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THE	
  MARKET	
  FOR	
  PORTABLE	
  
MEDICATION	
  COMPLIANCE	
  DEVICES	
  
Drivers,	
  Players	
  and	
...
TABLE	
  OF	
  CONTENTS	
  
1	
   Executive	
  Summary.......................................................................
4.1.5.5	
   Cons.............................................................................................................
LIST	
  OF	
  TABLES	
  
	
  
Table	
  1:	
  Philips	
  Lifeline	
  Channel	
  Partners	
  in	
  the	
  U.S.	
  and	
  Can...
LIST	
  OF	
  FIGURES	
  
	
  
Figure	
  1:	
  Reimbursement	
  Model	
  for	
  RMT	
  Devices	
  adopted	
  by	
  NHS,	
 ...
Executive	
  Summary FemtoTools
Market for Portable Medication Compliance Devices 1
	
  
	
  
	
  
1 Executive	
  Summary	...
Executive	
  Summary FemtoTools
Market for Portable Medication Compliance Devices 2
	
  
	
  
	
  
has	
  reported	
  on	
...
Introduction FemtoTools
Market for Portable Medication Compliance Devices 3
	
  
	
  
	
  
2 Introduction	
  
Poor	
  medi...
Introduction FemtoTools
Market for Portable Medication Compliance Devices 4
	
  
	
  
	
  
factor	
  tens	
  of	
  times	
...
Competition FemtoTools
Market for Portable Medication Compliance Devices 22
	
  
	
  
	
  
4 Competition	
  
There	
  are	...
Competition FemtoTools
Market for Portable Medication Compliance Devices 23
	
  
	
  
	
  
hosts	
  clinical	
  applicatio...
Competition FemtoTools
Market for Portable Medication Compliance Devices 24
	
  
	
  
	
  
4.1.1 Vitality	
  GlowCaps	
  
...
Competition FemtoTools
Market for Portable Medication Compliance Devices 25
	
  
	
  
	
  
4.1.1.3 Pros	
  
The	
  GlowCap...
Competition FemtoTools
Market for Portable Medication Compliance Devices 26
	
  
	
  
	
  
4.1.2 Philips	
  MD2	
  
The	
 ...
Competition FemtoTools
Market for Portable Medication Compliance Devices 27
	
  
	
  
	
  
4.1.2.1 Operation	
  
The	
  PM...
Competition FemtoTools
Market for Portable Medication Compliance Devices 28
	
  
	
  
	
  
4.1.2.5 Cons	
  
PMD	
  has	
  ...
Competition FemtoTools
Market for Portable Medication Compliance Devices 29
	
  
	
  
	
  
4.1.3 Healthonemed	
  DAP	
  
T...
Competition FemtoTools
Market for Portable Medication Compliance Devices 30
	
  
	
  
	
  
4.1.3.2 Cost	
  of	
  Acquisiti...
Competition FemtoTools
Market for Portable Medication Compliance Devices 31
	
  
	
  
	
  
4.1.4 MedSmart	
  MD2	
  Plus	
...
Competition FemtoTools
Market for Portable Medication Compliance Devices 32
	
  
	
  
	
  
4.1.4.2 Cost	
  of	
  Acquisiti...
Competition FemtoTools
Market for Portable Medication Compliance Devices 33
	
  
	
  
	
  
4.1.5 MedSignals	
  
MedSignals...
Competition FemtoTools
Market for Portable Medication Compliance Devices 34
	
  
	
  
	
  
When	
  the	
  device	
  is	
  ...
Competition FemtoTools
Market for Portable Medication Compliance Devices 35
	
  
	
  
	
  
overdose	
  is	
  a	
  serious	...
Competition FemtoTools
Market for Portable Medication Compliance Devices 36
	
  
	
  
	
  
Table	
  2:	
  Comparison	
  of...
Competition FemtoTools
Market for Portable Medication Compliance Devices 37
	
  
	
  
	
  
S.No.	
   Feature	
   Component...
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Market for Portable Medication Compliance Devices

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This report contains some sections of the report - "The Market for Portable Medication Compliance Devices - Drivers, Players and Challenges"

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Market for Portable Medication Compliance Devices

