Engineering Resources - BME 180A - Biomedical Design - Fall 2021 - Research Guides at University of California Irvine

Resources

You may want to visit the Biomedical Engineering Research Guide. These extracted resources are likely to be helpful:

Concise Medical Dictionary, 8th ed., 2010
Use this resource to better understand medical & clinical terms used in your reading & research
WebMD
More consumer oriented.

MedicineNet.com - Consumer health oriented - good for patients.
Access Surgery.com - Concordance of medical texts about surgical procedures and information.

AccessMedicine - Concordance of medical information from multiple sources.

Major database of peer reviewed scientific/medical journal articles with emphasis on clinical therapies - consider vocabulary carefully, for instance use neoplasms for cancer in search strategy; read abstract of the article first; use eLinks or Publishers icons for fulltext access to articles. These journal articles have gone through peer review, but please make sure that they are on the extensive list of journals that was shared . They will tend to be very clinical in nature and specific. Use the Advanced Search feature so you can identify easily every element of your search. Also use the filters on the left sidebar to refine your search strategy to make the output more relevant - i.e.) select Review; select Age range of patient; enter 5 years; restrict to English in Language fields; etc

CINAHL Complete - Current Fulltext Index to Nursing & Allied Health Literature - The Nursing literature is important in the clinical support for cancer patients.

Compendex Compendex is the Engineering Index & Abstracts database - use the UC eLinks to determine if the journal article is available - read the abstract first

Annual Reviews - This list of journals includes the Annual Review of Immunology, Biochemistry and 30 other titles. The entire database can be searched together or each titles can be searched separately.

Academic Search Complete

An interdisciplinary indexing & abstracting service containing a lot of full-text articles.

Scopus

Powerful database with heavy content in biomedical and bioscience coverage. Contains eLinks and requires sign-in with UCINetID.

Web of Science

Peer reviewed articles from major academic and scientific journals. You may want to restrict search to Science Citation Index so that you only search and retrieve the science/medical content. Contains some clinical content.

Google Scholar

Conduct a search in this database making sure that you are connected to VPN or on campus so you can use the UC eLinks to connect to the article. Use natural language to search - an example may be "Review Article" AND osteosarcoma AND pediatrics AND treatment

CRISPR Journal

The CRISPR Journal delivers cutting-edge multidisciplinary peer-reviewed research, advances, and commentary on CRISPR, the extraordinary technology that gives scientists the power to cure disease and sculpt evolution. Spearheaded by Editor-in-Chief Rodolphe Barrangou, PhD and aided by a diverse and accomplished editorial board, the Journal provides a high-profile forum for cutting-edge international original research papers, as well as a compelling mixture of frontmatter content—review articles, perspectives, profiles, and commentary spanning not only matters of research but the many social, ethical, and business issues confronting the field. The CRISPR Journal adds an exciting and dynamic component to the growing global CRISPR community and is the go-to resource driving the field forward.

JoVE*

The Journal of Visualized Experiments provides access to journal articles that utilize text, images, sound, video, and powerpoint to demonstrate science in the laboratory. Many of the medical or basic science content is laboratory or animal rather than human studies. You can search for the particular cancer across all the sections of JoVE.

Frost & Sullivan Healthcare

This resource requires a UCINetID login and does not allow for copying except by snipping in the html format.
Instructions: Under the heading "Latest Research", limit the "Market" tab from "Any" to "Healthcare" to view full-text reports. Use the pull-down menu for Type to select Industry wide or Technology driven analyses or Mega Trends or other sources before clicking on Update.

BCC Research - Another Marketing Reports database. No need to sign in, just use the VPN when off-campus.

MarketLine Advantage: Country Statistics Database

More than 215 country profiles include PEST/LE (Political, Economic, Social, Technological/Legal, Environmental analyses.

Passport Global Market Information Database

Robust reports covering extensive characteristics of resident populations for many countries worldwide. Includes emerging markets with hard-to-find information, demographic analysis, lifestyle & consumer information.

Encyclopedia of Global Health, 2008

Encyclopedia of Quality of Life and Well-being Research, 2013

Green Health: An A-Z Guide, 2011

Cancer Facts & Figures, 2020
Handbook of Materials for Medical Devices, 2003
Medical Device Link - The platform website for the medical device industry, provides news, information, employment and recruiting services, as well as collaborative opportunities for people who design, manufacture, and market medical devices.
Plunkett Research Online

Under the Health Care industry sector, there are updates like this that profile global initiatives and activities that can be researched further.
Factiva - This fulltext business database of trade papers and magazines may indeed support your topics if searched broadly with geography inserted in search query. Default is 3 month search so for longer periods, please remember to alter search accordingly.\
Gartner Campus Access - Gartner research highlights complex IT issues and emerging technologies and industry trends. Highly sophisticated “hypecycles” chronicle influences and compliment other authoritative Garner research, insights and analytics with reports, white papers and webinars.
Gates Foundation in Grand Challenges in Global Health
Institute of Medicine, Board on Global Health

