From idea to prototype to final product, getting a new orthotic or prosthetic device to market can be a long and harrowing road fraught with pitfalls. Anywhere along the way, a product can veer off course—or crash and burn completely. Development costs might be too high. The product may not fit an existing L-Code, or the time to get a new L-Code approved might be too long. Or, quite simply, patients may not like it.
While O&P devices are aimed at helping patients, in the end, profitability is a driving issue. The return on investment has to justify the development costs.
"You may get the code and still lose the war from a utilization standpoint," says David McGill, JD, vice president of legal affairs and reimbursement for Össur Americas, Foothill Ranch, California. "It may cost too much, although the technology works and Medicare likes it."
And so, as the saying goes, back to the drawing board.
The O&P EDGE asked several O&P device manufacturers about their product development process, and they agreed that when it comes to bringing a new product to market, treading lightly is the name of the game.* Indeed, most companies have carefully structured processes that have been meticulously developed to help ensure success. Producing a successful O&P product can mean millions of dollars in revenue and, potentially, thousands of happy end users—not to mention the practitioners who serve them. At the same time, killing a product that has all the signs of failure— or at least enough of them—sooner rather than later in the product development cycle can mean millions of dollars saved. Either way, the decision of whether to move forward or scrap a product requires an intuitive, market-savvy mindset balanced with just the right amount of educated foresight.
Michael Golfarb of Vanderbilt University and Reinecke of Freedom Innovations collaborate during a technology transfer meeting. Photographs courtesy of Freedom Innovations.
Where's My L-Code?
Many O&P device manufacturers can attest that the assignment of an L-Code can spell success or failure for a product.
"When you have a new product coming to market, there are two questions to ask," McGill says. "First, is it something that fits entirely within the current code set? If the answer to that is no, it has some unique characteristic, then the second question is how do I define that characteristic, and how do I submit an application to Medicare that is going to generate a new code?"
Since 2006, McGill says there have been more than 90 requests for new L-Codes for lower-limb prosthetics. In that time, the Centers for Medicare & Medicaid Services (CMS) has created only three. Össur has received two of the three.
Slope adaptation demonstrated by Freedom Innovations' powered knee and ankle system.
But the process, he says, is always a concern. That, he believes, may explain a recent trend that some companies are taking, claiming that new products have unique features but skipping the L-Code application process and recommending that practitioners file claims using unlisted procedure codes instead.
"It definitely bears watching, companies going without the code," he says. "I worry this could have significant ramifications long term, particularly to practitioners submitting claims with L-5999 codes [lower extremity prosthesis, not otherwise specified]."
McGill says that in some cases, companies lack confidence in the coding process itself. In other instances, companies fear that even if they get a code, Medicare will rule it "non-covered" or set a Medicare allowable for it that makes it unattractive financially.
Össur, however, has become adept at navigating the L-Code application process.
"We just brought our motor-powered prosthetic knee…to Medicare in the last 12 months and got the code on the first try, which is unusual," McGill says. "Now we are waiting for the right pricing."
Still, he says he understands why manufacturers often focus on creating products that fit existing L-Codes.
"If you have a product that doesn't have any distinct features from a coding standpoint, then obviously you can avoid the process [of new code development], which is time-consuming and demands a lot of company resources to do it effectively," McGill says.
Getting through the Gates
At Freedom Innovations, Irvine, California, the success of a new product depends on "getting through the gates." That is how the company refers to each progressive step in the research and development (R&D) process.
To help facilitate success, technology is carefully studied long before it gets to the company's R&D team, says Steve Reinecke, MSBE, executive vice president of research and development at Freedom.
"Before the product can be handed off to production, our research and development team must take the technology through five gates. The process was developed internally following FDA [U.S. Food and Drug Administration] guidelines to ensure a systematic approach is taken for each and every product launch, whether it's a cosmetic foot shell or a fully powered and intelligently controlled knee and ankle system.
"Each gate," Reinecke continues, "includes a multitude of steps that move the technology closer to realization."
Even if a product makes it through a gate, however, it can still get bumped. That's because at the end of each gate, there is a thorough review process to make sure the product is on course to meet its original goals and specifications.
"If it is not, we decide to either loop back to the beginning of that gate to start again or terminate the project altogether," Reinecke says.
