Operation Namaste Making 3D Printed Molds for Prosthetic Aligners in Nepal

Last January, Certified Prosthetist-Orthotist (CPO) Jeff Erenstone, the Chief Technology Officer of Create O&P, decided to leave the company he co-founded in order to continue advancing and improving clinical and prosthetic care in the developing world.

Jeff Erenstone fitting a prosthetic liner on an amputee’s leg

In addition to treating patients in his upstate New York clinics, he has now focused all of his attention on Operation Namaste, the non-profit organization he co-founded that is working to ensure amputees around the world have easy access to comfortable prosthetic care.

According to the organization’s website, it helps “determined people achieve by providing tools and support to Orthotic and Prosthetic practitioners in Nepal and beyond.”

Operation Namaste has worked on several helpful projects, such as hosting a summit on prosthetics and orthotics, setting up Camp Namaste for Nepalese children with limb differences, helping a Paralympic hopeful play basketball, and completing the Nepal Warrior Trek, where a team of amputees and business owners traveled to the country to raise awareness and financial assistance for victims of the 2015 Nepal earthquake.

Its latest project is SILC (silicone interface liner comfort) Solutions, which is a system for fabricating silicone liners locally. In October, Operation Namaste volunteers took a trip to Kathmandu, Nepal to test out the new program, which will work to improve prosthetic care – using 3D printing – in developing countries.

“Part service trip and part trek, this trip featured a team of prosthetists, a physiotherapist, and an amputee peer counselor who toured the beautiful country of Nepal, visiting several prosthetic clinics along the way and putting on an educational summit for Nepali practitioners discussing the latest care techniques,” the website stated about the organization’s Nepal Trek 2019.

Prosthetic liners go between an amputee and their prosthesis in order to increase mobility and comfort…which is great for patients in high-income countries with either medical insurance or the money to pay for them.

SILC Solutions prosthetic liner

Erenstone said, “Without prosthetic liners, amputees would not be summiting the Himalayas, returning to active-duty military service, and competing against able-bodied athletes in Olympic sports.”

Unfortunately, these liners are not readily available, or are too expensive, for most amputees in low-income, developing countries like Nepal.

Demonstration at educational conference in Nepal

Operation Namaste’s new SILC Solutions method uses CAD-designed, 3D printed molds to create standard-sized silicone liners. Compared to typical liners, which can cost upwards of $200, the sustainable ones created by the organization will cost less than $50 to fabricate – making them far more accessible to amputees in developing countries.

Erenstone mixing silicone to make a liner in Nepal

Erenstone has firsthand experience in seeing the positive difference that a quality prosthetic liner can make in the life of an amputee, especially in places like Nepal.

“I’m really excited for this project take off in Nepal, and beyond. Our goal here was to make liners affordable, accessible, and sustainable, and I think we are achieving that,” said Erenstone.

ROMP (Range of Motion Project), a Colorado-based nonprofit organization with dovetailing goals, is partnering with Operation Namaste to help achieve the goal of improving prosthetic care all around the world.

“Gel liners are just not within reach for most people in developing countries,” said Eric Neufeld, the chair of the board at ROMP. “This has been a limiting factor in the quality of care for amputees.”

3D printed liner mold

During Operation Namaste’s recent trip to Nepal, the team of volunteers successfully tested out the new SILC Solutions program, determining that it was possible to use 3D printed molds to make lower cost prosthetics anywhere. The organization plans to finalize its SILC prosthetic liners ahead of another planned trip to Nepal in spring 2020, where volunteers will deliver necessary materials to fabricate the liners and train practitioners on the process.

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[Images: Operation Namaste]

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Bionic Arm Advocate Tilly Lockey Speaks at the SingularityU South Africa Summit

Last week Tilly Lockey went on stage at the Kyalami Grand Prix circuit in Johannesburg, South Africa, during the SingularityU South African (SA) Summit, for a one on one with Benji Rosman, Principal Researcher in the Mobile Intelligent Autonomous Systems group at the Council for Scientific and Industrial Research (CSIR). The no-filter, expert public speaker, activist, and model has been touring the world to talk about her incredible bionic arms. And did we forget to mention she’s only 14 years old? Her triumphant take on life is breathtaking, known for opening up about the illness responsible for the loss of both hands at a very early age, as well as her upbeat and confident attitude. Throughout the last few years, Tilly has been a massive force for children, helping prosthetic companies develop customized products suited for kids. Today she is an ambassador for Open Bionics, a UK-based firm developing low-cost bionic hands, also known as Hero Arms.

Benjamin Rosman and Tilly Lockey at the SingularityU SA Summit (Credit: SingularityU South Africa)

Tilly was one of three speakers of the Summit’s Biotech and Medicine segment, along with Habib Frost, who talked about the future of medicine and technological advancements, and Kim Hulett who discussed designer babies. Showcasing her incredibly sleek bionic arms, Tilly focused on her vision for the human-machine convergence of the future.

According to SingularityU SA, during the segment titled Benjamin Rosman in Conversation with Tilly Lockey: What’s Possible in the Future, the two examined the connection between technology and human beings.

“Think about all the things you do with your hands on a daily basis. These hands help me both physically and mentally,” said Tilly. “All the money used to go to the aesthetics of the hands, how they looked and not how they worked.”

With an estimated five million upper limb amputees globally, companies like Open Bionics are essential to build and develop the next generation of bionic limbs, in what Rosman referred to as “turning disabilities into superpowers.” Technology is not only changing how prosthetics work. Prosthetics can be heavy, which is something to keep in mind when developing bionic arms for kids. Growing up also means that hands need to be recreated and replaced at least yearly. With Open Bionics, things began to change, the company 3D prints the prosthetics from plastic, making them lightweight and more affordable, while the cost lies in the battery and the motors on the inside. A pair of 3D printed bionic arms can often reach around £10,000 (that’s roughly 12,800 dollars), which often means a lot of fundraising is involved.

