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

Tutorial

Getting Started: Industry & Market Research

Databases

BCC Research
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]
Statista
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
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]
MarketLine Advantage
At the bottom of the "Sign in" box, look for “If you have IP Access” and use the Click Here button to enter. US and global industry profiles including Porters Five Forces Analysis, and company profiles including SWOT analyses, covering Healthcare and Pharmaceuticals. [Global coverage]
Plunkett Research
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]

Tutorial

Getting Started: Company Research

Databases

PitchBook
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]

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
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
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
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.

Patent Searching Resources

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.
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

Search for product classification and code

You can do a keyword search to see if there is an existing product classification for your type of product that you can use.

Product Classification
Contains medical device names and associated classifications, including product code and device class. Tip: Don’t be too specific. If you’re looking for a glucose monitor, just search “glucose” because it could be listed as a monitor or a meter, or something else

Search by similar known device

If you know a similar product has gone through a PMA or 510(k) process, you can enter the company name as the “Applicant” to see if you can find a similar product listed.

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)
Database of all Premarket Approvals (PMA) that are required of all Class III devices, with multiple searchable fields. Updated every week.

More information on Premarket Approval (PMA)

Additional databases

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

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.

CPT Professional 2023
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]
HCPCS Level II Professional 2024
Organized for quick and accurate coding, HCPCS Level II Professional 2024 Edition codebook includes the most current Healthcare Common Procedure Coding System (HCPCS) codes and regulations, which are essential references needed for accurate medical billing and maximum permissible reimbursement. HCPCS Level II codes are used primarily to identify products, supplies, and services not included in the CPT codes, such as ambulance services or durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) when used outside a physician's office. [eBook]
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.
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 (PFS) 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.

PFS Quick Reference Search Guide

Tutorial

Getting Started: Intro to Standards

Databases

ASTM Compass
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.
ANSI Standards Connect
Repository for American National Standards Institute (ANSI) standards licensed by the UC Irvine Libraries.Repository for American National Standards Institute (ANSI) standards licensed by the UCI Libraries. Select "View My Documents" in the right sidebar. You can then search for the standards we've acquired.
IEEE Xplore
IEEE Xplore provides web access to full-text documents from some of the world's most highly cited publications in electrical engineering, computer science and electronics.

More information

Standards and Specifications Guide

ASM Medical Materials Database
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

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
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
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]
Bringing a Medical Device to the Market: A Scientist's Perspective by Gennadi Saiko
Written by a medical device entrepreneur for first-time MedTech entrepreneurs. Covers topics such as: the regulatory environment, product development process, funding, IP, and business models. [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 2023 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]

Course Handouts

BME 180 BioENGINE - King