Kimberly J. Atiyeh Pamela M. Bays Charles M. Ekstien Ashley M
Contents
1. INDUSTRIES p resents O ueue Kimberly J Atiyeh Pamela M Bays Charles M Ekstien Ashley M Regazzi Daniel S Wong Columbia University Department of Biomedical Engineering apstone Industries b Ba Table of Contents Design Problem Design Brief Basic Summary of the Problem Product Description from an Engineering Design Prototyping Perspective An Interview with a Caregiver Safety Consideration Development of Target Specifications Consideration of the Needs of Hypothetical Clients Preliminary and Alternative Designs 10 Final Device Design 11 Consideration of Accessibility and Universal Design Principles 12 Accumulation of Costs 13 Cost of Final Prototype 14 Detailed Analysis of Prototype 15 Images of Final Prototype wo Ui 1 Design Problem Millions of Americans currently depend on a daily medication regimen often consisting of multiple drugs in different dosages and schedules Current management solutions rely solely upon the individual to remember to take certain pills on certain days at certain times These systems are inefficient and can result in serious medical complications from inaccurate and missed dosing In addition no single product currently available combines enough functionality to completely streamline the process 2 Design Brief Our goal was to develop a low cost portable device that unifies the various2. 596 CARBON FILM 5 resistor 0 05 0 10 16 1 Sparkfun com PRT 00115 Break Away Female Headers 1 50 1 50 17 4 Sparkfun com PRT 00116 Break Away Headers Straight 2 50 10 00 18 1 Sparkfun com BOB 08215 Breakout Board for DOSonCHIP FAT16 FAT32 uSD Module 44 95 44 95 19 1 Sparkfun com PRT 00553 Break Away Headers Right Angle 1 95 1 95 20 1 Allelectronics com SBZ 140 1 5 6 V AUDIO ALERT 1 25 1 25 21 1 Digikey com DS13374 ND IC RTC SERIAL 2WIRE LP 8 DIP Real Time Clock IC 2 41 2 41 22 1 Digikey com 728 1000 ND CRYSTAL 32 7 68KHZ Real Time Clock Crystal 0 35 0 35 23 4 Digikey com 8400K ND STANDOFF HEX M F 4 40 375 ALUM Hex Standoff 4 40 3 8 M F 0 40 1 62 24 2 Digikey com H342 ND SCREW MACHINE PHILLIPS 4 40X1 4 Standoff Screw 0 03 0 06 25 2 Digikey com 3348K ND WASHER FLAT 4 120X 250 NYLON Standoff Washer Nylon 0 03 0 06 26 2 Digikey com WM4200 ND CONN HEADER 2POS 100 VERT TIN Molex Header for LiPoly Battery 0 24 0 48 27 3 Digikey com EG1903 ND SWITCH SLIDE SPDT 30V 2A PC MNT Slide Switch for alerts 0 62 1 85 28 2 Sparkfun com PRT 08486 Polymer Lithium lon Batteries 2000mAh Molex Connector 16 95 33 90 29 1 Sparkfun com COM 08163 Flash Memory microSD 1GB 17 95 17 95 30 2 Sparkfun com LCD 00709 Basic 16x2 Character LCD FSTN White on Black 15 95 15 95 31 2 Sparkfun com WRL 00582 Bluetooth Modem BlueSMiRF Gold 64 94 129 90 32 2 Sparkfun com PRT 00726 LiPoly Charger Single Cell 3 7 7V Input 16 95 3
3. OHM 1 2W 5 CARBON FILM 680 ohm resistor 0 05 0 52 17 10 10KH ND RES 10K OHM 1 2W 5 CARBON FILM 10kohm resistor 0 05 0 52 18 2 AE1493 ND CABLE USB A B MALE 2M 2 0 VERS 3 36 6 72 19 1 585 1221 ND MICRO SD CARD 1GB 18 65 18 65 20 l2 2N4401 ND IC TRANS NPN SS GP 600MA TO 92 Transistor for Motor 0 12 1 44 th Costs as of May 5 2008 SparkFun ee S ttem Quant Sparkfun Part Description Customer Description Unit Price Total Price 1 2 PRT 08486 Polymer Lithium lon Batteries 2000mAn Molex Connector 16 95 33 90 2 2 08290 5 DC to DC Step Up VPack PCB 9 95 19 90 3 1 COM 08163 Flash Memory mcroSD 1GB 17 95 17 95 4 1 PRT 08293 LiPoly Fast Charger 5 12V Input 19 95 19 95 5 1 LCD 00709 Basic 16x2 Character LCD FSTN White on Black 15 95 15 95 6 2 WRL 00152 Transceiver nRF2401A with Chip Antenna 24 95 49 90 7 2 WRL 00582 Bluetooth Modem BlueSMiRF Gold 64 94 129 90 8 2 PRT 00726 LiPoly Charger Single Cell 3 7 7V Input Backordered 16 95 33 90 DigiKey item Quant Digikey Part Description Customer Description Unit Price Total Price 1 4 DS13374 ND IC RTC SERIAL 2WIRE LP 8 DIP Real Time Clock IC 2 41 9 64 2 3 DS1804 010 ND 5V IC POT TRIMMER NV 10K 8 DIP Digital Potentiometer 10K 3 10 9 30 3 4 728 1000 ND CRYSTAL 32 7 68KHZ 6PF Real Time Clock Crystal 0 35 1 40 4 20 8400K ND STANDOFF HEX M F 4 40 375 ALUM Hex Standoff 4 40 3 8 M F 0 40 8 08 5 100 H342 ND SCREW MACHINE PHILLIPS 4 40
4. The data storage unit also stores the medication dosing schedule that the user can program into the iQueue Given the portable nature of the iQueue s dispenser portion it is not always possible for the device to be able to contact a healthcare provider on a regular basis as a connection by phone or internet may not always be available For this reason a data storage device was incorporated into the iQueue dispenser allowing medication dispensing information to be recorded and stored until a time when a connection could be made to contact a healthcare provider The device used to achieve this functionality was a microSD card socket based upon a DOSonCHIP module which provided a basic DOS interface and file system compatible with those currently used by popular operating systems in modern personal computers The use of this common file system allows the data stored by the iQueue to be read without any special software to convert the files The particular microSD card socket module used also includes a built in real time clock which allows for the time and date of each scheduled doss to be recorded on the card The microcontroller can interface with this module using a serial universal asynchronous receiver transmitter UART interface over two pins of the Arduino board and increases the power consumption of the iQueue by 5mA Communication between the dispenser and the base station is used to relay data through the base station to a healthcare prov
5. advances to cut it in half Half of the pill is dispensed via the release hole and the other half is retained in the iQueue by the advanced blade The patient is alerted by a set of audible beeps which if the user prefers can be switched instead to a strong vibrating alert or a bright red light so the dose can be taken as prescribed Processor An Atmel ATMegal68 microcontroller programmed in an Arduino physical computing environment provides control for the various components and features of the device including motor control the user interface and data recording LCD screen Displays messages in high contrast with white text on a black background Buttons Four tactile response buttons that the user can push in response to prompts from the LCD Setting switch There are three modes 1 The program setting prompts a set of questions that enables the user to set the time date timing of dose and quantity of dose 2 The load setting allows for user to open the iQueue and insert the pill cartridge and 3 The lock setting prevents opening of device for safety reasons microSD card and socket Dosing schedule and dosing history are stored to commercially available solid state removable media card for later analysis and or transmission to a healthcare provider Pill cartridge An internal casing that can be customized and replaced for different pill types and can hold at least fourteen pills depending on pill dimensions th
6. and over take four or more prescribed drugs which may be impossible to manage without some form of help Alarm clocks positioning medication in visible places and taking medication at routine times such as meals have all been found by older people to be helpful in reminding them to take their medications 3 2 Health Problems Due to Non Compliance Not taking medication as prescribed can lead to major health complications 35 of patients make potentially serious errors in not following their medication regimen which result in 1196 of all hospital visits each year This may include overdosing or missing a dose of necessary medication An estimated 125 000 lives and 100 billion could be saved each year with better medication compliance Medications which are necessary for survival are often not taken regularly People who have had a myocardial infarction are 2 5X more likely to die within one year if their medications are not taken as prescribed Of those who have had an organ transplant and did not take their medications as prescribed 91 have died within one year 3 3 Causes of Non compliance According to the Office of the Inspector General there are four main causes of medication non compliance e Physiological factors Loss of vision or hearing can impede an elderly person s ability to read important information about his prescription or to hear instructions about his regimen Mobility limits type of disease the presence of symp
