August 10, 2022

A Paradigm Shift in Medical Tape

It all began with a bad experience. Isn’t that the catalyst for most innovations?

Professor Eric Seibel, a UW researcher in Mechanical Engineering and practical problem-solver, was by the bedside of his young son who had fallen out of a tree and ended up in Seattle Children’s Hospital with cracked ribs. During his treatment, Seibel’s son was given fluids through an intravenous catheter (IV) taped to his arm. Unfortunately, changing IVs caused terrible pain for his son both from jostling of the tubing inside his vein as well as skin tears and redness from the removal of the medical tape. According to the young patient, this painful IV removal process was by far the most miserable aspect of his hospital stay!

If you have not experienced problems with medical tape, it may come as a surprise to hear that adhesion – either too little or too much – can lead to serious consequences for the patient. Nurses are frustrated when adhesion is weak, resulting in tubing and devices dislodging and causing harm to their patients. Yet if the tape sticks strongly, it may damage the skin when it’s pulled off. This is especially serious in pediatric patients who have more fragile skin than adults, and in elderly patients whose skin tends to be dry and papery. Most medical tapes are made to work on the “average patient,” leaving many of these other patient populations poorly served.

Motivated by his son’s bad experience, Seibel decided to take a closer look at the medical tape issue. It just didn’t seem right that the worst aspect of his son’s hospital stay, broken ribs and all, was the IV changes and the resulting raw, sore skin from medical tape removal. Seibel was also amazed to hear from one of the nurses who was caring his son that the IV changing process on young patients was the worst part of her job! He thought that surely there should be a better solution.

Thus the project, “UnTape,” now called “ThermoTape,” was born. Seibel set the goal of developing a medical tape that would stick strongly when applied to the skin, but then become “unsticky” when it was time for removal. Drawing on his background in optical technologies, he came up with the concept of a clear tape that would weaken the bond to the skin when heated by near infrared (NIR) light, enabling easy removal. The rationale was that light wands are familiar to medical personnel because small flashlights are routinely carried by nurses. However, much to Seibel’s surprise, when an early prototype was put in front of mentors with medical product experience, including some doctors and nurses, there were strong objections to the non-contact light wand concept.

Listening to his customers and users, Seibel and his research team realized it was time for a technical pivot. During this retrenchment period he discussed the clinical problem with his colleague Len Nelson, PhD, Affiliate Assistant Professor at UW in Mechanical Engineering. Nelson is a career chemist who came to the university post-retirement to mentor students and help them learn how to apply their knowledge to practical problem-solving. His interest in the medical tape problem was piqued, so he began thinking about possible solutions beyond the one requiring a light wand. In Nelson’s opinion, it would be better to have an adhesive that would release under application of a heat pack with direct contact.

By this time a growing cadre of students from the UW Engineering Innovation in Health program got involved and several of them joined the regional Pacific Northwest/CoMotion NSF I-Corps program where, through customer discovery interviews with 20 to 30 nurses, they heard overwhelming feedback that heat packs were preferred over light wands. Nurses pointed out heat packs are readily available in hospitals making it easy to envision how the new medical tape would fit right into their patient care routines.

At this point, mechanical engineering graduate student Shawn Swanson jumped on board. He previously spun a technology company out of UW and was looking for a new project to focus on for his graduate studies that would also have potential as a commercial product. To him, this medical tape project looked compelling.

Nurse feedback in hand and a committed graduate student on the project, the team moved on to develop a new heat-release adhesive formulation. To do this, they realized they needed yet another set of skills, someone with the technical know-how to work on the adhesive chemistry. Len Nelson, being a good sleuth, managed to round up just the right person, chemistry graduate student Chris Fellin who was advised by Professor Alshakim Nelson. Building on the background chemistry Len Nelson had identified, Fellin drew on his creativity and technical know-how to come up with some great ideas right away.

