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Š	
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  Global	
  Health	
  Group	
  LLC.	
  	
  All	
  rights	
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1	
  
Karl Schulmeisters - CTO
February, 2015	
  
Medical Device Innovator Support	
  
 	
  	
  	
  
Š	
  Copyright	
  2013-­‐2015	
  Carver	
  Global	
  Health	
  Group	
  LLC.	
  	
  All	
  rights	
  Reserved.	
  	
  	
  	
  
2	
  
 	
  	
  	
  
Š	
  Copyright	
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  Global	
  Health	
  Group	
  LLC.	
  	
  All	
  rights	
  Reserved.	
  	
  	
  	
  
3	
  
3
Current    -­‐  Inconsistent  Data  Sources
Š	
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  2013-­‐2015	
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  Global	
  Health	
  Care	
  LLC.	
  	
  All	
  rights	
  Reserved.	
  	
  	
  	
  	
  CondenBal:	
  Please	
  Do	
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   4	
  
•  Over	
  a	
  Dozen	
  FDA	
  Databases	
  
•  HTML	
  	
  
•  Scanned	
  PDFs	
  
•  Centers	
  for	
  Medicare	
  Services	
  
•  Federal	
  and	
  State	
  
•  NaAonal	
  InsAtutes	
  of	
  Health	
  	
  
•  Clinical	
  Trials	
  Registry	
  
•  American	
  Materials	
  Standards	
  
•  BioMaterials	
  
•  Medical	
  Subjects	
  Headings	
  DicAonary	
  (MeSH	
  )	
  
Current    -­‐  Inconsistent  Data  Sources
Š	
  Copyright	
  2013-­‐2015	
  Carver	
  Global	
  Health	
  Care	
  LLC.	
  	
  All	
  rights	
  Reserved.	
  	
  	
  	
  	
  CondenBal:	
  Please	
  Do	
  Not	
  Copy	
  or	
  Distribute	
  
	
   5	
  
•  Over	
  a	
  Dozen	
  FDA	
  Databases	
  
•  HTML	
  	
  
•  Scanned	
  PDFs	
  
•  Centers	
  for	
  Medicare	
  Services	
  
•  Federal	
  and	
  State	
  
•  NaAonal	
  InsAtutes	
  of	
  Health	
  	
  
•  Clinical	
  Trials	
  Registry	
  
•  American	
  Materials	
  Standards	
  
•  BioMaterials	
  
•  Medical	
  Subjects	
  Headings	
  DicAonary	
  (MeSH	
  )	
  
 	
  	
  	
  
Š	
  Copyright	
  2014-­‐2015	
  Carver	
  Global	
  Health	
  Group	
  LLC.	
  	
  All	
  rights	
  Reserved.	
  	
  	
  	
  
6	
  
Š	
  Copyright	
  2013-­‐2015	
  Carver	
  Global	
  Health	
  Group	
  LLC.	
  	
  All	
  rights	
  Reserved	
  	
  	
  	
  	
  	
  
7	
  
ClearRoadmap  Solu7on
Š	
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  Health	
  Group	
  LLC.	
  	
  All	
  rights	
  Reserved	
  	
  	
  	
  	
  
8	
  
Pathways
We’ll	
  help	
  innovators	
  
uncover	
  the	
  steps	
  for	
  
pathways	
  	
  	
  
to	
  successfully	
  	
  
plan	
  and	
  execute	
  
Idea	
  to	
  Market	
  
Š	
  Copyright	
  2013-­‐2015	
  Carver	
  Global	
  Health	
  Group	
  LLC.	
  	
  All	
  rights	
  Reserved.	
  .	
  	
  	
  	
  	
  
9	
  
Š	
  Copyright	
  2013-­‐2015	
  Carver	
  Global	
  Health	
  Group	
  LLC.	
  	
  All	
  rights	
  Reserved	
  	
  	
  	
  	
  	
  
10	
  
pply	
  lters	
  to	
  secAons	
  
of	
  document	
  
and	
  	
  
Medical	
  Specialty	
  
	
  
o	
  Zoom	
  in	
  on	
  Specic	
  
usage	
  
Š	
  Copyright	
  2013-­‐2015	
  Carver	
  Global	
  Health	
  Group	
  LLC.	
  	
  All	
  rights	
  Reserved.	
  	
  	
  	
  	
  
11	
  
Customized  alerts  

Use	
  our	
  system	
  to	
  tailor	
  alerts	
  	
  
to	
  your	
  specic	
  preferences	
  	
  
to	
  track	
  changes	
  	
  
within	
  the	
  medical	
  device	
  
approvals,	
  recalls	
  and	
  
warnings.	
  
Just	
  choose	
  the	
  devices,	
  markets	
  and	
  acAons	
  you’re	
  interested	
  in	
  monitoring,	
  and	
  we’ll	
  deliver	
  
personalized,	
  comprehensive	
  and	
  real-­‐Ame	
  alerts	
  directly	
  to	
  your	
  Twi`er	
  feed	
  or	
  email	
  inbox.	
  
