Transcript Medical Device Resources by Marjorie Greer

Medical Device Resources
by Marjorie Greer
June 14th, 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
• Work with all divisions of Abbott Vascular
(R&D, Marketing, Regulatory, Clinical,
etc.) worldwide
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
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X Ray machines
Knee/hip replacements
Pacemakers
In vitro laboratory equipment
What this means
• Multiple components to think about
– Biological
– Engineering/Materials
– Marketing
– Regulatory Affairs
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:
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Lasers
Sauter
Bonding
Adhesive
Injection molded
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-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-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
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Medical devices are made of different
materials
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Gold
Platinum
Magnesium
Ceramic
Stainless steel
Plastic
A common theme for searches is-what kinds of
allergic reaction comes with a material?
Materials-References
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ASMs (Association of Society of
Materials)-Essential tool
(http://products.asminternational.org/mati
nfo/index.jsp)
– ASM Handbooks online
– Failure analysis center
– Alloy center online
Materials-References
• ASM’s materials for medical devices database
(http://products.asminternational.org/meddev/ind
ex.aspx)
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Cardiovascular
Orthopedic
Dental and Neurological-in production
Can identify which materials is what mechanical
design
– Can compare different materials, coatings, and
processes
Materials-References
• IEEE (www.ieee.org)
– Members are for collaboration on technologies that
benefit humanity, such as:
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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
• 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
• Devices have a different regulatory process to go through than
Drugs
• Stages are:
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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.
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 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
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ASM International=Booth 1622
ASTM International=Booth 1606
Elsevier Business Intelligence=Booth 1232
IEEE=Booth 1303
Informa Healthcare=Booth 634
Medical devices wrap-up
• Contact Information
– Marjorie Greer
– [email protected]