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1. Figure 3 Olimex MSP430 449STK development Figure 4 Olimex MSP430 413STK development board The Dallas port is at the bottom right of board 28 the board 28 34 Undergraduate Thesis SmartPill The 449S TK board which contains a TI MSP430F449 MCU was selected as the primary development board Memory size was the main reason for this choice The 449 board contains the maximum amount of memory that the MSP430 architecture can address 60KB of ROM and 2048 bytes of RAM The 413STK board was used as a backup Since both parts shipped from Bulgaria and had long lead times it was important to have a backup board 4 1 3 Dallas Semiconductor iButton The group considered several possibilities for the SmartPill cartridge memory The first option was a magnetic stripe similar to the technology found on credit cards By using a magnetic stripe the cartridges would not need any electronics Furthermore magnetic stripes cost only pennies This technology can only store a few bytes of data though and magnetic fields common in many environments can erase that data 43 3 SmartPill required several kilobytes of storage and data integrity was critical so magnetic stripes were not suitable The second possibility was a standard EEPROM or NVRAM memory chip Many different products exist which vary in terms of packaging storage capacity and power consumption This solution was also cost effective with most parts priced at less than one
2. anchors the schedule of the overall development project 31 15 The SmartPill project had finite time constraints By setting milestones the group narrowed the project s scope The planning activity helped the group decide what could be accomplished and ensured that those tasks would be completed on time 23 Undergraduate Thesis SmartPill 3 1 1 Tracking All group members recorded design decisions meeting minutes and other pertinent information in engineering logbooks The other tracking tools used during the project changed between the Research and Design see section 3 2 2 and Implementation see section 3 2 3 phases During the Research and Design phase the group used eproject a web based project management suite 32 eproject features a logged email list a document revision control tool and a calendar Whenever a change occurs such as the posting of a new document the system notifies group members via email This feature greatly enhanced communication within the group eproject had allowed free academic licenses but it discontinued that service in January 2004 Consequently the group looked elsewhere for a low cost alternative Information Technology and Communication ITC at the University of Virginia provided eproject s services at no cost ITC supplied a logged email list through the school s listserver Several gigabytes of storage on a Sun Microsystems Solaris server were also provided The server hos
3. gt Patient Pill Bottles 2 Problem Description a Definition This product addresses two main problems in the areas of drug prescription distribution and consumption 1 2 Prescription fraud Paper prescriptions with the doctor s name contact information and drug information are used for drug prescription today Paper prescriptions are easy to forge though Our solution increases the complexity of fraudulently obtaining drugs by several orders of magnitude By authenticating doctor and patient information and electronically encrypting the actual prescription our solution secures the prescription process Decrease improper drug use Many patients use multiple medications simultaneously Product literature usually runs several pages per drug In addition this information is often difficult to decipher By storing all of the usage information on the bottle and ensuring proper use via smart sensor networks we decrease the patient s risk b Target Customer Our target customers fall into three main categories 1 2 3 Doctors and hospitals These customers will need the drug prescription system components see section 5 1 Pharmacies Drug distributors will need the technology to decrypt and authenticate the prescriptions In addition they will need a machine that can load drug information onto each pill bottle and enable the sensor device see section 5 2 Patients and insurance
4. iButton block diagram Opcodes on the 1 Wire bus control all cartridges at any time If ordinary memory device s operation 43 4 chips had been used some of the MCU s address space would have been consumed by the external memory chips This was not a desirable solution since the code size of the onboard software was not known in advance The 1 Wire protocol though provides the capability to communicate with all connected iButtons over a single bus line without using any MCU address space see section 4 4 1 This feature was the primary motivation for using iButtons Figure 6 shows the unique iButton packaging la 16 25 17 35 14 55 jq 3 10 Figure 6 Dimensions of the iButton MicroCan package 43 12 All dimensions are in millimeters 36 Undergraduate Thesis SmartPill Dallas provides free iButton samples so EPROM EEPROM and NVRAM variants of the iButton product were obtained at no cost The NVRAM iButton variant DS1992L and DS1993L was selected after testing revealed that it was Figure 7 This DS1402D DRS reader the easiest to program Several iButton readers DS9092T which has two receptacles for 1 Wire DS9092L and DS1402D DR8 RS 232 port adapters PeO erk testing connects to a PC via a port adapter DS9097U S09 and circuit board mounting kits DS9094FS and DS9106S GN were also procured Several of the DS9092L readers were soldered together an
5. Brad Pinney then joined the project Deliverable Project Proposal Detailed project description and proposal consisting of a problem description solution strategy contextual analysis organizational and cultural project aspects project requirements and verification strategy Table 1 Proposal phase deliverable listing 3 2 2 Research and Design The Research and Design phase contained five parts customer needs concept selection requirements specification up front design and implementation planning Several important deliverables discussed here were created Table 2 lists other secondary deliverables The Statement of Work and Product Specification were two critical documents The Product Specification was based largely on customer needs see section 2 1 1 This technical document listed all virtual product parameters The Statement of Work showed which parts of the virtual product would be implemented for the proof of concept It also listed all project activities for the final two phases of the project The concept selection activity was another important part of this phase Several competing SmartPill designs were evaluated using criteria such as intuitive use cost and ease of integration into the existing pharmaceutical distribution infrastructure 37 The 26 Undergraduate Thesis SmartPill medication dispenser solution surpassed the other designs one of which involved placing wireless sensors on pill bo
6. COTS materials usually have short lead times With only a few exceptions most of the hardware components listed below can be procured at a good electronics store The software development environment can be downloaded for free from the Internet 26 27 4 1 1 Microcontrol Unit MCU The dispenser required an onboard processing unit Mr Harry Powell a University of Virginia technical staff member was able to focus the search for an appropriate MCU 7 Some of the major requirements were low power availability of software programming tools and amount of free I O pins Two potential units were selected the Motorola 68HC16 series and the Texas Instruments MSP430F4xx series These parts are comparable in terms of word size 16 bit addressable memory and power consumption Furthermore both have short lead times extensive documentation and are used for a wide range of embedded applications For large orders the unit price of both parts can be less than 10 A concept selection matrix was prepared to select one of the parts and two determining factors emerged software tools and available development boards Motorola supports several commercial software options for their part including Metrowerks Codewarrior Alternatively patches for GNU s gcc compiler are available on the Internet for certain parts in the series The Open Source projects maintaining these patches are not very active though Texas Instruments on the other hand provide
7. and the information 49 Undergraduate Thesis SmartPill on their website was largely incorrect Consequently the group had to blindly guess and check its way through much of the low level software development 50 Undergraduate Thesis SmartPill 6 0 Conclusions At present the project results are inconclusive Since development has been delayed and the project deadline has not passed there are no artifacts to verify and validate As a result this section describes the future work necessary to implement the virtual product It also lists some social and ethical considerations 6 1 Future Work Recommendations In order to move SmartPill to market a full virtual product prototype must be implemented The proof of concept demonstrated the SmartPill s novel features medication cataloguing dynamic usage scheduling and harmful combination detection The virtual product should show that the system as a whole can effectively combat prescription drug misuse All tiers of functionality see section 3 3 should be implemented Most importantly the mechanical pill dispensing apparatus should be designed and developed When completed the virtual product prototype should work out of the box Development of the SmartPill support infrastructure should also commence Each pharmacy will need the mechanism depicted in Figure 1 to load product information onto SmartPill cartridges This mechanism must have accompanying soft
8. between the MCU and the cartridge s memory unit e The medicine cabinet can read product information stored on the connected bottle Furthermore the algorithms for storing this information on the cartridges have been implemented e The medicine cabinet successfully requests and reads the unique read only memory ROM number of each cartridge over the 1 Wire bus e The MSP430 s counters and crystal oscillator have been used to implement an accurate clock see section 4 2 2 e The LCD displays on both Olimex development boards function properly The clock mentioned above has been displayed correctly on the displays e Additional hardware development work has been completed The Olimex boards buttons have been configured and tested The buzzer on each board functions properly e The fast prototyping tool see section 4 1 5 completed the medicine cabinet shell and several SmartPill cartridges Presently development is behind schedule Two major issues have delayed the group s progress First iButton software development has taken longer than expected When compiled the Public Domain Kit s code size exceeded the capacity of the MSP430 413STK board As a result the group could not continue until the MSP430 449STK board arrived Since most of the medicine cabinet s functionality depends on the input from the cartridges this obstacle has impeded much of the software development effort Second Olimex shipped both boards with no documentation
9. call a caregiver over the telephone to report compliance and refills No product in the prior art both eliminates user programming and secures loose pill bottles Furthermore the only system that does not require manual programming Sagar s design needs network access Patients in rural areas may not have such connectivity Finally no extant system detects harmful medication combinations In summary by solving previous design flaws SmartPill minimizes patient risk like no other product 17 Undergraduate Thesis SmartPill 2 1 3 Proof of Concept Vendor part documentation aided device selection and supported development Section 4 1 describes the proof of concept parts selection process at length Most of the documentation related to the Texas Instruments MSP430 microcontroller MCU and the Dallas Semiconductor iButton products The MSP430x4xx Family User s Guide is the authoritative MSP430 document 23 This extensive document contains schematics an instruction set description and block diagrams TI also provides datasheets for the two particular MCUs used in the project the MSP430F413 and MSP430F449 40 41 The mspgec compiler documentation was also helpful 42 The compiler developers provide efficiency tips and document JTAG debugging problems In addition this guide contains invaluable instructions that guide the user through the involved mspgcc installation process Finally the Olimex website contains information abou
10. ext a a at ee oodd Vel 40 a OA NOUO atico dicte eu P coa ci ades unc aci i ao o rod amba ud 41 523 Mistheaton PERE ori e a pde dia Ce ea t TR A a nd x d 46 4 4 4 Input Output Specification sess emn ee ee e rennen 47 MEI D A A i 49 AAA as aaninesilaenncabanaiiees 51 6 1 Future Work RL LE OOOO TT A id 51 6 2 Social and TI E eios d Lee esac es oii od os p bt ridi depu 52 70 REPASA dl oka aa hana 53 Undergraduate Thesis SmartPill Undergraduate Thesis SmartPill List of Figures Figure 1 SmartPill pharmacist programming cradle Drawing by Jonathan Kelley AAA A A er 12 Figure 2 SmartPill automatic medication dispenser Drawing by Jonathan Kelley ici 13 Figure 3 Olimex MSP430 449STK development board The Dallas port is at the bottom right of the board 28 ocoooonocoonnconnoncnononanocanononnnononanononcnonocncconnoocccccncconoconons 34 Figure 4 Olimex MSP430 413STK development board 28 34 Figure 5 iButton block diagram Opcodes on the 1 Wire bus control device s Diog DIM RII rada 36 Figure 6 Dimensions of the iButton MicroCan package 43 12 36 Figure 7 This DS1402D DRS reader which has two receptacles for 1 Wire network testing connects to a PC via a port adapter eee eee secte eese eene eee etn nenne ennu 37 Fig
