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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
Current -‐ Inconsistent Data Sources
© Copyright 2013-‐2015 Carver Global Health Care LLC. All rights Reserved. ConfidenBal: 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 )
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 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 10
Apply filters to secAons of document
and Medical Specialty
To Zoom in on Specific
usage
© Copyright 2013-‐2015 Carver Global Health Group LLC. All rights Reserved. 11
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
© 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 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
© 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