“Now kids get excited when they see me. My arms look like something out of an action movie, like from Marvel. They give other kids the idea that their disability is their superpower,” suggested Tilly.

Actually, she is not so far off from the cinematic universe. Last January, she received a pair of Alita: Battle Angel bionic arms from director James Cameron. The multi-grip functionality Hero Arms were designed by the team behind the movie, and Cameron invited her to the premiere of the highly awaited sci-fi futuristic action film where she got to show everyone her brand new hands.

The Hero Arm is now available through private prosthetic clinics for people with below-elbow upper limb differences, aged nine and above. They are considered the first medically certified 3D printed bionic arm. They are engineered and manufactured in Bristol, UK, in a lightweight and affordable myoelectric prosthesis, now also available in the US and France for below-elbow amputee adults and children.

Open Bionics ensures that each Hero Arm is custom-built using 3D printing and 3D scanning technologies. They claim the prosthesis is robust, and the socket is comfortable, adjustable and breathable too, which means it’s easy to take on and off. It’s a powered bionic limb controlled by the muscles, with intuitive lifelike precision. Additionally, it consists of a breathable removable socket for enhanced ventilation and easy cleaning, powered by high-performance motors, advanced software and long-lasting batteries. The hand, which comes in three sizes, is the lightest on the market but extremely strong, able to lift up to eight kilograms.

The inspiring Tilly Lockey, who was diagnosed with meningococcal meningitis as a 15-month old baby, lost both of her arms, yet her role as a leader in the development of technology in the field of prosthetics is very important and she has been working with Open Bionics for the past four years, providing input that became fundamental in the right development of bionic limbs. Her presentation draws on her personal experience using two 3D printed, customized arms, and her role as a leader in the development of technology in this field.

Tilly at the SIngularityU South Africa Summit (Image credit: SingularityU South Africa)

Tilly revealed during the presentation that she has added a few personal tweaks to her hands, providing customization (and sometimes crazy feature) feedback, to Open Bionics over the last years. What makes Tilly’s arms different–compared to regular, humanlike prosthetics–is that they have additional modes over and above open and close. All bionic advanced prosthetic arms work differently. What’s more, is that they’re personalized in terms of sensitivity, they work on flexing and releasing muscles.

The teen is very optimistic as to what the company will be able to do in the next five years, perhaps eventually offering features like projectors, a voice assistant, Bluetooth speakers, and even Haptic Touch feedback. Up until now, the company developers have proven that they can create much more than a simple open and close bionic arm, so expectations run high.

Tilly was able to help reimagine what a prosthetic extension could look like, welcoming a future where disabilities don’t hold her back, instead they become “superpowers.” She has a lot of followers and a massive presence among young people, often admitting that she enjoys the questions many kids make about her arms. The young role model suggested that creating new interesting technology is one thing, but it also needs to address gaps in society, moving out of research labs and into everyday lives.

Tilly Lockey at the Alita: Battle Angel premiere wearing her new Hero Arms (Image credit: Open Bionics)

SingularityU SA is the first African Country Partner and seeks to work with established businesses, entrepreneurs, and future innovators to create new opportunities for innovation and impact in the country. The education giant wants to “future proof Africa” by empowering its people to create abundant, sustainable, and holistic ways of living and working.

The World Health Organization states that just one in 10 people with physical disabilities in the developing world have access to technologies that could assist them, and with over ten million amputees around the world, this is certainly an innovation we need to advance. Making prosthetics available quicker, cheaper and better can solve one of Africa and the world’s challenges.

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Creating Prosthetic Limbs With 3D Printing

The tedious process of creating comfortable prosthetic limbs is well-researched, but new technology is always around the corner, and 3D printing is slowly making its way into the field of prosthetics. Traditionally, vacuum forming and cast-making have been used to create prosthetic limbs and sockets, but 3D printing is proving to be a viable alternative. Especially when the task is as complex as fitting a prosthesis to a patient, low-volume manufacturing with high accuracy and customizability is favored. Quite a few companies are finding success with 3D printing components for their prosthetic and bionic limb replacements.

Since prosthetics companies and start-ups design 3D-printable prostheses from scratch, there is a design phase that has to occur before a prosthesis can be tested and medically certified. Like any new product, bionics and prosthetics require iterating through many prototypes. Since 3D printing is accurate, affordable, and able to quickly produce quality parts, it is perfect for rapid prototyping.

Prototyping

Research teams make extensive use of 3D printing when creating prostheses and bionics prototypes. Since bionic limb replacements can be complex devices, many tweaks and adjustments need to be made before a final design is reached.

Some prototypes are made to test functionality, and others are made to judge form and aesthetics. Take a prosthetic hand, for example. A functional prototype might aid in testing the motion of the fingers as they clench, while an aesthetic prototype might be used to visualize the overall shape of the prosthesis. For both of these purposes, 3D printing is the perfect prototyping solution. 3D printing allows design teams and researchers to quickly and efficiently crank out the next iteration of their project, making it easier to move their product into production.

After a base design is reached, a prosthesis still needs to be fitted to every patient individually, and this is when the prosthetic socket is required.

What is a Prosthetic Socket?

Prosthetic sockets connect patients to their prosthesis. Sockets are the interface between the skin of the patient and the rest of the prosthesis, so they must be comfortable for the patient while providing rigidity and support.

Sockets are typically designed by qualified prosthetists. Prosthetists are medical professionals who can design sockets that fit comfortably while meeting the specific needs of each patient. Traditionally, producing a socket begins with a lengthy visit with a prosthetist, where measurements are taken and specific needs are addressed. Then over the course of a few weeks, a test socket is created, the fitting is tested by the patient, and then a permanent socket is created based on the feedback from the user, as well as the observations of the prosthetist.

