Medical Device Design & Development
INDUSTRY PERSPECTIVES
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![Arrow On Street]( "How To Drive Powerful CAPAs With Lean Six Sigma")
How To Drive Powerful CAPAs With Lean Six SigmaCorrective and preventive actions (CAPAs) are an important and integral part of any quality system for a life sciences company. And yet, strangely, CAPAs rank among the top reasons why companies get 483s and warning letters from the FDA. This article explains how Lean Six Sigma tools and techniques can be applied to improve the CAPA process.
Although the structure of ISO 13485 will expand from the current eight main clauses to ten, most of the QMS requirements should essentially remain the same.
This article -- the second in a two-part series -- examines how to navigate the complex problem of optimizing data quality while controlling for study costs and time constraints when employing independent HFE testing agencies.
In October, the U.S. FDA published an updated draft of Premarket Cybersecurity Guidance and introduced the concept of a cybersecurity bill of materials (CBOM) for medical devices. Some medical device manufacturers have since raised concerns regarding mandating CBOMs in the 510(k) or premarket approval packet.
With input from FDA and regulators, CQOs are pursuing means to analyze huge data sets, manage complex manufacturing systems, and operate smoothly between varied products, languages, and cultures.
WHITE PAPERS & CASE STUDIES
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![image1]( "3D Printing And Injection Molding: Same Team, Different Roles")
3D Printing And Injection Molding: Same Team, Different RolesThese 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.
A biotechnology company that manufactures injectable large molecules was seeking to evaluate elastomeric components that would help them to attain the highest quality standards for their manufacturing lines. The company took a proactive approach to meeting and exceeding regulatory guidelines concerning the cleanliness of their lifechanging medicines and were keen to learn how a supplier’s tight packaging specifications could help them with their approach.
Medical device manufacturers and designers must overcome various challenges to succeed in an expanding global marketplace, challenged along the way by aspects of design, research, validation, and bringing their devices to a competitive market in a cost-effective manner.
Despite advantages, brushless DC motors (BLDCs) have presented their own challenges in terms of technology, design, and capabilities. Typically, complex and bulky cabling has been required between motor and amplifier to attach discrete logic components “outside” the motor frame. With the latest advances in driver electronics that now can be integrated directly into brushless motor designs, BLDCs are evolving rapidly to become faster, smaller, more versatile, more controllable and more cost-effective.
DESIGN COMPONENTS & SERVICES
Of all of Proto Labs additive manufacturing services, stereolithography (SL) offers the widest selection of available materials, the best feature resolution, and the smoothest surface finish. This industrial 3D printing process is used to create concept models, cosmetic prototypes, and complex parts with intricate geometries in as fast as one day.
Parker Hannifin’s T2-05 series of air and gas micro diaphragm pumps are used in patient therapy and patient monitoring applications. Their compact size allows them to fit into tight spaces, making them ideal for integration into handheld devices, such as portable negative pressure wound therapy devices.
Applications that involve minimally invasive/micro surgery require precise visualization in very small spaces. Precision Optics, through the use of their proprietary microprecision™ technology, has the ability to develop micro optic lenses, precision lenses, and micro objective lenses as small as 0.37mm in diameter.
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.