.org

www.jaipurfoot.org

www.hi.org

About

Independent international organisation that focuses on humanitarian protection and assistance for victims of armed conflict and situations of violence.

Registered Indian NGO with the aim to provide mobility and dignity to people with disabilities.

International independent aid organisation focused on working with people with disabilities affected by poverty and exclusion and conflict and disaster.

Established

ICRC launched the Physical Rehabilitation Programme in 1979.

Founded in 1975, in response to polio crisis in India.

Founded in 1982, in response to landmine victims in Cambodia and Thailand.

Geographical coverage

170+ rehabilitation centres in 40+ countries in the Middle East, Africa, and Southeast Asia.

23 sites in India, with presence or partnerships in 27 countries. BMVSS has also held 73 temporary fitting camps in 30 countries.

94 rehabilitation projects in 49 countries, including Africa, the Middle East, Asia, and Central and South America.

Approach

The Physical Rehabilitation Programme was set up to support the physical rehabilitation of amputees by providing technical support and training to establish services, and to fit and supply mobility devices, prosthetic devices, or wheelchairs. Support also includes long-term rehabilitation, education, and social and economic inclusion.

BMVSS offers free prosthetic devices through a broad network of service points across India and through partners in other countries. All users are fitted within one day.

Supported by private and public donors, including the Ministry of External Affairs of the Government of India.

HI initiates projects in emergency response at the invitation of governments, with the goal to transition from emergency response to developing comprehensive services over time.

Impact

In 2017, supported 144 rehabilitation centres in 36 countries, providing 26,000 prostheses through local partnerships. ICRC focuses on conflict, humanitarian crises, and natural disasters; working through local partnerships to ensure long-term sustainability.

To date, the organisation has rehabilitated more than 1.8 million people with physical disabilities, at a rate of 60,000-80,000 users per year. Primary focus of impact is India, where BMVSS produces and delivers an estimated 25,000 prosthetic limbs per year, roughly 50% of the total market.

HI has supported access to physical rehabilitation services and products to 277,194 people. In 2018, it delivered 25,025 P&O devices.

Technology

In 1993, ICRC developed a low-cost polypropylene prosthetics solution, which won the ISPO Blatchford Prize for innovation because of its suitability for deployment in LMICs.

Until 2019, it was supplied by Swiss-based CR Equipment. In 2019, ICRC has switched to Alfaset, a non-profit arm of manufacturer Rehab Impulse, also Swiss-based.

ICRC’s prosthetic solution is deployed in ICRC-supported rehabilitation centres, as well as being available for purchase by other providers and service centres.

BMVSS centrally manufactures partially formed prosthetic limbs and other components in its manufacturing centre in Jaipur, India. The intermediary product, made from rubber and polypropylene, is then heated and formed into the final prosthetic device at the site of fitting. The device features a low-cost non-articulated foot and shank. It cost USD 50 to produce.

BMVSS’s Jaipur Foot component revolutionised foot componentry when it was released because it was low-cost, had a flexible keel and was able to be used appropriately in an Indian context (permitted squatting, cross-legged sitting, and used with sandals). The overall Jaipur lower-limb solution is shown to be unsatisfactory biomechanically, but continues to be deployed because of the low cost.

HI does not produce its own components and deploys modular components from a range of international suppliers. In partnership with Proteor, HI has developed an emergency prosthetic limb that can be fitted to any user to enable temporary mobility in conflict zones.

HI has also been conducting implementation research in the digital fabrication of orthotics and prosthetic sockets, testing for acceptability, cost-effectiveness of these technologies in various LMIC settings.

Annex F: Select regional NGO/FBOs

43

Organisation

Geographical coverage

Model

Impact

500 Miles

(Est. 2007)

www.500miles.co.uk

Focused on Malawi and Zambia, some presence in Tanzania (Zanzibar).

Mobility India

(Est. 1994)

www.mobility-india.org

India (South, East and North-Eastern States).

CURE

(Est. 1996)

www.cure.org

9 hospitals. Programmes in 27 countries, including Kenya, Uganda, Malawi, Zambia, and Ethiopia.

Association of the Physically Disabled Kenya

(Est. 1958)

www.apdk.org

Kenya.

Puspadi Bali

(Est. 1999)

www.puspadibali.org

Eastern provinces of Indonesia.

Limbs International (LI)

(Est. 2004)

www.limbsinternational.org

15 countries, including Kenya, India, Indonesia, and Mexico.

