As more medical devices are being connected to the internet, Wi-Fi and internal networks, security has become an increasing concern for healthcare organizations. With more healthcare organizations looking to implement security solutions, the demand for the connected medical devices security market will increase.
Lack of awareness about the benefits and availability of these security solutions among healthcare professionals could be the initial hurdles for the connected medical devices security market. The adoption of connected medical devices has created a new hostile environment which poses threats to these devices' security and the healthcare organizations that utilize them. This has ensured an increasing need for security to protect against unauthorized access and cyber attacks.
Battelle, UL, WhiteScope, Coalfire Systems, Drager Medical, Extreme Networks, and Synopsys are some of the primary players in the sector of connected medical devices security.
The seven key regions in the connected medical devices security market are North America, Latin America, Western Europe, Eastern Europe, APEJ, Japan, and the Middle East and Africa. The robust healthcare industry in North America will lead to the connected medical devices security market to dominate in the region.
The FDA has issued guidance to implement a set of practices to prevent unauthorized access and cybersecurity attacks for connected medical devices security that should help to encourage medical device manufacturers.
The FDA’s guidance supported by increasing awareness among healthcare professionals about the importance of these security solutions will drive the market.
The FDA in its medical device security action plan lays out the following plan of action to
- Establish a patient safety net for medical devices.
- Explore regulatory options to organize the implementation of post-market mitigations.
- Encourage innovation for safer medical devices.
- Integrate the Radiological Health's premarket and post-market offices and activities and Center for Devices. This to be done with the aim of expanding the use of a total product life cycle approach to device safety
The FDA’s Breakthrough Device Program, through innovative new devices, could be used to improve patient access and patient safety together. The FDA is also lobbying Congress to expand its authority and funding to improve medical device safety, including reducing cybersecurity vulnerabilities in devices.
A CyberMed Safety Analysis Board proposed to be a public-private partnership, with experts in hardware, software, networking, biomedical engineering and clinical environments, between the FDA and devices makers will help to complement response mechanisms and existing device vulnerability coordination.
The board would evaluate patient safety risks, assess vulnerabilities, assess proposed mitigations, adjudicate disputes, serve as consultants to organizations steering the coordinated function as a “go-team” that could be deployed to investigate a suspected or confirmed device and disclosure processes.
All this FDA action should help further growth in the medical device security market.