Medical Device Design & Development
INDUSTRY PERSPECTIVES
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![Transportation and technology GettyImages-1331571740]( "3 Steps For A Smarter Medtech Supply Chain")
3 Steps For A Smarter Medtech Supply ChainOur medtech industry has a huge opportunity to make our supply chains “smarter" by making the most of digital technologies and data. But we need to work in an agile manner to adopt and scale technology. This article shares three main steps to take.
Unlike traditional medical devices, software as a medical device (SaMD) can blur the lines between the design and development stages and the production aspect of commercialization. So, what are the activities necessary for medtech manufacturers to be compliant with the traditional cGMP framework?
Harnessing advanced computing technologies gives medtech companies almost unlimited profit opportunities, but it also comes with almost unlimited liability from cyber-attacks. This article discusses different harmful events and their costly ramifications to your medtech company. Don't be underprepared for a cyber-attack.
Read the FAQs and learn, for example, what the revision of ISO contains and the differences with previous version.
To respond to the unprecedented challenges presented by the pandemic, medical device providers have extensively implemented disruptive innovations in areas such as cybersecurity and 5G technologies. The article shares three additional trends in the space. All five trends will continue to drive innovation moving forward.
WHITE PAPERS & CASE STUDIES
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![Overcoming Challenges With Metal Cerclage Cables]( "Overcoming Challenges With Metal Cerclage Cables")
Overcoming Challenges With Metal Cerclage CablesAlthough, in many instances, metal cerclage cables work well, recently polymer cerclage cables have begun to take market share due to an accumulation of smaller benefits relative to traditional metallic cables.
In the last decade, Innovations in technology have led to the introduction of the leadless pacemaker, which is about 1/10th the size of a traditional pacemaker, or about the size of a vitamin.
Polyester amides (PEAs) bring several desired and differentiating properties to Drug eluting stent (DES) applications for treating Coronary Heart Disease (CAD).
New technologies and fabric modifications must be developed to meet both well-understood and emerging needs in the cardiovascular device space.
Manufacturing transfer always includes technical surprises, but difficulties as a result of inadequate communication or supply chain disruption can be minimized or eliminated through transparency and collaboration.
DESIGN COMPONENTS & SERVICES
The LMI series of digital low differential pressure sensors are ideal for medical applications involving ventilators, spirometers, CPAP, sleep diagnostic equipment, nebulizers, oxygen conservers and concentrators, and insufflators/endoscopy. They offer ultra-low pressure ranges from 25 to 2500 Pa (0.1 to 10 in H2o), and feature thermal flow measurement for increased sensitivity, high immunity to dust contamination, and humidity.
II-VI Optical Systems has increased its presence in the medical technology arena by applying their vast experience in precision space and defense technology to medical applications where that precision can lead to better diagnostic and therapeutic outcomes.
With decades of experience and a substantial capacity for producing kits, the B. Braun OEM Division is capable of packaging standard components with customers’ proprietary products to meet requirements of each medical procedure and application.
Since our inception, complex thermoplastic injection molding has been a core competency at SMC. We specialize in programs that rely upon complex geometry and challenging quality requirements. Using “scientific molding” practices we assure premium components with each press cycle. With our vast array of molding options, we are confident we can align a process that best fits your medical device.
Caplugs offers the MSN-TCS Series of tethered silicone caps for protecting tubes and ports from contamination. The caps are constructed from USP class VI silicone, and are designed for easy removal and reapplication for a variety of medical procedures such as fluid draining.
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.