For medical technology companies, pushing technology to new highs and filling voids of unmet needs with major product line advances are exciting, but they can be troubled with a variety of existential challenges, too. Will the invention perform as designed? How do we ensure product safety and efficacy? Is there enough of a market to ensure profitability?
 
For Corindus, a Siemens Healthineers Company, bringing advanced robotic technology to market for certain interventional medical procedures was a journey that included navigating design and development challenges and leveraging on-demand manufacturing to ease supply chain concerns.
 
The Waltham, Mass.-based medical device company was founded in 2002 in Israel by Dr. Rafael Beyar, an interventional cardiologist, and entrepreneur Tal Wenderow. Their product, the CorPath GRX System, applies remote control and robotic technology to coronary interventions.
 
Recently, the company worked with several manufacturers and suppliers—including Protolabs, a digital manufacturing company—to get prototyping and production help for key components of CorPath GRX. Together, the components make a molded, single-use plastic cassette, which attaches to a robotic drive system and articulating arm.

How CorPath GRX Works

CorPath GRX is a robotic system that helps physicians precisely control and move guidewires, guide catheters, stents, and balloon catheters during coronary and peripheral vascular procedures to open blocked arteries. It’s the only FDA-cleared and CE-marked (European certification) system of its kind for use in coronary and vascular procedures.
 
Vascular surgeons use robotic intervention, allowing for sub-millimeter precision and 1-millimeter device positioning. They can safely perform the procedure from within a radiation-shielded interventional workstation, reducing the occupational hazards of working with fluoroscopic X-rays needed for these procedures. When attached to the robotic arm, the cassette pinches, threads and advances guidewires or catheters, based on the surgeon’s commands.
 
Okay, so we geeked out about the device but let’s talk about the “how,” as I am sure many are asking what is the secret formula for success.

High Speeds, Low Volumes, Demand Uncertainties

Early in the cassette’s design and development, leading up to the second-generation model, “one of the biggest challenges was that we had an extremely tight schedule,” said Peter Falb, senior engineering manager at Corindus. Hopes of achieving their goals in the first prototyping round didn’t pan out, which added even greater urgency.
 
At first, Falb and his colleagues considered machining or 3D printing for prototypes. Machining, in this case, was too expensive. 3D printing also proved costly and wouldn’t provide the part quality and precision required.
 
Simultaneously, the company had to consider supply chain issues. Its team was unsure of initial market demand for CorPath GRX. It was a new product, and, indeed, early demand was “inconsistent,” said Jeremy Tarca, director of supply chain for Corindus. “At first, as we commercialized, we needed some flexibility from our supplier base.”
 
As a result, the company sought a manufacturer for most the cassette’s components that could deliver affordable, low-volume parts quickly, while mitigating early inconsistent demand.

On-Demand Manufacturing

The team at Protolabs suggested an on-demand manufacturing approach, using injection molding. It was more affordable at lower volumes than traditional mass production. This limited the financial risk that comes with large capital investments in production steel tooling. It also sped up tooling and parts production, which, in turn, reduced demand uncertainty because parts could be produced as needed.
 
“The ability to make tools [molds] fast, to make parts fast, being able to have support in low-volume [quantities] at a reasonable capital cost—these were the pieces we were looking for,” said Tarca.
 
Speed was paramount. With dozens of parts and in some cases multiple iterations, molds and parts were delivered in “...weeks instead of months…speed, low cost, and quality were the strongest points,” especially as they raced to meet pivotal verification deadlines including FDA evaluations, recalled Gary Kappel, Corindus’ principal mechanical design engineer. This carried over to production at low volumes.
 
Although initial product demand was inconsistent, demand has since stabilized.
 
Mitigating demand uncertainty was a crucial piece of the puzzle, but the flexibility of on-demand production in general allowed Corindus to innovate as the product evolved, said John Kelly, vice president of operations for Corindus.
 
Beyond speed, low volumes, and on-demand flexibility, Corindus engineers took advantage of Protolabs’ overmolding process, and experimented with a variety of in-stock and Corindus-supplied materials.

Cardiology Patients Helped Worldwide

Thanks in part to rapid on-demand manufacturing for critical cassette parts, the CorPath GRX systems are now FDA-cleared and CE-marked for major vascular therapeutic markets and are in use worldwide.
 
Perhaps the most important product outcomes are seen in reduction of treatment times, increased precision during treatment, raised standardization levels, and improved patient outcomes, while creating a safer working environment for healthcare professionals.

Reducing Risk in New Innovation

With innovation comes varying degrees of risk, some planned for, but many are often unwelcomed surprises. We have witnessed what separates the good teams from the greats are those that lean into the challenges during the early development phase through early commercial release. They are focusing on innovating with iterative design, leveraging learnings, and adopting to changing landscapes as quickly as possible.
 
I leave you with one final question to consider—Does your supply chain support uncertainly and flexibility, without sacrificing speed, cost, or quality?