CHAPTER 1 MARKET LANDSCAPE

3. Market Context

3.1. Globally more than 75 million people need an appropriate wheelchair, however 85-95% of those in need do not have access.

Wheelchairs are one of the most commonly used assistive devices; WHO estimates that 1% of the population, approximately 75 million people globally, require a wheelchair. 3 Those needing wheelchairs are those with mobility limitations and may include people born with congenital abnormalities, people with developmental and neurological conditions, such as cerebral palsy or muscular dystrophy, people with a spinal cord injury, people with musculoskeletal conditions such as lower limb amputation, people living with physical impairment which can be a result of polio or non-communicable diseases (NCDs) such as diabetes or stroke, and older people with gradual functional decline.

Four in five people who need a wheelchair live in LMICs, 4 and these countries account for the highest unmet need. While 90% of people with a need in high-income countries (HIC) are estimated to have a wheelchair, 5 this number is likely closer to 5% in LMICs. It is estimated that 64 million people need a wheelchair in LMICs (Table 1). This represents a crude estimate of need due to the lack of data available.

TABLE 1: MARKET SIZING FOR WHEELCHAIR NEED

WHO REGION	WHEELCHAIR NEED (IN MILLIONS)	ESTIMATED WHEELCHAIR COVERAGE (IN PERCENTAGE)	UNMET NEED (IN MILLIONS)
Americas (excluding HICs)	~6	5%	~6
Europe (excluding HICs)	~4	5%	~4
Africa	~10	5%	~10
South-East Asia	~26	5%	~25
Western Pacific	~20	5%	~19
HICs	~9	90%	~1
Global	~75		~65

The need for wheelchairs will only continue to grow globally, especially in LMICs. A growing need is driven by:

3.2. Access to an appropriate wheelchair is critical to increasing civic and economic engagement and preventing negative health outcomes

An appropriate wheelchair is defined as one that: meets the user's needs and environmental conditions; provides proper fit and postural support; is safe and durable; is available in the country; and can be obtained and maintained and services sustained in the country at an affordable cost. 10 The use of an appropriate wheelchair enhances users' personal mobility, which is a precondition for active participation in education, employment and civic life.

Being properly fitted with an appropriate wheelchair is critical to a user's health and quality of life. Proper fitting helps prevent various secondary health conditions such as: pressure sores and progression of postural deformities or contractures; respiration and digestion complications; and, in cases of people with spinal cord injuries and similar conditions, premature death. 11 A study from Sri Lanka showed that 75% of people with spinal cord injuries admitted to hospital died within 18-24 months from secondary complication because of their injuries; however, when healthcare training and appropriate equipment provision improved – including appropriate wheelchairs with cushions – the incidence of pressure sores reduced by 71% and repetitive urinary tract infection decreased by 61% within two years. 12

3.3. Appropriate wheelchair service, provided by trained personnel, plays a critical role in matching the user's needs to the appropriate type of wheelchairs needed throughout the user's lifespan.

WHO categorises wheelchairs as follows:

TABLE 2: EXAMPLES OF WHEELCHAIRS FROM EACH CATEGORY AND INDICATIVE PRICING 15

TEMPORARY USE

INDOOR/URBAN/ EVEN-SURFACE

OUTDOOR/RURAL/ ROUGH-TERRAIN

DUAL USE/ INDOOR-OUTDOOR

POSTURAL SUPPORT

Photo of an indoor/urban/even surface wheelchair

Photo of an outdoor/rural/rough terrain wheelchair

Photo of a dual use/indoor-outdoor wheelchair

PHOTOS USED WITH PERMISSION FROM CLASP.ORG

A wheelchair should be provided based on an assessment of the user's physical abilities, lifestyle and environment (Figure 2). The wheelchair service then fits a wheelchair to the user, adjusting the features to ensure maximal functions are possible whilst ensuring the safety of the user. The wheelchair user and their caregiver (where applicable) are trained on how to safely and effectively use and maintain the wheelchair. The wheelchair service provides follow-up, maintenance and repair services for the product.

FIGURE 2: FACTORS AFFECTING CHOICE OF WHEELCHAIR (LEFT) AND COMMON ADJUSTMENTS TYPICALLY MADE ON MANUAL ACTIVE OUTDOOR/RURAL/ROUGH-TERRAIN WHEELCHAIRS (RIGHT)

FACTORS AFFECTING WHEELCHAIR SELECTION

Need of mobility aids	Short duration/ intermittent Long-term/permanent
Ability to propel	Low (requires attendant/powered) Medium (e.g., one hand) High
Physical size	Paediatric/Adult Width, length, and height variations
Living & working environment	Outdoor/rough terrain Indoor/even surface/ urban setting Mixed (indoor and outdoor)
Risk of developing pressure sores	Low Medium High (e.g., people with spinal cord injury)
Postural support needs	Basic Intermediate Advanced

EXAMPLES: ACTIVE, MANUAL, ROUGH-TERRAIN WHEELCHAIR

3.4. Common guidelines exist to ensure the provision of appropriate wheelchairs in less resourced settings

Many wheelchair users in less resourced settings (LRS) receive wheelchairs without the appropriate related service. As a result, users often receive wheelchairs that are inappropriate for their needs, ill-fitting and provided without training on how to safely and effectively use their wheelchair.

In light of contextual realities, a consensus-driven process supported the development of the WHO Guidelines for the Provision of Manual Wheelchairs in Less Resourced Settings. The WHO Guidelinesemphasise eight 13 steps for appropriate wheelchair service (known as the WHO 8-Steps– see Figure 3) to assist stakeholders in developing an appropriate wheelchair provision system in different country contexts. 16 Following the release of the Guidelines in 2008, WHO developed the Wheelchair Service Training Package (WSTP) to support training.

