From concept to commercialization: The journey of an innovative medical device

According to the Centers for Disease Control and Prevention (CDC), catheter-associated urinary tract infections (CAUTIs) are one of the most common healthcare-associated infections – more than 75% of urinary tract infections developed in hospitals are related to catheter use, especially the indwelling catheters often used for female patients. More than an annoyance, CAUTIs are responsible for an estimated 13,000 deaths per year – as well as increased hospital stay lengths by two to four days and $400 to $500 million in additional U.S. healthcare costs annually.

But in 2015, Mary Tibbe, a former clinical nurse specialist at Spectrum Health (now Corewell Health) came up with an idea after seeing so many of the infections while working in the intensive care unit (ICU). She and her fellow nurses began documenting occurrences of the infections, particularly in relation to indwelling catheters. At the same time, she began conceptualizing a safer, more hygienic catheter design.

Spectrum Health saw promise in the idea and hired some recent business graduates to work with nurses (including Tibbe) and clinicians to further develop it and bring it to the prototyping stage. At that time, it became necessary to bring in some additional minds to get it to the manufacturing and commercialization level.

“One thing that’s very challenging in the beginning is to try to teach hospital systems how to commercialize their own ideas,” says Dan Byers, president and CEO of medical device development company SBE Medical, based in Comstock Park, Michigan. “They don’t have the expertise to go through regulatory and FDA requirements. So that’s why I partnered with them early on.”

After some early prototyping and evaluation, SBE Medical purchased the intellectual property (IP) rights to the design and began refining and optimizing it. Byers had a working relationship with fellow Michigan company Medbio, a medical device manufacturer and SBE Medical supplier located about 20 minutes away in Grand Rapids, so he brought them in to work through some of the design challenges and ultimately manufacture the finished device.

Medbio, which specializes in molding technology, was a natural fit for manufacturing the device, but the close collaboration between the two companies drove the efficiency and cost-effectiveness of the full process. Using design for manufacturing (DfM) strategies, Medbio and SBE Medical achieved a final design optimized for injection molding.

“The injection molding portion is pretty standard. It’s where we got into the assembly and that single piece flow, a fully line balanced system where we’re really utilizing Kaizen to optimize the completed system to final packaging,” says Randy Greenland, technical sales manager at Medbio. “You know, we could mold the parts, package them, pull them to our assembly group, take them out of boxing, go back and do the steps needed to put the PSA (pressure sensitive adhesive) on and assemble the product and then package it somewhere else. But the value came in doing it right at the molding machine where we really optimized that labor portion and kept the cost down.”

Optimizing design, materials

The Tibbe EUD is a completely external urinary collection device consisting of a ring and cup that can be separated for cleaning and care. The ring is attached to the patient’s skin with a medical adhesive typically used in wound care, while the easily removable cup can connect to a port and tubing leading to a Foley collection bag or leg bag. Medbio manufactured the device from thermoplastic elastomer (TPE) using the Arburg injection molding presses at its Grand Rapids facility, along with some press side fixtures developed specifically for the Tibbe EUD and operated manually by Medbio operators.

The material, as well as the nature of the part itself, presented some challenges. The low durometer TPE is a flexible yet tacky material, so extreme care was required to transfer the parts from the molding cycle into Class 8 cleanroom assembly so no particulate matter accumulated. In addition, Medbio had to develop a fixture that would position the PSA with extreme precision so it bonded correctly to the molded part.

“Once we got into the assembly portion, we had to come up with some tolerancing for that alignment,” Byers says. “We were originally aligned to line, but it’s such a challenging process when you have two flexible materials you’re trying to align. We came up with some tolerancing that was acceptable from both parties – again, it’s critical that we worked hand in hand during this whole process to make sure we were accepting of whatever changes were needed.”

The challenges of the material and the design were necessary to achieve one of the goals of the Tibbe EUD, which is to work with the body, not against it. The TPE’s flexibility allows the device to comfortably and securely mold to any body shape, while the closed-system design channels urine away from the skin to reduce the risk of moisture-related dermatitis or infection.

Preparing for launch

SBE Medical and Medbio agree the collaborative development of the Tibbe EUD helped bring it to market more quickly. Both companies believe in the importance of not only domestic but local supply chain – roughly 75% of SBE Medical’s supply chain is within Michigan. The partners have created their first production order of the patented device and are working with a major company to create a private label that will bring the device into the majority of acute care centers in the United States as well as into 70 other countries. They’ve also started their own organic market in long-term care and skilled nursing facilities.

The partnership worked out so well that SBE Medical and Medbio are continuing to collaborate on additional projects, including a line of other urinary management devices. Meanwhile, Mary Tibbe, 10 years after first coming up with the idea for an external urinary collection device, has joined SBE Medical as its chief clinical officer.

Developing a new product, especially a medical device, is never simple, and plenty of snags from supply chain issues to regulatory hurdles are part of every medtech development process. The successful launch of the Tibbe EUD is a result of many factors, from Mary Tibbe’s initial determination to reduce occurrences of a preventable infection to the local network of designers, manufacturers, suppliers, and others who worked together to perfect the device, streamline its production, lower costs, and make it accessible to the patients who need it most.

Medbio
https://medbiollc.com

SBE Medical
https://sbemedical.com