Wearables, adhesives
Wearables, adhesives

Beyond Innovation: Confronting the Complex Risks in Health Technology Development

By Justin Kozak

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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PFAS
PFAS

No Longer “Forever Chemicals”

By Dr. Christina Reufsteck

Because of the environmental and health risks that PFAS ─ per- and polyfluoroalkyl substances ─ pose, they are subject to a potential ban across the European Union. Such a ban would introduce a need for medical device manufacturers to identify and discontinue the sale of products containing PFAS, while also developing safe and effective alternatives. How will suppliers across the EU approach the impending shift away from these “forever chemicals”?

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REGULATORY REPORT 2024: Managing Global Regulatory Strategy & Compliance: Assessing Status, Gaps & Needs

An April 2024 survey of medical device regulatory professionals illustrates potential regulatory fatigue. See how resource constraints, ever changing global policy, and an underutilization of technology/digital process are impacting internal burden and fatigue and where implementing new regulatory strategies, upgrading organizational expertise, adding outsourced regulatory services are helping teams cope.

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