Jeremy Fishlow, Contributing Writer10.09.14
All too often, it takes years for medical technology to make it from bench to bedside, and the developers of a product seldom get to see the satisfied faces of patients who benefit from their cutting-edge technology. Processes such as additive manufacturing—also known as 3-D printing—increasingly are changing that dynamic.
Based on the tenet of using technology for good, Project Daniel—an initiative unlike any other—is helping young amputees in the war-torn country of South Sudan by providing them with 3-D-printed prosthetic arms.
When my colleagues and I first heard about the Project Daniel idea to crowdsource prosthetic designs, we had a lot more questions than answers. But what became clear during the course of the project is that a little technology can go a long way, especially when the full potential of that technical engineering know-how is realized for such an extraordinary purpose.
As a quality systems engineer at Farmingdale, N.Y.-based Precipart—a global supplier of precision custom mechanical components, gears and motion control assemblies—I had collaborated on a number of previous medical device designs. However, I had never worked on one quite like this. Volunteering with several other experts on the team, I had the privilege of helping the Project Daniel vision come to fruition. We were able to design simple and inexpensive prosthetic limbs that could be “printed” for children who have lost arms. The project’s success revolved around open-source design, 3-D printing technology and some basic principles of design for manufacturability (DFM).
The Creation of Project Daniel
Project Daniel started with an article in Time magazine about Daniel Omar, a boy in Sudan who had both of his arms blown off by a bomb. He was just 14 years old when he lost his arms and became one of 50,000 amputees in the region.
Mick Ebeling, CEO and founder of the Venice, Calif.-based healthcare humanitarian technology group Not Impossible Labs, read the article and knew he wanted to help. He hoped to provide Daniel and others like him with 3-D-printed prostheses to vastly enhance their quality of life.
During the course of a few short months, the idea quickly moved from concept to reality. Volunteers were recruited and financial support was raised for the endeavor, dubbed Project Daniel, and the team went to work designing the Daniel Arm. Following some DFM principles, the team modified an existing design, located Daniel in a village in the South Sudan Nuba Mountains and fitted him with a functional prosthetic arm. To further the mission, the team also set up a special on-site printing and training facility to help fit additional amputees with 3-D-printed prosthetic arms.
The project has been a huge success: Barring exceptional war conditions, the facility has provided an average of one arm per week to children who need them.
Assembling a Team
The first step involved a gathering of volunteers for an intensive “maker weekend” at Not Impossible headquarters. This facilitated the collaboration of some of the most knowledgeable people in related fields, including Richard Van As, inventor of the Robohand, who flew from South Africa to help alter his prosthetic hand design to fit the needs of Project Daniel. I volunteered representing Precipart, which provided engineering and financial support throughout the project.
Other volunteers included an Australian neuroscientist from the Massachusetts Institute of Technology, the owner of a 3-D printer company from California, and an American doctor working in Sudan (who spoke with the group at Not Impossible via Skype). Additional contributors specialized in such varied fields as design, 3-D printing and physical therapy. The weekend even had a coffee sponsor to keep everyone fueled.
As a quality systems engineer, I was excited for the chance to provide engineering experience that could be applied to an altruistic and unconventional endeavor.
Adapting Conventional Design Practices
The purpose of the maker weekend was to create a design that was feasible to manufacture given the location, limited resources and skill level of our recipients. Whereas conventional medical device design and development often includes detailed Production Part Approval Process (PPAP) requirements, we knew going into the weekend this would be the antithesis; we would have to move quickly with limited time and resources to put forward a viable solution.
Working for a supplier of high-precision gears and components in the medical industry, my proclivity is for a more methodical process that typically starts with a thorough feasibility study, includes a complete design review and ends with quality testing and evaluation. These standard processes–which usually take days, weeks or months to complete–include risk management, PPAP requirements and time-to-market milestones. Considering the maker weekend lasted just two days, to say that our design and production methods were accelerated would be quite the understatement.