•  mHealth	
  Innovators	
  who	
  want	
  to	
  sell	
  in	
  the	
  USA	
  
•  Get	
  our	
  free	
  Ideas	
  To	
  Market	
  guide	
  
•  Get	
  our	
  free	
  Checklist	
  	
  to	
  start	
  
•  Medical	
  Device	
  Innovators	
  who	
  want	
  to	
  sell	
  in	
  the	
  USA	
  
•  Use	
  Pathways	
  to	
  idenAfy	
  issues	
  
•  Use	
  Search	
  to	
  Find	
  ExisAng	
  devices	
  
•  Use	
  Reimbursement	
  to	
  develop	
  strategy	
  
•  Medical	
  Device	
  Consultants	
  
•  Improve	
  the	
  speed	
  and	
  quality	
  of	
  services	
  you	
  deliver	
  
•  Investors	
  
•  Get	
  be`er	
  insight	
  into	
  what	
  you	
  are	
  invesAng	
  in	
  
Š	
  Copyright	
  2013-­‐2015	
  Carver	
  Global	
  Health	
  Group	
  LLC.	
  	
  All	
  rights	
  Reserved.	
  	
  	
  	
  	
  
12	
  
Who  Should  Care?
Management  Team
•  Vizma	
  Carver,	
  Founder	
  and	
  CEO	
  
•  FDA	
  Entrepreneur-­‐in-­‐Residence	
  co-­‐leading	
  the	
  effort	
  to	
  rebalance	
  
pre-­‐	
  and	
  post-­‐market	
  data	
  requirements.	
  	
  
•  Implemented	
  the	
  rst	
  and	
  only	
  standards-­‐based,	
  integrated,	
  
worldwide	
  Electronic	
  Medical	
  Records	
  system	
  within	
  the	
  Department	
  
of	
  Defense	
  (DoD).	
  
•  Led	
  the	
  development	
  of	
  outcomes-­‐based	
  funding	
  for	
  health	
  services	
  
and	
  Health	
  InformaAon	
  Technology.	
  
•  Karl	
  Schulmeisters,	
  CTO	
  
•  30	
  years	
  of	
  IT	
  experience	
  across	
  a	
  broad	
  range	
  of	
  industries	
  and	
  
companies	
  including	
  Microsof,	
  Nike,	
  Boeing,	
  Mitsubishi,	
  	
  Dubai	
  Water	
  
and	
  Electric	
  Authority	
  
•  Director	
  of	
  SoluAons	
  Architecture	
  in	
  the	
  CTO	
  Oce	
  of	
  Unisys	
  
•  Microsof	
  Industry	
  Strategist	
  
•  Corbis	
  –	
  Sofware	
  Systems	
  Architect	
  
•  Delivered	
  soluAons	
  from	
  Cloud	
  CompuAng	
  and	
  Big	
  Data	
  to	
  mobile	
  
consumer	
  devices	
  
Š	
  Copyright	
  2013-­‐2015	
  Carver	
  Global	
  Health	
  Care	
  LLC.	
  	
  All	
  rights	
  Reserved.	
  	
  	
  	
  	
  CondenBal:	
  Please	
  Do	
  Not	
  Copy	
  or	
  Distribute	
  
	
  
•  mHealth,	
  tness	
  Startups:	
  	
  
•  h`ps://ClearRoadmap.com	
  	
  
•  Free	
  From	
  Idea	
  to	
  Market	
  
•  Free	
  mHealth	
  Checklist	
  
•  Discounted	
  2	
  Week	
  Trial	
  
•  Launch	
  Partners	
  
•  15%	
  discount	
  for	
  any	
  packages	
  purchased	
  in	
  February	
  and	
  March	
  
Š	
  Copyright	
  2013-­‐2015	
  Carver	
  Global	
  Health	
  Group	
  LLC.	
  	
  All	
  rights	
  Reserved.	
  	
  	
  	
  	
  
14	
  
Call  To  Ac7on
h`ps://ClearRoadmap.com	
  	
  
h`p://twi`er.com/@ClearRoadmap	
  	
  
h`ps://www.facebook.com/pages/Clearroadmap/581029671954902	
  	
  
	
  
Š	
  Copyright	
  2013-­‐2015	
  Carver	
  Global	
  Health	
  Group	
  LLC.	
  	
