An overview of the use of passive and active electromechanical and semiconductive/MEMS sensors in Class II and Class III medical devices
Analyses of market trends, citing sales data for 2008, estimates for 2009, and 5-year projections, with compound annual growth rates (CAGRs), through 2014
A focus on high-value products for which the sensor defines the medical device. This category of medical devices includes active implants, biosensors, chemical detectors, dosimeters, ion-detecting electrodes, systems, wearable monitors, and wireless sensors
Company profiles and patent analyses.

Introduction

Study Goal and Objectives

This study, HLC080A Medical Device Sensors: Technologies and Global Markets, describes and forecasts the global market for Class II and Class III medical devices for which sensors are the product-defining component.

REASONS FOR DOING THE STUDY

During the final years of the 20th century, medical devices revolutionized the practice of medicine as they dramatically improved the lives of millions of people who were suffering from the most deadly diseases, devastating injuries, and debilitating birth defects. As the first decade of the 21st century draws to a close, these devices have also been drawn into the national debate over health care reform. Beyond their clinical benefits, medical devices that are equipped with sensory apparatus and telecommunications capabilities have the potential to reduce runaway costs while improving patient outcomes. When properly executed, incorporating sensors into medical devices can be a workforce multiplier. Using sensor technology, pulse, blood pressure, temperature, and other vital sign measurements that trained personnel formerly manually collected and manually entered into a patient' s chart can be automatically entered into the patient' s historic medical record. Sensors on wheelchairs can provide formerly unimagined mobility, including the ability to climb stairs. As the patient population ages, sensors can unobtrusively watch over the elderly, offering gentle reminders to take medications and eat meals, alerting aides when a patient may be attempting movements that might lead to a catastrophic fall, and generally providing peace of mind to friends and family. The compilation of patient and treatment data also creates a de facto database of clinical experience. Experimentation is still in early stages, but already the use of data mining to evaluate treatments has produced improvements in clinical outcomes by, for example, creating default settings for respirators that correspond to those that promote faster recovery.

Medical devices represent an enormous, ever-evolving industry that has recently entered an initial phase of operational rationalization. Anticipating major reductions in payments as the result of what appears to be the inevitable introduction of reforming U.S. health care financing, major device manufacturers have announced sweeping efforts to maintain their competitive edge by reducing the cost of goods sold (COGS) line item on their spreadsheets. Semiconductor/MEMS technology sensors that are most easily integrated into digital information systems are in a particularly strong position to benefit from this new era of cost-consciousness. Consequently, BCC anticipates that the business of supplying original equipment manufacturers (OEMs) of medical devices with sensors optimized for clinical applications will grow to more than $8.3 billion by 2014. This rising tide of good financial fortune, however, can lead to an unequal distribution of its benefits. In this study, BCC identifies the product lines and basic sensor technologies that are poised to reap the greatest rewards.

Intended Audience

Potential beneficiaries of the information contained in this study include marketing executives, business unit managers, and other decision makers in the industrial sensor industries. Others are individuals with similar job functions in companies that supply the sensors industry, health care executives, hospital administrators, negotiators for health care workers' unions, institutional and accredited investors, and public policy makers.

Scope of Report

This report addresses the use of passive, active, electromechanical, and semiconductor/MEMS sensors in goods that the U.S. Food and Drug Administration (FDA) identifies as Class II and Class III medical devices - products that require generally greater control than the more commonplace consumer goods that are normally classified as medical devices. Lists of specific products are provided throughout the study in the discussions of the medical specialties in which they are used. What all of these devices have in common is the presence of a component that detects some change in the physical state of the device or its surroundings.

In this study BCC examines the market for medical sensors from three points of view:

The medical and regulatory communities, who see sensors as providing a means of improving the safety and efficacy of medical devices
Device manufacturers, who see devices as a means of making their products more useful and, equally important, more cost-effective
Sensor manufacturers for whom products designed for medical devices are both a reliable profit center and a flagship product for showcasing their technological expertise

This study is divided into eight chapters and two appendices.

Chapter Three describes the state of the medical device sensors industry in 2009.

Chapter Four discusses how sensors are used to measure temperature, position, pressure, chemical structure, force and load, flow, and level. The overview provided in this chapter continues in Appendix A, which includes tables showing sensor operating parameters.E of report (Continued)

Chapter Five describes the increasing role of 25 industry consensus-standards organizations in guiding the development of governmental regulations of complex technologies. The FDA and its foreign counterparts presently rely upon these organizations in determining technical standards for medical devices. Standards are grouped by areas of medical specialty, and citations for specific regulations are organized into tables.

