Expert Insights & Resources

A balanced analysis of five key ways the Trump administration is reshaping the MedTech industry—including FDA regulations, AI advancements, tariffs, leadership changes at HHS, and impacts on post-market surveillance—highlighting both the opportunities and challenges for innovation and patient safety.

A recent manufacturing sector breach demonstrates how attackers combine phishing tactics with legitimate tools to quickly gain control and move laterally within a network, emphasizing the need for enhanced detection and prevention strategies.

A ransomware attack on Ascension Health in May compromised the data of nearly 5.6 million individuals and raised concerns about potential harm to patients due to disrupted healthcare services

The Dutch Health and Youth Care Inspectorate (IGJ) recently conducted inspections of 13 medical device manufacturers based in the Netherlands and found that none fully complied with the Post-Market Surveillance (PMS) requirements outlined in the European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).

Learn how the FDA is using real-world data to proactively monitor device safety and what it means for patients, providers, and manufacturers.

The FDA issued several medical device recalls in July 2024, impacting companies like Inspire Medical Systems, Philips North America, Hamilton Medical, Baxter International, Bausch + Lomb/Synergetics, and Abbott Laboratories. The recalls address issues ranging from manufacturing defects and software malfunctions to potential non-sterility and inaccurate readings. These recalls highlight the critical importance of post-market surveillance to ensure patient safety.

In today's increasingly connected healthcare landscape, medical devices play a vital role, directly impacting patient well-being. However, their reliance on software and connectivity exposes them to potential cyberattacks. Mitigating these risks requires robust cybersecurity measures throughout the device lifecycle, from pre-market development to post-market monitoring. This blog post equips you with a comprehensive cybersecurity gap assessment framework to evaluate your medical device's cybersecurity posture, ensuring compliance and minimizing risks.

Audio is generated by DropInBlog's AI and may have slight pronunciation nuances. Learn more In today's digital healthcare era, the threat of cyberattacks on connected medical devices is escalating. Recent cyberattacks in connected healthcare highlight the vulnerability of devices like pacemakers and insulin pumps to hacking, posing significant health risks.

The healthcare sector faces a unique challenge in managing the cybersecurity of legacy medical devices. These devices, often operating beyond their intended lifespan, are integral to patient care but lag in modern security protocols, making them susceptible to cyber threats.

With Philips agreeing to pay out hundreds of millions in its initial settlement over its recalled respiratory devices, the company's ventilator crisis exemplifies the severe consequences device makers can face if product quality issues are not addressed proactively. The settlement provides critical but costly lessons for manufacturers seeking to avoid similar recall pitfalls going forward.

Expanding Medical Devices into Digital Tools and Applications to Create New User Experiences

A recent report by Sedgwick found that manufacturing defects are now the leading cause of medical device recalls in the U.S. This marks the first time in 12 years that quality issues, not malfunctions or sterility problems, are to blame

Smiths Medical issued a correction letter regarding two potential issues with the CADD Infusion System Infusion Sets: lack of delivery or under delivery of medication, and false "no disposable attached" alarms.

More on EU Health Commissioner proposed MDR delay

Apple Fixes 30 Cybersecurity Vulnerabilities in iOS 16.2 and iPadOS 16.2

Insulet Recalls Omnipod DASH for Battery Swelling, Leakage, or Extreme Overheating

Baxter Hillrom recalling WatchCare IMS, RF emissions may interfere with other medical devices

Linux desktop vulnerabilities give untrusted users root

Dangerously wrong oxygen readings spur FDA scrutiny

According to the U.S. product recall index released by Sedgwick’s brand protection division, Q3 2022 U.S. recall data show that the number of products recalled this year has officially reached a 20-year high

A previously undetectable Linux backdoor combines high levels of access with the ability to scrub any indication of infection from the file system, system activities, and network traffic. It was initially discovered in November and is known as Symbiote.

Risk Management Considerations for IoMT

Stolen OAuth tokens used to exfiltrate private data

Hackers are actively exploiting vulnerability in widely-used BIG-IP

Google recalls the Fitbit Ionic for causing burn injuries

The Problem with Medical Device Plastics