Now that they had key people in place and a validated clinical problem, the team applied for CoMotion Innovation Gap funding and made it through the review process to win an award that would help them take the project into the next stage of prototype development.

Prototyping required a good, FDA approved medical grade adhesive as the basis of the formulation. Len started making calls to companies selling medical grade adhesives to see if he could secure a supply for the project. He called company after company hearing, “No,” many different ways. Not one to give up easily, he kept at it and finally connected with a technical customer solutions expert at Henkel, a large global adhesive supplier, who surprised Len by saying, “Yes, we work with people like you all the time!” Finally, a collaborative relationship was born, free medical grade adhesive samples were provided, and the technical side of the project was on its way. Chris, using his chemistry chops, went to work and in short order came up with an additive that mixed well with one of the preferred adhesives Henkel had provided. The team synthesized small quantities and mixed it in various concentrations with the Henkel adhesive so they could test it.

The National Science Foundation (NSF) has a unique program called Partnerships for Innovation aimed at academic projects with groundbreaking technologies that are geared toward translation into new products. The grants require an industry partner to be involved and help coach the team through development. With Henkel on board, the team thought they were a good fit and applied. They came close to winning an award but did not quite make it. However, they were encouraged by NSF program managers to keep up the forward momentum by participating in the National NSF I-Corps program where they would go through fast-paced entrepreneurship training and conduct more than 100 customer discovery interviews. This program has been exceptionally successful at helping technical teams transition from research into commercialization. The team knew it was a serious time commitment but agreed to participate in the 7-week, nearly full-time, program. They dove in and interviewed more than 120 potential customers, investors, manufacturers, distributors, and others to hear feedback and see if their product concept would be validated or not. What they heard was that nurses clearly wanted new types of tape. The big surprise was that tape removal was not seen as the big problem, but strong adhesion was. Nurses noted that they frequently see tubing and devices dislodge because tape does not stick well enough. They really want a tape that adheres more strongly than those in common use, yet removes easily without causing skin damage. With this enhanced understanding the team was ready to tackle their product development.

Unfortunately, the project was nearly out of funds again. It was at this point the team learned about the WE-REACH Funding and Support program at UW and realized their early-stage commercialization project fit the criteria. Accepted projects are managed by the WE-REACH Biomedical Entrepreneurship Center, an NIH supported hub, and come with project management and coaching. It was just the thing the team was ready for, as reflected in the positive feedback their project received from reviewers. The team won an award and this propelled them into more sophisticated product prototyping and early clinical testing.

Deploying the WE-REACH funds and benefiting from the dedicated efforts of undergraduate students Allayna Gross and Ryan Smith from UW Materials Science and Engineering, under the guidance of Professor Devin Mackenzie at the Washington Clean Energy Test Beds, the team has been able to produce consistent, high-quality samples on a precision slot coater. These samples are being tested now in a clinical trial with healthy young adult subjects. This will be an important demonstration of the tape’s performance across a range of people before moving on to testing on patients.

Seibel and team agree that without WE-REACH funding and support the project would have lost momentum. They had applied for other grants but were at a stand-still while scampering for additional support. WE-REACH support has been critical as they worked through key prototyping steps and has enabled them to progress into early clinical studies, which are essential for proof-of-concept demonstrations to nurses and other potential customers.

Wherever the project heads next, this team is committed to powering through to provide a medical tape that serves patients better than what is available today. They envision a future where people don’t have painful experiences like those of Seibel’s son and nurses don’t have to dread the simple process of removing tape from fragile skin. The right tape for the right use means better patient care, and that is good news for all.

Read more in the team’s recent publication, “Prototype Development of a Temperature-Sensitive High-Adhesion Medical Tape to Reduce Medical Adhesive-Related Skin Injury and Improve Quality of Care.”

WE-REACH is one of the NIH Research Evaluation and Commercialization Hubs (REACH) and is supported by NIH Grant U01HL152401.

Learn more about WE-REACH.