11. i20 AC power AC DC converter D o 1 1 1 Wireless networking card 1 Total Funds Available Funds 69
12. is a major constraint we must limit the overall energy consumption of the sensor package Context aware computing Each sensor must have the capability to dynamically discover proximate pill bottles Ad hoc networking When multiple pill bottles come in close proximity to one another an ad hoc network is formed between the sensor packages on each bottle Facilitating these interconnections seamlessly is a major project design challenge Wireless connectivity We will equip each sensor package with an RF transmitter We must select a small and energy efficient transmitter The RF protocol must also allow us to perform ad hoc networking Embedded real time systems We will need to do some processing data comparison on the pill bottle which will require a small embedded real time system Real time systems have strict constraints on operation so we must balance computing power which implies a physically larger system with size Packaging We will need to package the embedded system so that it will fit onto a standard pill bottle 3 2 Organizational We have identified several critical organizational aspects of this project First the largest challenge PDS faces is in the legal arena Any medical device must win government approval before it can even be marketed We must carefully research government standards for this type of product We will need legal advisors to help us follow all regulations In addition we need legal ex
13. number of reasons for this problem but the most common is confusion SmartPill combats this problem in an innovative way The product which consists of an automated medication dispenser and special drug cartridges reduces the risks associated with prescription drug use through the application of Information Technology IT Customer needs were determined through interviews and a review of relevant literature This research confirmed that no product on the market today successfully automates the cataloguing of user medication and generation of a usage schedule As a result SmartPill s approach is novel A number of organizational obstacles must be overcome however for the project to be successful For example the system would require most pharmacies to change their business practices A proof of concept was implemented to demonstrate the system s novel aspects the electronic transfer and synthesis of prescription drug information Commercial off the shelf COTS parts were used to build the proof of concept The parts were chosen after a rigorous concept selection process To date the proof of concept has met the system s design goals Several recommendations for further system development are also made Undergraduate Thesis SmartPill Glossary of Terms 1 Wire The serial communication protocol used to communicate with Dallas Semiconductor iButtons CoMMERCIAL OF THE SHELF COTS Any product readily available in the marketpl
14. of their stores Fortunately the group found Amy Alderman a former CVS employee who provided the needed information In an interview she listed several factors that lead to misuse First few patients read prescription product literature The pharmacy s responsibility is limited to providing the literature and answering any questions Ms Alderman has watched patients discard medication literature before exiting the store Furthermore patients who fill multiple prescriptions simultaneously are overwhelmed by the sheaf of literature they receive 4 Second medication conflicts frequently arise when multiple doctors prescribe drugs for a patient Pharmacists can detect these combinations but only if they have a complete picture of the patient s drug regimen Unfortunately pharmacies only track Undergraduate Thesis SmartPill prescriptions filled at that particular pharmacy For example if a patient fills a prescription at CVS and then fills another at Walgreen s the pharmacist at Walgreen s is not aware of the previous prescription As a result pharmacists frequently cannot detect harmful medication combinations in the patient s drug regimen Some of the larger chains such as CVS have networked their own stores but pharmacists still do not have the information they need to protect patients 4 Third most pharmacies do not create usage schedules for their patients The user must synthesize all product information and create
15. port see Figure 11 C The latter two requirements though must be DAL x ii k implemented in software A lus delay can be synthesized by writing a method that when A ih called busy waits for the desired time Figure 11 Layout of the Dallas port on the Olimex development board This circuit provides a weak pull up The line labeled Dallas connects to one of the MSP430 s rate of the processor and the number of I O pins period This method depends upon the clock machine cycles required for instruction execution The MSP430 s adjustable clock rate further complicated the issue The Olimex board uses a 32 768 Hz crystal oscillator to drive the MSP430 s auxiliary clock 42 Undergraduate Thesis SmartPill ACLK The clock frequency of the processor MCLK is then multiplied by some user defined integer factor The schematic in Figure 12 shows how the MSP430 generates its clock signal The crystal oscillator is farthest to the left between XIN and XOUT FLL DIVX Divider noe crystal ACLK OSCOFF XTS FLL SCGO PUC Enable Reset XOUT gt 10 bit LFXT1 Oscillator Frequency XOSCxPF Integrator SCG1 FNx 4 off DC ri Generator Modulator FLLDx fpcocLK r DCOPLUS DCO Divider 4 11121418 SELS bco b B Le SMCLKOFF XT20FF XT2IN c XT20UT XT2 Oscillator Figure 12 The M
16. to mimic classes Each file class was specified using a Class Responsibility Collaboration CRC card Although XP stresses just in time design it was important to think about the overall structure of the system and the methods that each system component would need Changes were made later during the implementation process but the overall coherency of the design remained intact due to the up front design work Table 8 depicts an example CRC card 30 Undergraduate Thesis SmartPill Responsibility e Provides software interface to LEDs audio alarm and dispense button Services alarm on short alarm off short led on int num short led off int num short led test int num short dispense pill short bottle num short num pills int options detect dispense short Table 8 Hardware CRC card Alterations were made to the CRC cards weekly but the partitioning of the system remained intact 30 31 Undergraduate Thesis SmartPill 4 0 Proof of Concept Proof of concept implementation was the final phase of the SmartPill product development lifecycle The proof of concept served two purposes First it demonstrated the system design s feasibility Although not a complete implementation of the virtual product this prototype showed that the system s novel aspects could function as designed Second the proof of concept served as a tangible artifact that could be demonstrated for focus groups pote
17. work for a rhythm learn test code release 25 99 22 Undergraduate Thesis SmartPill 3 0 Methods and Approach Over three academic semesters the SmartPill project went from problem identification to implementation A well defined process directed the development effort and helped record the group s progress and accomplishments This section describes the three phase development process It also details the project management techniques used and how those techniques evolved in response to changing needs The section also illustrates lightweight design in practice Finally it lists the laboratory equipment 3 1 Project Management Two important aspects of project management are tracking progress and planning future direction Tracking is important for two reasons First it leads to opportunities for improvement 31 15 One of XP s main virtues is a short feedback loop This feedback loop requires accurate detailed information Without the management infrastructure to make information flow possible XP is severely crippled Second new individuals cannot be added to the project without detailed documentation For example a virtual product development effort would require several mechanical engineers Without a description of the design decisions that had been made these engineers could not efficiently do their job Planning is critical to any project s success Ulrich and Eppinger write that the 12 timing of milestones
18. 10 Conclusion We firmly believe that the hardware and software artifacts for this project can be developed in one year Professor Williams will serve actively on our advisory board There are various intellectual property opportunities in this project and we will pursue patents on several aspects of this system We believe PDS addresses a growing problem in our society today and we are excited about the future of this project 67 Undergraduate Thesis SmartPill 11 References Prescription Drugs Abuse and Addiction National Institute on Drug Abuse http www nida nih gov PDF RRPrescription pdf 2 Apr 2003 7 Smart card Technology http www raisonance com files pdf SmartCardPriceEuro PDF lt 2 Apr 2003 gt 12 Appendix Resumes 68 Undergraduate Thesis SmartPill Appendix C Project Budget Smart Pill Budget Updated 2 10 2004 Item Received Purchase Date Description 1 P N Supplier Quantity 1 1 i3 o fiEDary 27 1622 RadioShack 1 pap pp jBze 272060 RadioShack 1 sp Momentary Pushbutton 275 1548 RadioShack_ 1 6 x 10 31 2003 External Memory iButton 1 8 x 1731200 Password Protected 32kB EEPROMB JDS1977 DalesSem 4 9 x f 10 31 2003 iButon Plastic Card Mounts DS9093RA DalesSemi 1 1 2 1 1 1 1 JTAG Programming Board 1 1 1 19 Battery Backup CB
19. 4 Undergraduate Thesis SmartPill 35 Software Requirements A Prescription Drug Management System SmartPill 2003 SmartPill Document R00004 36 Hardware Requirements A Prescription Drug Management System SmartPill 2003 SmartPill Document ZR00005 37 Concept Selection A Prescription Drug Management System SmartPill 2003 SmartPill Document R00003 38 Functional Test Procedure A Prescription Drug Management System SmartPill 2004 SmartPill Document D03 39 Development and Test Schedule A Prescription Drug Management System SmartPill 2004 SmartPill Document D01 40 MSP430x41x Mixed Signal Microcontroller Revision F 2003 Texas Instruments Inc 41 MSP430x43x MSP430x44x Mixed Signal Microcontroller Revision C 2003 Texas Instruments Inc 42 mspgcec A Port of the GNU Tools to the Texas Instruments MSP430 Microcontrollers 2003 mspgcc 23 Mar 2004 http prdownloads sourceforge net mspgcc mspgcc manual 20031127 pdf download 43 Book of iButton Standards Dallas Semiconductor Corp 1 Dec 2003 lt http pdfserv maxim ic com en an appibstd pdf gt 44 Using the 1 Wire Public Domain Kit White Paper 2 Dallas Semiconductor Corp 45 1 Wire Search Algorithm Application Note 187 Dallas Semiconductor Corp 30 Undergraduate Thesis SmartPill Appendix A XP User Stories peser Dia Tinhwe soo the system detect
20. CU and the four bytes are type casted as a long The byte packing scheme also had another important benefit efficient use of storage space The initial storage design involved converting primitive types to strings and storing that data In that scenario one byte is used to store one alphanumeric character thus wasting a significant amount of memory Since each iButton only contains a few kilobytes of memory a more efficient design was necessary 4 4 3 Medication Dispensing The medication dispensing algorithm utilizes the non volatile memory on each SmartPill cartridge If product information were always read into RAM then that memory would be exhausted in some cases The system would also need to rebuild its product database whenever the power went out Consequently a better solution is to maintain a pointer to the next dispense time in memory Since the Dispense Times file in Table 7 is sorted into chronological order the software simply checks each cartridge at a regular interval to see if dispensing should occur That check occurs every minute in the proof of concept software Although 1 Wire reads introduce time delays performance is not critical in this system 46 Undergraduate Thesis SmartPill When the system detects that medication should be dispensed it creates a dispense time structure as shown in Table 11 The system maintains a buffer of dispatched dispense times When the dispense buffer is not empty the system
21. Development of a Prescription Drug Management System SmartPill A Thesis In TCC402 Presented to The Faculty of the School of Engineering and Applied Science University of Virginia In Partial Fulfillment Of the Requirements for the Degree Bachelor of Science in Computer Engineering by Spence Green Other Group Members Jonathan Kelley Electrical Engineering Brad Pinney Electrical Engineering March 23 2004 On my honor as a University student on this assignment I have neither given nor received unauthorized aid as defined by the Honor Guidelines for Papers in TCC Courses Signed Approved Technical Advisor Ronald D Williams Undergraduate Thesis SmartPill Approved TCC Advisor Claire Chantell Preface The SmartPill project was part of the Engineering in Context EIC program at the University of Virginia School of Engineering and Applied Science The EIC program exposes students to the non technical aspects of engineering Organizational issues such as legal requirements as well as cultural and ethical issues are discussed at length in the curriculum In addition the program allows students to carry out their thesis work as part of a multidisciplinary team Proposals are made in the spring of the third year Teams are then formed to develop the accepted proposals during the fourth year Funding for both the project and the EIC program was provided by Lockheed Martin Corp I would like to thank Jona
