SBE Medical partners with Medbio on the Tibbe EUD

NEWS RELEASE: SBE Medical Partners With Medbio to Prioritize Women’s Health and Wellness

Production and inspection of the Tibbe™ EUD in the clean room at Medbio’s manufacturing facility in Grand Rapids, Michigan [Photo courtesy of Medbio]

Since 2004, Medbio has been dedicated to delivering high-quality, cost-effective and timely manufacturing solutions to help bring new products to the medical marketplace. From components to assembly to final packaging, Medbio is an integral part of the process. While every project is important and serves a key purpose, a recent opportunity arose to help improve the quality of female healthcare and address a significant medical issue by developing a unique device called The Tibbe™.

About 3.5 million catheters are placed each year in the U.S., and faulty catheters can lead to urinary conditions and incontinence. Women are at higher risk for urinary conditions such as incontinence-associated dermatitis (IAD). With critical care patients in elder care settings, as many as 89% of patients experience IAD. IAD prevention is costly and labor intensive adding up to a range of $3,000–$5,000 in additional costs per patient.

The Tibbe™ was created as a solution to reduce or eliminate urinary tract infections (UTIs) and the extreme discomfort and problems caused by indwelling catheters in female patients. Medbio played an essential role, from making improvements to the final design to the overall production and packaging of the Tibbe™, facilitating the project to completion.

Reinventing the Catheter to Improve Urinary Healthcare

The SBE Medical Tibbe EUD is an innovative external urinary device created as a solution to address the unmet needs of female patients. [Image courtesy of SBE Medical]

Mary Tibbe worked as a Clinical Nurse Specialist at Corewell Health. In 2015, she was charged with reducing catheter-associated UTIs in the intensive care unit (ICU). Tibbe and her fellow nurses regularly documented indwelling-catheter-related issues associated with female patients, including skin irritation, leakage and incontinence as well as a loss of dignity. At the time, male patients had at least three other options for collecting urine. Female patients had zero.

Mary used her vast patient experience and medical knowledge to devise a better solution for urinary healthcare for women. After multiple design iterations, testing with patient volunteers and navigating trial and error, Mary refined the concept and eventually connected with Dan Byers and Nicholas Borgdorff of SBE Medical. SBE Medical is a veteran-owned small business specializing in the specification development of manufacturing medical devices. Together, they began to work on bringing Mary’s vision to life, making key design modifications to create a working model and securing additional grants and funding.

Still, SBE needed an experienced medical parts manufacturer to put the finishing touches on the design and get it ready for commercialization. Such a labor-intensive process might typically involve overseas manufacturing, but SBE wanted to produce the device in the U.S. Large manufacturers would not engage a project still in its development stage, and local molders did not have the expertise, resources or capabilities needed.

“We knew we wanted to stay stateside with all our manufacturing, and Medbio found solutions to do that and keep costs down,” said Dan. “There are a lot of medical device manufacturing companies that can do one or two things well. But, when you’re trying to integrate manufacturing processes, you do not want to keep adding steps and driving up your cost. Medbio is very creative. They come up with ways to keep your costs down and keep our product close to home.”

A big reason SBE was successful in implementing an onshore USA-based supply chain was because of solutions created by Medbio to mold, assemble and package the device and keep prices down. “I love their work ethic,” said Dan. “I love that we can tap into Medbio’s engineering and creative ideas to bring our product to market with a domestic supply base.”

Medbio Helps Take the Tibbe™ to the Next Level

A plastic injection molding machine for producing the Tibbe™ EUD at the Medbio manufacturing facility in Grand Rapids, Michigan [Photo courtesy of Medbio]

According to Medbio technical sales manager Randy Greenland, by the time the Tibbe™ got to him and his team, it had gone through roughly nine iterations. Medbio’s goal was to solve some key design challenges and build the proper tooling for cost-effectiveness.

“When we got the call, the design wasn’t raw, but it wasn’t finished,” said Randy. “We took that and added some wall and draft and molding configuration updates. We angled the drain port to really align to draw on the tool, so it became more manufacturable and simplistic from a tooling standpoint. We polished what was handed to us.”

The material selection was critical. It was also challenging from a molding perspective because it had to be clear, so visibility would not be obstructed in observing drainage and functionality. Medbio also modulated the surface to help facilitate positional accuracy and better adhesion to the patient.

“I think the texturing or frosting we recommended was very critical,” said Randy. “White parts or clear parts from a molding stance is difficult because you have a large cross-sectional area of what it is in any particulate or contaminant, whether it’s surface or embedded. Frosting gave us the ability to focus on the site window as clarity for criticality.”

Finding innovative ways to reduce costs is the strength of Medbio’s team of experts. From a tooling and manufacturing perspective, the use of a two-plus-two tool (two rings plus two cups) was fundamental to reducing molding costs. And, from a production and operations perspective, Medbio devised a highly efficient production process by molding, packaging, boxing and shelving the product in one unified space.

Packaging the Tibbe™ presented its own hurdle. Randy knew the packaging had to be something durable enough for shipment but not so heavy that it would add additional shipping costs. Medbio also needed to fix the product in protective trays to keep it supported, organized for easy access and uncontaminated during transit so it is ready to use right out of the box. The solution was a specially designed thermoformed tray, which met SBE’s needs for both functionality and cost.

The Tibbe™ is now patented and ready for commercialization, with additional patents coming. It is currently in testing across various hospitals, long-term care facilities, clinics and with home care patients, with hopes of taking it to full-scale production in 2025. Mary Tibbe and the SBE team are already looking ahead to a pediatric version for younger patients, a neonatal intensive care unit version and a male version with the same benefits of the Tibbe™.

Impacting Lives One Medical Part at a Time

The benefits of the Tibbe™ are numerous and will change urinary care for the foreseeable future. Not only does it reduce the incidence of UTIs, but it also offers a better fit, covers more surface area, is more flexible and comfortable for female patients and reduces patient emotional distress and embarrassment. It’s also hygienic and easy to remove, making life easier for nurses and medical professionals providing patient care.

“Obviously, as a nurse, your number-one passion is taking care of people,” said Mary.  “When patients are forced to urinate all over themselves, it causes skin issues and what’s called incontinence associated dermatitis. It’s very uncomfortable, and there’s also a loss of dignity for the patient.”

Roughly 15–25% of hospitalized patients receive an indwelling urinary catheter during their hospital stay. In nursing homes, about 5–10% of residents have long-term indwelling catheters, with females representing the majority of residents.

“It’s patient care, patient safety,” said Randy. “Catheterizing a patient, male or female, is one of the single largest ways to introduce infection and damage because of the soft tissue nature. The Tibbe™ is external and doesn’t present those same challenges. And that got us excited. That’s the true joy in this job—seeing that we affect people’s lives in a positive direction.”

With Medbio’s help, the Tibbe™ is now ready for production and distribution at a higher level when it hits the market.

“As a nurse, all I truly wanted was to make a device that would maximize the comfort, dignity and freedom for female patients, as well as ensure they were able to achieve the best possible outcome,” said Mary. “I believe the Tibbe™ device does this.”

The opinions expressed in this news release are the author’s only and do not necessarily reflect those of Medical Design & Outsourcing or its employees.