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Medical Device Resources by Marjorie Greer

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Medical Device Resources by Marjorie Greer June 14th, 2010 Marjorie Greer 13+ years with Abbott Vascular Abbott Vascular is part of Abbott Laboratories Abbott ... – PowerPoint PPT presentation

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Title: Medical Device Resources by Marjorie Greer


1
Medical Device Resourcesby Marjorie Greer
  • June 14th, 2010

2
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 (RD,
    Marketing, Regulatory, Clinical, etc.) worldwide

3
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

4
What this means
  • Multiple components to think about
  • Biological
  • Engineering/Materials
  • Marketing
  • Regulatory Affairs

5
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

6
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

7
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
  • AAMIs (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

8
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

9
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?

10
Materials-References
  • ASMs (Association of Society of
    Materials)-Essential tool (http//products.asminte
    rnational.org/matinfo/index.jsp)
  • ASM Handbooks online
  • Failure analysis center
  • Alloy center online

11
Materials-References
  • ASMs 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

12
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

13
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)

14
Regulatory
  • Devices have a different regulatory process to go
    through than Drugs
  • Stages are
  • RD 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.

15
Regulatory
  • The Sheets
  • For Medical, its 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.medicaldevicestod
    ay.com/regulatory/)
  • Has highlights from the Gray Sheet, Silver Sheet,
    In Vivo, Start Up, and Strategic Transactions)

16
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

17
Some vendors here at SLA
  • ASM InternationalBooth 1622
  • ASTM InternationalBooth 1606
  • Elsevier Business IntelligenceBooth 1232
  • IEEEBooth 1303
  • Informa HealthcareBooth 634

18
Medical devices wrap-up
  • Contact Information
  • Marjorie Greer
  • Marjorie.greer_at_av.abbott.com
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