FIGURE 3: THE WHO 8-STEPS TO WHEELCHAIR PROVISION

Image Description

Figure includes graphic images to demonstrate 8 wheelchair service steps. Step 1: appointment and referral. Step 2: assessment. Step 3: prescription (or selection). Step 4: funding and ordering. Step 5: product (wheelchair) preparation. Step 6: fitting. Step 7: user training. Step 8: maintenance, repairs and follow up. Logo of USAID and logo of W.H.O. included at the bottom right of the figure.

Image Description end

The WSTP consist of:

The Guidelines have been adopted by various NGOs and large charitable organisations to improve their delivery process and product design to be more in line with best practice. Uptake by country governments has been low due to lack of awareness of the WHO Guidelines, a lack of existing service provision systems for wheelchairs or AT, and limited donor support for the dissemination and adoption of the Guidelines worldwide.

3.5. USAID has been the primary bilateral funder addressing wheelchair needs in LMICs

To address the unmet need for wheelchairs in LMICs, USAID and other US government agencies have collectively invested more than US$70 million over the past ten-plus years. USAID's commitment to wheelchair provision is significant within the sector, but this amount represents a fraction of the spending required globally per year. Other bilateral funders, such as Australia's Department of Foreign Affairs and Aid, UK's Department for International Development and the Swiss Agency for International Development, have funded or fund wheelchairs or wheelchair provision, often through one-time grants.

In 2007, USAID established the Wheelchair Program to improve access to appropriate wheelchairs and trained service providers in developing countries. The Program has evolved from direct procurement of wheelchairs to supporting investments that would result in systemic and sustainable improvement for the sector. In order to achieve this, USAID has focused their investments in the following key areas: 1) policies to improve access to appropriate wheelchairs and quality services are developed and implemented; 2) access to quality, sustainable services improved; 3) professional standards clearly defined and adopted; and 4) appropriate products are more readily accessible.

Programmatic investments have included both country-based initiatives and global initiatives. A few examples of investments include an Indonesian programme to integrate wheelchair service into the healthcare system, a multicounty programme in partnership with World Vision to support appropriate delivery of wheelchairs in five countries and a Georgian programme to establish wheelchair production and provision. Examples of research funding include assessing influence of peer-group training for active wheelchair users in Romania and studying the impact of service on wheelchair usage in Kenya and the Philippines.

Examples of USAID global investments include:

4. Market Assessment

4.1. The global market for wheelchairs largely focuses on high-income markets and is largely fragmented

The global market for wheelchairs was estimated between US$4.0-4.5 billion 23 in 2018 with the United States and Western Europe accounting for about 40% and 20%, respectively. Manual wheelchairs make up about 60% of the sales revenue globally and are projected to grow 6% year-on-year. The powered wheelchairs segment is projected to grow faster at 15-20%. 24

The supply landscape is relatively fragmented with the five largest manufacturers controlling less than 50% of the global mobility market. In the United States, 218 different companies, representing over 400 different product lines, have registered wheelchairs with the US Food and Drug Administration (FDA). Leading global players are: Invacare (USA), Sunrise Medical (Germany/USA), Ottobock (Germany), and Permobil (Sweden).

4.2. Reimbursement policies drive product selection, pricing and ultimately profitability for suppliers to HIC markets

The payer landscape in HICs is dominated by public insurance systems that represent 80% or more of the market (Figure 4). Public pressure against the rising costs of health care has prevented a rise in reimbursement rates. Furthermore, a more consolidated payer landscape in HIC markets has spurred competitive tendering. This combination - along with a growing production cost - has eroded profit margins, resulting in market consolidation, increased focus on controlling cost and shifting to more commercially attractive segments.

FIGURE 4: PUBLIC SECTOR COVERAGE FOR WHEELCHAIRS IN HICS 25

Image Description

Figure includes 3 pie charts demonstrating breakdown of public sector coverage for wheelchairs in Sweden, Germany and USA. Pie chart for Sweden demonstrates 100% is covered by public payer. Public payer landscape with taxed funded insurance managed by public authorities. Pie chart for Germany demonstrates roughly 90% is covered by public health insurers and roughly 10% by other. State-dominated and highly fragmented payer landscape. Pie chart for USA demonstrates roughly 80% is covered by Medicare and Medicaid (CMS), roughly 10% is covered by private insurance and roughly 10% is covered by veteran affairs (VA). The 80% covered by CMS focused on elderly disabled or low-income population. VA buys the latest technology.

Image Description end

4.3. Global manufacturers mostly enter into LMICs through distributers, but this adds costs

The production of active wheelchairs for HICs is highly customised and localised, which limits the product range that could be provided cost-effectively in LMICs. Suppliers, such as Invacare, Sunrise or Permobil, have a limited presence in LMICs and mostly operate via local distributors. Custom ordered products are imported from manufacturing sites that are commonly based in Europe, North America or China. The final price offered to LMIC buyers increases due to high shipping costs, and in some cases, import duties. Small volumes and limited competition among distributors further raises the price. As it can be a lengthy and challenging process to obtain custom wheelchairs, local distributors often limit their wheelchair offering to those that can be easily obtained and warehoused to serve the largest number of people – leading to a higher volume of standard wheelchairs available.

In some countries, wheelchair manufacturers must work with local distributors to supply wheelchairs via the national tender. Distributors' margins increase the cost to the payer by 15% or more, yet they often do not provide additional services that could not be provided by the manufacturer.

4.4. There is limited public funding for procurement and provision of wheelchairs in LMICs; where procurement within the public sector exists, it is often fragmented and/or erratic

Generally, LMIC governments allocate insufficient and/or variable financial resources for the procurement and provision of wheelchairs. In some cases, resources are drawn from specific ministry or department budgets such as social welfare, education and defence, however, the funding is typically insignificant and fragmented. For many countries, whether the funding is coming from the Ministry of Health or another government entity, the amount spent on wheelchair provision is negligible.