22. P at Chrysler in the late 1990s Many books have been written on the topic over the last several years including Steinberg and Palmer s recent Extreme Software Engineering A Hands On Approach which serves as textbook for a college level XP course The information in these two books guided SmartPill software development This section gives a brief overview of XP XP is based on the notion of just in time design and is based on incremental development and continuous integration 20 94 20 12 It uses an evolutionary design a little build a little approach that relies on continual feedback from the client 20 4 Steinberg and Palmer write It XP accepts as given that the requirements for a system will change and brings a customer onto the development team to make quick decisions 20 4 For Beck XP is distinguished by short feedback loops an incremental planning approach a schedule that responds to changing business needs reliance on automated tests reliance on communication and reliance on an evolutionary design process 25 xvii Most software projects use front loaded design such as the waterfall or spiral method in which most design work is done before coding XP on the other hand leverages emergent behavior by relying on small localized decisions that evolve into an optimal design Beck articulates XP s twelve fundamental principles the planning game small releases metaphor simple design testing refactori
23. Pill 1 0 Introduction 1 1 Statement of Thesis Drug misuse due to either ignorance or accident is a growing problem The National Institute on Drug Abuse NIDA lists prescription drug misuse by elderly patients as a major healthcare industry concern The misuse of prescription drugs may be the most common form of drug abuse among the elderly Elderly persons use prescription medications approximately three times as frequently as the general population and have been found to have the poorest rates of compliance with directions for taking a medication 3 The sheer quantity of prescription medications consumed by patients necessitates a technological solution Bates and Gawande claim that the application of Information Technology IT is the best solution Safe patient care now requires a degree of individualization that is becoming unimaginable without computerized decision support 1 This paper details the development of SmartPill a prescription drug management system that combats accidental drug misuse The system facilitates electronic transmission of product information from a pharmacy to an end user A fully automated medication dispenser receives that information and manages the user s drug regimen My research focused on three aspects of the project development of the software artifacts the methodologies used to develop those artifacts and hardware software integration 1 2 Problem Definition Why do geriatric patie
24. SP430 s Frequency Locked Loop FLL Note the MCLK signal that clocks the microcontroller 23 The microcontroller uses 32 as the default clock multiplier resulting in an operating frequency of 1 048576MHz The only other information needed to write the delay function was the number of machine cycles required to execute instructions The MSP430 can perform register operations in a single cycle 23 3 2 Function call overhead requires an additional eight instructions resulting in the following equation 1 MCLK Equation 1 MSP430 delay equation n represents the number of register operations executed while busy waiting e 1 8 delay us 43 Undergraduate Thesis SmartPill A method was implemented in assembly language that simply decrements an integer input parameter until that parameter equals zero Consequently three machine cycles are consumed per iteration jump operations require two cycles Equation 1 then becomes e 3n 8 delay us MCLK Equation 2 Final MSP430 processor delay equation This equation factors in three machine cycles per loop iteration After the delay method was implemented it was possible to implement the Link level methods in the Button protocol stack These methods included owTouchReset and owTouchBit which reset the 1 Wire bus and perform read write operations respectively 24 A specific algorithm is used to communicate over the bus as shown in Table 9 Implementatio
25. Sept 2003 8 Lim James Programmable Automatic Pill Dispenser 2003 U S Pat 6 510 962 9 Lim James Programmable Automatic Pill Dispenser with Pawl Indexing Mechanism 1999 U S Pat 5 915 589 10 Shaw Thomas J Automatic Pill Dispensing Apparatus 1997 U S Pat 5 609 268 11 Agans Rita M Medicine Reminder and Dispenser 1992 U S Pat 5 159 581 12 Lewis Kermit E and Arthur S Roberts Jr Automatic Pill Dispenser and Method of Administering Medical Pills U S Pat 4 573 606 13 Hubicki Joseph T Automated System and Method for Dispensing Medications for Low Visions Elderly and Blind Individuals 2003 U S Pat 6 615 107 14 Sagar Richard Bryan Koninklijke Philips Electronics N V Bottle Cap Medication Reminder and Overdose Safeguard 2003 U S Pat 6 604 650 15 Picerno Virginia L Pill Bottle and Dispensing Cap Combination 1996 U S Pat 5 484 089 16 Talking Rx 2000 Millennium Compliance Corporation 25 Oct 2003 lt http www talkingrx com gt 53 Undergraduate Thesis SmartPill 17 e pill Medication Reminders 2003 e pill LLC 25 Oct 2003 lt http www epill com gt 18 Citro Jeremy and Sharon Hermanson Assisted Living in the United States March 1999 AARP 17 Mar 2004 lt http research aarp org il fs62r_assisted html gt 19 Product Specification A Prescription Drug Management System SmartPill 2003 SmartPill Document R00002 20 Steinberg D
26. Social and Ethical Considerations The SmartPill project has largely positive social effects It reflects the societal and cultural belief that human life has value By organizing and managing a patient s usage schedule SmartPill reduces the risks associated with the prescription drug use In addition it provides a last line of defense by detecting harmful medication combinations With the plethora of new drugs introduced to the market each year these features will become increasingly important Finally SmartPill benefits an impaired segment of society This demographic s size will grow as the Baby Boomer generation ages 52 Undergraduate Thesis SmartPill 7 0 References 1 Bates David W and Atul A Gawande Patient Safety Improving Safety with Information Technology 7he New England Journal of Medicine 348 25 2003 2526 2534 2 Consolidated Health Informatics Homepage United States Government 25 Oct 2003 lt http www whitehouse gov omb egov gtob health_informatics htm gt 3 Prescription Drugs Abuse and Addiction National Institute on Drug Abuse 2 Apr 2003 lt http www nida nih gov PDF RRPrescription pdf gt 4 Alderman Amy Personal Interview 3 Sept 2003 5 Williams Ronald D Personal Interview 10 Sept 2003 6 1 Wire Communication with a Microchip PICmicro Microcontroller Application Note 2420 Dallas Semiconductor Corp 7 Powell Harry Personal Interview 17
27. a daily regimen This task becomes unmanageable for geriatric patients without assisted care Ms Alderman stated that illiterate uneducated and non English speaking patients also have this problem 4 Finally pharmacists are almost completely unaware of the over the counter OTC and alternative medicines that a patient uses 4 Consequently the patient has no safeguard against conflicts between prescription drugs and OTC medications Since OTC and alternative medicines can be purchased in many other places besides pharmacies an end user solution i e a solution in the user s home is the only practical way to prevent harmful medication combinations In summary there is a substantial need for an IT based prescription drug management system 1 3 Literature Review The research for this project fell into the following areas customer needs a novelty search and device and concept selection Customer needs were determined primarily through expert interviews The novelty search involved reviewing United States patent literature and products currently on the market The group conducted device and concept selection by first determining a set of performance and cost metrics 10 Undergraduate Thesis SmartPill based on the SmartPill Product Specification 19 Several commercial off the shelf COTS components were then rated against the metrics The highest rated components were selected for the proof of concept Since my primary re
28. ace as opposed to components that must be custom made to order EXTREME PrROGRAMMING A lightweight agile software design methodology that uses a design a little build a little approach Gcc An Open Source C compiler common on most Unix Linux systems IBurroN An electronic memory device developed by Dallas Semiconductor that has only two leads data power and ground iButtons are attached to SmartPill cartridges JTAG Acronym for Joint Test Action Group An interface supported by some devices that allows program loading and in some cases remote debugging MCU Microcontrol unit sce MSP430 MEDICATION DISPENSER A device that contains pills and releases them to a user at prescribed intervals MSP430 The microcontrol unit MCU used in the proof of concept Pnoor orF coNcEPT A limited version of the final or virtual product The proof of concept demonstrates the novel system aspects medication cataloguing dynamic usage scheduling and harmful combination detection ReFactorinc One of eXtreme Programming s twelve fundamental principles It involves rewriting and optimizing existing software code SMARTPILL CARTRIDGE A pill container with attached electronic memory VIRTUAL PRObUCT The final conception of the SmartPill system The virtual product would be a final functional version of the proof of concept ready for manufacture and sale XP See eXtreme Programming Undergraduate Thesis Smart
29. aniel H and Daniel W Palmer Extreme Software Engineering A Hands On Approach Upper Saddle River NJ Prentice Hall 2004 21 Dallas Semiconductor iButton Site http www ibutton com 22 1 Wire Communication Through Software Application Note 126 Dallas Semiconductor Corp 23 MSP430x4xx Family User s Guide Revision C 2003 Texas Instruments Inc 24 1 Wire Software Resource Guide Device Description Application Note 155 Dallas Semiconductor Corp 25 Beck Kent eXtreme Programming Explained Reading MA Addison Wesley 2000 26 mspgcc 23 Mar 2004 lt http mspgcc sourceforge net gt 27 The Fedora Project 2003 Red Hat Inc 23 Mar 2004 lt http fedora redhat com gt 28 Olimex Ltd 2004 OLIMEX Ltd 23 Mar 2004 lt http www olimex com gt 29 Downloads for MSP430 Ultra Low Power Microcontrollers 2004 Texas Instruments Inc 23 Mar 2004 lt http focus ti com docs toolsw folders print msp430freetools html gt 30 Detailed Software Design A Prescription Drug Management System SmartPill 2003 SmartPill Document R00010 31 Ulrich Karl T and Steven D Eppinger Product Design and Development 2 ed Boston McGraw Hill 2000 32 eproject 2003 eProject Inc 23 Mar 2004 lt http www eproject com gt 33 Concurrent Versions System 2002 CollabNet Inc 23 Mar 2004 lt http www cvshome org gt 34 Mantis 23 Mar 2004 lt http www mantisbt org gt 5
30. companies Any individual that visits a healthcare professional will need a smart card that carries prescription information The doctor could distribute this card or the patient could purchase a reusable card The total cost of this system is passed down to the patient and their insurance provider so the patient also pays for the rest of the system when he purchases a drug 3 Problem Context and Significance This system saves lives Every year patients use drugs in non prescribed combinations or for non medical purposes Although we can never prevent patients from abusing legally obtained drugs we can greatly reduce an individual s risk in using medications through the use of smart technology 60 Undergraduate Thesis SmartPill 3 Technical There are a myriad of technical challenges facing this system We must solve problems in the following areas Security reliability This is the greatest technical challenge our system faces We must safeguard each pill bottle from tampering Liability is always a major issue in healthcare so we must create a system that will be reliable almost without exception Miniature sensor devices Since the sensor package must fit on pill bottle there are extreme size constraints The sensor system should not noticeably increase either the size or weight of the average pill bottle Power consumption The sensor package will need a power supply that will last for months Since size
31. d then connected to the Dallas port on the Olimex development board see section 4 2 2 4 1 4 Software Development Environment Two compilers were evaluated for the TI MSP430 software development environment TI supports the IAR Kickstart suite which is available for free download 29 This Windows based IDE includes a compiler assembler and debugger Unfortunately the software was difficult to configure in Windows 2000 and Windows XP The group encountered problems with the JTAG parallel port interface as well as the assembler The other option was the Open Source mspgcc package also available for free 26 mspgcc is a patched version of GNU s ubiquitous C compiler gcc The package also includes a proxy server for JTAG debugging an msp430 version of gdb GNU s debugger and several other tools The library of header files included with the package is also an important benefit Extensive documentation exists for mspgcc and its software libraries Fedora Core 1 Red Hat s desktop Linux distribution was used to test the package mspgcc was configured quickly and all group members were familiar with 37 Undergraduate Thesis SmartPill other variants of the tool so the package was selected as the software development environment 4 1 5 Fast Prototyping Jonathan Kelley used AutoCAD 2004 to model the medication dispenser A SmartPill cartridge was also created A Stratasys Dimension fast prototyping tool then used these
