Med Device Manufacturers’ Perspectives on Merging Global

Requirements

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Steve Roan Sr. Director, Portfolio Data & Standards

Dennis Black Director of eBusiness

Dawn Fowler Director, UDI / Master Data Management

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Smith & Nephew is a diversified advanced medical technology business that supports healthcare professionals in more than 100 countries to improve the quality of life for their patients.

We have more than 15,000 employees around the world.

15,000

100 Leading positions in:

• Sports Medicine

• Orthopaedic Reconstruction

• Trauma & Extremities

• Advanced Wound Mgmt

We Are Smith & Nephew

Large Global Catalog

Global Footprint – Design & Manufacturing

Complex IT Landscape

Emerging Corporate Approach to Data Management and Exchange

We are a leading global medical technology company uniquely positioned to improve both the

treatment of disease and the process of care.

• Global position: One of the top 5 medical

technology companies in the world

with ~$16 billion annual revenues

• Founded in 1897: A legacy of health impact

• Global reach: Serving 190+ countries

• Employees: 65,000

• Annual investment in innovation: $1+ billion

Improving Patient Outcomes and Reducing the Cost of Care

• Throughout its more than 25-year journey, Masimo’s mission – to improve patient care globally – has remained strong.

• Over 4,600 talented people worldwide

• Operations in North America, Europe, Latin America, the Middle East, Asia, and Australia

• Masimo is publicly traded with annual revenues of approximately $800 million.

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US UDI

EU MDR

UK NHS

Country Requirements (Ministry of Health, others) • UK NHS • Spain – Institute of Catalan • Nordic Region – tenders • Taiwan: (Voluntary) • Japan MHLW (Already in place)

Commercial • US IDNs (Kaiser, others) • US GPOs • US ONC/EHRs, CMS • Canadian GPOs • Abu Dhabi, Cleveland Clinic • Qatar, Hamad Medical • Netherlands, Hospitals • German GPOs • Swiss e-Comm

Regulation • Turkey: 2018 and beyond • India: 2022 • Saudi Arabia: 2019? • Taiwan: 2019-2020? • China: Spring 2020? • South Korea: 2019-2022 • Singapore? • Health Canada?

• MDIC/NEST • Case for Quality • Registries, Sentinel

Growing Demand for UDI & Data

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Institutionalize

Enable Through

Technology Engage Stakeholders

Smith & Nephew’s Emerging Corporate Approach Project Process

Deploy

Organize

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• Unrealistic “Data Buffet” – the list continues to grow

• Imprecise data definitions “Look-alike” attributes

• Lack of harmonization, at a fundamental level

• Different DI Triggers

• Country-specific bar code requirements

• Dissimilar manufacturer adherence to sometimes vague Issuing Agency standards causes confusion.

• Healthcare Providers knowledge & capabilities vary.

• New requirements & shorter implementation runways

Challenges

Data Buffet: Some of the data ordered is never consumed

Panel Discussion

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Shared Vision • Recommitment to global harmonization and

Standardization

• Resist the urge to add more attributes

• Focus

– Prioritize use-cases (what are we solving for)

– Understand what data is truly critical

– Intensify focus on enabling data consumption

– Invest in provider education & technology

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