1. Health Watch Product Identification

4. Need: Continued There is not an adequate system for measuring the day-to-day health of the elderly Our Health Watch aims to provide the health monitoring system that is vital to the lives of these elderly Moreover it will have the capability of monitoring the health of other individuals

5. Product Idea A health monitoring watch EKG band worn separately The watch is the central unit that collects information on the condition of the user The information includes: – Temperature (temperature sensor) – Impact (accelerometer sensor) – Heart condition (portable EKG) – Blood pressure – Location Global System for Mobile Communication System through our wireless provider

6. Product Idea: Continued The watch will have the capacity to store health metrics for up to 30 days – The information is stored in flash memory – It continuously records the information and be monitored in real-time The health information may optionally be forwarded to emergency contacts The information that the watch records is transmitted to a monitoring division – Thresholds are placed for the individual health information – If the thresholds are surpassed then the paramedics are alerted

7. Product Idea: Continued The information is transferrable across a wireless connection so that the paramedics can have vital information when responding to an emergency The information can also be accessed by the user’s physician and/or caregiver There are alerts to remind the user when to take their medication

8. Physical and Financial Viability Physical – Sensor NEED INFORMATION Financial – TBD

9. Market Assessment

10. Projected Market Targeting primarily the Elderly (65+ years old) Elderly population projected to increase to 54 million persons by 2020 from a previous total of 31.1 million in 1990 In 2004, per person health care spending for the 65 and older population was on average $14,797, which is almost 5.6 times higher than is spent per child and 3.3 times as much spent on working- age persons Sources: http://www.census.gov/apsd/wepeople/we-9.pdf https://www.cms.gov/NationalHealthExpendData/downloads/2004-highlights.pdf

11. Market Assessment The number of elderly is current increasing as a result of the members of the Baby Boomer generation which are just now in 2011 reaching the age of 65 The growth rate of the elderly is set to be double the growth rate of the overall population during the period from 1990 to 2020 and in 2020 it is expected that 1 in 6 Americans would be elderly Due to increasing life spans and population growth, a constant replenishing market of elderly persons is being created each year Sources: http://www.census.gov/apsd/wepeople/we-9.pdf

12. Challenges Introducing a new product to the market Formulating a timely partnership with a distinguished wireless company Existence of Technologies – So that adequate coverage is provided to the user

13. Uncertainty The main uncertainty involved in developing this product is whether or not the consumer would be willing to actually wear the band in conjunction with the wristwatch to provide them the best results There is also some uncertainty involved in whether or not the technologies incorporated into the wristwatch can be minimized to such a level that the size of the device matches what is considered appropriate for a watch by the consumer

14. Timing Necessary to move quickly to capture the first mover advantage in a highly lucrative environment Due to the emergence of many similar technologies that do not incorporate all of the features in our device, it is expected that in the very near future a competitor will emerge in our same area of focus

15. Customers The consumers may not be the users of the device Statistics 8.8 million elderly live alone 16 million only live with their spouse Stats on elderly in nursing home Family members of these elderly persons wishing to ensure the well being of their loved ones Target customers are concerned individuals looking to monitor their health as well as that of their elderly family members – A large portion of the customers for this product will likely be these family members giving the device as a gift to their parents or other loved ones they are concerned about Sources: http://www.census.gov/apsd/wepeople/we-9.pdf

16. What Customers Want Two segments of customers that each have different wants/needs from the product First is that of loved ones buying the product for their elderly relatives – Focused primarily on complete health coverage with the most accurate readings and the best ability to assist in an emergency situation Second is the elderly themselves using the product – Focused on ease of use and comfort while wearing the chest band and the watch – It must be easy and straightforward to monitor their health information and also have emergency help arrive once a situation does occur even if they are incapacitated

