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Medical Device Resources on Dialog & DataStar

Medical Device Resources on Dialog & DataStar. Bonnie Snow Director, Pharmaceutical Markets. Vendor Update SLA Pharmaceutical & Health Technology Division Toronto, June 2005. Answering medical device inquiries requires access to…. Biomedical bibliographic databases Engineering literature

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Medical Device Resources on Dialog & DataStar

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  1. Medical Device Resources on Dialog & DataStar Bonnie Snow Director, Pharmaceutical Markets Vendor Update SLA Pharmaceutical & Health Technology Division Toronto, June 2005

  2. Answering medical device inquiries requires access to… • Biomedical bibliographic databases • Engineering literature • Regulatory resources • A highly focused collection of full-text industry newsletters • Subject specialty company & product directories • Market research sources (reports, statistics) • Intellectual property databases

  3. Dialindex/OneSearch Category MEDDEV File 2:INSPEC 1969-2005 File 5:Biosis Previews(R) 1969-2005 File 6:NTIS 1964-2005 File 8:Ei Compendex(R) 1970-2005 File 34:SciSearch(R) Cited Ref Sci 1990-2005 File 35:Dissertation Abs Online 1861-2005 File 65:Inside Conferences 1993-2005 File 73:EMBASE 1974-2005 File 74:Int.Pharm.Abs 1970-2005 File 92:IHS Intl.Stds.& Specs. 1999/Nov File 94:JICST-EPlus 1985-2005 File 144:Pascal 1973-2005 File 155:MEDLINE(R) 1951-2005 File 158:DIOGENES(R) 1976-2005 File 172:EMBASE Alert 2005 File 182:FDA News Mar. 2002-2005 File 188:Health Devices Sourcebook 2004 File 198:Health Devices Alerts(R) 1977-2005 File 399:CA SEARCH(R) 1967-2005 File 434:SciSearch(R) Cited Ref Sci 1974-1989 File 441:ESPICOM Pharm&Med DEVICE NEWS 2005 File 444:New England Journal of Med. 1985-2005

  4. Some Distinctions Among Major Biomedical Bibliographic Sources… • MEDLINE • Best coverage of dental literature among major biomedical bibliographic databases • Pertinent subheadings to identify references to Instrumentation (IS) and Methods (MT) • EMBASE • Generally considered to provide better coverage of selected subject specialty areas, including: • Biomedical engineering & instrumentation, medical devices • Ophthalmology • Plastic surgery • Pharmaceutics (PR) singled out as a LINK term, as are routes of drug administration – Important in isolating references to new drug delivery systems that include a device component • Quicker to adopt new vocabulary for use in controlled indexing, e.g., drugeluting stent added as controlled (thesaurus) term in June 2003 • When primary source cites device brand name(s) and/or specific manufacturers, EMBASE includes names in online records (provides access to product-oriented literature, even when names have been omitted in the author’s original title and abstract)

  5. Some Distinctions Among Major Biomedical Bibliographic Sources… • BIOSIS Previews • Broader subject coverage: all life sciences, including biophysics & bioengineering • Pertinent Major Concept indexing: “Biomedical Engineering”; “Equipment, Apparatus, Devices and Instrumentation” • Emphasis on research, rather than routine clinical practice or established procedures, making it a good source for searching medical technologies under development & preclinical literature • Provides access to additional resources not found in other “Big 4” files • Books, theses, reports, U.S. patents, proceedings of scientific symposia, conference papers & poster presentations at scientific meetings • SciSearch • Multi-disciplinary in scope, with coverage of 5,200 journals, provides access to a cross-section of literature that includes not only biomedical journals, but also engineering, mathematics, biophysics, and pharmaceutical technology resources • Cover-to-cover indexing not found elsewhere • Extremely timely; very short lag time • Natural language indexing reflects terminology changes, new concept vocabulary • Cited reference search capabilities

