The development of new and improved medical devices plays a critical role in enhancing patient outcomes and improving the quality of care worldwide.
PEAK Performance Compounding, LLC proudly supports leading medical OEMs in the early stages of the product life cycle through comprehensive material development services, including formulation studies, material sampling, processing trials, and scale-up.
By combining internal technical expertise with a network of supporting processors and development partners, PEAK helps bridge the gap between material development and commercialization, reducing time to market and overall material costs.
The following case study highlights an actual Design of Experiments (DOE) conducted between PEAK Performance Compounding and a leading medical device manufacturer.
Customer Profile
The customer was a large medical device OEM developing a radiopaque catheter application.
Material Needs
The customer required a highly filled tungsten compound to provide device visibility under X-ray imaging technology.
Key material requirements included:
– High level of radiopacity
– Maximum dispersion of tungsten filler
– Optimized loading level based on formulation and extrusion studies
– Smooth surface finish
– Material free from agglomerates, bumps, and surface defects
Market Application
The material was intended for use in a narrow, thin-wall, radiopaque catheter.
Material Challenges
The OEM needed support in both the formulation and processing of a tungsten-filled catheter compound.
Prior to working with PEAK, the customer was unable to achieve the desired tungsten loading level and radiopacity without compromising blend quality and catheter surface finish. As a result, production yields were low, scrap rates were high, and overall material costs were elevated.
The PEAK Solution
PEAK leveraged extensive experience in processing highly filled compounds, including high specific gravity tungsten blends, to develop a customized material and processing solution for the customer.
Through formulation development, equipment optimization, and downstream process modifications, PEAK was able to meet the customer’s device requirements while improving production efficiency and reducing material-related costs.
PEAK’s support included:
– Development of a Design of Experiments (DOE) to evaluate the relationship between tungsten loading, specific gravity, and radiopacity
– Creation of multiple custom formulations and material samples
– Customization of the underwater pelletizing process to produce spherical pellets for improved processability and filler dispersion
– Use of a continuous blade sharpening procedure to support pellet consistency
– Implementation of customized feeder technology and screw design
– Process optimization to improve compound quality, consistency, and production yield
The Outcome
PEAK successfully met the customer’s unique material requirements and delivered both technical and business-related benefits.
Results included:
– A custom formulation that achieved the desired radiopacity, surface finish, and device performance
– Successful scale-up from lab DOE to production quantities
– High-quality spherical pellets with consistent size and shape
– Material free from agglomerates, bumps, nibs, strings, and tails
– Improved production efficiency with higher yields and reduced scrap
– Achievement of the customer’s cost target and commercialization timeline
– Support for successful device qualification
– Ability for the OEM to manufacture and market a cost-effective, high-quality radiopaque catheter
Summary
Through technical formulation expertise, specialized compounding capabilities, and process development support, PEAK Performance Compounding helped the customer overcome critical material challenges and successfully advance a radiopaque catheter application from development toward commercialization.
For more information on this case study or to discuss how PEAK Performance Compounding, LLC can assist with your unique material needs, please email info@peak-pci.com
