Market Studies

Biomedical Fiber Optic Sensors Applications & Markets

Published: May 2022

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Overview:

Optical fibers and fiber-optic sensors (FOS) have been attracting attention in the healthcare industry in recent years, leading to a wave of research activity and development of new products. Given their EM immunity, intrinsic safety, small size and weight, autoclave compatibility, and capability to perform multi-point and multi-parameter sensing remotely, fiber-optic-based sensors are ideally suited for a broad variety of applications — invasive and non-invasive — in life sciences, clinical research, medical monitoring, and diagnostics, ranging from laser delivery systems, to disposable blood gas sensors, to intra-aortic pressure probes.


Optical fibers have a variety of different uses in the medical industry, including endoscopes, illumination systems, fiber laser delivery probes, imaging systems (such as Optical Coherence Tomography — OCT), and of course, sensors. At present, the market share of this global market by fiber-optic sensors is relatively small — estimated to be at around $250 million in 2020 and growing at double-digit CAGR. However, the potential is tremendous, and fiber-optic biomedical sensors provide capabilities and features that cannot be attained with other technologies.

This report reviews the advantages of using optical fibers and fiber sensors and discusses what makes them such an attractive, flexible, reliable, and unique solution for the healthcare and life sciences industries. Present industry trends, commercial and technical drivers, as well as the various biomedical fiber sensor types and associated applications, are reviewed. The report also presents a market analysis on the future opportunities for optical fiber sensors in biomedical applications, with market forecasts out to 2025. Key industry trends are identified, along with relevant commercial opportunities and associated regulatory approval hurdles and technical challenges.

Table of Contents

1.    Introduction & Health Care Industry Trends 4
    1.1.  Healthcare Sector Trends 5
        1.1.1.      Global Population Issues 5
        1.1.2.      Aging Global Population 6
        1.1.3.      Chronic Diseases 7
    1.2.  Healthcare Industry Trends 8
        1.2.1.      Patient Instrumentation & Monitoring 8
        1.2.2.      Advanced Operating Rooms 9
        1.2.3.      Technical Innovations and Needs 10
            1.2.3.1. Drive towards minimally invasive surgery (MIS) 10
            1.2.3.2. Miniaturization, Automation & Robotics 10
            1.2.3.3. Sensors Compatible with MRI, CT, PET, RF & microwave 10
            1.2.3.4. Increased use of Lasers à Need for fiber delivery devices 10
            1.2.3.5. Increased use of optical imaging and scanning techniques 10
        1.2.4.      Minimally Invasive Robotic Surgery (MIRS) 11
        1.2.5.      MIRS - The Need for Sensors 12
        1.2.6.      Need for faster Biochemical Analysis 13
    1.3.  Key Takeaway: The Healthcare Industry is being revolutionized by Technology Innovation & Increased global demand 14


2.    Biomedical Uses of Optical Fibers 15
    2.1.The Impact of Light in Medicine 16
    2.2.  Why Fiber Optic Sensors for Medical Applications? 17
    2.3.  Biomedical Applications of Optical Fibers 18
    2.4.  Medical Application Areas for Fiber Optic Devices & Sensors 19
    2.5.  Fiber Illumination 20
    2.6.  Biomedical Uses of Optical Fibers: Lighting & Illumination 21
    2.7.  Surgical Illumination 22
    2.8.  Surgical Instrument Lighting 23
    2.9.  Medical Fiberscopes 24
    2.10.      Fiber Laser Delivery: Bio-Medical Applications 25
    2.11.      Laser Delivery: Sculpted Fiber Tips 26
    2.12.      Laser Delivery: Commercial Fiber Probe Examples 27
    2.13.      Fiber Optic Fused Tapers & Faceplates: Digital X-Rays 28


3.    Biomedical Sensor Fundamentals 29
    3.1.  What is a Bio-Medical Sensor? 30
    3.2.  Biomedical Sensor Requirements 32
    3.3.  Biomedical Sensing 33
        3.3.1.      Classification by location: In-Vivo, In-Vitro 33
        3.3.2.      Cells, Tissues & Organs 34
        3.3.3.      A Matter of Scale 35
        3.3.4.      Sources of Biomedical Signals 36
        3.3.5.      Basic Transducing Principle 37
    3.4.  Basic Biomedical Instrument System 38
    3.5.  Biomedical FO Sensors: Measurable Parameters & Applications 39
    3.6.  Biomedical Sensing: Vital Signs 40
    3.7.  Biomedical Sensing: Application Areas 41
        3.7.1.      Medical 41
        3.7.2.      Healthcare 41
        3.7.3.      Research 41
        3.7.4.      Veterinary Medicine 41
    3.8.  Biomedical Sensing: Sterilization Techniques 42
    3.9.  ISO 10993 Biocompatibility of Materials & Devices 43


