Medical Device Design & Development
INDUSTRY PERSPECTIVES
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![White Red Dominos]( "How To Implement Continuous Process Monitoring Of Validated Processes")
How To Implement Continuous Process Monitoring Of Validated ProcessesIt is time to consider augmenting your validated pharmaceutical, medical device, and tissue production processes, including processing, packaging, and labeling, with continuous process monitoring to ensure continued compliance with established specifications and requirements if you do not want to be cited by the FDA.
Engineers tend to focus on device failures and failure modes, and their causes and effects, in order to make sure the device “works” reliably. But device failures and failure modes don’t necessarily lead to hazardous situations and harms, and harms can occur even when there is no device malfunction. This is where a preliminary hazard analysis (PHA) can help.
This article is the first in a two-part series on how to demonstrate a high level of current good manufacturing practice (CGMP) compliance during inspections by implementing a strong quality culture; driving the open, transparent communication of risks; and establishing effective quality risk management and quality management review.
In this interview with Balaji Prabhu, from Evonik’s Medical Device Competence Center in the U.S, we review how medical device companies can best evaluate current biomaterial options for the four leading 3D printing technologies.
Test fixtures and inspection equipment are only useful to the extent that they produce accurate, repeatable data. In fact, flawed test fixtures that don’t produce such data can be more harmful to the program than if the test hadn’t been performed at all.
WHITE PAPERS & CASE STUDIES
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![Capture]( "Finding The Ideal Balance – Where Risk And Cost Of Quality Meet")
Finding The Ideal Balance – Where Risk And Cost Of Quality MeetIt is a constant challenge to keep improving product value for customers while reducing overall costs. Part of the solution resides in the functional activities of the risk involved and the cost of quality management. These critical processes are needed to reach and maintain the optimum operating space while providing the overall value that customers seek. This article delves further into the ideas behind finding the ideal balance of where risk and cost of quality meet.
The majority of medical device packaging is porous in nature. Some medical devices require a different layer of defense protecting against oxygen or moisture ingress. For some devices the ingress of moisture or oxygen over the shelf-life of the product can impact the device performance. Any time a foil barrier comes into play with a high-risk application, detection of microleaks is absolutely critical to assuring the shelf-life of the products.
COVID-19 put a kink in the global supply chain. And it exposed weaknesses with the power to halt the flow of business. Now, as the world takes steps to define a new business-as-usual post-pandemic, manufacturers are rethinking their supply chain.
These complementary processes can be adapted to serve countless prototyping and full-production demands, boosting medtechs’ bottom lines and speeding time to market.
A product’s manufacturability is influenced by the materials used, requested tolerances, part geometry, process control limitations, and more. A successful DFM process considers each of these factors from the start.
DESIGN COMPONENTS & SERVICES
Precision Optics Corporation offers models of micro-couplers with 10x magnification and 4.6x magnification. They’re able to image fiber endoscopes 1 mm or smaller, and feature focusable or fixed focus settings.
Proto Labs offers rapid overmolding and insert molding capabilities to produce parts from a range of thermoplastic and liquid silicone rubber materials for on-demand production, bridge tooling, pilot rune, and rapid prototyping needs. With the utilization of aluminum molds that offer cost-effective tooling, prototypes and on-demand production parts may be produced in as fast as 15 days.
The 2000S1G2z5 is a broadband amplifier designed for EMC compliance testing for medical devices. When used with a sweep generator, this air-cooled, self-contained, solid state amplifier will provide a minimum of 2000 watts of RF power and covers the 1-2.5 GHz frequency range.
The Lee MINSTAC System is made up of a variety of small, inert tubing and connection components that are designed to precisely control flow, rate, pressure, filtration and other performance factors of 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 Stroke
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 Watch
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 Body
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 Therapy
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 Technology
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 Platform
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 Disease
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 Test
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 Child
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 Smarter
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.