1. What is the problem / need you are addressing in the market?

A healthy, functioning body naturally increases its insulin levels so that its cells can absorb glucose, a broken down form of sugar from carbohydrates. For those with Type 1 Diabetes (T1D), the body cannot produce insulin and therefore cannot regulate the amount of sugar in the blood. Those with T1D then have to regularly inject themselves with insulin in order to compensate.

A major problem that T1Ds face is insulin shock, which can cause low blood sugar formally known as hypoglycemia. This occurs when T1Ds inject themselves with too much insulin, leading to dangerously low sugar levels which are below 70mg/dl (Fletcher). On average, most T1Ds experience two mild cases of hypoglycemia per week (Frank & Daneman, 2010). TD1s can be prescribed glucagon needles for emergency use. However, the complexities of the application can be intimidating and difficult to teach friends and family. Severe cases of insulin shock can result in diabetic coma, brain damage, and death (Story, 2014). In fact, 10% of the 270,000 type 1 diabetic patients in Canada die from experiencing insulin shock and failing to receive immediate medical attention (Cryer, 2012).

2. Who feels the problem / need most acutely? If there is more than 1 segment that feels this problem/ need, which will you target first and why?

There are three main segments that suffer from hypoglycemia: T1D, reactive hypoglycemia, and fasting hypoglycemia. Among the three groups, T1Ds constitute the highest percentage of hypoglycemia incidences. In addition, the effects of low blood sugar for reactive and fasting hypoglycemia are not as severe as it is for T1Ds. However, the reactive and fasting hypoglycemia segments are required to monitor their blood sugar level more often and follow a stricter diet plan.

We have decided to target the T1D in Canada first. There is a large T1D market in Canada; since the country is ranked third for having the highest prevalence level of diabetes among individuals aged 20 to 79 ("Institutional Links."). We believe the adoption rate for this segment may be higher as type 1 diabetics experience low blood sugars more often (Hamdy, 2015).

3. How is that problem / need currently being addressed by existing competitors? Why or how is the problem / need “underserved”?

Novo Nordis and Elli Lily both offer glucagon kits involving one-time needles in a complex eight-step application process (GlucaGen Hypokit & Glucagon for Injection). This process requires practice to perfect and can be intimidating for individuals with little to no medical background. Both companies suggest T1D to have two kits handy because mistakes can occur when administering the emergency kit.

In addition, those suffering from insulin shock are dependent on the bystanders who may be overwhelmed by the medical emergency and failed to consider grabbing the emergency kit in the first place. Since the Nano-patch will reduce the number of steps to administer, it will simplify the entire process for bystanders ("Overview.").

4. Are there any specific, important ‘show stoppers’ or ‘approvals’ or _____ in the Ecosystem?

Health Canada heavily regulates the drug and medical devices industry. New drugs or medical devices must comply with the regulatory body if it is to enter the Canadian market. Health Canada is known for its rigorous application process for medical products. The process of developing new drugs or medical

devices is therefore capital intensive, lengthy, and faces a high rejection rate ("Common Menu Bar Links.").

5. What are 2 or 3 possible products/services you could offer to address the problem/need? Which one are you leaning towards?

There are two products that we can offer. The first product is a patch that leverages Nano-patch technology. The patch consists of microneedles which are invisible to the eye but tough enough to penetrate the skin and deliver glucagon into the system painlessly and quickly (Injectable Nano-Network for Glucose-Mediated Insulin Delivery). The patch will be filled with glucagon for emergency use or daily replenishment or blood sugar as needed.

Another product we could offer is a device that combines the Nano-patch with a medication deemed the “Injectable Nano-Network for Glucose-Mediated Insulin Delivery”. This medication will automatically regulate the glucose level in the patient’s body, thus completely eliminating the risk of insulin shock. Although this is a more proactive solution to the problem, the medication is currently only tested on animals and has a long way before being approved for human use (Nanopatch Technology Overview).

We are leaning towards the first solution for three reasons. First, the glucagon emergency kit is already in use by the public and required by every T1D to purchase, the Nano-patch technology provides a more convenient method of glucagon delivery. Secondly, the Nano-patch is already approved and being used in Australia for vaccination purposes ("Nanopatch Vaccine Technology Company Attracts $25 Million.”). Lastly, the second solution is in an earlier research phase which will require much more capital and time span before reaching the market.