Research Guides: Entrepreneurship: Medical Devices

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Helpful Guide!

Academic Entrepreneurship for Medical and Health Scientists
Academic Entrepreneurship is a free open education resource that bridges the worlds of academic research and commercialization. This eBook is an easy-to-read guide for those new to the field, offering tools, advice, and best practices. Developed by the Children’s Hospital of Philadelphia (CHOP) and the University of Pennsylvania (Penn).

Recommended chapters:

Medical Devices

BCC Research This link opens in a new window
Industry reports addressing very specific technological niches across most high-tech and healthcare industry sectors, including Advanced Materials, Biotechnology, Chemicals, Healthcare, Instrumentation and Sensors, Manufacturing, Membrane and Separation Technology, Nanotechnology, Pharmaceuticals, Photonics, etc. The reports contain detailed analysis of the industry including global market data, competitive landscape, trends, and more. [Global coverage]
Frost & Sullivan This link opens in a new window
Global 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. [Global coverage]
Statista This link opens in a new window
NEW! A statistics portal that integrates thousands of diverse topics of data and facts from a wide range of sources onto a single platform. Sources of information include market research, trade publications, scientific journals, and government databases. In addition to tables and charts, Statista also provides infographics and studies on selected industries and topics. [Global coverage]
IBISWorld This link opens in a new window
Current and historic industry research reports for established and niche U.S. industries. Reports include key statistics and analysis of market characteristics, operating conditions, current and forecast performance, key players, and more. Also includes risk reports for established U.S. industries. [U.S. only coverage]
Fitch Connect This link opens in a new window
Global intelligence database with data, analysis, ratings, rankings, and forecasts for much of the world's countries and industries. Research features country risk, financial markets analysis, and industry research. [Global coverage]
MarketLine Advantage This link opens in a new window
US and global industry profiles including Porters Five Forces Analysis, and company profiles including SWOT analyses, covering Healthcare and Pharmaceuticals. [Global coverage]
Plunkett Research This link opens in a new window
Market research, industry statistics, trends, and in-depth analysis of top companies. Major industry categories include: Biotechnology, Drugs, Genetics, and Health Care. [U.S. only coverage]

PitchBook This link opens in a new window
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. Company profiles include patents. [Global coverage]
Users must create an account with their UCI email address. Download limits apply.

The vendor of this resource may monitor, collect, store, and analyze Subscriber’s usage of the Services (“Subscriber’s Usage Data”) on both a Subscriber and individual User basis for the limited purposes of providing or improving the services.

Learn this Search: Companies Search

S&P Capital IQ This link opens in a new window
Company intelligence database, including granular financial and capital structure information on companies worldwide. Company profiles contain data and graphs for historic stock prices, searchable SEC filings, mergers and acquisitions activities, and venture capital/private equity data. Also features biographic and professional connection information for business leaders. [Global coverage]
Mergent Intellect This link opens in a new window
Company directory database, powered by Dun & Bradstreet (D&B). Includes profiles for public and private companies globally. Particularly useful for building a list of companies and for understanding parent/subsidiary relationships. [Global coverage]
Factiva This link opens in a new window
Global full-text coverage of local and regional newspapers, trade publications, business newswires, press release wires, media transcripts, news photos, business-rich websites. [Global coverage]
Maximum 12 users at a time.

HCUPnet
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: Diagnosis 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
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
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
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
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

FDA Medical Device Databases

510(k) Premarket Notification
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.

More information on Premarket Notification 510(k)

Premarket Approval (PMA)
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.

More information on Premarket Approval (PMA)

Medical Device Exemptions 510(k) and GMP Requirements
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.

More information on 510(k) Exemptions

Product Classification
Contains medical device names and associated classifications, including product code and device class.
Establishment Registration & Device Listing
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
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
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
Resource from the FDA’s Center for Devices and Radiological Health (CDRH) that explains many aspects of medical device laws, regulations, guidance, and policies, encompassing the entire product life cycle.

CMS: Innovators' Guide to Navigating Medicare (Version 3, 2015)
The Centers for Medicare & Medicaid Services (CMS), through its Council for Technology and Innovation (CTI), has developed the Innovators’ Guide to Navigating Medicare to assist stakeholders in understanding the processes used to determine coverage, coding, and payment for new technologies under the Medicare fee-for-service program.

