Industrial Design Language for Baxano

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Message Industrial Design Language Lumbar spinal stenosis, a narrowing of the space for your spinal nerves, causes symptoms such as chronic, debilitating back pain, weakness, tingling or numbness in the lower back and legs. Spinal stenosis is the leading reason for spinal surgery among older adults in the United States. Baxano, Inc. aims to improve the quality of care available to millions of people who cope with the condition. The start-up medical device company developed the iO-Flex® System, an innovative suite of minimally invasive surgical tools, to reduce the destabilizing effects of collateral bone removal, which is an often unavoidable procedure when surgeons use traditional surgical instruments. The iO-Flex System thus holds the potential of improving surgical outcomes and diminishing the need for future surgical procedures. Baxano has initiated two post-approval clinical trials in 2011 to quantify post-surgical patient outcomes associated with the technology. Baxano, through considerable R&D and engineering achievements, in April 2007 received clearance from the FDA to begin patient trials. Initial trials proved successful. “Prior to my surgery, I had physical therapy and was prescribed back exercises. The pain was so severe that I was taking pain medication every four hours just to cope. I woke up in the recovery room and the pain was gone,” says an 83-year-old patient who, as a result of the surgery, has been able to return to her daily routine, including walking a mile a day. As the iO-Flex System moved toward commercial production, Baxano sought to improve its design to address ergonomic needs and to build surgeon confidence in the new system’s safety. Company founder and CEO Jeff Bleich, a former IDEO designer, asked the firm to collaborate with Baxano on a simple industrial design that would emphasize the suite’s cohesiveness, desirability, and usability. “The Probe solution looks very simple and elegant now, but at the time, we wanted the device to be able to be actuated with either one hand or two hands,” says Michael Wallace, senior vice president of R&D and operations at Baxano. “The challenge was being able to design the right interface on the handle and the plunger deployment element so it had the flexibility of accommodating either one-hand or two-hand use without making it subpar for one method.” At the outset of the eight-week project, IDEO’s human factors research and observations also underscored how imperative it is for surgeons to know immediately whether a tool is face up or down and to have precise control of all tools at all times. The team developed an industrial design language that provides visual and tactile indication of each tool’s position with strong color contrasts and textural cues. The design language also calls for comfortable shapes and grips for each tool, which at times may require skillful maneuvering yet forceful action. IDEO and Baxano explored various mechanisms and ergonomic forms through simple prototypes that demonstrated appearance, enabled assessment, and communicated the industrial design intent of the proposed solutions. IDEO created 3-D CAD surface databases of these solutions for Baxano’s engineering group and provided rough preliminary models. Baxano built detailed and functional prototypes, which were tested in a cadaver lab by surgeons on staff and from the field. Final designs were chosen after a review session with Baxano and the consulting physicians. The iO-Flex System relies on thin, flexible instruments to provide precision lumbar decompression from the “inside out.” The intuitive, controlled “over the wire” system is designed to: • Target and decompress bone and soft tissue in the foramen, lateral recess, and central canal; • Preserve the integrity of the facet joint (the small, stabilizing joints on either side of your spine), thus maintaining biomechanical stability and bone for fusion fixation; and • Minimize muscle trauma by allowing decompression of up to four spinal nerves through a single point of access. Decompression using the iO-Flex System may help reduce time in the OR and the length of a patient’s hospital stay. Because the suite of tools allows for a much less invasive procedure and can be used to treat patients with various conditions (central canal stenosis, lateral recess, and foraminal lumbar stenosis), surgical treatment of spinal stenosis may now be offered to more patients than before. The iO-Flex System has opened new market segments for Baxano. “This is the first disposable system for addressing lumbar spinal stenosis,” Wallace says. “But more importantly, there’s no product that goes out the foramen in this manner and allows you to get a full foraminal decompression from the inside-out, to avoid collateral damage to the integrity of the stabilizing facet joint structure.” After the first product in the iO-Flex System received clearance from the FDA in 2007, IDEO was retained to work with the Baxano engineering team to help develop the commercial platform that was successfully launched in late 2009. http://www.ideo.com/work/industrial-design-language