  6. Complementary Resources • International Pharmaceutical Abstracts • Can contribute unique references to specialty journals in the pharmaceutics & pharmaceutical technology subject areas – helpful when focusing on new drug delivery technologies that involve a device component • CA Search • Another source for pharmaceutics-oriented literature. Also indexes conference proceedings & provides a selective gateway to the patent literature • JICST • Coverage of literature published in Japan, encompassing all fields of science, technology, and medicine. Indexing of 6,000 journals + conference papers, technical reports • PASCAL • Often yields additional references to scientific & technical literature, including conference papers

  7. Engineering Literature Indexes • In the engineering literature, topical emphasis shifts to durability testing, mathematical analysis, materials science (preparation, characterization, manufacturing) • Database coverage of technical conference proceedings is a bonus • EI Compendex • Take advantage of hierarchical Classification Code indexing: Bioengineering codes under CC=46 • CC=46 (BIOENGINEERING) • CC=461.1 (BIOMEDICAL ENGINEERING) • CC=461.2 (BIOLOGICAL MATERIALS) • CC=461.3 (BIOMECHANICS) • CC=461.4 (HUMAN ENGINEERING) • CC=461.5 (HUMAN REHABILITATION ENGINEERING) • CC=461.6 (MEDICINE) • CC=461.7 (HEALTH CARE) • CC=461.8 (BIOTECHNOLOGY) • CC=461.8.1 (GENETIC ENGINEERING) • CC=461.9 (BIOLOGY) • CC=461.9.1 (IMMUNOLOGY) • CC=462 (MEDICAL ENGINEERING & EQUIPMENT) • CC=462.1 (BIOMEDICAL EQUIPMENT, GENERAL) • CC=462.2 (HOSPITALS, EQUIPMENT & SUPPLIES) • CC=462.3 (DENTAL EQUIPMENT & SUPPLIES) • CC=462.4 (PROSTHETICS) • CC=462.5 (BIOMATERIALS)

  8. Engineering Literature Indexes • INSPEC • Device related class codes under: CC=A87, CC=B75, e.g.: • CC=A8770 Biomedical engineering • CC=A8770E Patient diagnostic methods & instrumentation • CC=A8770F Electrodiagnostics • CC=A8770J Prosthetics & other practical applications • CC=A8780 Biophysical instrumentation & techniques • CC=A8780B Biosensors • CC=B7500 Medical physics & biomedical engineering • CC=B7510 Biomedical measurement & imaging • CC=B7510B Radiation & radioactivity applications in biomedicine • CC=B7510D Bioelectric signals • CC=B7520C Radiation therapy • CC=B7520E Prosthetics & orthotics • CC=B7530 Health Physics • CC=B7530B Radiation protection & dosimetry • CC=B7540 Hospital Engineering plus… • CC=C1290L Systems theory applications in biology & medicine • CC=C3385 Biological & medical control systems • CC=C3385C Prosthetic & orthotic control systems • CC=C7140 Medical administration • CC=C7330 Biology and medical computing • CC=D2060 Health care applications

  9. Engineering Literature Indexes MEDITEC: Biomedical Engineering • BMED on DataStar, 1986 - present, updated weekly • Compiled by FIZ Technik, the MEDITEC database contains citations, with abstracts, to the international literature on biomedical engineering. Information is compiled from journals, conference papers, books, technical reports, and dissertations. The primary language of the database is German, but many search terms and abstracts are also in English. • Topics covered include: • Biomedical measurements (recording, plotting, processing, and evaluation of physiological parameters) • Medical imaging (e.g., computed tomography, magnetic resonance imaging) • Data processing in medicine • Biomaterials and materials for medical instrumentation • Medical instruments for diagnostic and therapeutic applications • Prostheses and rehabilitation engineering • Clinical laboratory technology • Optometry and ophthalmological instruments • Dental technology • Clinical engineering, hospital management

  10. Answering medical device inquiries requires access to… • Biomedical bibliographic databases • Engineering literature • Regulatory resources • A highly focused collection of full-text industry newsletters • Subject specialty company & product directories • Market research sources (reports, statistics) • Intellectual property databases

