Medical Devices Domain

Basavaraju B Marulasiddappa

References
http://geography.about.com/library/maps http://www.mapsofindia.com/maps/india/india-political-map.htm http://www.researchandmarkets.com http://www.asianhhm.com/Knowledge_bank/industryreports/medical-devices_bricnations.htm http://www.geocities.com/medicalequip_go/ http://www.cis.rit.edu/htbooks/mri http://www.wikipedia.org/

Current state of medicine : World

State of Medical Devices

155.8 B market in 2005 Changing age profiles Changing patterns of disease Changing technology Changing consumer Information base Insurance requirements Legal requirements Regulatory requirements

The Big Players

BRIC nations medical devices

2005 Market size (USD) 2866 M 1832 M 2554 M 1318 M Per capita (USD) 15.6 13.0 2.0 1.2 2010 Market size (USD) 3696 M 2910 M 3499 M 1655 M Per capita (USD) 18.1 19.2 2.6 1.4

Brazil Russia China India

Brazil Russia China India

Databases for Industry Research

Standard & Poor's Net Advantage - Industry surveys - Bond ratings - Company profiles and corporation records - Stock, bond and fund research Plunkett Research Online (Industry Information) - Industry sector analysis and research - Industry trends and statistics - Market research and trends - Company profiles Reuters Research On-Demand - Real-time full-text investment research - Reports cover companies and industries - Over 750 contributing firms Value Line - Aggregate data and analysis on industries - Reports, articles, and company highlights ABI/Inform (via Pro Quest) - Indexes over 1000 business periodicals - Trade journals, business magazines, academic journals and other news sources - Most articles full text IBIS World - Over 700 full-text industry reports - Over 700 US industry risk rating reports - Information on over 8000 Publicly Traded Companies - Hundreds of economic and demographic profiles

http://www.libraries.psu.edu/business/industryguides/medicaldevices.htm

Industry Data (World)

Eucomed, the Voice of the Medical Technology Industry in Europe Eurostat (European Union) Foreign Trade Statistics (U.S. Census Bureau) Global Harmonization Task Force International Trade Statistics Yearbook United Nations Business Library, Reference: HF91.U47301 International Trade Statistics (World Trade Organization) RegSource.com - global regulatory and product development information SourceOECD (Organization for Economic Co-operation and Development) Economic indicators UN Comtrade (United Nations Commodity Trade Statistics Database) World Development Indicators (World Bank) World Medical Markets Fact Book Business Library, Reference: HD9994.A1W67

http://www.libraries.psu.edu/business/industryguides/medicaldevices.htm

Industry Data (US)

Center for Devices & Radiological Health / FDA Health Affairs, the Policy Journal of the Health Sphere Health Industries / International Trade Administration Medical Design Technology Medical Device Business Week Medical Device Reporting (MDR) / FDA Medicaid / Centers for Medicare & Medicaid Services Medicare - official site medi-lexicon - medical abbreviation dictionary MedWatch - FDA Safety Information and Adverse Event Reporting Program National Center for Health Statistics / U.S. Dept of Health and Human Services Regulation of Medical Devices: Background Information for International Officials / FDA The U.S. Approval Process for Medical Devices: Legislative Issues and Comparison with the Drug Model / Congressional Research Service, March 23, 2005

http://www.libraries.psu.edu/business/industryguides/medicaldevices.htm

Safety & Compliance Standards

Safety Compliance EMC testing Performance testing Restricted Substances Compliance Examples : IEC 60601-1 Medical Electrical Safety IEC 60601-1-2 EMC Compliance IEC 60601-2-27 ECG Safety ISO 13485/13488: Medical device industry standard EMC testing is a requirement of global conformance and safety standards. UL offers comprehensive EMC testing services that are accepted worldwide. UL has teamed up with three other testing and certification organizations to introduce the International "emc-Mark" to world manufacturers. TUV provides audits for ISO 13485/ 13488 certifications. The standard pertains to the business processes concerning critical medical equipment manufacture, testing, compatibility, endurance, installations and delivery. BIS has a standard for Medical Equipment and Hospital Planning (MHD)

