Challenges for the Medical Device Industry. James P. Vetro, P.E. GE Healthcare Global Engineering Manager RoHS & Substances 4 May 2011

Transcription

1 Challenges for the Medical Device Industry James P. Vetro, P.E. GE Healthcare Global Engineering Manager RoHS & Substances 4 May 2011

2 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 J. P. Vetro 2011 slide#1

3 A global company GE is a family of businesses aligned with our customers needs. Operations in over 100+ countries 300,000+ employees worldwide Manufacturing facilities in 40+ countries Energy Home & Business Solutions Technlology Infrastructure GE Capital Healthcare J. P. Vetro 2011 slide#2

4 GE Healthcare J. P. Vetro 2011 slide#3

5 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 J. P. Vetro 2011 slide#4

6 Challenges for the Medical Device Industry Safety and Reliability are highest priority Rotating Parts High G-Forces New Technology Innovation Complexity J. P. Vetro 2011 slide#5

7 Challenges for the Medical Device Industry Accurate medical diagnosis is critical Critical Information for Doctors Accurate diagnosis for the patients RoHS Compliant designs must not compromise system reliability J. P. Vetro 2011 slide#6

8 Large Scale Medical Diagnostic Scanners What are they made of? Computers Monitors Power supplies Mechanical Parts Plastics Cables Integrated Circuits J. P. Vetro 2011 slide#7

9 Safety and Reliability Required by Regulators Quality Management System Design Control Purchasing Control Production & Process Control Technical Considerations Tin whiskers Plating material Under fill Conformal coating Redundancy J. P. Vetro 2011 slide#8

10 RoHS Materials in Medical Devices Component s PWAs/HLAs Present in all products, at all levels of assembly!!! Plastic s Finished Product F&M OEM Parts J. P. Vetro 2011 slide#9

11 RoHS Exemptions for Medical Devices Medical Devices have unique requirements Lead for shielding X-Ray radiation Lead in solders in portable emergency defibrillators Lead in solders for bonding to ultrasonic transducers J. P. Vetro 2011 slide#10

12 How will GE Healthcare be RoHS Compliant? Supply Chain Expectations Finished product Assemblies Components 1) Certificate of conformance (Supplier declaration of conformance) 2) IPC1752 Material Declaration (Concentration data for RoHS substances 3) Test Reports* available * EU RoHS 2

13 EU RoHS 2 Requirements 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 J. P. Vetro 2011 slide#12

14 How will GE Healthcare be RoHS Compliant? Supply Chain Control 1. Clearly define requirements for supply chain 2. Train Suppliers (Awareness) 3. Assess suppliers capabilities (QMS) Supply chain control (2 nd and 3 rd tier) Inventory control Process control 4. Reduce / eliminate supplier risk through: Training On-site audits Incoming inspection 5. Sustain compliance J. P. Vetro 2011 slide#13

15 How will GE Healthcare be RoHS Compliant? Supply Chain Control Testing for Compliance diphenyl carbazide test for Cr+6 XRF Screening J. P. Vetro 2011 slide#14

16 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 J. P. Vetro 2011 slide#15

17 Thank You! J. P. Vetro 2011 slide#16

18 James P. Vetro, P.E. Global Engineering Manger RoHS and Substances GE 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 Education: B.S. Electrical Engineering, State University of New York at Buffalo M.S. Electrical Engineering, Syracuse University Six sigma Master black belt certified James.vetro@med.ge.com J. P. Vetro 2011 slide#17