Two men, Nick A. (left) and Nigel (right), sit at a white table, engaging in a lively and friendly conversation. Both wear checkered shirts and lavalier microphones, suggesting a filmed discussion or interview. Nick holds tissue samples in one hand and gestures animatedly, while Nigel smiles in response. Each has a white mug labeled with their name and a purple star logo. The background is a bright white, creating a clean and professional studio setting.
Resources

Fluorescent Protein Assay Testing in Medical Devices

Sector: Diagnostics
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Understanding the Fluorescent Protein Assay

In this Bio Break episode, Nick Allan and Nigel Syrotuck explain how a fluorescent protein assay helps engineers measure contamination and cleaning performance in medical devices. At StarFish Medical, the team develops controlled soil mixtures that safely simulate bodily fluids. These “artificial soil loads” allow precise testing of how effectively a device can resist or release contaminants.

The Science Behind Soil Load Visualization

To make invisible residues measurable, fluorescent dyes are introduced into the protein-based soil. Nick describes how common assays such as the Bradford Comassi and BCA assay use chemical reactions to bind with protein molecules. When exposed to certain light wavelengths, these compounds absorb and emit light differently, creating measurable fluorescence. This allows researchers to see exactly how much protein remains after cleaning.

Quantifying Cleaning Performance in MedTech

By using fluorescence to detect trace contamination, engineers can go beyond visual inspection. As Nigel and Nick discuss, results compared against a standard curve reveal how well a device resists soil accumulation or supports effective cleaning. These insights guide medical device developers toward safer, more reliable designs that meet regulatory expectations.

Businessman holding a glowing compliance icon with legal and regulatory symbols, representing REACH SVHC compliance for medical device manufacturers

Nigel Syrotuck breaks down REACH SVHC compliance for teams working with material suppliers and compliance questionnaires.

Medical Device Design Simulation

We examine when computational modelling and simulation, or CM&S, genuinely supports medical device simulation strategy and when it becomes a costly detour.

Transparent medical device prototype surrounded by computational simulation mesh representing modeling and simulation during medical device development.

Many teams still underuse CM&S, often bringing it late in device validation, when key decisions have already been made. That approach leaves much of the value of CM&S untapped.

Biomedical engineer reviewing a thermal simulation of human head tissue on a monitor, color-mapped from warm to cool gradients

This article traces the Pennes bioheat equation from its 1948 origins to modern multiscale approaches, explaining how engineers select the right level of modelling complexity across device categories.