Lumbar spinal stenosis, a narrowing of the space for your spinal nerves, causes symptoms such as chronic, debilitating back pain, weakness, tingling or numbness in the lower back and legs. Spinal stenosis is the leading reason for spinal surgery among older adults in the United States. Baxano, Inc. aims to improve the quality of care available to millions of people who cope with the condition. The start-up medical device company developed the iO-Flex® System, an innovative suite of minimally invasive surgical tools, to reduce the destabilizing effects of collateral bone removal, which is an often unavoidable procedure when surgeons use traditional surgical instruments. The iO-Flex System thus holds the potential of improving surgical outcomes and diminishing the need for future surgical procedures. Baxano has initiated two post-approval clinical trials in 2011 to quantify post-surgical patient outcomes associated with the technology.

Baxano, through considerable R&D and engineering achievements, in April 2007 received clearance from the FDA to begin patient trials. Initial trials proved successful. “Prior to my surgery, I had physical therapy and was prescribed back exercises. The pain was so severe that I was taking pain medication every four hours just to cope. I woke up in the recovery room and the pain was gone,” says an 83-year-old patient who, as a result of the surgery, has been able to return to her daily routine, including walking a mile a day.

As the iO-Flex System moved toward commercial production, Baxano sought to improve its design to address ergonomic needs and to build surgeon confidence in the new system’s safety. Company founder and CEO Jeff Bleich, a former IDEO designer, asked the firm to collaborate with Baxano on a simple industrial design that would emphasize the suite’s cohesiveness, desirability, and usability.

“The Probe solution looks very simple and elegant now, but at the time, we wanted the device to be able to be actuated with either one hand or two hands,” says Michael Wallace, senior vice president of R&D and operations at Baxano. “The challenge was being able to design the right interface on the handle and the plunger deployment element so it had the flexibility of accommodating either one-hand or two-hand use without making it subpar for one method.”

At the outset of the eight-week project, IDEO’s human factors research and observations also underscored how imperative it is for surgeons to know immediately whether a tool is face up or down and to have precise control of all tools at all times. The team developed an industrial design language that provides visual and tactile indication of each tool’s position with strong color contrasts and textural cues. The design language also calls for comfortable shapes and grips for each tool, which at times may require skillful maneuvering yet forceful action.

IDEO and Baxano explored various mechanisms and ergonomic forms through simple prototypes that demonstrated appearance, enabled assessment, and communicated the industrial design intent of the proposed solutions. IDEO created 3-D CAD surface databases of these solutions for Baxano’s engineering group and provided rough preliminary models. Baxano built detailed and functional prototypes, which were tested in a cadaver lab by surgeons on staff and from the field. Final designs were chosen after a review session with Baxano and the consulting physicians.

The iO-Flex System relies on thin, flexible instruments to provide precision lumbar decompression from the “inside out.” The intuitive, controlled “over the wire” system is designed to:
• Target and decompress bone and soft tissue in the foramen, lateral recess, and central canal;
• Preserve the integrity of the facet joint (the small, stabilizing joints on either side of your spine), thus maintaining biomechanical stability and bone for fusion fixation; and
• Minimize muscle trauma by allowing decompression of up to four spinal nerves through a single point of access.

Decompression using the iO-Flex System may help reduce time in the OR and the length of a patient’s hospital stay. Because the suite of tools allows for a much less invasive procedure and can be used to treat patients with various conditions (central canal stenosis, lateral recess, and foraminal lumbar stenosis), surgical treatment of spinal stenosis may now be offered to more patients than before. The iO-Flex System has opened new market segments for Baxano.

“This is the first disposable system for addressing lumbar spinal stenosis,” Wallace says. “But more importantly, there’s no product that goes out the foramen in this manner and allows you to get a full foraminal decompression from the inside-out, to avoid collateral damage to the integrity of the stabilizing facet joint structure.”

After the first product in the iO-Flex System received clearance from the FDA in 2007, IDEO was retained to work with the Baxano engineering team to help develop the commercial platform that was successfully launched in late 2009.