Published Date : 2025-Mar-20
As we approach 2025, the global medical device security market is witnessing significant growth, driven by the increasing integration of connected medical devices and the imperative to protect patient data. Several companies have emerged as leaders in this field, offering innovative solutions to safeguard healthcare infrastructures.
Below is a list of top companies leading the charge in medical device security: IBM Corporation, Cisco Systems, Philips, DXC Technology, Palo Alto Networks, Fortinet, Check Point Software Technologies, McAfee, Sophos and FireEye are among the leading players in the market.
The need for manufacturers to protect their products against cyberattacks and the increasing number of devices connected will be the primary drivers of this growth. Medical device security is a critical issue that needs urgent attention. By taking robust security measures, manufacturers are attempting to make patients' data secure and their devices immune to attack.
Medical equipment is becoming more and more networked, and therefore more vulnerable to cyber-attacks. Indeed, according to a Federal Trade Commission (FTC) study, cybersecurity vulnerabilities exist in nearly one-third of all medical devices. Hackers can exploit these vulnerabilities to gain access to confidential medical data or even remotely control the device. For example, in 2017, a hacker successfully manipulated the dose of medicine administered to patients by exploiting a vulnerability in a popular hospital infusion pump.
The key market players are concentrating on product development and software enhancements to improve the functionality of secure medical devices. For example, BT Radianz collaborated with security firm AlertEnterprise to create a technology that enables healthcare device manufacturers to embed advanced cyber security solutions into their products.
Awareness among end users of cyber threats is also increasing due to partnerships between security solution providers and device manufacturers. For example, following the attacks on it through malware last year, the Danish medical device company Maersk implemented an anti-virus application in its automated teller machines (ATMs) spread around Europe. Numerous medical device businesses have also begun distributing anti-virus software gratis to their users.
Healthcare and the industry need to both tackle medical device security as a matter of priority.
The market over the forecast period will grow with a CAGR of over 9%. Companies operating in the market for medical device security have to focus on product innovation and making their products function better currently if they need to capitalize on the growth opportunities that lie ahead.
The Department of Homeland Security's Industrial Control Systems Cyber Emergency Response Team has issued a notice of security flaws found in several medical devices made by Smiths Medical ASD, GE Healthcare, Philips Electronics North America Corp., and Roche Diagnostics Corporation. More alarming is the recent finding that hackers may access anaesthesia workstations and take control of the machines.
Also, there are concerns that other networks containing medical equipment would be targeted by hackers. For example, if a hacker were to gain control of a pacemaker, he or she could command the device to increase or decrease the patient's heart rate, leading to a heart attack. The FDA and other regulatory agencies for medical devices need to mandate strong security measures in all medical devices, and manufacturers need to spend the money necessary to make their products secure. Medical device security is an important problem that needs to be addressed. The cost of medical treatment would likely increase consequently, but at least the use of medical gadgets would be much safer.
The FDA has issued new regulations on the security of medical devices to fight increasing cyberattack threats. The guidelines recommend manufacturers be cautious about cyberattacks through encryption methods and use secure passwords. It further recommends that manufacturers implement plans to deal with and recover from cyberattacks.
Presently, the FDA mandates that device manufacturers abide by cybersecurity "post-market surveillance" guidelines when seeking approval of their products. These guidelines were refreshed in 2016 to necessitate the upgrading of devices by manufacturers with security patches and solutions to prior-existing vulnerabilities. A second draft recommendation, entitled "Postmarket Management of Cybersecurity in Medical Devices," is under development at the FDA. This new guidance will have special focus on managing risk related to unpatched or insufficiently patched devices throughout the lifetime of those devices. The agency aims to publish a final report by 2021 and has already conducted workshops and meetings where stakeholders may give feedback.
Over 18,000 hacking attacks on individual medical devices, pacemakers, and insulin pumps, have been reported globally in 2018. Because the medical confidentiality guidelines often keep them unreported. However, based on reported vulnerabilities in specific devices. The attacks come from various sources like hacktivists, pranksters, and cybercriminals who seize control of the device for illicit activities or ransom.
The worldwide medical device security market is seeing vulnerability emerging from the side of manufacturers not creating their products with security in mind from design to production This lack of thought means that lots of zero-day exploits exist on the black market which means there are more options for attackers to attack a system. Depending on their capability level, these exploits can range in price from $100 to $200k, or even be bought for as low as $5,000, so even people with ill intentions can obtain them. This lack of regard is not acceptable in most industry verticals, but especially in the medical device space, when one looks at the potential outcomes of an attack, such as death or permanent health damage.
As per IBM & Ponemon Institute report released in 2020, approximately 76% of healthcare organizations have suffered a data breach in the last four years alone with an average annual cost of $2.1 million for these attacks. The worth of private health information has grown so much that its mere existence threatens individuals' lives and livelihoods. And the importance of more security measures to be implemented is now greater than ever before. Blockchain technology can also prove to be beneficial in this context as it provides fine-grained control over each transaction, allowing patients to determine who can see their data while still providing access to doctors or other medical providers when necessary.
The market for medical device security is growing consequently, and it will just continue to increase in the years ahead. The market will see more spending on security because manufacturers understand its significance, along with enhanced security against attacks on medical devices.
The medical device security market in North America is expanding rapidly. The growth is being fuelled by the need for connected devices that can offer real-time data to healthcare professionals. The North American boasts the biggest market globally and is projected to grow at a CAGR of 8.5% during the forecast period. Wherein, the U.S. commands the regional market by accounting for more than 70% share. One of the causes of this rise could be that the Department of Health and Human Services (HHS) has issued a directive to healthcare professionals to encrypt wireless communications for Internet-connected medical devices or those that have an embedded or downloadable software application. Medical device manufacturers, in this situation, need to be helped to manage security weaknesses as well as handle FDA recalls. Device manufacturers in the region are constantly focusing on staying vigilant for weaknesses and addressing them immediately when they do occur to remain one step ahead of thieves. We are witnessing a move toward proactive security, particularly now with the enhanced realization of threats to medical devices.
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