32. dollar Packaging was a major drawback though since most devices have several pins that must be connected The group wanted a solution that had fewer pins so that the cartridge could slide into the medication dispenser with minimal user effort Furthermore the packaging on most memory chips was neither tamper nor water proof Radio frequency RF tags were another option Pill bottles could communicate with each other wirelessly and share information This option s main drawbacks were the 35 Undergraduate Thesis SmartPill inability to secure loose bottles and track compliance Users would still need to pick individual pills out of each bottle The final possibility was Dallas Semiconductor s iButton line of products These devices use the 1 Wire serial protocol which requires only two pins Data Power and Ground Furthermore iButtons come in water proof tamper resistant metal packaging Dallas provides a wide range of development materials including readers PC connectivity parts and software x N The most important iButton feature e e i though is the ability to create 1 Wire networks a OO O i ADDRESS B Ye vucriecexen CONTROL MEMORY e over a single bus line The medication noe ie A DATA OUT dispenser contains room for multiple cartridges A lE The onboard system must communicate with Figure 5
33. e as this is a mission critical application The imprinting process should also be authenticated and secured Involved Discipline Mechanical Engineering Electrical Engineering Computer Science Design Procedure We will develop a custom authentication and distribution application that utilizes strong encryption technology We will utilize standard software engineering practices such as risk analysis requirements analysis and system specification to develop the software artifact We will also utilize a commercially available smart card and smart card reader We will not create an independent machine to imprint the pill bottles Instead we will simulate this data transfer by flashing the memory hardware on the sensor package Design concerns What information will we imprint on the pill bottle What format will this data be stored in 5 3 Self Organizing Pill Bottle Network Pill bottles contain information about the medicine instructions and precautions associated with the drug When a pill bottle is placed among other pill bottles it will communicate with the rest of the pill bottles and check if any precautions have been violated such as incompatible drugs combinations In the event of a violation the system will alert the patient initially via LEDs In addition the user can view a simple LCD screen to obtain product information the inexpensive LCD will be sold independently Design Objectives Each pill bottle will conta
34. e dispenser prototype 4 4 Software Development The remainder of this chapter describes the onboard system s software The topics covered are those that have been completed by March 23 2004 Mundane topics such as libraries used are not discussed The high level functionality of this system is not complete so only the lower level system parts receive lengthy treatment 41 Undergraduate Thesis SmartPill 4 4 1 iButton Software Development Dallas Semiconductor provides iButton software drivers based on an Open Systems Interconnection OSI protocol stack architecture 21 The software has been ported to several platforms including Windows and Java Virtual Machine JVM Fortunately Dallas also provides a Public Domain Kit version 1 02 was used for this project for other architectures This kit includes full Network Transport File and Device layer implementations It requires hardware specific Session and Link layer implementations Consequently this development activity involved implementing those two layers Dallas iButtons require a platform with a bidirectional communication port open drain output and weak pull up on the line and the capability to generate an accurate and repeatable lus delay Furthermore communication operations must not be interrupted during generation 22 1 The MSP430 has bidirectional communication ports and the Olimex development board already had a weak pull up on the line connected to the Dallas
35. elow 59 e A scheduling feature that is configured automatically when a new medication is introduced to the system This feature prompts the user when in what quantity and how to take the medication e Anautomatic product information updating feature that does not rely on the Internet web e Securing of all SmartPill cartridges to prevent user access at unauthorized times Indicator Lights Data Lead Lid Receptor Lid Securing Block Communication Plug 12 Undergraduate Thesis SmartPill Smart Pill Control Cabinet Message Center Alarm Speaker Distribution Communication Panel Authorization Button Lid Locking Device iz Data Lead Holding Tray E Lid Receptacle Power Cord Plug Plug Internal Components of the Dispensing Tray Smart Pill Control Cabinet Power Cord Pill Distribution System Processor Logic Board we Dispensing Tray Figure 2 SmartPill automatic medication dispenser Drawing by Jonathan Kelley 1 6 Overview of Report This report details the SmartPill system development It summarizes the hardware related activities and focuses on software development and system integration my primary responsibilities Section 2 lists the research conducted during the project Section 3 covers the methods employed by the project team for project management software design implementation and testing In addition this sec
36. embedded network Software artifacts The prototype PDS system that will be developed as proof of concept For this stage of the project we will create the medical prescription software Next we will transfer the electronic prescription to a smart card The distribution software will then simulate both the distribution of the medication and imprinting of the pill bottle Finally a physical wireless embedded network will be implemented to handle violation checking and signaling 7 Future Possibilities 65 Undergraduate Thesis SmartPill Touch Screen Transaction Handling Program Smart card reader Credit card Cash reader Pill Box Dispenser If our product becomes successful we could eventually see a fully automated Medicine Dispensing Refill Machine A person could walk up to the PDS machine and insert a smartcard which would have the prescription information on it into the smartcard reader With the help of some other authentication method such as a password this person could then see the prescription that has been stored on their card If the patient wanted to purchase the prescription then he could insert a credit card or cash into the machine The machine would automatically fill the prescription and imprint the bottle with all the product data The assembled pill bottle would then be dispensed from the Pill Box Dispenser 8 Proposed Budget Phase 1 System prototype budget Goals Use ava
37. ent an architecture that polled for events seemed suitable Events were defined for various actions and a main loop that polled devices and handled events was constructed This architecture which is quite robust also merged well with XP Feature changes and new functionality could be quickly implemented 29 Undergraduate Thesis SmartPill The final two up front design steps involved specifying the system data formats and outlining the software classes using Class Responsibility Collaboration CRC cards iButtons can store data as files so the format and contents of several files were specified Table 6 shows an example file specification Table 7 contains brief descriptions of the other files stored on SmartPill cartridges Contents 1 National Drug Code 4 bytes 2 Patient Number 4 bytes 3 Number of pills in bottle 1 byte Table 6 Product Information file format Note that the data is packed along byte boundaries 30 Product Information prod 00 National Drug Code patient number and number of pills in bottle Updates and Special Features updt 00 Product updates for the whole system Usage Information Usage options for each dispense time in time 00 Table 7 Listing of the files stored on SmartPill cartridges The data is aligned along byte boundaries in each file 30 Since the C language does not support object oriented design natively groups of functions were separated into different files
38. erent ports and the different connections to those ports on one of the Olimex development boards 029 al jaje Sea Each port is mapped to E X nyo several eight bit registers in memory never Each bit in the registers corresponds g P3 1 81MDa 69 P3 2 80nIa ps to one of the eight port pins The EREF 11 SEREF as POET E parre E nsp43gr 449 2 registers used in this project were F LED L 18 18 DALLAS 15 E INPUT OUTPUT and DIR The x 22 ma BITTE DIR register specifies the direction of each pin Bits are set to 0 for 218 512 8 2 2 5 2 8 S 4 8 Figure 8 Olimex MSP430 449STK schematic showing the connections to the MSP430 s various I O ports Note that the Dallas iButton 1 Wire port is connected the proper bits the INPUT and to port 5 pin 6 P5 6 on the far right input or 1 for output After setting OUTPUT registers can be used The INPUT registers are read only When a digital signal appears on the pin the corresponding bit in the INPUT register is set to the value of that signal The user can write to the OUTPUT registers For example if bit 0 in the port 3 OUTPUT P3OUT register is set to 1 then a 1 signal appears on port 3 pin 0 The mspgcec software libraries define different C macros that allow intuitive control of these pins The following C code segment demonstrates typical I O pin usage 39 Undergraduate Thesis SmartPill finclude msp430x44x h Def
39. etermine customer needs 2 1 1 Customer Needs Professor Ron Williams an Emergency Medical Technician EMT originally informed the group of the need for a better medication organization system He noted that elderly persons often misuse medications for two reasons confusion and ignorance 5 The National Institute on Drug Abuse NIDA a subsidiary of the National Institutes of Health NIH corroborated Professor Williams claims Data taken from Veteran s Affairs Hospitals around the country shows that elderly persons take three times as many medications as the average adult and have the poorest rates of compliance 3 Amy Alderman a 4 Year Nursing Student at the University of Virginia and CVS employee detailed current drug distribution methods see section 1 2 4 Customer 14 Undergraduate Thesis SmartPill needs were determined by analyzing the deficiencies in those methods Recent journal literature has also addressed the misuse problem Bates and Gawande investigated ways to improve patient safety 1 They concluded If medicine is to achieve major gains in quality it must be transformed and information technology will play a key part especially with respect to safety 1 Few standards existed for the application of Information Technology IT to healthcare though until Congress passed the Consolidated Health Informatics legislation in March 2003 2 This legislation provides the legal foundations and sta
40. his clock has a PM indicator The clock can be set using two buttons an hour set and a min set When the hour set button is depressed the hour is incremented by 1 When the min set button is depressed the minute is incremented by 1 When the minute component is 59 and the min set button is depressed the hour component is NOT incremented 2 21 The system has four usage LEDs With Food 2 24 2004 Hardware With Water With Sleep and No Alcohol 22 Each pill slot has some mechanism like a pressure 2 24 2004 Hardware sensor by which the microcontroller can detect that a cartridge has been added to that slot This feature is necessary because the slot cannot be determined using the 1 wire net alone 23 If the system is turned off the contents of the 2 24 2004 Software Dispense Buffer and the Bottle List should be stored to non volatile memory The system should check non volatile memory when the power is restored to see if there is data there If so the system should verify the data by checking it against currently connected SmartPill cartridges before loading that data 24 If the hour set and min set buttons are held down for 2 24 2004 Software 10 consecutive seconds the system resets to the factory default state see Detailed Software Design 25 The system should be powered by a standard 120V 2 24 2004 Hardware AC wall socket The system should also have use two AA batteries as a backup po
41. iggered every second Variables in software can be adjusted in the interrupt handler to implement the 24 hour clock 40 Undergraduate Thesis SmartPill Timer NED CCRO X oh X h E MET CCRO Y Oh Set TAIFG Set TACCRO CCIFG Figure 10 Timer A up mode behavior When Timer A equals the value in CCRO an interrupt is triggered and the timer resumes counting from 0 23 11 6 4 2 3 iButton Network Figure 11 depicts the Dallas port layout on the Olimex boards Pin 1 is grounded while pin 2 serves as the power data lead One of the 1 Wire protocol s main virtues is that multiple iButtons can connect to the same power data lead Each slot on the SmartPill medication dispenser required an iButton reader so several DS9092L parts were simply soldered together and connected to the Dallas port Resistance in the wires becomes significant if too many readers are soldered together but this problem was not an issue for the small number of readers used in this project 4 3 Mechanical Development The plastic prototypes discussed in section 4 1 5 were modified using a Dremel tool Holes were cut at the base of each cartridge slot for the iButton readers Openings were also created for the different external LEDs on the device Finally the Olimex MSP430 449STK board was located underneath the prototype The cartridges were also modified Holes were created for the iButtons Furthermore the cartridges were sanded to fit in th
