The value proposition of Medi-Card is to simplify the self-administration of epinephrine through a device that is comfortable to use, easy to carry and less expensive to purchase.  The device addresses consumers’ most important needs (see Section 4) in a number of ways.  It is similar in dimensions to a credit card and can easily fit in a person’s wallet or on a key chain, making it simple to carry.  Its form allows it to be held comfortably during an injection, whether or not the individual is injecting themselves or another patient in need of assistance.  The device is not intimidating and therefore causes less fear or trepidation with the administration of the medication.  Its manually delivery mechanism empowers the user, giving them a sense of control over their relief.  Medi-Card will cost the consumer 20% less than other devices available on the market.

Medi-Life Cards LLC is currently working with both PreSource Technologies, an engineering firm based in New Jersey to manufacture a working prototype for submission to the FDA.  The Company is tracking all of the device inputs and outputs in order to obtain a 510K clearance, which is equivalent to a Premarket Notification (PMN).  Through this process, the FDA determines whether or not the device is equivalent to a device already placed into a classification category (see Appendix 6.1 for further detail).  Medi-Life is currently working with an FDA consultant to ensure that the processes followed are in compliance with the requirements needed for this type of submission.  As the device is utilizing a current syringe on the market and not a new delivery mechanism, a case for substantial equivalence may be made and the device will not require a PMA (approval required for unproven delivery mechanisms that may take approximately 7-10 years to obtain due to the requirement of extensive clinical trials).  Having a 510K clearance will give more value to the Medi-Card, proving its feasibility as a delivery device.

In order to sell the device and drug combination in the US, an ANDA approval, separate from the 510K (clearance for the device), is required.  In order to obtain this, Medi-Life Cards LLC intends to partner with a pharmaceutical firm with experience in FDA drug/delivery device submissions.  The Pharma partner would already hold the FDA approval on the generic drug (epinephrine) and could then attach this 510K to the device submission, significantly speeding up the ANDA approval process. 

Once approval has been achieved, Medi-Life Cards LLC will generate revenues through a supply and license agreement similar to that between DEY and King Pharmaceuticals.  Medi-Life will partner with a firm, such as Vetter Pharma-Fertigung GmbH & Co., to produce the pre-filled syringe and blister pack.  Medi-Life will then hire a contract manufacturing firm (CMO) to produce the remaining device parts and complete the final assembly of the Medi-Card.  The product will then be distributed and sold to the pharmaceutical partner.  The unit price will include a fee for manufacturing and a royalty payment.  The pharmaceutical partner will then market it to its network of physicians and distribute the product to the end consumer.