CPT Professional 2022 by American Medical Association
Current Procedural Terminology (CPT) is a listing of descriptive terms and identifying codes for reporting medical services and procedures performed by physicians and other qualified health care professionals. The CPT terminology is the most widely accepted medical nomenclature used to report medical procedures and services under public and private health insurance programs. [eBook]

ICD-10-CM Browser Tool
Allows users to search for codes from the International Classification of Diseases, 10th Revision, Clinical Modification (ICD-10-CM) and provides instructional information needed to understand the usage of ICD-10-CM codes. The application provides access to multiple fiscal year version sets that are available with real-time comprehensive results via the search capabilities.
Medicare Physician Fee Schedule (MPFS) Look-Up Tool
Medicare pays for services furnished by physicians (e.g., surgery, office visits, and other professional services) and services furnished by many other non-physician practitioners under a payment system known as the Medicare Physician Fee Schedule (PFS). This search tool provides more than 10,000 physician services, the associated relative value units, a fee schedule status indicator, and various payment policy indicators needed for payment adjustment.

How to Use the MPFS Look-Up Tool

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 This link opens in a new window
Repository for American National Standards Institute (ANSI) standards licensed by the UCI Libraries.

Use “View My Documents” on the right to browse the complete list of standards available.

ASTM Compass This link opens in a new window
A collection of industry-leading standards and technical engineering information. Covers a broad range of engineering disciplines, including aerospace, biomedical, chemical, civil, environmental, geological, health and safety, industrial, materials science, mechanical, nuclear, petroleum, soil science, and solar engineering.

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

ASM Medical Materials Database This link opens in a new window
A comprehensive, peer-reviewed database providing 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 international device and material producers.

Learn this Search: Producers

Investext This link opens in a new window
Analyst research reports of companies, industries, products, and countries from brokerages, investments banks, and independent research firms globally, including Clarivate Analytics' Cortellis Reports, which give a comprehensive overview of medical companies, including their pipeline portfolio.
Reports are typically embargoed for 14 days prior to being made available.

Learn this Search: Analyst Reports
Learn this Search: Cortellis Reports

PAREXEL Biopharmaceutical R & D Statistical Sourcebook
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. [Print]
ClinicalTrials.gov
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)
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.
Device Approvals, Denials and Clearances
Drug and Biologic Approval and IND (Investigational New Drug) Activity Reports

STAT+
Trade publication with exclusive reporting about the pharmaceutical and biotech industries, the health tech industry, science, and coverage at the intersection of health and policy, as well as access to exclusive events and other benefits.

First time users, create an account with your UCI email address.

PubMed@UCI This link opens in a new window
Provides access to millions of citations from MEDLINE and life science journals. Includes links to many sites providing full text articles and other related resources.
Business Source Complete This link opens in a new window
Content includes scholarly business journals (including open access journals), trade publications, news, conference proceedings, industry reports, country reports, company reports, and more.

Health Affairs
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. [Note: 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
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)
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)
A peer-reviewed journal with research articles and key information at the intersection of biomedical science and clinical practice.
Google Scholar
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 by Alexander Osterwalder; Yves Pigneur; Tim Clark
An overview and explanation of the popular "Business Model Canvas," along with examples. [Print & eBook]
Medical Device Design: Innovation from Concept to Market by Peter J. Ogrodnik
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. [eBook]
The Handbook of Market Research for Life Sciences Companies by Jean-Francois Denault
Tips, models, and tools entrepreneurs can use to collect, interpret, and present their market and integrate it into their business plan. [eBook]
Essentials of Health Care Marketing by Eric N. Berkowitz
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. [eBook]
Bioentrepreneurship and Transferring Technology into Product Development by Swati Agarwal (Editor); Sonu Kumari (Editor); Suphiya Khan (Editor)
Provides a comprehensive understanding of the role of biological sciences, specifically in transforming technology into commercial product. Discusses various factors, including creating business plans, acquiring funding, successful business models, small-scale product development, intellectual property rights, funding schemes for start-ups, and new prospective biotechnology product development. [eBook]
CPT Professional 2022 by American Medical Association
Current Procedural Terminology (CPT) is a listing of descriptive terms and identifying codes for reporting medical services and procedures performed by physicians and other qualified health care professionals. The CPT terminology is the most widely accepted medical nomenclature used to report medical procedures and services under public and private health insurance programs. [eBook]