A small number of LMIC governments procure wheelchairs directly and provide them through facilities and programmes under health, education, and/or social welfare ministries/departments. In these instances, wheelchairs are typically tendered for at the country or regional level, generally based solely on cost. Procurement and distribution or provision is often fragmented across different ministries, which leads to a variety of challenges, including: no single ministry having complete oversight on procurement and 17 provision within government or across partners; different ministries have differing levels of infrastructure or human resources to deliver and maintain wheelchairs; some ministries lack the supply chain or logistics capacity to effectively deliver products appropriately, which leads to a mass distribution model, whereby one wheelchair type is given out with limited service; different ministries have differing mandates on the population served and therefore some populations are left behind.

4.5. As the primary global manufacturers do not focus on LMICs, NGOs have filled the gap to design, produce and provide wheelchairs that are appropriate for use in LRS

As outlined above, the leading global suppliers have limited interest in LMIC markets due to low and erratic funding and demand, a reliance on a distributor network that is often poorly developed in LMICs, and a need to develop products with specific design features for use in LRS. Various NGOs and faith-based organisations (FBOs) fill that gap and deliver low-cost, manual wheelchairs that are specifically designed for LMIC environments.

A variety of NGOs provide quality, context-appropriate wheelchairs. These wheelchairs are often priced between US$150-350, are designed in line with the WHO Guidelines and are tested and certified for quality. The wheelchairs are considered context-appropriate because product design takes into consideration:

NGOs typically have full control over the value chain from product design to service provision. In most cases, the NGOs are structured as social enterprises and will contract third-party manufacturers. Income from wheelchair sales is used to support wheelchair access programmes. Such a model allows the NGO to raise funds for overhead and operational costs while keeping a minimum margin and therefore reducing the price of the final product. In addition to providing wheelchairs and services to users through their local service partners, they also sell their products to donors, other NGOs, and, on occasion, governments.

Volumes from NGO social enterprises for appropriate products are limited and they mainly supply products through donor-funded organisations within the same network. One NGO suggested that higher volumes could enable significant improvements on manufacturing economics. However, low overall demand and fragmented market in LMICs, characterised by fragmented, parallel funding and supply siloes, inhibit the potential for these efficiencies to materialise. In addition to NGOs, the largest FBO donors of wheelchairs for LMICs, LDS Charities and Free Wheelchair Mission (FWM), have designed and produced their own products. These two FBOs are discussed in the next section.

Some social enterprises have attempted to fill market gaps through a cross-subsidisation model. These social enterprises have designed products for users in both HICs and LMICs by considering the profile of users in HIC that are typically brand-conscious and performance-sensitive as well as the environmental condition in LMICs. The product is then offered at differential price points to allow larger margins gained from HICs market to subsidise sales in LIMCs market. Despite this promising model, these enterprises are 18 still limited by lack of capital, limited brand awareness to buyers in one or both markets, competition with insurance markets and low volume.

Other smaller and relatively new NGOs or social enterprises continue to enter the market, indicating that there is no shortage of innovation in the space, particularly for paediatric wheelchairs; however, market potential for uptake of innovation uptake remains limited.

4.6. Charitable organisations that donate product dominate funded wheelchair demand in LMICs

Most wheelchairs in LMICs are donor-funded with delivery models ranging from organisations distributing refurbished wheelchairs with limited services to mass distribution campaigns to organisations providing quality appropriate wheelchairs with services that meet WHO Guidelines. Regardless of the model, almost all chairs are delivered at little or no cost to the user.

FWM and LDS Charities are the largest donors of wheelchairs in LMIC. Large, independent funding sources and higher volumes allow them to have full control over the design, manufacturing, transportation, and inventory management of the primary products that they donate, while also reducing cost per wheelchair provided. To achieve higher volumes and the lowest possible cost, these groups are supplying a limited range of product.

FWM has improved the design and quality of their basic chair in recent years and is looking to better link their distribution campaigns to referral networks for those with more complex seating needs. FWM is interested in increasing their training and service provision; however, investment has been limited due to their commitment to donors to deliver the highest number of wheelchairs within their funding envelope.

LDS Charities often complements their product offering by purchasing other wheelchair types to support local suppliers and fill gaps in need; however, their own branded products designed and produced in partnership with Colors ‘N Motion Inc. now consist of standard, urban active, and rough-terrain active wheelchairs. 27

4.7. Local manufacturing to meet LMIC demand has been attempted and seen varying levels of success

Enabled by favourable government policies, incentives to manufacture locally, and the perception that wheelchairs are a low-tech product, several local manufacturers exist in LMICs. Their wheelchairs are at times designed for the local context and can be customised to match the user's needs, but the manufacturing process is often labour-intensive, expensive to initiate and requires materials or parts from abroad, which limits the ability to scale.

Local manufacturers come in different forms. Products from artisan local manufacturers, who build wheelchairs manually from a mix of locally sourced (metal tubing) and imported materials (wheels), are often seen as lower quality compared to imports. While these companies typically have a higher cost-structure compared to larger production sites, the proximity to the end-user and lower shipping cost as compared to international freight result in a supply chain that is more responsive to user needs. However, these companies appear to struggle due to low and erratic demand, resulting in low production capacity planning and utilisation and difficulties in sustaining production levels. Furthermore, they are hampered by low investment, training, available equipment, skills and quality assurance mechanisms, which all contribute to the cycle of low quality in production.

Prior to shifting some of its volume to medium and large-scale production through partnerships with contract manufacturers, Whirlwind Wheelchairs International (WWI) spent around 15 years focusing on an artisan model supporting the development of small-scale local wheelchair production in more than 40 countries. Many of the workshops are no longer operating, while some have survived and continue to produce wheelchairs for the community such as Kifas (Turkey) and Fundacion Bertha (Mexico). The main challenge has consistently been generating and maintaining demand to sustain the production levels. High political interest for local manufacturing by government rarely came with the support to procure the final product and to allocate public funding to purchase wheelchairs. Since most wheelchair users have low ability to pay, government financing for wheelchairs and supportive procurement policies (e.g. not solely based on the lowest cost; open to the non-commercial entity) are critical in ensuring demand for local production.

