Product Design & Manufacturing Standards
- ASTM Compass
ASTM collection of industry-leading standards and technical engineering info by the American Society for Testing and Materials.
- IEEE Xplore
Select Standards within IEEE Xplore, from the Institute of Electrical and Electronics Engineers.
- Industry Standards @ UCLA
Industry standards guide> Links to standards + whether or not at UCLA (e.g., ANSI, ASTM, ISO).
Medical Device Design and Regulation, by ISBN: 9780873898164Date: 2011Online book, from Knovel.
An introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices.
Medical Devices: Regulations, Standards and Practice, by ISBN: 9780081002919Date: 2015Online book, from Science Direct.
Sheds light on the importance of regulations and standards among all stakeholders, bioengineering designers, biomaterial scientists and researchers to enable development of future medical devices.
Healthcare Econ: Codes, Prices, Reimbursing, Utilization
Coding
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Current Procedural Terminology (CPT) Codes.
CPT is used to report medical procedures and services to federal and private payers for reimbursements.-
Current Procedure Codes with RVUs (2022).
Timely, accurate, and value-added info to power coding, billing and practice management systems, from Optum360. Essential coding and reimbursement data for the CPT® code. - CPT Code/Relative Value Search
AMA page to perform CPT code searches and obtain Medicare's relative value payment amount associated with a code. Perform searches using 5 digit CPT code number or key word(s) in the code description. Sign-in required (account is free).
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Diagnostic and Statistical Manual (DSM-5) Coding.
The DSM is a classification of current mental disorders with associated criteria. -
Diagnosis-Related Group (DRG) Coding.
Patient classification system that standardizes prospective payment to hospitals. A DRG payment covers all charges associated with inpatient stay, from admission to discharge. -
Healthcare Common Procedure Coding System (HCPCS) Codes.
Collection of standardized codes of medical procedures, supplies, products and services used to facilitate health insurance claims processing by Medicare and other insurers.- Alpha-Numeric HCPCS Codes, from the CMS.
- Alpha-Numeric HCPCS Codes, from the CMS.
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WHO International Classification of Diseases, ICD. A World Health Organization standardized tool for healthcare classification. Provides a diagnostic codes system for classifying generic and specific diseases in countries.
- ICD-10, electronic version.
- ICD-10 CM Medical Diagnosis Codes (2020 ICD-10-CM)
- ICD-10 Procedure Coding System (2020 ICD-PCS)
- ICD-11. Foundation to identify health trends and statistics globally; international standard for reporting diseases and health conditions. The diagnostic classification standard for all clinical and research purposes.
- International Classification of Functioning, Disability and Health (ICF). WHO tool to classify health and health-related domains; includes environmental factors.
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WHO Nomenclature of Medical Devices. WHO's various nomenclature systems used to code generically identifiable medical devices and health products.
Pricing
Procedures & Prescription Drugs
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Clear Health Costs.
Lists prices for medical procedures by geographical location. -
GoodRx.
List prices (ASP) for prescription drugs from over 60K U.S. pharmacies. -
Guroo.
Database of national, state, and local cost and quality info for common health conditions and services. -
Haiweb.
Sources for national drug prices (indicates type of price info) for many countries worldwide. -
MICROMEDEX Healthcare Series.
Contents: Dosing and therapeutic tools -- DRUGDEX -- DRUG-REAX -- IDENTIDEX -- IV index -- Martindale Pharmacopaeia -- CareNotes -- USP MSDS -- Drug consults -- TOMES system -- Reprorisk. Martindale: The Complete Drug Reference -- Material Safety Data Sheets (MSDS) from USP DI -- Physicians' Desk Reference -- Red Book -- REPRORISK - National Average Drug Acquisition Cost (NADAC).
Medicaid database with national average drug acquisition cost (WAC price/unit); historical data from Nov 2013-present.
Reimbursement
DRG Fingertip Formulary.
Reimbursement policies for specific drugs at specific insurance providers (with formulary tier, prior authorization, step therapy requirements).
Formulary Lookup.
Search by drug, city/state, channel (commercial, Medicare, Medicaid, etc.) for summary of percent with access to specific drugs (breakdown of access restrictions: Preferred, non-preferred, covered with PA/ST requirement).
Medi-Cal Reimbursement Rates.
Medi-Cal is California's Medicaid health care program. Site contains Medi-Cal fee-for-service rates listed by procedure code, and includes procedure descriptions, unit values, basic and child rates, and more.