This production process is shifting toward the use of more advanced technologies, such as 3D scanning, in order to more easily capture the complex shape of a patient’s limb.

Custom Manufacturing

3D printing isn’t just good for creating prototypes. Some bionics companies include 3D printed components in their flagship products. For example, Open Bionics has developed a medically certified bionic arm named the “Hero Arm”.

The Hero Arm is a partially 3D printed bionic arm that is fitted to each patient on an individual basis. It allows users to select from a variety of grip patterns and it works by closing its fingers when it senses muscle contractions in the patient’s residual arm tissue.

Since the Hero Arm has to be custom-fitted to each patient, there are some components that need to be custom-made. One of these components is a flexible, ventilated socket that attaches the Hero Arm to the user’s remaining forearm.

Creating a custom 3D printed socket is achieved with a unique approach. Initially, a cast of the patient’s arm is created by a prosthetist. This cast captures every detail and will fit the patient without being too tight or too loose. This cast is then 3D scanned. The 3D scan is then sent to Open Bionics. Designers at Open Bionics will use the 3D scan and computer-aided design (CAD) software to create a custom socket model for each patient. This model is then 3D printed, and attached to the rest of the arm.

Many patients choose to get unique colors, textures, or even superhero designs on their arms, and this is also easily achieved with the help of 3D printing.

Prosthetics for Infants

Most prosthetic limbs are designed for older children, teens, and adults. For infants though, there are currently very few options. Infants and toddlers grow very rapidly, and they’ll quickly outgrow most prostheses. Many children also reject the use of a prosthetic limb, as they can be uncomfortable and frustrating to use. Children with early prosthetics experience will benefit later on because they will retain muscle function in their residual limb. They’ll also more easily adapt to new prosthetics later in life. As a former psychology teacher, Ben Ryan, the founder of Ambionics, knew all about the importance of early prosthesis training. Ben wanted his child Sol (who unfortunately lost most of his left arm) to be able to grow up using a controllable prosthetic hand.

The Ambionics arm is mostly 3D printed. It uses a unique, human-powered hydraulic mechanism, and it is designed for children who are quickly growing. Using 3D scanning technology and 3D printing, new arm sockets can be created and delivered within just a few weeks. This method is accurate and much faster than traditional methods which typically involve a long visit to the prosthetist and over a month of waiting before getting a socket which might not even fit correctly.

Ambionics (now partnered with Glaze Prosthetics) has the goal of delivering affordable, functional prosthetic hands to children and infants.

Looking to 3D print your medical parts? Shapeways offers a variety of materials that are perfect for both prototyping and end-use medical products.

The post Creating Prosthetic Limbs With 3D Printing appeared first on Shapeways Magazine.

3DPOD Episode 9: 3D Printing Prosthetics, Interview with Scott Summit

On this episode, we interview Scott Summit. Scott is a great guy and also a pioneer in using 3D printing in medicine. Scott is an industrial designer who tells us about his journey from Apple and design agencies into the world of 3D printing. He developed the first 3D printed prosthetics in the world. He also pioneered the idea that you can make prosthetic devices beautiful. He later produced the first 3D printed scoliosis braces and postoperative braces. We had a great chat with Scott who told us about his path and gave some very insightful answers also. With me in Italy, Max having a late night in Hong Kong, Jake (who produces the podcast) in the states, we spoke with Scott who was crisscrossing Amsterdam per bicycle. A great little episode if I do say so myself.

The first podcast on going beyond PLA is here, our interview with Direct Dimensions CEO Michael Raphael is here while our interview with design pioneer Janne is here. Our episode on bioprinting is here3D printing in medicine is here3D printed guns is here. and here is the fourth industrial revolution, all of them are here. You can find them on Spotify here.

Casting New Light on Killer Applications

If there’s one constant throughout my career in both 2D and 3D printing, it’s that the key to growth lies in the ability to uncover and exploit “killer applications.” Nowadays people tend to think of software when they hear that term. They’re so used to thinking about apps on their phones and other devices. For them, a killer app is one that has a billion or more downloads.

But killer applications exist with many different technologies. For example the connected home seems like it will be one of the killer applications for the Internet of Things. People are buying all kinds of devices, from smart kitchen appliances to voice activated speakers and video doorbells, all in an effort to improve life in and around their living space.

While 3D printing is a 30+ year old business, the technology is just now becoming good enough, fast enough and cheap enough for killer applications to percolate. Most people in the industry believe those will evolve in key markets like automotive, aerospace and consumer products, among others. They certainly are moving in that direction, but arguably the industry with the fastest acceleration thus far is medical devices.

There’s plenty of examples out there. The hearing aid industry migrated entirely to additive manufacturing in less than 500 days. If you’re in that business now, parts of your product are most likely 3D printed. Invisible teeth aligners are another example. A scan is taken at the beginning of treatment and an algorithm determines each progression. Molds are then manufactured and the clear plastic aligners are formed around them. Often it can require a dozen or more stages to completely straighten a person’s teeth. With that much customization it’s hard to imagine the product could even exist without 3D scanning and printing technology.

Another application that seems to be booming is the manufacture of custom orthotics and prosthetics. Like hearing aids and invisible aligners, the ability to scan and print based on unique physical requirements creates a competitive advantage that other production methods can’t match. Digital technologies enable mass customization.

But it’s not only a matter of producing a better product. The environmental impact can also be profound.

”iOrthotics produces custom orthotics for the medical industry,” says Founder and General Manager, Dean Hartley. “Subtractive manufacturing is the ‘old school’ method. When orthotics are made that way, approximately 1.4 kilograms of material goes in the waste bin. With additive manufacturing, the parts comes out completely finished, saving a lot of time and skilled labor. But waste is the biggest component. With 3D printing we only have about 30 or 40 grams of waste per pair. In a facility where you’re making 10,000 pairs of orthotics per year, using the traditional method you’d be throwing about 15 tons of wasted plastic into a landfill yearly. With additive, we essentially save all that waste.”

