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Entrepreneurship: Medical Devices

This guide supports UCI’s innovation and entrepreneurship community by connecting users to relevant resources used to conduct research throughout the entrepreneurial process.
URL: https://guides.lib.uci.edu/entrepreneurship

Medical Devices

BCC Research
Access: UCI
Geography: US & Global

Comprehensive reports addressing very specific technological niches across most high-tech industry sectors including: Advanced Materials, Biotechnology, Chemicals, Healthcare, Instrumentation and Sensors, Manufacturing, Membrane and Separation Technology, Nanotechnology, Pharmaceuticals, Photonics, etc.

Frost & Sullivan

Access: UCI
Geography: US & Global (limited)

Industry research reports that integrate seven perspectives (competitive intensity, customer dynamics, industry convergence, disruptive technologies, global mega trends, new business models, and emerging markets) into a complete, overall view of the factors that impact covered industries.


IBISWorld

Access: UCI
Geography: US

Introductory industry research reports of 30-40 pages on over 700 U.S. industries, including: Healthcare & Social Assistance, and Life Sciences.

Fitch Connect (formerly BMI Research)
Access: UCI - Authorized Affiliates
Geography: US & Global

A global intelligence database featuring a Country Risk & Industry Research module with global, regional, and country risk assessments, analysis, and expert commentary on 20+ industries and more than 200 countries and territories that collectively account for 99% of world GDP. The industry and country specific reports provide 5 and 10-year forecasts and in-depth analysis of current risks and future opportunities. Industry reports also feature SWOT analyses.

MarketLine Advantage

Access: UCI
Geography: US & Global

US and global industry profiles including Porters Five Forces Analysis, and company profiles including SWOT analyses, covering Healthcare and Pharmaceuticals.

Plunkett Research Online

Access: UCI
Geography: US

Market research, industry statistics, trends, and in-depth analysis of top companies. Major industry categories include: Biotechnology, Drugs, Genetics, and Health Care.

S&P Capital IQ
Access: UCI - Authorized Affiliates
Geography: US & Global

A comprehensive company intelligence database, offering granular financial and capital structure information on millions of companies worldwide, including: data and graphs for historic stock prices, searchable SEC filings, mergers & acquisitions activities, and venture capital/private equity data. Also features biographic and professional connection information for millions of business practitioners.

PitchBook
Access: UCI - Authorized Affiliates
Geography: US & Global

Especially useful for finding up-and-coming companies in emerging industries. Data and research covering the private investment market, including venture capital, private equity, and M&A transactions. Information on companies, deals, investors, and funds. Users must create an account with their UCI email address. Download limits apply.

  • To get started:  [Left Sidebar] > click on Companies & Deals > Industry 


Mergent Intellect
Access: UCI
Geography: US & Global

Public and private company information, as available, for companies worldwide. Particularly useful for building lists of companies and for hierarchical parent/subsidiary relationships (use the Family Tree tab for a company). [Mergent Intellect replaces Hoovers Pro. Data for both Mergent Intellect and Hoovers Pro comes from Dun & Bradstreet (D&B).] 

Factiva
Access: UCI
Geography: US & Global

Worldwide coverage of local and regional newspapers, trade publications, business newswires, press release wires, media transcripts, news photos, and business-rich websites.

HCUPnet
Access: Public

A free, online query system based on data from the Healthcare Cost and Utilization Project (HCUP). The system provides health care statistics and information for hospital inpatient, emergency department, and ambulatory settings, as well as population-based health care data on counties. Includes data (as available) for both diagnoses and procedures.

  • Learn this search!
  • Tip: The ICD-CM (International Classification of Diseases, Clinical Modification) is used to code and classify both diagnoses and procedures. Current and previous versions of the ICD-CM are available through the CDC


MedlinePlus: All Health Topics
Access: Public

MedlinePlus brings together authoritative information from the National Library of Medicine (NLM), the National Institutes of Health (NIH), and other government agencies and health-related organizations. Most health topics will have a link to statistics.

