Industry Resources

Industry Resources

LifeScience Alley has assembled groups of related industry links to provide helpful resources for you. Click on any of the section titles below to view the full list of resources and Web site links:

State and National Congressional Links
State and U.S. Government Agencies
Centers for Medicare & Medicaid Services
Medical Technology & Bioscience Organizations
International Resources, Organizations and Associations
National, State and Regional Associations and Groups
Industry Information
Local Industry Resources
Local University/Educations Links
University of Minnesota Links
Other Useful Links


State and National Congressional Links

US House of Representatives
US Senate
State of Minnesota Legislature

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State and U.S. Government Agencies

Agency for Healthcare Research and Quality
Formerly known as the Agency for Health Care Policy and Research, AHRQ's mission is to improve the quality, safety, efficiency, and effectiveness of health care for all Americans.

FDA — Food and Drug Administration
A site for anyone involved in the purchase, sale or manufacture of medical products. Includes a wealth of information: regulations, pre-market and post-market issues, device alerts, international information and more.

FDA Center for Devices and Radiological Health International Program
Provides information about the Center's international programs and activities, as well as information to facilitate the export and import of medical devices.

FDA Center for Devices and Radiological Health
An essential site for any person or organization that sells, buys or manufactures medical equipment.

FDA MedWatch
Allows manufacturers, physicians, hospitals, consumers to report problems with medical devices and drugs.

FDA Regulation of Medical Devices: Background Information for International Officials
How the FDA regulates medical devices, what to do and how to comply.
A comprehensive guide to U.S. governmental databases.

The Food And Drug Law Institute (FDLI)
Provides a neutral forum for critical examination of the laws, regulations and policies related to drugs, medical devices, other healthcare technologies and foods. Site also features a daily email newsletter.

Freedom of Information Services, Inc.
Over 150,000 documents about the inner workings of the approval and regulation of medical devices, pharmaceuticals, biologics, veterinary products, foods and cosmetics.

U.S. Customs and Border Protection Service
Provides information about importing and exporting requirements as well as traveling to the United States from other countries.

U.S. Department of Commerce
Web site for the U.S. business, economic and trade communities Ñ providing authoritative information from the Federal government.

U.S. Department of Commerce — International Trade Administration — Medical Devices
Provides assistance to U.S. medical device exporters by working to open markets, disseminate information, break down trade barriers affecting the industry and conduct numerous trade promotion events. Provides trade statistics, foreign regulatory profiles, market research and country policy information.

Minnesota Department of Human Services (DHS)
Helps people meet their basic needs by providing or administering health care coverage, economic assistance and a variety of services for children, people with disabilities and older Minnesotans.

Minnesota District Export Council
A private, non-profit organization that brings together experienced international business people who provide guidance and assistance in international markets.

Minnesota Trade Office — Official Export Promotion Agency of Minnesota
Promotes and assists in the expansion of exports and foreign direct investments that contribute to the growth of the Minnesota economy. For new exporters as well as experienced international companies. Services include education and training, information and marketing, and counseling.

U.S. International Trade Commission
Provides information and assistance regarding the export of products from the United States. Also offers trade statistics and information on both imports and exports of medical devices, and other commodities.

National Institutes of Health (NIH)
Provides leadership and direction to programs designed to improve the health of the nation by conducting and supporting research in the cause, diagnosis, prevention and cure of human diseases; in the processes of human growth and development; in the biological effects of environmental contaminants; in the understanding of mental, addictive and physical disorders; in directing programs for the collection, dissemination, and exchange of information in medicine and health, including the development and support of medical libraries and the training of medical librarians and other health information specialists.

National Institute of Standards and Technology (NIST)
Provides information on a variety of useful subjects, including the National Voluntary Laboratory Accreditation Program (NVLAP), which provides third-party accreditation of testing and calibration laboratories.

State of Minnesota (Northstar)

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Centers for Medicare & Medicaid Services (CMS)

Centers for Medicare & Medicaid Services
Physicians™ National Correct Coding Initiative
Physician Fee Schedule Look-Up
Physician Regulatory Issues Team
Practice Administration

Acute Inpatient
Critical Access Hospitals
Hospital Outpatient
Long-Term Care
Inpatient Psychiatric Facility PPS
Inpatient Rehabilitation Facility PPS

Ambulatory Surgical Centers
Durable Medical Equipment

Provider/Supplier Resources
Medicare Modernization Act
Medicare Learning Network
Medlearn Matters
End Stage Renal Disease

Other Providers
Federally Qualified Health Centers
Home Health
Rural Health
Skilled Nursing Facility PPS

Additional CMS Web Pages
Helpful Contacts
Join a ListServ
Staying Informed — Quarterly Provider Update

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Medical Technology & Bioscience Organizations

Biotech Database
A hybrid biology/chemistry educational resource and research tool, BioTech is intended to attract students and enrich the public's knowledge of biology issues in the world today.

