Bridging Material Science and Regulatory Confidence in Medical Device Design
In the world of advanced materials and medical devices, precision and reliability are paramount. At Syensqo, we leverage cutting-edge tools and global expertise to ensure our customers achieve optimal material selection and design for their parts. One of the standout tools in our arsenal is Computer-Aided Engineering (CAE), which plays a crucial role in bridging the gap between material science and practical applications. Coupled with our comprehensive regulatory support, we provide a seamless pathway from design to market compliance.
Global Expertise, Local Support
Our team of CAE experts is strategically located across the globe, with offices in Alpharetta, Brussels, and Shanghai. This global presence allows us to offer regional support while maintaining a comprehensive, worldwide perspective. Whether you're in North America, Europe, or Asia, our experts are ready to assist you with your specific needs.
Connecting Material Science with Practical Applications
The primary goal of our CAE team is to connect material science with practical applications. We utilize a variety of simulation tools to achieve this, with Moldflow often being our first step in addressing design-for-manufacture concerns. Moldflow simulations help us answer critical questions such as:
- Can the cavity be filled?
- Is the gate in the best location?
- Will the part warp?
These simulations are vital for designers and molders to optimize material performance and ensure manufacturability. By identifying potential issues in the injection molding process early on, we can address them before they lead to costly delays or part failures.
Advanced Structural Analysis
In addition to Moldflow, we conduct structural analysis to verify if a component's design and specified material are appropriate for expected use cases. This helps our clients make informed decisions regarding material selection and design optimization. For example, we can determine:
- Does the part have adequate strength and stiffness?
- Has the right material been chosen?
- What happens at elevated temperatures?
For more advanced analyses, our CAE experts utilize coupled physics simulations to account for fiber orientation effects, strain rate dependence, or specific failure initiation criteria. We are continually developing new simulation capabilities to push the boundaries of what is currently possible.
Virtual Prototyping and Material Models
Our specialized CAE tools enable virtual prototyping, allowing us to accurately predict a part’s performance before creating a physical prototype. This is made possible by the advanced material models, or material cards, which our CAE team creates and validates. These material cards are available for many of our product grades and can be shared directly with customers, enabling them to design confidently with our materials.
Application Development Labs: A Hub for Innovation
Beyond CAE, our Application Development Labs (ADL) serve as our hub for innovation. Our team of technical experts designs customized, application-specific tests to investigate new ideas and prove out novel engineering concepts. Equipped with sophisticated manufacturing and fabrication tools, our ADL team focuses on the actual parts that our customers design and manufacture.
Our labs are also equipped to perform specialized secondary operations such as laser marking. In response to updated FDA UDI guidelines, we designed a rigorous study to evaluate our healthcare materials. We optimized laser-marking parameters and ensured the durability of the marks through repeat exposures in our on-site, hospital-grade sterilizer.
Comprehensive Support for Healthcare Applications
Our Application Development Team doesn't just support design; it's pivotal for application-level testing, developing custom testing protocols when standard procedures don't suffice, and ensuring our materials meet the highest standards in healthcare fields. The ADL is home to many creative engineering activities driven by the collaboration of Syensqo’s cross-functional teams. We invite our customers to visit and engage with us, fostering a collaborative environment.
Unmatched Regulatory Support
Complimenting our global technical support of customers, our regulatory experience is also global, with extensive supporting documentation. We adapt our documentation to updates in ISO 10993 standards for the assessment of biological safety and maintain Master Access Files in Japan and with the US FDA. We also have a long history of collaboration with Notified Bodies in Europe.
In Asia, particularly China and Japan, we work directly with the NMPA and PMDA to ensure our materials meet regional requirements, supported by our in-country Product Stewardship teams and partnerships with organizations like NAMSA. Our ongoing regulatory efforts keep us informed of the latest global changes, from CA Prop 65 to the EU’s REACH SVHC regulations.
Commitment to Excellence
Supporting customer applications is at the heart of what we do. Whether it's maintaining ISO 13485 for our quality management system, offering ISO 17025 accredited lab testing, or providing lot release testing for Solviva® biomaterials, our support is comprehensive. For our implantable grade materials, it's about more than just meeting standards; it's about robust manufacturing and quality testing procedures that solidify trust in our brand.
A Collaborative Approach to Innovation
Innovation in healthcare is a collaborative effort that requires synchrony between cutting-edge material science and stringent regulatory standards. At Syensqo, we work closely with our partners to understand their unique challenges and offer tailored regulatory strategies that align with their innovative goals. This synergy between innovation and compliance fuels the healthcare advancements of tomorrow.
Your Partner in Medical Innovation
In Syensqo’s journey of innovation, regulatory support isn't just a service—it's a cornerstone of our commitment to advancing healthcare. We are here to guide you through the regulatory maze and provide materials that stand the test of time and scrutiny. If you are looking to bring a medical innovation to life, reach out to us at Syensqo.
To learn more from our experts, visit our Expert Talk series.