Local manufacturers that serve larger domestic markets, such as CE Mobility in South Africa, show that local manufacturers can be economically viable. Key success factors include: 1) quality and competitive pricing; 2) receiving support from the local government in the form of tender purchases; 3) selling both domestically and through regional exports; and 4) ability to provide a more diverse wheelchair product-offering than traditional imports while maintaining the supply chain responsiveness that is unavailable via the Artisan model.

4.8. While not heavily utilised in LMICs at the moment, localised assembly of component parts could support a cost-effective supply of appropriate wheelchairs

Bulk manufacturing of parts with regional assembly is the standard manufacturing model employed in HICs. In this model, wheelchair parts are manufactured at a centralised manufacturing site – usually in China – and then shipped to a warehouse or facility that is specialised to do final assembly of certain models (Figure 5). Given the pressure on profit margins, suppliers are optimising warehousing and production costs while maintaining the ability to offer a highly customised final product. One supplier suggested that an assembly approach reduces shipping costs to 25% of the total cost of shipping assembled products. Most assembly of lower-cost wheelchairs happens in China, while more expensive, high-end products are commonly assembled in Europe or North America, closer to the end-user.

FIGURE 5: ILLUSTRATION OF WHEELCHAIR PRODUCTION IN HICS

Image Description

Figure uses images to demonstrate wheelchair production. Process starts with components manufactured in bulk in China. Arrows demonstrate these are shipped to warehouses and factories in North America and Europe then product is locally assembled. Local dealer then profiles the wheelchair to patient and finally patient provides feedback if adjustments are required. Arrow demonstrates this patient feedback channels through local dealer who create reports which provided to the original warehouses and factories creating a loop in the process.

Image Description end

Numerous NGOs & FBOs have developed an approach that involves ‘localised’ assembly of wheelchairs in LMICs:

Shipping parts for local assembly might be especially suitable for large volume distribution in a locality that has a significant need but is currently not manufacturing other products of similar complexity. Opportunities may exist to learn from the above-mentioned approaches to explore how quality products can be delivered via the volume purchasing power and a value-engineering approach.

4.9. Generic suppliers that serve as contract manufacturers for NGOs and FBOs to produce quality wheelchairs may be able to supply LMICs cost-effectively but lack market visibility or scale

Wheelchair manufacturing has largely shifted to Asian countries, such as China, Vietnam and Taiwan. China's large bicycle industry together with an extensive and diverse supply chain, indigenous supply of raw materials, high investment in production technology and volume manufacturing infrastructure makes for a very effective production base.

Most NGOs and FBOs use contract manufacturers in China. These companies have the manufacturing capabilities and excess capacity that could be used to serve LMIC markets, but lack understanding on what products are needed in these markets, who the potential buyers are and the size and demand of the potential market.

4.10. Product standards and specifications for wheelchairs in LRS have been developed or are in development, but uptake to guide purchasing and design has been limited

The WHO Guidelines also include guidance on minimum product quality standards, based on the user need. Quality standards provide requirements, specifications and guidelines to ensure products are designed and manufactured appropriately. In the WHO Guidelines, governments are encouraged to develop and adopt national wheelchair standards based on ISO 7176, the international standards for wheelchairs that evaluate the product's safety, durability, performance and product dimensions.

However, ISO 7176 does not test for factors typical for LRS such as rough terrain and environmental conditions, such as high humidity, exposure to water and sand, and high temperature that differ from HICs. Premature failures of wheelchairs in LRS may be due to shortcomings in product regulations, quality standards and testing. The community recommended that more rigorous standards be developed for wheelchairs in LRS as they are subject to these unique environmental and use conditions. 29

To improve reliability and usability of wheelchairs in LRS and guide product design, ISWP developed and published the Design Considerations for Wheelchairs Used in Adverse Conditions. 30 The document was created to complement the WHO Guidelinesby providing more detailed information in designing wheelchairs for adverse environment and common pitfalls to avoid. In addition, ISWP developed protocols and equipment to test casters, rolling resistance and corrosion for adverse conditions, labelling it the ISO-Plus, but no specific pass/fail thresholds have been determined as of now.

While documents exist to guide design for LRS products, the acceptance and adoption by the wider community has been limited. Different interpretations of minimum quality standards has led to a spectrum of products that are designed with varying degrees of quality considerations. For example, Motivation has its own Product Assessment Tool that was developed in collaboration with Humanity and Inclusion (HI) and APDK. These differences limit the visibility to suppliers on what is appropriate for LRS. Building consensus among key stakeholders, in particular in the developing world, on minimum accepted quality standards that can be translated into country's national standards, could enhance market participation, while ensuring optimal performance and durability.

At the moment, most LMICs include limited specifications in their tenders, often even restricting the request to a single word, such as “wheelchairs”. As a result, these countries may buy products that are not appropriate for their settings or for the users and lack desirable product features, including quality. The WHO, under the GATE Initiative, is developing Assistive Product Specifications (APS) for all assistive products listed in the Priority Assistive Products List, 31 including wheelchairs. The APS should be adapted to the local context and aims to serve as a set of objective specifications to support procurement and guide suppliers about market needs. The APS for wheelchairs should be available in late 2019.

4.11. A lack of clarity on the ideal products required to serve the highest proportion of the population, as defined by a PPP, contributes to a fragmented market space.

Different NGOs and FBOs have different views on the trade-offs between quality and cost, which in combination with the need for various types and sizes, contributes to a high proliferation of stock keeping units (SKUs; a term that refers to a distinct type of item for sale).

Preferred product profiles (PPP) for different types of wheelchairs that would be appropriate for use in LRS can rationalise demand and increase market transparency. Similar to a target product profile used in drug development, a PPP that contains preferred criteria and specifications for a product that is appropriate for LMIC markets can, when backed by funders, provide strategic guidance to product design wheelchairs. While the WHO Guidelines give providers and programme managers a framework for product selection, there is no mechanism to evaluate products against the criteria in the WHO Guidelines. The APS will help buyers with procurement, but don't include guidance on the desired price points and specific performance standards for LRS conditions.