Centers for Disease Control and Prevention: Data & Statistics
Access: Public
The CDC, in part, identifies and defines preventable health problems in the US. Its Data and Statistics portal is an excellent resource for information on major medical conditions.

National Center for Healthcare Statistics

Access: Public
A subset of the CDC that offers national and state-level data and statistics on major medical conditions, including physician office visits and emergency department visits for a given condition; also covers health care services, insurance, and expenditures.

HealthData.gov
Access: Public

This site is dedicated to making high value health data more accessible to entrepreneurs, researchers, and policy makers in the hopes of better health outcomes for all. Find data on a wide range of topics, including environmental health, medical devices, Medicare & Medicaid, social services, community health, mental health, and substance abuse.

Want More Statistics?
Advocacy groups (e.g., the American Heart Association) may collect and report more specific statistics than the US government. In Google, try a sample search like this: hearing loss association statistics site:.org

ASM Medical Materials Database
Access: UCI
Geography: US

Materials data to support medical device design. The database features both materials properties and biological response data for medical device designers. Also includes a searchable list of device and material producers. Producers listed may operate in the US and/or around the world, but have medical devices approved by the FDA for use in the US. Content in other sections, such as materials, coatings, and drugs has no region specificity.


​Investext (via Mergent Online)

Access: UCI
Geography: US & Global

This replaces the Thomson ONE database. Investext (i.e., the Thomson Reuters Embargoed Research Collection) offers analyst research reports from more than 1,700 brokerages, investment banks, and independent research firms around the globe, including Clarivate Analytics' Cortellis Reports, which give a comprehensive overview of medical companies, including their pipeline portfolio.  


PAREXEL Biopharmaceutical R & D Statistical Sourcebook [Print book]
Access: UCI
Located in the Langson Library Reference Collection (Call number: HD9665.4 .P37 2017 ) (Note: Reference books cannot be borrowed.) R&D statistics, trends, and proprietary market intelligence and analyses on the biopharmaceutical industry. Supported by thousands of graphs, illustrations, and analyses, the Sourcebook provides the latest intelligence on every aspect of biopharmaceutical development – from product discovery, to R&D performance and productivity, to time-to-market trends. 

ClinicalTrials.gov
Access: Public

A database, provided by the U.S. National Library of Medicine, of privately and publicly funded clinical studies conducted around the world.

Food & Drug Administration (FDA)
Access: Public

The FDA is responsible for protecting public health by regulating human drugs and biologics, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation. (The FDA's article "Is It Really 'FDA Approved?'" provides a great overview).

For more information, please see the Standards and Specifications Guide.
For questions or help finding standards, please contact Julia Gelfand, Research Librarian for Applied Sciences & Engineering. 


ANSI Standards Connect 
Access: UCI

Repository for standards licensed by the UCI Libraries. Use “View My Documents” on the right to browse the complete list of standards available. 

ASTM Compass
Access: UCI
Largest database of full-text standards. Includes access to standards, journals, and special technical publications and proceedings. Search by keyword, designation, or author. Use this website to browse standards by category, then search title in ASTM Compass. 


COVID-19 Standards

Many organizations have made standards related to the COVID-19 health crisis freely available during the pandemic in order to support research and innovation.

AAMI: Coronavirus Resources from the Field
Access: Public
As the COVID-19 crisis unfolds, AAMI is providing this curated collection of resources to assist the health technology field.

ANSI: Freely Available ISO Standards to Help Address COVID-19 Crisis
Access: Public

To support rapid response efforts to the COVID-19 pandemic, the ANSI is providing access to key international standards. Through the portal, select standards are accessible in read-only format at no cost during the crisis; additional standards may be added in the future. 

IEEE: COVID-19 Related Research
Access: Public

IEEE has identified articles and standards from the IEEE Xplore digital library that may help researchers understand and manage different aspects of the COVID-19 pandemic and technologies that can be leveraged to combat it. All content in this collection is now free to access for the duration of the global health crisis, with additional rights for all types of reuse, including full text and data mining, and analysis.