Our mission was to think realistically about the capabilities for printing and assembly in South Sudan. While DFM is a must-follow practice in any medical design project, we didn’t have the time or resources we do in a competitive commercial manufacturing environment. In standard commercial manufacturing, device designs are closely guarded from competitors and the emphasis tends to be toward perfecting a market-ready and regulatory approved finished product.
Herein lies the biggest difference between conventional design and the Project Daniel design, according to Elliot Kotek, co-founder and chief of content at Not Impossible and a key player in the initiative.
“The team decided early in the undertaking to rely heavily on open-source resources to keep their achievements and strategies available to the public,” Kotek said. “An open-source method reverses the onus of the design process. It becomes about getting an idea out there quickly, so that others can take it and improve it, and then re-upload it for open-source access. So instead of having to release the best design and the best product, you’re looking at releasing the best concept and the earliest form of the product.”
Following from this idea, the team’s decision to use open-source technology and to share the designs openly was an obvious one.
The guiding principle in this project was to use technology for the betterment of humanity and to improve lives in the simplest and most effective ways possible.
As part of a basic DFM approach, all aspects of the project were considered at the beginning. The team made sure to pay attention to details such as costs, supplies, electrical capabilities in the village and environmental conditions to ensure that the arm’s blueprint was practical to make and use in the specific conditions.
For this purpose, key players were involved from the very beginning. Designers advised on functionality and durability. The 3-D printing experts advised on manufacturing. And the physical therapist advised on prosthetic comfort. Suppliers were involved in the upfront work and we made a concerted effort to standardize and reduce material and component costs whenever possible.
The result was a prosthetic arm that worked within a very specific set of constraints. The final product had to be easy to manufacture in South Sudan by villagers who had limited training, and it had to be practical for use in the harsh environment. Discussing these considerations at the beginning of the design process helped avoid obstacles or unexpected expenditures later down the road.
Key Design Criteria
The team entered the maker weekend with a very specific goal. Our objective was not to engineer better solutions, such as highly designed arms with extensive robotic or electric capabilities, but to provide a basic and inexpensive alternative.
With that in mind, we set out to design a prosthetic arm that met the following key criteria:
Meeting these requirements proved quite challenging for the team of volunteers. However, during the maker weekend design phase, we came up with new and innovative ideas to overcome issues.
The most obvious issue was a lack of resources. Arms needed to be printed and assembled using little more than what was readily available in Sudan. Volunteers in the United States used Skype to connect with a doctor located in Sudan and learn about potential supplies. Eventually discovering that the doctor had very limited resources, the volunteers finally asked about his trash. The medical trash turned out to be a vital source of supplies; designers realized they could reuse IV bags for plastic, medical tubes for elasticity and cabling and needles for weight-bearing pieces.
The team was under a time constraint, wanting to move forward with the project as quickly as possible. Originally wanting an entirely new design, the team decided to forgo that idea and instead opted to start with the Richard Van As Robohand blueprint.
For time purposes, we also narrowed the focus of the project, concentrating on prostheses only for people who lost their arms below the elbow. An arm that attached to the shoulder or upper arm would have required a shoulder strap to keep it in place, which creates design and mobility challenges. The volunteers were amenable to this compromise; as Kotek said, one goal was to release a good concept, even if the product wasn’t perfected yet.
Additionally, the team had to consider the rugged environment of Sudan and the Nuba Mountains. We decided to encase all of the arm’s cables and include a closed-palm structure for the hand, making the device less exposed to the elements and less susceptible to dust and debris. These changes specifically were made for the Daniel Arm. They marked a diversion from the original Robohand, which had an open palm structure and therefore was more susceptible to environmental factors.
The team also paid attention to the device’s potential longevity. We planned to give the arm interchangeable pieces so someone could repair it by swapping out broken parts. We also integrated medical-grade steel into the design to avoid the friction and structural issues typically caused by plastic.
