Medical Device Design & Development
INDUSTRY PERSPECTIVES
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![Blockchain-GettyImages-1347310666]( "How To Close The Looming Life Sciences Data Storage Gap")
How To Close The Looming Life Sciences Data Storage GapOrganizations across life sciences are facing a data storage dilemma: how to balance the need to store and potentially monetize mushrooming amounts of data while managing IT budgets and limiting the total cost of ownership.
Major regulators including the FDA and EMA have established frameworks through which data must be captured and exchanged with them. But your pharma, biotech, or medical device company needs a solid plan for how that data will be governed.
September 2022 will be remembered as a seminal turning point in digital health in the U.S. With the FDA’s final guidance on Clinical Decision Support (CDS) software, the FDA disregards a Congressional directive when it enacted the 21st Century Cures Act in 2016.
No matter what the medical device in development, the first major milestone is usually proof of concept. How do you go from a build-of-one device to something you can manufacture reliably and at scale? This article shares key considerations in engineering and design, quality systems, and more.
Our 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.
WHITE PAPERS & CASE STUDIES
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![Digitize Technology]( "Digital Transformation In Production Planning And Scheduling")
Digital Transformation In Production Planning And SchedulingPlanning systems for manufacturers are valuable communication and coordination vehicles for breaking down interdepartmental barriers. Learn about improving your planning systems, "smart" manufacturing, production, enterprise resource planning, and more.
Regardless of the technology behind the filter, there are several key concepts that all filters share. Our new ebook provides a wealth of detailed fundamental filter information with the goal of helping customers simplify their future filtering decisions.
After CytexOrtho developed a new implant to restore joints in young patients with early joint disease, they needed the support of an experienced, quality-driven CMO for the production of the implant, which required a highly specialized 3D-printing process, along with packaging and sterilization management.
Coil embolization is a treatment for both aortic and cerebral aneurysms that fills the aneurysm with a coil-like material to close off the aneurysm sac and reduce the risk of bleeding or rupture.
Ideally, device engineers should partner with a textile component supplier as soon as possible during the earliest stages of product development. But how can a device manufacturer pinpoint the right textile partner?
DESIGN COMPONENTS & SERVICES
SnapQuik Series breakaway connectors are ideal for small bore applications. Their compact design delivers high-flow fluid transfer in a small profile, and their unique internal latching mechanism creates an exterior that is easy to clean and use.
The quality testing of medical device packaging is highly significant in ensuring the safe delivery of medical devices from their place of origin to the market. Guidance documents such as ISO 11607 provide a list of methods that have the capability to improve the package quality testing of today’s capability. PTI offers inspection methods that provide more reliable, sensitive, and traceable data. They offer in-depth feasibility studies, test method development, and test equipment to bring the supreme level of quality to high-value medical device applications. PTI’s inspection solutions are unique in their performance, reliability, and use of sensory technology.
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.
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.