Zimmer Biostatistics and Clinical Data Management (BCDM)

1. Zimmer Biostatistics and Clinical Data Management (BCDM) Noah Sheeley April 10,2014

2. Zimmer Profile • Zimmer is one of the largest orthopedic companies in the world with top worldwide market share in both hip and knee implants. • Zimmer employs nearly 9000 employees and has offices all over the world with 130,000 products being sold in over 100 countries, reaching worldwide annual sales of $4.6 billion in 2013.

3. Zimmer has 130,000 different products. • We are conducting clinical trials with hundreds of doctors at • dozens of sites around the world. These studies must meet the • requirements of the many regulatory bodies around the • world including the FDA. • Currently our department the BCDM group has: • 35 regulated projects (IDE studies, PMCFs) • 85 non-regulated projects (pilot studies, lab studies) • 15 publication studies Clinical Trials Knees Human Tissue Cups and Stems Hip

4. Start CompleteCRFs ShipCRFs ReviewCRFs Data EntryCRFs ReviewData Errors? InvestigateCRFs Errors? InvestigateCRFs Errors? InvestigateCRFs File CopyCRFs FileCRFs Process Complete Business Problem • Before: Check every field on every form • Error: Mail the form back to the site • Site mails the correction back to us • Check Every field on every form Current Process <= 3 Weeks

5. Additional Business Problems • Multi Page forms with over 100 Data Elements • Complex Calculations, Validations, Lists, etc. • Must be HIPAA Compliant & Secure • Must be FDA compliant out of the box • On-Line / Off-Line Issues • Self-Administration Required • Poor Legibility on Paper Forms creates: • Financial Liabilities • Potential for Medical Errors • Incomplete Medical Record • Statistical Analysis Errors

6. Key Decision Factors/Business Case • Enter Data while it is being Collected • Pre-Fill Form with: • Pick Lists (Meds, Devices, etc.) • Data from Previous Visit (Patient History) • Calculations • Enforce Accuracy with Real-Time Validations

7. Business Case • Highly-Skilled, Highly-Paid, Time-Constrained Surgeons & Physicians • Spending 2 to 4 desk hours per shift • Completing Medical Record & Billing Sheets • Need to Cut Data Collection Time by >= 50% • Without Sacrificing Accuracy or Acceptance • Time Savings, Billing, and Compliance • Estimated $1K to $2K Savings per Day • + Happier Surgeons

8. Business Case • Produce cost-justified increases in data collection speed and accuracy • Implement a software and hardware infrastructure as reliable as the current paper-based system • Deploy a system meeting the requirements of the current information technology infrastructure • Comply with HIPAA security requirements • Employ a data input interface capable of transcribing verbal observations to written data inputs • Provide an intuitive interface and workflow gaining end-user acceptance by examiners and clinicians • Allow multiple, doctor’s sites to participate • Satisfy all FDA 21 CFR Part 11 regulations and internal data quality monitoring requirements

9. Value Proposition “The one thing I can’t give my faculty is more time. The Optiform solution offers the opportunity to more effectively capture data and manage the care plan while decreasing the time investment.”

10. Start CompleteCRFs ShipCRFs ReviewCRFs Data EntryCRFs ReviewData Errors? InvestigateCRFs Errors? InvestigateCRFs Errors? InvestigateCRFs File CopyCRFs FileCRFs Process Complete Benefits Realized Paper Process <= 3 Weeks MiCo Process <= 72 Hours

11. Benefits Realized • In 2013, using MiCo we collected data for 5 FDA regulated studies and 24 Post Market Clinical Follow-ups • This was around 45,000 CRFs • Paper – .8 min per CRF to process the data & any discrepancies/DCFs eClinical – .1 min per CRF submitted • This is a nearly 90% reduction in discrepancy management.

12. Benefits Realized • Increased quality of care by providing more treatment time with patients as result of more efficient access to and collection of patient data. • Increased data quality by eliminating poor legibility of paper-based Progress Notes with the system’s on-the-fly, ink-to-text, recognition. • Prevention of medical record and/or billing errors by enforcing real-time validation of data. • Reduced data collection time by pre-filling Progress Note form fields with previous patient data, complex calculations, test results, medication lists, and treatment data.

13. Benefits Realized • Maximization of billing revenue by calculating diagnosis (ICD9) and billing codes without human intervention. • Elimination of the manual upkeep of a billing sheet log by automatically transferring Progress Note data to billing reports. • Bypass of the tedious paper capture by transferring digital ink forms directly to the electronic medical record (EMR). • Enhanced instructional experience by providing Attending Physicians with a simultaneous view of the Progress Note being presented by Residents

14. Mi-Forms Tablet PC Benefits • The speed of data collection has decreased from 3 weeks to less than 72 hours • There have been far fewer rejections of data sets resulting in a much higher data quality rate • Fewer trips to data collection sites for site monitoring tasks have been required • Resolving inconsistencies in submitted data requires less time due to a shorter time interval between collection and detection • The time required to file and organize case report forms has been eliminated • The cost of printing and distributing paper forms has been virtually eliminated • End-user training and acceptance has been positive • The operation and battery life of the Tablet PCs have been remarkably reliable • Electronic submissions between remote sites and the central site has been extremely stable

15. Mi-Forms Tablet PC Benefits • “We have been very pleased with the speed and accuracy of data collection that the new eCRF solution has provided” • “The data just shows up in the database” • “The dental device manufacturer has been equally pleased with the speed and accuracy of the data collection process” • “Ready for prime time!”

16. Demonstration

17. Summary – Business Lessons Learned • 2 page form = 1,000 hours of development • Lock-Down the SOW • Use Solution Implementation Sign-Offs • Do Weekly Status Reports / Change Orders • Data Dictionary is Key Component • Engage with IT Dept Early (don’t be fooled) • Keep your Champion Happy

18. Lessons Learned

19. Optiform Profile • HQ in Indianapolis • Focus on Healthcare • Develop “Best-of-Breed” Component Solutions for Clinical Data Collection Apps • Many Customers using Paper-Based Recognition Technologies (i.e. OCR/ICR) • Increasingly Difficult to gain Maximum Efficiencies with Paper-Based Technologies • Using Mi-Forms where Pain & Cost are High

21. Question & Answer