  1. 1.         THE  MARKET  FOR  PORTABLE   MEDICATION  COMPLIANCE  DEVICES   Drivers,  Players  and  Challenges               Dr.  Felix  Beyeler   and   Alok  Narula           June,  2012                  
  2. 2. TABLE  OF  CONTENTS   1   Executive  Summary.................................................................................................................1   2   Introduction...............................................................................................................................3   3   Market  Dynamics .....................................................................................................................5   3.1   SIMPHS  Report  on  the  Market  for  RMT/PHS  Devices ........................................................ 5   3.1.1   Data  Sources................................................................................................................................................6   3.1.2   Analyses  and  Outcomes..........................................................................................................................7   3.1.2.1   Frost  &  Sullivan...................................................................................................................................................8   3.1.2.2   Global  Market  Data............................................................................................................................................8   3.1.2.3   SIMPHS  Research...............................................................................................................................................9   3.1.3   Conclusions...............................................................................................................................................10   3.2   OECD  Demographic  Drivers  for  RMT/PHS  Devices ..........................................................12   3.2.1   Population  above  65  Years.................................................................................................................12   3.2.2   Public  Funding  of  Healthcare............................................................................................................13   3.2.3   Healthcare  Providers  per  1000  Population................................................................................15   3.2.4   Healthcare  Resources  per  1000  Population...............................................................................17   3.2.5   Prevalence  of  Chronic  Diseases........................................................................................................18   3.3   Health  Industry  Drivers  for  RMT/PHS  Devices..................................................................19   3.3.1   Missed  Pharmaceutical  Sales  due  to  Medication  Non-­‐Adherence....................................19   3.3.2   New  Revenue  Opportunities  for  Smartphone  Manufacturers  and  Mobile  Network   Operators ..................................................................................................................................................................20   4   Competition............................................................................................................................. 22   4.1   Existing  Products..........................................................................................................................22   4.1.1   Vitality  GlowCaps ...................................................................................................................................24   4.1.1.1   Operation............................................................................................................................................................ 24   4.1.1.2   Cost  of  Acquisition  (Buy)............................................................................................................................. 24   4.1.1.3   Pros ....................................................................................................................................................................... 25   4.1.1.4   Cons....................................................................................................................................................................... 25   4.1.1.5   Distribution  Channel ..................................................................................................................................... 25   4.1.2   Philips  MD2...............................................................................................................................................26   4.1.2.1   Operation............................................................................................................................................................ 27   4.1.2.2   Cost  of  Acquisition  (Buy)............................................................................................................................. 27   4.1.2.3   Cost  of  Acquisition  (Lease)......................................................................................................................... 27   4.1.2.4   Pros ....................................................................................................................................................................... 27   4.1.2.5   Cons....................................................................................................................................................................... 28   4.1.2.6   Distribution  Channel ..................................................................................................................................... 28   4.1.3   Healthonemed  DAP ...............................................................................................................................29   4.1.3.1   Operation............................................................................................................................................................ 29   4.1.3.2   Cost  of  Acquisition  (Buy)............................................................................................................................. 30   4.1.3.3   Cost  of  Acquisition  (Lease)......................................................................................................................... 30   4.1.3.4   Pros ....................................................................................................................................................................... 30   4.1.3.5   Cons....................................................................................................................................................................... 30   4.1.3.6   Distribution  Channel ..................................................................................................................................... 30   4.1.4   MedSmart  MD2  Plus..............................................................................................................................31   4.1.4.1   Operation............................................................................................................................................................ 31   4.1.4.2   Cost  of  Acquisition  (Buy)............................................................................................................................. 32   4.1.4.3   Pros ....................................................................................................................................................................... 32   4.1.4.4   Cons....................................................................................................................................................................... 32   4.1.4.5   Distribution  Channel ..................................................................................................................................... 32   4.1.5   MedSignals ................................................................................................................................................33   4.1.5.1   Operation............................................................................................................................................................ 33   4.1.5.2   Cost  of  Acquisition  (Buy)............................................................................................................................. 34   4.1.5.3   Cost  of  Acquisition  (Lease)......................................................................................................................... 34   4.1.5.4   Pros ....................................................................................................................................................................... 34  
  3. 3. 4.1.5.5   Cons....................................................................................................................................................................... 34   4.1.5.6   Distribution  Channel ..................................................................................................................................... 35   4.2   Large  Companies  in  the  RMT/PHS  Space .............................................................................38   4.2.1   Intel-­‐GE  Health  Guide...........................................................................................................................39   4.2.2   Bosch  Healthbuddy ...............................................................................................................................40   4.2.3   Honeywell  Hommed..............................................................................................................................41   4.2.4   Philips  TeleStation.................................................................................................................................42   4.2.5   Estimated  Revenues  of  the  5  Big  Players  in  RMT/PHS..........................................................43   4.3   Business  Models ...........................................................................................................................44   4.3.1   Pharmacy  Benefit  Managers  /  Distributors................................................................................44   4.3.2   Healthcare  Facilitator  /  Health  Insurance  Provider ...............................................................45   4.3.3   Charitable  /  Mainstream  Hospital ..................................................................................................45   4.3.4   Mobile  Network  Operator ..................................................................................................................46   4.3.5   Retirement  Community.......................................................................................................................46   4.3.6   Seniors  Homecare  Provider...............................................................................................................46   4.3.7   Medical  Devices  Developer................................................................................................................47   5   Intellectual  Property............................................................................................................ 