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 • • • • 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: – – – – – 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 • 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 • 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) – – – – 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: • • • • 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: – – – – 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 • • • • • 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 – Marjorie.greer@av.abbott.com