Transcript Vendor Update: Medical Device Resources Online

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
• Regulatory resources
• A highly focused collection of full-text industry
newsletters
• Subject specialty company & product directories
• Market research sources (reports, statistics)
• Intellectual property databases
Dialindex/OneSearch Category
MEDDEV
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2:INSPEC 1969-2005
5:Biosis Previews(R) 1969-2005
6:NTIS 1964-2005
8:Ei Compendex(R) 1970-2005
34:SciSearch(R) Cited Ref Sci 1990-2005
35:Dissertation Abs Online 1861-2005
65:Inside Conferences 1993-2005
73:EMBASE 1974-2005
74:Int.Pharm.Abs 1970-2005
92:IHS Intl.Stds.& Specs. 1999/Nov
94:JICST-EPlus 1985-2005
144:Pascal 1973-2005
155:MEDLINE(R) 1951-2005
158:DIOGENES(R) 1976-2005
172:EMBASE Alert 2005
182:FDA News Mar. 2002-2005
188:Health Devices Sourcebook 2004
198:Health Devices Alerts(R) 1977-2005
399:CA SEARCH(R) 1967-2005
434:SciSearch(R) Cited Ref Sci 1974-1989
441:ESPICOM Pharm&Med DEVICE NEWS 2005
444:New England Journal of Med. 1985-2005
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
author’s original title and abstract)
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
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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
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
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
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CC=46
CC=461.1
CC=461.2
CC=461.3
CC=461.4
CC=461.5
CC=461.6
CC=461.7
CC=461.8
CC=461.8.1
CC=461.9
CC=461.9.1
CC=462
CC=462.1
CC=462.2
CC=462.3
CC=462.4
CC=462.5
(BIOENGINEERING)
(BIOMEDICAL ENGINEERING)
(BIOLOGICAL MATERIALS)
(BIOMECHANICS)
(HUMAN ENGINEERING)
(HUMAN REHABILITATION ENGINEERING)
(MEDICINE)
(HEALTH CARE)
(BIOTECHNOLOGY)
(GENETIC ENGINEERING)
(BIOLOGY)
(IMMUNOLOGY)
(MEDICAL ENGINEERING & EQUIPMENT)
(BIOMEDICAL EQUIPMENT, GENERAL)
(HOSPITALS, EQUIPMENT & SUPPLIES)
(DENTAL EQUIPMENT & SUPPLIES)
(PROSTHETICS)
(BIOMATERIALS)
Engineering Literature Indexes
• INSPEC
– Device related class codes under: CC=A87, CC=B75, e.g.:
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CC=A8770
CC=A8770E
CC=A8770F
CC=A8770J
CC=A8780
CC=A8780B
Biomedical engineering
Patient diagnostic methods & instrumentation
Electrodiagnostics
Prosthetics & other practical applications
Biophysical instrumentation & techniques
Biosensors
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•
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•
CC=B7500
CC=B7510
CC=B7510B
CC=B7510D
CC=B7520C
CC=B7520E
CC=B7530
CC=B7530B
CC=B7540
Medical physics & biomedical engineering
Biomedical measurement & imaging
Radiation & radioactivity applications in biomedicine
Bioelectric signals
Radiation therapy
Prosthetics & orthotics
Health Physics
Radiation protection & dosimetry
Hospital Engineering
plus…
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•
•
•
•
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CC=C1290L
CC=C3385
CC=C3385C
CC=C7140
CC=C7330
CC=D2060
Systems theory applications in biology & medicine
Biological & medical control systems
Prosthetic & orthotic control systems
Medical administration
Biology and medical computing
Health care applications
Engineering Literature Indexes
MEDITEC: Biomedical Engineering
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•
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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
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
Regulatory Information Sources
DIOGENES FDA Regulatory Updates – File 158, DIOG (FOI Services)
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•
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
Regulatory Information Sources
Health Devices Alerts – File 198 (ECRI), updated weekly
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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
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
Extracts from RAJ Devices TOC –
March/April 2005 issue
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
• Country or region names
– e.g., “UK” or “European
Union”
• Article type
– e.g., “Worldwide update”
“Reference-Guidelines”
“Reference-Standards”
“Organisational Charts”
• Keywords - Controlled descriptors • Product sectors
identifying specific topics
discussed in articles
– Examples: “Environment” or
“Counterfeit Medicines”
• Subject categories
Regulatory Affairs Journal enhanced with
Images on DataStarWeb platform
Example from
RAJ - Devices
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..