48   5.1   Existing  Patents ............................................................................................................................48   5.1.1   U.S.  Pat  #6,294,999................................................................................................................................49   5.1.1.1   Operation............................................................................................................................................................ 49   5.1.1.2   Distinguishing  Claims  (including  Claim  #1)........................................................................................ 50   5.1.2   U.S.  Pat  #7,928,835................................................................................................................................52   5.1.2.1   Operation............................................................................................................................................................ 53   5.1.2.2   Distinguishing  Claims  (including  Claim  #1)........................................................................................ 53   5.1.3   U.S.  Pat  #8,069,056................................................................................................................................55   5.1.3.1   Operation............................................................................................................................................................ 55   5.1.3.2   Distinguishing  Claims  (including  Claim  #1)........................................................................................ 56   5.2   FemtoTools  PMU  Design ............................................................................................................59   5.2.1   Operation...................................................................................................................................................59   5.2.2   Distinguishing  Claims  (including  Claim  #1)...............................................................................61   5.2.3   Comparing  FemtoTools  PMU  with  Other  Patents....................................................................63   5.2.4   Crucial  Gaps  in  the  FemtoTools  PMU  Design.............................................................................66   6   FDA/CE  and  Continua  Guidelines  for  PHS  Devices .................................................... 72   6.1   FDA  Guideline  for  PHS  Devices................................................................................................73   6.2   CE  Guideline  for  PHS  Devices ...................................................................................................75   6.3   Continua  Guideline  for  PHS  Devices ......................................................................................77   7   Deployment  Issues  with  RMT/PHS  Devices ................................................................. 81   7.1   Barriers  in  the  Uptake  of  RMT/PHS  Devices.......................................................................81   7.1.1   Cost...............................................................................................................................................................81   7.1.2   Complexity ................................................................................................................................................82   7.1.3   Privacy ........................................................................................................................................................82   7.1.4   Perception .................................................................................................................................................83   7.1.5   Interoperability.......................................................................................................................................83   7.1.6   Scalability...................................................................................................................................................84   7.2   Solutions  for  Increasing  the  Uptake  of  RMT/PHS  Devices .............................................84   7.2.1   Strengthening  the  User  Base.............................................................................................................84   7.2.2   Achieving  Regulatory  Support..........................................................................................................85   7.2.3   Increasing  Government  Involvement............................................................................................85   7.2.4   Increasing  Physician  Acceptance ....................................................................................................86   8   References ............................................................................................................................... 87   9   Appendix .................................................................................................................................. 90    
  4. 4. LIST  OF  TABLES     Table  1:  Philips  Lifeline  Channel  Partners  in  the  U.S.  and  Canada .............................................................28   Table  2:  Comparison  of  FemtoTools  Portable  Medication  Unit  (PMU)  against  other  Medication   Compliance  Devices..............................................................................................................................................36   Table  3:  Comparison  between  the  FemtoTools  PMU  and  other  Patents  embodying  weight   sensing  for  measuring  Drug  Compliance ....................................................................................................63   Table  4:  Healthcare  Expenditure  by  GDP  in  30  OECD  Countries  in  the  Year  2000  and  2009 ........90   Table  5:  Per  Capita  Healthcare  Expenditure  in  30  OECD  Countries  in  the  Year  2000  and  2009..91   Table  6:  Healthcare  Expenditure  by  Provider  in  30  OECD  Countries  in  the  Year  2009....................92   Table  7:  Healthcare  Expenditure  by  Function  in  30  OECD  Countries  in  the  Year  2009....................93   Table  8:  Healthcare  Providers  in  30  OECD  Countries  in  the  Year  2000  and  2009..............................94   Table  9:  Healthcare  Resources  in  30  OECD  Countries  in  the  Year  2000  and  2009.............................95   Table  10:  Prevalence  of  Dementia  among  60+  in  30  OECD  Countries......................................................96   Table  11:  Residential  Status  of  Older  People  in  Europe..................................................................................97   Table  12:  Measured  and  Project  Population  over  65  Years  in  30  OECD  Countries  (2010  thru   2030)...........................................................................................................................................................................98   Table  13:  Projected  Change  in  Old  Age  Dependency  Ratio  in  30  OECD  Countries  between  2009   and  2030................................................................................................................................................................. 100   Table  14:  Projected  Public  Funding  on  Healthcare  as  a  percentage  of  GDP  in  30  OECD  Countries .................................................................................................................................................................................... 102   Table  15:  Estimated  Prevalence  of  Diabetes  in  30  OECD  Countries,  China  and  India  in  2011.... 104   Table  16:  Projected  Prevalence  of  Diabetes  in  30  OECD  Countries,  China  and  India  in  2030..... 106   Table  17:  Economic  Burden  of  Chronic  Disease  in  the  United  States  (Past  and  Future)............... 108   Table  18:  Prevalence  of  4  Major  Chronic  Diseases  in  Germany,  France,  Italy,  U.K.  and  Poland  in   2007.......................................................................................................................................................................... 109   Table  19:  Prevalence  of  4  Major  Chronic  Diseases  in  the  United  States  in  2007 .............................. 109   Table  20:  Pharmacy-­‐Related  Waste  in  the  United  States  in  2011............................................................ 110    
  5. 5. LIST  OF  FIGURES     Figure  1:  Reimbursement  Model  for  RMT  Devices  adopted  by  NHS,  U.K.................................................................... 11   Figure  2:  Overview  of  Personal  Health  System  (PHS).......................................................................................................... 23   Figure  3:  Smart  Tray  for  Monitoring  Drug  Compliance  –  USPTO  #6,294,999........................................................... 49   Figure  4:  Portable  Container  for  Monitoring  Drug  Compliance  –  USPTO  #7,928,835 .......................................... 52   Figure  5:  Smart  Containers  for  Monitoring  Drug  Compliance  -­‐  USPTO  #8,069,056 .............................................. 55   Figure  6:  Cradle  for  Smart  Containers  -­‐  USPTO  #8,069,056............................................................................................. 56   Figure  7:  FemtoTools  PMU  Setup.................................................................................................................................................. 59   Figure  8:  FemtoTools  PMU  Buildup............................................................................................................................................. 60   Figure  9:  Medicpen  Drug  Handling  Apparatus........................................................................................................................ 67   Figure  10:  Medicpen  Medication  Compliance  Device .......................................................................................................... 67   Figure  11:  Medication  Loading  in  the  Interactive  Medication ......................................................................................... 69   Figure  12:  The  Interactive  Medication  Dispensing  Machine  -­‐  USPTO  #6,611,733.................................................. 70   Figure  13:  Systems  and  Apparatuses  in  the  Interactive  Medication  Dispensing  Machine  -­‐  USPTO   #6,611,733 .................................................................................................................................................................................. 71   Figure  14:  Continua  Interfaces  and  Standards........................................................................................................................ 77   Figure  15:  Continua  Reference  Topology .................................................................................................................................. 78   Figure  16:  Continua  v1.0  Device  Interconnectivity  Standards......................................................................................... 79   Figure  17:  Continua  v1.0  WAN  Scope.......................................................................................................................................... 80  