7. calling for 5 pill doses twice per day involves one cutting operation per day for 90 days the blade apparatus should be useful for at least that many uses 7 13 What are major safety concerns There are small parts to the device and thus it should not be left in an area accessible by young children However the largest concern is for malfunction and causing the user to be unable take their medications exactly as directed by a doctor 7 14 Is it affected by FDA or other regulations This device would be considered a Class I device and would not require FDA approval The device would need to function as described on the packaging and would not be intended to override any sort of pharmacist s or doctor s directions 7 15 Who is the user The user would be a person with a strict medication schedule and or a person who needs several different types of medication per day who would purchase multiple devices 7 16 How is the device better than others This device would be able to cut pills a feature not included in most pill dispensers marketed currently Also the device would alert a friend family member or pharmacist is a dose is missed 7 17 How does it work The device consists of two parts a portable dispenser and a base station to be kept in the user s home The base station will be powered by electricity and will communicate using either a Bluetooth radio or an Ethernet connection while the dispenser will contain a rechargeabl
8. elements of a dosing schedule pill manipulation and physician correspondence into a single accessible device The prototype includes the prescribed specifications of dispensing correct dosage 1 2 or pills of a single medication only on a preset schedule alerting the user when a dose should be taken relaying a message offsite in the case of a missed dose and multi modal indicators of current status In addition to these basic design elements we also included a method of alerting both the user and a pharmacy when refills are needed as well as the ability to accommodate for pills in a variety of shapes and sizes through interchangeable cartridges The device is powered by a rechargeable battery that connects to a base station charger kept in the user s home of the device controls are clearly accessible by following the prompts on an LCD interface screen The base station not only charges the portable dispensing device but also connects to the dispenser via Bluetooth and can send information through an Ethernet connection to a caregiver or doctor to transmit missed dosages and other adherence records Furthermore our design includes a novel and efficient approach to cutting pills and multiple alert modes including audible notifications with volume controls a vibrating feature and a notification light Our primary design focus was to deliver a device that is easy to program and use which includes clear settings and a simple user interfac
9. from the user in order to do so the iQueue uses a small direct current DC motor to do this instead Loading experiments on text pills showed that between 15 and 25 N of force was required to snap a pill in half via a three point bending technique Given the size constraints of the iQueue the motor had to be small and powerful al5mm Faulhaber motor with an encoder and 90 degree gear were chosen for this purpose The encoder allowed the Arduino to interface with the motor with just two pins one driving the motor forward and the other in reverse However the power requirements of the motor exceeded that which could be provided by the Arduino board Therefore an H bridge consisting of several transistors was used to control the motor using outputs from the Arduino board and drive the motor directly from the iQueue s batteries at a higher current and voltage This required the use of four additional digital I O pins from the Arduino board which weren t available To work around this problem an eight bit shift register was used to convert serial signals sent by the Arduino board over three digital pins into parallel signals sent over the eight output pins of the shift register allowing the microcontroller to control not only the motor through the H bridge but also left pins available for interfacing with other devices Alert System The iQueue also features a multimodal alert system consisting of a buzzer vibrating motor and LED which a
10. hundred dollars for users Since many people are on multiple medications the device must be affordable enough to allow users to purchase multiple units 7 10 How important is reliability Reliability is crucial Users will rely on the device in order to correctly take their medications Failure of the device could result in serious issues due to overdoses missed doses and inconsistent dosing A secondary reserve battery could be used to provide minimal power to the device s clock in the event that the primary battery becomes depleted 7 11 How will it be serviced The product will come with a warranty in the event of a defective device However the product is not meant to be serviced Once the device wears out we intend that the user will simply purchase a new one The pill cutting module of the device should be available separately so that it can be replaced when it wears out reducing the user s cost of maintaining the device The device s pill cutting attachment will need to be replaced approximately every three refills to ensure proper function 7 12 What is the life of the product for the user The device should not malfunction or wear out for at least two years Most likely the battery life will slowly be depleted and it will stop responding to recharging Two years is an acceptable length of time for the cost of the device The cutting blade should last through one prescription at the very minimum so for a three month prescription
11. is the same as it was the day before For my own parents I would attribute this probably to dementia It s easy to forget when to take a medication but I think also that people falsely remember taking pills By that I mean for example they think they remember taking a pill earlier in the afternoon but in reality it was the previous afternoon For other clients who miss doses it probably has a lot to do with the difficulty of taking pills What are your clients common complaints about medications Dosages change regularly pills are difficult to handle pills are difficult to swallow they can t remember if they taken the pill yet they taste bad it s painful to open the bottle they have to schedule their day around taking pills they hate having to cut the pills they hate having to go get refills 6 Safety Consideration 6 1 Safety Concerns The foreseeable major safety considerations are as follows l Environmental Factors The pills must be contained securely so that undesired moisture or other environmental contaminants are unable to get inside the bottle The pills might be sensitive to overexposure of different elements and keeping dirt and other small detritus out is a hygienic concern Water and Electrical Hazard While the voltage from the battery in the device will be too low to cause serious harm to the user it must be protected from water and from accidental feedback that could damage the battery and cause its con
