Medical Device Prototype Design and Development

Medical Product Design & Development

  • 20 years of award winning medical product design experience
  • Has designed numerous medical products – surgical devices, drug  delivery systems, complex electronic systems with computer interfaces
  • Talented and experienced designers located in US and China

Globe's engineering design & development services include:

  • Integrated FDA, ISO, and OSHA design guidelines
  • Medical grade materials selection for biocompatibility and sterilization method (steam, ETO, or Gamma Ray)
  • Medical grade packaging and sterilization validation
  • Provide finished unit cost analysis during the design stage
  • Electronics design
  • Detailed quality assurance program development
  • In-house class 100000 cleanroom manufacturing

Prototyping (Functional Samples) Prototyping

  • Globe's engineering and design team provides precision machine cut medical prototypes to get an idea of its form, touch, and feel.  Make a quick adjustment to your medical product and accelerate time to market.
  • The finished functional samples are made with single cavity injection molds inside our class 100000 cleanroom manufacturing facility.  Assembly is also completed in the manufacturing facility.
  • In-house FDA medical grade packaging and ETO sterilization with sterilization validation 
  • Rapid development process from design to functional samples (good for FDA lab testing, investor evaluation, etc.) ensures your ability to quickly bring new ideas to marke

Injection Molding

  • Mold toolmaking
  • Class 100,000 cleanroom injection molding
  • Test molds/sample molds
  • Multicavity production modling
  • Blow molding
  • Co-injeciton molding
  • Composite molding
  • Compression molding
  • Flashless rubber molding

FDA Regulatory

  • Support the full spectrum of services provided from design, manufacturing, quality, regulatory submissions and compliance
  • FDA regulatory consulting
  • Regulatory approval for USA FDA including FDA 510k submission, Europe CE mark, Japan, China, Taiwan, Philippines, and around the world
  • Certificated to International Standards ISO 13485
  • Medical Electronic Design

  • Sensor development
  • PC interface and wireless communication
  • Biosensor wireless technology
  • Software and hardware design applicable to different medical device and development
  • Electronically power management
  • Digital electrosurgical suction medical device