Patient-Developed Medtech: A Success Story

Some of history’s most ingenious ideas were born of hair-pulling, banshee-screaming human frustration. 

The automatic dishwasher, for example, was beget by Josephine Cochrane’s aggravation with her china tableware (it reportedly chipped too easily when scoured by hand).

Similarly, Tim Berners-Lee’s annoyance with the absence of a global document viewing/filing system prompted him to develop HTML markup language and protocol. The CERN software engineer had long imagined a “virtual documentation system in the sky”; his vision is now a reality, with more than 14 billion pages of data accessible through the HTML code he dubbed the World Wide Web.

“It may be human nature to bitch and moan about what’s wrong with the world, but many successful innovators when faced with life’s aggravations don’t just complain,” a 2013 Fast Company article stated. “Instead, they take personal responsibility and marshall all their resources to figure out how to improve what’s wrong.”

Though he’s never considered himself an innovator, Andy Williams fits Fast Company’s description of one. For the past 15 years, he’s been living with Mitochondrial Disease, a chronic, genetic disorder caused by mitochondrial dysfunction. Found in every cell within the human body, mitochondria are considered cell “powerhouses,” converting food molecules into the energy that drives most cell functions.

Mitochondrial Disease-afflicted cells do not produce enough energy, rendering them inefficient or totally incapable of performing their job. The disease can be present at birth, but also can occur at any age; symptoms and severity varies depending on the number of affected cells and their location in the body. An estimated one in 4,000 people are diagnosed with the progressive, incurable condition.

Since every person diagnosed with Mitochondrial Disease has different combinations of working and non-working mitochondria, the ailment impacts each victim differently. The disease can target almost any body part but most commonly affects the brain, muscles, heart, liver, kidneys, eyes, ears, and pancreas.

For Williams, the disease manifested itself in his nerves and muscles, leaving him weak and in pain. He also suffered from seizures and gastrointestinal issues, and has been undergone 10 surgeries at the Cleveland Clinic while undergoing treatment for a nerve disorder, bladder failure, digestive problems, and Alström syndrome, which can cause progressive vision and hearing loss. While Williams claims to have “cured” Alström syndrome through daily vitamin/supplements intake, he sacrificed a large portion of his intestine to Mitochondrial Disease-related digestive issues and can now only sustain nourishment through a feeding tube.

That tube, however, has only exacerbated Williams’s medical misery—it’s frequently leaked, causing serious infections that required hospitalization. The leaks were embarrassing as well, forcing Williams to change his shirt several times a day.

Fed up with the regular hospitalizations and soiled shirts, Williams designed a protective device for feeding tubes with the help of his former doctor and eight representatives from Cleveland Clinic Innovations, the clinic’s commercialization arm that helps develop innovations in life sciences, medical devices, delivery solutions, and health information technology. Since its 2000 inception, Cleveland Clinic Innovations has helped secure a plethora of licenses and patents, including the Cosgrove-Edwards Annuloplasty System and AtriClip for mitral valve replacement and left atrial appendage repair, the Surgical Cooling Vest, and High-Line IV holder.

Williams’ protective device—a stoma—prevents leakage by using specialty silicone disks, bumpers, and/or balloons to form a tight, protective seal around the feeding tube at its point of entry in the abdomen. The device is designed for patients with enteral nutrition tubes (PEG tubes, J-tubes), or any other kind of tube (nephrostomy tubes, chest tubes, surgical drain tubes, etc.) that connects a body cavity to the outside world, according to its Cleveland Clinic Innovations description.

“It’s still under development,” Thad D. Meese, associate director of project development for Cleveland Clinic Innovations, said during a July 2021 interview.

Williams’s technology is unofficially named GioBey (though the moniker is still subject to change)—a combination of his middle name, Giovanni, and the full name of his business partner, Eric Yudelevich Blumrosen, M.D., an internal medicine specialist at Cleveland Clinic. Yudelevich Blumrosen was Williams’s physician before the pair partnered on the stoma device.

Williams and his former physician created multiple prototypes of GioBey in 2020 and are currently organizing patient studies to test the device’s performance with different body types, skin types, and skin conditions. Williams has used the stoma on himself and claims it’s prevented countless number of trips to the emergency room.

Upon completion of the trials, Williams and the GioBey development team hope to collect data supporting its clinical value. “Now we’ll see if it works on other patients,” he told the press last summer.

Regardless of its clinical outcome, the GioBey has already proven its worth to Williams by helping him discover a previously unknown side of himself.

And that, above all else, is priceless.