Additive Manufacturing Strategies

Non-Profits Make Affordable Prosthetic Liners in Ecuador with 3D Printed Molds

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Two non-profits are making prosthetic care more sustainable and accessible in Ecuador. Operation Namaste and the Range of Motion Project (ROMP) partnered to establish in-country fabrication of prosthetic silicone liners for amputees who previously did not have access to them. The new Namaste Liners use a fabrication method called Silicone Interface Liner Comfort (SILC) Solutions, which relies on CAD-designed, 3D printed molds to make silicone gel liners in standard sizes that range from small to extra large.

Prosthetic liners are the soft interface between an amputee and the prosthesis. They are critical to allow an amputee to comfortably wear a prosthesis and even do high-intensity activities, such as mountain climbing, and compete against other non-disabled athletes in Olympic sports. Most silicone liners from recognized brands cost over US$200, making them too expensive for low-income Ecuatorian workers who earn, on average, US$300 per month. Instead, Operation Namaste and ROMP bring down the cost of their SILC liners to less than US$50 by turning to local labor and advanced manufacturing technologies.

There are no specific statistics on amputee patients in Ecuador. After a 2010 national census, the National Disability Council (Conadis) determined that more than 340,000 people have motor disabilities. But even though the Ecuadorian government has failed to publicly disclose the specifics on amputee statistics, ROMP found out that there are at least 15,000 patients who need a prosthesis and even more who would require a prosthetic liner.

 

Taking a big step forward in making prosthetic care more sustainable in developing nations, eighteen months ago, Operation Namaste founder and clinician Jeff Erenstone started developing the SILC method to fabricate silicone prosthetic liners on a request from a fellow prosthetist in Nepal, Amit Bajracharya. After a year of testing at the organization’s headquarters in Lake Placid, New York, and four versions later, Erenstone developed a system that worked well. Unfortunately, his plans to deploy the product to Nepal in May 2020 halted due to global disruptions from the COVID-19 pandemic. But Erenstone didn’t waste any time and connected with ROMP executive director Dave Krupa in November.

Together, Erenstone and Krupa quickly implemented the liner system in Ecuador (a country that has reasonably controlled one of the world’s worst outbreaks of COVID-19 thanks to good public compliance). Within a week, supplies were shipped to Ecuador, and Erenstone flew down for two weeks to train ROMP’s staff on making liners using 3D printed molds and silicone. The team can now print the molds locally and make liners on demand.

Krupa and Erenstone soon fitted the first patient, named Sarah, with a locally manufactured liner. She immediately revealed that the Namaste Liner was much more comfortable than her previous mass-market product. Both Krupa and Erenstone said their initiative was a “game-changer.”  Erenstone, who has been working in 3D printed prosthetics for years, even revealed that this new process is one of the most effective and scalable uses he has encountered.

Operation Namaste and Range of Motion Project have now fitted the first prosthetic liner made in Ecuador. Image courtesy of Operation Namaste/Range of Motion Project.

Namaste liners are made with 3D printed molds that are complex in design but make fabrication more straightforward and use medical silicone, a material that has been on the market for years. The liners can be used with suspension methods commonly used in developing countries and do not require sourcing a locking mechanism or unique socket fabrication, making manufacturing faster and easier.

Operation Namaste began creating below-knee (BK) liners first, mainly because there is a more considerable demand, but has plans to continue work into above-knee (AK) liners shortly, as well as longer liners based on clinician and patient feedback. The liner itself is not considered a certified medical device. It is only supplied for testing purposes for now, but it is proving to improve the quality of life for amputees, one of ROMP’s primary goals.

Namaste Liner 3D printed molds. Image courtesy of Operation Namaste.

The healthcare organization has established locations in Guatemala, Ecuador, and the United States that provide prosthetic and orthotic care to those without access to these services. ROMP volunteers usually travel to Central American locations to learn how to build and fit prostheses for patients. For example, Colorado State University has created the Prosthetic Innovation in Ecuador study abroad program in partnership with ROMP to design and fabricate prosthetics for under-served populations in Ecuador’s capital city Quito.

Similarly, Operation Namaste’s mission​ is to help determined people achieve mobility by providing knowledge, technology, and support to orthotic and prosthetic practitioners worldwide. They accomplish this by supporting other organizations that already offer clinical care like ROMP, relying on local labor to deliver more affordable silicone prosthetic liners. ​Moving this new partnership into the next phase will improve the program and make better low-cost prostheses available to amputees in Ecuador and eventually in other developing countries.

Range of Motion Project’s Dave Krupa shows how the organization uses Operation Namaste’s SILC Solutions liner system in Ecuador. Image courtesy of Operation Namaste/Range of Motion Project.

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