COMPLY. Abstract. Market Trends and Challenges WHITE PAPER

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1 COMPLY WHITE PAPER Abstract Every year, millions of people are affected by their lifestyle, and chronic or degenerative diseases. Degenerative diseases accounted for over 6% of all deaths in the late 199s [1]. While people s health may be slowly deteriorating, their dependency on medication is increasing, with half the population taking at least one medicine a day, and a quarter requiring multiple prescription medications daily[2]. As is human nature, people tend to forget to take their medications - leading to health complications, tend to take improper dosages - resulting in overdosing or further ailments, or tend to simply dismiss the notion that the medicine will help improve their health. In 28, over 1.9 million people in the U.S. became sick due to improper dosage or wrong medication [3]. Over 5% who are prescribed medicine, don t take it, skip doses, or take the wrong amount [4], and this lack of compliance, has led to the unnecessary hospitalization of millions, the deaths of hundreds of thousands, and the loss of tens of billions of dollars in completely preventable healthcare costs [4]. Market Trends and Challenges Almost 5% of Americans are on medication [5]. In 213, their population was around 315 million [6]. A 27 study showed that close to 75% of people who were prescribed medication in the past twelve months, failed to fill it out, take them on time, or took the wrong dosage, and this led to several billions of dollars of unnecessary healthcare costs, the deaths of hundreds of thousands, and the hospitalization of many more[4]. A large source of the problem stems from compliance to the given medication. And as the dependence on medication grows, there is also the increasing danger of adverse reactions between conflicting medications. Drug related injuries and illnesses cost the U.S. over $2 billion, annually, and this figure is just from preventable cases of non-compliant patients[7]. While the problem of compliance has been recognized as a very real threat to the health and safety of the public, there are some steps being taken. These include weekly calls to check up and remind patients to medicate, weekly health checkups, pill boxes that hold correct drug doses on a daily basis, and even smartphone and tablet apps that remind users to take their medicines on time. However, smartphone alarms can be silenced, pills can still be forgotten to be taken from the pill box, and doctors have no way to check if patients are lying about having taken their medication. Bringing in a human to handle patient medication can become very expensive. The elderly, pose additional difficulties for Doctors. An estimated 9% of Americans over 65 years of age are treated with at least one medication for their chronic or lifestyle diseases [5]. Although they account for only 13% of the population, they consume almost 4% of all prescription drugs, with the average 65 year old taking at least 14 different prescriptions annually [8]. Several of them have poor vision, leading to genuine cases of pill mix ups and dosage changes. Most of them use multiple prescriptions, and improper dosing of medications can be fatal. They are prone to memory loss, posing both the problem of forgetting to take medication and forgetting they took their medication and overdosing. The challenge here is to create a low cost solution that works across age groups without requiring any prior training.

2 WHITE PAPER/1 Solution We propose an IoT enabled, Smart Pill Box, called Comply, with a digital display that keeps track of the current dosage level as well as the remaining pills. The solution pairs with a smartphone/tablet app, to which complex tasks are offloaded. The solution works alongside a wearable fitness monitor. Features FEATURE REMARKS Body Plastic cube of 4mmX4mmX4mm, hollow for keeping the medication Connectivity Bluetooth 4. Display Data and Power Alerts Memory Battery Others Top Facing LCD 2 male and female Micro USB 2. ports, for a total of four, one per side Buzzer and set of LEDs <4MB 5maH CMOS with an internal clock that can be synced online Diagrams LCD Display 4 CM.5 CM 4 CM USB 2. Interconnects Application Comply comes with an app that collates data from the individual Comply units. It can then analyze this data and send it to the cloud. Features Syncs with Comply over Bluetooth Keeps track of all Comply boxes the user has registered, their individual pill count, dosage, time before refill, and billing history and information Sends out messages to the concerned pharmacy when medication runs low Sends messages to doctors/physicians/nurses/care-takers when the user has not taken his/her medication after repeated alerts/warnings. Sends messages to the user/doctor in case his/her current medication has a known reaction with the new medication. Monitors medication use, and gives doctor recommendations on equivalent medicines.