After studying the technology, Freedom analyzes what the market wants. To get through this gate, the idea is to clearly define the concept of the product. The company establishes customer needs through market research and focus groups, and then looks at regulatory and reimbursement issues and sales forecasts and develops cost estimates so the company can estimate a return on investment.
"The management team reviews all of this information to determine if the proposed technology concept is feasible from a technical and business perspective. If it is, we move onto the next phase," Reinecke says.
During this phase, Freedom translates customer needs into a wholly different language—engineering specifications that can be measured. Specifications are measured against functional, performance, and safety requirements according to the intended use of the product, Reinecke says. Those specifications "become the acceptance criteria that must be met or exceeded for the product to be deemed acceptable for launch," he says.
The company's engineering team then develops concept designs, and from those designs, Freedom selects what it calls the "champion concept."
A research prototype of the powered knee and ankle system to be launched by Freedom Innovations.
From there, the champion concept enters the design phase, in which Freedom builds the actual product—including the mechanical design, software, and control systems—so it can be alpha tested. The product is tested in the company's lab and then is road tested by amputees and prosthetists to see if it hits targeted performance. It's also at this stage, Reinecke says, that the company looks for areas where improvements can be made. If improvements are made, the product is put through another round of testing.
When the product has successfully made it through all of these gates, it lands at what Freedom calls the pre-market phase. Here, the final alpha design is refined for beta testing. A larger sample and broader demographic or "real-world test" is used to validate the design.
Exactly how long the testing phase is and how many participants are involved varies depending on the complexity of the technology, Reinecke says. Before a product is deemed satisfactory, the product may face additional refinement and testing before it moves from R&D into the final stage: production.
At this stage, Freedom looks at producing the product on a larger scale and measures how much it will cost for a full market launch. Outside vendors are selected, and regulatory documentation and sales and marketing material are created. The management team then reviews the project before the product is put into production.
Once enough inventory has been manufactured, the product is launched.
"It may be launched globally from the start or released in a controlled manner to different geographic regions such as North America, Europe, Asia, and South America," Reinecke says.
Diversity Drives Development
Össur begins the product development process by working with clinical professionals and meeting with a lot of customers. The product development team analyzes problems using biomechanical principles, and from that it builds a rough prototype, says Magnus Oddsson, new technology search manager at Össur, Reykjavik, Iceland. "Our design group always begins with the same principle," he says. "We start by identifying an unfulfilled clinical need."
Össur's project groups include engineers and people with expertise in medicine, industrial design, graphic design, and machine building. That collection of diverse backgrounds, Oddsson says, "results in the generation of novel ideas and innovative solutions to clinical challenges."
After the concept development phase, Össur smoothes out the wrinkles of its rough prototype into a more functional version. Then the company starts a round of rigorous testing to see if there are any drawbacks to the design.
With its bionic devices, "we have sometimes found ourselves in the situation of having to wait for other industries' technologies to catch up to our vision; for example, finding an optimal set of sensors to support the real-time artificial intelligence capabilities found in our RHEO KNEE and PROPRIO FOOT prostheses," Oddsson says.
These safety and alpha tests may lead to more refinements, Oddsson adds, such as enabling potential customers to choose between the most important among several possible configurations. Beta testing is then used to validate the final design.
Products that have more complex modes of functioning may go through a more extensive verification process and clinical trials to determine how well the product fulfills the need it was designed to address.
Before clinical trials begin, a formal, written test protocol must be approved by an Institutional Review Board to ensure that the results will be objectively evaluated to indicate success or failure.
"Only after a clinical trial successfully verifies that an Össur prosthesis performs its biomechanical function and fulfills a medical need will the technology be released to the market," Oddsson says.
An example of a product that made it successfully through Össur's product development process is its recently released SYMBIONIC LEG.
"The SYMBIONIC LEG is a good example of Össur's innovation process because it demonstrates how existing ideas can be combined in new ways to solve unmet needs," he says. "As developers, we find designing prosthetics to be an inspiring task since the ultimate goal has already been defined. The human body itself is the model to which we aspire."
Garrison Wells is an award-winning freelance writer and author based in Colorado Springs, Colorado. He has written for newspapers and magazines nationwide and authored five books on martial arts. He can be reached at
*Editor's note: The content of this article is for informational purposes only and does not indicate sponsorship on the part of the participating companies or endorsement from The O&P EDGE. Multiple companies were invited to participate in the development of this article. The companies covered responded to our request for information by our copy deadline.
