1. Health Watch Group 6: Grace Fang, Eric Hengesbaugh, Michael Rhodes, Robert Richardson, Danial Sajed, Daniel Tepayotl

2. Health Watch Product Identification

5. Need: Continued There is not an adequate system for measure the day-today health of the elderly The Health Watch aims to provide for a health monitoring system for the elderly It will have the capability of monitoring the health of other individuals as well

6. Product Idea A health monitoring watch EKG band Information includes: – Temperature (temperature sensor) – Impact (accelerometer sensor) – Heart condition (portable EKG) – Blood pressure – Location (Global System for Mobile Communication, GSM)

7. Product Idea: Continued The watch stores the sensor information for up to 30 days – flash memory – It continuously records the information – Information can be monitored in real-time The health information can be forwarded to emergency contacts The health information is transmitted to a monitoring division

8. Product Idea: Continued The health information is transferrable across a wireless connection The health information can also be accessed by the user’s physician and/or caregiver Alerts can be uploaded to remind the user when to take their medication

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

10. Health Watch Market Assessment

11. 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 Willingness to wear the band in conjunction with the wristwatch The ability to incorporate technologies into the wristwatch can be minimized

14. Timing Necessary to move quickly to capture the first mover advantage in a highly lucrative environment Competitor will emerge with the same 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 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 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 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. 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 – Some standard limitations include powering the device

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 – 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 sensors capable of detecting emergency situations, even when the user is immobile or unconscious

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

23. Health Watch Design Concept and Technical Requirements

24. Wrist Watch Component Grace Fang

25. Required Functionality Being able to sense abnormalities in: – Radial Arterial Blood Pressure (refer to chart for normal ranges) – Pulse (heart rate) (60 – 100) Time Alert user to take medication (pre-set) Receiving signal from the chest strap Sending both records and emergency signals to the host company database Real time monitoring and data storage Large interface for ease of use Voice activation (for the hearing impaired) Microphone Manual push button in case of emergency Alert both the user and the headquarters in case of emergency

26. Technical Requirements Ideal weight range: ~6 oz. Ideal power usage: 3V DC supporting 12 months usage Ideal thickness: <20mm Ideal dimensions of interface: 3.5cmx3cm Waterproof (stainless steel material) Non-invasive Point in time or continuous measurements carefully spaced

27. Dasrao MS. Hock YJ. Sim EK. Diagnostic Blood Pressure Wave Analysis and Ambulatory Monitoring Using a Novel, Non-Invasive Portable Device.

28. Components Medical pressure sensor – Contains “free-floating” plunger that applanates radial artery – Piezoresistive nature detects change in pressure from 3 cables along wrist strap Strap provides constant force – Maintains applanation – Keeps steady position of sensor LCD display – Real time blood pressure & pulse – Flashes when vitals are abnormal or when emergency button is pressed Dasrao MS. Hock YJ. Sim EK. Diagnostic Blood Pressure Wave Analysis and Ambulatory Monitoring Using a Novel, Non-Invasive Portable Device.

29. Components Data transfer (input and output) – RS232 format or wireless via blue tooth technology or infrared Continuous reading of systolic/diastolic b.p. (Range: 10-300 mmHg) – 32 readings per second – Real-time analysis if necessary Storage capability and processor – Microprocessor – Flash memory – Up to 30 days of data Calibration needed (performed by physician) – Internal understanding of circadian rhythm and fluctuations in pattern Microphone and speaker Capacitance sensor (detect if worn) Emergency button sync (two side buttons held for 5 sec) Alert user to take medication

30. Results Augmented Pressure Systolic (tension) pressure time index Diastolic Pressure Time Index Sub-endocardial Viability Ratio Pulse Pressure Mean arterial pressure Mean Systolic Pressure Mean Diastolic Pressure Dasrao MS. Hock YJ. Sim EK. Diagnostic Blood Pressure Wave Analysis and Ambulatory Monitoring Using a Novel, Non-Invasive Portable Device.

31. Projected Cost Pressure sensor and cable leads: $20 Mark of Fitness MF-81 Wrist Blood Pressure Monitor Mini microphone: $5 M810 Cell Phone Camera Touchscreen Watch Mini speaker:$5 M810 Cell Phone Camera Touchscreen Watch Capacitance sensor: $5 M810 Cell Phone Camera Touchscreen Watch Memory and microprocessor (including data sending and receiving): $40 Product encasing: $5

32. Risks Cost of components – Microprocessors with built in data storage capable of acquiring and releasing data is costly Linking various technologies and computing on central processor – Ideally, need to link ECG, temperature readings, blood pressure, movement, touch, pulse together Safety from electrical shock Account for false alarms – Call back service Consumer friendly product – Reasonable size with all integrated technology Accurate readings despite movement of the wrist – Account for dislocation of the sensor

33. Design Concept & Technical Requirements Chest Component

34. Required Functionality Determines heart rate continuously Records EKG statistics Records body temperature 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

35. 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

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

37. Necessary Components EKG Sensors Accelerometer Thermometer CPU, Communications iPhone CPU, Components

38. Power, Weight Breakdown Power 4-6W – EKG - approx. 50mW – Accelerometer < 25mW – Processing (at 1GHz) - approx. 4W Weight 250-500g – EKG - approx. 17g – Accelerometer < 1g – Thermometer < 1g – Processor and wireless transmitter < 50g – Plastic casing, straps < 100g – Battery < 100g Research paper on low-cost, low-weight EKG sensors and tech: http://www.eecs.umich.edu/~prabal/teaching/eecs598- w10/readings/PCB+06.pdf

39. Cost Breakdown EKG sensors and module – Most expensive component and based on current retail costs can run up to $75 to produce. – Maybe have redundancies with processor than can be reduced 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. Accelerometer, Thermometer – Less than $0.50 to buy Straps and casing – Less than $2 to make/ buy EKG Sales (pricing info): http://bio-medical.com/products/thought-technology-ecgekg- sensorwith-wrist-straps.html iPhone information: http://www.radphone.info/apple-iphone-3g3gsipad-parts- datasheets-componentschematicsdiagram-and-info/

40. 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

41. Design Concept & Technical Requirements Network and Operators

42. Network- Concept and Requirements Connects the watch to the call center via existing networks Same basic functionality as a cell phone Be able to send a signal in the case of emergency to call center Contains a two way voice connection Able to send data to call center

43. Network Specialized Cell Phone Device is a specialized cell phone that can only call a single number Can report data via SMS Calling can be both manually triggered or automatically tripped We can partner with a preexisting carrier in order to reduce costs

44. Parts needed for Network Access Antenna microphone speaker special circuit componets integrated onto the circuit board

45. Network Risks Needs to be partnered with a major carrier in order to access the network the antenna would have to be integrated into the watch and be isolated from skin to avoid electrical issues Miniaturization of all parts to fit inside the watch total battery life may prove to be a major issue.

46. 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

47. 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

48. Call Center - Operators Operators have to talk to the customer in order to determine if the call is a false alarm or the actual emergency Communicate with authorities to inform them of the emergency and provide them with basic information and location Operators have to be able to understand some basic medical issues in order to help the customer with their issue

49. Health Watch Group 6: Grace Fang, Eric Hengesbaugh, Michael Rhodes, Robert Richardson, Danial Sajed, Daniel Tepayotl