HS+Product+Specification

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**1.1 Problem Statement and Brief Background and Justification**

The goal is to design an affordable, safe, efficient, unobtrusive, integrated health monitoring system for the early detection and prevention of heart disease that would reduce both patient morbidity and the financial burden on the healthcare industry.

Healthcare costs in Canada are at an all-time high with spending reaching $183 billion in 2009. Despite the spending, five million Canadians (or one in seven) do not have a primary care physician. Canada, with two physicians per 1000 people, rates 24th out of 28 OECD countries for physician to patient ratio, and last in the G8 countries. Canadians without physicians are 3.5-times more likely to go to the emergency department which results in higher costs for treatment. Canadians without physicians are also less likely to have diagnostic services performed (such as checking blood pressure), which results in less ability to detect and prevent serious disease. One goal of the health monitoring system is to provide a means for Canadians without physicians to have regular health monitoring to provide early detection and prevention.

Another contributor to high healthcare costs are people who go to physicians for unnecessary testing. For example, in Ontario, 3.4 million people go to their physicians for regular check-ups each year - 63% for reassurance that they are healthy. A health monitoring system may provide reassurance for those interested in monitoring their health, but will vastly reduce the cost to the healthcare system.

Among diseases, heart disease and stroke are two of the three leading causes of death in Canada (30%), and the leading cause of hospitalization (19.8% for males and 14% for females). Every 7 minutes, one person in Canada suffers a heart attack (lack of oxygen to the heart) and every 10 minutes one person suffers a stroke (blood clot to the brain). Both of these diseases have multiple early warning signs that if detected can prevent catastrophic outcomes. The most important tests are regular monitoring of blood pressure and heart rate, and blood tests for glucose and cholesterol. Detecting high blood glucose can also help prevent onset of diabetes (a disease with escalating prevelance and cost in Canada), as well as being strongly linked with heart disease. Once a disease such as diabetes is detected, it is our goal that our health monitoring system would provide more frequent monitoring and timely information for the healthcare system, as well as the patient. Faster diagnosis has been shown to result in more effective treatment, increased prevention of disease and reduced morbidity for the patient and overall cost for the healthcare system.

The goal of our healthcare monitoring system is to provide a service to those Canadians who either do not have a physician or do not go to physicians regularly. It should entice users through an incentive to monitor their health and encourage primary prevention of heart disease. The system should be accessible to large numbers of Canadians and seemless to use. The system must be flexible enough to monitor a healthy person very infrequently (such as every six months), or someone with diagnosed disease very frequently (such as 4-times per day with diabetes). Key tests (such as heart rate, blood pressure and blood tests) would be taken and compared with normative data. Results would be sent securely to the healthcare system for follow-up as necessary, and would also be provided to the patient through a choice of modalities. In addition to the test results, users would be encouraged to learn from health prevention information and education provided by the system. The system transfers some of the accountability for health monitoring to the patient therefore freeing up resources within the health system. The health monitoring system will save time for patients and reduce the burden on physicians and the heathcare system while providing improved early detection and disease prevention, thereby reducing healthcare costs and heart disease.

It has been suggested that “connected health” which includes a range of hardware, software and services that include consumer health electronics, monitoring and predictive modeling and decision support and collaboration, will be the next big thing in healthcare technology (Accenture Innovation Center for Health, 2009). The American Recovery and Reinvestment Act signed by President Barack Obama in February 2009 includes specific incentives to promote meaningful use of electronic health records to improve the quality of health care. This has resulted in various summits to encourage innovative solutions in remote health monitoring. A recent clinical demonstration project testing the impacts of remote monitoring on the frail senior population demonstrated a 40% reduction in emergency room visits, and a 64% decline in nursing home admissions with remote physiological monitoring for heart failure. This represented a savings to the health system of $500 million. Verizon Wireless has estimated the potential impact of mobile broadband solutions to the US healthcare system would result in a current savings of $7 billion and within five years this would increase to over $27 billion.

There is an increasing consumer demand for wireless communications, with annual growth rates of 100% from 2010 to 2012 (mobilehealthnews, 2009). At this point in the US, 90% of the population have either a cell phone or smart phone. It has also been estimated that there are 5000 health and medical applications currently available. It is also estimated that the market for wifi-enabled healthcare products will follow an exponential growth. Surveys have indicated 80% of US respondents have an interest in mobile health solutions. In response to this, both Apple and Microsoft have staked a claim on the mobile health market. Apple has formed partnerships with some US hospitals as well as a prominent electronic medical record vendor to integrate iPhone into health care delivery. Microsoft have launched HealthVault, a web platform that stores and shares health information integrating devices such as glucometers and blood pressure monitors for automatic capture and uploading. The timing therefore appears to be ideal for a health monitoring system aimed at early detection and reduction in heart diseases.

**1.2 Strategic Purpose**
Increase people's involvement and experience of preventing and reducing their heart disease

1.3 Vision Statement
The vision statement for our team participating in this project is: to learn something about design and healthcare early detection systems and have fun in the process.

