UCLA Biodesign Program Resources

This Guide was designed to support the research needs of the UCLA Biodesign Program Fellows, every Fall-Spring cohort

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).

Healthcare Econ: Codes, Prices, Reimbursing, Utilization

Coding

Pricing
Procedures & Prescription Drugs

  • 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." NoteUseful 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.
P
ublic 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.

 

Regulatory

Product Classification & Standards

  • 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

  • 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

  • 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.