  11. Regulatory Information Sources DIOGENES FDA Regulatory Updates – File 158, DIOG (FOI Services) • Premarket Application (PMA) approvals & 510K notifications (1976 - ) • Access to DIOGENES on Dialog facilitates downloading of retrospective data for post-processing and analysis, e.g., easy export of XML data in EXCEL spreadsheet format via DialogLink 5 • Product recalls (1984 - ) • More retrospective coverage than offered on FDA Web site (1990 - ) • FDA.GOV search capabilities for product recalls are extremely limited. The current search interface identifies only the co-occurrence of terms within entire issues of the FDA Enforcement Report, making it difficult to isolate pertinent data from individual recalls & resulting in many “false drops” • Enhanced accessibility to recall data through DIOGENES on Dialog • Easy to single out Class I, II, or III recalls for given companies in specified time periods • Dialog users of DIOGENES can also produce RANKed analyses of enforcement actions for comparisons/trend monitoring • Medical Device Reports (MDRs = adverse experience/incident reports), 1985 – • DIALOG RANK capabilities enable statistical analysis of MDRs, e.g., examination of a specified company’s product line by ranked incidence of adverse experience reports; review the “track record” of an entire device category & compare incidence of AEs associated with given companies

  12. Regulatory Information Sources Health Devices Alerts – File 198 (ECRI), updated weekly • Database compiles reports of problems with specified devices, plus references to published evaluations and technology assessments • MDRs (1985-1996) • Action Items – Most are related to recalls that ECRI has investigated or verified (1982 -) • Provide details not readily accessible elsewhere online, such as specific follow-up recommendations issued by manufacturers to avoid or remedy further problems with named devices • ECRI also often identifies errors or omissions in original FDA notices (e.g., incorrect serial #s of affected models) • Abstracts of articles from the published literature, 1977 - • Brand & mfg name access to pertinent bibliography in primary medical literature, augmenting accessibility to same articles cited in EMBASE & MEDLINE • ECRI abstracts of source documents typically provide more detailed data than that included in the original author abstract reproduced in other bibliographic databases

  13. Regulatory Information Sources • Regulatory Affairs Journal • PHRJ on DataStar, January 2003 – present • Forthcoming on Dialog • Worldwide regulatory intelligence, news, and informed commentary • Produced by T&F Informa UK Ltd (formerly PJB Publications), these full-text journals report on pertinent legislation, approval application requirements & guidelines, pharmacovigilance initiatives, and harmonisation, trade, and environmental issues with potential impact on drug regulation & marketing worldwide • RAJ Pharma, updated monthly, covers both human & veterinary drug regulatory developments • RAJ Devices, updated bimonthly, focuses on medical device & in vitro diagnostics

  14. Extracts from RAJ Devices TOC – March/April 2005 issue

  15. Article title & full text, including… Cited references Useful when searching for discussion related to specific regulations, directives, or guidelines issued by government authorities Keywords - Controlled descriptors identifying specific topics discussed in articles Examples: “Environment” or “Counterfeit Medicines” Country or region names e.g., “UK” or “European Union” Article type e.g., “Worldwide update” “Reference-Guidelines” “Reference-Standards” “Organisational Charts” Product sectors Subject categories Examples of searchable data elements in the Regulatory Affairs Journal online

  16. Regulatory Affairs Journal enhanced with Images on DataStarWeb platform Example from RAJ - Devices

  17. Regulatory Information Sources EURALex (formerly ERA News, EPLC Update) , 1994 - , updated monthly • Complete text in PHIND (File 129-130, PHIN/PHIC) • Reports on European legal and regulatory affairs likely to affect the human and animal drug and device markets, including changes in the structure and organization of national healthcare systems, individual governments’ policies regarding pricing and reimbursement, control of clinical trials, intellectual property protection, advertising, competition and company law, etc. • Includes expert commentary & analysis of implications • Each issue typical covers.. • New directives, regulations, and guidelines • Court cases & rulings • Developments at national, as well as European, level • Meetings

  18. Regulatory Information Resources CELEX - European Union Law (CLXE) • 1951 – present, updated weekly • CELEX provides the full text and/or references for all European Community legislation and is the only interactive online database covering all EC law. • Coverage includes treaties and other agreements, preparatory legislative documents, parliamentary questions, and individual nation’s implementation measures. • CELEX can help answer such questions as: • Has the EC passed legislation on a particular topic? • Has this been amended? • Has the European Court of Justice ruled on it? • Has there been a question in the European Parliament on it?