Publications focused on global health
Global Market Information Database (GMID)

Restricted to UCI affiliates and you must click through license agreement. Issued by Euromonitor providing consumer market data on over 350 consumer products in 52 countries. You may want to click through to Health & Wellness under Industries, and then under Consumer Health for a specific geography
Global Health Technologies Coalition

Points to many sources that are working on several assignments similiar to the ones for this project.
NIH Fact Sheets on Point of Care Diagnostic Testing

Point-of-care testing allows patient diagnoses in the physician’s office, an ambulance, the home, the field, or in the hospital. The results of care are timely, and allow rapid treatment to the patient. Empowering clinicians to make decisions at the “point-of-care” has the potential to significantly impact health care delivery and to address the challenges of health disparities. The success of a potential shift from curative medicine, to predictive, personalized, and preemptive medicine could rely on the development of portable diagnostic and monitoring devices for point-of-care testing.
Point-of-Care Diagnostics

Demonstrates how a new company rolls out a diagnostic platform.
CAB Direct

Major database for global & world health. Indexes journal articles and conference literature. Consult Library Search by source or title of journal noted containing the article referenced or indexed.

Standards

Remember, Technical Standards are an established norm or requirement. It is usually a formal document that establishes uniform engineering or technical criteria, methods, processes and practices. The documents prepared by a professional group or committee which are believed to be good and proper engineering practices and which contain mandatory requirements. The contain “how to” instructions for designers, manufacturers, and users. Standards promote safety, reliability, productivity, and efficiency in almost every industry that relies on engineering components or equipment. Standards can run from a few paragraphs to hundreds of pages, and are written by experts with knowledge and expertise in a particular field who sit on many committees.

You will have to use standards from different sources:

1. Class related Standards are in ANSI Standards Connect - you will find ISO 14971, 2d ed, 2007, Medical Devices there and others; click on View My Documents and then scroll through the documents and click on View. You can search the document for specific terms or coverage by entering "CTRL F"

2. Other COVID related documents are also available from other sources.

2. ASTM Standards & Engineering Digital Library - to be searched - for F04.15

3. Check in your Canvas source for other standards from ANSI

For additional information about standards and specifications, please consult Standards Guide or contact Engineering Librarian

FDA Pathways

Additional Resources

For visual images you may want to consult sources such as the following sources or consult the Visual Arts: Images Resource Guide and make sure that you have proper rights to use or copy images - that they are Open Access or not copyrighted::

How To Read a Patent

For background information, the Patent FAQ may answer some basic questions. Use a Patent Glossary if you need help with definitions. Patents appear to be outlined with numbers - these are Standard Field Codes or "INID codes" for international agreed numbers for the identification of bibliographic data and are consistent with patents from around the world. A review of how to read a patent will be helpful.

Drawings - each figure is numbered and explained - sometimes they are broken up into several sub-figures and they can also show a 3D view with parts numbered for identification.
Specification - the basic text but does not include the claims. Provides the summary of the invention and describes the drawings.
Claims - the most important part of a patent - often written in legalistic style. Two types of claims: Independent & Dependent where the latter only has meaning when combined with a preceding claim and the former claim stands alone. Usually the broadest claims of the patent are at the top or front of the list of what the patent is supposed to achieve or do.

FDA Resources

FDA COVID Provisions for Medical Devices
covers strategies for surgical gowns and masks, medical glove conservation, and ventilator supply mitigation
PreMarket (PMA) Review Process
Reviews 4-step review process for pre-market approval.
Premarket Approval
Premarket approval (PMA) is the FDA process of scientific and regulatory review to evaluate the safety and effectiveness of Class III medical devices. Class III devices are those that support or sustain human life, are of substantial importance in preventing impairment of human health, or which present a potential, unreasonable risk of illness or injury.
FDA Medical Device Databases
An approved Premarket Approval Application (PMA) is, in effect, a private license granted to the applicant for marketing a particular medical device.
510(k) Premarket Notification
A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval.
MAUDE - Manufacturer and User Facilty Device Experience
The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters 1 (manufacturers, importers and device user facilities) and voluntary reporters such as health care professionals, patients and consumers.
FDA's Establishment Registration & Device Listing
This database includes:

medical device manufacturers registered with FDA and
medical devices listed with 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 FDA.
ASM Medical Materials Database
Database contains mechanical, physical & biological responses as well as drug compatibility properties for the materials & coatings used in medical devices for cardiology/thoracic, orthopedics, neurological, and general surgery plus some coverage for urological, dental & anesthesiology. Includes FDA Emergency Use Authorized Devices ( including FDA EUA directives for latest COVID-related devices; Emergency Guidance Documents from FDA: EUAs, UK Medicines & Healthcare products Regulatory Agency, Australia's Therapeutic Goods Administration & Health Canada; latest FDA Approved devices (510(k) and PMA with links to associated materials, coatings & drugs noting producers, recalls and guidance documents.

