Albert Manero, PhD in mechanical engineering, President of Limbitless Solutions talks about the first 3D printed bionic arm that was made and how the organization has grown, along with its future plans for a clinical trial.
Interview conducted by Ivanhoe Broadcast News in February 2019.
Can you describe your role in the company?
MANERO: As one of the co-founders of Limitless Solutions, I’m working to be able to develop our program here and be able to maximize how much impact we can have for our community.
Talk me through how this started and what was the initial idea.
MANERO: This project really started at the kitchen table. I was really inspired by a radio interview from the gentleman who helped create the first 3D printed mechanical hand. And after hearing that interview, I reached out to them. And I got started with this idea that maybe we could support our community based on what we were learning in our academic classrooms. When a local family reached out to us and said that their son really needed help building a full bionic arm. And the child was quite unique case I put together a team and it has snowballed into all of this.
Tell me about that first arm that was built.
MANERO: The very first arm was done in about eight weeks over a kind of a summer project for Alex. And he was able to receive and use his bionic arm at the end of that experience. And it was such an exciting opportunity to be able to see how it affected him and his family. And that was when we knew we couldn’t stop there. And after the first video aired it went all the way around the world. And we started receiving the same information from so many families saying that their child too needed some of that 3D hope.
Why did you see a need to do this?
MANERO: For me, I was really inspired to be able to put into action some of the engineering that we were learning in the classroom. But Limitless wasn’t really started until it showed up in our inbox. And so when there’s a local family and there’s a real person on the other end of the request, it really drives things a little bit differently. And that was why we just wanted to be able to make a positive impact for them.
How are the arms created?
MANERO: We use something called additive manufacturing or 3D printing to be able to create all of the plastic parts of the bionic arm. So as opposed to carving away at a chunk of metal, we actually design in the computer exactly what we’re looking for that’s tailored to a specific child. And then we hit print. And out will come a full size one of these type of sleeves.
How does it work? How does the child control the arm?
MANERO: The arms are actually controlled when the children flex their muscles. We’re able to read, the muscle generates a voltage. And that voltage we can use in the small computer that’s inside the hand to be able to open close and do different gestures with the fingers.
And is each limb designed specifically for each person?
MANERO: Each limb is really designed specifically for the child that gets to select it. And there’s a core structure and it’s specified for the child’s size. And then the actual artistic sleeves really vary.
Can you tell me why just children right now?
MANERO: Ok. We started working with children who had congenital limb difference because we found that they had the least amount of access available for a type of functional and cosmetic prosthetic device. One of the challenges is that before the ACA being born with a congenital limb difference was just considered a pre-existing condition, which makes things quite different difficult. Coupled with high costs that the insurance companies, weren’t as likely to be going to reimburse a device that has to be replaced potentially every 18 months or as fast as a child can outgrow them. And you can imagine that it was deferred until they were maybe 18 years old normally.
So with congenital limb difference, are they usually born without an arm from the elbow down?
MANERO: It really be anywhere on the arm. There’s like a goldilocks region of where we need a little bit to work with. And then not too much so that we can put all the electronics into the hand.
How many kids so far have received a limb?
MANERO: In our prototyping phase we worked with over 20 families all primarily from the United States. And now we’re really excited to be gearing up for our first pilot clinical trial with Oregon Health and Science University and the University of Central Florida.
Tell me a little bit more about the clinical trial.
MANERO: The clinical trial is an incredible opportunity to be able to provide more arms for children and the latest cutting technology our lab has been able to make. And also be able to quantify its effect and its effectiveness for the children.
So why don’t these kids already have a prosthetic limb?
MANERO: For children getting access to prosthetics is still really challenging. That can be due to high cost, insurance policy or just the fact that a lot of providers don’t value the recurrent limbs available as effective or convenient enough for children. That could be because children outgrow them so quickly. Or that they’re too heavy. Or that they don’t provide the right amount of functionality. Or they break too often. And it takes too long to replace different parts.
What’s the cost to manufacture one of yours?
MANERO: Our hardware costs for our newest arm is just under $1,000. And the entire program to participate in the clinical trial, we’ve been able to fundraise with community and corporate support $10,000 per child to be able to see them through the entire year of the program.
how long does it take to make one?
MANERO: Normally we make all the arms in really big batches to try to be able to be as effective and efficient as possible. But I think it takes about a week from start to finish from being able to hit print, see the print process, the cleaning, the prep, the paint and all the testing in order to get an arm ready to go out the door.
How have these limbs improved the lives of these children?
