Science & Methods

Peer-Reviewed Research & Methodological Insights

Publications, meta-analytic methods, and perspectives on clinical evidence — from biomaterials science to modern evidence synthesis.

Evidence SynthesisJune 28, 2026

A Handbook of Advanced Meta-Analysis Techniques: 53 Concepts, One Honest Page Each

A free, plain-language reference for the pooling, heterogeneity, robustness, publication-bias, and certainty methods behind modern meta-analysis — one concept per page, formulas only where the formula is the idea, and an honest limits section for every method. Download the PDF.

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Evidence SynthesisJune 15, 2026

Automated Data Extraction for Systematic Reviews: Reclaiming the Most Expensive Hours Without Losing the Audit Trail

Data extraction is the slowest, most error-prone, and least examined step of a systematic review — and the one most ready for automation. This post breaks down the true cost of manual extraction, what tools like Rayyan, Covidence, and DistillerSR actually automate, and how an auditable LLM pipeline can read full-text PDFs into grounded, source-linked data without surrendering the audit trail your Clinical Evaluation Report depends on.

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Evidence SynthesisMay 28, 2026

The Confidence Interval Answers the Wrong Question: Why Every Meta-Analysis Needs a Prediction Interval

A random-effects meta-analysis reports a pooled effect and its 95% confidence interval, but that interval describes the average, not the next study. This post builds the prediction interval from first principles: what a 95% CI is, how heterogeneity enters, what the prediction interval adds, when it helps, when it misleads, and how to calculate it.

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Clinical InvestigationsApril 14, 2026

ISO 14155:2026 vs. ISO 14155:2020: What Actually Changed, and What It Means for Your Studies

The fourth edition of ISO 14155 replaces the 2020 version with a technically revised standard. This post walks through the substantive changes, separates the genuinely new requirements from the clarifications, and explains what sponsors and investigators need to do about ongoing and planned medical device studies.

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Clinical InvestigationsJanuary 10, 2026

Investigator-Initiated Studies in MedTech: The Good, the Bad, and the Ugly

Everyone loves investigator-initiated studies until they have to manage one. A walk through how IIS should work in the European medtech world, why they are genuinely valuable, where they quietly fail, and where they were never meant to succeed in the first place.

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Statistical MethodsDecember 28, 2025

Time Series Forecasting for Critical Systems: Building Reliable Predictions with ARIMAX

A practical guide to ARIMAX modeling for forecasting critical infrastructure, demonstrating how classical statistical methods deliver transparent, validated predictions—illustrated with German gas storage forecasting.

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Evidence SynthesisDecember 15, 2025

Forest Plots in R with metafor: From Basic to Publication-Ready

A hands-on guide to creating forest plots in R using metafor — from simple plots to publication-ready figures with heterogeneity stats, prediction intervals, and detailed study-level annotations.

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Evidence SynthesisDecember 10, 2025

Beyond the Standard Model: Multilevel and Multivariate Meta-Analysis for Complex Clinical Evidence

A practical guide to multilevel and multivariate meta-analytic models — handling dependent effect sizes, correlated outcomes, longitudinal data, and arm-based analyses in clinical research.

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Evidence SynthesisNovember 27, 2025

Meta-Analysis in Clinical Evidence Synthesis: From Effect Sizes to Regulatory Decision-Making

A practical overview of meta-analytic methods for clinical evidence synthesis — covering standard models, effect size measures, heterogeneity, publication bias, and their relevance for regulatory submissions in the medical device and pharmaceutical industry.

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Clinical InvestigationsNovember 6, 2025

ISO 14155 and the Sponsor-Investigator: When the Standard Meets the Ward

ISO 14155:2020 was written with industry sponsors in mind. But what happens when the investigator is also the sponsor? This post examines the real-world burden ISO 14155 places on sponsor-investigators, why most investigator-initiated studies fall short of compliance, and what this means for the relationship between academia and medtech.

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Evidence SynthesisOctober 15, 2025

Rapid Reviews in Clinical Evidence Synthesis: Speed vs. Precision — A Practitioner's Honest Assessment

Rapid reviews are gaining traction in medical device evidence generation. But what exactly do you trade when you sacrifice Cochrane-grade rigor for speed? This post dissects the method, compares it head-to-head with standard systematic reviews, and tells you when rapid reviews help — and when they can hurt your submission.

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AnnouncementOctober 1, 2025

Welcome to the MH-Analytics Blog

Welcome to our new blog where we share insights on clinical research, medical device regulations, and best practices in medical writing.

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