Challenges for the Medical Device Industry

James P. Vetro, P.E.GE HealthcareGlobal Engineering Manager – RoHS & Substances4 May 2011

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Agenda

• Who is GE Healthcare?• What challenges does the Medical Device

Industry face?• Safety and Reliability• Accurate Medical Diagnostics• Large Scale Diagnostic Scanners

• How will GE Healthcare be compliant with substance regulations?• Unique exemptions for Medical Devices• Supply chain expectations

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GE is a family of businesses aligned with our customers’ needs.

Healthcare

Home & BusinessSolutions

GE Capital

A global company

Operations in over 100+ countries

300,000+employees worldwide

Manufacturing facilities in 40+ countries

Energy TechnlologyInfrastructure

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GE Healthcare

http://www.youtube.com/watch?v=-iQLpqoEgCA

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GE Healthcare

GE Healthcare brings the world medical science and technologies that are helping to transform healthcare. We are working with our partners in healthcare to help them predict, diagnose, inform, and treat disease earlier than ever.

$17B business, 42,000 employees

Diagnostic Imaging • Interventional Cardiology & Surgery • Clinical Systems Healthcare Information Technologies • Services • Bio-Sciences

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Safety and Reliability are highest priority

Rotating Parts

High G-Forces

New Technology

Innovation

Complexity

Challenges for the Medical Device Industry

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Accurate medical diagnosis is critical

Critical Information for Doctors

Accurate diagnosis for the patients

RoHS Compliant designs must not compromise system reliability

Challenges for the Medical Device Industry

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Large Scale Medical Diagnostic Scanners

What are they made of?• Computers• Monitors• Power supplies• Mechanical Parts• Plastics• Cables• Integrated Circuits

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Quality Management System• Design Control• Purchasing Control• Production & Process

Control

Safety and Reliability Required by Regulators

Technical Considerations• Tin whiskers• Plating material• Under fill• Conformal coating• Redundancy

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Components

PWAs/HLAs

Plastics

F&M

OEM Parts

RoHS Materials in Medical Devices

Finished Product

Present in all products, at all

levels of assembly!!!

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• Lead for shielding X-Ray radiation

• Lead in solders in portable emergency defibrillators

• Lead in solders for bonding to ultrasonic transducers

Medical Devices have unique requirementsRoHS Exemptions for Medical Devices

1) Certificate of conformance(Supplier declaration of conformance)

2) IPC1752 Material Declaration(Concentration data for RoHS substances)

3) Test Reports* available

* EU RoHS 2

Finishedproduct

Assemblies

Components

Supply Chain ExpectationsHow will GE Healthcare be RoHS Compliant?

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Technical Documentation

• Description of product

• Drawings of components, sub-assemblies, circuits, etc.

• Descriptions necessary for the understanding of those

drawings and schemes and the operation of the product

• Test reports

EU RoHS 2 Requirements

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1. Clearly define requirements for supply chain2. Train Suppliers (Awareness) 3. Assess suppliers’ capabilities (QMS)

• Supply chain control (2nd and 3rd tier) • Inventory control • Process control

4. Reduce / eliminate supplier risk through: • Training• On-site audits• Incoming inspection

5. Sustain compliance

Supply Chain ControlHow will GE Healthcare be RoHS Compliant?

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Testing for Compliance

diphenyl carbazide test for Cr+6

XRF Screening

Supply Chain ControlHow will GE Healthcare be RoHS Compliant?

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Summary

• Safety and Reliability top priority• Accurate medical diagnosis is critical• Medical devices are made of commercial parts• Technical Documentation required• Supply Chain control is essential

• QMS• Declarations• Self audits, etc.

• RoHS Regulations are becoming more rigorous

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Thank You!

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James P. Vetro, P.E.Global Engineering Manger – RoHS and SubstancesGE Healthcare

James Vetro is the GE Healthcare Global Engineering Manager for RoHS and Substances.

As the Global Engineering RoHS and Substance manager for GE Healthcare, he has responsibility for leading the engineering teams across GE Healthcare. Specific responsibilities include interpreting RoHS regulations and developing engineering requirements for GE Healthcare products, analyzing the use of alternate materials while ensuring safety and reliability, developing processes and integrating tools into design workflows and driving execution of RoHS regulations into product designs.

James started his career as an electrical hardware design engineer with a defense contractor developing flight simulators. He then joined GE Healthcare in 1984 designing electrical hardware for the newly formed MRI product line. After about 10 years of design activities, he progressed through several management roles in the MRI Engineering organization including; Program Manager of MR guided Focused Ultrasound, Manager of Digital Hardware Engineering, Global Productivity Manager, Manager of Global Growth Technology Segment and Strategic Quality Leader, until his current role which he accepted in May of 2006.

Education:B.S. Electrical Engineering, State University of New York at BuffaloM.S. Electrical Engineering, Syracuse University

Six sigma Master black belt certified

James.vetro@med.ge.com