Animal-Derived Component Free Molding for Medical Devices
A group of representatives from Advanced Molding Technologies—David Johnson, Engineering Manager; Steve Fischer, Senior Manufacturing Engineer; Ryan Fuhr, Senior Manufacturing Engineer; Sven Nelson, Project Manager; and John Haley, VP of Operations—was a part of the staff written article, “Molders Address Biggest Device Issues.” They took time to present an array of responses that were not all able to be included in the article, so they are presented here.
Q: How can medical molders help device designers achieve compliance with the upcoming UDI rule?
Johnson, et al: “A UDI is a unique numeric or alphanumeric code that includes a device identifier, which is specific to a device model, and a production identifier, which includes the current production information for that specific device, such as the lot or batch number, the serial number and/or expiration date”—FDA.gov.
The most basic steps in helping device designers achieve compliance with the upcoming UDI rule are first researching and investing in UDI technologies. Molders must first be educated on the rule and in position to offer the capability to customers i.e. investing in a new laser technology. Furthermore, medical molders can help facilitate the unique marking of individual devices by working with material suppliers to recommend base resins or additives that react favorably with specific wavelengths of lasers to promote readability.
Q: What features are most important to device designers to achieve through molding material selection?
Johnson, et al: The most effective way for molders to help designers with material selection is to be involved early with the DFM and Risk Assessment (phases) of their products. With an understanding of the need for chemical resistance, radiation resistance, complete absence of organic additives, BPA concerns, etc., molders can be an integral part of determining the optimal materials.
For example, When Advanced Molding was approached by our customer that needed parts free of animal derivatives due to concerns that prions could survive the injection molding process, we partnered with them to develop a custom, Animal-Derived Component Free molding work cell. The ADCF clean room environment continues to produce product according to plan, making Advanced Molding Technologies one of the few companies able to produce ADCF certified parts today.
There is a trend with polycarbonate parts/applications being specified with alternative materials that are BPA-free. Common replacement materials are co-polyesters. Advanced Molding has experience with the complex tool design and process development required for these difficult-to-mold materials.
Q: How are the capabilities realized through micro molding changing medical device design?
Johnson, et al: The improved capabilities to mold smaller and smaller parts are allowing medical devices to become smaller and to be used in new applications.
- Allows for smaller components and/or material substitutions. Also allows for lower cost components (example machined component replaced with injection molded component). Can allow for elimination of aqueous washing or other cleaning operations, as compared to machined components.
- May allow more complex geometry than machining.
Q: What type of molding technique is gaining more interest with medical device engineers?
Johnson, et al:
- Mold temperature control via superheated water (instead of “dirty” oil or electrical)
- The use of superheated water temperature control provides the most efficient, cleanest, and safest way to maintain mold temperatures. These have proven successful for AMT; plans eliminate all oil heaters and replace with superheated water.
Q: How are molders addressing the movement to more patient-based devices?
Johnson, et al:
- Soft-touch overmolding
- Human Factors prototyping
- Higher-volume cleanroom molding
- Pad printing and other decorating at the molding machine
- More mechanization and automation at the molding machine
- Molders more involved in material selection
- Chemical stress testing
Q: Where is medical molding headed over the next five to ten years?
Johnson, et al:
- Device marketers who have no desire to “in-source” molding are looking to reduce their supply base, thus looking for more value-added from each remaining supplier.
- Advanced Molding has capability for complete turnkey medical device assembly including all supply chain management, molding, assembly, packaging, and sterilization management.
- More need—ADCF…DNase/RNase free—As mentioned above with ADCF, AMT’s experience will allow us to take the next step and provide RNase/DNase free product.
Q: Any thoughts/comments on molding or another related area that you would like to share with medical device manufacturers to aid them?
Johnson, et al: Device manufacturers should look for molders who:
- Actively strive to provide up-front DRM input
- Are well-versed in IQ/OQ/PQ
- Understand the entire device development and approval process