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

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Presentation on theme: "Medical Device Resources on Dialog & DataStar Bonnie Snow Director, Pharmaceutical Markets Vendor Update SLA Pharmaceutical & Health Technology Division."— Presentation transcript:

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 File 5:Biosis Previews(R) File 6:NTIS File 8:Ei Compendex(R) File 34:SciSearch(R) Cited Ref Sci File 35:Dissertation Abs Online File 65:Inside Conferences File 73:EMBASE File 74:Int.Pharm.Abs File 92:IHS Intl.Stds.& Specs. 1999/Nov File 94:JICST-EPlus File 144:Pascal File 155:MEDLINE(R) File 158:DIOGENES(R) File 172:EMBASE Alert 2005 File 182:FDA News Mar File 188:Health Devices Sourcebook 2004 File 198:Health Devices Alerts(R) File 399:CA SEARCH(R) File 434:SciSearch(R) Cited Ref Sci File 441:ESPICOM Pharm&Med DEVICE NEWS 2005 File 444:New England Journal of Med

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., drug eluting 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 authors 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= (GENETIC ENGINEERING) CC=461.9 (BIOLOGY) CC= (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, 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 ( ) – 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 ( ) – More retrospective coverage than offered on FDA Web site ( ) – 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 companys 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 ( ) 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, – 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 Examples of searchable data elements in the Regulatory Affairs Journal online 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



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

19 EURALex (formerly ERA News, EPLC Update), , updated monthly – Complete text in PHIND (File , 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 Regulatory Information Sources

20 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 nations 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?

21 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

22 Among full-text subject specialty sources in PHIND… Pharmaceutical & Healthcare Industry News Database (File , 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 current awareness & document delivery service -- see additional information in handout)

23 Customized current awareness service for ongoing monitoring of new developments User specifies keywords, other factors to be searched in each update to a database New material matching user-defined parameters forwarded daily, weekly, biweekly, or monthly Option for Multi-file Alert with duplicate detection TOC (Table of Contents) Interactive Alerts Full table-of-contents scans delivered to -box User checks off titles for which full text needed Full documents delivered within minutes by return Copyright compliance incorporated into service ALERT Capabilities on Dialog

24 Current Dialog users can set up TOC Alerts by logging on to DialogWeb ( with their standard user # and Go to the opening screen in Command Mode. – Note: You need not be familiar with Dialog commands to set up an Interactive Alert Dialog Interactive TOC Alerts Click on Alerts in the Quick Functions box.

25 From the subsequent Alerts screen, click on Add Subscriptions

26 Use the pull-down Publications menu to select a newsletter title After selecting a newsletter title, type in an address for the recipient (you, your client) Tip: Prior to initiating the service, you may wish to arrange for creation of a special mailbox within your organizations system, from which daily alerts will be disseminated internally to a designated distribution list. Each individual recipient will be able to order full-text documents directly, and Dialog will automatically aggregate multiple copy orders to calculate ERA discounts, when applicable.

27 Users simply check off items in their e- mail replies to order full-text articles (delivered within 2 hrs) at standard database output rates. Note that this is a non-invasive push (current awareness) service. No response is necessary, if no items in a Table of Contents are of interest. Built-in grace period: each Interactive Alert ends with a reply by date (usually two weeks hence) for automated document delivery.

28 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

29 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

30 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, 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.

31 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

32 ? 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 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--- Example of Major Section Headings in ESPICOMs 2004 profile for Abbott

33 Example of Major Section Headings in ESPICOMs 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 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

34 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 Table 3, Revenue by Product Category, (US$ million)* % Change 2003/2004 Reconstructive 1, , Trauma Spine Orthopaedic Surgical Products Total Revenue 1, , Extract from a sample record…

35 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

36 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

37 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

38 ? 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= E NR=0 (NOT AVAILABLE) E NR=1 (ALL PRECLINICAL) E NR=2 (ESTABLISHED STRATEGY) E NR=3 (NEW FORMULATION) E8 433 NR=4 (LOW NOVELTY) E9 851 NR=5 (2ND, 3RD OR 4TH COMPOUND) E NR=6 (LEADING COMPOUND) ? S E7 S 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

