Working with Globe

What are the steps to creating your new medical device?

Step 1: Contact us!

turnkey solution brochure new product evaluation standard nda
1. Review our Turnkey Solution (link: Turnkey Solution Advantage.pdf) and the phases of development 2. Fill out our New Product Questionnaire (link: New Product Questionnaire.doc) 3. Execute our standard NDA (link: Globe's Standard NDA .doc) or send us your version for consideration

We will return the executed NDA (normally on the same day)

Step 2: Tell us about your device.

If available, please send us:

  1. Instructions for use (step 1: do this, step 2: do that, etc.)
  2. Patent information (status, application document, approved patent, etc.)
  3. Device drawings (3d models in solidworks or proE are best but engineering drawings or hand drawings are helpful as well)
  4. Samples (functional or bench prototypes, product samples, similar product samples to highlight features, etc.)

Next: We provide a quote

We will provide you a quote to reach your unique development goals and schedule a time for a conference call to discuss it further.

  • When would you be available to discuss the project with our team? (please provide dates and times available)

The Turnkey Solution process includes either all (or any one of ) the following steps/sequence:

  1. Develop design criteria per FDA and ISO guidelines
  2. Select USP Class VI biocompatible materials
  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

See the many Turnkey Solution Advantages


 

Once you have functional samples we can potentially introduce you to investment partners.

We recommend you have the following:

1.       Marketing evaluation and plan (business plan would be even better)

  • Market information and plan (market size, target market, similar products, etc.)

  • Business plan (sales goals, licensing goals, timeline, etc.)

2.       For some products we can make assembled prototypes that are good for verifying design concepts and may be presentable for investor evaluation.

3.       Functional samples with FDA medical grade material for clinical testing and investor evaluation. 

AttachmentSize
New Product Questionnaire.docx26.69 KB
Globe Standard NDA.docx34.57 KB
Turnkey Solution Advantages.pdf422.97 KB