42. ilable resources from the department to build an embedded network with three devices Quantity Cost 7 1 1 1 Item Off the shelf printed circuit board Low power RF link As Total Funding Source Lockheed Martin 1000 Phase 2 Full System prototype budget 66 Undergraduate Thesis SmartPill Goals Use professional development tools to implement the whole system Funding Source National Collegiate Inventors and Innovators Alliance NCIIA 9 Verification Goals 1 Document the development and management processes 2 Develop multidisciplinary design strategy 3 Produce requirements analysis system specification and source code for the software components of the system 4 Implement the embedded network system along with all the embedded software 5 Produce simulation tools to test the system software and hardware Verification Procedure Step 1 Verify that all the critical development processes are sufficiently documented and all the software and hardware artifacts are built Step 2 Verify that members of the multidisciplinary team have adequately contributed to the development process Step 3 Run the software and hardware through simulation and verify the system behavior complies with the specification Step 4 Test the system for compliance with government standards and regulations Step 5 Perform extensive usability testing with a broad range of patients focusing on elderly people
43. in a durable embedded sensor package to store product information and facilitate ad hoc networking This device must satisfy strict cost power and profile constraints The networking of all the pill bottles should happen seamlessly All pill bottles owned by an individual user should carry a shared family identification code In addition the user should be able to view product information on an inexpensive LCD screen All functionality should be intuitive and simple to use Finally the information on the pill bottles should be secure and preserve the privacy of the owner 64 Undergraduate Thesis SmartPill Design Procedure Development will center on a sensor package consisting of a processor memory and short range RF transceiver We will also implement a service discovery protocol to identify other devices Finally we will develop an attachment mechanism for the sensor package Design Concerns What 1s an acceptable lifetime for the sensor How will we satisfy the low profile requirements How much memory will we need How much computational power will we need What are some other methods to signal the users when violation occurs Do we lock the cap of the bottle when an alarm is triggered Involved Discipline Electrical Engineering Computer Science 6 Prototype Product Vision Figure 2 Distribution Self organizing Pill Prescription Bygtle Network i 9 Simulated in Implemented in Hardware and software
44. ines msp430x449 macros int du P3DIR 0x00 Set all port 3 pins to input i P3IN Read the port 3 pins i amp 0x01 Mask upper 7 bits to look at pin 0 i now equals the value of port 3 pin 0 P3DIR OxFF Set all port 3 pins to output P30UT 0x01 Set port 3 pin 0 to 1 Figure 9 MSP430 I O pin control example C code like this appears in the SmartPill onboard software The LCD alarm buzzer Dallas port LEDs and buttons on the Olimex board are all connected to the MCU s I O ports By manipulating the port registers these devices can be controlled in software 4 2 2 MSP430 Clock Subsystem SmartPill s scheduling feature depends upon an accurate 24 hour clock MSP430 devices provide at least one configurable counter that can be used for such a purpose Timer A an asynchronous 16 bit timer counter with three capture compare registers is available on all MSP430x4xx parts 23 11 2 It has four configurable modes and a selectable clock source The counter triggers interrupts that can be processed in software Timer A can be set to count up to a value stored in register CCRO as shown in Figure 10 When Timer A reaches that value it triggers an interrupt and then counts up again from zero Both of the Olimex boards contain a 32 768 Hz crystal oscillator that functions as the MCU auxiliary clock ACLK Consequently if the value 32768 1s stored in CCRO and the clock source is set to ACLK then an interrupt is tr
45. models to create physical prototypes out of acrylonitrile butadiene styrene ABS a plastic resin 4 1 6 Miscellaneous Materials An IBM ThinkPad A20m laptop computer was used as a mobile laboratory This system was dual booted with Windows XP Professional and Fedora Core 1 The Olimex development boards and iButton readers were connected to the parallel and serial ports of this machine The laptop allowed the group to operate independently of a fixed laboratory location To complete the proof of concept other miscellaneous electronic components such as light emitting diodes LED resistors and capacitors were used 4 2 Hardware Development Hardware development centered on enabling the Olimex boards features and augmenting those features with several other components The former area required more work than anticipated The board shipped with no documentation and some of the information posted on the Olimex website was incorrect TI s MSP430x4xx Family User s Guide was an invaluable resource during development 23 4 2 1 MSP430 I O Interface The MSP430 architecture provides convenient access to its general purpose I O pins MSP430 devices have up to six digital I O ports implemented P1 P6 Each port has eight I O pins Every I O pin is individually configurable for input or output 38 Undergraduate Thesis SmartPill direction and each I O line can be individually read or written to 23 8 2 Figure 8 shows the diff
46. n Write 1 bit Send a 1 bit to the 1 Wire Drive bus low delay 6us slaves Write 1 time slot Release bus delay 64us Write 1 bit send a 0 bit to the 1 Wire Drive bus low delay 60us slaves Write 0 time slot Release bus delay 10us Read bit Read a bit from the 1 Wire Drive bus low delay 6us slaves Read time slot Release bus delay 9us Sample bus to read bit from slave Reset Reset the 1 Wire bus slave Drive bus low delay 480us devices and ready them fora Release bus delay 70us command Sample bus 0 device s present 1 no device present Delay 410us Table 9 1 Wire operations table 22 1 Figure 13 shows the above information represented as waveforms The bus is controlled by manipulating the I O pin connected to the circuit in Figure 11 44 Undergraduate Thesis SmartPill Waveform Legend 1 Master 1 1 Write 1 1 i Resistor pull up Write 0 1 Slave 1 i 1 1 1 1 T Read ia Master 1 Sample 1 sd 1 5 10us b sr Recovery time between 1 1 1 1 1 1 1 1 1 T 1 1 1 1 1 1 1 1 f time slots bits 2 o N Master 5 E se g 3 n AA ES i i 960us Figure 13 1 Wire waveforms Note that the bus uses a weak pull up so letting the wire float high releases the bus 22 2 Once the Link level methods were implemented the rest of the Public Domain Kit methods were quickly added Since memory wa
47. n set button e Min component of current time incremented Dispense button depressed Input e Alarm deactivated e The medication slot number is printed to the LCD followed by a five second pause followed by the number of pills to be dispensed This procedure occurs for each item in the Dispense Buffer The usage LEDs are illuminated according to that dispense time s usage options This procedure occurs for each item in the Dispense Buffer LED on that medication s slot set to FLASH SmartPill cartridge is unlocked Power deactivated Power LED turns off Contents of both the Dispense buffer and the Bottle Database are saved to non volatile memo Product Conflict Output e LEDs on conflicting medications slots set to FLASH e Alarm activated Table 12 SmartPill system I O specification 48 Undergraduate Thesis SmartPill 5 0 Results This section summarizes the proof of concept s implementation status as of March 23 2004 Development is ongoing since the project deadline is not until May 2004 Most of the system features are partially implemented To date 5 of the 21 eXtreme Programming XP user stories have been implemented and tested see Appendix A for a listing of these stories Another seven stories are partially complete The results can be summarized as follows e The Texas Instruments MSP430 microcontroller MCU detects the presence of SmartPill cartridges A DS9092L reader facilitates the connection
48. ndards necessary for IT solutions to patient safety problems 2 1 2 Novelty Search Lewis and Roberts created one of the first automated pill dispensers in 1986 12 This device has served as a reference for almost every subsequent design It consists of a detachable rotating wheel with 12 storage compartments A pharmacist can preload this wheel Pills are mixed together in the compartments and dispensed at regular programmed intervals every two hours four hours etc An audio alarm alerts the user that pills have been dispensed A major flaw is that dispensed unconsumed pills build up in the base of the apparatus making it easy for the patient to overdose In addition the patient must be competent enough to program the device Agans submitted a more complex design in 1992 11 A microprocessor controls this machine which dispenses pills at finer intervals than the Lewis and Roberts design Agans does not use a rotating wheel for dispensing a major innovation As a result the dispenser has more compartments while still maintaining a small footprint The mechanical dispensing mechanism is far more complex though than the elegant rotating wheel The dispenser provides push buttons for programming and an audio visual alert system 15 Undergraduate Thesis SmartPill Shaw solves many of the earlier designs problems 10 His system adds a Dispense button that the user must press to dispense medicine Consequently dis
49. ng pair programming collective ownership continuous integration 40 hour week on site customer and coding standards 25 54 Several of these principles require further elaboration First small releases 20 Undergraduate Thesis SmartPill means delivering code to the client at the end of every development iteration usually two weeks This principle creates a short feedback loop between the client and the developer XP literature refers to the small releases principle as you aren t going to need it or YAGNI In short the system should never be over designed for unanticipated needs 20 98 Next XP strongly emphasizes testing If a feature cannot be tested then it does not work 25 45 More importantly XP requires an unorthodox test and code approach Tests are created before code is written thus requiring programmers to think about what the code does before writing it Tests are compiled into an automated test suite that the system must always pass JUnit an automated testing tool created by Beck and Erich Gamma is the de facto standard 20 57 Refactoring is another unique XP principle When writing new code the developer should always find the simplest working solution Later working code is refactored or rewritten for optimization The code itself is subject to an evolutionary process Finally pair programming is the most noteworthy and controversial XP principle Code is always written in gro
50. ntable 3 3 Cultural Clearly the reduction of health risk and the preservation of life are PDS s positive cultural aspects The largest cultural challenge we face is acceptance Elderly patients usually take more medications than younger people Unfortunately this segment of the population is also the most reluctant to embrace new technologies We must take great care to emphasize the safety and reliability of this system In addition we must emphasize the benefits of PDS since it adds cost to medications Prescription drugs are already breathtakingly expensive so we must make both the patient and the patient s insurance provider believe that the extra dollar they spend is worth it 4 Team requirements We need personnel from several disciplines to complete this project We have divided the project team into a Board of Advisors who will provide expert support and an Engineering Team which will implement the physical system Board of Advisors Legal counsel 1 Since we must deal with government rules and regulations we need legal assistance during development We also need a strategy for limiting our liability as developers and vendors of the system Marketing 1 We need marketing and business research to understand the user requirements and the best way to sell this system Technical Advisor 1 Professor Ronald D Williams Associate Professor of Electrical and Computer Engineering has offered to advise us on the technical a
51. ntial investors and intellectual property consultants Several limitations constricted the proof of concept s scope Money and time were the most obvious constraints The total project budget see Appendix C amounted to only a fraction of the funding needed to fully develop the idea Furthermore the development team consisted of full time students which limited the amount of time they could spend on the project As a result the group focused on the novel aspect of the project automating the medication dispenser The mechanical pill dispensing apparatus was not implemented Although an integral part of the SmartPill product several acceptable dispensing designs already exist see section 2 1 2 In the end the SmartPill system would probably be integrated onto and thus automate an existing dispenser This section lists the development materials Summaries of both the hardware and mechanical development efforts are also included Finally software development my primary area of responsibility receives a rigorous treatment 4 1 Materials All of the materials used during development were commercial off the shelf COTS products COTS materials have several virtues First by leveraging economies of scale COTS products usually cost less than custom components This factor was 32 Undergraduate Thesis SmartPill crucial because of both the project s limited budget and the desire to minimize the virtual product s cost Furthermore