3 WHITE PAPER/2 Wearable SmartBand/Fitness Monitor Comply units can also be sold with a wearable SmartBand or be configured (via the Smartphone/Tablet App) to work with generic models of fitness monitors. The Wearables must have sensors that collate the following data: Heart Rate/Pulse, Temperature, Galvanic Skin response (to detect sweat) and an accelerometer. Case Study How Comply Works Comply works by keeping a track of the pills and their quantity, and alerts users when to take their medication. Initially, users need to take their Comply kits to the pharmacy when their doctors prescribe medicines, or Comply can be sold at the pharmacy along with the medication. The pharmacist provides the required pills, one type each, in one Comply unit, and updates the numbers for the units on the smartphone app. Dosage, times, and so on, may be entered as required. The pharmaceutical register number of the medication, as stored on the Comply website, is also entered as part of the data. As programmed, Comply will remind the user to take the medication, through a variety of beeps, blinking, or a combination of all to alert the user. Comply will not turn off the alert until the user has physically opened the box and taken the medication. At this point, Comply will display the dosage to be taken, the number of pills left, and how long before the user will require a refill. Comply will also beep a certain number of times to denote the dosage for visually challenged users. Comply can also ascertain if the user has taken the medication by correlating data from the wearable, which measures changes in pulse rate and in the future- blood sugar levels. Patients who have taken their medication will have markedly different body parameters than those who have not. After the user has taken his medication, Comply will then change the required counters as necessary. If the user attempts to retake the medication, Comply will alert the user about his actions through the App and enquire if the user took the wrong dose the first time or accidentally opened the Comply unit. Until the user responds on the App, the Comply Unit will beep/flash to indicate a sign of danger. All Comply units work independently of each other; but when connected through a matching set of protruding and depressed interconnects, can communicate with each other. This allows them to: Power each other. A single USB 2. connection charges multiple units at once. Communicate with each other about the medications they contain. This, along with access to the Comply website and smartphone app, will help users avoid taking medications that may not mix well. Sync up, so as to provide a single alert for when the user has to take multiple medications. Individual units will still have to have their individual lids opened, so the user must take all his medications, even though the group of Comply units may alert him only once. Once a new Unit has been joined to an existing Unit, medication information will sync over to the user s primary smartphone/tablet device. It will also display the user name and medication name on the LCD display. This will allow users to easily add/remove units as their requirements change. Visual Representation of Data Flow CLOUD DATA CENTRE Smartphone Application Local Gateway API Connector Data Connector Device Sensors Local Gateway API Connector Data Connector Device Sensors Local Gateway API Connector Data Connector Device Sensors

4 WHITE PAPER/3 Monetization and Addressable Market We see four large categories of consumers for Comply - Individuals, Pharmacies, Hospitals and Research Labs. Each will be targeted through separate methods. Both Comply units and Wearables can be sold in a variety of colors, to allow for personalization. Product Monetization There are several planned methods of monetization: Basic retail model: Comply units are sold in physical and online stores. Products are marketed through TV adverts, the Internet, and Print media. Pharmacy driven models: Pharmacies can sell Comply units while selling medication, keeping a cut of the profits. Marketing is through direct channels. Hospital driven models: Nurses and attendants will not be required to periodically check up on a patient s medication intake, since Comply will do that. Hospitals can thus reduce their staff, saving money. Comply can be leased out to hospitals or sold in bulk quantities, who can then sell Comply to out-patients. Marketing is through direct channels, both to hospitals and private practitioners. Similarly, Comply can be lent out or sold to Research Labs. HCL-Centric Monetization There are several planned methods of monetization: Device Level: Developing UI/software/interconnects, should costing, system integration Smartphone Level: Software development, Android/IoS/WP App Testing, network and connectivity management, UI/functionality Devtesting, troubleshooting, sustenance. Cloud Level: Patient/medication database management, big data analytics, maintenance (pushing firmware/software updates) Dashboard UI and visualizations. Market Size The total addressable market, or TAM, for Comply is the set of people taking any sort of prescription medication on a regular basis. In the U.S., this was around 15 million in 213. % Drugs Users Vs Population 4 6.% Population (Mn) Axis Title % 2.% Percentage of prescription drugs users Affected Population (Mn) Growth Prospect There are several planned methods of monetization: We assume that Comply should be out in the stores by the end of 216, given its relatively simple construction and size. Also, as Comply looks more like a gadget rather than a Smart Pill Box, we assume early adopters will take a hold of it first before other market segments become comfortable with it. For the first year, we assume modest sales of $1Mn, since people may require multiple Comply units. Sales will occur in multiple models, as has been previously discussed. Growth rate is assumed to be a healthy 2%-3% for two years, after which Comply is likely to explode. At this point, we predict growth rates in excess of 1%, since we would like to see more pharmacies and hospitals bundling Comply along with medication to first-time and longtime customers. Growth rates will stabilize over the next few years due to increasing competition and competitor products. Population data is available here[1].

