LIM Innovations has created a modular socket for amputees and may be on its way to improving care around the world. And all it took was collaboration across multiple disciplines, picking a real-world problem and focus on the ultimate user---the amputee.
The Infinite Socket is a good example of how innovation and simplicity and user need should go together. LIM's technology prompts you to wonder why it wasn't done before. The short answer is that companies can and do lose sight of the end user. LIM recently noted that its approach to innovation is User Generated Innovation (UGI), which revolves around "empathetic design and innovation" and responding to the "needs of the users of our products: amputees and prosthetics."
Infinite Socket, which has received press mentions in recent weeks, allows amputees to adjust to respond to daily fluctuations in limb sizes. Limbs swell and can fluctuate 5 percent a day just like your feet swell on a plane. Over time, limbs can fluctuate as much as 10 percent of their volumes. Imagine a scenario where you get fitted for a socket as an amputee and the cast is 2.5 times smaller today than it was six months earlier.
With a modular approach, the Infinite Socket is custom molded, but can be adjusted to accommodate volume changes. That modular approach also speeds up delivery times. It takes 30 days on average to provide a conventional socket and LIM can deliver one in three days.
We caught up with LIM Innovations CEO and co-founder Andrew Pedtke MD to talk innovation and focusing on the customer. Here's a look at the highlights:
The approach: LIM's socket includes a series of disciplines from multiple people. LIM's design theory: Less is more and to keep it simple. The team has a fashion designer, materials engineer and industrial designers. "It's purpose plus technology plus design," said Pedtke. "There's a science and art, but we're doing it because there's an actual need." LIM's approach is also being tried in multiple industries. The trick is to meld different people, skills and philosophies behind one mission.
Design counts: Design is more important for comfort and usability. The big hurdle: Is the socket immediately comfortable over time? "That's more of a design thing than technology or science," said Pedtke. Once the design makes sense engineers can align the physical parameters. While design is very important, there's a chicken and egg to the equation. New materials and patterns help comfort and usability.
The rollout: LIM launched the Infinite Socket in September and has at east six partners signed up and about 20 orders. "We're doing a limited market release and reaching out to providers interested in the technology," said Pedtke. Why limited? Pedtke said that LIM's technology requires training and the company has to teach physicians how to measure and direct an order.
The process: Typically, an above the knee amputee goes to see a doctor, who then purchases feet, knees and a socket component. Generally, these sockets are fabricated. The difference with the Infinite Socket is that it has a series of parts that play different roles and can be adjusted, said Pedtke. The Infinite Socket is more like a sneaker with a sole, fabric and other parts working together for function and comfort. The traditional socket process has more than 17 steps. In the near future, LIM is hoping that clinicians can take a series of measurements and pictures and have the company fabricate something.
What's the cost: The Infinite Socket will be more expensive than the typical version, but falls within the $7,000 to $30,000 range in the market. Pedtke, however, said total cost of ownership is lower for his product. "There's a 30 percent reduction in clinical time and patients can get a socket in weeks instead of months. More patients can go through efficiently," he said.
Starting the company: Pedtke and Garrett Hurley, chief innovation officer, founded the company after bouncing around ideas with each other. Hurley specialized in prosthetics and Pedtke was an orthopedic surgeon. The two co-founders did international trips together and saw how hard access to care and prosthetics were in places like Haiti and Nicaragua. LIM was started with money from friends and family that helped kick off an angel network to fund the company. LIM is backed by 36 high worth individuals and so far has avoided venture capital money.
Role of 3D printing: 3D printing is one component of the socket manufacturing process---notably for prototyping. Pedtke, however, sees 3D printing having a much larger role for braces and casts in the future. LIM does use 3D printers to form custom struts and has invented a method to capture a surface digitally and recreate it.
Focus on the real end user: Pedtke's working theory on prosthetics and medical devices is that they started being designed for clinicians and their teams. The user was in the picture, but products essentially revolved around what the clinician wanted. "As companies built out a large spectrum of products, user needs became diluted as financial factors became more important," said Pedtke. "Massive product lines needed clinicians to capture market share."
The medical device market: "As a surgeon I see so much junk in medical device development," said Pedtke. "I see so much that doesn't have any more medical benefit over existing technology. We don't need more devices, but we need ones that are more effective."
The typical patient: Pedtke said that more than 60 percent of amputees are geriatric with a minority of them active soldiers hurt in combat. The design of the Infinite Socket had to hit that amputee spectrum of patients. "The Infinite Socket is designed to be the everyday socket. It has to be a tight socket that's great for running and then can be adjusted on a plane," said Pedtke. "The goal is to wear it for 24 hours."
What's next? LIM is now setting its sights on products for below the knee amputees. Above the knee socket fittings were a harder problem to solve so LIM started there and worked its way down. "Above the knee amputees are harder to fit because there have fluid and muscle filled thighs," explained Pedtke. Below the knee products will land in 2015 and LIM is developing 2016 sport models for other products. LIM is also plotting a move into braces.