  19. Answering medical device inquiries requires access to… • Biomedical bibliographic databases • Engineering literature • Regulatory resources • A highly focused collection of full-text industry newsletters • Subject specialty company & product directories • Market research sources (reports, statistics) • Intellectual property databases

  20. Among full-text subject specialty sources in PHIND… Pharmaceutical & Healthcare Industry News Database (File 129 -130, PHIN/PHIC) includes: • Clinica – World Medical Device & Diagnostics News • Legendary for its scope and timeliness, Clinica reports on a broad spectrum of scientific, political, regulatory, and financial news of vital interest to device industry personnel. Coverage includes informed commentary, critical evaluation of current events, and trend analysis. • Instrumenta • Current awareness source focusing on the analytical instrument and laboratory equipment industries • Target • Focuses on worldwide drug delivery technology & business developments, including products/platforms incorporating medical devices • Each of these titles is offered for TOC Alerts (automated email current awareness & document delivery service -- see additional information in handout)

  21. Other full-text newsletters of potential interest to device searchers… • ESPICOM Pharmaceutical & Medical Device News (File 441, MDNE)includes: • Cardiovascular Device Business • Drug Delivery Insight • Medical Imaging Business • FDA News (File 182) includes: • Devices & Diagnostics Letter (weekly) • FDANews Device Daily Bulletin • The GMP Letter (monthly) • Gale Group Newsletter Database (File 636) includes: • Biomedical Materials • Biotech Equipment Update • Hospital Materials Management • Medical Textiles

  22. Answering medical device inquiries requires access to… • Biomedical bibliographic databases • Engineering literature • Regulatory resources • A highly focused collection of full-text industry newsletters • Subject specialty company & product directories • Market research sources (reports, statistics) • Intellectual property databases

  23. Subject Specialty Company Directories • Health Devices Sourcebook (File 188), updated annually • Provides current address and marketing information for more than 6,000 North American (U.S. & Canadian) manufacturers, distributors, and service companies associated with any of more than 4,500 classes of products. Listings include sources for diagnostic and therapeutic devices and materials, including laboratory equipment and reagents, systems and instruments used to monitor and test equipment, and selected hospital furniture or supplies. • Manufacturer records typically include • name, address, telephone number, fax #, website URL, e-mail address • year started • parent company (when applicable) • # employees, # sales people • total annual sales • fiscal year (month-month range used) • names & titles of executive staff • plus product categories or classes produced and their brand names • Also identify whether publicly or privately owned, minority-owned, woman-owned, eligible for GSA and/VA contracts • Service company entries show category of service (e.g., maintenance, repairs, leases), geographical areas covered, and contact information.

  24. Subject Specialty Company Directories ESPICOM Pharmaceutical & Medical Company Profiles (File 510, MDCO) • Detailed reports on more than 200 ethical pharmaceutical, generics, and medical device companies worldwide • New profiles published annually, updated monthly as new information becomes available

  25. Example of Major Section Headings in ESPICOM’s 2004 profile for Abbott ? RANK S1 SE;CONT;ALL DIALOG RANK Results -------------------- RANK: S1/1-108 Field: SE= File(s): 510 (Rank fields found in 108 records--8 unique terms) Page 1 of 1 RANK No. Items Term -------- ----- ---- 1 46 PRODUCT PORTFOLIO 2 35 AGREEMENTS 3 9 RESEARCH AND DEVELOPMENT 4 6 RECENT HISTORY/CORPORATE STRATEGY 5 5 STRUCTURE AND ACTIVITIES 6 3 FINANCIAL INDICATORS 7 3 GEOGRAPHICAL BREAKDOWN 8 1 PROFILE OVERVIEW ---end of results---