Market Size Matters

In each of those examples, one of the big reasons for success is the size of the market. Approximately 48 million Americans have some degree of hearing loss. That number only increases as our population ages. Another 30 million have dental issues that are severe enough to require some degree of orthodontic intervention. Over the past 50 years having braces have become so common that it’s now estimated that 50% of children end up wearing them before reaching adulthood. The orthotics and prosthetics industry is also far from small, estimated at $8 billion in annual revenue.

Life Enabled’s Prosthetics Being Fit.

But there are other areas of medicine that are ripe for digital disruption. Consider the market for casts and splints. It’s estimated that in the U.S. alone, 6 million people suffer a fracture each year. Other research puts the numbers much higher suggesting that hospitals, emergency rooms and physicians offices actually treat more like 20 to 30 million fractures annually. Of those, more than half are of the upper extremities, including the upper arm, forearm, wrist and fingers. Lower limb fractures including hip, upper leg, lower leg, ankle, foot and toes are reported in slightly lower numbers.  

Of the totals, it’s possible that upper arm, lower arm and wrist fractures (which usually require a splint, cast, or both) happen 10 million times per year. With lower extremities, let’s assume the addressable part of the market (upper leg, lower leg, ankle and foot) happens another 5 million times per year. If so, the total market size is maybe 15 million units annually. If all of that is true, then the market could be worth $3.5 billion or more.

How Casts Are Made Now

There are basically two ways casts are made today. Both involve wrapping the body part in a sleeve and a padded middle payer. Then either plaster or fiberglass is wrapped around, forming an exterior layer. While the materials are cheap and easy to acquire, the traditional approach offers several downsides. In fact, anyone who’s ever had to wear a traditional cast will tell you how much they suck.

Both options are bulky and add significant weight for the wearer, although fiberglass is definitely the lighter of the two options. Neither option is water resistant, making bathing difficult. They also aren’t breathable, so they end up being itchy, stuffy and smelly. The plaster versions can also be difficult to x-ray, creating instances where the cast must be removed and reapplied.

Who Makes It?

In most cases a cast isn’t made by a doctor or nurse. An orthopedic cast technician is the person who actually immobilizes a broken bone by straightening the limb and setting it in a cast, typically under the direction of a doctor or surgeon. The technician also removes the cast once the surgeon has determined the bone has healed completely.

Often hospitals and other medical facilities have a dedicated lab where casts are made and removed.

How Could the Industry be Disrupted?

With the prevalence of digital imaging technology, it’s not that difficult or expensive to get a three dimensional image of the affected area. Just like with invisible aligners or orthotics, once the image is processed it can be used to manufacture a product that’s made specifically for the user.

Advancements in 3D printing make it possible to create a lightweight, plastic cast that provide a better fit with fewer downsides. First, because they mimic the scan they can be more anatomically accurate. But also because they can be made from nylon (or other durable plastics) they can be tough and strong enough to handle the rigors of daily life. They’re also waterproof and more hygenic. They can even be designed with a lattice type structure to reduce weight and greatly enhance breathability, creating a much more comfortable experience for the patient.

Barriers to Entry

One might think speed is the primary barrier to entry. After all, a plaster or fiberglass cast can be made on the spot, with little need for complex machinery or tooling. But that’s not always a challenge. Often, especially after surgery, a patient will be fitted with a splint for anywhere from 24 hours to a week, to allow swelling and other post-operative issues to subside. Whether it’s manufactured onsite or elsewhere, there’s typically time.

Cost is certainly a challenge. While 3D printing has gotten much cheaper in recent years, its difficult to compete with the cost of labor and raw materials involved with traditional casts. Orthopedic technicians make anywhere between $30 to $65,000 and the average cast takes 20 to 45 minutes to fit. In the case of either plaster or fiberglass, material costs are negligible.

Yet still, the average cost of a cast (excluding physician fees) is estimated at somewhere between $225 and $250. At some point 3D printing becomes just as affordable.

The Who and the Where

Like every killer application, it seems the bigger questions are, “who produces the product, and where?” In the orthotics business, companies like iOrthotics have landed on a model where they manufacture from a central facility and then deliver to podiatrists and clinics who resell their products. In the dental field, NivellMedical is following a similar approach towards selling and distributing invisible aligners.


Could the same strategy be used with casts and splints? At least one company thinks so. ActivArmor has developed a process where a scan is taken by one of their orthopedic clinical partners, creating a 3D model of the patient’s limb. They then use it to create a completely individualized and fitted splint based on the physician’s specific positioning and instructions. The ActivArmor™ device is then custom fabricated for the patient and shipped back to the clinic for installation and fitment.

Outsourcing Has Its Advantages

Of course this strategy makes a lot of sense for health care providers who don’t want to invest in the capital equipment and expertise it takes to produce custom casts and splints in house. For dedicated service providers, making these types of products is their core competency. Through decades of experience they’ve learned to optimize their operations and produce the best possible products. They invest in the people, processes and technology needed to manufacture high quality products as efficiently and inexpensively as possible.

But, as I’ve mentioned more than a few times in the past, any time customization is involved, friction is inevitable. Customers have to spend more time trying to articulate their needs and preferences.

Workflow is Key

In any environment where products are personalized a digital workflow is critical. You must give customers the ability to communicate their needs and submit all the information necessary to successfully complete each job. But in the medical industry it takes more than a slick front-end. Data must be locked down to protect patient confidentiality and meet other industry regulations. For this reason, service bureaus selling into that market need to work with software providers who can ensure the security of their processes and data.