  6. 6. Executive  Summary FemtoTools Market for Portable Medication Compliance Devices 1       1 Executive  Summary   The  cost  of  healthcare  in  all  OECD  countries  is  growing  faster  than  the  incomes  of  those  who  pay   for  it.  Poor  medication  compliance  is  one  of  the  leading  reasons  for  spiraling  health  costs  and   premature  death  among  the  elderly.  Poor  medication  adherence  contributed  to  a  loss  of  US$  290   billion  to  the  U.S.  economy  and  also  resulted  in  the  avoidable  death  of  125,000  people  in  the   United  States  in  2009.  An  improvement  in  drug  adherence  can  help  everybody  touched  by  the   healthcare  industry.  Pharmaceutical  companies  can  gain  up  to  36%  in  extra  sales  by  improved   adherence  only.  OECD  governments  can  reduce  their  public  spending  on  healthcare  and  the   general  population  can  reduce  their  out-­‐of-­‐pocket  expenses  on  healthcare.  Portable  medication   compliance  devices  like  the  FemtoTools  PMU  can  make  a  big  difference  in  the  quality  of  life  of   mobile  patients  taking  regular  medication.  Unlike  large  and  bulky  medication  compliance   devices,  the  FemtoTools  PMU  is  a  small  hand-­‐held  apparatus,  which  can  be  used  on  the  move.     Medication  compliance  devices  fall  in  the  domain  of  Personal  Health  Systems  (PHS).  PHS  devices   have  been  developed  and  introduced  in  the  market  for  quite  some  time.  However,  it  is  only   during  the  past  4-­‐5  years  that  we’ve  seen  some  traction  in  this  field.  To  understand  the  market   dynamics  of  PHS  devices,  we  look  at  the  market  drivers  of  these  devices  and  make  a  good  guess   at  how  many  of  these  drivers  will  actually  work.  We  analyze  the  market  potential  by  referring  to   (1)  SIMPHS  reports  published  by  the  European  Commission,    (2)  OECD  Demographic  Drivers   and  (3)  Healthcare  Industry  Drivers.     There  are  many  variations  of  medication  adherence  systems  available  in  the  market.  These   adherence  systems  address  some  but  not  all  of  the  issues  surrounding  medication  compliance.   The  FemtoTools  PMU  does  not  have  any  serious  challenger  in  the  market  because  it  embodies  a   state  of  the  art  design  for  enforcing  drug  adherence.  The  PMU  measures  drug  consumption  via  a   capacitive  weight  sensor  fixed  on  a  state  of  the  art  apparatus.  The  PMU  can  be  used  straight  out   of  the  box,  as  it  does  not  need  an  expert  an  expert  caregiver  to  load  medicines  into  the  PMU.  The   PMU  snaps  on  to  a  standard  33mm  drug  enclosure  and  provides  the  means  to  calibrate  the  drug   dose  electronically.  At  the  medication  time,  the  PMU  alerts  the  patient  to  consume  the   medication  via  visual/audio  cues  and  records  a  missed  dose  if  the  patient  did  not  respond  to  the   medication  alerts.  The  drug  consumption  records  are  shared  with  the  patient’s  caregivers  so   that  appropriate  action  can  be  taken.  Compared  to  the  FemtoTools  PMU,  all  the  other  medication   compliance  devices  are  either  too  bulky  or  too  rudimentary  to  serve  any  purpose.     Hundreds  of  patents  for  medication  compliance  devices  have  been  filed.  Among  these,  some   patents  have  discussed  the  idea  of  using  weight  sensors  to  measure  drug  consumption.  We   analyzed  three  patents  in  detail  (USPTO  #6,294,999,  USPTO  #7,928,835  and  USPTO  #8,069,056)   to  establish  whether  there  was  any  overlap  in  the  method  we’re  using  to  measure  drug   consumption  versus  the  method  being  used  by  any  of  these  patents.  Fortunately,  we  did  not   come  across  any  claim  that  could  impinge  on  our  patent.  The  FemtoTools  PMU  design  is  unique   in  the  class  of  drug  compliance  devices.  It  is  the  only  portable  design  that  can  measure  drug   consumption  in  real  time  via  its  high-­‐resolution  capacitive  weight  sensor.  All  other  designs  are   either  non-­‐portable  and/or  cannot  measure  drug  consumption  in  real  time.     The  full  market  exploitation  and  utilization  of  PHS  requires  certification  processes  ensuring   stakeholders  that  their  requirements  on  critical  issues  such  as  patient  safety,  high  quality   services  and  interoperability  are  satisfied.  Individual  components  such  as  devices  (sensors,   medical  devices,  user  interaction  devices)  and  software  (communications,  DSS,  UI)  should   adhere  to  respective  industry  standards  and  should  be  certified  accordingly.  The  European   Coordination  Committee  of  the  Radiological,  Electromedical  and  Healthcare  IT  Industry  (COCIR)  
  7. 7. Executive  Summary FemtoTools Market for Portable Medication Compliance Devices 2       has  reported  on  certification  expectations  of  primary  and  secondary  stakeholders  for  Health  IT   products.  Healthcare  professionals  and  vendors  have  also  provided  their  expectations  for   certification  for  PHS  offering  health  monitoring  and  disease  management  applications.     FDA  and  CE  certification  are  prerequisites  for  marketing  PHS  products  in  the  U.S.  and  Europe   respectively.  These  certifications  address  safety  issues  for  both  medical  devices  and  software.   Additionally,  Continua  Design  Guidelines  are  recommended  to  ensure  interoperability  of   devices.  There  is  big  need  for  clinical  validation  standards  addressing  the  quality  of  medical   devices  as  well  as  the  interpretation  of  measurements  produced  by  intelligent  processing   modules.  Interoperability  advances  beyond  interconnection  of  devices  to  aspects  such  as   standardization  of  objective  and  subjective  measurements,  and  guidance  for  development  of   interoperable  applications  such  as  behavior  management  and  patient  empowerment.     Although  PHS  devices  have  tremendous  potential  in  improving  the  quality  of  medical  services,   the  uptake  of  these  devices  has  been  very  slow  till  now.  PHS  have  failed  to  gain  ground  even   though  most  of  the  technological  hurdles  in  their  development  have  been  overcome  for  several   years  now.  The  principal  reasons  for  the  slow  uptake  of  PHS  devices  include:  cost,  complexity,   privacy,  perception,  interoperability  and  scalability.    While  there  are  good  reasons  for  the  slow   uptake  of  these  devices,  there  are  better  reasons  why  these  forces  will  not  be  able  to  constrain   the  drive  towards  development  and  deployment  of  PHS  devices.  By  strengthening  the  user  base,   achieving  regulatory  support,  increasing  government  involvement  and  increasing  physician   acceptance  all  of  these  barriers  can  be  overcome.          
  8. 8. Introduction FemtoTools Market for Portable Medication Compliance Devices 3       2 Introduction   Poor  medication  compliance  is  one  of  the  leading  reasons  for  spiraling  health  costs  and   premature  death  among  the  elderly.  The  New  England  Healthcare  Institute  reported  in  its  2009   publication  “Thinking  Outside  the  Pillbox”  that  non-­‐adherence  with  suboptimal  prescribing,   drug  administration,  and  diagnosis  results  in  as  much  as  $290  billion  per  year  in  avoidable   medical  spending  or  13  percent  of  total  U.S.  healthcare  expenditures.  The  latest  Drug  Trend   Report  by  Express  Scripts  (a  leading  Pharmacy  Benefits  Manager  in  the  U.S.)  estimates  that  the   loss  due  to  non-­‐adherence  increased  to  US$  317  billion  in  2011.  The  cost  of  drug  non-­‐adherence   in  Europe  has  not  been  published  as  widely.  But  a  recent  report  by  the  Friends  of  Europe   indicated  that  that  non-­‐adherence  to  medication  contributed  to  the  premature  death  of  200,000   people  and  cost  €125  billion  in  2009.     The  World  Health  Organization  (WHO)  estimates  that  only  50  percent  of  patients  follow  their   doctor's  prescription.  Further,  WHO  estimates  that  this  figure  goes  down  to  25  percent  for   elderly  patients  who  are  at  the  maximum  risk  of  death  and  disability  due  to  medication  non-­‐ compliance.  Poor  medication  compliance  is  attributed  to  many  reasons.  The  most  common  ones   are  as  follows:     • High  cost  of  medication   • Unpleasant  side  effects  of  medicines   • Forgetfulness  in  taking  medicines   • Difficulty  in  reordering  of  medicines   • Poor  visibility  on  the  benefits  of  treatment  to  the  healthcare  provider   • Mix-­‐up  of  different  medicines     An  improvement  in  drug  adherence  can  help  everybody  touched  by  the  healthcare  industry.   Pharmaceutical  companies  can  gain  up  to  36%  in  extra  sales  by  improved  adherence  only.  In   addition,  every  time  a  patient  benefits  from  adhering  to  a  drug  regime,  the  pharmaceutical   company  gains  in  equity  from  the  goodwill  expressed  by  the  patient  and  the  healthcare  provider.   Adherence  to  drug  regime  helps  in  keeping  both  public  and  private  health  spending  under   control.  