4.    Biomedical Fiber Optic Sensors & Types 44
    4.1.  Biosensor Technologies 45
    4.2.  Advantages of Fiber Optic Sensors 46
    4.3.  Fiber Optic Sensor 47
        4.3.1.      Basic Configuration 47
        4.3.2.      Classification by Type, Principle & Application 48
        4.3.3.      Intrinsic Type 49
        4.3.4.      Intrinsic Fiber Optic Sensors Classification Table 50
        4.3.5.      Extrinsic Type 51
        4.3.6.      Extrinsic Fiber Optic Sensors Classification Table 52
        4.3.7.      Classification by Technique 53
    4.4.  Fiber Optic Bio/Chem Sensors Sensing Mechanisms 54
    4.5.  Biomedical Applications: Key Specialty Fiber/Cable Considerations 55


5.    Applications and Sensor Examples 56
    5.1.  Spectroscopy: FO Probes 57
        5.1.1.      Optrodes 58
        5.1.2.      FO Optrode Sensing Principle 59
        5.1.3.      Typical Extrinsic Optrode Configurations 60
        5.1.4.      FO Sensor with Porous Microsphere 61
        5.1.5.      pH Optrode Sensor 62
        5.1.6.      Glucose Optrode 63
        5.1.7.      pHOptica™ 64
        5.1.8.      pH Optrode Sensors: Dye indicators 65
        5.1.9.      Optrode Advantages and Drawbacks 66
    5.2.  Evanescent Wave Sensors 68
        5.2.1.      Evanescent Field Sensors 69
        5.2.2.      Evanescent-Wave Sensor Principle 73
    5.3.  Optical Fiber Pressure Sensors: Operating Principles 76
        5.3.1.      Etalon (Fabry-Perot) Based Fiber Sensors 77
        5.3.2.      Fiber Bragg Gratings (FBG): Operating Principle 78
    5.4.  Temperature Sensors 79
        5.4.1.      Typical Applications 80
        5.4.2.      Magnetic Resonance Imaging (MRI): Patient Monitoring 81
        5.4.3.      RF Ablation 82
        5.4.4.      FO Temperature Probe: GaAs Etalon 83
        5.4.5.      FO Fluorescent Sensor: Luxtron Temperature Sensor 84
    5.5.  Pressure Sensors 85
        5.5.1.      Medical Applications for Pressure Sensing 86
        5.5.2.      Fabry-Perot Sensors: Some Examples 87
        5.5.3.      Intensity FO Sensor: Intra-cranial Pressure 88
        5.5.4.      Fabry-Perot Sensor: Intra-aortic Pressure 89
        5.5.5.      Fabry-Perot Sensor: Intra-aortic Balloon (IAB) Catheter 90
        5.5.6.      Pressure Monitoring: Fractional Flow Reserve (FFR) 91
        5.5.7.      Pressure Monitoring: OptoWire 92
        5.5.8.      Fluid Pressure Probe 93
        5.5.9.      FO Microphone/Pressure Sensor 94
        5.5.10.   Bragg Grating Sensors: Biomedical Pressure/Strain Sensors 95
        5.5.11.   Gastro-Intestinal Manometer Catheter 96
        5.5.12.   Multi-Point Pressure Monitoring: FBG Manometry – Operating Principle 97
        5.5.13.   Gastro-Intestinal Manometer Catheter 98
        5.5.14.   Multi-Point Pressure Monitoring: FBG Manometry Sensor Array 99
        5.5.15.   FBG Pressure Array: Patient Sleep & Bedsore Sensor 101
        5.5.16.   FBG Pressure Array: Patient Heart Rate & Respiration Sensor 102
        5.5.17.   FBG Pressure Sensor: Bandage Pressure Monitoring 103
        5.5.18.   FBG Pressure Sensor: Prosthetics Design Improvement 104
        5.5.19.   FBG Pressure Array: Orthopedic Applications 105
    5.6.  Strain, Force, Position, Shape Sensors 106
        5.6.1.      Cardiac Force Probe: FBG Intra-Cardiac Sensor 107
        5.6.2.      Fiber Optic Force Sensing in Ablation Catheter 108
        5.6.3.      Retinal Microsurgery Tool: FBG Force Sensor 109
        5.6.4.      FBG Pressure Probe: Spinal Disc Pressure Monitoring 110
        5.6.5.      Deflection and Force Sensing of Biopsy Needles 111
        5.6.6.      FBG Shape Sensing 112
        5.6.7.      Needle Tip Position & Force Sensing 113
        5.6.8.      FBG Respiration Sensor: MRI Environment 114
        5.6.9.      Smart Fabrics: Patient MonitoringàOFSETH Project 115
        5.6.10.   FBG Kinematics Sensor 116
        5.6.11.   Polymer Optical Fibers (POF) & Fabrics: Photoplethysmograph (PPG) 117
        5.6.12.   FBG Array Sensor: Femur Prosthesis Testing 118
        5.6.13.   FBG Array Sensor: Dental Prosthesis Testing 119
        5.6.14.   FBG Tendon & Ligament Testing 120
    5.7.  Flow Sensors 121
        5.7.1.      Fiber Optic Laser Doppler Velocimetry (FOLD-V) 122
        5.7.2.      Blood Perfusion Monitoring 123
    5.8.  Gas Sensors 124
        5.8.1.      Fiber Optic Pulse Oximeter 125
        5.8.2.      FO Near IR Oxymeter 126
        5.8.3.      Fiber Optic Blood Gas Sensor 127
    5.9.  Bio-chemical Sensors 128
        5.9.1.      FO Biosensors: Basic Types 129
        5.9.2.      Sensing System Approach 130
        5.9.3.      Optical Fiber Approach 131
        5.9.4.      Sensing Platforms & Techniques 132
        5.9.5.      Type II Biosensors: Biologically-Based Sensors 133
        5.9.6.      Biochemical Recognition Elements 134
        5.9.7.      Biomolecule Immobilization Techniques 135
        5.9.8.      Fiber Optic Immunosensor: Evanescent Field 136
    5.10.      Fiber Optic Imaging 137
        5.10.1.   Biomedical Imaging: Types of FO Probes 138
        5.10.2.   Optical Coherence Tomography (OCT): A FO Interferometric Sensor 139
        5.10.3.   Standard vs. Long Range OCT 140
        5.10.4.   Standard-Range, High Resolution OCT 141
        5.10.5.   Long range OCT: Scanning Probe 142
        5.10.6.   Side-Imaging OCT Probe 143
        5.10.7.   Intravascular Imaging: Coronary Lipid Scanner 145
        5.10.8.   Optical Needle Probes 147