  26. Example of Major Section Headings in ESPICOM’s 2005 profile for Zimmer RANK: S4/1-61 Field: SE= File(s): 510 (Rank fields found in 61 records -- 8 unique terms) Page 1 of 1 RANK No. Items Term -------- ----- ---- 1 36 PRODUCTS 2 10 CORPORATE HISTORY 3 6 FINANCIAL REVIEW 4 3 RESEARCH AND DEVELOPMENT 5 2 CORPORATE STRUCTURE 6 2 INTERNATIONAL ACTIVITIES 7 1 OVERVIEW 8 1 STRATEGIC FOCUS ---end of results--- Financial Review includes separate records tabulating revenue by geographic segment, by operating division, and by product category, as well as overall “financial indicators” data

  27. Extract from a sample record… DIALOG(R)File 510:ESPICOM Pharm & Med Co. Profile (c) 2005 ESPICOM Bus. Int. All rts. reserv. Main Title: Zimmer 2005 Medical Device Company Pub. Date: FEBRUARY 2005 Source: Medical Device Companies Analysis FISCAL 2004 (Part 4) Sales of orthopaedic surgical products rose by 9% in 2004 based on combined results for Zimmer and Centerpulse in 2003. Table 3, Revenue by Product Category, 2003-2004 (US$ million)* 2003 2004 % Change 2003/2004 Reconstructive 1,521.0 2,456.3 61.49 Trauma 150.1 172.9 15.19 Spine 35.1 134.2 282.34 Orthopaedic Surgical Products 194.8 217.5 11.65 Total Revenue 1,901.0 2,980.9 56.81

  28. Answering medical device inquiries requires access to… • Biomedical bibliographic databases • Engineering literature • Regulatory resources • A highly focused collection of full-text industry newsletters • Subject specialty company & product directories • Market research sources (reports, statistics) • Intellectual property databases

  29. Subject Specialty Product Directories Drug Pipeline databases • DO cover products under development in formulations that use drug delivery technologies combining devices + drugs or biologics • Examples: • Drug-eluting stents • Surgical implants • Metered-dose inhalers

  30. Pharmaprojects (File 128,928,PHAR) • Only pipeline file to enhance the EPhMRA therapeutic classification scheme with an entire category designed to improve indexing of formulations • Only file to have hierarchical indexing for routes of administration, as well • “Novelty” rating will help identify products involving new formulations • Sample application… • Drug-eluting stents are indexed with the TC code F9A (Formulation, Implant) • This code can also be used to locate products in other therapeutic areas under investigation for delivery via implantation

  31. ? S TC=F9A S1 85 TC=F9A ? E NR= Ref Items Index-term E1 1 NA=99MTC-ECD E2 1 NA=99MTC-5T4 MAB E3 0 *NR= E4 1495 NR=0 (NOT AVAILABLE) E5 1349 NR=1 (ALL PRECLINICAL) E6 1657 NR=2 (ESTABLISHED STRATEGY) E7 1390 NR=3 (NEW FORMULATION) E8 433 NR=4 (LOW NOVELTY) E9 851 NR=5 (2ND, 3RD OR 4TH COMPOUND) E10 1743 NR=6 (LEADING COMPOUND) ? S E7 S2 1390 NR='3' (NEW FORMULATION) ? S S1 AND S2 S3 43 S1 AND S2 F9A represents FORMULATION, IMPLANT EXPAND for Novelty Rating options Focusing on anticancer products (K category) ? S S3 AND TC=K S4 11 S3 AND TC=K

  32. IMS R&D Focus (File 445, 955, IPUR) • Indexing of drug-eluting stents • “Stent” may appear in the product Name ( /NA) or in the pharmacological action ( /AC) field • However, for stents still in early stage of development, keyword could appear in record text (/TX) • Recommendation: search “stent” without qualification to a specific field Drug Name: drug delivery system, vascular stent sirolimus; sirolimus vascular stent DRUG INFORMATION: Pharmacological Action: antiproliferative agent; stent Therapeutic Class Code: C1D (Coronary Therapy); V7A (All Other Non-Therapeutic Products) Clinical Indications: restenosis