Chapter Six presents BCC' s forecasts for the global market for medical device sensors. After the introductory material, the chapter is divided into 13 sections, one for each area of medical specialty:

Anesthesiology and respiratory therapy
Cardiology
Clinical chemistry
Ear, nose, and throat practices
Gastroenterology - urology
General hospital
General, orthopedic, and plastic surgery
Hematology and pathology
Neurology
Obstetrics and gynecology
Ophthalmology
Orthopedics
Radiology

Following the organizational scheme BCC used in an earlier report, IAS006C Industrial Sensor Technologies and Markets, separate global forecast values are provided for the following:

Passive sensors
Active sensors
Electromechanical sensors
Semiconductor/MEMS sensors

Each section contains nine forecast tables, a summary table, and one table for each of the eight major categories of medical sensor purchasers:

Analytical laboratory instrument manufacturers
Electromedical and electrotherapeutic apparatus manufacturers
Irradiation apparatus manufacturers
Laboratory apparatus and furniture manufacturers
Ophthalmic goods manufacturers
Optical instrument and lens manufacturers
Surgical and medical instrument manufacturers
Surgical appliance and supplies manufacturersSCOPE of report (Continued)

A total of 117 forecast tables are presented in this chapter. Each offers the following information:

A U.S. dollar value for each of the four basic sensor technologies: passive, active, electromagnetic, and semiconductor/MEMS
Historic sensor requirements for 2007 and 2008
Forecast requirements for 2009 and 2014
2009 to 2014 compound annual growth rate (CAGR) calculation

In addition to the nine forecast tables, each section contains three informational tables. The first identifies the 10 most commonly treated medical conditions associated with the medical specialty that is the topic for the section. The second and third are, respectively, lists of sensor-dependent Class II and Class III medical devices associated with the medical specialty.

Chapter Seven profiles and provides basic location information for 122 sensor manufacturers and buyers, business-academia research consortia, and others involved in advancing the development of medical devices. Firms were selected based on qualification criteria that included being issued a sensor-related medical device patent, holding a leadership in the business, or involvement in research development.

Chapter Eight contains a narrative discussing key medical device sensor patents issued from January 2000 to the end of November 2010. Separate tables list 20th- and 21st-century patents. Appendix B continues the discussion with abstracts of the patents, along with basic identification of their inventors and patent assignees.

METHODOLOGY

Primary research for this work included comprehensive and exhaustive research of the literature on industrial sensors. Forecasts were constructed from product descriptions in FDA 510(k) filings; public companies' SEC annual and quarterly filings; company product literature; patents, product, treatment, and device cost information from open-source databases that the FDA, BEA, U.S. Patent and Trademark Office, and the Security and Exchange Commission maintain. .

Information Sources

BCC reviewed more than 500 companies to obtain data for this study. We also reviewed reports and studies prepared for peer-reviewed professional literature and reports by the technical staffs of the World Health Organization (WHO), the Department of Health and Human Services (HHS), the National Institute of Medicine, the National Academy of Engineering, the National Cancer Institute, the National Institutes of Health, and the Government Accountability Office (GAO), as well as presidential directive and policy statements. In addition, BCC compiled data from scientific and technical conferences, presentations prepared for financial analysts, the European Union, and the European Commission.

Chapter- 1: Introduction -- Complimentary
- Study Goal and Objectives
- Reasons for Doing The Study
- Intended Audience
- Scope of Report
- Scope of Report (Continued)
- Scope of Report (Continued)
- Methodology
- Information Sources
- The Analyst' S Credentials
- Related BCC Research Reports
- BCC Online Services
- Disclaimer 6
Chapter-2: Summary
- Smmary Table Global Requirements for Medical Device Sensors, through 2014 ($ Millions, Class Ii and Class Iii Devices)
- Summary Figure Global Market for Medical Devices Sensors by Technology, 2007-2014 ($ Millions) 8
Chapter-3: The Medical Sensors Industry in 2009
- The Medical Sensors Industry in 2009 (Continued)
- Three Industry-Driving Trends
- Three Industry-Driving Trends (Continued)
- Three Industry-Driving Trends (Continued) 11
Chapter-4: Sensors Used in Medical Devices
- Government Regulatory Authorities
- Consensus Standards Organizations
- Broad Interest Organizations
- Association for The Advancement of Medical Instruments (Aami)
- American National Standards Institute (Ansi)
- American Society for Quality (Asq)
- Astm International (Astm)
- European Committee for Standardization (Cen)
- Table 2 Cen Member Countries
- Electrostatic Discharge (Esd) Association
- International Electrotechnical Commission (Iec)
- International Organization for Standardization (Iso)
- International Organization ... (Continued)
Chapter-5: Standards and Regulations
Chapter-6: Forecasts
Chapter-7: OEM-Level Medical Device Sensor Forecasts
Chapter-8: Company Profiles
Chapter-9: Patents
Appendix A Sensor Basics
Appendix B Patent Abstracts

Pharmaceutical Market Research

Medical Device Sensors