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Full Impact: UDI in the Real (Evidence) World• Karen Conway, Executive Director, Healthcare Value, GHX• Phil Thurlby, Scan4Safety Workstream Lead, Leeds Teaching

Hospital NHS Trust (former)• Dawn Fowler, Program Manager, UDI and Master Data, Massimo• Melissa Finocchio, Project Portfolio Leader, Global Quality,

bioMérieux

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People rely on [medical] devices every day and expect them to be safe… and incorporate the latest progress in science and innovation…certain incidents -e.g. with breast implants and metal hips - highlighted the weaknesses of the current legal system and damaged the confidence of patients, consumers and healthcare professionals in the safety of medical devices.

- European Commission News Release31 May 2017

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By promoting incorporation of UDIs into electronic health information, a vast quantity of untapped real-world data from clinical experience with devices housed in EHRs and other electronic information sources may become available for use in understanding the benefit-risk profiles of medical devices .

- Jeffrey Shuren, MD, JDUS FDA Center for Devices and Radiological Health

April 28 2015

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…the benefits of UDI can only accrue if all stakeholders, from the manufacturer to healthcare providers and patients, use UDI throughout their workflow systems. A globally harmonized and consistent approach to UDI is expected to increase patient safety and help optimize patient care by facilitating the: a. traceability of medical devices…b. adequate identification of medical devices through distribution and use; c. identification of medical devices in adverse events; d. reduction of medical errors; e. documenting and longitudinal capture of data on medical devices.

International Medical Device Regulatory Forum 9 December 2013

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How will they use the UDI in the healthcare delivery environment?

What do they need to realize value?

How will their use of UDI help you?

Capstone Research Findings

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• Overall, relatively low levels of customer interaction • Positive correlation: Manufacturer View of Value and Customer

Interaction/Focus

• Systems and process change prerequisites for adoption and value

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Don’t look now, but people are watching!

Reality TV for medical devices?

RWE initiatives on the rise, worldwide

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© 2017 Global Healthcare Exchange, LLC. All rights reserved. GHX proprietary information. Do not copy or

distribute.10

MDIC Case for Quality Product

Quality Outcomes Analysis

National Evaluation System for

Health Technology

(NEST)

Medical Device Epidemiological

Network (MDEpiNet)

Quality Product Data

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Case for Quality Product Quality Outcomes Analytics

“…information to make better purchase decisions that improve patient access to high quality medical devices.”

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Getting it Right the First TimeThe programme began with orthopaedics and is now being rolled out to 32 different surgical and medical specialisms across the English NHS.

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Local Initiatives – Global CoordinationWe envision international collaboration in medical device evidence generation, synthesis and appraisal….The international collaboration will harness the global strength of international experience with devices.

-International Medical Device Regulatory Forum

A global framework- ability to leverage global warehouse of data to promote innovation and protect patient safety.

WW Vice President of Regulatory and Clinical Affairs and Global Head of Evidence Generation Medical Device Companies of Johnson & Johnson

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1. UDI Helps Create Usable and Accessible Evidence (consistent, standardized)

2. But Only if It is Captured Here and Reported in a consistent and quality manner

3. And only if the data carriers and information provided by manufacturers is usable (accurate and relevant)

A Continuous Learning System Depends on Quality Data across the Medical Device Lifecycle

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Do Customers Want UDI?Can they even use it?

(6 Dec 2017)

Phil ThurlbyFormerly Leeds Teaching Hospitals UK

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Not Just a Regulation…

• PIP Breast Implants• Metal-on-Metal Hips

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Traditional Recall…

• Numerous Types• Centrally coordinated• Clinical Staff Involved

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The Real Issue…

• Scandals• Staffing Levels• Patient Care

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What Providers Must Do…

• Can’t just demand UDI• Need to use it

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Why Should You Care…?

• The Patient• The Customer• The Brand

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The Medical Device Manufacturer Perspective

• Dawn Fowler, Program Manager, UDI and Master Data, Massimo

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Customer Input is Critical • Leverage customer experience for feedback

– All thru supply chain to end user• UDI/direct mark placement

• Ease of use - identification/consistency• Non-optimal design due to timelines, cost• “ We just want to get it over and done”

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Manufacturer Experience• Clearly understand requirements• Competing/conflicting/ever changing • Key factor in understanding the evolving

requirements landscape - RA Intelligence

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• Leverage use of UDI carrier and Master Data information from “cradle to grave”– Both internal and external advantages– Potential cost savings throughout supply

chain

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Not a “One & Done”• Continue evolving and honing processes• Plan for future expansion

– Governance/guidance – Short/long term solutions

• Company recognition of importance and long term implications to the business

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The IVD Manufacturer View• Melissa Finocchio, Project Portfolio Leader, Global

Quality, bioMérieux

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• Remember the IVDR origin : safety• Take a close look at end to end processes• Put your product in the hands of the user• Don’t focus only on gaps

IVD Manufacturer Perspective

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Time for Questions

and Answers