  33. IMS R&D FocusBroader approaches to searching drug delivery • As was illustrated in the previous record extracts, “Drug Delivery System” may be identified in the product Name field ( /NA) • The phrase may also appear in the Substance Origin field • Recommendation: search the phrase without qualification to a specific field • Additional records can be located by searching… • “Delivery System” in the Indications field • “Drug Design Technology” in the /IN field • The keyword “Technology” in Status ( /ST) indexing

  34. IMS R&D FocusBroader approaches to searching drug delivery ? DS Set Items Description S1 1260 DRUG()DELIVERY()SYSTEM/PROFILE S2 965 (DELIVERY()SYSTEM OR DRUG()DESIGN()TECHNOLOGY)/IN S3 873 TECHNOLOGY/ST S4 966 S2 OR S3 Locates additional records not identified with previous strategy. /AVAIL limits results to products available for licensing. ? S S4 NOT S1 S5 748 S4 NOT S1 ? S S5/AVAIL S6 474 S5/AVAIL Because many of these records lack specific Therapeutic (TC) or Indications indexing, search keywords for potential applications as “free text” (without field qualification). ? S S6 AND VACCINE? S7 53 S6 AND VACCINE? See sample record in handout

  35. Adis R&D Insight (File 107,907,ADRD) • Adis does not provide systematic, controlled indexing for easy identification of products incorporating new drug delivery technologies • However, “textword” searches using terms illustrated here will help locate pertinent records. Results could be combined with Indication keywords or Therapeutic Categories ? S DRUG()DELIVERY(3N)(SYSTEM OR TECHNOLOGY OR PLATFORM OR PROPRIETARY OR FORMULATION?)/TX S1 242 DRUG()DELIVERY(3N)(SYSTEM OR TECHNOLOGY OR PLATFORM OR PROPRIETARY OR FORMULATION?)/TX Extracts from sample records in handout

  36. Answering medical device inquiries requires access to… • Biomedical bibliographic databases • Engineering literature • Regulatory resources • A highly focused collection of full-text industry newsletters • Subject specialty company & product directories • Market research sources (reports, statistics) • Intellectual property databases

  37. Resources for Market Research include… • MARKETFULL collection of full-text syndicated market research reports • INVESTEXT (File 745,545, INVE) for access to complete investment analyst reports • Statistical sources such as… • Incidence & Prevalence (File 465, IAPV) • TableBase (File 93,BTBL) • Country profile data from ESPICOM…

  38. ESPICOM Country Healthcare Reports(File 511, MDST) • Provides overviews of • Healthcare administration and provision • Manufacturing & trade regulations • Registration procedures (drug & device approval process) • Price controls • Avenues of distribution • Reports include extensive statistical data • Geographic scope: 74 nations

  39. ?S CN=BRAZIL S1 380 CN='BRAZIL' ?REPORT S1/TITLES DIALOG(R) ONLINE TABLE OF CONTENTS LIST OF REPORT TITLES ITEM NUMBER, MAIN TITLE ------------------------------------------------------ 1 Brazil 2005 Generic Markets Analysis March 2005/19 records 2 Brazil 2005 World Medical Market Analysis January 2005/49 records 3 BRAZIL 2005 World Pharmaceutical Market Analysis January 2005/63 records 4 Brazil 2004 World Medical Market Analysis April 2004/40 records Enter one item number, P for next page, or EXIT to leave TITLES: ?2 Enter (S)ection Headings only, (C)omplete table of contents, M to return to Main Menu Listing or EXIT to leave TITLES: ?C Note that Generic [Drug] Market Assessments have recently been added to this database

