Life Sciences Technology Trends: The Shift to Patient-Centric Care

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From Promise to Proof

Every company has heard the AI promise by now. Do more, spend less, move faster, and let the machines carry the load. It is a good promise, and it is worth wanting. The harder part is making it last....

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Compliant Augmentation: More Together, Under Command

A calm settles into the work when the machine does something impressive and the person trusts it. A system studies pictures of the process, reads what the eye alone would miss, and recommends the...

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From Validated to Augmented

This series offers a knowledge-based perspective on how to develop AI-based systems that life sciences can trust. The idea is simple. An AI-based system is best understood through what it knows, in...

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Define: What the System Is Allowed to Know

For this series I have followed one running example: an AI-enabled robotic cell-culture system that grows cells for advanced therapies. It watches the culture as the process runs, and recommends the...

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Review: The Validation That Learns

For several editions now I have followed the same running example: an AI-enabled robotic cell-culture system that incubates cells for advanced therapies, watches the culture as the process runs, and...

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Monitor: When the Model Should Say It Doesn’t Know

For three editions now I have examined different aspects of the same system: an AI-enabled platform that incubates cells for advanced therapies, watches the culture as the process runs, and...

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Automation Does Not Remove the Human. It Promotes Them.

Picture the same system from the last two editions, the one that incubates cells for advanced therapies. It watches the culture, sees a problem forming, and recommends the machine’s next move....

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Lock: Why Nothing the Model Is Told Gets Overwritten

Last time, I described an AI-enabled system that incubates cells for advanced therapies. It watches the cells as the process runs and recommends the machine’s next move. The goal: fewer failed...

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Context Language Validation: The Second Lifecycle for AI in Regulated Systems

The assignment is the kind the team takes on gladly: develop software for a robotic device that cultures cells. The system controls movement and timing, adjusting critical process parameters based on...

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The Client Said No to AI. Then She Said Yes to This.

Twelve instrument assembly work instructions. Some made up of up to two hundred knowledge packets. A knowledge packet is one self-sufficient instruction: the command to carry out, the parts and their...

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Three Routes. One Architecture.

A few weeks ago, in a workshop I was facilitating on compliance excellence in medical device development and manufacture, a Quality Systems Manager stated something I have heard, in some form or...

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Why Oxygen and Carbon Dioxide Matter in Cell Therapy Manufacturing

Cell culture is at the heart of cell therapy manufacturing. Two gases, oxygen (O2) and carbon dioxide (CO2), play a crucial role in this process.

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