Medical Device Design & Development
EU MDR’s Benefit-Risk Ratio: Making Your Clinical Evaluations Safety-Focused
The EU's Medical Device Regulation refers to a benefit-risk ratio multiple times, especially with respect to clinical evaluation and in Sections 1 and 8 of Annex I. However, no universally accepted method exists for calculation of such a ratio. This article proposes a method for calculating it in the spirit of focusing on patient safety and the ability to track changes in the safety profiles of products.
Software is rapidly emerging as a critical product differentiator in the medical device industry. While the software development life cycle described here is widely applicable to a wide range of medical devices, this article focuses on software development for cardiac devices — and more specifically, implementing advanced signal processing software into a cardiac device.
During the pandemic, our industry has realized that electronic medical record (EMR) systems needed some changes. This article discusses the new EMR specifics, including improved operability, advanced analytics, and smooth integration with diverse systems.
Initial visceral impressions and intuitiveness of use impacts a user's choice of medical device. Addressing the affordance theory means understanding what a user will likely perceive and expect of a proposed design interaction. This article delves into more detail and includes discussion on user interfaces and the user experience process in designing medical devices.
The proposed revision to the U.S. Quality System Regulation (aka 21 CFR Part 820) takes a giant leap toward harmonization with other major global medical device regulations, but some U.S.-specific terms and requirements will remain in effect. This article shares the details and also discusses the impact on inspections.
WHITE PAPERS & CASE STUDIES
Vision And Paperless Ops Make Northeast Scientific A MedTech Industry Leader
Managing all the documentation for the many devices Northeast Scientific remanufactured was complex and prone to errors. A modern manufacturing execution system allowed them to manage documentation by eliminating paper.
Training defines the quality of the single most important asset of your organization: your employees. A good training management process serves as a preventative measure against poor quality.
Molecular diagnostics is increasingly used for the rapid detection and identification of existing and emerging pathogens. The need for rapid results has required testing to move from normal settings, such as physician’s offices, to smaller, more widespread, and often temporary point of care (POC) locations.
Product quality is a top priority in any business because nothing else matters without it. Measuring the impact of quality instantly becomes the No. 1 business imperative when those process inefficiencies begin to negatively affect the bottom line. See how these companies digitized and connected their document management processes to help accelerate the time it takes to get a product to market without jeopardizing regulatory compliance.
For contract development, manufacturing, and packaging organizations, improving operational flexibility, increasing capacity, shortening lead times, and improving product quality is more important than ever.
Noninvasive Optical Sensors Provide Real-Time Brain Monitoring After Stroke2/21/2018
Each year, nearly 800,000 people in the U.S. experience a stroke, and almost 90 percent of those are ischemic strokes in which a clot cuts off blood flow to part of the brain. To prevent further injury, blood flow to the brain must be restored as quickly as possible.
Embrace Becomes First FDA-Cleared Seizure-Monitoring Smart Watch2/5/2018
Empatica Inc has received clearance from the FDA for Embrace, its award-winning smart watch. Embrace uses AI (advanced machine learning) to monitor for the most dangerous kinds of seizures, known as "grand mal" or "generalized tonic-clonic" seizures, and send an alert to summon caregivers' help.
Researchers Create Fiber Optic Sensors That Dissolve In The Body2/5/2018
For the first time, researchers have fabricated sensing elements known as fiber Bragg gratings inside optical fibers designed to dissolve completely inside the body.
NUS Researchers Develop Wireless Light Switch For Targeted Cancer Therapy1/30/2018
A team of scientists from the National University of Singapore (NUS) has developed a way to wirelessly deliver light into deep regions of the body to activate light-sensitive drugs for photodynamic therapy (PDT).
TU Wien Develops New Semiconductor Processing Technology1/22/2018
Extremely fine porous structures with tiny holes - resembling a kind of sponge at nano level - can be generated in semiconductors.
Tyndall, Sanmina Partner To Develop Sub-GHz Wearable Health Monitoring Platform1/10/2018
Tyndall and Sanmina Corporation have announced a research collaboration, which will focus on the development of a novel wireless technology for a commercial wrist-worn health-monitoring platform.
An Organ-On-A-Chip Device That Models Heart Disease1/2/2018
When studying diseases or testing potential drug therapies, researchers usually turn to cultured cells on Petri dishes or experiments with lab animals, but recently, researchers have been developing a different approach: small, organ-on-a-chip devices that mimic the functions of human organs, serving as potentially cheaper and more effective tools.
Nanowire Device Holds Promise To Detect Cancer With A Urine Test12/26/2017
Cells communicate with each other through a number of different mechanisms. Some of these mechanisms are well-known: in animals, for example, predatory threats can drive the release of norepinephrine, a hormone that travels through the bloodstream and triggers heart and muscle cells to initiate a "fight-or-flight" response.
Developing The First Pediatric Heart Valve Designed To “Grow” With The Child12/20/2017
Each year 40,000 babies in the U.S. are born with a congenital heart defect, often caused by a defective heart valve, which is estimated to account for 8,000 to 13,000 new cases in the U.S. alone.
Mass Spectrometric Imaging Technique Makes Diagnosis Easier And Smarter12/17/2017
A team of researchers at DGIST has recently developed a technology which enables to acquire a high resolution mass spectrometry imaging in micrometer size of live biological samples without chemical pretreatment in the general atmospheric pressure environment.