A  National  Bureau  of  Economic  Research  (NBER)  paper  “Does  Prescription  Drug   Adherence  reduce  Hospitalizations  and  Costs”  reports  that  increasing  diabetic  drug  adherence   from  50%  to  100%  reduced  the  hospital  admissions  by  23.3%  and  emergency  admissions  by   46.2%.  In-­‐patient  care  typically  cost  US$  2,000/visit  and  emergency  care  typically  cost  US$   5,000/visit.  Any  reduction  in  hospitalization  and/or  emergency  admission  amounts  to   significant  savings  in  healthcare.       The  government  and  the  healthcare  industry  have  responded  to  the  challenge  of  non-­‐adherence   in  bits  and  pieces,  but  never  in  a  concerted  manner.  Most  of  the  medication  compliance  devices   available  in  the  market  are  either  too  large  or  bulky  to  be  carried  around  by  a  mobile  worker  or   too  rudimentary  to  serve  its  intended  purpose.  Even  the  latest  (2010)  patents  on  medication   compliance  devices,  such  as  patent  #7828147  awarded  to  Inrange  Systems  for  Electronic   Medication  Management  Assistant  (EMMA)  have  resisted  the  transition  to  hand-­‐held   apparatuses,  which  can  be  used  by  mobile  workers.     Against  this  backdrop,  the  FemtoTools  Portable  Medication  Unit  (PMU)  represents  a  quantum   jump  in  the  technology  of  medication  compliance.  If  we  compare  the  Inrange  EMMA  to  the   FemtoTools  PMU,  we  find  that  EMMA  is  like  the  IBM-­‐360  computer  and  the  FemtoTools  PMU  is   like  the  IPad.  While  both  apparatuses  achieve  medication  compliance  by  alerting  the  patient  to   take  medicines  at  the  appropriate  time,  the  PMU  achieves  medication  compliance  in  a  form  
  9. 9. Introduction FemtoTools Market for Portable Medication Compliance Devices 4       factor  tens  of  times  smaller  than  EMMA  and  also  provides  a  framework  for  extending  the   capabilities  of  the  device.     The  FemtoTools  PMU  is  a  portable  medication  compliance  device  that  monitors  medicine   consumption  through  a  weight  sensor  featuring  sub-­‐milliNewton  resolution.  The  PMU  alerts  the   patient  to  take  medication  at  the  prescribed  time  through  visual  /  audio  cues  and  by  triggering  a   telephonic  reminder  if  the  patient  did  not  respond  to  the  earlier  alerts.  Each  time  the  patient   removes  the  medication  for  consumption,  the  high-­‐resolution  weight  sensor  computes  the   remaining  drug  in  the  medication  container  (e.g.  pill  bottle,  vial  box,  pill  organizer).  If  the  patient   removes  more  than  the  prescribed  medication,  the  PMU  alerts  the  patient  to  an  overdose.  If  the   patient  removes  less  than  the  prescribed  medicine,  the  PMU  alerts  the  patient  to  an  underdose.   Thus,  the  PMU  ensures  that  the  patient  is  adhering  to  the  medication  regime  prescribed  by  its   healthcare  provider.     The  PMU  is  not  limited  in  capability  to  medication  alerts  only.  Since  it  measures  drug   consumption  in  real  time,  the  PMU  sends  a  reorder  request  to  the  nearest  pharmacy  before  the   medications  run  out.  The  PMU  also  compiles  and  shares  the  patient’s  medication  compliance   reports  with  the  healthcare  providers  and  caregivers.     Measuring  drug  compliance  with  the  FemtoTools  PMU  is  very  easy.  You  can  either  snap  a   standard  33mm  drug  enclosure  via  the  FemtoTools  PMU  clamp  or  you  can  insert  the  drug   enclosure  into  the  FemtoTools  PMU  enclosure.  Since  the  FemtoTools  PMU  does  not  require  the   patient  to  transfer  drug  from  the  original  container  to  the  monitored  container,  there  is  no   chance  of  a  medication  mixup.  The  PMU  has  a  RFID  reader  and  a  Barcode  reader  to  read  the   drug  manufacturer’s  information  embedded  in  the  medication  container.       To  save  the  planned  medication  doses  and  consumption  times,  the  system  control  electronics   includes  a  timer  and  a  memory  such  as  an  EEPROM.  The  memory  can  be  programmed  using  the   wireless  transmitter.  Alternatively,  the  planned  medication  doses  and  consumption  times  can  be   saved  on  a  memory  card  (e.g.  flash-­‐cards,  SD-­‐cards)  that  can  be  inserted  into  the  memory  card   reader  of  the  portable  system.  The  EEPROM  or  memory  card  may  be  used  to  save  statistics   about  the  drug  consumption,  which  helps  the  doctor  to  optimize  the  treatment  of  the  patient.   Wireless  communication  using  the  wireless  transmitter  can  be  used  to  program  the  EEPROM  or   memory  card  as  well.     The  transition  to  portable  medication  compliance  devices  is  a  necessity  due  to  the  fact  that  many   chronic  diseases  such  as  type-­‐2  diabetes  are  striking  population  at  a  much  earlier  age  than   before.  The  2012  International  Diabetes  Federation  (IDF)  Diabetes  Atlas  shows  that  in  2011   there  were  40  million  confirmed  diabetes  patients  of  age  20-­‐59  years  in  30  OECD  countries   (Table  15).    IDF  is  predicting  that  this  figure  will  go  up  to  44  million  patients  in  the  same  age   group  by  2030  (Table  16).  Unless  steps  are  taken  both  to  prevent  and  manage  chronic  diseases   through  monitoring  and  regular  medication,  it  is  certain  to  overwhelm  the  healthcare  budgets  of   all  OECD  countries.  Portable  medication  compliance  devices  like  the  FemtoTools  PMU  have  the   potential  to  improve  the  quality  of  life  of  millions  of  people  with  chronic  diseases  by  connecting   them  with  the  pharmacy  and  the  healthcare  providers  in  a  closed  loop.  By  periodically   reminding  the  patient  to  consume  its  medications  and  warning  against  any   overdose/underdose,  the  PMU  can  improve  the  prognosis  of  patients  on  regular  medication.
  10. 10. Competition FemtoTools Market for Portable Medication Compliance Devices 22       4 Competition   There  are  many  variations  of  medication  adherence  systems  available  in  the  market.  These   adherence  systems  address  some  but  not  all  of  the  issues  surrounding  medication  compliance.   Additionally,  many  medication  adherence  systems  have  been  invented  but  not  commercialized   yet.     The  FemtoTools  PMU  design  does  not  have  any  serious  challenger  in  the  market  as  of  now.    We   can  say  this  confidently  because  of  the  following  reasons:     1. The  current  generation  of  medication  compliance  systems  is  mostly  designed  for  retired   people  (above  65  years)  who  do  not  maintain  an  active  life  outside  their  homes.  The  current   systems  can  alert  the  patient  to  take  medication  only  when  they're  in  close  proximity  of  the   medication  container.  They  don't  address  patients  with  a  mobile  lifestyle  such  as  working   professionals  who  take  daily  medication  but  also  go  to  the  office  5  days  a  week.     2. Many  of  these  compliance  systems  are  very  bulky  and  need  assistance  from  an  expert   caregiver  to  calibrate  the  device  for  dispensing  the  appropriate  medicine  dose  and  alert  the   patient  to  consume  its  medication  at  the  prescribed  time.  Most  of  the  existing  systems   cannot  be  used  in  combination  with  the  original  drug  container  provided  by  the  Pharmacy  or   Doctor.  The  drugs  have  to  be  transferred  into  the  medication  compliance  system,  which  is  a   source  of  error  since  the  label  (name  of  the  drug,  dosage,  expiration  date)  of  the  original   container  is  not  transferred  during  that  process.  This  results  in  the  danger  that  the  patient  is   accidentally  taking  incorrect  medicine  or  incorrect  dosage.     3. None  of  the  existing  compliance  systems  are  capable  of  unambiguously  measuring  drug   removal  from  the  medication  container.  Existing  systems  measure  drug  removal  based  on   the  number  of  times  a  medication  container  was  opened  and  closed.  This  mechanism   triggers  false  alarms  and  is  unable  to  either  prevent  an  accidental  drug  underdose  or  drug   overdose.       4. None  of  the  existing  compliance  systems  can  automatically  issue  a  medication  reorder   request  before  the  medicines  run  out  of  stock.  Since  the  existing  compliance  systems  cannot   measure  drug  removal  via  a  weight  sensor,  it  measures  drug  consumption  based  on  the   number  of  times  a  medication  container  was  opened.  When  the  open  and  close  counter   reaches  a  specified  maximum,  a  drug  reorder  request  is  issued  to  the  pharmacy.   Alternatively,  the  compliance  system  provides  a  manual  process  to  initiate  drug  reorder  by   pressing  a  push  button  at  the  underside  of  the  medication  compliance  device.     5. None  of  the  existing  systems  are  capable  of  interacting  with  Vital  Signs  Monitors,  Smart   Cards  or  the  EMR  (Electronic  Medical  Records)  Cloud  Gateway  to  provide  better  visibility  on   the  patient’s  health  record  to  the  healthcare  providers  and  medical  researchers.     4.1 Existing  Products   PHS  devices  usually  span  across  three  sites  as  illustrated  in  Figure  2.  At  the  remote  patient   environment,  sensor  devices  record  vital  signals  together  with  other  context  information  that   are  transmitted  to  user  interaction  devices.  User  interaction  devices  (smart  phones,  PCs,  TV  set-­‐ top-­‐boxes,  standard  phones)  and  Storage  Server  host  patient-­‐friendly  applications  that  support   the  users  for  their  daily  disease  management.  They  also  provide  communication  software  that   transmits  the  collected  data  to  a  backend  server  at  a  medical  center.  The  medical  center  also  
  11. 11. Competition FemtoTools Market for Portable Medication Compliance Devices 23       hosts  clinical  applications  that  enable  healthcare  professionals  to  review  the  data  provided  by   patients.       Figure  2:  Overview  of  Personal  Health  System  (PHS)       Data  processing  occurs  either  at  the  site  of  acquisition  (e.g.  with  on-­‐body  electronics)  or  at  the   medical  centre.  The  processed  and  analyzed  data  are  then  communicated  between  various   actors,  in  a  loop  that  is  from  patient/individual  to  medical  centre,  from  medical  centre  that   analyzes  the  acquired  data  to  doctor/hospital  and  then  and  back  to  the  patient/individual  from   either  directly  through  the  data  acquisition  and/or  data  processing  systems  itself  or  through  the   doctor  or  the  medical  centre  (e.g.  in  the  form  of  personalized  feedback  and  guidance  to  the   patient,  adjusted  treatment  via  closed  loop  therapy,  control  of  therapy  devices).     In  the  following  section,  we  describe  five  products  that  embody  some  of  the  principles  of  PHS   devices  and  share  the  same  domain  space  as  the  FemtoTools  PMU.  At  the  end  of  the  section,  we   compare  the  FemtoTools  PMU  against  the  five  products.  The  five  medication  compliance   systems  described  are  as  follows:     • Vitality  GlowCaps   • Philips  MD   • Healthonemed  DAP   • MedSmart  MD2   • Medsignals  
