Medical Device Design & Development
INDUSTRY PERSPECTIVES
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![审计合规监管istock - 1161029738]( "MDSAP Audit Approach Updated From Rev. 6 To 7")
MDSAP Audit Approach Updated From Rev. 6 To 7On April 15, 2022, MDSAP Audit Approach AU P0002.007 was updated from version 006 to 007. This article summarizes the changes important for medical device manufacturers to know.
的digital revolution that resulted in the IoT, IoMT, SaMD, and connected devices comes with the possibility of cyberattacks. The FDA's latest efforts to enhance medical device cybersecurity include a new draft guidance (covered in this article) and bipartisan congressional support of the PATCH Act of 2022 (which will be covered in a future article).
的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.
WHITE PAPERS & CASE STUDIES
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![Sterilize sterilizing GettyImages-1340554274]( "Vision And Paperless Ops Make Northeast Scientific A MedTech Industry Leader")
Vision And Paperless Ops Make Northeast Scientific A MedTech Industry LeaderManaging 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.
DESIGN COMPONENTS & SERVICES
ColOSSIS™ from DSM Biomedical is an injectable, settable, drillable putty designed for remodeling bones. It offers improved handling in preparation and delivery and can be mixed with saline, blood, and bone marrow aspirate, allowing for an affordable, fast-remodeling, settable, and drillable biomimetic solution to fracture repair.
AR’s solid state amplifiers are often used in medical EMC compliance test efforts. The 50S1G6 is a class A solid state amplifier which provides 50 watts of output power from 0.7 to 6 GHz.
MPC Series couplings add ease of use and security to your most critical fluid handling applications. Choose from a full line of connectors and configurations, including pressue sealing caps and plugs in sizes to fit 1/4" and 3/8" tubing.
KMC Systems offers decades of experience in solving complex medical engineering and design challenges, and in considering innovative, highly-automated solutions for the development of full-system instrumentation. KMC Systems engineers work collaboratively with customers to achieve optimal interdisciplinary solutions to laboratory automation challenges, Design for Manufacturability and Serviceability (DFM and DFS) challenges, and medical device verification and validation.
Ducommun’s series of single-pole, double-throw switches covers the DC to 400 MHz frequency range. The switches weigh just 9 ounces and are ideal for integration into MRI machines as well as hyperthermia and ablation equipment.
This 35 mm high x 80 mm wide stage offers reliable positioning in space-restricted medical device applications. The multi-axis platform can be used in normal or cleanroom environments and has selectable travels of 25, 50, 100, and 150 mm.
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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提供实时Brai无损光学传感器n 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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你维恩新半导体加工技术的发展nology1/22/2018
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.