12. like to have better control of her urinary function while participating in athletic activities If Jamie takes pills for any health issues she could greatly benefit from the freedom of having a portable device to notify her when it is time for her medication dispense the pills and cut the pills 1f needed which would help her to continue to maintain her very active lifestyle The device is very easy to carry around allowing Jamie to maintain her independence Betty is a 65 year old woman who has limited and asymmetrical lower extremity range of motion due to a bad hip She also has limited strength in her right leg due to decreased use of her right leg because of the pain caused by her hip If Betty takes pills for her health issues she would greatly benefit from the freedom of having a device to notify her when it is time for her medication dispense the pills and cut the pills if needed The iQueue is very portable allowing Betty to maintain her active and independent lifestyle Violet is a 32 year old woman of short stature who is on blood pressure medication She is also a mother of 3 and is very active within her family and community If Violet takes pills for her health issues she would greatly benefit from the freedom of having a portable iQueue device to notify her when it is time for her medication dispense the pills and cut the pills if needed Being a mother of three she would find the auditory visual and vibrational
13. the wall outlet to perform functions With this much space we would not have had C problem holding all the components but its bulk was about as far from a cap as possible The cutting mechanism works by taking a pill from the well securing it tightly in a small area and then rotating around meshing with a separate wheel with a blade to cut the pill The espresso machine was a great start but we had a long way to go especially in the size part of the design We wanted to make sure that our customers could carry their medication dispenser with them discreetly and not have to always worry about being home at the right time to take their medications We used this notion as a springboard to develop our next design making some concessions and trying to fix the problems that we had foreseen m Idea 2 In this idea the cassette player we shrunk the entire device it is still not a pill cap but it is starting to approximate something portable The user would load a small disposable cassette with pills of a specific type This cassette will have apertures for multiple days worth of an average medication regimen for that particular pill and will fit securely in the device The dispenser itself will have a very easy interface to navigate with a large LCD screen to display all the relevant information to the user Also as in the first idea the user will not be using any force to cut the pill this will all be done mec
14. 3 90 33 1 Gridconnect com GC XPORT AR EXTEMP XPort AR Embedded Processor Module NEW LOW PRICE 64 75 64 75 34 2 Allelectronics com RTP 10K 10K MULTITURN TRIMMER POT 1 25 2 50 35 2 Digikey com 438 1045 ND BREADBOARD 2 13x6 496 SLDLESS Breadboards 8 73 17 46 36 15 BME Department Resistors 234 7 5tahm 2a 288ahm 2457 7ahm 2411 7 tatm 241 B2ahm 241 SOahim 22ahm 400ahm 240ahm Estimated Cost 5 00 37 5 BME Department Capacitor 3x0 1uF 2x10uF Estimated Cost 5 00 38 1 BME Department Casing 3D Rapid Prototyping Materials Estimated Cost 20 00 39 1 BME Department Motor Faulhaber 1524E0065123 motor with 15 55141 1KB32 gearhead and HES164A encoder Estimated Cost 15 00 The total cost of all of the components in the final prototypes is 639 41 This cost is extremely high but this can be attributed to the fact that many components would be far less expensive if ordered in bulk mass machined or priced via negotiation It is estimated by viewing the various company s bulk ordering prices and by looking at alternative dealerships than many of these component s prices could be reduced by at least 5096 thus making the device cost about 300 to manufacture 14 Detailed Analysis of Prototype The final iQueue prototype consists of two primary sections the dispenser and the base station These parts complement one another and provide the necessary functionality for a full feature managed pill dispensing system The dispenser section pro
15. 90 degree angle at the top of the dispensing block The central dispensing column is the component of the iQueue which actually holds the medication to be dispensed and was designed to accommodate pills of various sizes and shapes The current column was designed to dispense generic acetaminophen capsules but the interior dimensions of the column can be modified to hold and dispense other sized and shaped pills Pills in the column are pushed upward by a spring attached to the spring base so that the next dose is always ready to be dispensed The column platform supports the pills above the spring and the column lid prevents pills from being ejected from the column by the spring The central column also has two pairs of holes near the top for infrared sensors to be mounted to detect the presence of pills in the column The cutting block holds pills after dispensing if the pill needs to be cut and has an opening for the cutting blade to enter the block on the bottom The block is also grooved to accept a gate to lock pills in place while cutting The motor mounting block holds the cutting block as well as the motor and cutting blade in position ready to cut pills if necessary 15 Images of Final Prototype
16. X1 4 Standoff Screw 0 03 2 98 5 1 H6MMS 1636M ND DIP CABLE HDM16S AE16M HDM16S LCD cabie 6 66 6 66 4 20 4801K ND STANDOFF M F HEX 4 40 NYL 375 Hex Standoff 4 40 3 8 M F 0 42 8 46 8 20 2202K ND STANDOFF HEX 4 40THR ALUM 375 Hex Standoff 4 40 3 8 F F 0 34 6 86 9 20 1902BK ND STANDOFF HEX 375 4 40THR NYLON Hex Standoff 4 40 3 8 F F 0 52 10 44 10 100 3348K ND WASHER FLAT 4 120X 250 NYLON Standoff Washer Nylon 0 03 3 09 11 10 S9001 ND CONN JUMPER SHORTING GOLD FLASH 2 Pin Jumper for SV Step up PCB 0 09 0 87 ig 1 923351 ND BREADBOARD JUMPER WIRE KIT 350PC Jumper Wire Kit 30 60 30 60 13 2 438 1045 ND BREADBOARD 2 13x6 496 SLDLESS Breadboards 8 73 17 46 14 5 WM4200 ND CONN HEADER 2POS 100 VERT TIN Molex Header for LiPoly Battery 0 24 1 20 15 10 EG1903 ND SWITCH SLIDE SPDT 30V 2A PC MNT Slide Switch for alerts 0 62 6 16 16 20 67 1049 ND LED 2 5 RECTANG SUPER RED DIFF Red LEDs 0 18 3 56 17 1 WOOSM BPMS ND IC BRIDGE RECT 1 5A 50V WOM B1 Bridge Rectifier 0 34 0 34 18 10 493 1108 ND CAP 220UF 50V ELECT VR RADIAL C1 C2 Capacitor 0 23 2 25 19 10 478 4277 1 ND CAP CER 10UF 50V DISC RAD C3 C9 Capacitor 0 30 2 97 20 10 1N5230B TPCT ND DIODE ZENER 500MW 4 7 V D035 D1 Diode 0 08 0 75 21 1N4148FS ND DIODE SGL JUNC 100V 4 0NS DO 35 D2 D3 Diode 0 03 0 32 22 1 BA17805T ND IC REGULATOR 3PIN 5V TO220FP IC1 Voltage Regulator 0 84 0 84 23 1 296 1577 5 ND IC HEX SCHMITT TRIG INV 14 DIP IC2 Hex Invert
17. ading relevant medication information to a pharmacist or physician Cutting was accomplished using a rotational motion similar to those used in common pepper grinders of these ideas addressed specific constraints and helped us to develop our final prototype design Problems that we foresaw with each idea were considered and eventually we were able to use them to incorporate just about everything we wanted into one accessible device 10 Final Device Design A user can adjust the iQueue to his her own medication regimen by setting the device to program mode following the simple set of questions displayed on the LCD screen and responding with button pushes The user interface is similar to that of an automatic teller machine with predefined menu options All programmed dosing schedule information as well as a record of whether or not a dose was successfully dispensed at the appropriate time is recorded to a removable media card Four 4 AA size batteries or two 2 rechargeable lithium polymer batteries provide power for the iQueue Once the iQueue is programmed the mode must be set to load so a pill cartridge of up to 14 pills can be loaded into the central column The iQueue is then ready for use when returned to lock mode At the times of the day designated by the user the cutting and or dispensing motor is engaged The pill at the top of the column is displaced from its resting position to the cutting position where the blade