Range of Motion Project

(Est. 2005)

www.rompglobal.org

Guatemala, Ecuador, and US.

Exceed Worldwide (Est. 1989) www.exceed-worldwide. org

South & Southeast Asia (Cambodia, Sri Lanka, Indonesia, Philippines, Myanmar)

Supported the establishment of P&O training schools. Develops capacity of ISPO-accredited professionals for expansion of services in region. Expanded P&O services through social enterprise model with pricing based on ability to pay.

Annex G: Description of traditional socket fabrication and fitting process

5-step process with a foto illustrating each step 1. Negative mould: made by wrapping the residual limp with a wet plaster-of-Paris bandage 2. Positive mould: Made by fitting the cast with a mixture of plaster-of-Paris and water 3. Rectify: Rectifications are made to the positive mold. 4. Socket formed: Socket is formed by draping polypropylene or using laminated resins. 5. Final changes: Final adjustments to the socket made using machinery, suspension attached. Annex G: Description of traditional socket fabrication and fitting process

44
45

Annex H: Overview of select novel socket fabrication technologies with potential for adoption in LMICs

46

Company

Product/innovation

Commercial Status

Amparo

(Est. 2014)

Germany

www.amparo.world

Confidence Socket (BK): Thermoplastic direct-fitted on residual limb in 2 hours. Can be remoulded up to 10 times. Each socket arrives structurally formed and needs to be heated to be moulded to the residual limb. Fitted on-site with a mobile tool set that can be transported outside the prosthetic service unit and bypasses the need for orthopaedic workshop equipment and machinery.

Össur

(Est. 1971)

Iceland

www.ossur.asia/prosthetic-solutions/products/post-op-solutions/direct-socket-tool-kit

Össur Icecast: Uses air pressure to mould the socket directly on the residual limb without orthopaedic workshop machinery. The pressure casting system loads the residual limb with even pressure, eliminating the need for modification of the socket shape. Carbon fibre and resin hardens to form the final socket.

Prosfit

(Est. 2013)

Bulgaria

www.prosfit.com

PandoFit: End-to-end solution that enables cost-effective building of prosthetic service provision capacity. Combines 3D scanning (which creates a digital scan of the limb) with cloud-based and/or offline rectification software to design sockets. Socket is 3D printed via a global network of certified 3D manufacturing partners (currently a non-exclusive partnership with HP) which allows delivery of products with consistent quality. The socket is printed with PA12 Nylon and is 1kg lighter than traditional designs.

Nia Technologies

(Est. 2015)

Canada

www.niatech.org

3D Printability: On-site digital toolchain used to 3D print lower-limb prosthetics and orthotics. The toolchain includes: 3D scanner, NiaFit rectification software, and 3D printer. Prosthetic sockets can be printed in 5-8 hours using polypropylene material.

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Annex I: Different component supply channels observed in LMICs 46

Annex I: Different component supply channels observed in LMICs Graphs with symbols for amputees and others which pictures the following flows: Fulfillment No 1: Individual Orders from International Supplier Prothetist assesses amputee who returns home Prosthetist places individual order directly with international supplier Shipping & logistics takes 1-2 months and is costly Prosthetist notifies who returns to the service provider to be fitted Fulfillment No 2: Public Sector Prosthetist assesses amputee Prosthetist checks inventory at the central procurement store or prosthetic service unit If components are available, fit amputee (Because central and provider procurements are made annually or periodically, it can be difcult to predict demand and stock the desired components. Components may not have a long shelf life and bulk orders can also be delayed due to processing of order or customs challenges.) If desired components are not available, order direct from international supplier (Alternatively, if desired components are not available, sub-optimal components that are available in stock may be chosen instead.) Shipping & logistics takes 1–2 months, is costly Fulfillment No 3: NGO Prosthetist assesses amputee NGOs have access to capital to negotiate and procure regular stock of components Amputee is fitted right away or: NGO has specialized international suppliers(s) Fulfillment No 4: Local or regional distributor Prosthetist assesses amputee Prosthetist places order with local or regional distributor Local distributor offers inventory of a variety of component solutions from various international suppliers at different price points Distributor orders in bulk and negotiates volume pricing with international suppliers to serve a network of local prosthetists and providers Distributor manages customs clearance and import process Local distributor is able to respond to the order in a short time period and deliver the components locally

back cover with the logos of ATscale, the Global Partnership for Assistive Technology; AT2030 and UK aid. This report was delivered under the AT2030 programme funded by UK aid.