An opportunity exists to define a PPP for each of five product groups that providers should be able to choose from: 1) standard wheelchair; 2) active urban wheelchair; 3) active dual use/indoor-outdoor wheelchair; 4) active rough-terrain wheelchair; and 5) wheelchair with postural support. All products should be available for both adults and children.

4.12. To address the challenges of a fragmented market landscape, USAID funded the development of a global distribution hub of context appropriate wheelchairs

A distribution hub may help address challenges faced by buyers and service providers in LMICs including product variety and size of order offered by individual suppliers, extensive lead times, and high logistical burden. Distribution hubs may support the increase in market visibility of appropriate, quality products and increase affordability of products by acting as a consolidating agent or pooling mechanism to take advantage of economies of scale through larger volumes for supplier. A distribution hub can benefit suppliers by serving as a global distributer that de-risks market entry for new products and supports marketing, sales and logistics, as well as providing a platform to expand market reach for suppliers.

Consolidating Logistics for Assistive Technology Supply and Provision (CLASP) is a USAID-funded, UCP Wheels for Humanity managed global consolidation or distribution hub launched in 2015. Through a consolidation hub in China, CLASP enables buyers to make large or small orders of mixed products and sizes, delivering mobility devices that best suit users' individual needs. It purchases, warehouses, consolidates and transports assistive products from a number of manufacturers and ships them directly to service providers (Figure 6). This mechanism allows buyers, from NGOs to governments to donors, increase access to preferences as they are able to make large or small orders of a variety of wheelchairs and related products from diverse manufacturers versus buyers purchasing a minimum number of one type from one supplier, while also reducing lead times as products are supplied from the warehoused stock.

CLASP includes an international competitive bidding process for the different products that are included in its portfolio. Through its Product Advisory Council (PAC), which is comprised of users, clinical and technical experts, CLASP evaluates the specifications, quality, price and function of products and makes recommendations for inclusion in the mechanism. The PAC sets a minimum threshold for each criteria for inclusion in the product catalogue. This criteria is shared with product suppliers and designers, which may influence quality improvement and product design in the longer term. The inclusion of the PAC process has helped limit perceived conflicts of interest and standardised the product selection process. Through its Committee of Suppliers, CLASP is able to increase market information for suppliers, including sales and product performance data. This data combined with feedback from the PAC may support suppliers to identify gaps in the market as well as product design and quality deficiencies to improve product quality and increase innovation.

FIGURE 6: HOW CLASP WORKS

Image Description

Figure uses images to demonstrate CLASP process. Process starts with suppliers then moves to CLASP warehouses who can ship out in two weeks with full logistic support to wheelchair providers. CLASP then promotes the appropriate provision to wheelchair users. These users provide feedback to CLASP warehouse, creating a feedback loop to adjust to shifting demands and give suppliers feedback.

Image Description end

While CLASP exemplifies the advantages of a global distribution hub to building and supplying demand for optimal, quality product, it has not been without challenges. CLASP buyers are primarily NGOs and USAID-funded programmes and procurement volumes have been low. Additionally, CLASP has seen limited success in accessing and responding to government tenders due to tender regulations and practices. The low procurement volumes limit availability of working capital to purchase products for warehousing and limits the ability of CLASP to take full advantage of pooled volumes and economies of scale. For example, as CLASP is not the exclusive distributer for suppliers, suppliers have sold directly to buyers below the manufacturer suggested retail price offered by CLASP and therefore, CLASP is perceived as having more expensive products.

5. Market Challenges

LMIC markets for wheelchairs are nascent, with a need to focus on demand creation. In order to make appropriate, affordable, quality AT available to LMICs in a sustainable manner, a number of criteria need to be met and therefore investigated. The demand and supply dynamics that have challenged the development of a wheelchair market are summarised below.

