Medical Device Design & Development
INDUSTRY PERSPECTIVES
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![Ethics-GettyImages-1359117986]( "Quality Engineers: Are You Making The Right Call?")
Quality Engineers: Are You Making The Right Call?As a quality engineer, a lot of us have had a project leader ask us to sign off on a project when the data has too many outliers. How do you navigate that situation?
The FDA's proposed update to the Quality System Regulation that was originally released in 1996 references ISO 13485:2016 Medical devices — Quality management systems — Requirements for regulatory purposes, which is in its third edition. Let's take a closer look.
In the context of ISO 14971:2019 and risk management for medical devices, manufacturers and designers are often confused about the implementation of hazard analyses and FMEAs, especially since this standard takes a hazard-based approach. In this article, Jayet Moon demystifies the topic.
Femtech (female health technology) has made significant progress toward bringing women’s health to the forefront of medical attention. However, a significant number of software-based femtech devices are not reviewed and regulated by the FDA and do not have to prove accuracy. What can we do as medtech developers to improve clinical relevance of these devices and software?
The point of care is shifting, taking place increasingly outside the hospital setting and moving into patients’ homes. However, cloud computing has some limitations. Edge inference is the practice of deploying machine learning models directly onto devices, allowing the data to be captured and processed at the point of care, rather than in the cloud.
WHITE PAPERS & CASE STUDIES
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![Nordson - Nitinol Wire Forming]( "Nitinol Wire Forming and Manipulation for Custom Components: Meeting Customer Requirements")
Nitinol Wire Forming and Manipulation for Custom Components: Meeting Customer RequirementsWith its shape memory properties, nitinol wire is a highly suitable material for a range of medical applications. Given its exceptional mechanical and thermal properties, the demand for nitinol products is on the rise. This paper delves into the process of forming and manipulating nitinol wire to create customized components.
This guide will examine why OEMs are increasingly turning to integrated RFID to add value to their products in an increasingly crowded marketplace, and provide key applications for RFID in the medical device field.
RFID is increasingly being used in medical devices. OEMs can either develop their own RFID solution or partner with an experienced supplier - this guide provides guidance on finding a suitable partner, including what to look for in a supplier, case studies, and proprietary technologies.
Boomerang projects in micro molding, where customers' projects return to the manufacturer for rework or modifications, present challenges due to design changes, quality issues, material-related challenges, and poor communication.
Knowles Capacitors offers build-to-print services for thin-film circuit design and construction, which can help customers save time and money by reducing the need for in-house engineering and manufacturing resources.
DESIGN COMPONENTS & SERVICES
The LHL Series of magnetic latching solenoid valves are available in plug-in, face mount, and soft tube ported configurations. Their low power (5.5 mJ per switch), low heat, and small size, make these valves ideal for portable, battery powered medical devices. They’re also an ideal flow control solution for oxygen delivery systems, patient monitors, air calibration equipment, ventilators/respirators, and more.
The LFN Series Solenoid Valves are 2-way, normally closed, diaphragm valves. These valves feature an isolation diaphragm on an inert housing, making the valves suitable for controlling critical and aggressive fluids.
MEDICAL DEVICE DESIGN & DEVELOPMENT
Medical device design and development is the cyclical process of creating a device for a specific task or set of tasks, and then continuously reevaluating its effectiveness and improving upon it until the device reaches obsolescence. Design and development begins with ideation and the creation of a concept that, if found to be both fiscally and clinically viable, is then designed, engineered, and prototyped. This preclinical period includes bench testing — accomplished through simulated use of the product — and animal testing, along with any necessary redesign work.
Throughout the process, the proposed medical device, and the process by which it will be manufactured, is examined for flaws that may negatively impact the device’s safety, market viability, regulatory acceptance, customer satisfaction, usability, or profitability. Any shortcomings are corrected, and the improvements applied to the final design. Due to the wireless connectivity capabilities of many modern medical devices, cybersecurity and interoperability also must be incorporated into the design. Clinical testing is conducted, using human subjects, to further expose flaws and confirm product strengths. Once both the product design and the manufacturing process have been validated and approved by the U.S. Food and Drug Administration (FDA), production and commercialization of a device may begin.
LATEST HEADLINES
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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.
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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.
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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.
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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).
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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.
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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.
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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.
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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.
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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.
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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.