  12. 12. Competition FemtoTools Market for Portable Medication Compliance Devices 24       4.1.1 Vitality  GlowCaps   GlowCaps  by  Vitality  is  a  screw-­‐on  cap  for  a  standard  33mm  drug  enclosure.  The  cap  has  a  multi-­‐ color  LED  for  signaling  a  medication  reminder,  a  sensor  for  measuring  the  open-­‐close  cycles  of   the  cap  and  transmitter  to  transmit  the  open-­‐close  data  to  a  router/hub  that  is  connected  to  a   back  office.  The  cap  also  has  a  push  button  at  its  underside  that  can  be  pushed  to  reorder   medication  from  a  pharmacy.       4.1.1.1 Operation   GlowCaps  are  programmed  via  a  home  computer  to  send  pill  reminder  alerts  to  the  patient.  The   system  works  by  flashing  a  light  on  the  GlowCaps  at  the  pill  time.  If  the  pill  bottle  is  not  opened   within  the  next  half-­‐hour  of  pill  time,  a  three-­‐tone  alert  and  then  a  five-­‐tone  alert  is  sounded.  If   the  bottle  is  still  not  opened,  the  system  makes  an  automated  reminder  phone  call  to  the  patient   or  a  caregiver.  The  GlowCaps  system  compiles  adherence  data  that  anyone  can  be  authorized  to   track.       GlowCaps  can  send  a  pill  order  request  to  the  pharmacy  automatically  or  via  the  push  button   under  the  GlowCap.  The  GlowCaps  ecosystem  records  the  number  of  times  the  patient  opens  a   drug  container.  When  the  open-­‐close  cycle  reaches  a  specified  maximum,  the  ecosystem  sends  a   drug  reorder  request  to  the  nearest  pharmacy  selected  by  the  patient.   4.1.1.2 Cost  of  Acquisition  (Buy)   S.No.   Particulars   Fixed   Cost   (US$)   Monthly   Recurring   Cost  (US$)   Cost  over   2  Yrs   (US$)   1   Modem,  Night  Lamp,  and  2  Glowcaps   99   0   99   2   Additional  Glowcaps  (2  Nos)   20   0   20   3   Missed  Dose  Reminders   4   Compliance  Monitoring  and  Reporting   0   15   360       Total  Operational  Cost  over  2  Years       479   Note:  Item  #3  and  #4  are  typically  charged  for  monitoring  3  Glowcaps  although  we've  assumed  the  same   expense  for  4  Glowcaps.  If  the  patient  is  taking  >  3  different  medications,  the  monitoring  fee  will   correspondingly  increase.  
  13. 13. Competition FemtoTools Market for Portable Medication Compliance Devices 25       4.1.1.3 Pros   The  GlowCaps  medication  compliance  device  is  portable  and  also  precludes  any  medication  mix-­‐ up  because  the  patient  only  replaces  the  original  drug  container  cap  with  GlowCaps  to  get  the   system  operational.  GlowCaps  is  also  economical  to  use.  A  patient  using  4  GlowCaps  runs  a  bill  of   only  US$479  to  achieve  medication  compliance  for  2  yrs.   4.1.1.4 Cons   Although  GlowCaps  is  portable,  its  alerting  mechanism  is  useful  only  when  you’re  in  close   proximity  of  the  GlowCaps  medication  compliance  system.  GlowCaps  reminds  patients  to   consume  their  medication  through  a  night  lamp/modem  that  is  linked  to  the  AT&T   telecommunication  infrastructure  through  a  wired  connection.  The  telephonic  reminder  and   automatic  drug  reorder  works  only  when  the  GlowCaps  fitted  medication  container  is  located  in   close  proximity  of  the  night  lamp/modem  that  receives  the  open-­‐close  data  from  the  GlowCaps   container  and  transmits  this  information  to  a  back  office  for  processing.     The  GlowCaps  mechanism  of  measuring  drug  consumption  is  also  error  prone  and  simply   incapable  of  measuring  a  drug  overdose  or  drug  underdose.  It  is  a  known  fact  that  drug   overdose  is  a  serious  issue.  The  Center  for  Disease  Control  estimates  that  accidental  overdose  of   painkillers  killed  14,800  patients  in  the  U.S.  in  2008.   4.1.1.5 Distribution  Channel   GlowCaps  is  retailed  by  the  leading  PBMs  (Pharmacy  Benefits  Managers):  Express  Scripts  and   Apothecary  Shop.  PBMs  act  as  an  intermediary  between  the  payer  and  everyone  else  in  the   healthcare  system.  They  generally  make  money  through  service  fees  from  large  customer   contracts  for  processing  prescriptions,  operating  mail-­‐order  pharmacies,  and  negotiating  with   pharmacies  and  drug  makers.  Their  contracts  can  include  incentives  for  cutting  costs.  Some  of   that  savings  gets  passed  on  to  customers  and  some  of  that  become  their  earnings.  PBMs  are   increasingly  moving  away  from  being  just  administrators  and  working  to  offer  new  services  that   can  help  save  their  clients  money.  These  include  increasing  patient  compliance  with  taking   prescribed  drugs,  helping  better  manage  drug  formulations,  and  aiding  drug-­‐related  decisions   with  the  use  of  diagnostics  and  comparative  effectiveness.       There  are  also  Internet  reports  that  Vitality  has  partnered  with  four  pharmaceutical   manufacturers  to  distribute  their  product.  Browsing  on  the  Internet,  we  discovered  that  Vitality   has  partnered  with  Novartis  to  improve  the  adherence  of  their  speciality  drugs  Glivec  and   Tasigna,  which  treat  Chronic  Myeloid  Leukemia  (CML)  and  Gastrointestinal  Stromal  Tumors   (GST)  respectively.  We  also  discovered  that  Vitality  has  partnered  with  Pfizer  to  improve  the   adherence  of  their  cholesterol-­‐lowering  drug  Lipitor.        
  14. 14. Competition FemtoTools Market for Portable Medication Compliance Devices 26       4.1.2 Philips  MD2   The  Philips  MD2  medication  dispenser  (PMD)  is  sold  as  a  part  of  the  Philips  Lifeline  product.   PMD  is  a  reliable  and  easy  to  use  medication  dispensing  system  that  fits  on  a  kitchen  counter   top.  It  is  perfect  for  adults  who  take  multiple  medications  or  who  have  difficulty  remembering  to   take  medications  as  prescribed.  The  PMD  offers  these  patients  peace  of  mind,  convenience,   flexibility,  control  and  value.  It  holds  10-­‐40  days  of  medications  in  pre-­‐filled  dosage  cups  and  can   dispense  up  to  6  times  per  day.         The  PMD  system  consists  of  six  main  components:     1. Medication  Cups:  Medication  cups  are  reusable  containers  to  store  pills.  Each  reusable  cup   can  store  20-­‐25  pills  and  as  many  as  six  cups/doses  can  be  delivered  per  day.  The  number  of   days  that  can  be  loaded  into  the  PMD  depends  on  the  number  of  doses  taken  per  day.  For   example,  if  a  patient  consumes  3  doses  per  day,  20  days’  of  medication  can  be  loaded  into  the   dispenser.   2. Dispensing  Button:  The  dispensing  button  is  prominently  located  at  the  front  of  the  device.  It   is  conveniently  oversized  and  requires  a  gentle  push  for  triggering  a  dose.   3. Medication  Reminders:  PMD  provides  medication  reminders  by  sounding  an  audible  alert   via  a  built-­‐in  speaker.  It  can  also  initiate  a  telephonic  reminder  by  sending  a  missed  dose  to  a   back  office  for  processing.   4. Locking  Storage  Compartment:  The  PMD  medication  storage  compartment  is  located  in  a   locking  compartment.  The  locking  compartment  keeps  the  medication  safe  and  in  order.  It   can  be  preloaded  with  a  maximum  of  60  medication  cups.   5. Keypad:  The  keypad  is  located  in  the  locking  compartment  to  prevent  accidental  changes  or   tampering.  It  is  used  to  calibrate  the  dosage  and  reminder  service  in  the  device.   6. Battery  Backup:  The  rechargeable  battery  can  keep  the  PMD  operational  for  up  to  18  hrs   during  a  power  outage.    
  15. 15. Competition FemtoTools Market for Portable Medication Compliance Devices 27       4.1.2.1 Operation   The  PMD  dispenses  medications  in  pre-­‐filled  medication  cups  at  a  dispensing  schedule  chosen   by  the  patient.  The  medication  cups  are  manually  filled  with  medicines  either  by  the  caregiver  or   by  the  patient.  A  loading  tray  (included  in  the  package)  is  used  to  line  up  empty  medication  cups   and  then  fill  them  with  the  appropriate  medication.  The  filled  medication  cups  are  subsequently   loaded  into  the  PMD  storage  compartment.  Finally,  the  medication  dosage  time  is  scheduled  via   the  keypad  located  in  the  storage  compartment.         When  it’s  time  for  medications,  the  dispenser  provides  audible  reminders.  At  the  push  of  the   dispensing  button,  medication  is  dispensed  in  the  medication  cup.  If  a  dosage  is  missed,  the   dispenser  can  trigger  a  telephonic  alert  to  the  patient’s  family  and  caregivers.     4.1.2.2 Cost  of  Acquisition  (Buy)   S.No.   Component   Fixed   Cost   (US$)   Monthly   Recurring   Cost  (US$)   Cost  over   2  Yrs   (US$)   1   Dispenser   $845   0   845   2   Installation   $50   0   50   3   Blank  Cartridges  /  Cups  (pack  of  200)     $40   600   4   Missed  Dose  Reminders     0   0   5   Compliance  Monitoring  and  Reporting     $30   720   6   Emergency  Alert     $38   912       Total  Operational  Cost  over  2  Years       3,127   4.1.2.3 Cost  of  Acquisition  (Lease)   S.No.   Component   Fixed   Cost   (US$)   Recurring   Cost  (US$)   Cost  over   2  Yrs   (US$)   1   Dispenser   0   75   1,800   2   Installation   50   0   50   3   Blank  Cartridges  /  Cups  (pack  of  200)     40   600   4   Missed  Dose  Reminders     0   0   5   Compliance  Monitoring  and  Reporting     30   720   6   Emergency  Alert     38   912       Total  Operational  Cost  over  2  Years       4,082   Note:   1.  Cost  of  cartridges  /  cups  have  been  computed  assuming  the  patient  draws  4  cups  a  day,  thereby   consuming  200  cups  in  50  days  or  3000  cups  in  2  years.     2.  In  the  lease  scheme,  item  #  1,  5,  and  6  are  billed  monthly.     4.1.2.4 Pros   The  PMD  is  a  robust  medication  compliance  device  for  people  taking  multiple  medications.  More   than  700,000  patients  in  the  U.S.  and  Canada  subscribe  to  Lifeline  services.    PMD  is  backed  by   Philips  Healthcare,  which  is  one  of  the  leading  companies  in  the  healthcare  business.  Philips   Healthcare  recorded  sales  of  €8.9  billion  in  2011.  The  PMD  is  also  supported  by  trained   personnel  who  are  accessible  by  phone  24  hours  a  day  to  answer  questions  and  assist  in   calibrating  the  device.      