52. nts misuse prescription drugs The project s first task was to determine the factors that lead to patient non compliance Professor Ronald D Williams of the Electrical and Computer Engineering Department at the University of Undergraduate Thesis SmartPill Virginia originally alerted the project team to the problem Professor Williams has worked as an Emergency Medical Technician EMT since 1991 On numerous occasions every year he has been called to the home of an elderly person who has overdosed on his medications Usually the person overdosed for one of several reasons e The patient forgot that he had already taken his medication at one point during the day The patient then took his medication again and overdosed e The patient was taking so many medications simultaneously that he either became confused and took the wrong medications or took his medications in the wrong dosage e The patient s pharmacist or doctor did not detect a harmful medication combination in the patient s regimen Presently a pharmacist only knows about the medications that a patient has filled at that particular pharmacy making it difficult for the pharmacist to detect harmful combinations As a result of this interview the project team originally focused on geriatric patients The next step was to determine how current prescription drug distribution practices lead to misuse CVS and some of the other national franchises would not speak about the operation
53. o one week iterations The story groups were then prioritized and compiled into a Gantt chart Finally each story was broken into individual tasks and assigned to different group members Initially the group s time estimations were inaccurate For example iButton software source porting see section 4 4 1 which was estimated to take about 10 man hours over one iteration actually took 4 iterations and around 30 man hours Consequently iterations were adjusted frequently at the beginning of the Implementation phase 3 2 Project Phases 3 2 1 Proposal The Proposal phase s main objective was identification of a problem that required a technical solution Professor Williams as mentioned previously articulated the problems with geriatric prescription drug use see section 1 2 After the problem was identified some background research was conducted A National Institutes of Health 25 Undergraduate Thesis SmartPill NIH report on prescription drug abuse was the linchpin 3 Next potential solutions were brainstormed The group considered several concepts based on complexity cost and most importantly estimated time to complete a proof of concept Finally the group wrote a proposal that articulated the problem outlined a solution and listed the anticipated project requirements see Appendix B The proposal was selected from a field of fourteen entries by a three member faculty panel to receive funding Jonathan Kelley and
54. oblem with this system is the transaction method which makes it relatively easy to obtain prescription drugs fraudulently The NIDA also reported an alarming trend In 1999 an estimated 4 million people almost 2 percent of the population aged 12 and older were currently use in past month using certain prescription drugs non medically In addition health care professionals including physicians nurses pharmacists dentists anesthesiologists and veterinarians may be at increased risk of prescription drug abuse because of ease of access as well as their ability to self prescribe drugs Prescription Drugs 4 Our system will secure the prescription system by electronically encrypting prescription information on smart cards and authenticating all transactions The other major problem that our system addresses is drug misuse By placing wireless sensors on medication bottles patients can physically place bottles together to determine the safety of use The wireless sensors will automatically detect any dangerous combinations and alert the user In addition inexpensive LCD displays will be available to access product information which is also stored in the sensor package The proposal s original formatting is preserved in this Appendix 39 Undergraduate Thesis SmartPill Figure 1 PDS conceptual system outline Prescription Doctor Self organizing Pill ecure Bottle Networks e gt
55. ogramming of the device to simply moving analog switches He also notes that programmable systems in the prior art do not appeal to many senior citizens who have limited incomes and little experience in programming high tech equipment 13 16 Undergraduate Thesis SmartPill One inventor approached the development of a medication organization system without using a storage cabinet Sagar submitted a system with an electronic pill bottle cap 14 The cap has lights that indicate when a medication should be taken The lights utilize color coding to instruct the user The cap also has a sensor that tracks compliance Sagar s most important innovation involves the electronic transfer of product information The system retrieves information from a database and automatically programs the bottle cap eliminating the need for manual programming The medications are not automatically dispensed however meaning that the user must still pick pills out of loose bottles at designated times Several relevant products are currently available on the market The Talking Rx is a small device that attaches to the base of a pill bottle 16 A pharmacist or caregiver can then record audio instructions The user has a small receiver that plays the instructions E pill of Wellesley MA also sells several dispenser models including the MD 2 17 This product features 60 pill containers audio visual usage prompts and a lockable cabinet In addition it can
56. pensed pills do not accumulate This advanced system receives stores and processes prescription data which the user enters with a folding keyboard The top lid locks to prevent medication access at unauthorized times Finally Shaw adds a logging feature to track patient compliance Lim made the first attempt at coaching the user with his 1999 design 9 This dispenser allows a caregiver or pharmacist to record audio usage instructions for each medication In addition the device has a communication subsystem that connects to the phone network If the patient does not comply with his regimen the system can alert an off site caregiver This device however does not account for human error The audio instructions can become disassociated with the corresponding medication Two designs have been submitted in the past year Lim improved his design by solving a previously unaddressed problem securing loose pill bottles 8 All previous designs require the patient to transfer pills from bottles to the dispenser Excess pills remain in the pill bottles The system cannot track these pills and for a patient taking multiple medications the bottles can become lost Lim s new design locks the loose bottles in a compartment Hubicki also takes a novel approach by providing compartments for medications in non pill form liquid powder etc 13 His design incorporates a mobile paging unit that prompts the user to take medications Hubicki simplifies pr
57. perts to draft disclaimers and all other necessary documentation to limit our liability In short this project cannot succeed unless we follow all legal regulations 61 Undergraduate Thesis SmartPill The second organizational aspect is the drastic impact this product will have on the healthcare industry Pharmaceutical companies will need to reformat their product literature to fit on our devices we could provide this service though Institutions such as medical schools will need to train doctors about the proper use of PDS Practicing medical professionals including pharmacists will also need proper training Each patient will need to understand the operation of the system from an end user perspective A stated goal of this system is to move all complexity away from the patient so this type of user should not need formal training The final organizational aspect of this system is infrastructure This is a revolutionary system and there is not a single pharmacy or medical office in the world that we know that supports anything like it Once the system is developed we must facilitate deployment on a scale that will rapidly make the system ubiquitous This is a major corporate distribution problem Clearly there are major organizational challenges for this system We believe that these challenges are more significant than the technical problems facing the system We are confident however that none of these obstacles are insurmou
58. programmed cartridge into the first slot Then serially insert a cartridge with preprogrammed conflicting medication description into each other slot The test is successful when the conflict signal is communicated to the tester in each case Two SmartPill cartridges loaded with conflicting prescription information Table 3 A test description from the Functional Test Procedure 37 Contains a user story listing test equipment list acceptance test list task log and risk analysis manufacturing Proof of Concept Functional system prototype Virtual product usage instructions Verification Test Procedure A procedure for verifying that the product meets its specification after development Table 4 Implementation phase deliverable listing 3 3 Applied Lightweight Design The group made several modifications to XP during software development First since time was a limiting factor the group prioritized the functionality that would be 28 Undergraduate Thesis SmartPill implemented during the semester Five tiers were defined with one as the highest tier with the lower tiers containing features that were not critical to the proof of concept Tier 1 e Catalogue medicines available to a user dynamically when medicines are introduced to the system This cataloguing should require no user input or programming e Alert the user to any potentially harmful medication combinations Tier 2 e Provide a scheduling feature
59. rstand prescription drug information in the 11 Undergraduate Thesis SmartPill first place Furthermore geriatric patients usually cannot perform complex tasks such as programming SmartPill catalogues all medications dynamically and generates a usage schedule This approach will eliminate the need for a knowledgeable caregiver to setup the system a requirement of every other design on the market Finally the use of electronic product information allows the system to detect harmful medication combinations 1 5 The SmartPill System SmartPill users own an automatic medication dispenser that accepts SmartPill cartridges pill storage containers with electronic product information Pharmacists use a programming cradle and a software application to load information onto cartridges The system has seven basic features Smart Pill Programmer e Cataloguing of medications available to the user dynamically when medicines are introduced to the Communication system No user input or SER programming is required e Audio and visual cues to guide the user through the process of taking medications e Automatic detection of potentially f harmful medication combinations Pieure Ioman pharmacist programming cradle Drawing by Jonathan The user is alerted through audio and kelley visual cues e Logging of the user s compliance history SmartPill also prompts the user for a refill when the number of pills in a cartridge drops b
60. s a free integrated development environment IDE the MSP430 IAR Kickstart package 29 An active well documented port of gcc for the entire MSP430 series also exists for free download 26 The latter option was attractive for the group as all members had 33 Undergraduate Thesis SmartPill experience with gcc and the other GNU C development tools The MSP430 options were deemed better in terms of both cost and documentation The other determining factor was the availability of development boards Several preconfigured boards exist for both lines of MCUs but Olimex provides an MSP430 development board that features a preconfigured Dallas Semiconductor 1 Wire port Dallas iButtons had already been selected as the SmartPill cartridge memory unit so this feature was extremely attractive No similar boards were available for the Motorola MCU As a result of these two factors the TI MSP430 was selected as the onboard MCU 4 1 2 Olimex Development Board Olimex provides a line of TI MSP430 development boards that have the following features e Preconfigured liquid crystal display LCD e Four momentary state buttons e Preconfigured Dallas 1 Wire port e JTAG interface for real time debugging e RS 232 serial port e Several free general purpose I O pins Two different boards were purchased for development MSP430 449STK and MSP430 413STK Figure 3 and Figure 4 show the two boards i888 9 http wwws ollmex com de yv
61. s a major constraint unnecessary methods were removed 4 4 2 iButton Data Storage A major design challenge involved transferring data from a 32 bit PC platform to the 16 bit MCU Table 10 shows the different sizes of C primitive types on the two architectures used in the SmartPill system TI MSP430x4xx Intel 32 bit x86 IA 32 long 4bytes S bytes Table 10 Primitive type sizes for the two different architectures used in the SmartPill system In order to eliminate incompatibilities between the two architectures all types are broken into individual bytes The data is then stored along byte boundaries in character arrays on the SmartPill cartridges Each file described in section 4 4 is actually a character array Note that both the MSP430 and IA 32 are little endian architectures so 45 Undergraduate Thesis SmartPill no reordering at the bit level is necessary General purpose methods were written that pack a variable number of bytes in an array starting at a given byte Arrays are only packed on the IA 32 platform These arrays are then read when an iButton is detected by the onboard software Since the file formats were standardized in terms of bytes the data could be unpacked from the arrays and then type casted as the appropriate primitive type on the MCU For example four bytes an int are stored in a character array of length four on the A 32 platform That array is then unpacked on the M
