This document discusses strategies for medical device companies to adopt CDISC standards. It notes that while medical devices make up about 1/3 of the overall life sciences market in terms of revenue, they represent a larger number of studies than pharmaceuticals. It then presents 5 winning strategies for medical device companies to adopt CDISC standards: 1) Start with the team, 2) Make a plan from day one, 3) Prioritize, 4) Rely on experts, and 5) Leverage technology. The presentation concludes by envisioning a world where medical device data is increasingly standardized and shared using CDISC standards.

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2. © CDISC 2014
Presented by Ale Gicqueau, President & CEO, Clinovo
at the CDISC Europe Interchange 2014
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CDISC Standards Adoption:
Winning Strategies for
Medical Device Companies
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1/3 of the overall life science market
3
69%
31%
Revenue
76%
24%
Medical Device
Number of Studies
Sources: IMS 2012 / Center on Budget and Policy Priorities 2012 / clinicaltrials.gov 2014
Pharma
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Spread of small-sized companies
• 80% of medical device companies have 50 or
fewer employees.
• 10 largest medical device makers account for 86%
of the sales of medical devices.
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Challenging Regulatory Environment
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Adoption of CDISC Standards
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2016 Pharma
Medical Device
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5 Winning Strategies
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1 | Start with the team
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2 | Make a plan from day one
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3 | Prioritize
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4 | Rely on the experts
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5 | Leverage technology
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• SAS-based solution to map clinical data to SDTM
• Accelerated CDISC conversion: Up to 4 times
faster
• Downloaded 1,000 times on clinovo.com
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Benefits of Open Source
• Large user & developer community
 Users community influence roadmap
 Developer community to fix bugs, maintain, and enhance the
code
• State-of-the-art features
 Motivated engineers dedicating own time to contribute to
system
 High quality through peer review
• Cost-effective solutions
 No vendor lock-in
 No license fees
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Concerns
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Issue Mitigation
No vendor responsible for open source
product
 Contract with the leading vendor
Timely and costly validation
 Rely on existing validation
packages
Back door access / viruses
 Use latest code reviewed, revised
version
Complicated licenses  Involve your legal department
Potential push-back from QA  Educate and become a champion
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Open Source Systems in Clinical Trials
• Operating Systems: RedHat, Suse, UNIX
• Languages: Java, C/++, PhP, Python, PERL
• Web servers : Apache, Tomcat
• Databases : MySQL, PostgreSQL, Sleepycat
• Productivity Tools: OpenOffice, Mozilla
• Business Intelligence : Pentaho, JasperSoft
• Collaboration Portals : Alfresco
• Systems Integration: Intalio, Talend
• Cloud: Cloudstack, Openstack
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• EDC: ClinCapture, OpenClinica, Yale
TrialDB, REDHat
• CDISC: OpenCDISC, CDISC
Express
• Electronic health or medical record:
OpenEMR
• Clinical research: Labkey Server
• Analysis: R project
• DICOM Imaging: OsiriX
• Health Information Exchange: Misys
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17. Conclusion
A World of Medical Device

18. © CDISC 2014
A World of Medical Device
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