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Brace Yourself

Tue, 02/18/2014 - 2:12pm
David Mantey, Editor-in-Chief, PD&D

The T Scope features a telescoping design that enables a fast, universal fit. (Credit: Breg)Breg attempts to shake up hip brace design by engineering a post-operative rehab product that patients actually wear. This article looks at the development process with a specific focus on each significant area, including materials, collaboration, failure points, software, supply chain, and the final product success.

With an estimated 70,000 procedures performed each year in the United States, hip arthroscopy proves to be one of the fastest growing surgical procedures. The procedure is meant to give doctors a clear view of the inside of the hip joint by inserting an arthroscope into the hip and snapping pictures with the small camera along the way. The surgeon then uses these images to guide miniature surgical instruments. The mend after the procedure can take anywhere from two to 12 weeks, during which time the patient requires post-operative hip rehabilitation as well as a hip brace to provide additional support, protection, and—in an ideal world—comfort. Enter Breg, a manufacturer of products that have helped advance orthopedic patient care, and the company's latest design, the T Scope Hip Brace.

Founded in 1989, the Carlsbad, CA-based company's initial success came in the form of motorized cold therapy. It has since added a focus on non-operative sports medicine products—essentially, the company provides bracing supports from head to toe. The new T Scope Hip Brace is the company's most recent design win.

According to Matt Hollister, product development engineer at Breg, the T Scope was born out of an advisory board made up of hip doctors who were invited into the Breg offices for a panel review of the current state of the medical device industry. After all, what better way to take the pulse of the industry than to bring the heartbeat in for a brainstorm session?

The advisory board concluded that the time was right for a new brace that not only met the true needs of the patient, but the needs of the physicians as well.

"We were engaging with the doctors in several different areas of their business and practice," recalls Hollister. "The T Scope grew organically through the conversations. I don't think that there was the mindset of developing a brace at the very beginning, it just evolved."

Breg consistently tries to identify doctors' (its customers') needs. What is missing from their practice? What do doctors need for better patient care? "We seek out industry experts and use our own internal expertise to develop products that will meet their needs," adds R.J. Smith, senior product manager. 

A patented, range of motion hinge provides quick-adjusting stops. (Credit: Breg)Before the T Scope, similar hip brace products existed in the marketplace, but the decision to create a new design was rooted in an age-old challenge associated with all medical braces: comfort. "In a patient's mind, braces tend to be big, bulky, heavy, and uncomfortable—particularly when you're talking about a hip brace," Smith says. To support the hip joint, the brace not only impacts the legs and lower extremities, but also the torso. "We needed to work around patient comfort, ease of use, how patients apply it, and overall performance. Did [existing] braces work as well as they could have?"

Material Selection Is Comfort
In an effort to meet the high quality standards that the team set for itself, they turned to a number of different materials and manufacturing processes to ensure that the T Scope was comfortable, easy to use, and functional. The company not only reached out to its suppliers, but utilized various connections in other industries to see where the technology was moving. Breg opened its doors to industry experts to help develop the product and test the materials, ensuring that they met the specifications that the company laid out in the beginning of the development process.

"We have a supply chain that our engineering team works with closely. We've built up a list of the ‘good' suppliers that we trust to bring these kinds of products," Hollister says. "We start with them and, if we have needs that can't be met, we start going to trade shows, or reach out to our contacts in other industries to find suppliers that can meet our needs."

A wide array of materials were used in the design:

  • Injection Molded Plastic Parts: According to Hollister, the engineers opted for a more engineered-style plastic rather than a commodities-style plastic, because of spec requirements, strength, and robustness.
  • Loop Materials: The brace has a lot of fabrics in its design, particularly loop materials. Breg worked with the companies in the industry that are at the forefront of hook-and-loop combinations, cycle testing, and use-over-time.
  • Foams: The design incorporates many foams, so Breg worked with market leaders in foam processing and development to make sure that the materials met comfort and functionality requirements.
  • Aluminum: For the aluminum parts, the team went with an aircraft-grade, 6061 heat-treated aluminum.

A unique waist compression lacing system gives patients an intimate fit as well as additional back support. (Credit: Breg)According to Hollister, the Breg culture is different when it comes to the relationships between the product development teams. "The engineering team is constantly meeting with our supply chain teams, trying to build those relationships further so that it doesn't feel like it's a church and state separation,'' he says. "We understand that you can't get to that end goal without both [engineering and supply chain] driving in the same direction. These relationships get us there faster."

The tight bond between teams begins with the project kickoff, during which the company sets up detailed expectations for the project in terms of financial results, the overall deliverables, supply chain operations, quality, marketing, and engineering. "We have this meeting upfront to make sure everyone is aligned," adds Smith.

Common Failure Points
Common failure points on previous product iterations hark back to Breg's core focus: comfort, ease-of-use, and functionality. Previous generations had rigid components that were not designed to fit the anatomy and the braces often neglected to have adequate padding.

Former products also lacked the micro-adjustability. The braces were designed to fit an array of people, which affects the comfort and function. "If you have a brace that is so high-profile, you're trying to capture too many anatomies under one product, and it's not necessarily designed with the human body in mind," Hollister says. If the patient refuses to wear the brace, its overall effectiveness is non-existent. After all, what good is a brace that collects dust on a shelf?

The T Scope features Breg's telescoping design that enables a fast, universal fit. The telescoping bars also limit hip abduction and adductions, and the semi-rigid cuffs help maintain control of the femur. A patented, range-of-motion hinge provides quick-adjusting stops and it also features a "Quick Lock" to lock out brace positions with the push of a button. A unique waist compression lacing system gives patients an easy "one-handed pull" for an intimate fit as well as additional back support, and extra padding throughout the brace provides additional comfort.

Once Breg arrived at the prototype stage, multiple staff members wore the brace to get a feel for it in the field. "I was in the brace at least once a day," says Hollister. "I slept in it quite a few times, wearing it under and over clothes, as well as the little nuances that patients might have." Those nuances included using crutches while wearing the brace. "We thought we had a great design, so we went out into the field to a doctor's physical therapy unit and saw a patient in a brace, using crutches. Up until that point, it wasn't something that we had even considered." As a result, the team added cushioned hand protection for people using crutches. It's a subtle, but necessary tweak that helps keep that brace on the patient's body.

The engineering team also worked closely with an in-house industrial designer to ensure that they weren't developing a functional, comfortable eyesore. "The industrial designer worked throughout the project to make sure that it looked like a product that people would actually like to wear," Hollister says. "The engineering team worked with him to make sure that the aesthetics and functions went hand-in-hand."

Stresses & Strains
Since Breg began work on the T Scope in 2012, the team has primarily used Solidworks as its CAD software. The industrial designer incorporated work in Adobe Illustrator, but the bulk was executed in Solidworks, particularly with the software's finite element analysis (FEA) tool. According to Hollister, he used FEA to put stresses and strains on the parts in an attempt to test as much in the computer environment as possible.

As they moved into tooling for the injection molded components, the team turned to Solidworks Plastics to determine the flow of the plastic in the tool and make sure that quality parts were coming out of the tool. From start to finish, including the core team members and those on the fringe, about 20 people had input along the way, so the staff also used a Solidworks product data management (PDM) package to keep control of the model files.

Until now, a better hip brace didn't exist because previous challenges were deemed insurmountable. With increased comfort, as well as micro-adjustability to customize the fit to each individual patient, the T Scope is designed to stay on the patient, and off of their floor.

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