To keep costs low, the team standardized the necessary hardware and components. Whereas an early design involved 24 different components and multiple assembly tools, Precipart’s engineers worked with suppliers to standardize and source different hardware and reduce costs so that only two assembly tools and eight types of components are necessary, helping to meet the goal of keeping costs at $100 per arm.
A physical therapist advised on the comfort factor of the arm, and the team ultimately decided to use Orthoplastic for the socket. Orthoplastic is an ultra-high-molecular-weight polyethylene. Although this medical-grade plastic makes up the arm’s largest material cost, it is essential for Project Daniel’s success and well worth the added expense. Orthoplastic becomes malleable when it’s placed in boiling water, which allows the arm’s socket to be custom-molded to each individual prosthesis recipient. This ensures a perfect and comfortable fit, which encourages the wearer to continue using the arm.
In the finalized design, the medical-grade plastic is used to mount the prosthesis to the upper arm. Strings run the length of the device, from the upper arm, past the elbow and down to the fingers. Motion in the wearer’s bicep, tricep and shoulder either increases or decreases the tension in the strings, causing the fingers to grasp or release. And a twist in the wearer’s shoulder causes the wrist to rotate using a tongue and groove joint. The simplicity of the design allows the arm to be fully functional using only mechanical, spring-loaded joints.
Mission Success
We had barely finalized our design when several members of the Project Daniel team headed to Sudan a few weeks before Thanksgiving in 2013. Once there, the volunteers managed to track down Daniel, then 16 years old. They printed and assembled their first complete arm and fitted it to Daniel, who was thrilled to be able to feed himself for the first time since losing both his arms two years earlier.
After the initial medical device was assembled and fitted, the team set up the world’s first 3-D printing prosthetic laboratory and training facility. They taught local Sudanese trainees to print and assemble additional prostheses. And the arms are so easy to print and assemble that even Daniel was able to undergo training to help create more arms. The trainees soon printed and fitted two more arms, giving hope that the project would be a long-term success.
Since the Project Daniel team returned to the United States, the trainees have continued working to enhance the lives of those around them. When conditions permit, they have been able to create an average of one prosthesis per week.
The Future of Project Daniel
The team has made great strides since starting the project, but there’s still plenty more work to do.
Volunteer designers continue to improve the wrist, as the tongue and groove joint wears down over time. They are looking at replacing this with a pin format, and Precipart is continuing to lend engineering support in an effort to improve this design.
The “Daniel hand” is on its way to increased functionality, with considerations for a wider range of attachments, such as tools for farm work or hooks to lift buckets. Robotic parts also are being considered for use in areas of the world that have ready access to electricity.
The team hopes to implement all these improvements without raising the cost of materials. As with any medical device design project, whether destined for the operating room or the mountains of South Sudan, we know that we must always strike a balance between utility and the ability to manufacture it effectively and that we need to follow basic DFM principles before production, regardless of the environment.
From the initial maker weekend to the continued optimization of the prostheses, we are thoroughly happy with the project’s steady accomplishments. Open-source blueprints for 3-D-printed prosthetic arms, including the Robohand, readily are available online. Ideally, others will use the designs and ideas to develop similar projects.
“It’s crucial to recognize the importance of leveraging disruptive technologies such as 3-D printing to help advance humanitarian efforts,” said Precipart’s Chairman Edouard Laubscher. “We truly believe in technology’s capacity to make significant and honorable improvements in the world.”
Jeremy Fishlow joined Precipart as a project engineer in January 2012. He has a bachelor of science degree in industrial and systems engineering from Binghamton University in New York, and currently is a quality systems engineer at Precipart.
Based on the tenet of using technology for good, Project Daniel—an initiative unlike any other—is helping young amputees in the war-torn country of South Sudan by providing them with 3-D-printed prosthetic arms.
When my colleagues and I first heard about the Project Daniel idea to crowdsource prosthetic designs, we had a lot more questions than answers. But what became clear during the course of the project is that a little technology can go a long way, especially when the full potential of that technical engineering know-how is realized for such an extraordinary purpose.
