Annexes

Annex A: List of Consultations for Product Narrative Development

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

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

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.

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.

Annex D: Select prosthetic components developed for LMIC context

Technology Provider 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

Annex E: Overview of prominent international organisations providing prosthetic services45

Organisation International Committee of the Red Cross (ICRC) Bhagwan Mahaveer Viklang Sahayata Samiti (BMVSS) Humanity & Inclusion (HI)
Website 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

Organisation Geographical coverage Model Impact

500 Miles

(Est. 2007)

www.500miles.co.uk

Focused on Malawi and Zambia, some presence in Tanzania (Zanzibar).
  • Sponsors the training and accreditation of 18 prosthetists/orthotists.

  • Offers free P&O services and devices at the Kamuzu central hospital in Lilongwe as well as through community outreach services.

  • Provide funds to users who have to travel for transport and accommodation.

  • Funding comes from government, and support from other local partners and donors.

  • Has fitted over 3,500 users.

  • Sponsored the training and accreditation of 18 prosthetists/orthotists at ISPO-accredited training schools.

Mobility India

(Est. 1994)

www.mobility-india.org

India (South, East and North-Eastern States).
  • Provides rehabilitation services and mobility devices including P&O to the most vulnerable populations.

  • Provide prosthetist/orthotist training through its Rehabilitation Research and Training Centre in Bangalore.

  • Develops and manufactures low-cost components and mobility products that are designed for LMIC contexts.

  • Committed to employing persons with disabilities in its operations and in its training programmes.

  • Provided over 220,000 assistive devices and interventions.

  • Trained over 5,000 rehabilitation personnel.

  • Community outreach programmes have reached 6,000 persons with disability, and reached 402 urban slums and rural communities.

CURE

(Est. 1996)

www.cure.org

9 hospitals. Programmes in 27 countries, including Kenya, Uganda, Malawi, Zambia, and Ethiopia.
  • International Christian FBO.

  • Establishes and operates orthopaedic paediatric charitable hospitals, and offers a full range of care from surgical treatment to rehabilitation and fitting of mobility devices.

  • Specialised programmes focused on birth defects and neuro-orthopaedic disorders such as club foot, spina bifida and hydrocephalus.

  • Although medical and surgical interventions are provided free of charge, mobility devices are typically paid for OOP.

  • Performed over 213K orthopaedic operations on paediatric patients.

Association of the Physically Disabled Kenya

(Est. 1958)

www.apdk.org

Kenya.
  • Charitable organisation that offers range of services to identify, rehabilitate, and reintegrate people with disabilities.

  • Services include medical rehabilitation, provisioning of mobility devices including P&O, physical therapy, community-based rehabilitation, education, vocational and skills training, and micro-financing for entrepreneurs with disabilities.

  • Rehabilitated over 600,000 persons with disabilities.

  • In 2018, 1,698 clients were attended to, 53 orthopaedic operations sponsored and 497 orthopaedic devices provided.

Puspadi Bali

(Est. 1999)

www.puspadibali.org

Eastern provinces of Indonesia.
  • Non-profit organisation that focuses on providing mobility devices and rehabilitation services to persons with disability.

  • Services include outreach to remote islands to identify and refer amputees and build awareness, production of lower limb P&O devices, provision of wheelchairs, and advocacy for policy reform at local and national levels.

  • P&O devices are provided free of charge.

  • Provide services to 580 people every year, 400 of which are for P&O devices: 160 TF, 100 TT, and repair for ~200 users).

  • Around 65% of the 20 staff are physically-disabled.

Limbs International (LI)

(Est. 2004)

www.limbsinternational.org

15 countries, including Kenya, India, Indonesia, and Mexico.
  • Developed a ‘Limbox’ solution that contains all components required to fit a TF amputee (not the socket). This low-cost solution (USD 600) won the Drucker prize for innovation in 2019.

  • Utilises partners to identify potential users who have access to a community-based rehabilitation programme and provides the Limbox free of charge

  • In 2018, LI delivered 400 limbs.

Range of Motion Project

(Est. 2005)

www.rompglobal.org

Guatemala, Ecuador, and US.
  • Non-profit organisation that provides support to develop local capacity (training prosthetists and local manufacturing), providing medical care to those with physical disability, and developing and deploying innovative prosthetic technologies.

  • Engages in advocacy and awareness-building activities.

  • 9,249 patient visits, with 3,345 devices delivered since establishment.

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.
  • Established 5 P&O schools in region and trained over 500 professionals.
  • Supplied over 55,000 custom-made P&O devices.
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.
  • Established 5 P&O schools in region and trained over 500 professionals.
  • Supplied over 55,000 custom-made P&O devices.

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

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.
  • Commercially available in Europe, North America and Asia.

  • Acceptability pilot/clinical trial in Kenya: results expected in 2020.

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.
  • Commercially available globally.

  • Clinical studies have been conducted in South Africa and Indonesia to show it performs on a par with traditional sockets, but comfort issues arise due to liner sores.

  • Durable and efficient, but 5-6x the cost of traditional sockets.

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.
  • Commercially available globally.

  • Sockets meet ISO standards and are regulated as medical devices in Europe, Australia, and Singapore

  • Clinical investigation conducted in 2015.

  • Clinical trials in Syria, Togo, and Madagascar in 2016 showed viability of solution and to improve prosthetist productivity; albeit cost of 3D printing is much higher than traditional socket fabrication methods and not yet economically feasible.

  • Trial in Middle East in 2018-2019 combined telehealth approaches and PandoFit that enabled task-shifting to local physiotherapists to fit 40 amputees in a challenging environment.

  • Prosfit is launching a capacity building project in East Africa that offers training on the PandoFit solution, infrastructure development, tele-health, data collection, and policy recommendations. First phase is estimated to fit 200-250 users and will cost EUR 0.5-EUR 1 million.

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.
  • Commercially available and currently recruiting early adopters.

  • Clinical trials in Cambodia, Uganda, and Tanzania show performance and acceptability on a par with ICRC sockets. However, issues with socket cracking and discomfort caused by (previous version) material.

  • Nia is a non-profit social enterprise. Currently forming a new for-profit company and seeking investors to commercialise NiaFit software in developed countries.

Annex I: Different component supply channels observed in LMICs46

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.


  1. Source: CHAI expert consultations with NGOs and organisation websites as denoted in Annex A.↩︎

  2. Diagrams from CHAI, based on CHAI expert consultations.↩︎