18. al Hospital and Personal Use Miscellaneous Devices 7 Development of Target Specifications 7 1 How is it powered Since the device needs to be portable the dispenser cutter will be powered by a rechargeable battery The device will come with a charger base upon which the dispenser cutter will remain seated until a pill is needed or the dispenser cutter needs to be brought to another location away from home by the user 1 if the person would like to go out for the day The base station itself will be powered using a standard 120V AC wall socket connection with a DC transformer 1 http www accessdata fda gov scripts cdrh cfdocs cfcfr CFRSearch cfm CFRPart 880 7 2 How can it be tested A prototype can be easily tested by adding pills to see if the device dispenses and cuts pills at the appropriate times Since the device is a Class I FDA device it does not require clinical trials before commercial use 7 3 Do ergonomics matter Yes The device needs to be portable needs to have an LCD screen with a large display font and will have large buttons for ease of operation by users with limited or otherwise impaired dexterity 7 4 Does style matter Yes It will need to be presentable as a reliable medical device 7 5 Does accessibility matter Accessibility is a major portion of this project The intended user is a person who needs to take medications several times per day Since elderly people and people with disabilit
19. at have been stacked and oriented Platform spring loaded platform that advances pills to the top of the cartridge Motor 141 1 gear ratio 5 Volt motor that advances the cutting blade along the blade track Angled blade A long lasting steel blade that cuts pills cleanly with minimal force Cutting block Pills are pushed here prior to cutting When the blade is advanced the pill is cut using a combination of force and three point bending The dispensed pill exits here Infrared sensors The positions of pills within the column and cutting block are tracked allowing the processor to intelligently operate based on the status of the device Pushing mechanism The user must simply slide a lever to dispense a pill Multimodal indicators LEDs a speaker and a vibrating motor in any combination alert the user when a dose is ready Power supply The device is designed to draw power from and last for at least a week on two rechargeable lithium polymer batteries 11 Consideration of Accessibility and Universal Design Principles The Principles of Universal Design have been developed through the Center for Universal Design by a working group in 1997 Story 1998 Story and Mueller 2002 and include the below considerations for universal accessibility 1 Equitable Use The design is useful and marketable to people with diverse abilities The user interface and instructions can be easily navigated by people with a wide variety
20. ave with such a low frequency portability may not be that important to them Where are your clients generally when they take their medications A variety of places You d be surprised where some people put their medications The most common places are in the kitchen in the bathroom and by a bed What do your clients use now to organize their medications Almost all of my clients use pill boxes Many use the standard SMTWRFS boxes but those that take medications multiple times a day quite a lot use pill boxes that have separate compartments for morning noon evening night Do many clients require the use of a pill cutter How do they currently split pills Splitting pills is a difficult task for many people A lot of my clients have problems with arthritis and opening pill boxes or bottles alone is difficult Some people have pill cutters that they use but even so many cutters require the user to position the pill in the cutter first which can be a painful task for a lot of people Those that don t have pill cutters use knives but even I have difficulty using knives to cut pills I can t imagine it s easy for them Do your clients ever miss doses If so why I think they miss doses more than they realize I actually call my own parents who are in an assisted living community to ask if they taken their medicines and while they say yes most of the time I ofien find when I go over there that the number of pills I count in the bottle
21. e to maximize usage benefits and can be enjoyed by users of all ages and levels of physical fitness and dexterity 3 Basic Summary of the Problem 3 1 Inconsistent Medication Routine Prevalence Research has shown that many people dependent on medication regimens do not take their medications as prescribed by a doctor It has been found by various studies that 50 of patients over 60 years old do not take their medications as directed In one example a study of 130 patients discharged from four hospital wards dealing mainly with acute medical cases showed that 66 deviated from the drug regimen prescribed on discharge Of the patients 46 did not have a clear understanding of the regimen non comprehension and 20 of the remaining 84 patients understood the prescribed regimen but did not follow the instructions non compliance Over half of the patients in this study did not take their medications as prescribed Non compliance 65 could be due UK Department of Health http www dh gov uk en Publicationsandstatistics Publications PublicationsPolicyAndGuidance DH 400 8020 A study by D M Parkin C R Henney J Quirk and J Crooks http www pubmedcentral nih gov articlerender fcgi artid 1688349 to participants simply forgetting to take their medications not wanting to worry about following a strict schedule or simply choosing not to worry about attempting to do so It has also been found that approximately 36 of people aged 75
22. e battery The dispenser contains the device controls and display the cutting attachment and the relevant machinery for each component to function 8 Consideration of the Needs of Hypothetical Clients Phylis is an active 77 year old woman with rheumatoid arthritis that has caused diminished hand strength joint stiffness and pain Phylis also has age related macular degeneration and hearing loss but she is determined to remain active and independent Although she is outgoing and bold in general she is easily intimidated by many of the high tech gadgets her grandchildren use she prefers simple interfaces If Phylis takes pills for her RA or for other health issues she would greatly benefit from the freedom of having a device to notify her when it is time for the medication dispense the pills and cut the pills if needed abilities that the iQueue can handle well Due to her diminished hand function and dexterity the cutting and dispensing of medication would be especially useful High tech gadgets are often intimidating to people who are not used to them and therefore the instructions will be made extremely clear and the user interface will not be complicated to use The device is very portable about the size of a book allowing Phylis to maintain her active lifestyle Aaron is a 23 year old man a returning Iraq war veteran with an arm amputation above the elbow chronic neck pain and recurring headaches Although Aaron someti
