1. New Product Development Capabilities

    Synectic is a full service, ISO 13485 and 9001 certified, medical product development company. Founded in 1981, Synectic develops medical products for clients on a contract basis. We offer the following services.

    Custom Mechanical, Biomedical Engineering and Industrial Design

    Synectic’s design team is composed of senior level mechanical, electrical, biomedical and industrial designers with diverse backgrounds and experiences.
    Custom Design process:
    • Product Development Specification (PDS)
    • Intellectual property review and strategy
    • Competitive Device Analysis
    • Concept generation/brainstorming
    • Quality documentation per ISO13485
    • Concept matrix
    • Initial concept design using Solid Works or Pro Engineer
    • Initial prototype development
    • Bench and tissue testing
    • Finite element analysis (FEA)
    • Tolerance Analysis
    • Engineering Drawings in client’s formats
    • Regulatory Strategy

    Electrical Engineering

    • Analog and digital circuit design
    • Custom circuit design and validation
    • Capital equipment / electrical testing fixtures design and validation
    • Design for electrical safety : 60601-1 compliant
    • Embedded systems
    • RF and Blue Tooth design
    • Flex circuit design
    • PCB layout and test fixture design
    • Gerber file design
    • Schematic generation
    • Software design and validation
    • Graphical User Interface (GUI)
    • Microprocessor programming

    Quality and Regulatory Support

    Synectic’s quality and regulatory department has over twenty years of experience in quality system’s and regulatory affairs services. We have a certified ISO 13485:2003 quality system that complies with the FDA’s 21 CFR Part 820 regulations.

    Rapid Prototyping

    Synectic has the capabilities through strategic partners to produce high quality rapid prototypes at a low cost.
    Capabilities Include:
    • CNC Milling, turning and laser welding
    • Machining
    • Wire and Plunge EDM
    • SLA / SLS / FDM
    • Aluminum Molding
    • Metal Stamping
    • Extrusions
    • Dip Molded Balloons
    • Blow Molded Balloons
    • Staple Formation
    • Electrical board fabrication
    • Nitinol, Stainless Steel, Titanium, Elgiloy implants
    • Absorbable and non-absorbable

    Voice of Customer

    Synectic has the capabilities to conduct “Voice of Customer” research for developing the customer needs and clinical requirements documents prior to developing products. This voice of customer capabilities can be local or national and single or multisite studies.

    Contract Manufacturing

    Synectic is a full service design and manufacturing company supporting the customer needs from concept development through low or high volume manufacturing.

    Capabilities Include:
    • Process development
    • Design for Manufacturability or Assemblability
    • Component sourcing and validation
    • Assembly tools, fixture design and fabrication
    • Line layouts, BOM development
    • Process FMEA
    • Process and product validation
    • Sterilization validation
    • Packaging design and validation
    • Device Master Records
    • Quality Documentation