Artificial Intelligence

Beyond quoting, order entry and job management, the company that successfully disrupts this market will also need robust software to convert a patient’s digital scan into a fully optimized plastic cast that can be additively manufactured as quickly and inexpensively as possible. I’ve been saying for years that the combination of multiple emerging “platform” technologies could create a lot of interesting new business opportunities. In this example, artificial intelligence and 3D printing could be combined to do a lot of the heavy lifting.

Just Do It

But the good news is, companies are already doing it in plenty of related fields. Whether we’re talking hearing aids, invisible braces, or prosthetics, companies have built business models to that allow them to receive 3D scans and convert them into unique physical products. In some cases they’re fully automated. In others there’s someone behind the curtain pulling levers each time an order is placed. But even if they’re relying on labor today they know they must replace it with technology tomorrow. One is scalable, the other is not.

While splints and casts have the potential to become a “killer application” for 3D printing in the medical industry, they’re certainly not alone in that market or others. For existing companies and startups, the challenge is to find a need and better solve it. Those who do have the potential to own a niche. Those who wait for an application to be developed have little choice but to commoditize it. In a complex environment, that’s too often difficult to achieve and sustain.

John Hauer is the Founder and CEO of Get3DSmart, a consulting practice which helps companies understand and capitalize on BIG opportunities with 3D printing.

John’s original content has been featured on Forbes, TechCrunch, Futurism, QZ.com, and 3DPrint.com among others. Follow him on Twitter at @Get3DJohn

Amin Hasani’s Blue Heart Hero Makes Custom 3D Printed Assistive Devices for Amputees

Amin Hasani is the designer behind the Havenlabs utility band. Havenlabs is a nonprofit that aims to use 3D printing to aid veterans. Designer Amin now wants to take a broader approach and use his skill to aid amputees of all kinds through a commercial company Blue Heart Hero. With Blue Heart Heroes he hopes to work with the amputees themselves to develop the perfect prosthetic and assistive devices for them, their lives and their pastimes.
3D printing excels in creating specific solutions for specific problems at low cost. If you need a unique geometry, texture or functionality quickly then 3D printing is an almost unbeatable technology. Especially in polymers, we can see that in a day one can print an assistive device for a few dollars. Assistive devices need to be tough, reliable and dimensionally accurate. Creating these kinds of parts is well within the performance envelope of quotidian materials such as PLA and the everyday desktop printers that you have at home. Even a relatively simple device, tweaked well could make something like this.
The medical world has through barriers to entry and institutionalization managed to insulate itself from design and new innovative solutions. Partially this is very understandable and good we want a heavy regulatory touch and focus on safety on those products that are used in a medical context. However, this means that we get safe but one size fits all kinds of boring “medi-gray” solutions. For people who have a unique medical challenge the established system often can not provide for them. This is why 3D printing has taken such flight in assistive devices. This area often creates unique problems that require one-off solutions such as a CMU making a unique device for a Cello player or this Russian amputee who required a device to assist his freediving record attempts. Other examples include a wireless switch, an adaptable button, and a wheelchair joystick, all by assistive collective Pôle-Ergo. We even made an article on top ten 3D printed assistive devices for the disabled. In future many more medical cases and unique problems will find 3D printed solutions. Especially interesting will be the development of braces, splints, postoperative braces and to see how this percolates from richer countries to mid-tier and developing ones.

Amin Hasani now wants to make open source assistive designs for those who need them. His first customers include “a world traveler and photographer. He is publishing a book, with photos of the difficulties that amputees have around the globe. I am designing him some 3D printable attachments for his camera” Amin tells us. He aims to make custom solutions for peoples singular problems but at the same time share these designs so that many more could benefit for them. In this way, his commercial business will have positive externalities.
He mentions to 3DPrint.com that, “We don’t accept donations, we only accept funding for projects”,  “this way designers are funded to achieve better results.” What’s more, he hopes to inspire teachers to let their students take money in order to fulfill design requests. We often see things like assistive devices as either charity, something for the government to do or the realm of large faceless medical companies. By engaging the profit motive and making learning very hands-on Amin is doing something different. Ideally, amputees will become very discerning and demanding because they have to pay while students will excel because they are doing something worthwhile that pays. It may seem that a charitable solution to the same problem could be cuddlier. For some, it may also feel wrong to charge for this. At the same time, there are a lot of charities that are self-supporting bureaucracies that are inefficient and excel only in putting out ads that make us feel bad.

Why do you do this?

My mission is to identify most needed subjects and share it with colleges and have them fund their students to solve those problems. Allowing amputees to purchase designs online was a great decision because they want to be treated normally as opposed to receiving prosthetics for free as charity.

Some amputees don’t know for example they can play guitar… if they request on the website, some engineer can design them the right attachment! We’re giving amputees a chance to do anything they thought they could not do! I believe I can affect many lives world wide by giving them the opportunities they haven’t had.

What progress have you made?

So far I have designed an attachment that can apply to any kind of partial arm single amputee. This attachment is open-source, meaning that any engineer or designer can design a new attachment and upload on the website to share. I am currently working on another 3D printable assistive device that is designed for double amputees with both partial arms. To allow them to put on different attachments without another’s help. It is a very basic mechanical snapping feature. Right now I am mostly trying to invite more engineers and designers to the community and link with organizations who support amputees.

What’s holding you back?

I am a full-time H1B employee, I cannot quit my job to fully focus on this. And I haven’t discussed fund raising with any venture capital. My focus is to gather more designs and contact communities who are support amputees, to collect more requests from amputees.

What printers and material do you use?

I have a Creality Cr-10, I mostly use PLA. I am trying to save some money to buy SLA printer and print standard resin, rough, durable and flexible. I have 3 3D printers at work, I am the head designer of a company in Long Island. After I introduced 3D printing to this company, we slashed our prices by 30% and saved thousands of dollars in prototyping our new products.