  16. 16. Competition FemtoTools Market for Portable Medication Compliance Devices 28       4.1.2.5 Cons   PMD  has  two  major  drawbacks  because  of  which  this  device  has  very  limited  usefulness.  The   first  major  drawback  is  that  the  product  is  not  portable  by  any  measure.  The  device  measures   13”  x  12”  x  14”  in  size  and  12  lbs  in  weight.  Additionally,  the  device  is  very  power  hungry  as  it   consumes  8  watts/hr.       The  second  major  drawback  of  this  product  is  that  it  has  a  highly  error  prone  method  of   calibrating  the  medication  dose  of  the  patient.  Since  the  reusable  medication  cups  are  manually   filled  by  transferring  the  medication  from  their  original  packing  to  the  medication  cups,  there  is   a  big  chance  of  medication  mix-­‐up  in  the  transferring  process.       Other  drawbacks  of  this  device  include  the  fact  that  it  is  very  expensive  (costs  US$  3,127  to  buy   and  US$  4,082  to  lease)  to  run  and  also  it  needs  a  landline  telecommunications  link  to  provide   missed  dose  reminders.   4.1.2.6 Distribution  Channel   Philips  sells  the  PMD  dispenser  as  a  part  of  the  Lifeline  services.  The  Lifeline  services  are  offered   by  more  than  2,500  health  care  and  community  organizations  in  the  U.S.  and  Canada.  It  is  also   distributed  through  the  American  Red  Cross.  The  following  table  lists  some  of  the  Lifeline   channel  partners  in  the  U.S.  and  Canada.     Table  1:  Philips  Lifeline  Channel  Partners  in  the  U.S.  and  Canada   S.No.   Channel  Type   Company/Organization   Region   Country   1   Charitable  Hospital   Montefiore   U.S.   United  States   2   Healthcare  Facilitator   Caregiver  Partnership   U.S.   United  States   3   Healthcare  Facilitator   Delta  Health  Technologies   U.S.   United  States   4   Healthcare  Facilitator   Medicalert  Foundation   U.S.   United  States   5   Mainstream  Hospital   Palomar  Health   U.S.   United  States   6   Mainstream  Hospital   Northwestern  Memorial   Hospital   U.S.   United  States   7   Retirement  Community   Assured  Life  Association   U.S.   United  States   8   Retirement  Community   Red  Cross   U.S.   United  States   9   Seniors  Homecare  Provider   Wellawaresystems   U.S.   United  States   10   Seniors  Homecare  Provider   Visiting  Nurse  Association   of  America   U.S.   United  States   11   Seniors  Homecare  Provider   Homeinstead   U.S.   United  States   12   Mainstream  Hospital   Victoria  General  Hospital   Canada   Canada   13   Mainstream  Hospital   St.  Joseph's  Health  Center   Canada   Canada   14   Veterans  Health  Affairs   Royal  Canadian  Legion   Canada   Canada                    
  17. 17. Competition FemtoTools Market for Portable Medication Compliance Devices 29       4.1.3 Healthonemed  DAP   The  Healthonemed  Dispense-­‐a-­‐Pill  (DAP)  medication  compliance  device  is  very  similar  in  design   to  the  Philips  MD2.  This  device  weighs  10lbs  and  easily  fits  on  top  of  a  kitchen  counter.  The  DAP   device  can  store  90-­‐day  medicine  supply  of  up  to  8  different  types  of  medication.  The  device  can   be  programmed  to  alert  the  patient  to  consume  medication  at  the  prescribed  time.  It  can  also   initiate  a  telephone  reminder  when  the  audio/visual  alerts  have  failed  to  have  the  desired  effect.         4.1.3.1 Operation   The  DAP  device  contains  8  separate  chambers  for  storing  medicines.  These  chambers  are  loaded   with  medicines  at  the  start  of  a  monitoring  cycle.  When  it’s  time  for  medication,  DAP  alerts  the   patient  to  press  the  dispensing  button  to  receive  the  correct  medication  dose.  The  DAP  uses   patented  dispensing  technology  (USPTO  #  7,213,721)  to  sort  the  correct  number  of  pills  for  each   dose  of  each  medication.  The  dispensing  system  selects  the  correct  medicine  from  each  medicine   chamber  and  places  them  into  a  dispensing  cup  for  consumption.       The  DAP  plugs  into  the  household  electricity  and  is  intended  to  be  run  on  household  electricity.   If  there  is  a  power  outage,  the  system  reverts  to  a  battery  backup  that  can  last  up  to  24  hrs   depending  on  usage.  For  missed  dose  reminders,  the  DAP  device  needs  a  landline   telecommunication  link  so  that  a  telephonic  reminder  can  be  sent  to  the  patient.     The  DAP  device  can  dispense  medicine  pills.  For  other  types  of  medicines  like  liquids,  injections   and  topical  creams,  the  patient  can  set  up  reminders.  These  reminders  are  triggered  just  like  pill   reminders.                
  18. 18. Competition FemtoTools Market for Portable Medication Compliance Devices 30       4.1.3.2 Cost  of  Acquisition  (Buy)   S.No.   Component   Fixed   Cost   (US$)   Monthly   Recurring   Cost  (US$)   Cost  over   2  Yrs   (US$)   1   Dispenser  with  1yr  Warranty   995   0   995   2   Extended  Warranty  for  2  more  years   195   0   195   3   Missed  Dose  Reminders     0   0   4   Compliance  Monitoring  and  Reporting     0   0       Total  Operational  Cost  over  2  Years       1,190   4.1.3.3 Cost  of  Acquisition  (Lease)   S.No.   Component   Fixed   Cost   (US$)   Recurring   Cost  (US$)   Cost  over   2  Yrs   (US$)   1   Dispenser  with  1yr  Warranty   304   55   1,569   2   Extended  Warranty  for  2  more  years   195   0   195   3   Missed  Dose  Reminders     0   0   4   Compliance  Monitoring  and  Reporting     0   0       Total  Operational  Cost  over  2  Years       1,764   4.1.3.4 Pros   The  DAP  device  is  better  than  PMD  because  it  eliminates  the  burden  of  sorting  pills  into   individual  dosage  cups.  The  device  automatically  selects  the  correct  medicine  from  each  storage   chamber  and  places  them  into  a  dispensing  cup  for  consumption.  At  the  outset,  it  appears  that   the  device  is  also  cheaper  than  PMD.  However,  we  must  add  that  we  haven’t  been  able  to  confirm   that  the  reminder  and  monitoring  fee  is  embedded  in  the  cost  of  the  product.  If  the  reminder  and   monitoring  fee  is  separately  charged,  the  cost  of  acquisition  will  drastically  change.   4.1.3.5 Cons   The  DAP  device  shares  the  drawbacks  with  PMD.  The  device  measures  9.5”  x  8”  x  8.5”  in  size  and   weighs  10  lbs.  The  system  also  needs  a  landline  telecommunications  link  to  provide  missed  dose   reminders.  Both  these  attributes  make  the  device  unsuitable  for  a  mobile  patient.  The  DAP   device  is  also  very  new  in  the  market  and  the  company  selling  the  product  does  not  have  a  long   history  of  making  healthcare  products.  Consequently,  the  product  does  not  have  the  same   credibility  as  PMD.   4.1.3.6 Distribution  Channel   The  DAP  device  can  be  purchased  online  through  the  company's  website.  We  have  no   information  if  this  product  is  being  retailed  through  any  other  channel.  
  19. 19. Competition FemtoTools Market for Portable Medication Compliance Devices 31       4.1.4 MedSmart  MD2  Plus   MedSmart  MD2  Plus  is  a  user-­‐friendly  medication  compliance  device  that  organizes,  stores,   reminds  and  dispenses  pills  in  accordance  with  prescribed  regimens.  The  dispensing  unit   contains  a  circular  tray  that  has  cells  to  organize  and  store  medications  to  be  taken  from  1  to  6   times  per  day.  MedSmart  MD2  Plus  is  calibrated  through  a  programming  keypad  embedded  in   the  device.  The  device  can  remind  patients  to  take  their  pills  through  visual  and  audio  alarms.   When  it’s  medication  time,  the  device  plays  the  visual  and  audio  alerts  for  a  maximum  of  90   minutes.  The  visual  and  audio  alarms  are  turned  off  when  the  MedSmart  unit  is  turned  over  and   the  pills  are  dispensed.     MedSmart  MD2  Plus  can  transmit  dispensing  history  and  device  information  to  a  secure  website   via  the  Event  Reporting  Docking  Base  /  Modem.  It  can  also  trigger  telephonic  reminder  to  the   patient  when  a  dose  is  missed.  The  dispensing  history  can  be  accessed  by  authorized  individuals,   caregivers,  or  healthcare  professionals.         4.1.4.1 Operation   MedSmart  MD2  Plus  stores  medicines  in  a  circular  tray  that  has  cells  to  organize  medications  to   be  taken  from  1  to  6  times  per  day.  The  circular  tray  is  loaded  with  the  correct  medication  dose   by  lining  up  each  cell  against  a  guide  device  (loading  guide  disc).  Once  the  circular  tray  is  loaded   with  medication,  the  device  is  programmed  to  play  audio/visual  alerts  and  send  a  telephonic   reminder  when  the  alerts  haven’t  had  the  intended  effect.     At  the  medication  time,  MedSmart  MD2  Plus  "beeps"  and  then  rotates  to  open  a  compartment   revealing  the  correct  pills  to  take.  To  turn  off  the  "beeping",  the  patient  picks  up  the  dispenser   and  pours  out  the  pills.  The  pill  dispenser  then  automatically  resets  for  the  next  set  of   medications.      
