SFDC/DHR Interface Systems Add Parametric Data to Support Medical Manufacturers

Access to parametric data allows OEMs to monitor device performance throughout production, and is particularly useful for new product introduction. In this era of ever more stringent FDA oversight and regulations, the responsibility for vigilance falls on medical manufacturers and their manufacturing partners or customers. Those companies that support a “best practices” medical manufacturing environment often rely on a shop floor data collection (SFDC) system that embeds attributive data in each unit’s device history record (DHR). More recent advances allow for parametric, or performance, data to be captured as well, so that not only can the medical device’s progress through the manufacturing process be monitored, the device’s quality of performance at each stage can also be assessed. Access to this data facilitates timely decision- making, ensuring the highest quality medical product, and saving money due to reduced downtime, scrap and/or repair work.

Posted in: Bio-Medical, Manufacturing & Prototyping, FDA Compliance/Regulatory Affairs, Medical, Data Acquisition, Briefs, MDB


EyeBrain Tracker for Early Diagnosis and Monitoring of Neurological Disease

This medical device includes a computer with two screens, a helmet, three software programs, and a recording device for taking eye movement measurements. The EyeBrain Tracker (EBT) is an eyetracking medical device, which uses algorithms to accurately track eye movements for the diagnosis of Parkinson’s disease and multiple sclerosis. The brain uses many different areas to produce eye movements, so if an area of the brain does not function well, the eye movements it controls will produce an abnormal behavior.

Posted in: Bio-Medical, Medical, Diagnostics, Briefs, MDB


Optical Manufacturing Guidelines for Medical OEMs

With careful planning, system integrators can select the optimal optics, filters, light sources, and cameras for their medical diagnostic instrumentation. Custom integration of original equipment manufacturer (OEM) products can be complex, particularly for medical device integrators that build diagnostic instruments incorporating numerous optical components. Often, objective lenses, illumination sources, and imaging detectors are assembled and custom-mounted into finished instruments. Such components must not only meet stringent performance requirements, but often have to meet established Food and Drug Administration (FDA) standards.

Posted in: Bio-Medical, Photonics, Manufacturing & Prototyping, Medical, Briefs, MDB


Virtual Ultrasound Guidance for Inexperienced Operators

This audio/video system provides real-time help to inexperienced ultrasound operators in remote environments. Medical ultrasound or echocardiographic studies are highly operatordependent and generally require lengthy training and internship to perfect. To obtain quality echocardiographic images in remote environments, such as on-orbit, remote guidance of studies has been employed. This technique involves minimal training for the user, coupled with remote guidance from an expert. When realtime communication or expert guidance is not available, a more autonomous system of guiding an inexperienced operator through an ultrasound study is needed. One example would be missions beyond low Earth orbit, in which the time delay inherent with communication will make remote guidance impractical.

Posted in: Bio-Medical, Software, Medical, Diagnostics, Briefs, TSP, MDB


Using Proprietary Solvent Technology to Swell Silicone

Presents a solution to certain challenges that design engineers and manufacturers face when working with silicone rubber. While silicone is the obvious material of choice in many medical applications because of its excellent biocompatibility, its physical properties make it challenging to work with. Design engineers, especially those who work with medical devices, know the difficulties of connecting flexible silicone tubing to barbed fittings or mating molded silicone parts with complex geometries to hard plastic parts. The combined elements of its flexible consistency, its inability to expand or stretch without mechanical or chemical assistance, and the tacky surface of silicone rubber, make assembly with rigid parts difficult.

Posted in: Bio-Medical, Materials, Coatings & Adhesives, Composites, Medical, Briefs, MDB


Mechanical Components for Demanding Applications

Small-diameter ball screws and stainless steel linear actuators deliver performance and durability for compact, portable, and lightweight applications. Advanced medical device designs are evolving rapidly and demand higher standards for medical equipment reliability. Applying linear motion components to these medical applications yields the best results when collaboration begins at the early stages of the design. Beginning with specification requirements provided by the medical device manufacturer, definition of design priorities must be incorporated for finished devices intended for human use, including:

Posted in: Bio-Medical, Mechanical Components, Medical, Briefs, MDB


Handheld Universal Diagnostic Sensor

A single drop of blood enables chemistry, hematology, and biomarker diagnostics in minutes. The rHEALTH technology is designed to shrink an entire hospital testing laboratory onto a handheld device. A physician or healthcare provider performs the test by collecting a fingerstick of blood from a patient. The tiny volume of blood is inserted into the rHEALTH device (see figure). Inside the device is a microfluidic chip that contains small channels about the width of a human hair. These channels help move the blood and analyze the blood sample. The rHEALTH sensor uses proprietary reagents called nanostrips, which are nanoscale test strips that enable the clinical assays. The readout is performed by laser-induced fluorescence. Overall, the time from blood collection through analysis is less than a minute.

Posted in: Bio-Medical, Medical, Briefs, TSP


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