MANERO: When you see the smile on the child’s face when they realize that this is their arm and then they get to take it home, that really changed everything for us. And that’s why we keep working so hard to be able to make the best arm possible for them and to really fulfill our belief that families shouldn’t be financially burdened because their child was born with a limb difference.
Can you tell me about the video game and how it works?
MANERO: The video game system that Limitless is producing is one of our newest features. One of the challenges that a lot of providers will say is that it’s really hard to teach a child even as young as age 6 to be able to use a complex electro miographically actuated hand, by being able to hide the training regiment inside of a videogame that when they flex their muscles it does different superpowers inside of the game that actually link to what they would be doing with their arm, we’ve been able to kind of hide the vegetables for them so that they’re willing to put in more time to learn. And it’s a lot more fun.
What is the future for this company?
MANERO: The future for Limitless is really just beginning. Our hope is to be able to continue to merge this arts and express expression creativity with the technology and the engineering aspect and then integrate that into the medical environment. The arms are our first device that’s going into the clinical trials. And we were able to show you a little bit about our new wheelchair project. You actually drive a wheelchair with your face muscles. And this could be applicable for ALS or M.S. or a spinal cord injury patients. Really we want to be able to add expression and advance accessibility technology for children and then adults so that we can make a more bright and inclusive future.
Could you tell me about how that works with the wheelchair and driving it with your face muscles?
MANERO: Our wheelchair project or we like to call it Project Xavier works by being able to flex the muscles on your face with two different sensors similarly to how the arms work. In that case and for a lot of people in those demographics they have a hard time using a joystick to control wheelchair. Many of their wheelchairs don’t even have a joystick on the front of the chair because there isn’t an expectation that they’ll be able to control it. By being a little bite down left right. And a combination of those you’re able to drive a wheelchair anywhere you want to go. And for us we find that that brings back a sense of independence and the dignity that comes along with that. And our hope is to be able to use that as a framework for being able to help even more people.
Are there any other projects that you’re working on that you want to talk about?
MANERO: We always have a few projects in the back. But those are the main ones we’re working on right now.
Is there anything that I didn’t ask you that you want people to know?
MANERO: Limitless Solutions is a nonprofit that’s built on community support in an effort to make all this possible. What’s really unique here is that there’s 30 undergraduate students learning the basic research concepts able to power this forward. And we couldn’t do it without them. But they’re not all engineering students. In fact only about a third of them are from the engineering environment. This is really a cross discipline fusion between arts, Fine Arts, Digital Arts, Communications, premed or biological sciences as well as the engineering side.
Why put something to clinical trial? First of all, why is that important?
MANERO: For us being able to learn how well the arms work and how we can make them better is the most important thing. We really want to be able to communicate both to the FDA and to the insurance companies that these arms will be ready for the open market. Our hope is to be able to continue the process where families don’t have to ever be financially burden for one of these arms. And in order to do that, this is the next steps.
It has to be covered by insurance.
MANERO: And FDA approval.
And FDA approved. So how are you technically going about doing that? Have you partnered with hospitals? How many people are you looking for? Just because we have nationwide viewers. So I wanted to get some of that information out.
MANERO: Right. We first partnered with Oregon Health and Science University which is in Portland, Oregon. They’re one of the premier medical institutions on the West Coast. And their primary investigator Dr. Albert Chi is really quarterbacking this effort. They’ve approved the first pilot program which will be our first 20 kids in the program. And they will receive one of the newest bionic arms that we can make. And then we’ll go through an assessment period over the course of a year to able to assess both the quality of life impact as well as the effectiveness of the arm for them.
And to assess that quality of life, how are you measuring that?
MANERO: There’s a variety of survey instruments that we’re using to assess quality of life. And our hope is to that pair that along with their basic prosthetic use cases through their occupational therapists. This is really a national endeavor. And so Oregon is our first host site, in addition to here at the University of Central Florida. And our hope is to be able to add more host sites all over the country so that we can really meet children in their backyard and minimize the travel distance.
Sitting here where you are today, you’re not that many years out of out of college out of your education here, did you ever imagine that this is where you would be?
MANERO: We never dreamed that this would go from the kitchen table to now this entire lab space. And we really believe this is just the beginning. Our goal is to be able to make thousands of these arms a year and in order to do that, we’re going to have to continue to grow. And the clinical trial and getting all that feedback is really just one step on that journey.
Why the prosthetics and why the limitless solutions? Do you have a story in your past where you touched by somebody, do you know someone or was it just a natural outgrowth of what you studied in college?
MANERO: For me, it was really when I got an email from a family and you start to see that demand show up in your inbox, it was something that I just couldn’t walk away from after learning that there was such a need.
END OF INTERVIEW
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