23. h for a user to pick up and take with them even place in a bag regardless of the person s strength or motive ability A person of any size and strength or with limited space can easily use this device 12 Accumulation of Costs Costs as of February 21 2008 SparkFun Core Components Description SKU Unit Cost Quantity TotalCost Compnent Site Details Arduino USB Board DEV 00666 34 95 2 69 90 http www sparkfun com commerce product info php products id 666 Arduino ProtoShield Kit DEV 07914 16 95 2 33 90 http www sparkfun com commerce product info php products id 7914 Breadboard Mini Self Adhesive PRT 07916 10 95 2 21 90 http www sparkfun com commerce product info php products id 7916 Wall Adapter Power Supply TOL 00298 5 95 2 11 90 http www sparkfun com commerce product info php products id 298 Jumper Wires Premium M M PRT 08431 3 95 6 23 70 http www sparkfun com commerce product_ info php products id 8431 AVR 28 Pin 20MHz 16K 6A D ATMegal68 COM 07957 4 93 5 24 65 http www sparkfun com commerce product info php products 10 7957 Description SKU Unit Cost antity TotalCost C nent Site Details Basic 16x2 Character LCD FSTN White on Black LCD 00709 15 95 2 31 90 http www sparkfun com commerce product info php products id 709 Vibration Motor ROB 08449 6 95 2 13 90 http www sparkfun com commerce product info php products id 8449 Infrared Emtters amp Detectors SEN 00241 1 76 10 17 60 htt
24. hanically so that anyone with a loss of dexterity or strength in their hands wil be able to easily operate the device Cutting on this device is also a little bit different from before Here the device does not so much cut as utilize a three point bending system to break the pill in half Idea 3 ec A major concern of these devices is knowing when a pill should c be cut Most pills are not designed to be cut and all pharmacists recommend never cutting pills unless specifically directed by a physician This second idea would include programming that would only cut a pill if specifically directed to do so However we were still not satisfied with our design and we felt that among other things loading the device should be much easier and the size should be even smaller Our last preliminary idea finally resembles a pill cap though it is significantly larger than any regular cap on a bottle of the same size This last idea really tried to combine the best aspects of previous designs into a sleeker package From the simple interface with LCD screen right on the device to the easy attachment of a whole pill bottle to eliminate the need for constant refills this idea seemed to be a great aspiration It was discreet portable and included a lot of features like a vibrating alarm that would be a comfort to the user The separate base station would act as both charger and data hub charging the device about once a week and uplo
25. ider to do this a pair of Bluetooth radios are used one in the dispenser and one in the base station The Bluetooth radios used are the BlueSMiRF modules by Sparkfun Electronics based upon the Roving Networks RN 41 Bluetooth module The microcontroller can interface with this module using a serial universal asynchronous receiver transmitter UART interface over two pins of the Arduino board and increases the power consumption of the iQueue by 160mA when active Since both the Bluetooth radio and the microSD card socket must both use serial communication with the microcontroller and the Arduino board has only one hardware serial port the microSD card socket was moved to a software serial interface still only using two digital I O pins on the Arduino board Communication between the iQueue base station and a healthcare provider can be achieved through the use of an embedded server module the Lantronix XPort AR This device provides support for an Ethernet connection to a network and the internet and supports a wide range of internet protocols including TCP IP HTTP FTP SSH and SSL as well as the SMTP mail transfer protocol Using this the iQueue can transmit data to healthcare providers in multiple formats either by e mail or secure connection to a website or server Motor Control The iQueue dispenser can also cut pills in order to dispense a 2 pill dose Current pill cutting devices require the application of significant physical force
26. ies could have poor dexterity and may not want to spend time learning how to use a complicated device the device needs to be very accessible 7 6 Is training required No The device will be straightforward to use by simply reading the user manual Additionally any added complexity of the device that would necessitate training would introduce additional avenues toward misuse and potential failure of the device both physically and as a product intended to reduce complexity and errors associated with current medication management methods 7 7 What is the product s social impact The primary impact of this product will be the improvement of quality of life for people who must maintain a strict dosage schedule There would be fewer medical issues due to medication not being taken as prescribed In addition the device s users could become more independent and not have to rely on a friend or family member to aid in their medication routines Greater independence will be the single most noticeable effect of this device on its users 7 8 How is it sold It will be sold to drug stores and pharmacies so users can buy the device over the counter at their own discretion or if recommended by a healthcare provider Labeling on the device packaging would encourage customers to bring the device with them to the doctor s office for programming and additional support if necessary 7 9 How much will it cost to buy The device should cost no more than a few
27. ing Schmitt Trigger 0 47 0 47 24 2 296 2067 5 ND IC 4 IN AND GATE DUAL 14 DIP IC3 4 Dual 4 Input NAND Gate 0 55 1 10 25 10 2N3906 APCT ND TRANSISTOR PNP GP 40V T092 Q1 PNP Transistor 0 06 0 60 26 4 296 8319 5 ND IC DUAL 4 BIT BIN CNTR 14 DIP V1 V4 dual 4 bit binary counter 0 44 1 76 27 5 CF1 41KS595RCT ND RES 1K OHM 1 4W 536 CARBON FILM R18 0 03 0 15 28 5 CF1 410KS99RCT ND RES OHM 1 4W 5 CARBON FILM R19 20 0 03 0 15 29 20 470QBK ND RES 470 OHM 1 4W 596 CARBON FILM R1 17 0 05 1 08 30 1 T980 PSP ND XFRMR WALL MNT SVDC 0 66A E STAR SVDC Adapter 6 98 6 98 31 1 CP 057A ND CON PWR JCK 2 0 X 6 3MM DC Power Jack 0 65 0 65 32 7 365 1191 ND LED 470NM OVAL BLUE 5MM LED 1 11 7 77 33 7 365 1192 ND LED 525NM OVAL GREEN 5MM LED 1 29 9 03 34 7 365 1193 ND LED 618NM OVAL ORANGE 5MM LED 0 66 4 62 Gridconnect com Item s ant Gridconnect Part Description Customer Description Unit Price Total Price E AR ort mbedded Processor Module W T5 gt Sum Total of Monies Used as Part of Design Competition Fund 1 193 29 Additional Monies Used in Development of Prototype ttem Quantity Digikey Part Description Customer Description Unit Price Total Price 1 1 3006P 103LF ND POT 10K OHM 3 4 RECT CERM MT 10K Potentiometer 1 72 1 72 Misc Parts Purchased By Columbia University for Project Quantity Part Description Customer Description Unit Price Total Price 1 1 N A Rapid 3D Prototyping Materials Blank cartridges and re
28. k Away Headers Right Angle 1 95 5 85 Semi total 78 25 DigiKey 6 ttem Quant Digikey Part Description Customer Description Unit Price Total Price 1 5 296 2040 5 ND IC STATIC SHFT REG 8STG 16 DIP CD4021BE Digital Input Expansion 0 48 2 40 2 5 296 1600 5 ND IC 8 BIT SHIFT REGISTER 16 DIP SN74HC595N Digital Output Expansion 0 62 3 10 3 5 296 9911 5 ND IC HALF H DRVR QUAD 16 DIP L293 SN754410 H Bridge Motor Driver 1 65 8 25 4 15 3M5475 ND SOCKET IC OPEN FRAME 16POS 3 16 pin IC socket 0 16 2 34 5 3 3M5480 ND SOCKET IC OPEN FRAME 28POS 3 28 pin IC socket 0 30 0 90 6 3 P828 ND TOUF 50V MINI ALUM ELECT KA C1 10uF for Standalone uC 0 16 0 48 7 3 P824 ND 1 0UF 50V MINI ALUM ELECT KA C2 1 0uF for Standalone uC 0 14 0 42 8 6 399 4279 ND CAP 22PF 200V 596 CER RADIAL C3 4 22pF for Standalone uC 0 29 1 74 9 3 LM7805CT ND IC REG 1A POS 40 125DEG TO 220 IC4 7805 IC for Standalone uC 0 72 2 16 10 3 300 8499 ND CRYSTAL 16 000 MHZ HC49 US Q1 16MHz Oscillator for Standalone uC 0 63 1 89 11 10 10KQBK ND RES 10K OHM 1 4W 596 CARBON FILM R1 for Standalone uC 0 05 0 54 12 10 220QBK ND RES 220 OHM 1 4W 5 CARBON FILM R2 220 for Standalone uC 0 05 0 54 13 10 SW400 ND SWITCH TACT 6MM MOM 100GF S1 Switch for Standalone uC 0 20 2 00 14 10 5 6KH ND RES 5 6K OHM 1 2W 5 CARBON FILM 5 6kohm resistor 0 05 0 52 15 10 5 6H ND RES 5 6 OHM 1 2W 5 CARBON FILM S 6ohm resistor 0 05 0 52 16 10 680H ND RES 680