Medicare Physician Fee Schedule (MPFS).
Look-up tool: Payment rate, relative value, and policy info for services covered by Medicare.
Pharmacoeconomic Guidelines Around The World.
Country guidelines, by International Society for Pharmacoeconomics and Outcomes Research (ISPOR).
Utilization
Agency for Healthcare Research & Quality, AHRQ.
Evidence-based info on healthcare outcomes, quality, cost, use, access. Note: Gain access to longitudinal data re patient interactions with healthcare system, with all transactions and their codes (indicating procedures, diagnosis), plus service location to help develop market segments.
Healthcare Cost and Utilization Project (HCUPnet).
Online query system of health statistics and info on hospital inpatient stays, readmissions and emergency dept utilization at national, regional, state levels.
Medical Expenditure Panel Survey (MEPS).
Longitudinal datasets on healthcare expenditures of U.S. families, individuals, medical providers, insurers/employers; "the only and most complete national data source measuring how Americans use and pay for medical care, health insurance, and out-of-pocket spending." Note: Useful for detailed analysis of market segments, sizing; can be labor intensive. Available for conditions with 1% prevalence rate or greater.
National Healthcare Quality and Disparities Reports, annual, 2007-present.
Medicare Provider Utilization and Payment Data.
Public data set summarizing utilization and payments for procedures and services to Medicare fee-for-service beneficiaries by specific inpatient or outpatient hospitals, physicians, other suppliers; has 100 most common inpatient services, 30 common outpatient services, all physician and other supplier procedures/services performed on 11+ Medicare beneficiaries.
Patents and Trademarks
Issued to promote new inventions as "engines of commerce" and drivers of business activity, patents protect inventor rights to profit from the invention, and publicly disclose invention details so others may enhance and further that knowledge.
- U. S. Patents & Trademarks Office (USPTO).
U. S. Department of Commerce agency issuing patents to inventors and businesses for their inventions, and trademark registration for product and intellectual property identification.
- Index to the Manual of Classification of Patents.
Alphabetical directory of all patent classification codes used by the U.S.P.T.O.
- Guide to Patent Searching.
Information from The University of Texas at Austin.
- WIPO: World Intellectual Property Organization.
United Nations agency dedicated to the use of intellectual property (patents, copyright, trademarks, designs, etc.) as a means of stimulating innovation and creativity.
Regulatory
Product Classification & Standards
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FDA Product Code Classification Database.
Database of all medical devices with their associated classifications, product codes, FDA premarket review organizations, etc. Note: Can be used to search for a predicate device for 510(k) submissions. - Recognized Consensus Standards, FDA.
Database of national and international standards recognized by the FDA; part of the info to make an appropriate decision re clearance or approval of a submission.
Product Databases
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FDA 510(k) Premarket Notification.
Database of premarket submissions made to FDA to demonstrate that the device to be marketed is at least as safe and effective, or, substantially equivalent, to a legally marketed device. - FDA Premarket Approval (PMA).
Searchable database of FDA class III medical devices.
Safety and Product Experience
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MAUDE: Manufacturer and User Facility Device Experience.
Database of mandatory and voluntary reporting info on medical device reports (MDRs) or adverse events. FDA uses MDRs to monitor device performance, detect potential device-related safety issues, and contribute to product benefit-risk assessments; limited to adverse event reports in past 10 years. -
FDA Medical Product Safety Network (MedSun) Reports.
CDRH program for adverse events reporting, launched in 2002. -
FDA Total Product Life Cycle (TPLC).
Database of pre- and postmarket data on medical devices: Device Classification Product Codes, Premarket Approvals (PMA), Premarket Notifications (510[K]), MAUDE Medical Device Adverse Event Reports, and CDRH Medical Device Recalls. - ISPOR Road Map.
Info on country/region-specific decision-making processes for regulatory (market access) approval, and reimbursement and economic evaluations of medical devices, pharmaceuticals and diagnostics worldwide; from the International Society for Pharmacoeconomics & Outcomes Research.
University Licensing
- AUTM Innovation Marketplace (AIM).
Database of university-owned technology available for licensing. Draws from 800 universities, research centers, hospitals, businesses and governments worldwide; with 19,000+ technologies listed to-date; from Association of University Technology Managers.
- Easy Access IP.
Open access network of universities granting companies and individuals free licensing of intellectual property.
- iBridgeSM Network.
Global centralized resource for unbiased info about early-stage technologies and inventions from university-developed intellectual property.