As a quality systems engineer at Farmingdale, N.Y.-based Precipart—a global supplier of precision custom mechanical components, gears and motion control assemblies—I had collaborated on a number of previous medical device designs. However, I had never worked on one quite like this. Volunteering with several other experts on the team, I had the privilege of helping the Project Daniel vision come to fruition. We were able to design simple and inexpensive prosthetic limbs that could be “printed” for children who have lost arms. The project’s success revolved around open-source design, 3-D printing technology and some basic principles of design for manufacturability (DFM).
The Creation of Project Daniel
Project Daniel started with an article in Time magazine about Daniel Omar, a boy in Sudan who had both of his arms blown off by a bomb. He was just 14 years old when he lost his arms and became one of 50,000 amputees in the region.
Mick Ebeling, CEO and founder of the Venice, Calif.-based healthcare humanitarian technology group Not Impossible Labs, read the article and knew he wanted to help. He hoped to provide Daniel and others like him with 3-D-printed prostheses to vastly enhance their quality of life.
During the course of a few short months, the idea quickly moved from concept to reality. Volunteers were recruited and financial support was raised for the endeavor, dubbed Project Daniel, and the team went to work designing the Daniel Arm. Following some DFM principles, the team modified an existing design, located Daniel in a village in the South Sudan Nuba Mountains and fitted him with a functional prosthetic arm. To further the mission, the team also set up a special on-site printing and training facility to help fit additional amputees with 3-D-printed prosthetic arms.
The project has been a huge success: Barring exceptional war conditions, the facility has provided an average of one arm per week to children who need them.
Assembling a Team
The first step involved a gathering of volunteers for an intensive “maker weekend” at Not Impossible headquarters. This facilitated the collaboration of some of the most knowledgeable people in related fields, including Richard Van As, inventor of the Robohand, who flew from South Africa to help alter his prosthetic hand design to fit the needs of Project Daniel. I volunteered representing Precipart, which provided engineering and financial support throughout the project.
Other volunteers included an Australian neuroscientist from the Massachusetts Institute of Technology, the owner of a 3-D printer company from California, and an American doctor working in Sudan (who spoke with the group at Not Impossible via Skype). Additional contributors specialized in such varied fields as design, 3-D printing and physical therapy. The weekend even had a coffee sponsor to keep everyone fueled.
As a quality systems engineer, I was excited for the chance to provide engineering experience that could be applied to an altruistic and unconventional endeavor.
Adapting Conventional Design Practices
The purpose of the maker weekend was to create a design that was feasible to manufacture given the location, limited resources and skill level of our recipients. Whereas conventional medical device design and development often includes detailed Production Part Approval Process (PPAP) requirements, we knew going into the weekend this would be the antithesis; we would have to move quickly with limited time and resources to put forward a viable solution.
Working for a supplier of high-precision gears and components in the medical industry, my proclivity is for a more methodical process that typically starts with a thorough feasibility study, includes a complete design review and ends with quality testing and evaluation. These standard processes–which usually take days, weeks or months to complete–include risk management, PPAP requirements and time-to-market milestones. Considering the maker weekend lasted just two days, to say that our design and production methods were accelerated would be quite the understatement.
Our mission was to think realistically about the capabilities for printing and assembly in South Sudan. While DFM is a must-follow practice in any medical design project, we didn’t have the time or resources we do in a competitive commercial manufacturing environment. In standard commercial manufacturing, device designs are closely guarded from competitors and the emphasis tends to be toward perfecting a market-ready and regulatory approved finished product.
Herein lies the biggest difference between conventional design and the Project Daniel design, according to Elliot Kotek, co-founder and chief of content at Not Impossible and a key player in the initiative.
“The team decided early in the undertaking to rely heavily on open-source resources to keep their achievements and strategies available to the public,” Kotek said. “An open-source method reverses the onus of the design process. It becomes about getting an idea out there quickly, so that others can take it and improve it, and then re-upload it for open-source access. So instead of having to release the best design and the best product, you’re looking at releasing the best concept and the earliest form of the product.”
