Medical and Biological Sensors and Sensor Systems: Markets, Applications, and Competitors Worldwide

Basic Concepts

• Definitions and Categories
• Terminology

Integrated and Smart Sensors

Biomedical Applications

Sensor Manufacturing Technologies


• Monolithic Semiconductor Technologies
• Ceramic-Based Sensors
• Processing of Polymer Films
• Optical-fiber Technologies

General Biosensor Technology

Chapter Three: Biocompatibility And Standards For Medical Sensors

Biocompatibility Considerations

• Strategies for Reducing Blood coagulation on Sensor Surfaces
• Applying New Cellular Process Research

Sterilization Process for Medical Sensors

Testing and Approval Standards for Medical Sensors

The Review and Approval Processes


• Step by Step
• Nonclinical Testing
• Clinical Testing
• Biocompatibility of Medical Materials
• The Standards Organizations
• Types of Standards
• Who Uses Standards?
• The ASTM System

Chapter Four: Glucose Sensors

Designing for Home Use

• Friendly and Portable Equipment
• Smaller Packages
• Example of a Sensor for the New Medical Market

Glucose Monitoring Equipment: Market Characteristics


• Market Size and Growth

Diabetes Monitoring Technologies


• Dual Sensors: Earlier Warning for Diabetics
• Implantable Electrochemical Glucose Sensors
• Hypoglycemia Alarm
• New Glucose Monitors, More Information
• Three Sensor Strategies
• Implanting a Sensor
• Further Work Needed
• Moving Implantables to Market
• Implanted Sensor Stability

Smart Insulin Pumps: An Artificial Pancreas

Chapter Five: Selected Medical Sensor Technologies

Sensor Classification and Packaging

Surgical Applications for Sensors

Sensors for Diagnosis and Monitoring

Important Design and Performance Considerations


• Nontechnical Issues Can Be Critical
• Precision and Accuracy
• Cost of Ownership
• Sample Collection and Handling
• Performance Characteristics
• System Size
• Time per Test
• Versatility
• Sensitivity and Specificity
• Manufacturing Technologies
• Cost-Effectiveness

Electrochemical Considerations


• The Power Source
• The Pacemaker Battery
• Even Higher Currents Needed
• Advanced Materials: A Must for Biosensor Development
• Fuel Cell Power Sources
• Sensors Based on Ion Selective Electrodes (ISE)
• Distinguishing Between Medical Sensors and Biosensors

Planar Electrochemical Biosensors


• Requirements for Planar Sensor Systems
• Precision and Accuracy of the System
• Use- and Shelf Life
• Ease of Use
• Regulatory Requirements
• Connectivity

Chapter Six: Market Dynamics

The Medical Sensor Market

• Antibody and Protein Sensors
• Growth in the Market

Non-Medical Biosensor Markets


• Environmental Analysis
• Water Analysis
• Air and Gas Analysis
• Explosives and Narcotics Detectors

Ancillary Markets and Future Directions


• Miniaturization, Automation, and Robotics
• Intelligent Sensing: Micro Noses; Eyes and Ears
• Medical Diagnostics
• Drug Delivery Systems Tied to Medical Sensing

Chapter Seven: Current Research

Medical Sensor Technology Based on DNA

• New Biosensors
• Hybrid DNA Biosensors
• Hepatitis C Sensor
• Ruthenium-Based Redox System
• Molecular Bioelectronics Research Trends

Medical Sensor Technologies Based on Optical Detection


• Critters on a Chip
• Bioluminescent Chips
• Surface Plasmon Resonance Sensors
• Infrared Device for Breast Cancer Testing
• Other Space Technology
• Oxygen Sensors Based on Luminescence Quenching

Medical Sensing Technology for Imaging


• Charge-coupled Devices (CCDs)
• Bioengineering and Imaging Merge at NIH
• The Capsule Endoscope

Miscellaneous Sensor Developments


• Biosensor Tool Kit
• Imprinted Gels
• Diagnostic Tests Using CD Players

Chapter Eight: Detection Of Living Organisms And Potential Threats

The Challenge

Overview of Biological Warfare Defense

Detection of Chemical and Biological Weapons


• Portable System Detection Developed at University of Delaware
• Evaluating Symptoms Correctly
• Genetic Analysis of Pathogens
• Breath Testing
• Biological Warfare Canaries
• Accelerating Detection
• The Search for a Small Portable Sensor for Airborne Toxins, Viruses, or Microbes
• A Double-Edged Sword
• Science and Deterrence
• New Sensor Will Detect Chemical and Biological Pathogens at Incredibly Small Doses
• Radio Controlled Aircraft