5.1. Demand

AWARENESS	There exists a lack of awareness around the need for and importance of appropriate wheelchairs among end-users, service providers and policymakers. *At the policy level:* Policymakers lack awareness and data on the need, importance, and impact of appropriate wheelchairs for users and society. This affects prioritisation in policy, programmatic, personnel's training, and financing decisions. Adoption of the WHO Guidelineson wheelchair provision for LRS has been limited at the country level and mostly driven by NGOs. *At the provider level:* Wheelchair service provision and training on seating and positioning is often not seen as part of the scope of practice for relevant professionals such as physical therapists, occupational therapists, orthotists and prosthetists. Training packages, such as the WSTP, have not been adopted in training curriculums or by professional associations. *At the user level:* Most wheelchair users in LMICs are marginalised members of the community who are not empowered with knowledge on appropriate wheelchairs. When users do not understand the importance of an appropriate wheelchair or do not know that multiple types exist, they will prioritise the lowest cost option or accept an inappropriate wheelchair delivered through mass-distribution. *Among the public:* The public can stigmatise a person for using a wheelchair, this can prevent or limit use. Furthermore, the buildings, transport systems and large parts of the built environment remain inaccessible to wheelchair users, meaning they are excluded or take undue risks (e.g. wheeling on busy roads).
POLITICAL WILL	Government involvement is low. Donor funding that fills this gap and supports ‘free’ product inhibits the development of a public market. Only recently have many LMICs developed national policies for people with disabilities, so the implementation has not reached optimal levels. Low prioritisation from governments results in limited to no financing for the purchasing and provision of appropriate wheelchairs. Where funding is available, the amount is low and often divided across different Ministries, with lack of coordination. There is little investment by government to set up the systems and train providers. Charitable organizations, supported by independent donations, drive the funded demand in LMICs. The donor landscape is concentrated around two FBOs, followed by multiple NGOs providing wheelchairs through a variety of access points in local communities. These organisations emerged to fill gaps not being met by government; however, key informant interviews suggest that delivery by these actors has inhibited government engagement, possibly due to government perception that other organizations are meeting user needs and therefore there is not a role for government to play.
25
PROVISION	*The capacity for service provision in line with the WHO Guidelines* is limited.** Due to a lack of awareness, prioritisation and investment in this sector, even donated products are often not provided through a wheelchair service, resulting in a lack of users being appropriately assessed and fitted. Countries lack providers that are trained in line with the WSTP. Misconceptions that providing the product is sufficient and desire to ‘do good’ leads to mass-distributions of wheelchairs where no user-assessment and fitting by trained personnel are conducted and no follow-up or maintenance is available. Where trained providers exist, they are concentrated in a few urban areas or in specialised or NGO hospitals that are inaccessible or unknown to users. Countries and providers often lack the willingness to invest in more comprehensive training modules, particularly for fitting more users with more complex seating needs. Experience suggests that once people start participating in training and see the value of appropriate fitting and difference it can make, then they demand more training to meet more users' needs. Getting sufficient training funded at the outset is often very hard for the reasons mentioned above. Currently, funding is overly invested in the purchase of wheelchairs, with limited amounts invested in training for proper provision, even though the per unit training costs are minimal.
FINANCING	There is a lack of financing - both public and private - for the purchase of appropriate wheelchairs. Governments lack policies or insurance schemes that allocate funds for wheelchair procurement and provision. When funds are available, they are insufficient and therefore governments look to purchase the cheapest products that they are aware of, which are often of low quality. Frequently, transport-type wheelchairs for temporary users rather than wheelchairs appropriate for long-term users are purchased. Lower quality chairs have a short life span and can increase long-term costs to the public system. For many people who need a wheelchair, even low-cost wheelchairs are priced above the ability to pay, so out-of-pocket payments are limited or non-existent, especially among the poorest. Small user contributions have been used by some NGOs to gain user buy-in to the maintenance of the product and to increase user engagement. There is limited evidence if user contributions reduce abandonment or breakdown rates.
PREFERRED PRODUCT PROFILE	Limited consensus on a range of preferred product classes and no commonly accepted objective measure of what is an appropriate wheelchair has contributed to a proliferation of products. Different interpretations exist among global stakeholders about the minimum quality standards for wheelchairs in LRS environments that ensure products are robust and durable. Some organisations have developed tools to assess quality, but acceptance and adoption is limited. In addition to a lack of consensus on quality standards, NGOs and FBOs have designed and manufactured their own range of products, which contributed to fragmentation in financing, procurement and product design. FBOs have significant buying power, but the focus on controlling costs has led to these organisations designing their own product range rather than buying existing products. Many NGOs on the other hand often operate a social enterprise model where revenues from wheelchair sales are an important income stream to sustain other programmes.

5.2. Supply

APPROPRIATE DESIGN	Limited feedback loop from end-users to inform product design and innovation. The initial focus to design and develop wheelchairs that are lower cost and more robust in LRS has led to products that are typically heavier and less portable compared to HIC markets. Both the portability as well as the style are deemed important by users to reduce stigma, which points to a lack of user-centred design. Research is ongoing to look at the issue, but this research is often not initiated by or in collaboration with the manufacturers and their research and development teams. One of the best ways to obtain feedback from users is to have a presence in the field, which has supported the dual role of supplier and service provider used by Motivation or UCP Wheels. However, these NGOs have difficulties finding and accessing early-stage investment for product R&D to bring new or improved products to market. Distribution hubs may be able to pool user feedback from disparate environments and buyers for suppliers.
PRODUCTION ECONOMICS	Manufacturing economics for current appropriate products are unfavourable. Small volumes and wide range of SKUs lead to inefficient manufacturing schedules and increased production costs. Annual volumes from NGOs and FBOs are low, with the exception of FWM and LDS Charities. Low volumes lead to higher raw material costs and a higher number of changeovers on production lines, increasing downtime. Low volumes also limit the investment case for: 1) lines with a higher capacity and lower incremental capital investment per unit produced; and 2) the automation of certain production steps in order to increase throughput. Demand is commonly driven by donor purchasing, with erratic procurement patterns. Similarly, some governments tend to buy in cycles. Because wheelchairs are costly and relatively bulky products to store, suppliers need a high amount of working capital to hold a good stock level and suppliers will mostly produce to order, which complicates the workforce and production planning.
COMPETITIVE LANDSCAPE	Leading global manufacturers have limited interest in entering LMIC markets. Leading global manufacturers, such as Invacare or Sunrise, do not invest in products and systems to supply LMIC markets because they don't see the pathway to profitability. As a result, these companies are trying to fit HIC models and approaches into an LMIC context. This includes a bespoke production model and the need to work with distributors that provide customisation support. Such approaches further increase cost in markets where there is limited ability to pay and opportunity for value creation. Governments have a preference for locally manufactured products. Governments perceive wheelchairs as relatively simple to manufacture and a good case to create employment opportunities for people with disabilities. However, the market shows that due to limited demand, many local manufacturers struggle to reach scale to produce cost-effectively and competitively. Due to the relatively high capital expenditure required to set up a level of automation and/or working quality control systems, local manufacturers are often smaller, artisan workshops, producing lower quality products than what could be sourced elsewhere.
COST-EFFICIENT SUPPLY CHAINS	Limited use of cost-effective supply mechanisms. Most wheelchairs are manufactured in China and shipping costs are high. CLASP has been designed to reduce transaction costs while making supply more efficient and appropriate. Uptake has been limited for the variety of reasons outlined above, including that it is often less expensive to procure directly from the manufacturer. High import taxes increase price to the final payer. High import taxes for raw materials and parts increases the cost of local manufacturing making local products less competitive than assembled, imported products, which often benefit from tax breaks or exemptions. High import taxes on spare parts also hinders the ability to have spare parts for maintenance available.