39 DRUG INFORMATION: Pharmacological Action: antiproliferative agent; stent Therapeutic Class Code: C1D (Coronary Therapy); V7A (All Other Non-Therapeutic Products) Clinical Indications: restenosis 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

40 IMS R&D Focus Broader 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

41 ? DS Set Items Description S DRUG()DELIVERY()SYSTEM/PROFILE S2 965 (DELIVERY()SYSTEM OR DRUG()DESIGN()TECHNOLOGY)/IN S3 873 TECHNOLOGY/ST S4 966 S2 OR S3 ? 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? Locates additional records not identified with previous strategy. /AVAIL limits results to products available for licensing. IMS R&D Focus Broader approaches to searching drug delivery See sample record in handout

42 DIALOG(R)File 445:IMS R&D Focus (c) 2004 IMS Health & Affiliates. All rts. reserv Drug Name: Powder Mediated Epidermal Delivery Brand Name: PMED R&D Focus - September 27, 2004 ( ) COMPANY INFORMATION: Originator: PowderMed; (UK); NA; NA; NA Licensing Countries: Worldwide COMPANY INFORMATION: Licensing Contact: Brenda Reynolds, Chief Operating Officer, PowderMed Ltd, 4 Robert Robinson Avenue, The Oxford Science Park, Oxford, OX4 4GA, UK; Tel: ; Fax ; DRUG INFORMATION: Pharmacological Action: biotechnology Therapeutic Class Code: V7A (All Other Non-Therapeutic Products) Clinical Indications: delivery system Drug Status: New Drug Molecular Code: Extract from sample record

43 LATEST INFORMATION: 27 September 2004: At the European Partnering & Investment Conference, 16 September 2004, London, UK, R&D focus discussed PowderMed's proprietary Powder Mediated Epidermal Delivery (PMED) technology with Clive Dix, CEO of PowderMed, and Brenda Reynolds, COO. The PMED technology has utility in the development of therapeutic DNA vaccines, and PowderMed is seeking partners interested in collaborations using the PMED technology. The technology uses the PowderJect device to propel DNA precipitated onto microscopic gold particles into the epidermis. Microscopic gold particles, 1-3 mcM in diameter, have an appropriate density and size for direct DNA delivery into immunological active antigen presenting cells (APC). Once inside the APC, the DNA elutes off the gold and produces the encoded protein; the presentation of this protein by the APC to the lymphocytes results in the generation of T-cell-mediated immune responses. The technology can be used to develop vaccines that generate T-cell mediated responses to a broad range of viral and cancer antigens…. IMS R&D Focus – sample record continued…

44 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

45 injection formulation of the nonsteroidal anti- inflammatory drug meloxicam (see separate profile) using its proprietary parenteral drug delivery Biochronomer(TM) system. The formulation is in preclinical development for the treatment of inflammation following arthroscopic surgery, as......see separate profile: Teriparatide injection) for this indication. The technology: Macroflux(TM) is a transdermal drug delivery technology, which utilises a titanium microprojection array to create superficial pathways through the skin barrier developing a proprietary formulation of anaesthetic propofol (Propofol IDD-D(TM)) using its Insoluble Drug Delivery (TM) (IDD) technology. The IDD technology is complimentary to SkyePharma's proprietary nanoparticle technology that is developed to... Extracts from sample records – Adis R&D Insight

46 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

47 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…

48 ESPICOM Country Healthcare Reports 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

49 ?S CN=BRAZIL S1 380 CN='BRAZIL' ?REPORT S1/TITLES DIALOG(R) ONLINE TABLE OF CONTENTS LIST OF REPORT TITLES ITEM NUMBER, MAIN TITLE 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


51 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, (US$000S) 41MEDICAL 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, (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, (US$000S)

52 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

53 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)

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