ISO: COVID-19 Response
Access: Public

Relevant standards have been compiled to support global efforts in dealing with the COVID-19 crisis. They are freely available in read-only format.

FDA Medical Device Databases
 

510(k) Premarket Notification
Access: Public

This database of releasable 510(k)s can be searched by 510(k) number, applicant, device name or FDA product code. Summaries of safety and effectiveness information is available via the web interface for more recent records. The database is updated once a week.


Premarket Approval (PMA)
Access: Public
Premarket approval by FDA is the required process of scientific review to ensure the safety and effectiveness of all devices classified as Class III devices. An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device. This database may be searched by a variety of fields and is updated once a week.


Medical Device Exemptions 510(k) and GMP Requirements
Access: Public
A breakdown of 510(k) exempt medical devices listed by device class. All devices in this list are 510(k) exempt unless further qualified by a footnote.


Product Classification
Access: Public
Contains medical device names and associated classifications, including product code and device class.

Establishment Registration & Device Listing
Access: Public
This database includes: (1) medical device manufacturers registered with the FDA and (2) medical devices listed with the FDA. Note: Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by the FDA. Updated weekly.
 


Helpful FDA Webpages

 

How to Study and Market Your Device
Access: Public
Bringing a device to the market in the United States can be complex. This page outlines a four step process designed to assist you in navigating the process.

Device Classification Panels
Access: Public
Useful for determining the classification of your device. Each device classified includes: a general description including the intended use, the class to which the device belongs (i.e., Class I, II, or III), and information about marketing requirements.

Device Advice: Comprehensive Regulatory Assistance
Access: Public
Resource from the FDA’s Center for Devices and Radiological Health (CDRH) that explains many aspects of medical device laws, regulations, guidances, and policies, encompassing the entire product life cycle.

PubMed
Access: UCI
Geography: US & Global

A massive database of over 16 million citations from MEDLINE and other life science journals. Includes links to many sites providing full text articles.

Business Source Complete
Access: UCI
Geography: US & Global

A massive database covering virtually all business subjects. Thousands of entries for both scholarly and trade business and healthcare publications, including: Health Management TechnologyMarketing Health Services, Healthcare Executive, Frontiers of Health Services Management, and Healthcare Financial Management. 

Health Affairs

Access: UCI
A peer-reviewed journal on the intersection of health, healthcare, and policy. Analysis and discussion on improving health and healthcare, and addressing such issues as cost, quality, and access. Access is via the ProQuest Database with a one-year delay on new content. Articles published in the past year may be requested for free via InterLibrary Loan (ILL).

Health Care Management Review

Access: UCI
A peer-reviewed journal on topics including finance, marketing, labor relations, cost containment, quality assurance, planning, computers and technology, staff recruitment, pay and benefits, etc.

Journal of the American Medical Association (JAMA)

Access: UCI
A peer-reviewed journal with articles on a diverse range of medical topics, covering important issues that affect medicine, health, healthcare, and health policy. 

New England Journal of Medicine (NEJM)

Access: UCI
A peer-reviewed journal with research articles and key information at the intersection of biomedical science and clinical practice.

Google Scholar
Access: Public

Google Scholar is a freely accessible web search engine that indexes the full-text or metadata of scholarly literature across an array of publishing formats and disciplines.

Business Model Generation
Access: UCI
An overview and explanation of the popular "Business Model Canvas," along with examples.

Medical Device Design: Innovation from Concept to Market
Access: UCI

Takes the reader through the process of medical device development, from very early stages of conceptualization, to commercialization on the global market. Addresses medical device regulatory (FDA and EU) requirements, methodologies, and design protocols. 

The Handbook of Market Research for Life Science Companies
Access: UCI
Tips, models, and tools entrepreneurs can use to collect, interpret, and present their market and integrate it into their business plan.

Essentials of Health Care Marketing
Access: UCI

Offers foundational knowledge of the principles of marketing and their particular application in health care. Chapters focus on: product strategy, prices, distribution, promotion, advertising, sales, and ethical considerations.

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