Reduction in commercial lead times by nearshoring
Successful biocompatibility testing & sterilization validation
Established and validated a new manufacturing process for a novel wound dressing
Global Biomedical Technologies
Medical Adhesive Skin Related Inquiries (MARSI)
Adhesive bandages and dressings are commonly used to cover wounds, secure catheters and hold medical equipment and transdermal patches in place. In most cases, removal of the dressings presents little difficulty apart from slight patient discomfort. However, in a significant number of cases, further complications arise due to medical adhesive-related skin injuries (MARSI).
MARSI is an injury to the skin caused when adhesive bandages are removed. Symptoms include erythema (redness of the skin), epidermal tears, skin erosion, and small blisters, also known as vesicles. The condition is painful, and the affected areas are susceptible to further infection. Depending on the patient’s skin and the extent of the injury, the top layer of the skin may actually be torn off along with body hair. The presence of MARSI adjacent to a wound or treatment site may complicate treatment, increase the cost of care, and delay recovery.
According to a journal from the American Nurse Association, anyone with an unusual skin condition may be susceptible, especially those whose skin layer is particularly thin. This includes infants as well as elderly people. Other factors that increase the risk include:
- Dry and fragile skin
- Illnesses affecting blood circulation that compromise blood flow to the skin
- Skin thinning caused by medication such as steroids
- Poor nutrition
- Dermatitis, eczema and skin allergies
- Radiation and chemotherapy
- Age-related illnesses
Numerous studies have taken place to determine the incidence of MARSI. Results vary considerably and are generally related to the patient’s age and condition. In a random sample of MARSI studies, the lowest incidence of MARSI recorded was 5.8% for outpatients attending an academic medical center, and in a U.S study, it was approximately 13%.
As would be expected, the incidence among oncology patients, whose immune systems are compromised, is higher. In this Chinese study, 19.7% of patients experienced MARSI while in another Chinese study, the incidence was 29.8%. Approximately 16% of elderly patients in long-term care experience MARSI, while in neonatal intensive care, the incidence of skin-stripping due to adhesive tape was 17%.
Based on these figures, it can be expected that nearly 15% of hospital patients will experience a MARSI injury. While the U.S. costs for treating MARSI aren’t widely available, figures from the UK indicate that treatment costs around $100. Because MARSI is a hospital-acquired condition, it’s quite possible that pay for performance programs won’t cover treatment costs.
The Comfort Release® Platform
Conventional ways to reduce the risk of MARSI are referenced in this 2013 article in the Journal of Wound Ostomy Continence Nursing and include selecting the best type of tape, taking into consideration the degree of adhesion required, the location of the injury and the potential risk of MARSI along with other considerations. While doing this may well reduce the severity of the condition, it doesn’t eliminate the problem entirely. The core of the problem is the residual strength of the adhesive, which, if too high, may tear the skin when the bandage is removed.
Global Biomedical developed the Comfort Release® Platform to address the challenge of MARSI. Its patented adhesive system is able to temporarily disable adhesive when removing bandages.
The technology incorporates an advanced polymer system in the adhesive coating that, temporarily, causes the adhesive to release when rubbing isopropyl alcohol is applied. The patient feels no pain when the bandage is removed, and the risk of skin tearing is eliminated.
In a product evaluation with Nurses with an average of nearly 20 years of pediatric, adult, and geriatric experience 100% of the Nurses acknowledged a decrease in skin tears with the use of Comfort Release®. 100% of these nurses also agreed that patient comfort improved with the use of Comfort Release®.
Establishing a Commercial Partnership
Global Biomedical was looking for a partner to translate identified user needs into product specifications and develop a validated 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 Technologies, Global Biomedical 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.
Design & Engineering Challenges
The initial product line Global Biomedical wanted to develop for their Comfort Release® portfolio were transparent window dressings used for IV catheter securement and advanced wound care dressings. While the Comfort Release® products provide a novel patient solution, they also presented some significant design and manufacturing challenges.
When evaluating the design for manufacturing in the early stages of development, it was anticipated that challenges that would arise due to the material properties of both a nonwoven layer and a film layer. Both materials are thin, stretchy, and utilize an aggressive adhesive. Maneuvering these materials through a complex web path with multiple waste matrices and release liners required careful consideration.
Product specifications and tolerances were derived 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, the Boyd Technologies team visually inspected three standard deviations from the mean to determine an acceptable range. As flexible materials have inherently more variability than rigids, it is important 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. Alongside verification and validation work, third-party biocompatibility testing services and sterilization validation for the products was also completed.
User-identified needs were translated into product specifications and designed a manufacturing process that could scale in tandem with Global Biomedical’s growth—from prototypes to high volume production. 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.