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© Copyright 20132015 Carver Global Health Group LLC. All rights Reserved 1 Karl Schulmeisters - CTO February, 2015 Medical Device Innovator Support

Clear Roadmap

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©  Copyright  2013-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved            1  

Karl Schulmeisters - CTO February, 2015  

Medical Device Innovator Support  

       

©  Copyright  2013-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved.        2  

       

©  Copyright  2013-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved.        3  

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Current    -­‐  Inconsistent  Data  Sources

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•  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

©  Copyright  2013-­‐2015  Carver  Global  Health  Care  LLC.    All  rights  Reserved.          ConfidenBal:  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  )  

       

©  Copyright  2014-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved.        6  

©  Copyright  2013-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved            7  

ClearRoadmap  Solu7on

©  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  

©  Copyright  2013-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved.  .          9  

©  Copyright  2013-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved            10  

Apply  filters  to  secAons  of  document  

and    Medical  Specialty  

 To  Zoom  in  on  Specific  

usage  

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Customized  alerts  

Use  our  system  to  tailor  alerts    

to  your  specific  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  

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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  first  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  Office  of  Unisys  •  Microsof  Industry  Strategist  •  Corbis  –  Sofware  Systems  Architect  

•  Delivered  soluAons  from  Cloud  CompuAng  and  Big  Data  to  mobile  consumer  devices  

©  Copyright  2013-­‐2015  Carver  Global  Health  Care  LLC.    All  rights  Reserved.          ConfidenBal:  Please  Do  Not  Copy  or  Distribute    

• mHealth,  fitness  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  

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Call  To  Ac7on

h`ps://ClearRoadmap.com    h`p://twi`er.com/@ClearRoadmap    h`ps://www.facebook.com/pages/Clearroadmap/581029671954902      

©  Copyright  2013-­‐2015  Carver  Global  Health  Group  LLC.    All  rights  Reserved  15