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  3. Prototyping and Tooling

Prototyping and Tooling

Functional, Effective, and Fast Prototypes 

Whether it is a product freshening or a completely new design, iterative improvements are part of the innovation process.Medical device component prototypes can give you the opportunity to try different manufacturing options and processing methods to ensure that a part is producible and well designed for your medical device needs.Saint-Gobain stands ready to assist you to test your medical device design, make revisions and explore creative options that could make it even better than you imagined.Bring us your concept or drawing, and we can quickly produce an advanced prototype from production intent material.

Let Saint-Gobain make your drawings come to life in the form of a rigid 3D model or a functional silicone component, and beyond.

Our teams of engineers and designers will work with you in developing a manufacturable design and recommend a material that meets your performance requirements.We leverage Saint-Gobain’s in-house tooling design expertise and our established relationships with tooling manufacturers to produce quality molds using advanced molding-grade steel and precise, high-speed CNC machining.With the ability to test multiple designs throughout the pre-production phase, rapid prototyping will help you to get your medical device to the market as fast as possible.

Through our prototyping process, Saint-Gobain offers:

  • Dimensionally accurate prototype parts
  • Fully functional models
  • Production intent material
  • Full IQ/OQ/PQ and article validation
  • Single cavity tools
  • Molding-grade steel  

At Saint-Gobain, we understand and meet your most urgent needs. We offer experience, superior quality and our commitment to excellence throughout the design and development process. To learn more about how our prototyping services can meet your application needs,contact us.

Tooling: From Prototype to Production

Critical medical procedures rely upon a physician's knowledge and expertise, but also on the quality and consistency of the medical devices being used.As a result, part design, raw material choice and manufacturing techniques can greatly impact the performance of medical devices and patient outcomes.

Saint-Gobain is an industry leader in developing prototype and production tooling for silicone and thermoplastic molded components.Our teams of engineers and journeymen toolmakers work together, combining decades of experience with state of the art machining equipment including CNC and EDM machines with the latest design support software to design and manufacture a precision tool for your specific project needs.

Fast Track to Product Launch

Time is of the essence when it comes to the development and launch of new products. Saint-Gobain's in-house tooling services help you take your products to market faster by eliminating outside vendors, hidden problems and possible delays. Working closely with your engineers, we will design and build a prototype mold that is capable of producing production quality parts in a fraction of the time and at reasonable cost.

Our fast-track approach to prototyping means you have quality parts quickly for evaluation and testing. Throughout the iterative prototyping process, we work with you to fine-tune and modify the tool to accommodate design changes that result from your prototype testing and analysis. These iterative steps can then be carried over to the production tool, minimizing process development times and helping to keep your project timeline on track.

Saint-Gobain's application and tooling engineers are available to assist you in transitioning your design concepts to successful medical devices.

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About Saint-Gobain

Saint-Gobain designs, manufactures and distributes materials and solutions which are key ingredients in the wellbeing of each of us and the future of all. They can be found everywhere in our living places and our daily life: in buildings, transportation, infrastructure and in so many industrial applications.

 

Saint-Gobain Performance Plastics' group of businesses gather solutions to save energy, provide protection, improve comfort and sustain the environment for a variety of markets.

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Saint-Gobain’s medical products are distributed exclusively to medical device manufacturers for use in the manufacture, assembly or distribution of their medical devices. Saint-Gobain cannot authorize the sale of its medical products directly to device user facilities (e.g. hospitals, surgery centers, nursing home, clinics, etc.), nor directly to end users (e.g. patients, patients’ caregiver, prescribing physician, nurse, pharmacist, etc.), including distributors serving device user facilities and end users directly. In accordance with every jurisdiction globally, Saint-Gobain’s customers are responsible for determining that any medical device they manufacture and market that incorporates a Saint-Gobain’s medical product, is compliant with each country-specific medical device regulations and has received proper country-specific clearance, certification or registration authorizing the sale of this medical device.


Saint-Gobain’s medical products offer covers:
- Medical Components [21 CFR 820.3(c)], intended for processing or use in the manufacture or assembly of medical devices before the finished medical device is packaged/labeled; Medical Components are intended to be included as part of the finished, packaged, and labeled device [21CFR820.3(c)].
- Finished Devices [21CFR820.3(l)] made on behalf of medical device manufacturers [21 CFR 807.20(a)(2)] under contract-manufacturing agreement. In accordance with the United States’ jurisdiction, Saint-Gobain complies with the FDA’s requirements for contract manufacturers of finished devices.

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