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 (R&D, 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 • 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

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.asminternational.org/matinfo/index.jsp) • ASM Handbooks online • Failure analysis center • Alloy center online

11. 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

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: • 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.

15. 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)

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 International=Booth 1622 • ASTM International=Booth 1606 • Elsevier Business Intelligence=Booth 1232 • IEEE=Booth 1303 • Informa Healthcare=Booth 634

18. Medical devices wrap-up • Contact Information • Marjorie Greer • Marjorie.greer@av.abbott.com