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Anyone can develop an allergy at any time in his or her life, even without specific risk factors. Yet some people, including asthmatics, children, and those with a history of anaphylaxis, have an increased susceptibility to allergic reactions. The likelihood and severity of experiencing a repeat allergic reaction depends largely upon the type of allergen and the individual's sensitivity to it.
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The business model is attractive in terms of growth rate and profitability. The growth rate expected for the venture is approximately 44% between Year 3 and Year5 with gross profit margins of 53% by Year 5 (see Section 8). The industry has continued to grow at approximately 20-25% over the last three years. As discussed in the market section (see Section 4), the number of individuals diagnosed with severe food allergies continues to grow at a rapid rate. The Company holds the patent on the device, which has 18 years remaining before expiration, creating protection over possible imitators. Also, once the device has received approval, another medical device or pharmaceutical firm will have to go through the same approval process, giving Medi-Life a 1-2 year head-start over potential competitors.
Customer relationships and industry partnerships developed by the firm will create further sustainability of the product in the marketplace. By continuing to monitor consumer needs, Medi-Life expects to develop strong ties to the marketplace, creating a sustainable presence. The company also brings value to its pharmaceutical partner which also increases the sustainability of the company. Extensive market research, connections with consumer groups, such as the Food Allergy and Anaphylaxis Network and PeanutAllergy.com and the 510K approval (within a year) will further reduce the risk to the pharmaceutical partner and give them a device which allows them to deliver four medications in one purchase.
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.
Medi-Life will have to continue to gather feedback from the marketplace to find opportunities to innovate further to sustain its advantage.
Possible Impacts to Sustainability
There has been a recent initiative from the biopharmaceutical firm, Genetech, to develop a medication that can alleviate allergies for up to three months. The clinical trials were determined to be too dangerous and were discontinued in January of 2006. Even though research in this area continues to be done, experts agree that these medications only address certain aspects of the allergy and that a cure for the disease is far from discovery. This is an indication that the market for epinephrine injectors will continue to be sustained for many years to come.
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Value Proposition
Sustainability 