17. Governmental Regulations Code of Federal Regulations Title 21: Food and Drugs – Outlines various classes of devices which are subject to monitoring and approval – Details which class of products must participate in pre-market approval and post-market surveillance Goal is to create a device that is categorized as a “Class I” device – This means that the device is subject to only general restrictions such as misbranding. – A device is in Class I if general controls are sufficient to provide reasonable assurance of the safety and effectiveness of the device – Also, a device is Class I if it is not life-supporting, life-sustaining, or not of substantial importance in preventing impairment of human health and which does not present a potential unreasonable risk of illness or injury Since our product is simply monitoring vitals and not promising to sustain the user’s health, our goal is to have it classified as a Class I device and therefore subject to the least stringent amount of regulation by the government Source: www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm

18. Physical/Technical Limitations The physical limitations of the device are that the chest strap must be adjustable to fit around any elderly person’s torso and still maintain accurate readings The wristwatch must also be adjustable to fit any sized wrist while still being able to provide verifiable readings with the variety of sensors used Technical limitations are primarily regarding the overall size of the device – All components must fit in the size of a watch or slightly larger so as to not interfere with the user’s day to day life – Some standard limitations include powering the device, resulting in the need for either a charger or battery system and also the technical challenges of incorporating all sensors together in one single compact device while having all components work properly

19. Major Risks Inaccurate measurements from sensors – Can result from the watch/strap not being placed correctly on the user, therefore a health problem might not be accounted for if safeguards are not put in place Remedy this with notifications to the user that the sensors are not attached properly – False-positives resulting again from inaccurate readings Product must be able to label false-positives and discard them as such to prevent improper emergency alerts Inability to shrink components into a suitable size for the user – Can result from the technology not scaling down enough when incorporating all components together – Alternative would be to provide the user with a choice of a few limited components they would like included in the product or the option for larger, bulkier product that provides all of the functionality

20. Competition and their Strategies LifeAlert – Unless we decide to sell to them – LifeAlert offers in home protection to users who are conscious but immobile in their home and need service Other emerging medical device companies looking to enter this market

21. Our Strategy Broad Spectrum of Service – We intend to offer a range of detectable emergency situations, even when the user is unconscious

22. Requirements of Project Rapid Compilation Effective wireless Partnership Comfort of wear Utilization of technology Collaboration

23. Design Concept and Technical Requirements Wrist watch component Grace Fang

24. Required Functionality Being able to sense abnormalities in: – Blood Pressure (refer to chart for normal ranges) – Pulse (heart rate) (60 – 100) – Body Temperature (ideal range: Oral: 36.8 °C (98.2 °F), Under arm: 36.4 °C (97.6 °F)) – Movement (detect falls, when the watch is not worn, etc.) Time Glucose monitoring (optional) Storage capability Receiving signal from the chest strap Sending both records and emergency signals to the host company database Large interface for ease of use Voice activation (for the hearing impaired) Microphone Manual push button in case of emergency

25. Technical Requirements Ideal weight range: ~6 oz. Ideal power usage: ~5 Watts Ideally charged by a lithium battery Ideal thickness: <20mm Ideal dimensions of interface: TBA Waterproof (stainless steel material)

26. Current model systems Blood pressure and heart rate Novel Wristwatch: http://www.healthstats.com.sg/images/publications/Pub_ 01.pdf http://www.healthstats.com.sg/images/publications/Pub_ 01.pdf Body Temperature and movement Hitachi http://www.ageinplacetech.com/pressrelease/aframe- digital-health-monitoring-technology-seniors http://www.ageinplacetech.com/pressrelease/aframe- digital-health-monitoring-technology-seniors Time http://electronics.howstuffworks.com/gadgets/clocks- watches/digital-clock7.htm

27. References to look up http://www.springerlink.com/content/w2267j 2v654827t7/

28. Design Concept & Technical Requirements Chest Component Danial Sajed

29. Required Functionality Determines heart rate continuously Records EKG statistics Determines if user suffers a severe impact e.g. falls, vehicle collisions Communicates information to wrist component Central processing unit interprets data and determines if there is need for medical assistance

