Public Health Impact of Medical Device Supply Chain Vulnerabilities

By Michelle Tarver, M.D., Ph.D.

The FDA’s Center for Devices and Radiological Health issued a statement on medical device supply chain vulnerabilities, the public health impact they have on patient care, the FDA’s actions to prevent and mitigate potential shortages, and solutions to strengthen the domestic supply chain and address these vulnerabilities.

The FDA’s Center for Devices and Radiological Health issued a statement on medical device supply chain vulnerabilities, the public health impact they have on patient care, the FDA’s actions to prevent and mitigate potential shortages, and solutions to strengthen the domestic supply chain and address these vulnerabilities.

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Sustainable from Start to Finish

By Dr. Max Rehberger

The European Commission’s Green Deal sets specific sustainability targets across the EU, while policies like the German Supply Chain Act (LkSG) of 2023 are setting standards domestically. TÜV SÜD explains how hospital operators and medical device manufacturers can position themselves sustainably in the market.

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How will deregulation in the US affect the international medical device market?

By Matt Burton

The United States is currently under the spotlight as Donald Trump’s recent appointment and consequent nomination of Robert F. Kennedy Jr as Department of Health and Human Services secretary are likely to bring a series of crucial changes that will affect the medical device market globally. Manufacturers everywhere are addressing their attention to the US market and waiting for new decisions to be made. In particular, deregulation is on the cards for the sector and the biggest concern is the restructure of the Food and Drug Administration (FDA), as a reduction in regulatory red-tape, though favoring increased competition, could also dangerously shrink examination processes.

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Designing for the Future:
How CGM Devices Are Adapting to Meet the Needs of a Growing User Base

By Chris Dawson

Continuous glucose monitoring (CGM) technology is rapidly expanding beyond Type 1 diabetes to reach a wider demographic, including Type 2 diabetics and wellness users. How manufacturers advancing CGM technology to address these diverse needs, focusing on ease of use, device reliability, and adherence strategies? By prioritizing these areas, manufacturers can empower a growing user base to manage their health more effectively and independently.

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Taking the Headache out of Maintaining 21 CFR Compliance

By Bryan Christiansen

Overcoming 21 CFR compliance challenges – stringent equipment maintenance requirements, overwhelming documentation demands, the need to maintain data integrity. Insights into challenges healthcare organizations face with compliance and how to incorporate new tools and processes for streamlining maintenance processes, reducing compliance burdens, and ensuring the highest standards of safety and efficiency.

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Wearables, adhesives

Beyond Innovation:
Confronting the Complex Risks in Health Technology Development

By Justin Kozak
Wearables, adhesives

Wearables are changing the game for health monitoring. From smartwatches and rings to skin patches, glasses, and even bras, companies are in a race to bring the latest innovations to market. But as this trend gains momentum and competition heats up, so do concerns about potential risks like data privacy, cybersecurity vulnerabilities, and the possibility of inaccurate health readings that could critically impact user safety.

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