  40. Extracts from Table of Contents • MEDICAL DEVICE MARKET • 2 MEDICAL DEVICE MARKET--Current Size--TABLE 1, TABLE I. SUMMARY OF THE • MEDICAL DEVICE MARKET IN BRAZIL IN 2004--Projections--TABLE 2, TABLE • II. MARKET PROJECTIONS, 2004-2009 (US$ MILLIONS)--TABLE 3, TABLE III. • 3 Outlook--TABLE 4, TABLE III. SWOT ANALYSIS OF THE BRAZILIAN MEDICAL • DEVICES MARKET--Market Structure (Part 1)--Medical Device • Imports--TABLE 5, TABLE IV. IMPORTS OF MEDICAL EQUIPMENT & SUPPLIES, • 1998-2002 (US$000S) • 4 Market Structure (Part 2)--TABLE 6, TABLE V. IMPORTS OF MEDICAL • EQUIPMENT & SUPPLIES, 1999-2002 (% CHANGE OVER PREVIOUS YEAR)--Market • Structure (Part 3)--Domestic Production--ABIMO / SINAEMO--TABLE 7, • DOMESTIC PRODUCERS INC • Market developments--Cuts in Import Tariffs • 6 KEY NATIONAL DATA PROJECTIONS--TABLE 8, TABLE VI. KEY DATA • INTERNATIONAL MARKET COMPARISONS • 7 INTERNATIONAL MARKET COMPARISONS--INTERNATIONAL MARKET COMPARISONS • (Part 1)--TABLE 9, TABLE VII. THE WORLD'S TOP 50 MEDICAL DEVICE • MARKETS, 2004-2009 (US$ MILLIONS)--TABLE 10, TABLE VIII. THE WORLD'S • TOP 50 MEDICAL DEVICE M

  41. REGULATORY ENVIRONMENT 32 REGULATORY ENVIRONMENT--TABLE 41, ANVISA REGISTRATION FEES (R$); SF=TABLE 33 Import Requirements--Purchasing Procedures 34 Technical Standards • MEDICAL DEVICE IMPORTS • 40 MEDICAL DEVICE IMPORTS--MEDICAL DEVICE IMPORTS (Part 1)--TABLE 42, • IMPORTS OF MEDICAL EQUIPMENT & SUPPLIES, 1998-2002 (US$000S) • MEDICAL DEVICE IMPORTS (Part 2)--TABLE 43, LEADING SUPPLIERS OF • MEDICAL EQUIPMENT & SUPPLIES, 2002 (US$000S)--MEDICAL DEVICE IMPORTS (Part 3)--TABLE 44, LEADING SUPPLIERS BY CATEGORY, 2002 (US$000S) • DOMESTIC PRODUCTION • 42 DOMESTIC PRODUCTION--Trade Associations--ABIMO / SINAEMO--Domestic • Producers (Part 1)--Baumer--Dabi Atlante Ind. Med. Odonto. Ltda- • Dixtal Biomed Ind. Com. Ltda--EDLO • 43 Domestic Producers (Part 2)--Fanem--GMReis--Gnatus--JP Ind#stria • Farmac#utica SA--Domestic Producers (Part 3)--Mediphacos • Ltda.--Multinational Activity--Scantek Medical--Siemens--St Jude • Medical • 44 Exports (Part 1)--TABLE 45, EXPORTS OF MEDICAL EQUIPMENT & SUPPLIES, • 1998-2002 (US$000S)--Exports (Part 2)--TABLE 46, LEADING • DESTINATIONS, 2002 (US$000S) • 45 Exports (Part 3)--TABLE 47, BALANCE OF TRADE IN MEDICAL EQUIPMENT & • SUPPLIES, 1998-2002 (US$000S)

  42. Answering medical device inquiries requires access to… • Biomedical bibliographic databases • Engineering literature • Regulatory resources • A highly focused collection of full-text industry newsletters • Subject specialty company & product directories • Market research sources (reports, statistics) • Intellectual property databases

  43. Medical Device Resources on Dialog & DataStar See also: “Beyond Science Fiction: Medical Technology in the 21th Century” – presentation by Cindy Meisner & Beth White (Ethicon Endo-Surgery) www.sla.org/division/dpht/Annual2003/presentations2003/Cindy_Meisner.ppt

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