Custom 3D Printed Ocular Prosthetics: Through A Semi Automated Fabrication Process

In a previous post we mentioned the work of a team from the Severance Hospital South Korea on ocular prostheses. Led by Professor Yoon Jin-sook and working together with artificial eye maker Baik Seung-woon, the team was able to create an artificial eye using 3D printing technology. Recently the study of the project has been published and it explains in detail how they did it, that is the reason for this post.

The loss of an eye can have several physical and psychological consequences for people. It reduces by half the ability to see and also alters considerably the appearance of the person. Nowadays restoring the sight from a lost eye is not possible, but a prosthetic eye can improve the aspect of the person. Cosmetic rehabilitation using custom-made prosthetic devices in the form of ocular prostheses helps upgrade an individuals quality of life.

Professor Yoon said,

“Our team plans provide top-notch public health services through high-quality artificial eyes and a network that can increase patient access.”

Picture of the process from getting the mold to 3D printed eye

3D model of impression mould of patient’s anophthalmic socket and 3D printed output

The first step to create a 3D printed custom eyeball to obtain an impression of the target patient’s eye socket to determine the shape and size of the prosthesis. Once the mold is taken, it is necessary to create a high-resolution image of the model and digitally correct the file.

Directly from the abstract:

“In this study, we used a light intensity 3D scanner (Cara Scan 3.2, Kulzer Inc., Germany) that reflects the laser beam from the surface of an object to obtain 3D model data.

“The resultant image can include noise and artifacts, which inevitably had to be removed to produce the 3D model. This was achieved using the graphic editing software ZBrush 4R7 (Pixologic Inc., Los Angeles, CA, USA) to remove the internal and external noise of twisted meshes and to correct artifacts using the healing wizard function. Moreover, the software was used to smoothen the surface of the impression model.”

Picture of a DS131 3D printer

Carima DS131

Once the STL file is ready, it is possible to 3D print it.The polymer used for the Severance team is a biocompatible photopolymer resin (FotoTec DLP.A, Dreve Inc.) as the base material.

After evaluating the cytotoxicity of the material, the cytotoxicity of the final product was assessed in accordance with the ISO 10993-5 recommendations.

The 3D printer used by the Korean team is a Carima DS131. It is a digital light processing (DLP) 3D printer with 50-μm resolution in the X–Y plane. The Z-axis, that is, the layer thickness, can be set in 25-μm increments.  It is a high-resolution 3D printer usually used for dental solutions.

To create a sense of realness, the sublimation transfer technique was used to print the image of the iris and blood vessels on the 3D-printed ocular prosthesis. For this technique, the desired pattern was printed with biocompatible ink on transfer paper. Once ready, the output of the ocular prosthesis is printed with a dye-sublimation transfer system.

Picture of the process of printing iris and blood vessels

Printing iris and blood vessels onto printed ocular prosthesis (a) The contralateral normal eye was photographed using a slit lamp. (b) Image of contralateral normal eye modified for printing. (c) Image of iris and blood vessels transferred to 3D printed ocular prosthesis.

Finally, the ocularist applied a transparent to the 3D printed ocular prosthesis to complete the fabrication process.

The amount of time that traditional processes need to make an eyeball is around 10 hours compared to the 8 hours that the 3D printing manufacturing process takes. It is not a large difference if we look at the numbers. However, it has to be considered that with 3D printing the amount of manual labor is reduced to 3 hours from ten. 

The proposed method reduces the time and skill required to fabricate a customized ocular prosthesis, and is expected to provide patients with easier access to quality custom-made ocular prostheses. Now, the craft of making eyeballs is considered an artistic work that consumes a large amount of time in manual labor and needs highly skilled professionals. Semi-automated fabrication of prosthetic eyes reduces considerably the amount of manual labor and the need for technical expertise. Although, this technique requires skills as well in software for 3D graphics and modeling, which were not previously required. Taking all into consideration, 3D printing should make ocular protheses much more affordable and available.

Picture of shinny eye

Final output of the customized ocular prosthesis fabricated using 3D printing and surface printing.

Also, the use of 3D printing for this purpose can be considered an improvement when it is necessary for the replacement of the eyeball when the piece has been lost or damage. Because it is possible to store the data of the patient, it is not necessary to repeat the whole process, it can just be printed. Although it is important to mention, that the space of the eye socket may change through life due to age or weight changes. And one of the great features of existing eyeballs prosthetics, whether are made of glass or synthetic materials, is the capability of being reshaped if necessary to fit the patient’s evolving needs.

So, all together, the advantage of using 3D printing manufacturing methods for this purpose is the shortening of time and skills necessary to make a custom eyeball prosthesis. It would reduce the waiting periods to get a prosthetic eye and will make it cheaper by reducing the time of skilled professionals. It is exciting to think what it could bring for developing countries where there are not many artisans specialized in eye making.

So far the study has been focused on the development of the 3D printed prototype and manufacturing processes. It didn’t include human trials, therefore, the cosmetic outcome and the patient’s comfort when wearing the fabricated ocular prosthesis has not been measured. The next step to prove the worth of the findings would be to conduct clinical trials for the proposed method. Hopefully, in the near future, we can bring you positive outcomes of such trials.

[Source: “Semi-automated fabrication of customized ocular prosthesis with three–dimensional printing and sublimation transfer printing technology“]

Twikit’s Twikbot Brings Mass Customization Using 3D Printing To Prosthetics and Orthotics

Twikit is a Belgium based startup that makes mass customization software. The firm created parametric software that can be used to, within well-defined parameters, make unique 3D printed products. For BMW, for example, the company created a tool that would let Mini owners customize polymer car parts to their liking. Mini owners can now get 3D printed customized outside panels with their own text or parts that let their LED lamps spell out their names. By letting a person customize something, ensuring that this can be visualized in the browser and then also actually be a file that can be manufactured Twikit ties unique inputs to makable things. Twikit’s software takes the potential of 3D printing to make unique things and turns it into something that many can use (within limits).

