Table of Contents

  • Acknowledgements
  • Acronyms
  • Executive Summary
  • Introduction
    • 1. Assistive Technology and Market Shaping
    • 2. Product Narrative
  • 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.
      • 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.
      • 3.3. Prosthetic devices are available across a spectrum of materials and technologies and are customised based on needs of the user.
      • 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.
      • 3.5. Trained and accredited prosthetists/orthotists are critical to the service delivery process.
      • 3.6. Donor funding is limited, with support mainly focused on training prosthetists/orthotists and establishing service provision capacity.
    • 4. Market Assessment
      • 4.1. The global prosthetics 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.
      • 4.2. LMIC markets for prosthetic devices are small as they lack capacity for provision.
      • 4.3. Lack of LMIC government investments has left a gap that has been filled by non-governmental (NGOs) and faith-based organisations (FBOs).
      • 4.4. Collaborations between the public sector and for-profit organisations may have the potential to mobilise cross-sector investments to expand access.
      • 4.5. Collecting amputee data supports improved advocacy to drive investment in prosthetic services and improvements to quality of care.
      • 4.6. The starting point for prosthetic services is a link between amputation and rehabilitation, but poor referral pathways lead to patient drop-off.
      • 4.7. When patients are referred, the service point can be costly and difficult for amputees to reach.
      • 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.
      • 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.
      • 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.
      • 4.11. Responsive supply channels are needed in LMICs and could be met via regional distributors.
      • 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.
    • 5. Market Challenges
      • 5.1. Demand
      • 5.2. Supply
      • 5.3. Enablers
  • Chapter 2: Strategic Approach to Market Shaping
    • 6. Strategic Approach to Market Shaping and Market Building
      • 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.
      • Strategic Objective 5: Strengthen regional supply to increase affordability and availability of quality prosthetic components.
    • 7. Next Steps
  • Annexes
    • Annex A: List of Consultations for Product Narrative Development
    • Annex B: Designations in Prosthetist/Orthotist professions according to 2018 Education Standards (detailed)
    • Annex C: Global Component Supply Landscape
    • Annex D: Select prosthetic components developed for LMIC context
    • Annex E: Overview of prominent international organisations providing prosthetic services
    • Annex F: Select regional NGO/FBOs
    • Annex G: Description of traditional socket fabrication and fitting process
    • Annex H: Overview of select novel socket fabrication technologies with potential for adoption in LMICs
    • Annex I: Different component supply channels observed in LMICs
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