Slide 1

Benefits of UDI in Supply ChainJune 8, 2017

Dennis BlackBD

Use of GTINs

Sample GTIN Data:

00382903065073

30382903065074

50382903065078

Pallet License Plates: SSCC

Investment in GS1 Standards: ERP System

• Item Master Data is based on GS1 Standards• Many processes utilize the GS1 Standards• Adding another data standard is inefficient

• Prefix selection, allocation, and maintenance

• GTINs created for each product and package level

• Product data defined, created and managed

• Alignment of electronic processes

• Product data stored in ERP

• Data is shared between BD locations

BD: Internal Use of Data Standards

• Production order and GTINs pulled from ERP

• GTINs and production data (Lot/Expiry, etc.) printed on products (barcode andhuman readable)

• GTINs used to track products during manufacturing and to track shipments

• Manufacturing data stored in ERP system

BD Factory

• GTINs and production data used for :• receipt verification• accuracy of picked products• Creation of pallet license plate (SSCC)

• Pallets identified and tracked with SSCC numbers and bar codes

• Production data, inventory and delivery information stored in ERP system

BD Distribution Center

Supply Chain Interest in Tracking Medical Devices

Supply Chain Benefits Include:•Accurate Shipments•Supply Chain Efficiency•Common Business Language•Etc.

Data Standards: Many Possible Internal Supply Chain Benefits

• Provides a precise method of enumerating products• GS1 standards provide a company-wide method of

applying bar codes• May facilitate accurate purchase orders, invoicing and

payment• Clean data on delivery locations and account information• Can enable up-to-date item master and vendor master• Better product and lot number tracking• Creates a common numerical systems that can be used

externally

Slide 9

Real World EvidenceIn Medical Devices

June 8, 2017

Myoung Kim & Kade EtterJohnson & Johnson

Slide 10

Content

• Real World Evidence (RWE) in Medical Devices– What is RWE (or RWD)?– Why RWE?– The future of RWE

• Why RWE matters to manufacturers• Examples of RWE at J&J• RWE in Med Devices at its tipping point

11

Lack of Device-Level Data

• Limited clinical data from FDA 510(k) process

• Small clinical trials and PM studies are limited – Underpowered/short – Lack of comparison device – Restricted to single sites or regions

• Use of large claims databases? – No unique identifiers submitted– 2005: ICD-9 codes added for bearing surface material

• Not required for payment

12

Real World Evidence?

13

RWE/ RWD(by-product of healthcare

delivery and financing)Clinical

Trial Data

J&J Licensed

Databases

RWE Sources

14

Source: IMS Health

Real World EvidenceAs a Balanced Solution for Safety and Innovation

15

Safety Innovation

Adoption of EHR Systems among U.S. Non-Federal Acute Care Hospitals: 2008-2015

Source: ONC Data Brief 35 | May, 201616

• Virtually aggregate EHR and link with insurance claims, lab tests, x-rays, etc., all with UDI, enabling device-specific research

• Nest registries and clinical trials in EHR• “Partner with patients” through patient-

powered technology platforms• Within EHR, clinical research and clinical care

integrate as a continuum to support a learning healthcare system, with patients at the center

EHR is the Future of RWE!

*Hugo presented as an example at FDA MD Active Surveillance Think Tank Mtg on June 1 2016.

17

Why RWE matters to Manufacturers

• Robust RWE is critical in monitoring and ensuring patient safety, effectiveness, and supporting innovation

• UDI adoption will dramatically increase the utility of RWE for medical device research

• RWE is top CDRH priority 2016-17 for evaluating safety and effectiveness

• Evidentiary standards are rapidly rising globally– Regulatory demand– Demand for RWE around comparative

effectiveness and value– Precision Medicine Initiative

18

RWE sources we currently use

Insurance Claims

Hospital Billing Records

MAUDE

UK EHR

Other US databases

OPTUM Integrated

19

Examples: RWE for Effectiveness Studies

Hyaluronic Acid (HA) and Time to Total Knee Replacement

A1C level among patients with Bariatric Surgery, compared to Matched Control

J of Knee Surgery 2015

Accepted for publication in Diabetes, Obesity and Metabolism

20

Example: RWE for Comparative Effectiveness Studies

Axxxx® vs. Txxxx™ Total Knee Systems: Hospital Length of Stay (LOS) and Discharge Status1

• A recent Real World matched cohortstudy compared Axxxx (N=1178) withTxxxx (N=5707) in Premier Databasewith respect to LOS and dischargestatus.

Figure 1: Adjusted hospital Length of stay

Figure 2: Adjusted proportion of patients discharged to skilled nursing facility1. Etter, K., J. Lerner, C. de Moor, A. Yoo, and I. Kalsekar. "PMD10-Comparative Effectiveness of Attune® Versus Triathlon tm Total Knee Systems: Real-World Length of Stay And Discharge Status." Value in Health 19, no. 3 (2016): A298.

Submitted for publication

21

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Projected Growth inclusive of all aspects of RWE: (1) Volume of brand-level RWD, (2) Publications, (3) Market & regulatory expectations, (4) Overall sector spend on data & FTEs, etc.

Procedure-Level Data Device Brand-Level Data

• UDI• NEST

22

RWE in Med Devices is at a tipping point

Slide 23

Slide 24

Medical Device Evaluation Paradigm Shift: Today and Tomorrow

Active SurveillanceLeverage RWE to

support regulatory decisions throughout

TPLC

Collect data during routine clinical care

Shared system to inform the entire Ecosystem (Patients, Clinicians,

Providers, Payers, FDA, Device Firms)

National Evaluation

System

Passive Surveillance

Challenging to find right pre/post

market balance without confidence in post-market data

Parallel Track to Clinical Practice

Inefficient one-off studies

Current

Slide 25

2017 MDIC NEST

UDISystem

National Evaluation

System

Improve

Demonstrations

Executive Director – Rachael L. Fleurence, Ph.D

26www.fda.gov

Required on the device label, packages or, in some cases, on the device itself

Code in plain text and machine readable format (AIDC)

UDI = DI + PI

*+X999123ABC0/$$3140102A1234/S1234/16D20100102J*

GS1

HIBCC

ONE STANDARD for IDENTIFICATION

Slide 27

http://accessgudid.nlm.nih.gov/

ONE STANDARD REFERENCE

Slide 28

MULTIPLE WAYS to ACCESS

Slide 29

Submit Once – Capture/Use Multiple Ways

GUDID

Registries

Hospitals

Distributors

Payers

Labeler

Slide Number 1Slide Number 2Investment in GS1 Standards: ERP SystemSlide Number 4Slide Number 5Slide Number 6Supply Chain Interest in Tracking Medical DevicesData Standards: Many Possible Internal Supply Chain BenefitsSlide Number 9Slide Number 10Slide Number 11Lack of Device-Level DataReal World Evidence?RWE SourcesReal World Evidence�As a Balanced Solution for Safety and InnovationAdoption of EHR Systems among U.S. Non-Federal Acute Care Hospitals: 2008-2015�EHR is the Future of RWE!Why RWE matters to ManufacturersSlide Number 19Examples: RWE for Effectiveness Studies�Example: RWE for Comparative Effectiveness Studies��Axxxx® vs. Txxxx™ Total Knee Systems: Hospital Length of Stay (LOS) and Discharge Status1�Slide Number 22Slide Number 23Medical Device Evaluation �Paradigm Shift: Today and Tomorrow2017 MDIC NESTSlide Number 26http://accessgudid.nlm.nih.gov/Slide Number 28Submit Once – Capture/Use Multiple Ways