Twikit has just released its Twikbot software platform for Prosthetics and Orthotics. Now Twikit can not only be used for customized car parts or parts of consumer electronics but also for medical applications. With the Twikbot platform, companies can now create workflows where unique scan data gets turned into a 3D printable file. Defined limits of the 3D printing process, essential structural elements, and part constraints can be defined in advance. Once this has occurred, and if the 3D scan is good, the path from 3D scan to 3D file for printing is automatic. We’ve seen a lot of movement on implementing more and more prosthetics and orthotics in 3D printing. These are increasingly being made using FDM (FFF), SLS and MFJ technologies but so far there hasn’t been an automated customization package that could mass customize 3D prints for all platforms. We interviewed Twikit’s CTO Olivier den Deken about a new development that the firm has just released.

What does Twikit do for orthotics & prosthetics?

3D printing is a cornerstone technology in the digital transformation of the orthotics and prosthetics market. It also enables to design better products with a perfect fit. In order to obtain a working flow, different dots need to be connected. In comes Twikit.

Twikbot engine takes care of product customization starting from a 3D scan, creating the perfect shape and fit. The cloud software automates your design process and delivers a unique production-ready file. Additionally, Twikit provides design engineering and integration services to implement the technology.

How does it work?

It is important to note that this solution has been developed for Certified Prosthetists Orthotists. CPO’s can create a custom 3D product by using the easy-to-use interface. After choosing the product type, they are able to upload a 3D scan. The CPO sets all required parameters (e.g. adaptations of the 3D scan, measurements) and corresponding points on the scan. Based on this information, the product template (e.g. a knee brace) is automatically reshaped to fit the patients scan.

Finally, the product (e.g. the knee brace) can be finetuned with aesthetical options such as patterns and color.

The CPO can review and order when she is ready. The application runs in the cloud for full scalability and is easily accessible on all devices (including tablets).The Twikbot platform will now create a production-ready-file in the cloud. The production files can be directly connected with the Order Services Module which is used to distribute the parts and parameters to the internal or external manufacturer.

How does it save money?

With the solution in place, either the manual production flow and/or the flow to manually design each unique digital model becomes obsolete. This saves many hours of manual labor and it eliminates errors. Through further automation of the order process, files can be processed quicker resulting in a scalable solution for the offerings of Orthotic and Prosthetic brands.

What will happen with the medical scan data of my patient?

The production file based on the medical scan is assigned with an encrypted code for further tracking and handling. No personal data is stored or spread unless consented to by the patient.

What is the output in terms of files?

Twikbot exports production ready files for additive manufacturing (.stl) or vector files (cutting) depending on the product.

What 3D scan data can I input? and how?

3D scan data can be obtained from 3rd parties or from handheld tablet compatible scanners like Occipital’s Structure Sensor. The 3D scan can be uploaded in the applications where further operations like scan checkup and manipulation can be done.

 

 

Interview with Prosthetist and Orthotist Brent Wright of LifeEnabled on 3D Printing Prosthetics

Amidst the hubble and bubble of optimism, money and growth, there are also people doing good things with 3D printing. Open source prosthetics are one of the most exciting areas of 3D printing. Here is an area where widely available desktop printers and industrial systems can be used to make patient-specific prostheses, braces, and medical assistive devices. These can also be made on location and very cost-effectively. 3D printing has the potential to completely transform the production and distribution of these devices. The idea is great but what is the reality like in the field? In order for that to happen a few talented individuals will have to be the tip of the spear and actually implement these technologies. One person who is pushing inexpensive 3D printed prosthetics is the prosthetist and orthotist Brent Wright. He is bringing the industry knowledge and training that he has to 3D printing and implement it in technology and capital deprived areas worldwide. Brent founded LifeEnabled a nonprofit that provides prosthetics to people worldwide. Brent also works for EastPoint Prosthetics and Orthotics where he honed his craft. Brent and LifeEnabled are an inspiration and you should help them push the envelope for helping.
What is LifeNabled?
“LifeNabled is a non-profit organization that specializes in creating high quality, low cost, durable, and new prostheses for the developing world.  We believe that everyone missing a limb deserves to have mobility and access of a prosthesis.”
Why should I work with you?
“If you love people and like to see individuals that otherwise would not be able to walk get a prosthesis there is a place for you supporting LifeNabled.”
What kind of companies are you looking to partner with?
We take our partnerships very seriously and they come from a diverse background.  It truly takes all types of people and companies to make LifeNabled successful.   For example we have a partner that does baseball training and loves what we do and gives LifeNabled exposure to their clients.  We have a company that has convenience stores that provide exposure at the stores as well as access to business consulting via the CEO.  We have another company that works with donors if they want to donate stock to us. None of these companies have experience in prosthetics but they believe in our mission.”
What does a prosthetist do?
“I always like to break down prosthetics and orthotics in a word picture.  Most people have seen the classic movie Forest Gump.  Forest Gump wore orthoses and Captain Dan wore prosthetics.
An orthotist works with someone with all their extremities to provide correction or support to specific part of the body.
A prosthetist works with a person that is missing a part of their body.”
When did you start using 3D printing and why is it so relevant for you??
“I started printing in 2016. 3D printing allows me to reach people in the developing world with a prosthesis without the need to build a large and expensive fabrication facility.”
What is holding 3D printing back in your area?
“Currently, it is materials.  Many of the materials are just not strong enough compared to traditional fabrication and when you make them strong enough they are quite heavy.  I see a lot of promise though with filament manufacturers jumping into extruding PolyPropylene and other innovative new materials.”
What 3D printers do you use?
“Depends on the application.  I have a Raise 3D printer that is highly modified so I can print lots of materials.  I use Filament Innovations machines to print large nozzle and large volume objects.  I use a Lulzbot Taz 6 and Mini’s for detail parts with more resolution.  Lastly, I use my Blackbelt machine for interesting shaped prostheses that traditionally would require a lot of support.”
What materials do you use?
“I use a little bit of everything but have settled on CF PETG and PETG for most applications. I see a lot of promise for the Polypropylene though.”
How could 3D printing materials be improved for you?
“I really think it is a combination of materials and machine.  The closer we get in strength to traditional lamination the better off we are.  A lot more work needs to be completed on how the environment plays a roll in getting a good print.”
What do you think of FDM vis a vis MFJ and SLS?
“I love MJF I am not familiar with SLS but know that the cooling time is an issue with both however MJF allows you to cool parts in another chamber.  The parts are amazing and strong and the resolution is incredible.  The parts are definitely more expensive but the price is coming down.  FDM is still the most cost effective way to print but in my opinion, the reports generated on the MJF machines about how the printer performed and the consistency makes the most sense when we decide to make an end use product.”
Do you think that 3D printing will fundamentally change your field?
“Fundamentals are fundamentals, I think prosthetists are the best in the world creating one of cost effective prototypes.  The rules for comfort and alignment do not change but materials and fabrication styles change. I am looking forward to getting soft materials and hard materials in the same prosthesis. I am looking forward to mass customization that is cost effective.”
Will patient specific braces and orthoses be the norm?
“On upper extremity orthoses, it will be the norm.  Lower extremity orthoses will become more mainstream as we gather data on durability.”
How cost effective is using 3D printing compared to traditional methods?
“For prosthetics, the economics almost work compared to traditional fabrication.  On the orthotic side, it is less work to print the items however the costs are higher when compared to the price we get paid for a given device.  I foresee those costs getting better over time though.”

