Medical Device Design & Development
INDUSTRY PERSPECTIVES
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![iStock-1320989364]( "Attribute Vs. Variable Testing For Device Functionality: What They Are & When To Use Which")
Attribute Vs. Variable Testing For Device Functionality: What They Are & When To Use WhichTesting performed during medical device development serves to (1) demonstrate that the developed manufacturing process can produce good products that meet the established specification reliably and (2) demonstrate with confidence that the device design will consistently meet the established specification. This article discusses the difference between variable and attribute testing, when to use which, and strategic approaches to selecting one over the other.
The expanding use of extended reality (XR) in medical applications presents a number of unique opportunities and challenges. Due to the extensive reliance on software and networked data, cybersecurity risks must be addressed during the design, development, and use of XR devices. And, of course, compliance with all regulations concerning privacy and control of PII is essential.
Collaborative communities are a global grassroots effort convened by interested public and private stakeholders who work to solve shared challenges and achieve common goals related to medical devices. These communities do not replace established regulatory mechanisms, are not federal advisory committees, and are not chaired or convened by the FDA, but FDA may participate. Here are the descriptions, goals, and contact information for each of the 12 collaborative communities that have FDA CDRH participation.
When different perspectives and backgrounds come together, it sparks innovation that can drive significant technological advancement. The most diverse companies are now more likely to outperform their less diverse peers. Beyond company performance, ensuring adequate representation throughout the product development pipeline leads to better outcomes for patients in underserved and underrepresented communities.
Why do we experience teams that seem to start out well, then stumble throughout the project, resulting in delayed launches, product defects, and poor sales? How do they differ from teams that start out similarly yet appear to breeze through the project development stages to launch a successful product? This article also examines each team member's role in improving trust and communication.
WHITE PAPERS & CASE STUDIES
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![Digitize Technology]( "Quality System Metrics That Matter")
Quality System Metrics That MatterProduct 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 (CDMOs, CMOs and CPOs) improving operational flexibility, increasing capacity, shortening lead times and improving product quality is more important than ever as demand and competition for contract services increases. In these examples we show how moving from a paper to a digital solution these customers were able to eliminate data entry errors, reduce deviations, and improve overall efficiency and productivity.
As someone working in quality, you understand how vital your role is for improving efficiency, achieving quality, and meeting compliance. Your work is critical, and it’s essential to have the right tools do your job well – which means having a digital quality management system (QMS). Most executives cite the high cost of adopting technology as the main reason they reject plans to invest in digital systems. This article offers guidance that will help you quantify and communicate the importance of quality, and how a digital QMS delivers considerable savings.
The best way to build quality into a product is with an effective, connected quality management system (QMS), which serves as the foundation for long-term regulatory compliance and market success. However, not every QMS has the same capabilities and connectivity. A QMS that isn’t connected to other areas of the enterprise still slows down quality processes and introduces the possibility of more human error. In this article we highlight six features of a QMS system that will help companies realize maximum value for years to come.
Careful handling of the large amounts of documentation required for regulated products is critical for achieving compliance. Furthermore, document control guidelines enforced by the U.S. Food and Drug Administration (FDA) and the standards set by the International Organization for Standardization (ISO) continue to evolve. This means your document control system should be agile and scalable to keep up with the changing regulatory landscape. This article details the FDA guidelines and ISO standards that apply to document control, and it illustrates how digitizing document control processes is essential for ensuring ongoing compliance and future relevance.
DESIGN COMPONENTS & SERVICES
These circular connectors are ideal for medical devices that transfer data or involve data communications due to their 360o electromagnetic shielding. This is a key feature for patient monitoring systems, home health monitors, and EEG/ECG systems.
PICMA® Stack Ceramic-Insulated Piezo Actuators for Pumping and Dosing
- Sub-Nanometer sensitivity
- Superior lifetime (>100 billion cycles)
- Non Magnetic and High Vacuum compatible
- Microsecond response and high stiffness
- Very large operating temperature range
The OV’R Driver is a miniature electronic device placed between a voltage source and a solenoid valve. This circuit has a self-contained 'spike & hold' voltage controller that allows the valve to run at various voltages to compensate for fluctuations in power sources. One key advantage of the OV’R Driver circuit is its ability to self-adjust the pulse width of the output spike voltage based on the input voltage level.
Spanner bushing filters solve those tight center-to-center hole spacing requirements. The spanner bushings are designed without the hex used on the standard bolt-in series. The spanner feedthrus are easily installed using the CMI spanner tool. Spanner bushings can be installed with center-to-center spacing down to .110” or 2.8mm when using the 2*56 threaded size. Spanners are available with capacitance up to 10,000 pF and sizes from 2*56 to 8*32.
Brimrose hyperspectral imagers utilize a NIR camera with an acousto-optic tunable filter as a monochromator to produce hyperspectral imaging of any target area, or to measure visible or NIR hyperspectral imaging information remotely on a variety of materials.
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.