Following from this idea, the team’s decision to use open-source technology and to share the designs openly was an obvious one.
The guiding principle in this project was to use technology for the betterment of humanity and to improve lives in the simplest and most effective ways possible.
As part of a basic DFM approach, all aspects of the project were considered at the beginning. The team made sure to pay attention to details such as costs, supplies, electrical capabilities in the village and environmental conditions to ensure that the arm’s blueprint was practical to make and use in the specific conditions.
For this purpose, key players were involved from the very beginning. Designers advised on functionality and durability. The 3-D printing experts advised on manufacturing. And the physical therapist advised on prosthetic comfort. Suppliers were involved in the upfront work and we made a concerted effort to standardize and reduce material and component costs whenever possible.
The result was a prosthetic arm that worked within a very specific set of constraints. The final product had to be easy to manufacture in South Sudan by villagers who had limited training, and it had to be practical for use in the harsh environment. Discussing these considerations at the beginning of the design process helped avoid obstacles or unexpected expenditures later down the road.
Key Design Criteria
The team entered the maker weekend with a very specific goal. Our objective was not to engineer better solutions, such as highly designed arms with extensive robotic or electric capabilities, but to provide a basic and inexpensive alternative.
With that in mind, we set out to design a prosthetic arm that met the following key criteria:
- Easy to assemble. The arms had to be replicable by Sudanese villagers who had extremely limited technological knowledge and limited availability of materials. Not Impossible also wanted amputees themselves to be able to print arms for others once they received their own arms. This required the simplest possible printing process, instructions and assembly.
- Cost-effective. Minimizing the cost of parts was a priority so that more people could benefit from the humanitarian project.
- Durable. The arm had to withstand the harsh, dusty conditions in South Sudan.
- Fluid. The design had to minimize friction between parts to best maximize utility.
- Versatile. Designers wanted to be able to attach tools so that users could perform basic functions like writing, eating and using farm tools. The basic goal was to make an arm that could carry a bucket and use a spoon, but allow the arm to be modified for future developments. For example, allowing the prosthesis recipients to be able to use styluses with a computer, so they could be trained to print more prosthetic arms for other amputees.
- Repairable. Easy maintenance and repairs would be necessary to keep costs low and help improve longevity of the prosthesis.
- Working joints. The team wanted the 3-D printed arm to have a mobile wrist.
- Comfortable. If the arms weren’t comfortable, people most likely would stop wearing them altogether, rendering all the other work useless.
- Mechanical. Sudanese have limited access to electricity. So, the team had to create an entirely mechanical prosthesis rather than a robotic one.
Meeting these requirements proved quite challenging for the team of volunteers. However, during the maker weekend design phase, we came up with new and innovative ideas to overcome issues.
The most obvious issue was a lack of resources. Arms needed to be printed and assembled using little more than what was readily available in Sudan. Volunteers in the United States used Skype to connect with a doctor located in Sudan and learn about potential supplies. Eventually discovering that the doctor had very limited resources, the volunteers finally asked about his trash. The medical trash turned out to be a vital source of supplies; designers realized they could reuse IV bags for plastic, medical tubes for elasticity and cabling and needles for weight-bearing pieces.
The team was under a time constraint, wanting to move forward with the project as quickly as possible. Originally wanting an entirely new design, the team decided to forgo that idea and instead opted to start with the Richard Van As Robohand blueprint.
For time purposes, we also narrowed the focus of the project, concentrating on prostheses only for people who lost their arms below the elbow. An arm that attached to the shoulder or upper arm would have required a shoulder strap to keep it in place, which creates design and mobility challenges. The volunteers were amenable to this compromise; as Kotek said, one goal was to release a good concept, even if the product wasn’t perfected yet.
Additionally, the team had to consider the rugged environment of Sudan and the Nuba Mountains. We decided to encase all of the arm’s cables and include a closed-palm structure for the hand, making the device less exposed to the elements and less susceptible to dust and debris. These changes specifically were made for the Daniel Arm. They marked a diversion from the original Robohand, which had an open palm structure and therefore was more susceptible to environmental factors.
