Our Process

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With over 30 years in the OEM space Facet Technologies has developed a process that delivers the product you want, the quality you need.

Concept

At Facet, we know how to transform your ideas and business needs into products that perform in the marketplace.

Have a design IDEA or concept for a new medical device?

  • Facet’s experienced project management team would like to meet with you to understand your concept and show you the benefits Facet will provide in bringing your idea to life.
  • Facet understands the need for the highest level of confidentiality when creating new products.
  • Our first step prior to meeting and sharing ideas will be a Non-Disclosure Agreement to protect your vision.

Research

Facet has a developed history of in-house user studies and a vast database of medical device clients allowing us to perform market research of new and current products.

Facet will RESEARCH the needs and wants of your consumers.

  • Investigational Market Research
  • User Studies
  • On-staff certified clinical research professional to develop clinical protocols and perform user studies
  • Clinical lab includes a one-way window, allowing Facet to invite our partners to observe research as it is performed

Design

Our Design Team excels at creating high quality products that exceed customer expectations.
Facet’s R&D team will take your concept, paired with research results, and bring it to life through DESIGN.

Facet offers expertise in:

  • Product Styling
  • Ergonomic Analysis & Design
  • Mechanical Design
  • Intellectual Property
  • Reliability Testing

Facet's design studios offer state of the art technology, including:

  • 3-D Solid Modeling (ProEngineer and SolidWorks)
  • Rapid Prototyping (3D Printing)
  • Allows us to quickly provide functional product models for trade shows and demos

Facet's Design Team consists of:

  • Accomplished Project Managers
  • Industrial Designers
  • Mechanical Engineers
  • Regulatory & Quality Professionals

Preproduction

Facet’s team works in close cooperation with an extensive, international network of manufacturing partners to produce high quality tooling to support the market needs of your product.
Facet’s PREPRODUCTION work helps ensure medical device quality.

Established molding partners in multiple countries

  • Low-volume prototype tooling
  • Test devices to ensure design meets marketing requirements
  • Iterate design through testing and data analysis
  • High-volume production tooling
  • High cavitation, very high volume production tooling

Automated Assembly

  • Performed at Facet’s manufacturing facilities
  • Facet also offers availability of offshore automated assembly manufacturing facilities in multiple countries

Manual Assembly

  • Performed at Facet’s facilities
  • Established offshore options readily available

Verification and Validation

Based on the design created for the new device and samples made during preproduction, Facet’s team will conduct Verification and Validation activities to ensure the device satisfies all requirements and specifications prior to commencing full scale manufacturing.

We execute VERIFICATION and VALIDATION processes prior to manufacturing

  • Installation Qualification (IQ)
  • Operational Qualification (OQ)
  • Performance Qualification (PQ)
  • Design Verification Testing (DVT)
  • System Validation and Clinical Testing

Manufacturing

Our customized production processes are designed to ensure that your device volume, quality, and cost targets are achieved.
Facet’s flexible MANUFACTURING systems offer versatility to accommodate a wide spectrum of production requirements from manual assembly to automated high-speed

Put our manufacturing expertise to work for you

  • All equipment is built and maintained to the highest cGMP Standards
  • Facet employs a highly trained, qualified and experienced workforce to ensure fulfillment of all requirements while operating in an FDA environment
  • Facet utilizes efficient manufacturing processes to minimize waste while maximizing product flow and provide consistent quality throughout the production process
  • Facet offers 30 years of experience working with offshore production facilities

Our manufacturing facilities are:

  • QSR/cGMP Compliant
  • ISO 13485:2003 Certified
  • FDA Registered

Fulfillment

Facet’s skilled Storage and Distribution Managers, along with our 30,000 square foot warehouse, enable us to quickly and accurately fulfill customer’s orders.

Facet FULFILLS your product.

  • Facet takes pride in a clean and orderly stockroom and shipping dock.
  • Facet will work with your carrier of choice to have shipments made in the mode and specifications that meet your needs.
  • Facet’s Quality System ensures products and components are inspected and documented upon receipt and prior to release for shipment.