5.3. Enablers

QUALITY

Limited quality assurance mechanisms at the demand and supply side.

Demand: Where countries have funding, they select low quality, cheaper products that do not meet the needs of users. Quality standards and product specifications for what constitutes appropriate product and provision are not in place. When government puts out a tender for wheelchairs, often the only information they have is price.

Supply: Due to the lack of regulation around quality assurance in many LMICs the quality assurance approaches from suppliers into LMIC markets is effectively voluntary and often driven by the business philosophy of the supplier. Quality assurance is an added cost, therefore many suppliers will not undertake testing if not paid for or necessitated by regulation. In contrast NGOs' suppliers, will generally necessitate quality testing – due to funder requirements and restrictions, – which adds cost to their product. Therefore NGO wheelchairs are less attractive to LMIC governments than contracting directly with - for example - a standard Chinese supplier whose quality may be substandard.

PROCUREMENT

Fragmented funding drives fragmented procurement and limits reach.

Fragmentation across the NGO and public sector limits the ability to aggregate demand and incentivise volume- and value-based procurement. It contributes to a lack of visibility and data on actual demand. In many cases, the presence of a charity model masks the actual demand for appropriate wheelchairs.

NGO sector: FBOs, NGOs and CSOs, such as Lion's Club or Rotary Club, consolidate monetary and product donations to then be provided to the community that they work in. Products are often distributed at different levels with little to no coordination, which leads to unequal distribution of the limited resources that are available. For example, one community could receive wheelchairs multiple times a year from campaigns, while other localities are never reached.

Public sector: Where a public payer does exist in LMICs, funding is fragmented across ministries or difficult to access. Ministries may not routinely budget for wheelchairs and often submit orders or accept donations in an ad-hoc manner. Limited record keeping and visibility on who has previously received products leads to some end users receiving multiple wheelchairs and others who are never reached.

Procurement is often not linked to service delivery so inappropriate product types are selected. This contributes to an inability to forecast for a mix of appropriate products.

MARKET VISIBILITY

There is limited to no data on unmet need and funded demand for appropriate wheelchairs in LMICs.

Buyers: lack understanding of available and quality suppliers and their product offerings. Purchasers are unable to make informed choices when navigating a highly fragmented, unorganised market of suppliers with a vast product mix. Frequently products can be received but are then not used as they are not fit for purpose leading to further invisibility of the market.

Suppliers: lack of demand information such as visibility to government tenders and capacity to respond to government tenders that do exist limits investment in production capacity and allocation of capacity for appropriate products thus increasing transaction costs.

BARRIER ADDRESSED	Low and erratic demand in LMICs with limited government engagement and funding.
RATIONALE	There is limited awareness within government on the need for and return on investment for appropriate wheelchairs. Integrating the provision of wheelchair services into the health sector could drive regular purchases from government, leveraging existing infrastructure and capacity for service provision, product distribution and procurement. Health systems are well suited to support user identification, service delivery and procurement in particular for remote settings in LMICs. Buying appropriate wheelchairs and pressure relief cushions can be cost-saving overall to the health system by offsetting negative health outcomes.
PROPOSED ACTIVITIES	Support the integration of wheelchair provision into the health system at country-level: In a sub-set of identified countries [selection process to be developed], increase provision through integration, expanding and further developing proven models for delivery. This includes: 1) mapping the provision landscape and need, where appropriate; 2) developing a roadmap or strategy to integrate wheelchair services into the national health system; 3) developing or expanding personnel and capacity for service provision, including follow-up and maintenance. Document learnings to inform the global toolkit. Develop advocacy and implementation toolkit to be used by decision-makers to integrate wheelchair provision into the health system: Develop and disseminate tools to support the implementation and advocacy at government level, including: 1) tools to model the need; 2) investment case for integration of wheelchairs, including financial and societal return on investment (ROI); 3) a road map template including policy, guideline development, procurement guidelines and operational management guidance that can support countries with the integration of services; and 4) a sample budget impact model for scale-up.
29
TARGET OUTPUTS	Unmet need better understood and quantified Improved awareness of the need for, and value of, appropriate wheelchairs Demand generated (sustainably and predictably) in a number of countries Model for integration tested and evaluated for scaling to meet need that: Improves ownership and coordination Provides quality-assured product through services
LONG-TERM OUTCOME	Predictable, sustainable and sufficient demand for appropriate, quality wheelchairs which leads to positive outcomes for wheelchair users.

BARRIER ADDRESSED	Fragmented market driven by a lack of coordination among buyers of wheelchairs for LRS and a limited focus on deploying the available resources to effectively support the development of a public sector market.
RATIONALE	Across various LMICs, donors operate parallel delivery systems that often lack coordination with the government. Successes in other health areas show that viable LMIC markets can be developed through partnering with governments, and with targeted support from donors. Opportunities exist to expand domestic expenditure and catalyse government participation for both product procurement and service delivery, potentially using innovative financing mechanism (e.g. results-based financing & co-financing). Pooling the available resources - both donor and government - allows for the channelling of resources to a single payer, thereby strengthening purchasing power, increasing market visibility to suppliers and predictability in funded demand.
PROPOSED ACTIVITIES	Test model(s) to pool resources from key donors: Facilitate and test innovative models with select donor(s) to leverage available resources. This may include, match funding, subsidy, product purchasing support, etc. Leverage donor funds (e.g. from FBOs) to activate government purchasing and unlock additional resources: Work with donors and government to commit resources (in line with innovative funding model, such as match funding) towards wheelchair purchasing or provision, supporting integration into government-owned supply chain.
TARGET OUTPUTS	Government payer activated Purchaser landscape consolidated and buyer power strengthened Increased funding predictability Increased market visibility Key donors commit to taking proven innovative funding approach to scale
LONG-TERM OUTCOME	Donor funding is effectively deployed to catalyse funded public demand and strengthen systems for the provision for appropriate wheelchairs