  All	
  rights	
  Reserved	
  
15	
  

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  • 1.                                                                                                                           Š  Copyright  2013-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved             1   Karl Schulmeisters - CTO February, 2015   Medical Device Innovator Support  
  • 2.         Š  Copyright  2013-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved.         2  
  • 3.         Š  Copyright  2013-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved.         3   3
  • 4. Current    -­‐  Inconsistent  Data  Sources Š  Copyright  2013-­‐2015  Carver  Global  Health  Care  LLC.    All  rights  Reserved.          CondenBal:  Please  Do  Not  Copy  or  Distribute     4   •  Over  a  Dozen  FDA  Databases   •  HTML     •  Scanned  PDFs   •  Centers  for  Medicare  Services   •  Federal  and  State   •  NaAonal  InsAtutes  of  Health     •  Clinical  Trials  Registry   •  American  Materials  Standards   •  BioMaterials   •  Medical  Subjects  Headings  DicAonary  (MeSH  )  
  • 5. Current    -­‐  Inconsistent  Data  Sources Š  Copyright  2013-­‐2015  Carver  Global  Health  Care  LLC.    All  rights  Reserved.          CondenBal:  Please  Do  Not  Copy  or  Distribute     5   •  Over  a  Dozen  FDA  Databases   •  HTML     •  Scanned  PDFs   •  Centers  for  Medicare  Services   •  Federal  and  State   •  NaAonal  InsAtutes  of  Health     •  Clinical  Trials  Registry   •  American  Materials  Standards   •  BioMaterials   •  Medical  Subjects  Headings  DicAonary  (MeSH  )  
  • 6.         Š  Copyright  2014-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved.         6  
  • 7. Š  Copyright  2013-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved             7   ClearRoadmap  Solu7on
  • 8. Š  Copyright  2013-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved           8   Pathways We’ll  help  innovators   uncover  the  steps  for   pathways       to  successfully     plan  and  execute   Idea  to  Market  
  • 9. Š  Copyright  2013-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved.  .           9  
  • 10. Š  Copyright  2013-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved             10   pply  lters  to  secAons   of  document   and     Medical  Specialty     o  Zoom  in  on  Specic   usage  
  • 11. Š  Copyright  2013-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved.           11   Customized  alerts   Use  our  system  to  tailor  alerts     to  your  specic  preferences     to  track  changes     within  the  medical  device   approvals,  recalls  and   warnings.   Just  choose  the  devices,  markets  and  acAons  you’re  interested  in  monitoring,  and  we’ll  deliver   personalized,  comprehensive  and  real-­‐Ame  alerts  directly  to  your  Twi`er  feed  or  email  inbox.  
  • 12. •  mHealth  Innovators  who  want  to  sell  in  the  USA   •  Get  our  free  Ideas  To  Market  guide   •  Get  our  free  Checklist    to  start   •  Medical  Device  Innovators  who  want  to  sell  in  the  USA   •  Use  Pathways  to  idenAfy  issues   •  Use  Search  to  Find  ExisAng  devices   •  Use  Reimbursement  to  develop  strategy   •  Medical  Device  Consultants   •  Improve  the  speed  and  quality  of  services  you  deliver   •  Investors   •  Get  be`er  insight  into  what  you  are  invesAng  in   Š  Copyright  2013-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved.           12   Who  Should  Care?
  • 13. Management  Team •  Vizma  Carver,  Founder  and  CEO   •  FDA  Entrepreneur-­‐in-­‐Residence  co-­‐leading  the  effort  to  rebalance   pre-­‐  and  post-­‐market  data  requirements.     •  Implemented  the  rst  and  only  standards-­‐based,  integrated,   worldwide  Electronic  Medical  Records  system  within  the  Department   of  Defense  (DoD).   •  Led  the  development  of  outcomes-­‐based  funding  for  health  services   and  Health  InformaAon  Technology.   •  Karl  Schulmeisters,  CTO   •  30  years  of  IT  experience  across  a  broad  range  of  industries  and   companies  including  Microsof,  Nike,  Boeing,  Mitsubishi,    Dubai  Water   and  Electric  Authority   •  Director  of  SoluAons  Architecture  in  the  CTO  Oce  of  Unisys   •  Microsof  Industry  Strategist   •  Corbis  –  Sofware  Systems  Architect   •  Delivered  soluAons  from  Cloud  CompuAng  and  Big  Data  to  mobile   consumer  devices   Š  Copyright  2013-­‐2015  Carver  Global  Health  Care  LLC.    All  rights  Reserved.          CondenBal:  Please  Do  Not  Copy  or  Distribute    
  • 14. •  mHealth,  tness  Startups:     •  h`ps://ClearRoadmap.com     •  Free  From  Idea  to  Market   •  Free  mHealth  Checklist   •  Discounted  2  Week  Trial   •  Launch  Partners   •  15%  discount  for  any  packages  purchased  in  February  and  March   Š  Copyright  2013-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved.           14   Call  To  Ac7on h`ps://ClearRoadmap.com     h`p://twi`er.com/@ClearRoadmap     h`ps://www.facebook.com/pages/Clearroadmap/581029671954902      
  • 15. Š  Copyright  2013-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved   15 Â