Medical Device Design & Development
INDUSTRY PERSPECTIVES
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![Risk-Benefit-reward-GettyImages-1264804060]( "EU MDR’s Benefit-Risk Ratio: Making Your Clinical Evaluations Safety-Focused")
EU MDR’s Benefit-Risk Ratio: Making Your Clinical Evaluations Safety-Focused欧盟医疗器械监管是指本efit-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.
软件正在迅速成为一个关键的产品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
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![Sterilize sterilizing GettyImages-1340554274]( "Vision And Paperless Ops Make Northeast Scientific A MedTech Industry Leader")
视觉和无纸化行动使东北科学成为Medtech行业的领导者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.
分子诊断越来越多地用于对现有病原体的快速检测和鉴定。对快速结果的需求需要测试从正常设置（例如医师办公室）转变为较小，更广泛的，通常是临时的护理点（POC）位置。
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.
对于合同开发，制造和包装组织，提高运营灵活性，增加容188bet软件下载苹果量，缩短交货时间和提高产品质量比以往任何时候都更为重要。
DESIGN COMPONENTS & SERVICES
Heatron’s ceramic core alumina heater is ideal for dialysis, CPAP, DNA analysis/testing, blood diagnostics, surgical devices, blood/fluid warming, MRI equipment, instrument sterilization, temperature therapy, and vessel sealers.
The IMH Pressure Relief Valves for plastic incorporate a simple, press-in design for easy installation. With features including metal to metal seating, the valves provide low leakage, highly repeatable cracking pressure, and compatibility with a wide range of fluids and gases.
The new Hybrid from Colder eliminates the need for multiple connections and simplifies the user interface between remote tools and a device. It features an easy-to-use twist latch to securely connect everything in one simple motion.
Caplugs has been a global leader in plastic molding with six different molding processes and thousands of material options. The in-house team of engineers works with customers throughout their comprehensive process to design a unique solution process from creating concepts and rapid prototyping to packaging and inventory management.
Producing precision optical systems demands a comprehensive opto-mechanical design. II-VI Optical Systems’ team of experienced engineers work collaboratively with your team to design intricate, highly producible systems. We specialize in designing complex systems that are precisely matched with our manufacturing and assembly capabilities to deliver high yields and predictable, optimized results.
Patented NS4 Series couplings feature non-spill valves in a compact size at a great price. These innovative couplings are lightweight, chemically resistant, and easy-to-use.
MEDICAL DEVICE DESIGN & DEVELOPMENT
医疗设备的设计和开发是为特定任务或一组任务创建设备的周期性过程，然后不断重新评估其有效性并在其上进行改进，直到设备达到过时为止。设计和开发始于构想和一个概念的创造，如果发现，如果发现既有财政和临床上的可行性，又是设计，设计和原型的。临床前时期包括基准测试 - 通过模拟产品的使用和动物测试以及任何必要的重新设计工作来完成。
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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无创光学传感器可提供中风后实时大脑监测2/21/2018
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
来自新加坡国立大学（NUS）的科学家团队已开发出一种无线向人体深部区域输送光线的方法，以激活光敏化药物以进行光动力疗法（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
细胞通过多种不同的机制相互通信。其中一些机制是众所周知的：例如，在动物中，掠食性威胁可以推动去甲肾上腺素的释放，去甲肾上腺素是一种激素，它通过血液传播，并触发心脏和肌肉细胞发起“战斗或飞行”的反应。
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Developing The First Pediatric Heart Valve Designed To “Grow” With The Child12/20/2017
每年在美国，有40,000名婴儿出生时患有先天性心脏缺陷，通常是由心脏瓣膜缺陷引起的，仅在美国就估计将占8,000至13,000例新病例。
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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.