A device malfunctioned, an implant failed, or someone was hurt. We determine what happened from the physical and clinical evidence — independently, and to a standard that holds up in court.
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Medical device and implant failures sit at the intersection of engineering and biology, and that intersection is where most investigations go wrong. A catheter that fractures inside a vessel, a hip stem that fails at the modular taper, an infusion pump that under-delivers because of a firmware race condition — each leaves a distinct physical signature, but reading it requires knowing what the device was supposed to do, what a normal tissue response looks like versus a failing one, and which standard the manufacturer was actually held to. This department covers the failure modes across active devices, implants, orthopedic hardware, tubing and catheters, and the biomechanics of injury causation itself.
Each specialization area covers a distinct device category or injury mechanism with its own physics, examination protocol, and governing standards. Start with the one that matches your incident.
Infusion pumps, ventilators, monitors, and active implantables — firmware, sensor, and mechanical malfunction.
investigateBreast implants, hernia mesh, cardiac leads, and other soft-tissue implantables — rupture, migration, and corrosion.
investigateInjury causation analysis — occupant kinematics, fall biomechanics, and traumatic injury mechanisms.
investigatePlates, screws, rods, and joint replacement hardware — fatigue fracture, loosening, and taper corrosion.
investigateIV catheters, central lines, and tubing sets — fracture, connector misconnection, kinking, and material degradation.
investigateThese investigations combine engineering analysis with clinical and regulatory evidence that other failure-analysis work rarely touches.
Technical briefings and case analyses on medical device, implant, and injury biomechanics failures — written by the people who investigate them.
The dangerous device failures announce nothing — a sensor drifting inside its displayed range, an alarm that never triggers, a software state nobody tested. What the design and surveillance records show.
readEvent logs, alarm history, power state and the settings as found are the strongest record of what an infusion pump or ventilator did. Routine ward turnover and biomedical servicing erase most of it within days.
readCalling a device event operator error settles nothing. Usability engineering treats a mistake at the interface as evidence about the design, and the manufacturer's own file records which mistakes were foreseen.
readA modular junction is a crevice with micromotion in it. Reading the degradation means examining the surfaces before cleaning, verifying the alloy, and addressing assembly and patient factors explicitly.
readMost of what an explanted implant could prove is decided in theatre, not in the laboratory. Cleaning, fixation and sterilisation remove the surface record before anyone identifies it as evidence.
readA worn implant surface and the tissue around it answer different questions. Reading the wear mode, characterising the debris, and establishing the host reaction are separate acts of evidence.
readIt carries a regulatory and biological layer that most product investigations do not. A device's failure has to be understood against the FDA submission pathway it went through, its adverse-event history in the MAUDE database, and its design history file — and, for anything implanted or used in a patient, against the clinical record and, often, pathology findings from the treating team. The physical evidence still matters most, but it is read alongside a much larger evidentiary record than a typical mechanical or electrical failure.
That is usually the single biggest risk to the investigation. Explanted implants and returned devices are frequently cleaned, discarded, or handled through routine hospital or biomedical-engineering processes that destroy the surface evidence — wear patterns, corrosion products, fracture surfaces — before anyone realizes a forensic question exists. Coordinating a retrieval and chain-of-custody protocol as early as possible, ideally before the explant procedure, materially changes what can later be proven.
By comparing the as-found condition of the device against its design specification and manufacturing records, and separately comparing the reported use against the labeled instructions for use and usability engineering file. A defect signature is intrinsic to the device — a material out of specification, a firmware logic error, a manufacturing deviation. A use-related or clinical cause tends to correlate with technique, patient anatomy, or placement documented in the medical record. The two are frequently confused from the outside and rarely confused once the underlying records are reviewed.
It depends on the device. The FDA governs premarket clearance and approval (510(k) and PMA pathways) and adverse-event reporting through MAUDE; the EU applies the Medical Device Regulation. Quality-system work references ISO 13485, risk management references ISO 14971, biocompatibility references ISO 10993, and electrical medical devices reference the IEC 60601 series. Implant-specific work adds material and mechanical standards such as the ASTM F-series and ISO 7206.
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