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New directives, regulations, and guidelines
Court cases & rulings
Developments at national, as well as European, level
Meetings
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:
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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?
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
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)
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:
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Biomedical Materials
Biotech Equipment Update
Hospital Materials Management
Medical Textiles
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
Subject Specialty Company Directories
• Health Devices Sourcebook (File 188), updated annually
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•
•
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.
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
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.
-------1
2
3
4
5
6
7
8
Items Term
----- ---46
PRODUCT PORTFOLIO
35
AGREEMENTS
9
RESEARCH AND DEVELOPMENT
6
RECENT HISTORY/CORPORATE STRATEGY
5
STRUCTURE AND ACTIVITIES
3
FINANCIAL INDICATORS
3
GEOGRAPHICAL BREAKDOWN
1
PROFILE OVERVIEW
---end of results---
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.
-------1
2
3
4
5
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7
8
Items Term
----- ---36
PRODUCTS
10
CORPORATE HISTORY
6
FINANCIAL REVIEW
3
RESEARCH AND DEVELOPMENT
2
CORPORATE STRUCTURE
2
INTERNATIONAL ACTIVITIES
1
OVERVIEW
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
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
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
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
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
? S TC=F9A
F9A represents
S1
85 TC=F9A
FORMULATION, IMPLANT
? E NR=
Ref
Items Index-term
EXPAND for Novelty
E1
1 NA=99MTC-ECD
Rating options
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
? S S1 AND S2
S3
43
? S S3 AND TC=K
S4
11
NR='3'
(NEW FORMULATION)
S1 AND S2
S3 AND TC=K
Focusing on anticancer
products (K category)
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
Drug Name: drug delivery system, vascular stent sirolimus;
sirolimus vascular stent
DRUG INFORMATION:
Pharmacological Action:
Therapeutic Class Code:
Clinical Indications:
antiproliferative agent; stent
C1D (Coronary Therapy); V7A (All
Other Non-Therapeutic Products)
restenosis
– 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
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
IMS R&D Focus
Broader approaches to searching drug delivery
? DS
Set
S1
S2
Items
1260
965
Description
DRUG()DELIVERY()SYSTEM/PROFILE
(DELIVERY()SYSTEM OR
DRUG()DESIGN()TECHNOLOGY)/IN
S3
873
TECHNOLOGY/ST
S4
966
S2 OR S3
Locates additional records not
identified with previous
? S S4 NOT S1
strategy.
S5
748 S4 NOT S1
/AVAIL limits results to products
available for licensing.
? S S5/AVAIL
S6
474 S5/AVAIL
Because many of these records
lack specific Therapeutic (TC) or
? S S6 AND VACCINE?
Indications indexing, search
S7
53 S6 AND VACCINE?
keywords for potential
applications as “free text”
(without field qualification).
See sample record in handout
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
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
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…
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
?S CN=BRAZIL
S1
380 CN='BRAZIL'
?REPORT S1/TITLES
DIALOG(R) ONLINE TABLE OF CONTENTS
Note that Generic
LIST OF REPORT TITLES
[Drug] Market
ITEM NUMBER, MAIN TITLE
Assessments have
-----------------------------------------------------1
Brazil 2005 Generic Markets Analysis
recently been added
March
2005/19 records
to this database
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
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$000S)
4
Market Structure (Part 2)--TABLE 6, TABLE V. IMPORTS OF MEDICAL
EQUIPMENT & SUPPLIES, 1999-2002 (% CHANGE OVER PREVIOUS YEAR)--Market
Structure (Part 3)--Domestic Production--ABIMO / SINAEMO--TABLE 7,
DOMESTIC PRODUCERS INC
5
Market developments--Cuts in Import Tariffs
6
KEY NATIONAL DATA PROJECTIONS--TABLE 8, TABLE VI. KEY DATA
INTERNATIONAL MARKET COMPARISONS
7
INTERNATIONAL MARKET COMPARISONS--INTERNATIONAL MARKET COMPARISONS
(Part 1)--TABLE 9, TABLE VII. THE WORLD'S TOP 50 MEDICAL DEVICE
MARKETS, 2004-2009 (US$ MILLIONS)--TABLE 10, TABLE VIII. THE WORLD'S
TOP 50 MEDICAL DEVICE M
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)
41 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. LtdaDixtal 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)
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
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