LABORATORY MANAGEMENT ARTICLES

In this third article in his series on statistics, Stephen MacDonald moves on to look at precision studies, focusing on issues such as their practical use, terms used, study design, and interpretation. Also included is a worked example and important take-home points for the reader.

The European Commission’s targeted revision proposal of the EU Medical Devices Regulation and In Vitro Diagnostic Regulation aims to bring urgently needed reforms to increase patient protection and trust in medical technologies. Here, trade association MedTech Europe assesses the changes.

In this second article in his new series, Stephen MacDonald moves on to hypothesis testing. Here, he looks at statistical assumptions, study design and data quality, which are central to arriving at the correct decision about what test to run, if at all.

After a busy 2025, the next few months will see further change in the regulation of medical devices around the globe. Jonathan Ripley picks 10 trends to monitor.

With the UK’s first cobas Mass Spec solution, Roche Diagnostics is promising a step change in advanced diagnostics.

Beth Loudon provides an introduction to value‑based procurement for practitioners working in NHS pathology services, who may have limited exposure to NHS purchasing practice. This article expands on common challenges and offers practical steps to make VBP workable.

With the first in a new series of articles, Stephen MacDonald returns to the pages of Pathology in Practice. Here, he begins with an introduction to statistical interpretation focusing on improving the quality of the first statistical encounter with a dataset.

This year marks the start of a series of deadlines to ensure Class C medical devices remain in step with new regulations. Many diagnostic devices face a more demanding future as the new IVDR requirements are set to heighten scrutiny of laboratory and POCT equipment, as Liz Harrison explains.

New research from CPI reveals systemic barriers facing UK MedTech startups and spinouts and calls for coordinated reform across regulation, investment and NHS adoption, to unlock innovation and deliver national health and economic strategies.

Advances in molecular and genomic technologies are transforming oncology diagnostics, bridging screening, risk stratification, and treatment selection into a connected model of early cancer detection.

Stephen MacDonald concludes his series of articles on risk-based quality management by drawing together the various elements on which each of the previous seven articles focused.

Earlier this year, South West London Pathology celebrated the installation of new analysers and automated tracking at Croydon Hospital’s essential service laboratory. Six months on, Pathology in Practice Editor Andy Myall caught up with SWLP‘s Managing Director Simon Brewer to see how the project is progressing.

With laboratories under pressure, automation allows staff to gain back time. Here, Megan Northam explains how her laboratory has benefited from the features of the OsmoPRO MAX Automated Osmometer.

In this seventh article in his series on risk management, Stephen MacDonald moves on to consider internal audits and periodic reviews of examinations, which are fundamental to delivering safe and reliable laboratory services.

In this sixth article in his series, Stephen MacDonald considers the need for a broader, risk-based approach, where monitoring activities are chosen and applied according to the potential for patient harm.

Andrew Turner explains how pathology services and ultimately patients can benefit, by analysing and then optimising the pre-analytic phase.

Debra Padgett, Clinical Pathology Lead and Lead Healthcare Scientist, and an IBMS Past President, discusses pathology, working towards Net Zero, and Biomedical Science Day as well as the recent refurbishment of her laboratory.

In this fifth article in his series, Stephen MacDonald focuses on the implementation of risk-based turnaround time management, which requires collaboration across laboratory and clinical teams, supported by robust IT infrastructure and real-time monitoring tools, and, most importantly, cultural change.

By moving away from fixed quality control schedules and embracing a framework rooted in clinical risk and analytical performance, laboratories can tailor their quality systems to reflect real-world challenges. Here, Stephen MacDonald introduces the role of analytical performance specifications, Sigma metrics, and the MaxE(nuf) model.

The third in Stephen MacDonald’s latest series of articles focuses this month on the use of risk-based approaches and the application of methods such as FMEA, FTA, RCA and Process Mapping.