6.    Market Overview 148
    6.1.  Market Opportunity 149
    6.2.  Fiber Optic Biomedical Market Product Categories 150
        6.2.1.      Specialty Fibers (large core, high-power, metal-coated, etc.) 150
        6.2.2.      Fiber Bundles (incoherent & Coherent) 150
        6.2.3.      Fiber Cables 150
        6.2.4.      Lensed Fibers 150
        6.2.5.      Fiber Assemblies 150
        6.2.6.      Probes (Sensing & Imaging) 150
        6.2.7.      Fused Tapers & Faceplates (Digital X-Rays) 150
    6.3.  Global Fiber Optic Biomedical Market Forecast 151
    6.4.  Biomedical Market: Segmentation by Application (2015) 152
    6.5.  Global Fiber Optic Biomedical Sensor Market Forecast 153
    6.6.  Fiber Optic Biomedical Sensor Companies 154
    6.7.  From Research Lab to Hospital: Pathway to Commercialization 155
    6.8.  FDA Requirements for Medical Devices 156
        6.8.1.      Class I Devices 156
        6.8.2.      Class II Devices 156
        6.8.3.      Class III Devices 156
        6.8.4.      510(k) Premarketing 157
        6.8.5.      Premarket Approval (PMA) 157
        6.8.6.      Investigational Device Exemption (IDE) 157
    6.9.  European Union Medical Directive 158
        6.9.1.      Class I 158
        6.9.2.      Class IIa 158
        6.9.3.      Class IIb 158
        6.9.4.      Class III 158
    6.10.      Future R&D Opportunities 161
        6.10.1.   Custom-tailored specialty fibers 161
        6.10.2.   Active fiber coatings 161
        6.10.3.   Holey and hollow-core fiber based sensors 161
        6.10.4.   Fiber arrays 161
        6.10.5.   Plastic fiber sensors & FBGs 161
    6.11.      Future Opportunities/Trends: Lab-on-a-Fiber 162


7.    Conclusions 163


Author’s Bio 166
Recommended Bibliography 167


Appendix:
Company Overviews of Select Biomedical Fiber Optic Sensor Suppliers 169


ADInstruments Ltd 169
ADInstruments Inc. 169
AFL / Verrillon 169
Verrillon Optical Fiber 170
Coherent, Inc./ Nufern 171
Endosense SA 172
Fibercore 173
FISO Technologies Inc. 174
Fujikura Ltd. 176
Hansen Medical, Inc. 178
Infraredx, Inc. 178
Intuitive Surgical, Inc. 179
Intelligent Fiber Optic Systems (IFOS) 180
Intelligent Optical Systems, Inc. 181
ISS, Inc. 182
LEONI Fiber Optics GmbH 184
LEONI Fiber Optics Inc. 184
LumaSense Technologies, Inc. 186
Maquet Getinge Group 187
Micronor Sensors, Inc. 188
Neoptix, Inc. 188
Nonin Medical Inc. 189
OFS 191
OmniGuide, Inc. 193
Opsens Inc. 193
RJC Enterprises, LLC 194
Samba Sensors 196
Technobis Group 196