UNIQUE DEVICE IDENTIFIERS IMPLEMENTATION ALTERNATE PERSPECTIVES New Directions Technology Consulting, LLC FDA

1. UNIQUE DEVICE IDENTIFIERS IMPLEMENTATION ALTERNATE PERSPECTIVES New Directions Technology Consulting, LLC FDA UDI WORKSHOP FEBRUARY 12, 2009 1

2. NAPOLEON MONROE BACKGROUND Pharma and device development, manufacturing and distribution. (~40 years.) Managed Henry Schein�s private labels. (10+ years-including initial CE marking.) Active in several healthcare associations. Automatic Identification and Data Capture, (AIDC) an area of personal interest. (UDI=AIDC.) 2

3. UDI BACKGROUND Spoke from the floor at the October 25th, 2006 UDI meeting. Facilitated subsequent client and trade association meetings. Alternate site healthcare providers, smaller manufacturers and distributors need to be included as stakeholders in the UDI process. These stakeholders have information, requirements, roles and opportunities which have not been widely recognized. Requirements should be well reasoned, logical, easily understood, cost effective and harmonized with other requirements; and should allow adequate time for implementation. Relationship of electronic medical records and telemedicine to AIDC. 3

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6. SOME INDUSTRY UDI VIEWS Some believe AIDC is soon going to be part of the healthcare system. Those firms are trying to guide and understand UDI. They also want to find ways to profit from the identities and other data which can be captured. Investment is still limited. Specifics and focus less well defined than for pedigree. 6

7. SOME INDUSTRY UDI VIEWS Some say, �Tell us what to do and we will do it�(in some cases, grudgingly)�.� Some believe AIDC is soon going to be part of the healthcare system. Those firms are trying to guide and understand UDI. They also want to find ways to profit from the identities and other data which can be captured. Investment is still limited. Specifics and focus less well defined than for pedigree. Some still hope UDI will go away or they say, �Not in my lifetime!� Non-compliance with regulations is not an option.

8. BUSINESS RATIONALE FOR AIDC IN HEALTHCARE Patients, practitioners, administrators, manufacturers, distributors, payors and regulators have unmet information requirements. All of the above stakeholders have underused or under- appreciated information. Continuous improvement is key to long term profitability. Added emphasis on innovation. Proven technological developments (UPN, AIDC devices, 3G, GPS and others) take information management possibilities into areas not previously appreciated. Costs have declined. The right time to maximize value and competitive advantage is the earliest practicable time. The use of information is critical to enhancing both. 8

9. RELATED INITIATIVES Regulatory requirements. FDAAA (UDI, surveillance, and pedigree). Other federal legislation. State legislation. EC proposed pharma Directive including serialization. Other international regulations. Healthcare cost containment and entitlement management. Healthcare infrastructure improvements. EMR�s, claims processing and telemedicine. Customer (DoD and GPO) requirements. European veterinary pharmaceutical track and trace (IFAH). Product safety initiatives. Country of origin for fresh food. 9

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11. Produce? If country of origin is required, why not do more? 11

12. UDI (AIDC) IMPLEMENTATION BEST CASE ALTERNATE SITEINDUSTRY VIEW Developing understanding of likely requirements, standards, available technologies and (sometimes) opportunities. Investing very selectively and formulating tentative plans for: Compliance. Systems improvements. New or improved product and service offerings. Unsure which way to go. Telemedicine community excited. 12

13. HOW TO PROGRESS? Secure information as in the meeting today. Inform stakeholders. FDAAA requirements from 2006. Consistent with healthcare including stimulus initiatives of current administration. (~$20,000,000,000.) Advantages. Formulate proposals to clarify. Specifics and timing. Inform stakeholders.

14. EXAMPLESHEALTHCARE AIDC OPPORTUNITIES BEYOND COMPLIANCE Supply chain efficiencies. (Cited in FDA publications.) Cost reductions. Warranty tracking from manufacture through repair. Automated rather than physical lot separation. Reduced administrative costs. (Recall verification.) New or improved products and services. Practitioner and patient support including automated replenishment services, IFU language translations and point of use instruction. Product use and storage information. Integrated into telehealth systems. Notices based on storage and use. Outcomes based on information captured. EMR, practice management and telemedicine capabilities. 14

15. EXAMPLESALTERNATE SITE UDI CONCERNS Cost-especially for smaller companies. (Especially now.) Specific requirements and alternatives. Timing, priorities, UPN�s, carriers, inference, kits, DPM, components, exemptions, data transfer�. Harmonization/coexistence with pharma, biological product and international requirements. Impact on legacy production, inventory management and e- commerce systems. Resource requirements. Good guidance, informed staff, systems and equipment, technology suppliers, and contract manufacturer and affiliate readiness. Nomenclature. UNSPSC/GMDN. Label size. Many dental products are, by necessity, small. Dental anesthetic cartridge functionality compromised with linear barcodes. Eventual applicability to vet? (Exempt in FDAAA.) 15

16. �Change is Coming� Title of article in September 1st, 2009 Medical Device Link. That article and other links can be found at www.newdirectionsconsulting.net. Contact Information: New Directions Technology Consulting, LLC 718-427-303 nap.monroe@newdirectionsconsulting.net Henry Schein 631-414-8385 nap.monroe@henryschein.com 16