The team also paid attention to the device’s potential longevity. We planned to give the arm interchangeable pieces so someone could repair it by swapping out broken parts. We also integrated medical-grade steel into the design to avoid the friction and structural issues typically caused by plastic.
To keep costs low, the team standardized the necessary hardware and components. Whereas an early design involved 24 different components and multiple assembly tools, Precipart’s engineers worked with suppliers to standardize and source different hardware and reduce costs so that only two assembly tools and eight types of components are necessary, helping to meet the goal of keeping costs at $100 per arm.
A physical therapist advised on the comfort factor of the arm, and the team ultimately decided to use Orthoplastic for the socket. Orthoplastic is an ultra-high-molecular-weight polyethylene. Although this medical-grade plastic makes up the arm’s largest material cost, it is essential for Project Daniel’s success and well worth the added expense. Orthoplastic becomes malleable when it’s placed in boiling water, which allows the arm’s socket to be custom-molded to each individual prosthesis recipient. This ensures a perfect and comfortable fit, which encourages the wearer to continue using the arm.
In the finalized design, the medical-grade plastic is used to mount the prosthesis to the upper arm. Strings run the length of the device, from the upper arm, past the elbow and down to the fingers. Motion in the wearer’s bicep, tricep and shoulder either increases or decreases the tension in the strings, causing the fingers to grasp or release. And a twist in the wearer’s shoulder causes the wrist to rotate using a tongue and groove joint. The simplicity of the design allows the arm to be fully functional using only mechanical, spring-loaded joints.
Mission Success
We had barely finalized our design when several members of the Project Daniel team headed to Sudan a few weeks before Thanksgiving in 2013. Once there, the volunteers managed to track down Daniel, then 16 years old. They printed and assembled their first complete arm and fitted it to Daniel, who was thrilled to be able to feed himself for the first time since losing both his arms two years earlier.
After the initial medical device was assembled and fitted, the team set up the world’s first 3-D printing prosthetic laboratory and training facility. They taught local Sudanese trainees to print and assemble additional prostheses. And the arms are so easy to print and assemble that even Daniel was able to undergo training to help create more arms. The trainees soon printed and fitted two more arms, giving hope that the project would be a long-term success.
Since the Project Daniel team returned to the United States, the trainees have continued working to enhance the lives of those around them. When conditions permit, they have been able to create an average of one prosthesis per week.
The Future of Project Daniel
The team has made great strides since starting the project, but there’s still plenty more work to do.
Volunteer designers continue to improve the wrist, as the tongue and groove joint wears down over time. They are looking at replacing this with a pin format, and Precipart is continuing to lend engineering support in an effort to improve this design.
The “Daniel hand” is on its way to increased functionality, with considerations for a wider range of attachments, such as tools for farm work or hooks to lift buckets. Robotic parts also are being considered for use in areas of the world that have ready access to electricity.
The team hopes to implement all these improvements without raising the cost of materials. As with any medical device design project, whether destined for the operating room or the mountains of South Sudan, we know that we must always strike a balance between utility and the ability to manufacture it effectively and that we need to follow basic DFM principles before production, regardless of the environment.
From the initial maker weekend to the continued optimization of the prostheses, we are thoroughly happy with the project’s steady accomplishments. Open-source blueprints for 3-D-printed prosthetic arms, including the Robohand, readily are available online. Ideally, others will use the designs and ideas to develop similar projects.
“It’s crucial to recognize the importance of leveraging disruptive technologies such as 3-D printing to help advance humanitarian efforts,” said Precipart’s Chairman Edouard Laubscher. “We truly believe in technology’s capacity to make significant and honorable improvements in the world.”
Jeremy Fishlow joined Precipart as a project engineer in January 2012. He has a bachelor of science degree in industrial and systems engineering from Binghamton University in New York, and currently is a quality systems engineer at Precipart.