Saint-Gobain Medical Molded Parts

Considerations When Choosing a Silicone Molding Partner for Medical Device Components

When looking for a collaborator in any business, you should strive to find the right fit – someone who will push you to new heights, challenge you to think differently and guide you through the unknown. This is particularly important in the medical device component industry, where not only time and quality matter but, ultimately patient outcomes. With resilience in the value chain becoming top of mind post-COVID, here are some considerations when looking for a molding partner:

  1. Molding experience and deep material expertise
  2. Design for manufacturability (DFM)
  3. Innovative Tooling Strategy
  4. Quality Culture and Change Management 

Understanding Material Properties for Molding Design 

 Custom molded medical components from Saint-Gobain
Custom two-shot molded Saint-Gobain medical components.

To properly meet design specifications, your molding partner must understand material properties such as melt flow rates, density, tensile strength, elongation, and shrink rates. How much understanding do they have related to silicone interactions with other materials?  

From overmolding metal inserts to covalently bonding polycarbonate to silicone via a two-shot molding process, understanding the material properties differences between covalent and mechanical bonding of silicone is critical to ensure that materials maintain strong adhesion.  Dive deeper into the topic of two-shot molding.  

In addition to adhesion, how much does your molder understand about the elasticity of elastomers? A good understanding of elasticity is important when using silicone in pumping applications, as it plays a critical function in establishing the ideal fluid flow rate and the ability to create critical seals in devices such as glucose monitoring devices. 

Design for Manufacturing (DFM) 

When evaluating the DFM competencies of a molding vendor, it is critical to assess if they will be able to deliver the optimal component at scale – without having to make concessions on your part design. Many factors must be taken into account when evaluating how to scale your part design such as parting line locations, proper gating, overflows, de-molding, and packaging automation. For example, while a single cavity mold prototype can be de-molded manually by an operator, higher cavitation then requires a pick-and-place robot to de-mold the parts and place them in position for packaging.  

Best in class design for manufacturability starts with prototyping – does your molder have in-house prototyping services? Capabilities to look for in prototyping services include in-house tool design & fabrication, dimensionally accurate prototype parts, fully functional models, production intent material, and molding-grade steel. Prototyping allows for early risks to be taken during early development phases to prove concepts, so risks are lowered before later stages during production launch. 

Tooling Capabilities  

Do they have internal tooling capabilities and deep external partnerships both locally and globally? The combination of internal tooling capabilities and strong external partnerships enables flexibility to offer a range of tooling options that can be selected to match the project timing, budget, and level of part design complexity.  

Additionally, your molder should have an internal tool room to support and maintain your tooling for production. The preventive maintenance schedule should be laid out at the start of the project and having preventative maintenance occur in-house can reduce the amount of time the tool is out of service.   Preventative maintenance is essential to maintaining production effectiveness.

Repeatability Over Time

After asking if your molder can produce the part at scale and automate from one cavity to full-scale the next question is: Can they do it repeatedly? This is a result of having validation procedures in place and proper Acceptance Quality Limit (AQL) monitoring during manufacturing. It’s important that the first component is the same as the last component or you could be facing unforeseen delays and costs due to poor quality. Defective components can contribute to Costs of Poor Quality (COPQ) such as scrap, rework, additional inspections, and even recalls.  Do they have the appropriate certifications such as ISO 9001 or 13485? International standards help you know that your molding partner meets regulatory and quality management system expectations. 

Mitigating Supply Risk Through Strong Quality Culture  

Once your project is taken to scale with ongoing production, how well does your molding partner manage when the unforeseeable happens? The global pandemic taught us that the global supply chain is constantly in flux and raw materials can go out of stock at a moment's notice. Does your molder have the internal project management resources and change management competencies to help you mitigate supply chain risk?

As a key supplier of components to the medical device industry, we understand the crucial role that strong change management protocols play in ensuring the quality and reliability of our products. In an industry where precision and safety are paramount, our commitment to implementing robust change management processes is fundamental. These protocols serve as a systematic framework, allowing us to navigate the complexities of evolving regulatory standards, technological advancements, and market demands. By adhering to stringent change management practices, we not only enhance the quality and safety of our components but also contribute to the overall reliability of the medical devices manufactured by our clients. This structured approach enables us to assess and implement modifications efficiently, minimizing risks and ensuring compliance with the highest industry standards. In essence, our dedication to a strong change management culture reflects our unwavering commitment to delivering components that meet the evolving needs of the medical device industry while prioritizing patient safety and well-being.

Saint-Gobain Medical, your trusted silicone molding expert 

Saint-Gobain Medical works to find the optimal solution to your silicone molding challenges. With decades of experience in developing custom solutions for medical devices, we can draw on our expertise and experience when presented with the complex. We take risks and try new things. Learning what not to do is as important to our process as what to do. We are energized to help you develop your next breakthrough solution to help enable better patient outcomes. Let’s get started on your next project.