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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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marjorie greer
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
medical devices defined
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
what this means
What this means
  • Multiple components to think about
    • Biological
    • Engineering/Materials
    • Marketing
    • Regulatory Affairs
engineering
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
engineering references
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
engineering references7
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
engineering references8
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
materials
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?
materials references
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
materials references11
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
materials references12
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
marketing
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)
regulatory
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.
regulatory15
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)
medical device current future challenges
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
some vendors here at sla
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
medical devices wrap up
Medical devices wrap-up
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