 3D Printed Prosthetics To Offer Hope to People in War-Ravaged Countries

A shelf with test and rejected hands at the Jordanian hospital.

Approximately 86,000 Syrians have lost limbs during the last seven years of war in their country, according to the World Health Organization and Handicap International (now known as Humanity & Inclusion). In Jordan, which borders on Syria, the Médecins Sans Frontières (MSF) Foundation is working to bring 3D printed prosthetics to as many of those people as possible, as well as to patients from Jordan, Yemen and Iraq. Some of these patients have congenital conditions, but many of them have been wounded in the war.

The MSF Foundation initiated the program in 2016, and this year has been focusing more on field testing the devices in the real world.

“We see it as our duty to bring scientific evidence to what remains until now, a feeling,” said Director Clara Nordon.

The $150,000-per-year program is working to provide better alternatives to conventional prosthetics, which can be clunky, heavy, and uncomfortable. 3D printing offers more lightweight, well-fitted devices that can be easily upgraded or replaced as children grow, and can be made in appealing colors or patterns. The program is also seeing success at using 3D printing to make face masks to help burn patients heal.

The ability to easily create perfectly customized prosthetics that fit each individual patient is an often-touted benefit of 3D printing, but according to Nordon, more credit should be given to 3D scanning technology.

“Now what is really a breakthrough is not so much the printer but rather the scanner!” she said. “It opens hundreds of leads to optimise tele-expertise, remote advice, and actual remote designing.”

Imagine that – professionals being able to design and create custom prosthetics for patients without ever actually having to be in the same room – or country – as them. This enables experts from across the world to weigh in on treatment – which is not to take anything away from the dedicated individuals actually present in clinics like the one in Jordan, but allows them to take advantage of a full range of expertise that may not be available in person.

The MSF Foundation is not the only organization hard at work to provide prosthetics to people affected by war. The International Committee of the Red Cross (ICRC) provided prosthetics to more than 22,000 conflict-affected people in 2016, and has been developing and field testing 3D printed prosthetic components. ICRC’s Innovation Lead, Nan Buzard, cautions against getting over-excited about the technology, however. There’s certainly plenty to be excited about, but many people don’t realize how much regulation is required before 3D printed prosthetics can be more widely implemented. Many countries require assistive medical devices to pass international certification.

A Syrian man is fitted for a prosthetic arm.

In addition, most 3D printed prosthetics have been hands and arms; while plenty of people benefit from upper-limb prosthetics, there are still many, many others who have lost legs or feet. In fact, 95 percent of ICRC’s amputee patients have lost all or part of their lower limbs. Lower limb prosthetics must be stronger than upper limb prosthetics, as they must bear the weight of the body, and thus are more difficult to create using 3D printing. 3D printing materials are evolving and becoming stronger, making 3D printed lower limb prosthetics more feasible, but developing them is still much more challenging than creating 3D printed hands and arms.

Occupational therapist Noor al-Khatib teaches a patient how to tie his shoelaces with only one hand.

Handicap International has tested 3D printed sockets on patients with below-the-knee amputations in Madagascar, Syria, and Togo. Costs were higher than conventional prosthetic methods, although the MSF Foundation has reported deep savings on 3D printed prosthetics. Feedback from patients was positive, however, and according to Handicap International, the sockets met structural and medical requirements. Several issues still need to be evaluated, the organization states, including a review of technical training needs; cost of raw materials and workshop space; costs of scanners and printers; and speed and effectiveness of fittings.

For all of the issues that still need to be addressed, though, there’s no denying the effect that 3D printed prosthetics have had on people in need. Violence across Syria and other countries continues to take lives and severely impact others, but losing one or more limbs, while life-changing, doesn’t need to be life-ruining.

Discuss this and other 3D printing topics at 3DPrintBoard.com or share your thoughts below. 

[Source: IRIN/Images: Ben Parker]