Insights

The rising cost of clinical trials (CTs), coupled with the commercial risks of failure, mean it’s increasingly important to harness the power of real-world data to inform effective trial designs, better understand outcomes and maximise the likelihood of clinical success...

The FDA is changing what is regulated and what not, and how.  New openings are arising out of the shift in this line.  In additional, medical devices are no longer just ‘devices’; Software as a Medical Device (SaMD) is a whole...

To understand the current usage and future potential of liquid biopsy, we brought together experts from a range of disciplines to answer the following question: What is the current and future clinical utility of liquid biopsy based testing in oncology?

I’ve just got back to the office from a very interesting workshop looking to address the challenge of delivering rapid microbial testing in cell and gene products...

The new General Data Protection Regulation (GDPR) that will become law in May requires users to give consent for the collection of their sensitive personal data through a formal agreement rather than an assumption of...

In this series of blogs about systems engineering we have covered five key elements so far: 1) Understanding and analysis of project requirements; 2) Functional analysis, and system architecture definition; 3) Design...

The development of point-of-care (POC) devices is probably one of the most challenging endeavours a medical device developer will face.

dPCR is a well-established and powerful technique but there remains a need to reduce the read time for the very large, multispectral droplet count necessary for serial measurement. This applies particularly...