62. s that the bottle has been added MEC A connected bottle Each slot on the medicine cabinet is assigned a static 1 26 2004 number REVISION The 1 wire net assigns one iButton to be the master and additional buttons as slaves Each button s unique ROM serial number is used to identify it on the bus 4 The system has the capability to poll slots on the 1 26 2004 Software medicine cabinet in order to take inventory of what bottles are available Using the information stored on each pill bottle the 1 26 2004 Software system creates a usage schedule that integrates all currently connected medications This action occurs dynamically with no user input other than inserting the bottle into the system The system updates the usage schedule during 1 26 2004 Software operation of the system If a bottle is removed that medication is removed from the schedule If a bottle is added that medication is added to the schedule Medications are organized in the usage schedule by 1 26 2004 Hardware Software dispense times on a 24 hour clock When a dispense time is active one or more medications should be dispensed then the system activates the alarm the dispense button is depressed by the user When the user depresses the dispense button the 1 26 2004 Hardware Software following actions occur e The user s compliance is logged in the compliance database An entry is added stating the dispense time medications dispensed and the time when
63. smart card Each doctor will have a unique identification tag for authentication when the pharmacist decrypts the prescription The integrity of the digital prescription must be guaranteed and immune from attacks Involved Disciplines Electrical Engineering Computer Science Design Procedure We will develop a custom prescription application that utilizes commercial encryption technology We will utilize standard software engineering practices such as risk analysis requirements analysis and system specification to develop the software artifact We will also purchase a smart card and smart card reader that plugs into a PC or PDA Design concerns Which authentication method and encryption technique should we use What information needs to be stored on the customer s card How will we assign unique identification codes to each doctor 5 2 Distribution System 63 Undergraduate Thesis SmartPill Pharmacists will utilize this component Upon receiving the prescription from a customer the pharmacist can decrypt the prescription data and authenticate both the doctor and patient information After transaction authentication drug product information is transferred onto a pill bottle and the medicine is distributed to the customer Design Objectives The pharmacist will be able to verify that the prescription is for a particular customer The entire process should be largely automated The software system must be reliable and secur
64. sounds an audio alarm The user must then depress the Dispense button on the medicine cabinet When that button is depressed the alarm ceases and the buffer is emptied with product information printed to the dispenser s LCD The medication s National Drug Code pills to disp The number of pills to be dispensed at this time options 2 bytes Usage options from the Usage Options file corresponding to this dispense time dispatch time 2 bytes The time in minutes corresponding to when this struct was placed in the Dispense Buffer bottle num 1 byte This dispense time s corresponding bottle Table 11 Dispense time data structure 4 4 4 Input Output Specification The software system is heavily I O dependent In dealing with geriatric patients though the number of inputs and outputs had to be minimized and simplified A design was finalized that had only three major user inputs cartridge insertion a Dispense button and clock set buttons Any user capable of operating an alarm clock can use SmartPill Table 12 lists the proof of concept s inputs and outputs 47 Undergraduate Thesis SmartPill Bottle inserted into system e LED on that pill slot set to ON Bottle removed from system e LED on that pill slot set to OFF Depress both min set and hour Input e System resets to factory default state set buttons and hold for 10 seconds Depress hour set button e Hour component of current time incremented Depress mi
65. spects of this project He has extensive experience in building embedded systems including some embedded medical devices Engineering Team 62 Undergraduate Thesis SmartPill e EE CpE 1 We need an individual to design and implement the sensor package for the pill bottles e CS CpE 1 Simulation software for the prototype system must be developed see section 6 We need an engineer with experience in computer simulations and graphical interfaces e ME 1 The physical pill bottle as well as an attachment mechanism for the sensor package must be developed by a mechanical engineer with experience in the area of materials science With three diligent engineers and three knowledgeable advisors we believe this system can be developed successfully in one year S Design Strategy There are three components in this system the prescription system the distribution system and the self organizing pill bottle network system Different design strategies and concerns exist for each of these components 5 Prescription System This system will allow doctors to digitally prescribe medications for patients The customers can then take the digital prescriptions on a smart card to the pharmacist Finally the pharmacist will deliver the prescribed medicine to the patient Design Objectives The doctor will make the prescription on his computer or PDA A smart card reader will then flash the encrypted electronic prescription onto a
66. sponsibility was software design I also researched software development methodologies Lightweight design has been an active research area over the last few years so I decided to try eXtreme Programming XP for this project Lightweight design involves a design a little build a little approach whereas conventional methods such as the waterfall and spiral methods require extensive up front design before implementation 20 4 Authoritative XP texts such as Kent Beck s eXtreme Programming Explained were reviewed at length The research focused on adapting lightweight software design to a project with concurrent hardware development Section 2 2 introduces and explains XP 1 4 Rationale and Scope of Project As the so called Baby Boomer generation ages the need for SmartPill will increase dramatically A 1999 AARP study showed that two of the top three needs for assisted living patients were medication dispensing and medication reminders Fifty nine percent of all patients required the former while 50 required the latter 18 Patients that cannot afford assisted living which currently costs several thousand dollars a month have an even greater need Although pharmaceutical management systems have existed for years the SmartPill approach is novel in its degree of automation it requires no user programming Other systems require the user to enter product information Research clearly shows however that the target user base cannot unde
67. t not occupied ON Slot occupied and functioning properly FLASHING Refill necessary or product conflict This function should be implemented in software When a bottle is introduced into the system that 1 26 2004 Hardware bottle is locked in place mechanically by the system Only the system can release the bottle from the slot proof of concept Bottle release only occurs when the medication is empty The system shall maintain an onboard clock The 1 26 2004 Hardware Software time can be retrieved from this clock the clock can be set and the clock may be tested to ensure correct operation The system shall have an LCD screen capable of 1 26 2004 Hardware Software printing text For the proof of concept this screen will show the type of medication and number of pills dispensed When pills are not being dispensed the screen shows the current time For the virtual product the only function of this screen is to show the current time For each currently connected bottle the system shall 1 26 2004 Software maintain product updates for that bottle These updates are retrieved from other bottles connected to the system The product update storage space for each bottle is treated by the system as if it is actually on the bottle itself 2d Undergraduate Thesis SmartPill 0 A 12 hour clock will be displayed on the LCD screen 2 24 2004 Hardware Software when the system is not dispensing medications T
68. t the MSP430 development boards 28 Olimex provides schematics datasheets and sample assembly code for both the MSP430 413STK and MSP430 449STK boards Dallas Semiconductor supplies extensive documentation for its iButton products Most of the documents consulted during this project related to iButton software interfacing The encyclopedic Book of iButton Standards contains a detailed description of the Button design 43 It explains the merits of the product technical specifications and the differences between the different iButton models NVRAM EPROM and EEPROM The document also details the 1 Wire communication protocol Several other papers supplement the information in this guide White Paper 2 describes the different files in the Public Domain Kit see section 4 4 1 including which files are needed to build the protocol stack 44 It serves as a 18 Undergraduate Thesis SmartPill good non technical introduction to the software The 1 Wire Software Resource Guide Application Note 155 is a more comprehensive technical document 24 This helpful guide describes every method in the Public Domain Kit and explains each layer in the protocol stack Most importantly it lists the methods that must be implemented to port the software to different hardware architectures Application Note 126 1 Wire Communication through Software gives an example implementation of those methods 22 It also describes the 1 Wire bus
69. ted a Concurrent Versions System CVS repository which provided version control for both documents and source code 33 A Gantt chart stored in the CVS repository replaced the group calendar Mantis version 0 16 an Open Source error issue tracking system was also used during Implementation 34 Mantis features a web based front end and a MySQL database back end The MySQL back end was chosen for data transportability Issues related to software hardware and documentation were posted on the website Responses were added to the postings until the issues were resolved 24 Undergraduate Thesis SmartPill 3 1 2 Planning Planning occurred at the beginning of each phase A portion of each weekly meeting was also devoted to readjusting milestones according to the current stage of the project Each phase s milestones were compiled into Gantt charts During the Proposal and Research and Design phases milestones corresponded to deliverables Tasks required for deliverable completion were then arranged ahead of the milestone Since fixed milestones anchored the schedules of those two phases the calendars were fairly rigid The Implementation phase guided by XP was more fluid At the start of Implementation user stories were created from the Software Requirements Document Hardware Requirements Document and Product Specification 35 36 19 The group collectively estimated the time required for each story and then grouped stories int
70. than Kelley and Brad Pinney my fellow group members In this paper I have noted the portions of the project that these two individuals worked on Professor Ronald D Williams initially highlighted the problem addressed by SmartPill I would also like to thank Clement Song who co authored the initial proposal He had the first conversation with Professor Williams that led to the idea for this project Finally Professor Dan Bauer the project s EIC advisor was instrumental in the project s success Our conversations with him frequently fell outside of the technical realm We learned much more from him than just engineering Undergraduate Thesis SmartPill Table of Contents ic DD IAM M LL c c uu T M LEE ee RENE S Y Ria A AA AS 10 APO cu am 13 20 Literature REV a A A A A AA 14 E ues AAA eT TE Tee TT eer eT rT 14 LLL a SS INE Ge unn da cod Er avandia Cac be d ce i En c dead 14 212 EU aio ce aec esu disks is de e iM LE ii 15 UR Ms ee eR ME rc oed A A 18 E TI Munu germeni a hk eich nen ld 23 DA VACA A ERR 24 3 1 2 Planning MN 25 4 0 Proof of Concept P D 32 4 1 Materials Ate 32 2 1 3 Dallas Semiconductor d ftoi dicia O 33 4 1 4 Software Developinent Enyir nment air rr e cbe e Eo 37 PRAE D E a 38 4 1 6 Miscellancous Materials nnd do Eau eco i bra eo rna a Eid 38 42 Hardware E A had a lee 38 C NUN BLUR ROO O meri e RERUM 38 2 2 MSEJ IO Clock SUBS a a caa eR