BARRIER ADDRESSED	Proliferation of low-quality products that do not meet end-user needs Inability to support value-based negotiations Opaque market environment with limited information available to suppliers and buyers
RATIONALE	Aligning on product specifications and/or a PPP that establishes product quality standards, specifications and target pricing can increase transparency for purchasers, such as government programmes, and suppliers. Thus, making procurement easier for governments, potentially supporting value-based price negotiations, centralised contracting or donor co-financing. A procurement or distribution hub that rationalises supply and negotiates directly with suppliers may serve as a step toward centralised contracting.
PROPOSED ACTIVITIES	Develop PPP to be adopted into countries' procurement: Establish baseline set of standards and specifications for products in LRS; Develop key strategic document that communicates PPP requirements for products that fulfil priority needs. The PPP includes desired specifications and requirements, including on environmental conditions, quality and cost; Develop standards in line with PPP that would be applied to support quality testing and implement testing body with easy to access testing centres. Promote the adoption of new wheelchair standards by ISO; Advocacy with donors/funders (donors, UNICEF SD, governments, NGOs, FBOs, etc.) should be targeted to emphasise buying only products meeting the minimum requirements and specifications as outlined in the PPP. Increase market visibility: Develop a market intelligence platform that tracks supply and buyer landscape, including data from UNICEF, CLASP, ATscale and AT2030 initiatives, and other field practitioners and NGOs. Strengthen procurement and distribution mechanisms to ensure the ability to meet market needs: Work to increase market information, including upcoming tenders and volumes, available to procurement mechanisms, such as UNICEF SD, CLASP and others; Include products meeting PPP specifications (and future products meeting PPPs) within global procurement mechanisms, such as UNICEF Supply Division catalogue; increase country knowledge on product availability; Assess and further develop distribution hub models, such as CLASP, by increasing its independence, diversifying its funding base, reducing product acquisition cost and supporting capacity to increase scale, product range, reach and responsiveness.
TARGET OUTPUTS	Increased visibility of quality suppliers in the market with products that meet PPPs Demand rationalised as the requirements of buyers are standardised Buyers have adopted standardised product specifications and standards (in line with PPP) and implemented procurement principles to adopt quality, appropriate product
LONG-TERM OUTCOME	Transparent flow of information on demand and supply enables the market to grow in a cost-effective manner.

BARRIER ADDRESSED	Unfavourable manufacturing economics and high shipping costs significantly increase the cost to LMIC payers. Governments may prefer ‘local products’, therefore limiting international supply and uptake of international distribution mechanisms (e.g. CLASP).
RATIONALE	Proven models of affordable, quality, localised supply exist. Manufacturers of quality, low-cost wheelchairs or wheelchair components exist that could meet LMIC market needs. Increasing the use of globally recognised minimum quality standards may help filter out lower quality manufacturing in support of new mechanisms for cost-effective supply.
PROPOSED ACTIVITIES	Improve understanding of the economics of local manufacturing versus local assembly: Conduct detailed analysis on the economics of local assembly versus local production in specific countries to support government decision makers and private sector business development units. Test models for localised cost-effective supply systems: Work with (local) suppliers already operating in LMICs and/or with large global suppliers to test approaches for the supply of products that meet quality and price goals. This may include – for example – facilitating a joint venture, supporting licensing agreements between social enterprises and contract manufacturers or supporting the development of a (regional) distribution network.
TARGET OUTPUTS	Governments have the tools and information required to make informed investment and procurement decisions regarding localised production Proven model for a responsive and cost-effective supply of appropriate wheelchairs in country
LONG-TERM OUTCOME	A healthy supplier base of quality, appropriate products for LMICs that are delivered at optimal prices that can efficiently service market needs.

ORGANISATION	NAME
ATscale	Alison End Fineberg
Beeline Wheelchairs	Mark James Richard
CE Mobility	Rodney Outram
Dare Consult	Elsje Sophia Scheffler
Diversability Development Organization	Sharmini Constantinescu
El Comité de Rehabilitación - Colombia	Sara Munera
Free Wheelchair Mission	Don Schoendorfer
GDI Hub	Vicki Austin Catherine Holloway Richard Frost (Consultant)
Independent Consultant	Mark Sullivan
International Disability Alliance	Ana Lucia Arellano
International Society of Prosthetics and Orthotics	Claude Tardif
International Society of Wheelchair Professionals	Jon Pearlman Mary Goldberg
LDS Charities	Eric Walter Wunderlich
LeTourneau University	Karen Rispin
Loh Medical	Perry Loh
Massachusetts Institute of Technology	Matt McCambridge
Motivation Charitable Trust and Motivation Direct Ltd	David Constantine Amanda Wilkinson Tamsin Langford Jane Parker
Motivation Romania	Cristian Ipas
Norad	Ivar Evensmo
34
Office of WHO Ambassador for Global Strategies	Phyllis Heydt
Participant Assistive Products	Keoke King
Pan American Health Organization	Antony Duttine
Permobil	Karin Leire
Philippines Society of Wheelchairs Professional	Cheryl Ann
Rehasense	Roger Dutton
Rough Rider America, LLC	Mark Krizack
Shonaquip	Shona McDonald
Sunrise Medical India (Scoot Wheelchairs)	Vinod Krishnan
UCP Roda Untuk Kemanusiaan Indonesia	Tri Wibawa
UCP Wheels for Humanity	Perth Rosen Leesa Hagens
UK DFID	Sara Boiten Sophie Bracken James Droop Anne MacKinnon David Woolnough
UNICEF	Gopal Mitra Dennis Soendergaard
University of Limerick	Rosemary Gowran
Universidad CES - Colombia	María Luisa Toro Hernández
USAID	Michael Allen Amy Lin Nikki Tyler
Whirlwind Wheelchair International	Bruce Curtis
WHO	Chapal Khasnabis Wei Zhang
WHO Regional Office for Europe	Satish Mishra