Your Integrated Solution

The two-time winner of the Medical Design Excellence Award (MDEA Award 2008 and 2010 by UMB Cannon, USA read more) for drug delivery technologies and one-time winner for supplier, Globe Medical Tech, Inc., based in Houston, Texas, has over 20 years experience in integration of product design, development, injection mold making, cleanroom injection molding, and manufacturing, and is a leader in providing turnkey solutions for safety medical devices and drug delivery systems.

With expertise in electromechanical and software design integration, Globe Medical Tech provides comprehensive services for each stage of product development, from patent analysis, sophisticated engineering design, and prototype validation to assistance in FDA clinical trial testing and low-cost clean room manufacturing in China.

Discover the stages of new medical device development:

  1. Develop the design criteria per FDA and ISO guidelines
  2. Select materials per your application's requirements including implantable USP Class VI biocompatible
  3. Competitors and market analysis (Option)
  4. Provide finish product cost (in sterilized pouch) estimate for investment evaluation, (In early design stage)
  5. Patentable technologies analysis and development (Option)
  6. Make assembled, testable prototypes to verify initial design
  7. Develop engineering documents for FDA 510k submission (Option)
  8. Make one cavity injection molds for functional sample purpose
  9. Make 1,000 (or as requested) function sample (In sterilized pouch) for clinical/hospital trial and FDA lab test
  10. Make multi cavities production molds to prepare for mass production
  11. Prepare manufacturing/sterilization validation and small pilot run
  12. Develop product quality assurance program per FDA guidelines
  13. Make 1,000 to 10,000 finished product for market evaluation
  14. Develop FDA 510k master file and tests for FDA 510k submission
  15. Start mass production

Integration means you pay less for more: 20 plus years experiences in medical device / drug delivery system design, development and manufacturing means you save time, money, and effort with experienced, efficient, and cost effective operations.

See the many Turnkey Solution Advantages > 

 

Our Key Strengths & Technologies Demonstrated by the following devices:

I. Drug Delivery Devices:

  • Safety prefilled syringes (single and dual chamber) with vacuum auto-retractable needle, Collapsible plunger technology to reduce package and storage volumes of prefilled syringes.
  • Needle free connectors
  • Insulin pump
  • Vacuum-operated auto-retractable safety syringe and IV catheter
  • Wireless programmable drug delivery device (waterproof, 3 days dosage or longer)

II. Silicone Implantable (short and long term) device:

  • Liquid injection molds for silicone rubber with assembled prototypes in one month

III. Patient Monitor and Recording Devices:

  • Blood pressure and Oxygen, Temperature sensor, blood oxygen, and syringe injection flow speed sensor development
  • Software design and validation
  • Power management
  • PCB (circuit board) and LCD screen development and integration
  • PC input / output, data transfer by USB or wireless

IV. Electrical Surgical Devices:

  • Motorized electrical handpieces
  • Electrosurgical pencil
  • Motor driving technology to minimize vibration and noise
  • Heat transfer, metal housing, stainless axis system
  • Rechargeable battery pack and speed adjustment, autoclavable materials

V. Traditional Infusion Devices:

  • IV administration set, Burette set, blood transfusion set, IV auto stop device, needleless connector

See photos and details in our Success Stories >