While bioabsorbables seem like a new trend, MTD has been micromolding bioabsorbable medical components for 15 years and has worked with numerous types of bioabsorbable polymers.
MTD believes a successful bioabsorbable micromolding project will meet the following criteria:
- premium part quality from a robust molding process window,
- less invasive devices with increased precision and capability,
- superior post-mold mechanical and functional properties,
- consistent and minimal post-mold IV loss, and
- highly capable critical dimensions.
Here are just a few ways MTD helps achieve bioabsorbable micromolding success:
MTD’s MicroRunner tool has a ratcheting runner system that varies in diameter and aids in determining the minimum runner size required to fill the volume of your part with the goal of sizing a runner system to adequately mold a product without sacrificing material. This is extremely important for bioabsorbable materials, given that they are so expensive.
savings on material
Validating a bioabsorbable part requires more steps than a non-bioabsorbable part, but with good planning and exact execution, the timeline to get to production is far from daunting. One customer said it best. “We assumed that the smallest component in our device would be the hardest to validate, being that it was bioabsorbable, the most intricate, and critical-to-function. However, it turned out to be the smoothest validation process out of all the [larger, simpler] components in the device”.
With a collaborative approach, MTD fully documents and customizes our validation processes for each client and project. We store each part’s quality score with all the process data, providing a high level of traceability for all our micro medical device parts.
Many micro molders need to outsource their testing for Inherent Viscosity (IV) and Differential Scanning Calorimetry (DSC), which can add weeks or months to the project timeframe. MTD has the in-house capability for real-time, continuous testing. This allows us to monitor, optimize, and report IV loss throughout the development and validation processes of a product as well as verify post-mold IV to release every production lot to the customer.
in development process
Minimal and Consistent IV Loss
What’s important to keep in mind is that post-mold inherent viscosity (IV) loss is dependent on the micro molder and the material. Even if a micro molder has the equipment to work with a particular material, they may have trouble delivering consistent product with controlled IV loss for each molding run if they are not familiar with the complexities of the material. On-site IV and DSC testing capability enables the impact of process variables on these outputs to be determined and adjusted immediately, allowing for a better optimized molding process, minimal and consistent IV loss, and improved capability.
One of MTD’s high volume production lines -having zero product returns with over 15 million components produced- has a historical post-mold IV variation of less than 2%.
Controlled Handling and Packaging
Storage of bioabsorbable and sensitive materials and molded inventory in temperature controlled environments. Temperature is monitored, logged, with alert limits if critical settings are exceeded. All manufacturing occurs in environmentally controlled ISO Class 8 cleanrooms. Specialized shipping procedures for sensitive materials—high and low volume shipments—where temperature is controlled and monitored.
Customized, Specialized Equipment
Specialized micromolding equipment in place to control critical bioabsorbable processing factors like residence time, shear, and degradation rate of material. MTD creates customized screws in-house, specialty drying media and procedures – not only are we investing in specialized equipment, we customize it completely once it arrives. Nothing is off the shelf.
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