Medical Device Security: Technologies and Global Markets

Friday, October 13, 2017 Corporate News
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NEW YORK, Oct. 12, 2017 /PRNewswire/ --

• The global market for medical device security totaled $4.7

billion in 2016. The market should total $5.2 billion in 2017 and $7.5 billion by 2022, increasing at a compound annual growth rate (CAGR) 7.4% from 2017 to 2022.

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• The hardware segment totaled $2.8 billion in 2016. The market should total $3.0 billion in 2017 and $4.2 billion by 2022, increasing at a CAGR of 6.7% from 2017 to 2022. • The software segment totaled $1.0 billion in 2016. The market should total $1.2 billion in 2017 and $1.8 billion by 2022, increasing at a CAGR of 8.4% from 2017 to 2022.

Chapter 1: Introduction According to the Medical Devices Innovation, Safety and Security Consortium, medical devices comprise a $100 billion market, with one-quarter of these digitally connected devices. Although the Food and Drug Administration (FDA) requires assurance that new devices are 100% secure, legacy devices deployed prior to regulations regarding cybersecurity are still in use. These pose a security threat, with more than two dozen device types being investigated by the Department of Homeland Security Industrial Control Systems - Cyber Emergency Response Division.

The visibility and sensitivity of medical device security provide a strong opportunity for suppliers to offer ways to secure both new and legacy devices. Unlike consumer devices, medical devices must meet guidelines for intelligence sharing regarding potential cyber threats. This includes reporting to federal information sharing organizations and providing vulnerability disclosures and remediation programs.

This means a layer of embedded security features is added in the design phase of the devices. Manufacturers must implement embedded security measures and monitoring within devices as well as software-based data collection and sharing systems within networks.

Study Goals and Objectives The goal of this report is to spotlight the key technologies and global market opportunities for medical device security. Opportunities are expressed in terms of potential revenue for the addressable market for medical device security technologies by geographic region, application type and technology type. This is a companion report to reports on medical device technologies and connected medical devices provided by BCC Research.

Reasons for Doing This Study The purpose of this study is to size the market for medical device security and the underlying technology. Specifically, the repost estimates the size of medical device security technology hardware, software and platforms, provides related forecasts and discusses the market in depth. This data will enable manufacturers to determine the most effective directions for research and development, product packaging and marketing and sales strategies.

Scope of Report This report covers the global market for medical device security technologies and provides regional analyses of the markets in North America, Latin America, Europe, Middle East and Africa (EMEA) and Asia-Pacific. Component segments include chip sets, platforms, software, and services. The market is also segmented by end users such as providers, payers and manufacturers. Furether, application areas such as consumer, wearable, embedded, and in-hospital devices are sized.

Information Sources The primary information sources include global manufacturers and suppliers of medical device security technology and associated products, suppliers for the manufacture of these products, major users of these products, research organizations, governmental agencies, trade associations, and various equipment suppliers. Additional secondary research sources such as databases, trade literature, specialized journals, and government statistics were used to compile this report.

Methodology Both primary and secondary research methodologies were used to prepare this report. Initially, a comprehensive and exhaustive search of the literature on medical device security was conducted. These sources include relevant journals and related books, trade literature, marketing literature, other product/promotional literature, annual reports, analyst reports, and other publications. Subsequently, telephone interviews and email correspondence were conducted with marketing executives, product sales engineers, international sales managers, application engineers, and other personnel of medical device companies. Other sources included academics, related suppliers, technical experts, and consulting companies.

Geographic Breakdown In this report, the geographic regions considered for market analysis are the following: • North America. • Europe. • Asia-Pacific. • Rest of world.

Medical Device Security, by Technology Hardware Software Services

Medical Device Security, by End Use Market Healthcare Provider Manufacturer

Medical Device Security, by Application Consumer Monitoring Wearable External Internally Embedded Stationary

Chapter 2: Summary and Highlights For patients, healthcare providers and device manufacturers, cybersecurity in healthcare is "the wild wild west", according to Josh Singletary, CIO for the National Health Information Sharing and Analysis Center (NH-ISAC). Singletary is referring to the number and types of threats, which range from ransomware to credential harvesting.

The motivation in most cases is financial as healthcare associations report that protected heath information (PHI) records are worth $50 each on the black market, which is six times the value of a social security number. Credential harvesting can be used to access PHI records or for other aspects of identity theft in addition to credit card or other financial data. Most recently, ransomware such as WannaCry simply locked down internal systems until the medical provider paid a ransom via Bitcoin.

Protecting against these varied and increasingly sophisticated attacks is difficult as the medical information system footprint is quite large with multiple entry points. Providers must consider incursions across the entire stack of systems, ranging from enterprise IT infrastructure to networks and end points, especially medical devices. In this environment, medical devices can be major entry points into vulnerable healthcare systems.

"Devices have risks, you need to know them and work them," Kevin Fu, CEO of Virta Laboratories and an associate professor and leading research participant for the Archimedes Center for Medical Device Security at the University of Michigan, has stated. The state of vulnerability of medical devices increased in phases. Initially, there were few incursions so over time, legacy devices were deployed with minimal security. Within the last few years, however, the capability to access medical devices via remote wireless signals has ratcheted up risk.

A few recent cases include: • Johnson & Johnson famously became the first device manufacturer to issue a security warning. The warning was regarding its Animus OneTouch Ping Insulin Pump, which could be accessed through unencrypted wireless remote communications to trigger a potential overdose. • In another famous case, a consultant was able to remotely activate a pacemaker, giving him the ability to administer a potentially fatal shock. • According to the Identity Theft Resource Center, more than 300 security breaches were reported by healthcare facilities in 2017, exposing 1.3 million patient records.

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