  20. 20. Competition FemtoTools Market for Portable Medication Compliance Devices 32       4.1.4.2 Cost  of  Acquisition  (Buy)   S.No.   Particulars   Fixed   Cost   (US$)   Monthly   Recurring   Cost  (US$)   Cost  over   2  Yrs   (US$)   1   Dispenser  including  2  Medication  Trays   790   0   790   2   Additional  2  Medication  Trays   25     50   3   Missed  Dose  Reminders     0   0   4   Compliance  Monitoring  and  Reporting     0   0       Total  Operational  Cost  over  2  Years       840   Note:  Additional  Medication  Trays  have  been  added  to  factor  any  breakage  during  the  2-­year  period.   4.1.4.3 Pros   The  MedSmart  MD2  Plus  is  a  user-­‐friendly  compliance  device  for  people  taking  multiple   medications.  The  device  can  be  easily  loaded  with  the  prescribed  medication.  Programming  the   device  also  appears  to  be  a  simple  task.  Although  not  many  people  have  commented  on  the   product  on  Amazon,  the  available  reviews  suggest  that  the  people  are  happy  with  it.  MedSmart   MD2  Plus  is  also  considerably  cheaper  than  PMD  because  the  reminder  and  monitoring  fee  is   embedded  in  the  cost  of  the  product.   4.1.4.4 Cons   MedSmart  MD2  Plus  has  several  drawbacks  that  limit  its  usefulness.  The  first  major  drawback  is   that  the  product  is  not  portable.  MedSmart  MD2  Plus  needs  a  landline  telecommunications  link   to  provide  missed  dose  reminders.  Additionally,  the  device  is  fairly  large  in  size  (8  1/2”  x  2  1/2”)   and  weight  (793  gms)  to  be  carried  around  freely.     The  second  major  drawback  of  this  product  is  that  it  has  a  highly  error  prone  method  of   calibrating  the  medication  dose  of  the  patient.  To  calibrate  the  medicine  dose,  the  patient  or  the   caregiver  manually  loads  the  circular  medication  tray  with  the  medication  for  the  week/month.   This  process  introduces  a  big  chance  of  medication  mix-­‐up.   4.1.4.5 Distribution  Channel   MedSmart  MD2  Plus  can  be  purchased  online  from  epill.com  and  other  retailers  such  as   Amazon.com  and  medicalwatches.com.  We  have  no  information  if  this  product  is  being  retailed   through  any  other  channel.  
  21. 21. Competition FemtoTools Market for Portable Medication Compliance Devices 33       4.1.5 MedSignals   MedSignals  is  an  integrated  pill  reminder  system  that  alerts  the  patient  via  four  distinct  signals   (beep,  flashing  light,  voice,  and  text)  to  take  the  pill  at  pill  time.  The  device  automatically  detects   the  opening  of  the  pillbox  and  maintains  a  history  of  lid  openings  during  the  week.  MedSignals   provides  a  personalized  web  page  to  the  patient  and  authorized  health  providers  showing  the   patient's  monthly  pill  adherence.         4.1.5.1 Operation   The  MedSignals  multi-­‐function  dispenser  can  store  up  to  4  drugs  in  separate,  programmable   compartments,  each  with  associated  signals.  Each  compartment  has  an  associated  recessed   button  that  serves  two  purposes:  displaying  that  pill’s  relevant  information  on  the  LCD,  and   programming  the  compartment.  A  press  of  the  button  sequentially  announces  and  displays   usage  information  for  each  compartment:  (1)  time  since  last  lid  opening,  (2)  time  until  next   dose,  and  (3)  number  of  pills  taken  in  24  hours.     The  portable  device  rests  in  a  cradle,  which  allows  connection  through  its  adapter  to  electrical   power  and  by  telephone  line  to  a  host  server  plugged  to  the  user’s  phone.    The  patient’s   medication  dose  can  be  programmed  manually  through  the  buttons  of  each  medication   container  or  via  a  web  interface.     At  medication  time,  MedSignals  signals  a  beep  corresponding  to  the  number  of  pills  to  be  taken   and  flashes  an  LED  over  the  bin  containing  the  drug  that  the  patient  needs  to  take.  Subsequently,   a  text  message  is  displayed  on  the  unit’s  LCD  screen  indicating  how  many  pills  to  take  and  what   instruction  or  warning  to  heed.  If  the  time  isn’t  convenient,  the  patient  can  press  the  Snooze   button  for  a  30-­‐minute  delay.  Or,  if  the  patient  wishes  to  skip  the  dose,  it  can  press  the  Snooze   button  twice  to  silence  it  until  the  next  scheduled  dose.       Each  time  the  patient  opens  the  lid  of  the  medicine  compartment,  the  time  is  recorded  in   memory.  The  device  subsequently  auto-­‐dials  a  toll-­‐free  number  to  upload  the  patient’s  usage   data  to  the  database  where  it  is  captured  in  the  patient’s  secured  record.  MedSignals  can  upload   the  patient’s  pill  consumption  data  immediately  or  at  a  scheduled  interval  based  on  the   monitoring  scheme  selected  by  the  patient.     The  device  can  also  be  removed  from  its  cradle  and  taken  away.  During  this  time,  the  unit  runs   on  its  battery  power  and  records  the  pill  removal  times  in  its  memory.  
  22. 22. Competition FemtoTools Market for Portable Medication Compliance Devices 34       When  the  device  is  returned  to  the  cradle,  the  device  makes  contact  with  sensors  that   automatically  begin  recharging  the  batteries  and  detecting  a  phone  line.  It  then  auto-­‐dials  a  pre-­‐ programmed  1-­‐800  number  to  transmit  lid  opening  records  to  the  secured  database,  based  on   the  chosen  upload  frequency.   4.1.5.2 Cost  of  Acquisition  (Buy)   S.No.   Component   Fixed   Cost   (US$)   Monthly   Recurring   Cost  (US$)   Cost  over   2  Yrs   (US$)   1   Dispenser   200   0   200   2   Setup   0       3   Daily  Missed  Dose  Reminders     15   360   4   Compliance  Monitoring  and  Reporting     0   0       Total  Operational  Cost  over  2  Years       560   4.1.5.3 Cost  of  Acquisition  (Lease)   S.No.   Component   Fixed   Cost   (US$)   Recurring   Cost  (US$)   Cost  over   2  Yrs   (US$)   1   Dispenser   0   29   348   2   Setup   50   0   50   3   Daily  Missed  Dose  Reminders   0   15   360   4   Compliance  Monitoring  and  Reporting     0   0       Total  Operational  Cost  over  2  Years       758   Note:   1.  When  the  unit  is  leased,  the  cost  of  the  Dispenser  is  amortized  over  1  year  @  $29  /  month.     2.  When  the  unit  is  leased,  there  is  a  one-­‐time  setup  fee  of  US$  50.   3.  Scheduled  monitoring  costs  US$15  /month.  Immediate  monitoring  costs  US$  30/month.     4.1.5.4 Pros   MedSignals  is  a  sleek  and  portable  medication  compliance  device.  It  measures  5"  x  3"  x  1"  and   easily  fits  into  most  purses  or  pockets.  The  unit’s  large  bins  can  store  up  to  a  month’s  supply  of   small  tablets  and  as  much  as  a  week  of  large  ones.  The  device  can  monitor  4  different  drugs.     Among  all  the  devices  reviewed,  only  MedSignals  has  implemented  a  wireless  (Bluetooth)   interface  to  collect  data  from  vital  signs  monitors,  thus  allowing  it  to  work  as  a  hub.  MedSignals   consolidates  the  data  on  the  patient’s  medication  behavior  and  the  data  from  vital  signs   monitors.  It  then  compiles  a  set  of  integrated  charts  where  patients  and  caregivers  can  view   readings  from  blood  pressure  monitors,  glucose  meters,  and  precision  weight  scales  in   relationship  to  each  other  and  to  the  patient’s  medication  records.   4.1.5.5 Cons   Although  MedSignals  is  portable,  its  alerting  mechanism  is  useful  only  when  you’re  in  close   proximity  of  the  MedSignals  medication  compliance  system.  MedSignals  uses  a  fixed  line   telecommunication  link  to  connect  to  its  back  office.  This  arrangement  precludes  the  device   from  sending  a  missed  dose  telephonic  reminder  when  the  patient  is  mobile  and  carrying  the   device  with  it.     The  MedSignals  mechanism  of  measuring  drug  consumption  is  also  error  prone  and  simply   incapable  of  measuring  a  drug  overdose  or  drug  underdose.  It  is  a  known  fact  that  drug  
  23. 23. Competition FemtoTools Market for Portable Medication Compliance Devices 35       overdose  is  a  serious  issue.  The  Center  for  Disease  Control  estimates  that  accidental  overdose  of   painkillers  killed  14,800  patients  in  the  U.S.  in  2008.   4.1.5.6 Distribution  Channel   MedSignals  can  be  purchased  online  through  the  company’s  website  and  from  Amazon.com.  We   have  no  information  if  this  product  is  being  retailed  through  any  other  channel.                  
  24. 24. Competition FemtoTools Market for Portable Medication Compliance Devices 36       Table  2:  Comparison  of  FemtoTools  Portable  Medication  Unit  (PMU)  against  other  Medication  Compliance  Devices   S.No.   Feature   Component   FemtoTools   PMU   Vitality   Glowcaps   Philips   MD2   Healthonemed   DAP   MedSmart   MD2   Medsignals   Preconfigured  Medication  Cartridges   /  Cups   N   N   Y   N   Y   N   1   Device  Setup   Universal  Clamping  /  Housing   Mechanism   Y   Y   N   N   N   N   RFID  Reader   Y   N   N   N   N   N   Barcode  Reader   Y   N   N   N   N   N   Wireless  Transceivers  (802.11,   Bluetooth)   Y   N   N   N   N   N   Smartcard  Reader   Y   N   N   N   N   N   2   Device  Calibration   Ethernet  Link   N   Y   Y   Y   N   Y   Rechargeable  Lithium  Ion  Battery   Y   N   Y   Y   N   Y  3   Power  Supply   A/C  Power  Adaptor  /  Cradle   Y   N   Y   Y   Y   Y   USB   Y   N   N   N   N   N  4   Battery  Charging   Photovoltaic  Cells   Y   N   N   N   N   N   Pills   Y   Y   Y   Y   Y   Y   Liquids   Y   N   N   N   N   N   5   Drug  Handling   Powder   Y   N   N   N   N   N   Incorrect  Medication   Y   N   N   N   N   N   Drug  Overdose   Y   N   Y   Y   Y   N   Drug  Underdose   Y   N   Y   Y   Y   N   6   Compliance   Management   Medication  Mix-­‐up   Y   N   N   N   N   N   Missed  Dose  Recording   Y   Y   Y   Y   Y   Y  7   Record  Management   Remote  Event  Monitoring   Y   Y   Y   Y   Y   Y   Anywhere  Notification/Alerting   Y   N   N   N   N   N   Biometric  Based  Emergency  Alert   Y   N   N   N   N   N   Telephonic  Missed  Dose  Alert   Y   Y   Y   Y   Y   Y   Device  Non-­‐operational  Alert   Y   N   Y   Y   Y   Y   8   Event  Management   Visual  Alarm   Y   Y   Y   Y   Y   Y  
  25. 25. Competition FemtoTools Market for Portable Medication Compliance Devices 37       S.No.   Feature   Component   FemtoTools   PMU   Vitality   Glowcaps   Philips   MD2   Healthonemed   DAP   MedSmart   MD2   Medsignals   Audible  Alarm   Y   Y   Y   Y   Y   Y       Battery  Low  Alarm   Y   N   Y   Y   Y   Y   Digital  Clock   Y   N   Y   Y   Y   Y  9   Status  Display   LCD  Readout   Y   N   Y   Y   Y   Y   GPS  Locator   Y   N   N   N   N   N   Proximity  Sensor   Y   N   N   N   N   N   Temperature  Monitor   Y   N   N   N   N   N   10   Sensing   Weight  Sensor   Y   N   N   N   N   N   11   Reordering   Automatic  Medication  Reorder   Y   N   N   N   N   N   Childproof  Lock   Y   Y   Y   Y   Y   N  12   Access  Control   Biometric  Lock   N   N   N   N   N   N   Adaptive  Drug  Delivery  thru  Direct   Physician  Intervention   Y   N   N   N   N   N   Software  I/F  with  EMR  Cloud  to   Read/Write  Patient  Records   Y   N   N   N   N   N   13   Extensibility   Wireless  I/F  to  Capture  Vital  Stats   from  Health  Monitoring  Devices   Y   N   N   N   Y   N  

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