Food Safety


• Lab on a Chip
• Microchip Bacteria Sensor
• Tracking Foodborne Bacterium

Water Safety


• Security concerns
• Productivity and Efficiency
• Regulatory Forces

Chapter Nine: Biosensor And Medical Sensor Companies

• Abaxis, Inc.
• ACLARA BioSciences, Inc.
• Advanced Biosensor, Inc.
• Affymetrix, Inc.
• Alaris Medical, Inc.
• APL Group International LLC
• Apollo Research Corp.
• Arrhythmia Research Technology, Inc.
• Avantes
• Biacore International AB
• BICO, Inc.
• Biofield Corp.
• Bio-logic Systems Corp.
• Careside, Inc.
• Cholestech Corporation
• City Technology Ltd.
• Cognex Corporation
• Criticare Systems, Inc.
• DecisionLink, Inc.
• Diametrics Medical, Inc.
• EP MedSystems, Inc.
• Erich Jaeger GmbH
• FISO Technologies Fiber Optic Sensors Inc.
• Gamma Biologicals, Inc.
• GE Medical Systems
• GEFRAN S.p.A.
• Genelabs Technologies, Inc.
• Hemagen Diagnostics, Inc.
• HL Planartechnik GmbH
• Hoffrichter GmbH
• Hologic, Inc.
• Illumina, Inc.
• Incyte Genomics, Inc.
• Integrated Photonic Technology (IPITEK)
• International Sensor Technology
• Introtek International
• Invivo Corporation
• i-STAT Corporation
• LifeChart.com, Inc.
• Lifestream Technologies, Inc.
• Masimo Corporation
• Medtronic MiniMed
• Minco Products
• Novametrix Medical Systems Inc.
• Novitron International, Inc.
• O.I. Corporation
• Oesch Sensor Technology
• Omron Corporation
• Optical Sensors Incorporated
• Physiometrix, Inc.
• PolyMedica Corporation
• PVL Ltd.
• Provalis plc
• Quest Diagnostics Inc.
• Respironics, Inc.
• Select Engineering Inc.
• Sensor Scientific Inc.
• Sentronic GmbH
• Spacelabs Medical, Inc.
• SpectRx, Inc.
• TECHNE Corporation
• TheraSense, Inc.
• TT electronics PLC
• Utah Medical Products, Inc.
• Zevex Inc.

Chapter Ten: Medical Sensors And Biosensors: Analyst’s Projections

Sensitivity and Selectivity

A Dreamer’s Biosensor of the Future

Is their Another “Killer Application” Biosensor?

The Future of Medical Sensor Technology


• Medical Sensor Applications
• Physical Sensors
• Chemical and Biosensors

Commercialization of Sensors

Wireless Sensors


• Wireless Sensors
• Communications and Computers

Medical Treatment

Associated Technologies


• Fiber-Optics Applications
• Infrared Local Area Networks
• On-Chip, Discrete RF Microelectromechanical Systems (RF-MEMS)

Nanotechnology

Appendix: Recent Biosensor Patents

List of Exhibits

Table 2-1: The Average Time for the Beginning of Blood Coagulation on Various Materials Table 2-2: Examples of Class I, II, and III Devices
Table 2-3: Selected Representative ASTM Standard Test Methods for Polymers
Table 2-4: Selected Typical ASTM Materials Standards
Table 2-5: Selected Representative AAMI and ASTM Device Standards
Table 2-6: Some Representative AAMI and ASTM Procedure Standards
Table 4-1: Market for Blood Glucose Monitoring Equipment and Supplies in the Seven Major World Healthcare Markets, 1999-2007
Table 6-1: World Biosensor Market by Application, 2001 and 2005
Figure 4-1: Trending in the World’s Major Blood Glucose Monitoring Markets, 1999-2007
Figure 4-2: Distribution of the Blood Glucose Monitoring Markets by Country
Figure 6-1: Distribution of Biosensor Revenues by Application, 2001 and 2005