PermeaDerm®
Complete combination drug-device solution
Application: The world's first variable porosity primary dressing for the temporary treatment/healing of burn and chronic wounds
Product type: Silicone/Nylon Matrix, coated sheet
Dr. Aubrey Woodroof, a pioneering burn and chronic wound care specialist came to Trelleborg Healthcare & Medical with a theoretical concept, based on extensive clinical experience with similar wound care products, and basic handmade prototypes of a proposed wound dressing system. He initially asked Trelleborg to provide a single silicone element in the system.
The PermeaDerm®-Trelleborg Solution
PermeaDerm® approached Trelleborg Healthcare & Medical experts initially for reinforced silicone sheeting for a new wound dressing product. This request led to a joint engineering and production project starting with design and testing through to manufacturing and supply.
PermaDerm® came to our experts with:
- An initial manufacturing process describing how to convert key raw materials (gelatin, I-10, knitted nylon and medical grade silicone) into dressing prototypes
- Custom designed equipment to make slits in two designs: B and C
- A method for precision bio-coating using custom designed BioDot spray equipment
- A sterilization procedure
After reviewing the product design and characteristics, the Trelleborg engineers worked closely with PermeaDerm® to provide:
- Raw material research and selection
- Equipment design
- Manufacturing process development
- Packaging
- Equipment and process validation
- Complete drawings to PermeaDerm®’s specification
- Work instructions
- Material certifications
- Quality control system
- World-class manufacturing and quality systems
Trelleborg Healthcare & Medical and PermeaDerm® worked hand-in-hand to develop the manufacturing and quality assurance processes that exist today. By delivering a complete manufacturing solution, including processes, documentation and validation, Trelleborg Healthcare & Medical experts took over the portion of development needed to manufacture the product and get it to market. This allowed Dr. Woodroof to focus on writing critical scientific publications, identifying new investors and promoting the PermeaDerm® products.
Successes
The partnership resulted in global, regulatory acceptance for a combination drug-and-device solution and the launch of PermeaDerm®
- World’s first “Variable Porosity Primary Dressing”
- Satisfied the unmet need for treating chronic wounds and burns
- Significantly improved wound healing with reduced scarring
- Reducing overall infection rate
- Produced a scalable product
- Delivery of proprietary University of Rochester anti-scar compound
- Quantifiable cost savings for providers and payors