The International Society for Prosthetics and Orthotics Canada

Ethics of Additive Manufacturing in Prosthetic & Orthotic Care – A Panel Discussion

Abstract: Appropriate Assistive Technology is known to enable persons with disabilities to live dignified, independent and healthy lives.^1,2 However, inappropriate prescription and/or provision of devices has been reported to waste health care dollars and result in delays in achieving expected improvements in an individual’s symptoms/health.³

For these reasons it is of importance to seek avenues to increase access to appropriate devices while mitigating the risks associated with an inappropriate treatment models.

The World Health Organization estimates that only 1 in 10 persons who require assistive products, including prosthetics and orthotics, have access to them, owing to a range of barriers including high cost, lack of availability, insufficient policies, and a limited of supply of trained personnel to deliver services.⁴

Additive manufacturing processes (including 3D printing) hold great potential for application in prosthetics/orthotics which may remove barriers to accessing services, reduce cost and help to optimize resources. However, the proliferation of technology in additive manufacture brings with it the risk that complex clinical systems will be over simplified resulting in a reduced quality of care and ultimately may compromise the potential outcome for individual users.

The objective of this session is for an expert panel to discuss the opportunities and risks associated with additive manufacturing as it relates to prosthetic/orthotic care and highlight the ethical responsibilities of individuals providing devices using digital technologies.

Target audience: This session will be of interest to clinicians, engineers, and researchers with interest in the field of prosthetics/orthotics, clinical application of additive manufacture and/or the design of hardware or software for the purpose of creating assistive health technology, particularly prosthetics/orthotic devices.

Moderator: Ed Lemaire

Panelists:

• Alison Williams
• Gordon Ruder
• Jan Andrysek
• Sandra Ramdial
• Matt Ratto

Reference:

1. World Health Organization. Priority Assistive Products List. http://www.who.int/phi/implementation/assistive_technology/low_res_english.pdf. Published 2016. Accessed June 1, 2016.
2. World Health Organization. Standards for Prosthetics and Orthotics Part 2. Implementation Manual. Geneva, Switzerland; 2017. http://apps.who.int/iris/bitstream/10665/259209/2/9789241512480-part2-eng.pdf?ua=1.
3. Fisk JR, DeMuth S, Campbell J, et al. Suggested Guidelines for the Prescription of Orthotic Services, Device Delivery, Education, and Follow-up Care: A Multidisciplinary White Paper. Military Medicine. 2016;181(2S):11-17. doi:10.7205/MILMED-D-15-00542
4. World Health Organization. Standards for Prosthetic and Orthotics Services Provision Part 1. Geneva, Switzerland; 2017. http://apps.who.int/iris/bitstream/10665/259209/1/9789241512480-part1-eng.pdf?ua=1.

Biographies

Panelist: Dr. Alison Williams has had an extensive career in ethics where she has held roles in a diverse range of health care organizations. She began her career as a Clinical Ethicist with the Clinical Ethics Service shared by St. Michael’s Hospital, St. Joseph’s Health Centre and Providence Centre. She then worked as a Clinical, Research and Organizational Ethicist at The Scarborough Hospital. Alison has also worked as an Ethics Consultant to Ontario Shores Centre for Mental Health, and as a Bioethicist at SickKids. In all of these roles she has provided ethics consultation on a variety of clinical and organizational issues, education to a variety of health care professionals, policy development and review, and was an active member of their Research Ethics Boards. She is currently the Chair of the Research Ethics Board at the Bloorview Research Institute at Holland Bloorview Kids Rehabilitation Hospital. Alison has a PhD in ethics and philosophy of education from the University of Toronto.

Panelist: Gordon Ruder is the Coordinator and an Instructor of the Prosthetic and Orthotic educational programs at George Brown College in Toronto, Canada for the past 25 years.

He has extensive clinical experience as a practicing Certified Orthotist, with a particularly strong focus around the lower limb orthotic management of pediatric cases with developmental disorders.

