Specialty polymers for medical device design
To ensure the highest possible quality and safety standards, medical devices must undergo rigorous testing before they can be sold. As a result, original equipment manufacturers (OEMs) only select components that comply with applicable healthcare standards.
Balancing regulatory compliance with functionality has always created design complexity. Beyond meeting safety standards, medical devices need to be comfortable, breathable, and flexible to support long-term patient adoption. Choosing the right raw materials is key to achieving this, but many wearable technology designers find themselves spending a significant amount of time and effort trying to get the right balance of versatility, comfort, and other properties in line with compliance.
“With Baymedix® raw-materials from Covestro, we can create a versatile, flexible and regulatory-compliant foam for the healthcare industry. This will open up new creative avenues for medical device designers and help OEMs secure approval from regulators.”
Materials innovator and foam specialist Mayser set out to create a foam suitable for next-generation wearable medical devices and other popular medical equipment, including wound protection solutions and orthopedic supports.
As well as being soft to the touch, breathable and biocompatible, Mayser targeted a froth foam design that could provide reliable formability and easy processability. Plus, with OEMs increasingly preferring more sustainable materials, Mayser had to find a solution that avoided using solvent-borne technologies to realize its innovative froth foam concept.
“Our partnership with Mayser clearly demonstrates the potential of our Baymedix® portfolio in healthcare applications. MAYSER BLUEFOAM® DG-T will help medical device manufacturers bring innovative products to a growing market.”
By using a combination of Baymedix® FD103, Baymedix® AD111 and other proprietary ingredients, Mayser developed MAYSER BLUEFOAM® DG-T. Specially designed for medical applications, Baymedix® offered the right foundation for Mayser to manufacture this new foam in a non-reactive foaming process for use in wearable medical devices and healthcare environments.
As aqueous polyurethane dispersions, Baymedix® FD103 and Baymedix® AD111 provide robust flexibility and significantly increase design freedom for OEMs and product designers.
By using Baymedix® as the building block for MAYSER BLUEFOAM®, Mayser could ensure that its froth foam was absorbent, breathable, and suitable for skin contact. To support medical device review processes, Mayser also conducted in-vitro cytotoxicity tests and found that MAYSER BLUEFOAM® DG-T is biocompatible in accordance with standards set out in ISO 10993.
*Source: Wearable Medical Devices Market Size | Forecast Report [2032]
Key benefits
- Biocompatible: Baymedix® grades align with compliance requirements for a wide range of medical devices.
- Breathable: With a high MVTR (moisture vapor transmission rate), polyurethane foams based on Baymedix® provide lasting comfort.
- Versatile: Thermoformable froth foam offers greater flexibility and design freedom for OEMs.
