Presentation on theme: "Medical Device Resources by Marjorie Greer"— Presentation transcript:
1 Medical Device Resources by Marjorie Greer June 14th, 2010
2 Marjorie Greer 13+ years with Abbott Vascular Abbott Vascular is part of Abbott LaboratoriesAbbott Vascular specializes in developing & manufacturing devices for the coronary and endovascular areas of the bodyWork with all divisions of Abbott Vascular (R&D, Marketing, Regulatory, Clinical, etc.) worldwide
3 Medical Devices Defined Medical device vs drugDrug is considered a product that produces a chemical reaction in the bodyMedical devices are products that affect a human or animal that does not have a chemical reaction in the bodyX Ray machinesKnee/hip replacementsPacemakersIn vitro laboratory equipment
4 What this means Multiple components to think about Biological Engineering/MaterialsMarketingRegulatory Affairs
5 EngineeringSome medical devices have multiple parts that need to be put together, and also are the same people who manufacture the deviceDevices can be put together by:LasersSauterBondingAdhesiveInjection molded
6 Engineering References Thomas Net (www.thomasnet.com), was Thomas RegisterIndustrial search engineCan search for parts and materials, can narrow it down by state, has been around for over 100 yearsOne downside-companies are not included automatically, have to contact Thomas netAn example-an employee needs to make a injection mold, and they come to you to find out what companies serve LouisianaAnswer-A company in Pennsylvania serves the state
7 Engineering-References Rules and guidelines have to be met for medical devices within the United StatesASTMs (American Society for Testing and Materials) (http://www.astm.org/ )Standard Specification and Test Methods for Metallic Bone StaplesStandard Specification for Polysulfone Resin for Medical ApplicationsStandard Guide for Accelerated Aging of Sterile Barrier Systems for Medical DevicesAAMI’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 alloysA 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 EuropeISO (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 TorsionBiological evaluation of medical devices Part 14: Identification and quantification of degradation products from ceramicsWelding and allied processes - Classification of geometric imperfections in metallic materials - Part 1 : fusion welding
9 Materials Medical devices are made of different materials GoldPlatinumMagnesiumCeramicStainless steelPlasticA 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 onlineFailure analysis centerAlloy center online
11 Materials-References ASM’s materials for medical devices database (http://products.asminternational.org/meddev/index.aspx)CardiovascularOrthopedicDental and Neurological-in productionCan identify which materials is what mechanical designCan compare different materials, coatings, and processes
12 Materials-References IEEE (www.ieee.org)Members are for collaboration on technologies that benefit humanity, such as:ComputingRoboticsElectrical EngineeringBiotechnologyConferences, books, journals include titles such as:IEEE Transactions on device and material reliabilityIEEE Transactions on biomedical engineeringIEEE 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 is7 sectors only (Atrial fibrillation, CRM, regeneration, Drug eluting stents, etc)Includes searching by product, company, trials, IP)Online free newslettersMedical Device and Diagnostic Industry online newsletter (http://www.mddionline.com/)Have to read where the start-ups get their funding from:Start Up journalIn Vivo journalMedtech Insight journal (all published from Elsevier Business Intelligence)Clinica Medtech Intelligence (published by Informa Healthcare)
14 RegulatoryDevices have a different regulatory process to go through than DrugsStages are:R&D PhasePre clinical phaseClinicalPre market approval (PMA) or 510 (k)sMedical Device Reporting - 21 CFR Part 803Incidents 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 Medical device websites For Medical, it’s the Gray Sheet and the Silver Sheet (published by Elsevier Business Intelligence)Medical device websitesIdrac (http://www.idrac.com/)International website, both pharma and medical deviceIncludes the language the documents are originally inMedical 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 exampleChallengesRegulatory-CDRH AND CDER ReviewedChemistry of Drugs and MaterialsChemistry of Drugs and Polymer
17 Some vendors here at SLA ASM International=Booth 1622ASTM International=Booth 1606Elsevier Business Intelligence=Booth 1232IEEE=Booth 1303Informa Healthcare=Booth 634
18 Medical devices wrap-up Contact InformationMarjorie Greer
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