5 WHITE PAPER/4 YEAR Growth Rate NA 2% 3% 12% 8% 7% 6% 5% 4% 3% Affected Population(Mn) Units of Comply(Mn) Market Share.63%.75%.96% 2.9% 3.72% 6.27% 9.94% 14.71% 2.37% 26.12% Comply Growth Rate and Market Shares Affected Population (Mn) Units of Comply (Mn) Market Share Common Issues and Challenges A database of medicines is to be maintained on the cloud and constantly updated. Each medication will have to have its own unique ID as well as the IDs of medications it is known to interact with. While the device can alert and coerce the user into physically opening the unit, it cannot force the user in to taking the medicine. Comply cannot prevent the user from willingly overdosing. It can display the correct dosage on its display, but it is up to the user to heed the instructions Comply is heavily reliant on the smartphone app for lower hardware complexity and costs. Comply cannot physically monitor the medication within itself. It relies on the expertise of pharmacies and doctors to fill the associated applications with correct information. Comply s Differentiators and Best Practices Comply forces users to physically interact with the device and take their medicine. Comply combines the smartphone app with alerts to doctors in case the user has not taken his medicine on time or takes it irregularly. Any deviation from normal health conditions is measured with the Wearable. Comply allows pharmacies to provide timely, reliable refills to the Comply units, as a value-add. Comply can improve the collection of medical-relevant data. Any tests based on drug usage, side effects, long-term effects, etc. can be monitored more effectively using Comply. And since Comply forces users to more closely follow their prescriptions, any findings from these tests become more accurate. The vast information collected from Comply units can also be analyzed to understand customer buying patterns of medications based on medication size, shape, color, taste, etc. This can be used to improve the medication and possibly boost its sales. Doctors can change dosages from their smartphone app, which syncs across the internet, the user s smartphone, and the Comply unit. This allows the flexibility to change dosages, knowing that Comply will not allow the patient to use an obsolete dosage.

6 WHITE PAPER/5 Conclusion As technology becomes more intertwined with our lives, we need to find a way for it to seamlessly improve all aspects of our health and well-being. Comply allows users with no prior training to start taking their medication in a timely and regulated manner. Comply also allows doctors to keep track of the health of their patients, collect more accurate data on tests, and make better recommendations to future patients. The huge amounts of data from Comply allows for a wealth of information to be accessed, leading to cross-product placements, direct advertising, and much more. However, more than anything, Comply makes taking medications much more simple, safe, and effective. Author Samarth Bharani; Global Engagment manager, High tech and Consumer Pre sales References [1] Leading Causes of Death, : [2] Snapshot of medication use in the US: [3] Medication-Related Injuries on the Rise: [4] Take meds faithfully: ompliancefinal.pdf [5] Health, United States, 213. Table 92, [6] U.S. Population 213: on-people [7] CVS Caremark Undertakes Multi-Year Study to Improve Patient Medication Adherence: [8] ASCP Fact Sheet: [9] Age and Sex Patterns of Drug Prescribing in a Defined American Population: [1] Population Projections of the United States:

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