Clear, Expert Analysis of Medical Device Failures
We help attorneys, manufacturers, and startups solve complex problems with honest, detailed analyses.
Our Services
We provide qualified expert analyses, reports, and honest testimony for attorneys, specializing in products liability, patent infringement, human factors, and witness memory, including pre-suit evaluations.
We assist manufacturers by performing in-depth root cause failure analyses for mechanical or material failures, delivering actionable solutions to prevent recurrence.
Our experienced engineers empower startups and established manufacturers with innovative prototype designs for wearable electronics, medical devices, and complex automotive components.
Decades of Proven Expertise
- Unbiased, In-Depth Analysis: Commitment to honest, meticulous investigation that stands up to scrutiny.
- Industry & Legal Acumen: Deep understanding of both medical device engineering and the legal standards.
- Clear Communication: Translating complex technical findings into understandable and convincing reports and testimony with a rigorous basis.
Medical Device Industry Insights
Learn more about medical device design, failure analysis, testing and regulation.
Distinguishing Between Use Error and Design Deviation: The Role of Human Factors Engineering
January 6, 2026 – Is a reported failure truly ‘user error’ or a symptom of a design interface deviation? This technical resource examines the boundary between Abnormal Use and Foreseeable Misuse under IEC 62366, providing a framework for analyzing the Design History File in litigation. Read more…
Distinguishing Design Verification from Design Validation in Medical Device Development
December 4, 2025 – In the analysis of medical device performance and regulatory adherence, the terms “Verification” and “Validation” (often abbreviated as V&V) are frequently conflated. However, under FDA Quality System Regulations (21 CFR Part 820) and ISO 13485, these represent distinct phases of the design control process with unique objectives and evidentiary requirements. A… Read more…
The Disconnect Between Wear Simulation and Clinical Reality in Metal-on-Metal Hip Implant Devices
October 13, 2025 – In the lifecycle of orthopedic implants, a significant technical paradox often emerges: a device can meet every applicable consensus standard during laboratory testing yet exhibit unexpected failure modes in the clinical environment. This discrepancy is particularly evident in the history of large-diameter Metal-on-Metal (MoM) hip systems. Understanding this gap requires analyzing… Read more…