29. ler machines ATMs commonly found in banks grocery stores and other commercial operations The benefit of this design is that no special instruction or training is necessary to operate the iQueue The LCD used a Xiamen Ocular GDM1602K display uses the common HD44780 parallel interface chipset The Arduino board can be programmed to interface and control this LCD using a four bit LCD display driver library developed by a member of the Arduino development community The addition of this device in the electronics of the iQueue occupied six of the Arduino s 13 digital I O pins and increased electrical consumption of the circuit by a maximum of 170mA In order to conserve the use of the Arduino board s digital I O pins one side of each of the buttons was wired to a resistor each with a different value and the other side connected to group through an LED as well as one of the analog inputs of the Arduino board In this manner each of the buttons when pressed would close the circuit with a specific voltage determined by the resistor and this voltage would allow the microcontroller to differentiate between the different buttons Data storage amp Communication Another primary component of the iQueue is its data storage and communication abilities the latter of which has been broken out into two separate parts internal communication between the base station and the dispenser and communication between the base station and a healthcare provider
30. mes wears a prosthetic device with a pinching mechanism most often he improvises and uses one hand to complete tasks He takes a number of medications mostly for pain management It may be helpful for Aaron to have a pill dispensing device like the iQueue to remind him when to take all of his medications In addition if any of his medications require cutting it may be a challenge for him to complete this task A pill dispenser with cutting capabilities would allow him the ease and freedom of cutting pills with the use of only one hand The device s great portability will allow Aaron to travel and keep active Keisha is an 84 year old woman who recently had a stroke causing hemiplegia on her right side that has affected the function in her dominant hand She has also experienced some memory loss after the stroke so she appreciates the reminders her family provides her Before the stroke Keisha had minor hearing loss and it has continued to worsen in recent years due to aging Although she wears a hearing aid every once in a while if she s going out at home and at most other times she does not use it She also has occasional challenges with incontinence If Keisha takes pills for her health issues she would greatly benefit from the freedom of having a device to notify her when it is time for her medication dispense the pills and cut the pills if needed Due to her diminished dominant hand function and dexterity the iQueue s cutting and dispe
31. nsing of medication would be especially useful Since Keisha has some hearing loss a device with both an auditory and visual vibrational notification system would be the most helpful to her The caregiver physician notification system will allow Keisha to get additional help if she still cannot maintain a correct dosing regimen Jerry is an 82 year old man with Parkinson s disease which causes him to have tremor rigidity and decreased range of motion he also has difficulty with urinary control Jerry has recently started experiencing symptoms of Dementia but with the help of his family he is determined to remain in his own home as long as possible If Jerry takes pills for his health issues he would greatly benefit from the freedom of having a device to notify him when it is time for his medication dispense the pills and cut the pills if needed Due to his decreased motor function the iQueue s cutting and dispensing of medication would be especially useful The portable iQueue device would allow Jerry to control his dosing regimen independently and safely The caregiver physician notification system will allow Jerry to get additional help if he still cannot independently maintain a correct and healthy dosing regimen and his family would be free to continue to give him certain reminders Jamie is a 42 year old woman with a T11 spinal cord injury She mainly uses a manual wheelchair and is a serious wheelchair basketball athlete She would
32. ntended actions The most hazardous element the sharp cutting blade is well shielded and there would be no way that the user would come into contact with it unless the device was deliberately disassembled The most probable malfunction of the device would be the loss of power due to battery life loss causing it to fail to notify the user when to take his or her medication However this would be preceded by the screen becoming dim and the notification system elements becoming less noticeable thus indicating that the battery must be charged If the user simply gets into the habit of leaving the batteries charging while at home then the batteries should never run out of life at a crucial time In addition the iQueue Pill Dispenser has a override ability in the case that a pill is dropped by the user i e on a dirty floor and another is immediately needed 6 Low Physical Effort The design can be used efficiently and comfortably and with a minimum of fatigue The device is designed so that pills are dispensed with the slide of a lever and the push of a button thus minimizing fatigue and physical effort in any body position of the user Manipulation and repetitive actions on the device are only needed during initial programming and loading 7 Size and Space for Approach and Use Appropriate size and space is provided for approach reach manipulation and use regardless of user s body size posture or mobility The device is small enoug
33. ntent of a pharmacist s label and the ability of a patient to ask questions can all affect compliance 4 Product Description from an Engineering Design Prototyping Perspective 4 1 Who is the customer The customer would be the drug store or pharmacy to stock the device and sell it This method of distribution will allow for wide market availability and reduce the need for an independent distribution network 4 2 Who is the user The user would be a person with a strict medication schedule and or a person who needs several different types of medication per day who would purchase multiple devices 4 3 What type of device is needed A device is needed that can reliably dispense medications when a user needs them and can be programmed by a doctor of pharmacist if necessary 1 e if a user does not understand his her medication schedule Many of the reasons cited about why non compliance exists are due to the fact that several different types of medications are needed several times a day This sort of schedule is difficult to manage especially if cognitive ability is impaired In addition the device must be able to accommodate many types of pills 4 4 Why our approach is crucial to health care needs Many different medication management devices are available on the market Many products that have functions similar to our device cost hundreds of dollars and therefore are not affordable to a majority of medication dependent people The
34. nter 310 Plus 3D printer further allowed for the rapid development of the iQueue dispenser s mechanical parts which were designed in the SolidWorks 3D CAD program v F lj Pill Column C 20080329 1 4 Electronic Components User Interface A central component of the iQueue both in the dispenser and the base station sections is the user interface which is composed of a liquid crystal display LCD and four tactile buttons The display a two line 16 character white on black LCD was chosen for its ease of integration with the Arduino platform as well as its size and high Gees ERE contrast display The tactile buttons were selected over other options due to considerations regarding ease of use for users of the iQueue and specifically because the N tactile buttons provided a physical feedback response to 1 the user In addition larger buttons could be made an LRT TIT 6 placed over these smaller tactile buttons allowing for SEES Su ie 4 flexibility in the final product design to accommodate the rre d f id f 3 AN needs of a wide range of users This user interface was designed programmed to be simple and straightforward with a menu system similar to that of automatic tel
