Medical Device Turnkey Solution

Globe has developed a solid reputation in the United States and around the world for developing turnkey solutions (a one-stop service) for medical devices.  Check out a few of our Success Stories!

The Product Turnkey Solution integrates all phases of new medical device development: from design through prototyping, mass production, and regulatory approval.  Our projects ranging from simple IV tubing sets to complex electronic drug delivery and patient monitoring devices with pc interfaces that include software design with FDA safety validation.

Advantages of Product Turnkey Solutions:

  1. Extensive integrated solution reduces trial and error in the design and development phase.

  2. Improve your product development speed and quality.

  3. Our in house team can integrate design, regulation requirement, assembled prototype, injection molding, assemble finished functional sample, develop quality assurance and manufacturing process that will provide you a one stop solution and eliminate all possible project management headaches.

  4. Simplify your prototyping by providing fully assembled and tested functional samples. We also provide engineering opinions throughout prototyping in order to improve the design for better molds and mass production assembly capability.

  5. Reduce the difficulties for coordinating different outsourcing engineers and contractors.

  6. Eliminate the hassle of negotiating with, and coordinating multiple external suppliers for each stage of the project. In the US, for example, most prototype supplier only provide individual components, once these are acquired you still have to find another company (or tools) to assemble them, and yet another to predict future feasibility and effectiveness of mass production.

  7. Material selection at the earlier design stage. We can help you to evaluate the availability and cost factor for FDA certified suppliers (in the US or Asia) or other local materials for different market target. In this early stage, we can provide a more accurate and cost effective finished unit (includes medical grade pouch and sterilization) for your investment / profit evaluation.

  8. We can develop and organize the FDA 510K required documents during the entire turnkey process. For example, to develop and conduct the followings: design control, performance and function test, shelf life test, reliability test, manufacturing and sterilization validation, biocompatibility test, etc. You can save time and money for FDA 510K submission by early involvement.

  9. Reduce cycle time by integrating the design, molds and assemble all at beginning stage.

  10. Provide options for different market targets. For example, US FDA and the China FDA have different certified programs for material suppliers and clinical safety factors which result in different pricing structures. You have options to supply the US market and third world market with different medical grade materials.

  11. Increased materials savings by reducing scrap rates and optimizing materials usage.

  12. Better mold design, consistent quality, and shorter injection production cycles due to the early integrated development.

  13. Greatly enhanced manufacturing efficiency.

 

Phases of Turnkey Medical Device Development

Phase I: Design and Development Review - Concept, design draft and patent evaluation and recommendation

Phase II: Engineering - 2D & 3D Design Material selection, specifications, regulations, ISO standard, etc.

Phase III: Prototypes - Assembled and tested, for initial design verification

Phase IV: Sample Molds - Single cavity injection molds (for plastic parts) and metal tooling (for metal/steel parts) based on final approved design

Phase V: Assemble Functional Sample (as finished product in sterilized pouch) - from one cavity sample molds for bench testing, FDA application, and investor evaluation

Phase VI: Production Molds (multi-cavity) - for mass production with monthly output starting from 50,000 units.

Phase VII: Manufacturing Validation and Quality Assurance Programs - Implemented in preparation for production

Phase VIII: Mass Production

Phase IX: FDA 510K Submission (if necessary)

 

Our Product Development Cycle can save you to 20% to 30% in cost & time

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Turnkey OEM brochure.pdf255.06 KB