FDA Regulations
Registration and Listing (21 CFR part 807) Labeling (21 CFR part 801) Good manufacturing practice requirements as set forth in the quality systems (QS) regulations (21 CFR part 820) Electronic product radiation control provisions (Sections 531-542 of the Act, 21 CFR 1000-1050). Substantial equivalence of device (section 501k) can allow pre market notification. Center for Devices and Radiological Health, Office of Device Evaluation

Skills required to develop Medical Devices

Domain and application knowledge Transducer knowledge Analog + Digital logic design Signal processing (Analog and Digital) Board Design Embedded Firmware Application Software

Current state of medicine : India

State of medical devices : India

1.2B population by 2010, 58M aged 65 and older Changing patterns of disease High levels of unmet clinical needs 0.7 hospital beds, 0.6 physicians per 1000 $654M medical equipment market in 2005 Equipment valued $1,260 M in 2004 Expected $41.7 billion in 2010 Expected growth 4.7% per year World Bank assisted projects for rural areas Medical Tourism prospects

Types of Medical Equipment

Radiology and Diagnostic Equipment Medical monitors Surgical and Therapeutic Equipment Life support Equipment Medical Laboratory Equipment Hospital Management Systems

Radiology and Diagnostic Equipment

X-Ray Scanner C-Arm Mammography Fluoroscopy Cath Lab CT scanners MRI scanners DICOM3 image storage systems Ultrasound Scanners Ultrasound Doppler/Color Doppler scanners Bone Densitometers Gamma Cameras Linear accelerators

MRI Scanners

MRI Scanner Block diagram

http://

www.cis.rit.edu/htbooks/mri/inside.htm

CT Scanner

Radon Transform
Attenuation occurs exponentially in tissue:

where (x) is the attenuation coefficient at position x along the ray path. Therefore generally the total attenuation of a ray at position r, on the projection at angle , is given by the line integral:

Projected X-rays are clearly visible on this slice taken with a CT-scan Using the coordinate system of Figure 1, the value of r onto which the point (x,y) will be projected at angle is given by:

So the equation above can be rewritten as

where f(x,y) represents (x,y). This function is known as the Radon transform (or sinogram) of the 2D object.

CT Scanners : Principles

Ultrasound Scanner

Ultrasound images

Ultrasound Scanner : block diagram

http://hitachi.com/ICSFiles/afieldfile/2004/06/01/r2003_04_106.pdf

Patient Monitoring Equipment

ECG EEG Blood Pressure (Invasive) Blood Pressure (Non-Invasive) Dissolved Gases (O2,N2,CO2) Fetal Monitors Central Workstations

ECG Fundamentals

Life Support Equipment

Respiratory system (ventilator) Cardiovascular system (heart-lung machine) Renal system (dialysis machine) Gastrointestinal system

Dialysis machine

http://www.nephros.com/products_h2h.htm http://people.hofstra.edu/faculty/sina_y_rabbany/engg81/kidney.html

Medical Laboratory equipment

Microbiology Hematology (blood and plasma) Immunology Serology (Serum) Histology Cytology (smears of cells) Virology DNA Analysis

Lab Management System

http://www.sysmex.com/us/img/MOLISWAM_Brochure_1203(1).pdf

Surgical and Interventional Equipment

Surgical Diathermy Endoscopes Cardiac Ablators Robotic Surgery

Anesthesia equipment
Anesthesia equipment
Respirators Ventilators Anti hypoxic devices Gas (O2/N2O ratio) monitoring systems

Cardiac Revival Equipment

Cardiac Revival Equipment
Pacemakers and pacemaker programmers Defibrillators (External/Internal)

Cardiac Ablator System

Catheter Mapping System

Hospital Management Systems

Patient Registration Appointment Scheduling Admission Discharge Transfer Bed Management Wards Management Patient Relations Patient Billing Insurance and Contracts Management Management Information System (MIS) Hospital Administration Roster Management HRMS Financial Accounting Doctors Workbench Nursing Workbench Operation Theater Electronic Medical Record Clinic Specialties Laboratory Information System Radiology Information System Pharmacy Central Sterilized Supply Department Blood Bank Dietary (F&B) Housekeeping/Laundry Equipment Maintenance System (EMS) Healthcare Packages

http://www.acgil.com/products/hospital_management_system_001.htm

Thank You !