Biotechnology: A Life Sciences Online Resource Guide

Online biotechnology resources including terminology, basic concepts, science resources, and professional resources.

Biotechnology Statistics Progress Report 2004
Statistical work on biotechnology is carried out under the aegis of the Organization for Economic Co-operation and Development (OECD) Working Party of National Experts on Science and Technology Indicators (NESTI).

Device, Drug, Equipment Medical Glossary
Over 3000 new terms (drugs, devices, procedures, FDA approvals) updated weekly as well as other useful resources (surgical terms, classifieds, links etc).

Medical Design Technology
Covers new products, equipment, instrumentation and materials for the medical device manufacturing market and features a searchable product and supplier database.

Medical Device Safety Reports (MDSR)
A repository of incident and hazard information Ñ documenting problems that have occurred with medical devices and lessons learned over the past three decades. Focuses on the steps to prevent or reduce medical device risks to patient care and healthcare worker safety. Search by cause of incident, device type or clinical specialty/department.

MMC Medical
The link between newest technology in medicine and international distribution, fostering the partnerships between manufacturers and international distributors required to achieve a viable global presence.

QMED (Formerly MedicalDeviceLink)
Searchable database of over 4000 suppliers, 18,000 articles pertaining to medical device industry and more. Current medical device industry news.
Aims to accelerate the development of biotechnology and medical devices by radically improving access to global regulatory and other product development information from agencies such as the U.S. Food and Drug Administration, European Medicines Evaluation Agency (EMEA), Canada's Health Protection Branch (HPB), Medicines Control Agency (MCA) and other international regulatory bodies.

RSNALink (Radiological Society of North America)
A comprehensive three-part series of articles reviewing medical device regulation in the U.S.

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International Resources, Organizations and Associations

Association of British Health-Care Industries (United Kingdom)
Lead trade association for manufacturers and distributors of medical device technology in the UK. Member companies supply the NHS and global healthcare markets with a vast array of equipment ranging from latex gloves to life support machines.

Australian Society for Biomaterials
Provides a national focus for professionals with interests in research, education, development and regulation of biomaterials and medical devices. Internationally, the Society is a member of the group of Biomaterials Societies that coordinate international activities, including the World Biomaterials Congress.

Australian Therapeutic Goods Administration
Provides useful information about the regulation of medical devices and pharmaceutical products in Australia. Any product for which therapeutic claims are made must be entered in the Australian Register of Therapeutic Goods (ARTG) before the product can be supplied in Australia.

Bio Commercialization Canada, Inc.
Contains biotech database with advanced searching capabilities. Information on bioregulations, bioresearch, bioassociations and bioresearch in Canada, US, Australia, Asia, Europe, Africa and South America.

Biotechnology Gateway
Developed and maintained by the Life Science Branch of Industry Canada. Offers a rich variety of information products and services on all aspects of biotechnology. Overview of the Canadian biotechnology industry, market reports, exporting information, biotechnology regulatory virtual office and biotechnology employment centre.

European Agency for the Evaluation of Medicinal Products
Authorizing body for the certification of medical products throughout EU countries. To sell to Europe, you've got to come here.

European Commission Multilingual Medical Glossary
Multilingual glossary of technical and popular medical terms in nine European languages.

European Co-operation for Accreditation
The branches of European national accreditation bodies have been handled separately by EAC (European Accreditation of Certification) and EAL (European co-operation for Accreditation of Laboratories) concerned with certification bodies or with laboratories. These organizations have joined to form European Accreditation (EA), which now covers all European conformity assessment activities: testing, inspection, certification, and environmental verification.

The European Confederation of Medical Devices Association
Representing the medical technologies industry in Europe, this site's goal is to generate a clear understanding of issues of importance to the industry, and to ensure that such issues are raised appropriately at both European Union and national government levels.

European Diagnostic Manufacturers Association
The trade association that represents Europe's in vitro diagnostics (medical testing) industry.

German Institute for Medical Documentation and Information
DIMDI has the task to set up database-supported information systems for drugs according to the German Drug Law, and for medical devices according to the Act on Medical Devices. Operates within the Federal German Ministry of Health.

Global Harmonization Task Force
Working towards harmonization on medical device regulation, this voluntary group represents national medical device regulatory authorities and the industry. Since its inception, the GHTF has been comprised of representatives from five founding members grouped into three geographical areas: Europe, Asia-Pacific and North America.

Global Import Regulations for Pre-Owned Medical Devices
Offers country-by-country information regarding regulations for import of used medical equipment. Also provides info on which countries to expect sales growth of pre-owned equipment. A MUST site if you plan to sell used equipment abroad.

Health Canada Therapeutic Products Programme (TPP)
The national authority, regulating drugs, medical devices and other therapeutic products used in Canada.