30. Technical Requirements Ideal weight range 250-500g – About the weight of a men’s shirt Ideal power usage 4-6W – The same usage as an iPhone 4G – With an equivalent battery, should only require charging at night No more than 2cm thick – Will be nearly invisible underneath a sweater or a loose shirt Under $100 to make

31. Exterior Design Primary Electronic Components in Plastic Casing Adjustable Elastic Band Optional Shoulder Supports

32. Necessary Components EKG Sensors Accelerometer CPU, Communications iPhone CPU, Components

33. Power, Weight Breakdown Power 4-6W – EKG - approx. 50mW – Accelerometer < 25mW – Processing (at 1GHz) - approx. 4W Weight 250-500g – EKG - approx. 17g – Accelerometer < 1g – Processor and wireless transmitter < 50g – Plastic casing, straps < 100g – Battery < 100g

34. Cost Breakdown EKG sensors and module – This is easily the most expensive component and based on current retail costs can run up to $75 to produce. If mass produced, costs should be able to be reduced. There also may be redundancies between the module and the main CPU, so that cost can likely be driven down. Accelerometer, wireless technology, processor – The costs of these components have all been driven down due to mass manufacturing in smart phones. On one chip, these will probably cost only $30 to mass produce. Straps and casing < $2

35. Risks Cost – The biggest risk to this project is the cost of the components The EKG equipment is extremely expensive Further research may be required to eliminate cost by reducing redundancy with central processor – Processor Ideally, we will be able to use components like wireless technology, accelerometers, flash memory and CPU that have been driven down in cost by the production of smart phones Power – Integration of components may require more power than anticipated Battery may end up being bulky, heavy or expensive

36. Sources EKG – Research paper on low-cost, low-weight EKG sensors and tech http://www.eecs.umich.edu/~prabal/teaching/eecs598-w10/readings/PCB+06.pdf – Sales (pricing info) http://bio-medical.com/products/thought-technology-ecgekg-sensorwith-wrist- straps.html http://bio-medical.com/products/thought-technology-ecgekg-sensorwith-wrist- straps.html Processor, Communication, Accelerometer – iPhone information http://www.radphone.info/apple-iphone-3g3gsipad-parts-datasheets- componentschematicsdiagram-and-info/ http://www.radphone.info/apple-iphone-3g3gsipad-parts-datasheets- componentschematicsdiagram-and-info/

37. Receiver-Concept and Definition Interfaces between worn watch and telephone line (landline) Hooks into an existing telephone line maintains link between system and watch link contains voice and data upon request – data is requested via operator control cheap technology

38. Receiver-Subsystems telephone hook in interface board – communications with watch and phone small box, can be plugged into the wall

39. Receiver-Alternative Cell Phone Hook in Advantages service everywhere EMS knows your location no additional devices needed can be an app Disadvantages cell phones are not in every home would need deal with provider cell phone can already serve as an emergency device

40. Receiver- Contains speaker Advantages only need to get data when send a message and to initiate call Disadvantages speaker needs to be loud enough to be heard and integrate a microphone to receive Depending on placement, wont be useful in all places in home

41. Receiver-Requirements -Communicate wirelessly with watch -can receive a signal from watch -can receive data from the watch upon request -autodialing through phone line -plugs into wall

42. Receiver-Risks and Money risk inherent in the design – make all the devices communicate – train operators to understand how they work Financial issues – receiver would be smaller than an answering machine – technology already exists Reasons for Subsystem – this allows for interface with call center – makes watch more than just a fancy watch – required for product effectiveness

43. Call Center-Concept Call center to interface between the Watch user and EMS Determine if the emergency is real or if its a false alarm comfort the user if its an emergency while informing authorities access to telephone and basic medical records training to understand what they are needed to do Uses existing call center systems that require minimal retraining

44. Call Center-Design Alternative Computer Voice system Advantages Save money by removing the human operators in the call center Rapid EMS response Disadvantages Can’t separate out false alarms Larger volume of false alarms EMS could get annoyed at having a computer voice that cant respond back