He acquired his Masters of Science, Biomechanics from the University of Waterloo in 1989, resulting in several significant publications in the area of human gait and balance control.

Gordon is interested in the relationship between prosthetic and orthotic education, the technical and clinical aspects of orthotic practice, and research. He has been involved in research projects that investigate key aspects of  3D printing as it applies to the clinical practice of prosthetics and orthotics. In addition, he has had a leading role in establishing additive manufacture as part of the core curriculum in the prosthetic/orthotic  programs of George Brown College.

Panelist: Dr. Jan Andrysek is a Senior Scientist at the Bloorview Research Institute of Holland Bloorview Kids Rehabilitation hospital, Canada’s largest teaching hospital focused on paediatric disabilities. He is also an Associate Professor within the Institute of Biomaterials and Biomedical Engineering, University of Toronto. His research program focuses on the development and improvement of treatments and assistive technologies for children and adults with mobility impairments. Specific areas of study include prosthetic and orthotic limb control, bio sensing and biofeedback systems, and instruments to measure assistive-technology-facilitated mobility and physical activity in real-life environments. Current research is also focused on understanding the global need for prosthetic technology, and impact on mobility, physical function, and quality of life. He is the recipient of prestigious awards including the 2017 Ontario Profession Engineers Engineering Medal for Research and Development, Clifford Chadderton Award for Prosthetics and Orthotics Research, and first price at the 2015 Accessibility Innovation Showcase Tech Pitch Competition sponsored by the Government of Ontario. Dr. Andrysek is also the co-founder and Chief Scientific Officer at Legworks Inc., a social for-profit enterprise focused on improving prosthetic technologies and care for individuals with amputations worldwide.

Panelist: Sandra Ramdial is a certified prosthetist and operations manager for the Orthotics and Prosthetics department at Holland Bloorview Kids Rehabilitation Hospital and has direct involvement in client care. She has been involved with the International Society for Prosthetics & Orthotics many years before the formal start of the Canadian National ISPO. She has demonstrated evidence of high professional standing and is a Fellow with Orthotics Prosthetics Canada, past president of the Canadian Association of Prosthetics & Orthotics and the International Society for Prosthetics & Orthotics Canada and Secretary-Treasurer for the Association of Children’s Prosthetic-Orthotic Clinics. Sandra has presented her work at various national and international conferences and has contributed to publications and review journals. In addition to her extensive experience, Sandra brings an even greater amount of enthusiasm and passion for research and development, and new technologies to the field.

Panelist: Dr. Matt Ratto is an Associate Professor in the Faculty of Information at the University of Toronto and directs the Semaphore Research cluster on Inclusive Design, Mobile and Pervasive Computing and, as part of Semaphore, the Critical Making lab. His work explores the intersections between digital technologies and the human life world, with a particular focus on new developments that trouble the divide between online and offline modes of production. Ratto is an avowed expert on 3D printing and digital fabrication, having carried out research on this topic since 2009. His research also addresses pervasive and ubiquitous technologies including wearable computing and the Internet of Things. Ratto created and ran the ThingTank  from 2009-2011, a collaborative project between private, non-profit, and academic partners working collectively on new IoT products and services.

A current project involves the development of a cost-effective software and hardware toolchain for the scanning, design, and 3D printing of lower-limb prostheses for use in the developing world. This work is being carried out in partnership with non-profit CBM Canada, CoRSU hospital in Uganda, Autodesk inc., and Toronto prosthetics and orthotics experts.

Moderator: Dr. Ed Lemaire received a PhD in Bioengineering from the University of Strathclyde (Glasgow) and MSc in Biomechanics from the University of Ottawa. In addition to academic appointments in the uOttawa Faculty of Medicine and Health Sciences, Dr. Lemaire is a member of the Ottawa-Carleton Institute for Computer Science and the Ottawa-Carleton Institute for Biomedical Engineering. He is President-Elect of the International Society for Prosthetics and Orthotics (ISPO) and serves on the ISPO International Scientific Committee.