Regulations and Compliance

Federal Drug Administration
this agency is responsible for the regulatory passage of pharmaceuticals and medical devices.
Code of Federal Regulations
Chapter 21 - Food and Drugs
Chapter 42 - Public Health
This is the official compilation of federal regulations.
Full print: LL REF KF 70 A3
Medical Devices: FDA Should Take Steps to Ensure That High-Risk Device Types Are Approved through the Most Stringent Premarket Review Process
GAO, 2009
Search for FDA Guidance Documents
The table contained in this link lists all official FDA Guidance Documents and other regulatory guidance. You can search for documents using key words, and you can narrow or filter your results by product, date issued, FDA organizational unit, type of document, subject, draft or final status, and comment period.

This feature is provided to give a convenient way to search for all FDA guidance documents from a single location.

If you cannot find the document you’re looking for here, you can browse separate collections of guidance documents by topic.
BioDesign: The Process of Innovating Medical Technologies
Review of Regulatory Basics that includes videos on different aspects including Regulatory Pathways, Guidance for Mobile Medical Applications, and Regulatory Expertise.
CDRH Super Search
Searches across multiple FDA Databases, including the device listing database,510(k) and PMA databases. Recommended for device classification coverage.
FDA Device Classification Panels
Lists the medical specialties used to review medical devices.
FDA Product Classification Database
Enables users to classify a device based on the device name, review panel, regulation number, producy code, submission type, third-party eligibility and device class.
ASM Medical Materials Database
Database contains mechanical, physical & biological responses as well as drug compatibility properties for the materials & coatings used in medical devices for cardiology/thoracic, orthopedics, neurological, and general surgery plus some coverage for urological, dental & anesthesiology. Includes FDA Emergency Use Authorized Devices ( including FDA EUA directives for latest COVID-related devices; Emergency Guidance Documents from FDA: EUAs, UK Medicines & Healthcare products Regulatory Agency, Australia's Therapeutic Goods Administration & Health Canada; latest FDA Approved devices (510(k) and PMA with links to associated materials, coatings & drugs noting producers, recalls and guidance documents.

Patents

PATENT RESOURCES - the following sources are highly recommended but for additional direction, please consult the Subject Guide for Patents - you will be restricting your searches to US Patents and there is a box there for how to read & understand a patent. When using some of the following databases, you may find some references to European patents (EP#) - sometimes US companies, like Medtronics register for foreign patents hoping that it will take less time to successfully be awarded the patent. Opening up the illustrations or drawings in some patent databases may require special TIFF software - record the patent # and search in another database or follow instructions on how to download special TIFF software.

Google Patents

A tool for searching the full text of the U.S. patent corpus. In 2015, Google began classifying material in Google Scholar with CPC (Cooperative Patent Classification) codes, so that when searching for patents by classification you can also find journal articles, books, reports, etc. on the same topic. May not be perfect but it allows you to bring all information sources together.
U.S. Patent & Trademark Office (USPTO)

Official sources to help search for patents and trademarks with links to the Library of Congress for Copyright Information. Definitions, application forms and instructions, handbooks, notices, and patent attorney directory are just a few of the products provided. Full-text searching is available. Contains illustrations contained in patent.
Scopus

UCI's subscription to Scopus allows searching over 39M patent records from 5 global patent offices:
1. World Intellectual Property Organization (WIPO)
2. European Patent Office (EPO)
3. US Patent Office (USPTO)
4. Japanese Patent Office ( JPO)
5. UK Intellectual Property Office (IPO.GOV.UK)

The best way to search for patents is by creating a thorough document search, and then selecting ‘View xxxx Patent Results’ on the top right side of the search results screen.
Google Scholar

Google Scholar's Advanced Scholar Search can now be used to find patents.
Free Patents Online

Large community-based website covering different aspects of intellectual property. Contains list of cardiology related patents at http://www.freepatentsonline.com/CCL-600-16.html
WikiPatents

This is one of the largest free databases of patents open for public comment on the internet,allowign PDF downloading of patents, free patent translationn into multiple languages and additional information and resources.

Notes about Patent Searching
You can search patents that have been awarded fro 1976 - today; or those in application mode as they are protected as soon as they are filed.

BME 180A - Biomedical Design - Fall 2021: Engineering Resources