Co-founder and CEO Levin Sliker has commercialized prosthetic fingers and thumbs for a historically neglected market.
Point Designs launched out of technology for a prosthetic finger developed at the University of Colorado Denver.
“We were developing a mechanical, ratcheting prosthetic finger,” says Sliker. “We worked on it for a couple of years in the lab, and got it to the point that we had a lot of stakeholders in the field who wanted what we were developing, so we decided to start a company with the sole purpose of commercializing that one piece of technology.”
One of four founders, Sliker is focused on a market that hasn’t had too many options in the past.
“The partial-hand amputee population has historically been really underserved,” says Sliker, citing an estimated average of 60,000 partial-hand amputations in the U.S. every year. “When you get into the transradial amputee population or even the transhumeral, there are a lot of different options for those folks. When it comes to people with partial hand amputations, there isn’t a whole lot out there.”
Traditionally served by largely immobile prostheses, people missing one or more fingers have sacrificed dexterity and function with most previous products. “Twenty years ago, there weren’t many options besides a silicone opposition post,” says Sliker. “It would be immobile, it would be stuck in whatever position they built it in. There’s some cosmetic benefit, but limited function.”
Subsequent body-driven mechanisms “introduces motion distal to your amputation and dexterity, but there’s definitely some efficiency loss,” says Sliker. “You get a loss in grip force, you need to maintain muscle contraction in order to maintain a grasp.”
And it doesn’t work for every patient: “You have to have part of your finger left. When we came on the market, there really wasn’t an option for people that had truly full-finger amputations right at that first joint, the MCP joint.”
Point Designs’ prosthetic fingers and thumbs improve on this by eschewing the status quo. “We made an intentional decision to make our products non-body-driven,” says Sliker. “They’re what we call passive positional: Once you position them, they lock into place and they stay there, and that’s intentional because it provides a really stable opposition for a remaining thumb or any other intact digits to oppose against.”
“We developed a mechanism that can be operated really intuitively. It’s very intuitive to position the digit both in flexion and also extension. We have this release mechanism where if you fully flex the finger, it pops back into full extension, so you don’t need your opposite hand to position the prosthesis, you can just push it up against an opposing surface — a leg, table — position it, and release it.”
After getting regulatory clearance from the FDA, Point Designs launched its first prosthetic in early 2017. The company now has four products: the original Point Digit; Point Digit Mini; Point Partial; and Point Thumb.
“As part of our regulatory classification, we can only sell to certified prosthetists,” says Sliker. “Our customers serve the amputee, the end user. . . . They build our product into a fully customized prosthesis.”
Most end users’ amputations have been the result of a workplace injury. “Getting that person back to work is the goal,” says Sliker. “That’s something we have found our product is very suitable for, because it’s very robust and durable. A lot of these folks who sustain workplace injuries are working in fairly challenging environments with heavy machinery and things like that, so they need something that can get dirty and wet.”
Manufacturing both in-house and with a network of vendors, Point Designs relies on 3D Systems in Littleton, Colorado, for titanium parts made with additive manufacturing. “They are our main supplier for 3D printing,” says Sliker. “We don’t do any production 3D printing in-house — we’re doing R&D and product development — but for production, we find it a lot easier to work with an outside vendor to manage the production of those parts.”
The prostheses are assembled and tested in-house at the company’s 4,400-square-foot facility in Lafayette. “The average finger has 15 different parts, and I think 13 of those 15 are custom,” says Sliker. “There’s like two off-the-shelf components.”
About 700 people in 12 countries have used Point Designs’ prostheses to date, 1,500 devices in all.
The company’s sole employee when he launched out of his garage in 2017, Sliker says sales grew by 220 percent in 2018 and 50 percent in 2019, necessitating a move from a small space in Louisville to the current facility in Lafayette. Growth has remained strong at 20 to 25 percent in 2020 and 2021. “My goal is to see another 20 percent growth in 2022,” says Sliker.
“I think it’s got some traction,” he adds. “We’ve brought on five additional people this past year, partly to build out our production team, just to give us some more bandwidth there.”
Challenges: Interfacing with insurance providers, as there is no CMS code for a partial-hand prosthetic. “It falls under a miscellaneous code,” says Sliker, noting that more than 90 percent of Point Designs’ end users are reimbursed by their insurance providers. “It’s hardest to get insurance approval when you don’t have a dedicated insurance code. Getting a dedicated insurance code is a long, arduous process, and it involves a lot of entities.”
Opportunities: Three new products are in the works. “We’ve got a modular component for our thumb prostheses,” says Sliker. “It adds two additional degrees of freedom: rotation at the base and abduction and adduction. The purpose is to provide some additional functionality for thumb amputees, and also serve an additional patient population — people with slightly higher thumb amputations.”
The second product will be a new version of the Point Digit. “We’ve redesigned it to simplify it and to bring the cost way down. The intention is to place a cosmetic glover over it. This is probably not going to be a huge seller in the United States. The product is intended for international markets where reimbursement just is not the same as it is in the United States.”
Needs: Sliker says he plans to hire a full-time clinician in 2022 for “technical support and sales and assist with new development of products to bring in a clinical perspective.”
Point Designs also needs more space (or more efficient use of existing space) and equipment to expand in-house manufacturing capabilities. The latter, focused largely on CNC and additive technology, will be funded by a $250,000 Advanced Industries grant awarded by the Colorado Office of Economic Development and International Trade.
“One of the things we’re doing with that grant, we’re insourcing some of our manufacturing capabilities,” says Sliker, noting that it’s tied to potential changes in reimbursement structures if there is a new CMS code. “That’s to help bring down the cost of some future products, so we can position ourselves to reduce our costs if necessary.”