35. of electronic and mechanical skills The ability to use the device is the same for most users regardless of background and other variations including but not limited to older users and users with disabilities or other health issues The three different types of notification systems auditory beeping visual flashing light and vibrational will allow people with impaired vision or hearing to use the iQueue device equally well Some users may have trouble loading pills into the device if they only have limited dexterity in their hands and may ask for help during the initial loading of the device 2 Flexibility in Use The design accommodates a wide range of individual preferences and abilities The program allows for users to schedule dosing by day i e 3 times a day and by hour 1 e every 8 hours depending on their preferences for how they understand their dosing schedule best In addition the user can choose any or all of the notification alarm systems turning one or more off depending on situation and setting The pace and handedness of use are not factors that would decrease ability for a person to use this device 3 Simple and Intuitive Use The design is easy to understand regardless of the user s experience knowledge language skills or current concentration level After the initial programming the device requires minimal involvement in maintaining an effective medication regimen If the user has some ability the de
36. p www sparkfun com commerce product info php products id 241 Mini Push Button Switch COM 00097 0 32 10 3 20 http www sparkfun com commerce product info php products_id 97 Triple Output LED RBG COM 00105 1 76 10 17 60 http www sparkfun com commerce product_ info php products id 105 Basic LED Green COM 08532 0 32 10 3 20 http www sparkfun com commerce product info php products id 8532 Total Order Subtotal 248 70 McMaster Carr Raw Materials amp Tools Description SKU antit Unit Unit Cost TotalCost C ient Site Details Black Delrin Rectangular Bar 3 4 Thick 1 Wide 8662K51 3 feet 9 64 28 92 High Speed Steel Keyseat Cutter 1 4 Cutter Diameter 1 16 Face American Standard 202 3031A11 1 each 21 05 21 05 Safety Pak Industrial Single Edge Razor Blade Standard 0 009 Blade Thick 10 Ea Pk 7071A11 1 pack 2 90 2 90 Industrial Grade Single Edge Razor Blade Plastic 0 040 Thick 5 Ea Pk 3962A7 1 pack 1 68 1 68 High Temperature Silicone Rubber Tubing Soft 1 2 ID 5 8 OD 1 16 Wall White 10 L 51135K41 10 feet 1 29 12 90 High Temperature Silicone Rubber Tubing Firm 3 8 ID 1 2 OD 1 16 Wall White 5 L 51135K82 5 feet 2 10 10 50 High Temperature Silicone Rubber Tubing Soft 3 8 ID 1 2 OD 1 16 Wall White 10 L 51135K35 10 feet 1 31 13 10 Spring Tempered Steel Continuous Extension Spring 36 Length 1 8 Outside Diameter 0 012 Wire Packsof 5 9664K41 pack 12 48 12 48 White Del
37. re all driven by the microcontroller through the shift register Each individual alert can be toggled on or off using a simple sliding switch Dispensing Dispensing of medication by the iQueue is monitored by infrared emitter detector pairs located in a few locations in the device One pair is located at the top of the dispensing column and checks if a pill is present in the column to be dispensed Two more pairs in the cutting block check if a pill is present in the cutting block either being dispensed waiting to be cut or already cut and waiting for the next scheduled half dose Mechanical Components Most of the mechanical components of the iQueue were designed in SolidWorks and printed in a ZPrinter 310 Plus 3D printer The primary mechanical parts are the dispenser base the central dispensing column the cutting block and the motor mounting Peripheral parts are the dispensing knob the column platform column lid spring base and cutting block gate The dispenser base is the core of the iQueue s mechanics and acts as the enclosure for the central column the mounting base for the motor and electronic circuitry the carrier for the iQueue s batteries as well as the housing for the dispensing plunger which advances pills into the cutting block from the dispensing column The dispensing knob is connected to a 0 20 diameter spring with a small block on the end in order to advance pills spring was used in order to bend through the
38. re are several devices lower in cost available but these do not have the same functionality as the intended functionality of our product i e dispenses pills only when timer goes off both vibrates and beeps calls a family member friend doctor if a dose is missed etc In addition none of the devices researched were able to cut pills 5 An Interview with a Caregiver 5 1 Interview with Ann Erikson caregiver for mostly elderly clients Communicated via email 10 11 2007 How important are aesthetics Many people keep their medications in one place and generally that place is not on display That is medications are generally kept in dedicated cabinets drawers or areas on a counter While I think that aesthetics are always important to an extent many elderly people have been taking pills for years and have gotten used to keeping their medications out of sight How important is size and portability For most people not that important Most of my clients live in nursing homes assisted living developments or retirement communities They generally stay within their homes or buildings where meals are provided entertainment is available and other people come to 1 would say that most clients of mine leave their homes or communities anywhere from 1 to 4 times a week usually to do grocery shopping or get a meal with family or friends These excursions generally don t last too long a few hours at most Because my clients tend to le
39. reminders useful in organizing her medication regimen Paul is a 43 year old man with diabetes The diabetes has caused neuropathy in his hands and feet which eventually necessitated two below the knee amputations and some loss of vision If Paul takes pills for his health issues he would greatly benefit from the freedom of having a device to notify her when it is time for her medication dispense the pills and cut the pills if needed The auditory reminders and clear user interface would be most useful to him due to his slight loss of vision 9 Preliminary and Alternative Designs As we began the design process and started developing concrete design parameters we focused on three initial designs Each addresses many different aspects of the competition specifications from given constraints to what we saw as necessary for the livelihoods of our product s users Of the designs below none of them are evident in our final prototype as a whole we were able to take the best aspects of each and combine them into our final device creating what we believe is the best solution to the given problem Idea 1 For our first idea we were not sure how to encase all of the E prescribed functions into a pill cap This D e machine appropriately dubbed the 7 _ eee espresso machine would sit on a gt Bess countertop be incredibly easy to load with one or multiple pill types and would be able to pull power from
