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.
The Mechanics of Biocompatibility, Supply Chain Variability, and Reference Standards
September 2, 2025 – In medical device litigation and regulatory enforcement, a “biocompatibility failure” is often framed as a static design flaw. However, engineering analysis frequently reveals that the root cause is not the base polymer, but rather dynamic variables within the supply chain and manufacturing process. For attorneys and quality engineers, understanding the distinction… Read more…
The Predicate Device Framework: Analyzing “Substantial Equivalence” in FDA 510(k) Submissions
May 26, 2025 – The 510(k) Premarket Notification is the regulatory pathway for the vast majority of Class II medical devices entering the US market. A frequent point of confusion in both engineering reviews and legal discovery is the distinction between a device being “identical” to a predecessor and being “substantially equivalent” (SE). It is… Read more…