71. that is configured automatically when a new medication is introduced to the system This feature prompts the user when in what quantity and how to take the medication Tier 3 e Log the user s compliance history and prompt the user to obtain refills when necessary Tier 4 e Lock all loose pill bottles in place Tier 5 e Make language based paper based product information and education optional by relying solely on a combination of audio and visual prompts e Provide an automatic product information updating feature that does not rely on the Internet web Second the group classified each user story as a hardware component a software component or both This activity provided a basis for dividing labor among the group members Finally the group identified several key technical risks E Risk Description Abatement Strategy Software code size Ordered a new board with the maximum amount of memory the msp430 architecture can address Hardware defect or When implementing a hardware feature test that feature extensively before software defect integrating with software and vice versa For hardware software features define tests that best isolate the hardware and software components of that feature Table 5 The risks associated with the onboard software development activity 30 After the process was defined the next step was to determine the overall architecture of the system Since the SmartPill dispenser is heavily I O depend
72. the alarm was sounded For each medication the medication and number of pills dispensed is written to the LCD screen proof of concept 10 The system keeps a running count of the pills 1 26 2004 Software available in each bottle When a medication is dispensed the count is decremented When the running count of pills for a slot equals 10 1 26 2004 Hardware Software 56 Undergraduate Thesis SmartPill of the original amount the system prompts the user to refill the medication flashing the LED on that pill slot When the running count equals 0 the system unlocks the bottle The system will have an LED on each pill slot The 1 26 2004 Hardware system will be able to toggle three states for the LED on off and flashing In the flashing state the LED will toggle between on and off every half second The system will maintain a compliance database that 1 26 2004 Hardware Software lists the time and number of pills for each time a medication is dispensed This database can be downloaded via the system s serial port When a medication is introduced into the system the 1 26 2004 Software system will be able to detect harmful combinations between all currently connected medications This feature involves comparing the list of connected medications to the list of harmful medications stored on each pill bottle The LED on each pill slot operates as follows 1 26 2004 Hardware Software OFF Slo
73. timing constraints Used in conjunction Application Notes 155 and 126 can guide a user through the process of porting the Public Domain Kit to various unsupported hardware platforms Two other iButton references were used during software development Application Note 187 describes an algorithm for searching a 1 Wire network for new devices 45 iButtons use a master slave bus architecture and a large number of slaves can be chained onto the bus The master must search the network to find the unique read only memory ROM numbers of each new slave Application Note 2420 was also helpful This paper shows how to port the Public Domain Kit to a Microchip PICmicro microcontroller 6 The PICmicro MCU is similar to the TI part used in the SmartPill dispenser As a result the procedure described in this paper was adapted to the MSP430 porting process 2 2 Software Development Lightweight agile software design has been an active research area over the last few years The group wanted to try lightweight design for both their own education and to investigate how it worked with parallel hardware development Several methodologies exist including eXtreme Programming XP Feature driven Development FDD and 19 Undergraduate Thesis SmartPill Crystal Of these agile methods XP is the most fully formed 20 4 Kent Beck s eXtreme Programming Explained is the authoritative XP text Beck along with Ward Cunningham and Ron Jeffries developed X
74. tion covers the product development lifecycle In section 4 the proof of concept s noteworthy aspects are explained The proof of concept was the focal point of the project so important design decisions and tradeoffs are discussed at length The final two sections 5 and 6 list the project results and conclusions Most importantly section 6 1 contains recommendations for future work Several appendices supplement the information in the text 13 Undergraduate Thesis SmartPill 2 0 Literature Review The research conducted for this project fell into the areas of customer needs a novelty search and device and concept selection The former two items related to the virtual product and determined the product features see section 1 5 Those features were then prioritized and the most important items were implemented Device and concept selection which related to the proof of concept was driven by the virtual product research Application notes datasheets and part specifications were consulted Finally I conducted software development research in order to adapt lightweight design to the project This section details the important research findings 2 1 System Research Automated pill dispensers first appeared in the mid 1980s Since that time inventors have developed a number of variations Most of the relevant literature comes from two sources patents and existing product documentation In addition several sources were used to d
75. tivities was the most noteworthy The Development and Test Schedule s three main parts were the user story listing the acceptance test listing and the task log One or more acceptance tests were created for each XP user story The task log which was updated weekly listed both future activities and recorded past tasks For each activity in the task log the due date 27 Undergraduate Thesis SmartPill number of man hours required to complete and status were recorded Later in the semester a risk analysis section was added to the Development and Test Schedule see Table 5 Two other important documents the Functional and Verification Test Procedures were created later in the phase The Functional Test Procedure would be used during production The document listed 14 tests that would verify a product s operation immediately after it left the assembly line Table 3 shows one of those tests The Verification Test Procedure on the other hand would be used on a control group of virtual products after development completion The Verification Test Procedure lists a detailed test including the procedure and required equipment for each item in the Product Specification Test 4 Description Test Item Description Pill bottle receptacle communication with microcontroller Test Objective Ensure that microcontroller can read every receptacle Reference Documents Hardware Requirements Software Requirements Test Description Insert a pre
76. ttles Next Hardware and Software Requirements documents were prepared as part of the up front design activity These documents which stated what the system had to do were also based on customer needs Finally Detailed Hardware and Software documents which served as blueprints during Implementation were created based on the requirements evaluate several virtual product designs organizational aspects Detailed Software Design SmartPill software system blueprint Hardware Requirements Explains what the system hardware must do Preliminary Design Review PDR Report Project status report for the PDR which took place in mid November 2003 Product Specification Contains the virtual product technical details Project Review II Report Project status report for the final Research and Design Project Review Software Requirements Explains what the system software must do Statement of Work Lists proof of concept features and all Research and Design and Implementation development activities Table 2 Research and Design phase deliverable listing 3 2 3 Implementation The proof of concept was created and evaluated during this segment which consisted of both implementation and verification steps The latter step is slightly misleading though since software verification in XP occurs throughout implementation Of the documents created the Development and Test Schedule which served as both a plan and a record of Implementation ac
77. ups of two with a pilot and a navigator The pilot writes the code while the navigator consults documentation designs and checks the pilot s work At any time the pilot and navigator can switch roles The rationale for this scheme is that two people can find defects faster than one but three people is probably too many at a single workstation Some developers though are hesitant to work with a partner As a result this principle is frequently ignored To design a system XP developers create user stories on 3 in by 5 in index cards Each story captures a way in which the system is used The client must accept 21 Undergraduate Thesis SmartPill each story Stories are then broken into tasks and assigned to programmers for implementation New stories are added to the system as needed Appendix A lists the stories used in this project Any XP development effort should focus on three critical issues First dissemination of information within the group is critical XP depends on timely rapid communication 20 87 Email is usually the preferred communication medium Second No code sits unintegrated for more than a couple of hours At the end of every development episode the code is integrated with the latest release and all the tests must run at 100 25 97 Finally the development group should always have one set meeting time and place per week to plan and coordinate 20 87 In summary the development team should
78. ure 8 Olimex MSP430 449STK schematic showing the connections to the MSP430 s various I O ports Note that the Dallas iButton 1 Wire port is connected to port 5 pin 6 P5 6 on the far righi eere ertet en etn nennen bone ae pono operae ehe e e gap 39 Figure 9 MSP430 I O pin control example C code like this appears in the SmartPill onboard SOUMWALC vcsessccrscdissiscssievcdenvsestscdesusesasensdesusagyevisentousceussesnbueverdoaseasnnedad 40 Figure 10 Timer A up mode behavior When Timer A equals the value in CCRO an interrupt is triggered and the timer resumes counting from 0 23 11 6 41 Figure 11 Layout of the Dallas port on the Olimex development board This circuit provides a weak pull up The line labeled Dallas connects to one of the MSP430 s VO PANS M RC 42 Figure 12 The MSP430 s Frequency Locked Loop FLL Note the MCLK signal that clocks the microcontroller 23 ee eee eee ee eee eee eee eene eene tette ettet eaae eee 43 Figure 13 1 Wire waveforms Note that the bus uses a weak pull up so letting the wire float high releases the bus 22 2 eese eerte eere esee eere eere n netten ttn n assets enun 45 Undergraduate Thesis SmartPill Abstract Elderly illiterate uneducated and otherwise impaired individuals have difficulty complying with prescription drug regimens As a result misuse is common among these types of patients Researchers have documented a
79. ware that interfaces with both the pharmacist s customer database and a remote database containing SmartPill formatted product information Obviously the latter database must also be developed SmartPill should be phased in gradually This paper describes the final vision of the product but such a product would require a significant organizational change Insurance companies would need to decide whether to reimburse the cost of the 51 Undergraduate Thesis SmartPill cartridges and or the dispenser The system particularly the cartridges might require government approval Pharmacies would need SmartPill s support infrastructure The cartridges would require new distribution channels As a result product iterations should incrementally add the more involved features For example one initial version of the product might read all product information from a Smart Card or from the Internet rather than from cartridges As pharmacies embraced the product and started offering SmartPill cartridges that functionality could be added In any case vendors must be convinced of the system s unique value for the product to gain acceptance Another possibility might involve licensing SmartPill s novel features to existing vendors For example e pill has a full line of medication dispensers that would greatly benefit from SmartPill s electronic product information approach 17 A patent should be obtained if this course of action is pursued 6 2
80. wer supply that is used when the power cord is not connected to the 120V AC source 58 Undergraduate Thesis SmartPill Appendix B ENGR302 Project Proposal A Pharmaceutical Prescription Distribution and Self Organizing System Spence Green Clement Song University of Virginia SEAS University of Virginia SEAS wsg6f virginia edu cs2bs virginia edu 1 Abstract In a recent report by the National Institute on Drug Abuse NIDA prescription drug misuse by elderly patients was listed as a major concern in the healthcare industry The misuse of prescription drugs may be the most common form of drug abuse among the elderly Elderly persons use prescription medications approximately three times as frequently as the general population and have been found to have the poorest rates of compliance with directions for taking a medication Prescription Drugs 6 Clearly there is a need for to improve and simplify the prescription distribution and use of medications We propose a medicine Prescription Distribution and Self organizing PDS system that will authenticate all prescriptions eliminate incorrect or fraudulent distribution and decrease the risk to the patient Such a system would save lives every year Currently a patient receives a paper prescription from a medical professional and takes the prescription to a pharmacy The pharmacist will then distribute the medication with literature on the particular drug The first pr

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