mdi Consultants, Inc. has helped many In-Vitro Diagnostic Device companies through a number of difficult research and development problems and issues. Can you respond “yes” to any of the following questions:
1. Do you lyophilize your calibration controls, antibodies or any other reagents?
2. Do you recommend, to your customer, to refrigerate reagents, once opened?
3. Do you ship your diagnostic kits with ice packs?
4. Do you experience lot-to-lot variations?
5. Do you have reagent stability issues?
6. Are you looking for lot-to-lot consistent, room temperature stable reagents that require no reconstitution?
7. Do you need R&D assistance to develop a new product?
If you have answered yes to any of these questions, we may be able to help you.