International Laboratory Accreditation Cooperation (ILAC)
Access ILAC publications, information on laboratory accreditation programs around the globe, advice and assistance with technical issues related to trade and acceptance of test results. This site will be of interest to anyone involved with: laboratory accreditation, quality assurance, standardization, testing, calibration, measurement, technical barriers to trade, international acceptance of test data, international agreements.

International Organization for Standardization (ISO)
A network of the national standards institutes in 146 countries. ISO standards contribute to making the development, manufacturing and supply of products and services more efficient, safer and cleaner.

JETRO (Japan External Trade Organization)

Helps U.S. companies establish a Japan office by providing free support services, including Japan market information, programs for finding a Japanese business partner, and temporary office space in Japan. Provides lesser-known information, including which local governments in Japan are offering special incentives to attract life science companies planning to open a Japan office, lab, or other facility.

Japan National Institute of Health Sciences
Provides useful information about the regulation of medical devices and pharmaceutical products in Japan.

MEDEC – Canada’s Medical Technology Companies
Canada's national industry association representing medical device and diagnostic companies. Members are dedicated to serving the health care community through the research and development and provision of high quality medical products and services that benefit Canadians. The primary source for advocacy, information and education for the medical device industry.

TI Working Paper 2004/8: Biotechnology Statistics in OECD Member Countries: An Inventory
This document reflects recent efforts made by the OECD to obtain an accurate assessment of the current state of biotechnology statistics in OECD member and observer countries.

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National, State and Regional Associations and Groups

American Institute for Medical and Biological Engineering (AIMBE)
American National Standards Institute
American Medical Association
American Society for Quality (ASQ)
American Society for Testing and Materials (ASTM)
Association for the Advancement of Medical Instrumentation
Association of Clinical Research Professionals (ACRP)
Association of Medical Diagnostics Manufacturers (AMDM)

BioBusiness Alliance of Minnesota

Biomedical Consortium Task Group
Biotechnology Industry Organization (BIO)
BIO State affiliates listed alphabetically
California Healthcare Institute
HealthCare Institute of New Jersey
Indiana Medical Device Manufacturers Council, Inc.
International Business Forum (IBF)
Massachusetts Medical Device Industry Council (MassMEDIC)
Medical Group Management Association
Medical Device Manufacturers Association (MDMA)
Minnesota Biomedical Business Network (MBBNet)
Minnesota Section of American Society for Quality (ASQ)

Minnesota Venture Capital Association (MVCA)
National Electrical Manufacturers Association
Pharmaceutical Education and Research Institute (PERI)
Pharmaceutical Research & Manufacturers of America
Regulatory Affairs Professionals Society (RAPS)
Society for Biomaterials
Washington Biotechnology & Biomedical Association
Wisconsin Biotechnology and Medical Device Association

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Industry Information

Economic Impact of Biopharmaceutical Industry by State (PhRMA)

Minnesota Biobusiness Statewide Assessment (BBAM)

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Local Industry Resources

James J. Hill Library
Mayo Clinic
Minnesota Department of Employment and Economic Development
Minnesota Department of Health
Minnesota Medical Association
St. Jude Medical — Clinical Studies
University Enterprise Laboratories (UEL)
University of Minnesota Academic and Corporate Relations Center (ACRC)

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Local Minnesota University/Educational Links

Anoka-Ramsey Community College
College of St. Catherine
Dunwoody College of Technology
Hennepin Technical College
Minneapolis Community & Technical College (MCTC)
Minnesota State Colleges & Universities (MnSCU)
Minnesota State University — Moorhead
Normandale Community College
North Hennepin Community College
Northwestern Health Sciences University
St. Cloud State University
St. Cloud Technical College
University of St. Thomas Center for Business Excellence

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University of Minnesota Links

University of Minnesota Academic Health Center
University of Minnesota BioTechnology Institute
University of Minnesota Carlson School of Management
University of Minnesota College of Biological Sciences
University of Minnesota College of Continuing Education
University of Minnesota College Of Food, Agricultural and Natural Resources
University of Minnesota College of Pharmacy
University of Minnesota College Of Veterinary Medicine
University of Minnesota Duluth
University of Minnesota Experimental Surgical Services
University of Minnesota Hormel Institute
University of Minnesota Initiative for Renewable Energy and the Environment
University of Minnesota Institute for Engineering in Medicine

University of Minnesota Institute for Molecular Virology
University of Minnesota Law School
University of Minnesota Lillehei Heart Institute
University of Minnesota Medical School
University of Minnesota Office of Business and Community Economic Development
University of Minnesota Office of Continuing Medical Education
University of Minnesota Office of Sponsored Projects
University of Minnesota Physicians
University of Minnesota Rochester
University of Minnesota School of Medicine Duluth
University of Minnesota Supercomputing Institute

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