Global Biomedical was looking for a manufacturing partner to translate identified user needs into product specifications and develop a process to bring their Comfort Release® advanced wound care portfolio to market in a manner scalable for high volume production. Prior to engaging with Boyd, Global had released a line of first-aid products and worked with a manufacturer with a production facility in China. They weighed the advantage of cheaper production against a number of factors: the time taken to ship the material to and from China; tariffs; delays due to the language barrier; and IP concerns. Especially for a start-up venture, the long and unpredictable turnaround time made for complicated inventory management. When it came time to expand their portfolio to more complex products, they needed to partner with someone who could develop specifications, work through validation, and scale the product line to high volume production.
The initial products Global Biomedical wanted to develop for their Comfort Release® portfolio were transparent window dressings used for IV catheter, tubing, and wound securement, as well as other advanced adhesive wound care products. Comfort Release products use a powerful medical adhesive with a proprietary polymer that, when triggered by isopropyl alcohol, acts as a “switch”, breaking the adhesive bond with the skin and allows for the removal of the dressing with no injury to the patient. On the transparent window dressings, the patented, switchable, pressure-sensitive adhesive is applied to the nonwoven border while the transparent, thin polyurethane film in the center has a very low level of adhesion.
We were recommended to Global Biomedical by our mutual suppliers, as a manufacturer who could progress a novel product through the development pipeline with capabilities to scale up to high volume production. The materials chosen for use by Global were primarily with the end-use performance in mind and, while they outperform other dressings on the market in areas of moisture vapor transmission rate (MVTR), adhesion, and ease of removal, some of the characteristics inherent to the materials increase the difficulty of manufacturability.
When evaluating the design for manufacturing in the early stages of development, our engineering team anticipated several challenges that would arise due to the material properties of both the nonwoven and film. Both materials are thin, stretchy, and sticky, and travel a complex web path in production, with multiple waste matrices and release liners. The web path required to place a nonwoven window pane atop a film window is also complicated, and it is difficult to maintain tension without the film stretching.
In one specific example of a difficulty our engineers encountered, a corner wrinkle occurred due to the stretchiness of the materials. Cosmetically, it looked terrible, but the wrinkle in the nonwoven itself was a more significant issue: if the nonwoven lifts off the film, it jeopardizes the sterility of the area covered because the dressing would no longer seal around the wound or venous line properly. We determined that the cause was a decrease in lateral tension (across the web). Once the nonwoven was die-cut, the outer material would dip towards the center, the center of the nonwoven web path would lose tension, and the resulting slack would cause it to make contact unevenly with the release liner when it picked up the film.
In troubleshooting, our engineers traced issues back to the point of occurrence and worked to eliminate the contributing factors. Due to the non-linear relationship between the speed of production and the tension of the web path, it was critical to identify quantifiable criterions. They discovered that the parameters that most affected the end product were:
- Speed of production
- Maintaining equal tension between tension pairs (i.e., between the film and the film’s release liner waste web)
We derived product specifications and tolerances through Edge of Failure (EOF) and Design of Experiment (DOE) studies. To quantify the acceptance criteria defined by Global Biomedical as performance and aesthetic benchmarks, we visually inspected three standard deviations from the mean to determine an acceptable range. As flexible materials have inherently more variability than rigids, it is essential to set reasonable tolerances to be only as tight as needed to ensure functionality when designing for manufacturability. Otherwise, delays, added expenses, and an increase in failing acceptance criteria can be expected.
Finally, we managed third-party biocompatibility testing services and sterilization validation for product that was manufactured in our ISO Class 7 cleanroom.
We translated user-identified needs into product specifications and designed a manufacturing process that could scale in tandem with Global Biomedical’s growth—from prototypes to high-volume production. Our development engineers solved problems that arose in working with the specified materials and validated a robust process to ensure consistent quality when bringing Global Biomedical’s product to market.
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Global Biomedical Technologies is a fast-growing medical technology company with innovations in chemistry and biomaterials. They are committed to developing products that improve the quality of patient care while remaining cost-effective and practical for healthcare providers. To this end, the company has invested extensively in research and development to find innovative solutions to today’s clinical challenges and to redefine care standards.
Comfort Release® is borne from Global Biomedical Technologies' vision to revolutionize the landscape of medical adhesives – offering healthcare providers a new option that will help them protect their most vulnerable populations. They developed this technology to help people of all ages who have experienced the pain or injury associated with the removal of bandages, tapes or medical dressings.