**1.4 Mission Statement**
**Product Description:**
 * measures, analyses and reports information for the early detection and prevention of heart disease
 * unobtrusive system
 * accessible to a large range of the population
 * simple to use
 * high usability
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">customizable for those with existing heart disease
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">customizable for different application
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">enjoyable, educational and provides incentive to use
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">cost-effective compared with current health care system monitoring

<span style="font-weight: normal; margin: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">**Key Goals:**
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">fast track information to the medical system
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">motivate people to take care of their health
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">reduce healthcare costs by 15% within 5 years
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">fully developed within 12 weeks

<span style="font-weight: normal; margin: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">**Market Segment:**

<span style="font-weight: normal; margin: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">Primary market - Canadians (over 18 years of age) without access to physicians and those who choose not to go to physicians for health monitoring <span style="font-weight: normal; margin: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">Secondary market - Canadians with diagnosed heart disease who must continually monitor their disease markers

<span style="font-weight: normal; margin: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">**Assumptions:**
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">Accurate to within 2% of current clinically administered tests
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">Operates within current health care infrastructure (compatible)
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">Blood analyzer chip meets approvals and becomes commercially available
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">10-20 year lifetime

<span style="font-weight: normal; margin: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">**Stakeholders:**
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">government health care system
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">general population (users)
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">product manufacturer
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">medical personnel

<span style="font-weight: normal; margin: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">**Opportunities for Creativity:**
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">minimally invasive testing
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">testing in non-healthcare environment
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">modularity in testing types
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">inherent incentive to use and monitor health

<span style="font-weight: normal; margin: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">**Marketability:**
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">fun, useful, educational and incentive to use
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">birth-to-cradle sustainability
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">integrates with current technology
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">integrates with health care system

<span style="font-weight: normal; margin: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">**Scope Limitations:**
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">size and limits of current technology
 * <span style="font-weight: normal; margin: 0.5em 0px 0px; padding-bottom: 0px; padding-left: 3em; padding-right: 0px; padding-top: 0px;">concept testing required prior to mass production

<span style="font-size: 1.1em; margin: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 5px;">**1.5 Addressing the Mission Statement**
<span style="font-weight: normal; margin: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">**Degree of Innovation:**

<span style="font-weight: normal; margin: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">Remote testing of heart disease markers involves a high degree of innovation. While devices exist for portable monitoring of heart rate and blood glucose, there are no devices we could ffind that collect, analyze and send out information about a range of tests. Current systems for monitoring blood glucose are cumbersome and unlikely to be used by healthy iindividuals. They also do not test the blood for other purposes, such as cholesterol. At present, blood must be taken in large quantities in a medical laboratory, shipped to an analysis site, and analysed by a combination of people and test machines. Test results take time to process and be provided to the patient. The innovation in this project is in finding a way to test for heart disease indicators in a safe, effective way outside of a laboratory.

<span style="font-weight: normal; margin: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">A major goal of the health monitoring system is that it provides an incentive for healthy individuals who may otherwise not be interested in tests to monitor their risk of heart disease. This aspect of designing an enticing and accessible system also involves a high degree of innovation.

<span style="font-weight: normal; margin: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">**Functional Complexity:**

<span style="font-weight: normal; margin: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">Our goal is that the health monitoring system be simple and uncomplicated to use to appeal to as wide a range of demographics as possible. However, to take health samples, analyse these and transmit the information to the healthcare system involves considerable complexity. Our intent is that this complexity is not apparent to the user. To have a wider appeal than simply a health monitoring system, we also aim to include other fun, entertaining, educational and useful aspects to the system. This also adds to the functional complexity, especially as the goal is for the system to be portable.

<span style="font-weight: normal; margin: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">**Customization:**

<span style="font-weight: normal; margin: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 0px;">Our team firmly believes our health monitoring system must be customizable to suit a wide range of the population. Those who are non-technical (for example, seniors) may want siimple commands and user interfaces, and options for verbal rather than visual activation for example. Inherent in the system, it must customize the testing to the user (based on information such as age, gender, previous health problems, height, weight, etc.). We also intend for the software to be customizable and provide feedback and health education in a variety of ways. The appearance of the final product will be customizable in feature such as color. As well, we have envisioned many different usage scenarios for the system ranging from home use to work vehicles. The system must therefore be able to be customized to meet these various requirements.

<span style="font-size: 1.1em; margin: 0px; padding-bottom: 0px; padding-left: 0px; padding-right: 0px; padding-top: 5px;">**1.6 Initial Background Research**
In order to become more familiar with the topic of individual health monitoring and to be able bring relevant information to the discussion, the group members performed background research. The research covered the general areas of assessing the present state of the healthcare system, and exploring which health issues in society would be best targeted by an individual health monitoring system. We also researched the currently available health monitoring technology that could help in the traditional delivery of healthcare. Lastly, we looked at modernized and futuristic health care systems.

The results of our background research were quite extensive, an encouraging indicator of the amount of information available. We found a variety of critical statistics describing physician availability and population groups lacking physicians. We also discovered vital information about the frequency of doctors’ visits and regular checkups. We found data discussing health care indices that need monitoring in order to prevent common illnesses and diseases - those factors would determine the primary functions of the health monitoring system. Another important set of facts that we gathered was related to the costs, methods and waiting times of the current health system, which we would hope to improve with our design.

Once the statistics were collected, it was time to investigate existing and emerging technologies that already address some individual health monitoring needs. A few of the areas were: medical devices at home for young and the elderly, innovative portable devices that monitor vitals, including technology used in fitness, we discovered clothing used in rehabilitation that has biosensors and electrodes embedded. A big breakthrough for this project was a recent announcement from the University of Calgary about the development of a new microchip capable of analyzing blood and other bodily fluids without a time-consuming trip to the lab. The possibilities seemed almost endless.

Finally, we examined health care systems across the border and abroad, again present and proposed, that have or shortly will have a process in place for individual health monitoring. Korea’s u-Healthcare Strategy and the Health Hero Network proved particularly informative. The research activity was a crucial and an eye-opening stage of the development of our health monitoring system. A link showing the results of our background research activity is below.

Initial Background Research Appendix