40. rin Rectangular Bar 1 1 2 Thick x 1 1 2 Widt 8739K93 1 foot 22 66 22 66 Polyethylene idpe Rod 1 4 Diameter 8754K42 8 feet 0 67 5 36 Total Order Subtotal 131 55 Costs as of March 26 2008 Allelectronics com item ant _Allelectronics Part Description Customer Description Unit Price Total Price 1 1 DCM 286 12VDC GEARHEAD MOTOR 19 25 19 25 2 1 DCM 285 MINI GEARHEAD MOTOR 166 1 RATIO 17 75 17 75 3 2 SBZ 140 1 5 6 V AUDIO ALERT 1 25 2 50 4 2 PE 35 1 36 DIAMETER X 0 34 ENCASED PIEZO 0 75 1 50 5 4 BST 3 9 VOLY BATTERY SNAP 3 LEADS 1 00 for 4 0 25 1 00 6 2 BH 60 COIN CELL BATTERY HOLDER 20MM DIA CELL 0 65 1 30 7 2 BH 32 BATTERY HOLDER 2 AA CELLS 0 75 1 50 9 2 BH 341 BATTERY HOLDER 4 AA CELLS 1 10 2 20 10 2 BAT 4PK VERY SPECIAL PRICING 4 HD AA BATTERIES 0 50 1 00 11 2 LBAT 20 3 VOLT 180 MAH LITHIUM BUTTON CELL 1 00 2 00 12 2 DCJ 1 2 1 MM DC POWER JACK 0 35 0 70 13 2 GR 5 SET OF 5 GEARS AND BUSHINGS 2 75 5 50 14 2 RTP 10K MULTITURN TRIMMER POT 1 25 2 50 5 SSW 46 SPDT MINFSLIDE SWITCH 1 00 for 5 0 20 1 00 Subtotal 59 70 item Quant SparkfunPart Description _ Customer Description UnitPrice _TotalPrice _ 1 6 PRT 00115 Break Away Female Headers Sa rr TTA 50 9 00 2 3 PRT 00116 Break Away Headers Straight 2 50 7 50 3 1 PRT 07916 Breadboard Mini Self Adhesive 10 95 10 95 4 1 08215 Breakout Board for DOSonCHIP FAT16 FAT32 uSD Module 44 95 44 95 5 3 PRT 00553 Brea
41. sin materials 200 00 200 00 2 1 N A Lab Waste Recycled for Material Pieces of plastic springs and metal used 10 00 10 00 Complete Total Used in Development of Device Prototype 1 405 01 13 Cost of Final Prototype Quant Vendor Part Description Customer Description Unit Price Total Price Spring Tempered Steel Continuous Extension Spring 36 Length 1 8 Outside 1 1 McMaster Carr 9664K41 Diameter 0 012 Wire Packs of 5 12 48 12 48 2 1 McMaster Carr 8739K93 White Delrin Rectangular Bar 1 1 2 Thick x 1 1 2 Width 1 Length 22 66 22 66 3 2 Sparkfun com DEV 00666 Arduino USB Board 34 95 69 90 4 2 Sparkfun com DEV 07914 Arduino ProtoShield Kit 16 95 33 90 5 2 Sparkfun com PRT 07916 Breadboard Mini Self Adhesive 10 95 21 90 6 2 Sparkfun com TOL 00298 Wall Adapter Power Supply 5 95 11 90 Y 4 Sparkfun com PRT 08431 Jumper Wires Premium M M 3 95 15 80 8 1 Sparkfun com ROB 08449 Vibration Motor 6 95 6 95 9 4 Sparkfun com SEN 00241 Infrared Emitters amp Detectors 1 76 7 04 10 8 Sparkfun com COM 00097 Mini Push Button Switch 0 32 2 56 11 2 Sparkfun com COM 00105 Triple Output LED RBG 1 76 3 52 12 2 Sparkfun com COM 08532 Basic LED Green 0 32 0 64 13 1 Digikey com 296 1600 5 ND IC 8 BIT SHIFT REGISTER 16 DIP SN74HC595N Digital Output Expansion 0 62 0 62 14 1 Digikey com 296 9911 5 ND IC HALF H DRVR QUAD 16 DIP L293 SN754410 H Bridge Motor Driv 1 65 1 65 15 2 Digikey com 5 6H ND RES 5 6 OHM 1 2W
42. tents to leak The base station has a higher risk of electrical shock associated with the higher voltage and should be designed to carry no risk of serious shock or injury to the user The base and cap should be designed to include minimal electrical contact points that are as small as possible Mechanical Hazards Since the device will have a very sharp razor blade as part of the pill cutting apparatus the blade must be firmly seated without the ability to be removed consciously or accidentally by the user The blade must be readily visible to reassure the patient that the integrity of the metal is consistent If the blade is not secured in a strong housing there is a possibility that it could become harmful to the user Either the housing could crack exposing the blade or the blade could fracture and pieces of either could be dispensed along with the medication Medical Safety and User Interface This is by far the largest category of danger for the user and could be potentially harmful or fatal to the user Sections of the FDA Medical Device Use Safety Risk Management are related below Summary Since our device is a modification on an existing product a pill organizer dispenser and there is no high rate of morbidity mortality from misuse we are exempt from FDA premarket notification Unfortunately there is no specific reference in the Device Classification Panels though our product would probably fall under Part 880 Subpart G Gener
43. toms memory loss depression and cognitive impairment are other physiological variables that can negatively affect compliance e Behavioral factors These include social isolation social and health beliefs and economic condition Many elderly people live alone Studies have shown that people who live alone more often fail to comply with medication regimens For those elderly on fixed minimal incomes the ability to purchase expensive medications may also be a factor in noncompliance e Treatment factors These include the duration and complexity of the medication regimen Compliance rates decrease when the treatment is long term and when the regimen includes many different medications that must be taken concurrently Other treatment factors include the type of medication prescribed and the patient s perception of the medication e Health Care Provider Patient Interaction factors These include how well the physician the pharmacist and the patient communicate with each other The Social Care Institute for Excellence Information Technology Association of America http www itaa org isec events presentations 1154 ppt4 375 12 Where Is The Problem The Biggest gt School of Pharmacology London www patientsikkerhed dk admin media pdf dfflef42849b6990b0673e8f0ed1561a pdf Office of the Inspector General Report http oig hhs gov oei reports oei 04 89 89121 pdf quality and content of a physician s instructions the co
44. vice is easy to use and to program If the user is unable to program or load the device and if a friend relative or physician is available they can provide initial help in setting the dosing schedule after which the user can use the device independently The high contrast display shows instructions clearly and a person could easily follow the prompts and program the device without training A person who only has very limited English reading skills may have some trouble in programming the device and may have to ask someone to translate the prompts for initial programming 4 Perceptible Information The design communicates necessary information effectively to the user regardless of ambient conditions or the user s sensory abilities Due to the high contrast display and multiple notification systems people with diminished hearing and visual abilities can still enjoy full use of the device However if the user has total vision loss then this person may require some assistance in initially programming the device due to the fact that the prompts for programming appear on the screen After the initial programming though this person could simply be instructed as to which button to push to dispense the pill after the alarm sounds He or she can then simply push that button each time the alarm is heard or felt due to the vibrator motor notifier 5 Tolerance for Error The design minimizes hazards and the adverse consequences of accidental or uni
45. vides most of these functions including medication storage timekeeping scheduled alerting pill dispensing pill cutting and medication dosing monitoring The base station supports the dispenser by extending its functionality beyond what the portable dispenser section could reasonably accommodate and remain portable namely the recharging of the dispenser s batteries and communication to a healthcare provider The base station and dispenser share a common microcontroller foundation for their electronic components the dispenser itself also has a mechanical component associated with it necessary for the physical manipulation of medication A microcontroller was used as the basis for the iQueue dispensing system in order to provide the greatest functionality and flexibility for the specified design objectives The Arduino electronics prototyping platform was selected for this purpose as its open source nature reduced development costs while still providing both breadth and depth of interactive functionality and in addition the Arduino platform is based on a C C like language making it easy to program Using this platform as a foundation the user interface and overall functionality of the iQueue system could be fully customized and prototyped in a fast an efficient manner By interfacing with various hardware components the microcontroller provided the means by which the iQueue could meet all of the design objectives Similarly the use of a ZPri
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