Medical device post market surveillance: Updates and trends
Post-market surveillance (PMS) is a critical part of pharmacovigilance, the science that focuses on the detection, evaluation, monitoring, and prevention of the unwanted effects of pharmaceutical products. It is vital in ensuring the safety and effectiveness of medical devices.
With the crucial role PMS plays in the healthcare industry, it merits the attention of patients, device manufacturers, and regulators. There have been developments involving or affecting post-market surveillance that needs to be highlighted because of their far-reaching consequences.
Supply chain vulnerabilities hit medical and IoT devices
Researchers at Forescout's Vedere Labs have discovered a set of vulnerabilities targeting the PTC Axeda agent which is commonly used in medical and IoT devices.
The Axeda agent enables device manufacturers to remotely access and manage connected devices, making these vulnerabilities reminiscent of the Kaseya hack and the SolarWinds Orion compromise.
OT and ICS vulnerabilities increase in the second half of 2021
Operational technology and industrial control systems saw a 110 percent increase in the number of vulnerabilities disclosed in the second half of last year.
The latest Biannual ICS Risk & Vulnerability Report from Claroty shows that remotely exploitable vulnerabilities are still causing problems, demonstrating the importance of securing remote connections.
These Apple devices can literally kill you
Apple devices can be literal life-savers. For instance, in an emergency, you can call 911 with an iPhone to summon help. Not to mention, there have been documented cases of Apple Watch detecting undiagnosed medical conditions. People ultimately go to the doctor to follow-up, and as a result, it ends up saving their lives.
As great as Apple devices are, they can also sometimes kill you. Like, seriously, some Apple products can possibly end your life -- if you have certain medical devices, that is, such as a pacemaker. And now, Apple is sharing a full list of its products that can interfere with medical devices and potentially lead to death. This expands upon its previously released list.
Millions of medical images openly available online
The analyst team at digital risk protection firm CybelAngel has discovered that more than 45 million medical imaging files, including X-rays and CT scans, are freely accessible on unprotected servers.
The findings are the result of a six-month investigation into Network Attached Storage (NAS) and Digital Imaging and Communications in Medicine (DICOM), the de facto standard used by healthcare professionals to send and receive medical data.
The technological makeover of pharmaceutical manufacturing
Manufacturing has been revolutionized by technology. However, pharmaceutical manufacturers are only just beginning to see the potential of innovative product creation. The potential benefits of technology in healthcare are vast, and revolutionary techniques are clearing the way for a cost-effective, efficient, and tailored approach to medicinal production.
One study suggests that the cost of bringing a new drug to market is upwards of $985 million. This is then reflected in the cost paid by insurance companies and end-users. The need to accelerate technology to drive these costs down is essential, and innovation is key. Here we look at the technology which is allowing pharmaceutical manufacturing to be revolutionized.
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