Product Development Technologies Contributes to the Creation of a Revolutionary Product for Dysphagia Sufferers

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The swallow-enhancement device aims to improve quality of life for the millions of people suffering from difficulty or discomfort in swallowing.

“Of all the medical devices we’ve worked on, none has had such an opportunity for immediate and direct impact on patients’ lives. Throughout the project, we understood that our work would become a permanent addition to these patients’ daily routines."

Product Development Technologies (PDT), a global, full-service product development firm, announced today the results of its partnership with Dr. Peter Belafsky, M.D., M.P.H., Ph.D. in the creation of a new swallow enhancement device for sufferers of dysphagia, a condition that makes it difficult or painful to swallow. Together, PDT and Dr. Belafsky, an otolaryngology specialist in Sacramento, California, researched, designed, and developed the device, which allows patients to externally control their swallowing after a minimally invasive procedure.

Researching a Solution

Dr. Belafsky had conducted extensive preliminary research to ultimately develop a solution for patients with swallowing disorders. After reviewing thousands of swallow studies, he found that one of the biggest barriers to swallowing occurs when the voice box sits against the spine, and cannot appropriately elevate toward the jaw. From this research, Dr. Belafsky imagined a solution that would be implanted into patients which allowed them to manually pull their voice box forward via a thin thread extending from an aperture on their throat, simulating the mechanism of swallowing. He then contacted PDT to discuss prototyping the device.

After research and testing with PDT, the team became concerned that the thread could be a source of infection for patients, and instead focused on a design that would magnetically pull the throat open via attraction through the patients’ skin. This direction was prototyped and tested successfully in animals, but later proved an impediment to imaging procedures such as MRIs (critical for many patients with Dysphagia). Working closely with the PDT team to identify a solution that would best accommodate patient needs and behaviors, Dr. Belafsky was struck with an idea: a device inspired by body piercings.

“After taking my daughters to get their ears pierced, I was inspired by this concept of body piercing and came up with the idea for the device’s final design,” said Belafsky. “The piercing did away with the issues we experienced with the string and magnetic prototypes, while still providing a way for the patient to open their throat manually.”

Bringing the Solution to Fruition

The final device is a small metal plate implanted on the front of the patient's cricoid cartilage (a ring of cartilage located in the neck around the trachea). A post is located on the front of the plate which extends, just like a cosmetic piercing, through a small incision to the outside of the patient’s throat. The far end of the post features a small hole through which a thin ring or chain is looped. The patient can gently pull on the chain to expand their esophagus and create the means for a natural slide within their throat, allowing the patient to "swallow" any food waiting to go down.

“Of all the medical devices we’ve worked on, none has had such an opportunity for immediate and direct impact on patients’ lives,” said Joel Delman, Design Director of PDT Los Angeles. “Throughout the project, we understood that our work would become a permanent addition to these patients’ daily routines, so we designed the product to allow it to seamlessly integrate into their activities.”

Given the nature of Dysphagia and the patients who suffer from the condition, the project presented unique requirements and challenges. The device had to accommodate differences in patients' weight and skin thickness, for instance. PDT was not only able to create a solution that will work with all body shapes and sizes, but also worked to ensure the design was attractive and unobtrusive, in hopes that patients would feel comfortable using it at restaurants and other public spaces.

“Initially, we thought we would need several device models to support patients’ varying shapes and sizes,” said Dr. Belafsky. “However, we were able to create a device that is ‘one size fits all,’ making it a much simpler product to work with.”

Current Results

The product is currently patented and was implanted into a dysphagia sufferer in Uruguay in the fall of 2010, with successful results to date. Dr. Belafsky has submitted a grant request to the National Institute of Health (NIH) for funding to do animal testing, which would allow the team to obtain the necessary data that will eventually lead to an approved clinical trial in people.

“PDT provided specialized and advanced expertise on the project, including an innovative problem-solving process that allowed us to develop a solution that I think could benefit many patients,” said Dr. Belafsky.

About PDT
Product Development Technologies, Inc. (PDT) is a global, full-service product development firm with over 120 employees in eight offices worldwide. Team members have expertise in a wide range of product development disciplines, including strategy, design research, industrial design, user interface development, electrical and mechanical engineering, software development, laser scanning, and tooling. PDT’s award winning product designs have been recognized by BusinessWeek, the Industrial Designers Society of America, Design Journal, The Consumer Electronics Association, Inc. Magazine, Chicago Athenaeum of Architecture and Design, and Parametric Technologies Corporation.

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Kari Brownsberger
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