FEATURED EDITORIAL
Beyond Australia: Why Medtech Startups Are Re-Evaluating FIH Trial Destinations
The advice handed to medtech companies planning a first-in-human (FIH) study has been: go to Australia. That advice is now overdue for a rewrite. Not because Australia stopped working, but because the math changed.
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Where can digital technologies can solve real problems for patients, healthcare providers, and industry, while avoiding unnecessary complexity? Here's where the strongest value propositions currently sit.
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P-tau217 blood tests could accelerate Alzheimer’s diagnosis. Lilly’s Nino Sireci, MD, MSc, explains the research, evidence thus far, potential clinical use, and next steps.
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The European Commission's simplification package is being debated almost entirely as an MDR story. The IVDR provisions carry the same legal force, and the window to shape them closes this fall.
INDUSTRY INSIGHTS
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Your Quality Team Is Already Using AI To Draft Compliance Documents
Quality teams already use general-purpose AI for deviations and submission drafts without validation. Regulators expect governance, and the gap is an undocumented process step, not unreliable output.
Clean audit results confirm past compliance but say little about future performance. As products, markets, and regulations multiply, readiness depends on whether evidence stays connected.
Passing inspections no longer signals that a growth-stage biotech can sustain clinical-stage complexity. The gap between audit readiness and operational readiness opens quietly.
Spreadsheets and siloed quality systems conceal five compounding exposures, from single-person knowledge dependencies to scalability limits, that tend to surface only when an inspector finds them.
A recent USP <788> revision introduces meaningful changes to particulate matter testing methods, with implications for laboratories working with small-volume injectable products.
MED DEVICE ONLINE CONTENT COLLECTIONS
Artificial Intelligence and Machine Learning are taking the life sciences world by storm. Do you know how to harness its power for your medical device? Check out our latest e-book which examines the opportunities AI and ML offer to both complement and supplement human intelligence in the medical device industry.
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