Accelerate Your Product Development
Applying Biomaterials with Exceptional Results
Develop and commercialize your medical device, delivery system, or single-use solutions with the support of our product development teams, who can expertly integrate applied biomaterials that optimize your innovation.
Development Levels from Off-the-Shelf to Expansive Customization
We partner with you at every stage of development, beginning with accessible off-the-shelf options for rapid prototyping and evolving into fully customized solutions tailored to your specific needs. Our collaborative approach ensures solutions are developed efficiently, with transparent communication and expert guidance throughout.
Off-the-Shelf Options
To help customers get started quickly, we offer a range of off-the-shelf (OTS) textiles, thin polymer films, and single-use solution options. These readily available materials and products enable rapid prototyping and initial concept development without the need for custom fabrication. By using proven, validated fabrics or films as a starting point, customers can efficiently evaluate designs and performance, reducing lead times and costs before moving on to more advanced or customized solutions. Ready to prototype? Get Polyzen film quick on Chamfr. Shop now!
2D Structures & Post Processing
MedTech innovators seeking the next level of customization can utilize our OTS materials by specifying them to exact requirements. Additional processes such as laser cutting, heat treatment, ultrasonic welding, and sealing can create specific shapes and characteristics.
2D Structure Customizations
Additional properties can be modified to optimize your polymeric or textile solution. Examples include adjusting thickness, lubricity, porosity, color, permeability, and more. Our team can determine what processing techniques and materials are best suited to meet your requirements.
Custom 3D Structures
While OTS fabrics enable customers to rapidly prototype their devices with validated materials, our advanced manufacturing capabilities allow the creation of fully customized three-dimensional shapes, tailored to meet the unique needs of your device or application. By leveraging specialized textile engineering and innovative polymer processing techniques, we can produce complex 3D structures—from seamless tubes and multi-layered scaffolds to intricate geometries—designed for optimal function and integration. This flexibility allows customers to move beyond standard materials, opening new possibilities for device performance, fit, and clinical outcomes.
Off-the-Shelf Options
Charter Medical’s portfolio of customizable polymer-based single-use solutions for biological fluid handling, cell growth, and cryopreservation can help you bring efficiency, flexibility, and scalability to your biological product manufacturing processes. From early-stage development to commercialization, Charter helps you bring your next breakthrough therapy to life with transparent collaboration, nimbleness, and proven expertise.
Single-use Customization
Whether you need simple or complex solutions, Charter Medical can work side by side with you to customize your cell-based fluid management processes. Leveraging Charter’s standard component library, you can develop and integrate unique bag geometries, connectors, filters, sensors, and manifolds into your biological product manufacturing processes, all while ensuring the materials they’re made with work best for your applications, from benchtop to bedside.
Our 3-Step Integrated Product Development Process
Our product development process is built on a collaborative, stage-gated approach that transforms breakthrough concepts into manufacturable solutions. It begins with an in-depth consultation to understand your application, performance requirements, and design constraints.
Feasibility to Design Freeze
- Collection of Product Requirements
- Material and Tooling Decisions
- Feasibility Trials & Assessment
- Manufacturing Technology Selection
Process Scale Up to Process Freeze
- Product Design Specifications
- Scalability Assessment
- Design of Experiments
- Test Method Validation
- IQ & OQ Reports
- Test Method Development
- Risk Management Documentation
Process Qualification
- Process Qualification Strategies
- Validation Execution
- Manufacturing Plan
- Product Transfer to Manufacturing
Our Multidisciplinary Team
We leverage advanced modeling, material science expertise, and rapid prototyping to iterate quickly, ensuring feasibility and alignment with your goals. Rigorous process verification and risk analysis are integrated at every step, while our process validation ensures your solution meets regulatory and manufacturability standards.
Throughout the journey, our technical experts work as an extension of your team, providing transparent communication, real-time problem-solving, and a clear path from ideation to scalable production. Key considerations during the development process include:
- Assessment of clinical and engineering requirements
- Identification of structural and design concepts
- Evaluation of biomedical challenges
- Narrowing of performance characteristics
- Optimization of design
Customization that Solves Your Challenges
Using Secant’s textile capabilities, Polyzen’s polymer technologies, and Charter Medical’s single-use solutions expertise, we can collaborate with you to develop a manufacturable component such as:
- A stent graft textile for your final medical device,
- A low-pressure balloon or catheter sheath for your delivery system,
- A bag or filter for your biological product manufacturing processes.
With customization in materials and processing technologies, the possibilities are endless.
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