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Medical Device Resources by Marjorie Greer. June 14 th , 2010. Marjorie Greer. 13+ years with Abbott Vascular Abbott Vascular is part of Abbott Laboratories Abbott Vascular specializes in developing & manufacturing devices for the coronary and endovascular areas of the body

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Medical Device Resourcesby Marjorie Greer

June 14th, 2010


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Marjorie Greer

  • 13+ years with Abbott Vascular

  • Abbott Vascular is part of Abbott Laboratories

  • Abbott Vascular specializes in developing & manufacturing devices for the coronary and endovascular areas of the body

  • Work with all divisions of Abbott Vascular (R&D, Marketing, Regulatory, Clinical, etc.) worldwide


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Medical Devices Defined

  • Medical device vs drug

    • Drug is considered a product that produces a chemical reaction in the body

    • Medical devices are products that affect a human or animal that does not have a chemical reaction in the body

      • X Ray machines

      • Knee/hip replacements

      • Pacemakers

      • In vitro laboratory equipment


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What this means

  • Multiple components to think about

    • Biological

    • Engineering/Materials

    • Marketing

    • Regulatory Affairs


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Engineering

  • Some medical devices have multiple parts that need to be put together, and also are the same people who manufacture the device

  • Devices can be put together by:

    • Lasers

    • Sauter

    • Bonding

    • Adhesive

    • Injection molded


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Engineering References

  • Thomas Net (www.thomasnet.com), was Thomas Register

  • Industrial search engine

  • Can search for parts and materials, can narrow it down by state, has been around for over 100 years

  • One downside-companies are not included automatically, have to contact Thomas net

  • An example-an employee needs to make a injection mold, and they come to you to find out what companies serve Louisiana

  • Answer-A company in Pennsylvania serves the state


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Engineering-References

  • Rules and guidelines have to be met for medical devices within the United States

    • ASTMs (American Society for Testing and Materials) (http://www.astm.org/ )

      • Standard Specification and Test Methods for Metallic Bone Staples

      • Standard Specification for Polysulfone Resin for Medical Applications

      • Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

    • AAMI’s (Association for the Advancement of Medical Instrumentation) (http://www.aami.org/ )

      • Biological evaluation of medical devices— Part 15: Identification and quantification of degradation products from metals and alloys

      • A Compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices


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Engineering-References

  • Rules and guidelines have to be met for medical devices within Europe

    • ISO (International Standards Organization)

      • Orthopaedic Joint Prostheses Part 6: Method for Determination of Endurance Properties of Stemmed Femoral Components of Hip Joint Prostheses Without Application of Torsion

      • Biological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramics

      • Welding and allied processes - Classification of geometric imperfections in metallic materials - Part 1 : fusion welding


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Materials

  • Medical devices are made of different materials

    • Gold

    • Platinum

    • Magnesium

    • Ceramic

    • Stainless steel

    • Plastic

  • A common theme for searches is-what kinds of allergic reaction comes with a material?


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Materials-References

  • ASMs (Association of Society of Materials)-Essential tool (http://products.asminternational.org/matinfo/index.jsp)

    • ASM Handbooks online

    • Failure analysis center

    • Alloy center online


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Materials-References

  • ASM’s materials for medical devices database (http://products.asminternational.org/meddev/index.aspx)

    • Cardiovascular

    • Orthopedic

    • Dental and Neurological-in production

    • Can identify which materials is what mechanical design

    • Can compare different materials, coatings, and processes


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Materials-References

  • IEEE (www.ieee.org)

    • Members are for collaboration on technologies that benefit humanity, such as:

      • Computing

      • Robotics

      • Electrical Engineering

      • Biotechnology

    • Conferences, books, journals include titles such as:

      • IEEE Transactions on device and material reliability

      • IEEE Transactions on biomedical engineering

      • IEEE Transactions on nanotechnology


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Marketing

  • Devices are relatively new compared to drugs

  • Nothing out there quite like Thomson Pharma (yet)

    • For cardiovascular device area, there is www.cvpipeline.com

      • 7 sectors only (Atrial fibrillation, CRM, regeneration, Drug eluting stents, etc)

      • Includes searching by product, company, trials, IP)

  • Online free newsletters

    • Medical Device and Diagnostic Industry online newsletter (http://www.mddionline.com/)

  • Have to read where the start-ups get their funding from:

    • Start Up journal

    • In Vivo journal

    • Medtech Insight journal (all published from Elsevier Business Intelligence)

    • Clinica Medtech Intelligence (published by Informa Healthcare)


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Regulatory

  • Devices have a different regulatory process to go through than Drugs

  • Stages are:

    • R&D Phase

    • Pre clinical phase

    • Clinical

    • Pre market approval (PMA) or 510 (k)s

  • http://www.fda.gov/MedicalDevices/default.htm

  • Medical Device Reporting - 21 CFR Part 803

  • Incidents in which a device may have caused or contributed to a death or serious injury must to be reported to FDA under the Medical Device Reporting program. In addition, certain malfunctions must also be reported. The MDR regulation is a mechanism for FDA and manufacturers to identify and monitor significant adverse events involving medical devices. The goals of the regulation are to detect and correct problems in a timely manner.


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Regulatory

  • The Sheets

    • For Medical, it’s the Gray Sheet and the Silver Sheet (published by Elsevier Business Intelligence)

  • Medical device websites

    • Idrac (http://www.idrac.com/)

      • International website, both pharma and medical device

      • Includes the language the documents are originally in

    • Medical Device Today (http://www.medicaldevicestoday.com/regulatory/)

      • Has highlights from the Gray Sheet, Silver Sheet, In Vivo, Start Up, and Strategic Transactions)


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Medical device - Current/future challenges

  • Medical devices have a fast growing segment of combination products (drugs/devices)

    • Drug Eluting stents one example

  • Challenges

    • Regulatory-CDRH AND CDER Reviewed

    • Chemistry of Drugs and Materials

    • Chemistry of Drugs and Polymer


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Some vendors here at SLA

  • ASM International=Booth 1622

  • ASTM International=Booth 1606

  • Elsevier Business Intelligence=Booth 1232

  • IEEE=Booth 1303

  • Informa Healthcare=Booth 634


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Medical devices wrap-up

  • Contact Information

    • Marjorie Greer

    • [email protected]


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