Medical Device Design & Development
Using Production And Postmarket Data To Validate FMEA Assumptions
One common issue with regulatory agencies and certification bodies regarding failure mode and effects analysis (FMEA) is that organizations are not utilizing production and postmarket surveillance data to validate the probability of occurrence and probability of detection assumptions, which leads to inspectional observations and audit findings.
Risk-based incident trending for postmarket signal detection is quickly becoming an expectation from most regulatory agencies and EU MDR is one of the first regulations to expressly document this requirement. Jayet Moon concludes his four-part article series on risk-based postmarket surveillance in the age of EU MDR by examining the salient features of a sound risk-based trending process and methodology and discussing what to look for in a trend analysis.
When your company focuses on improving its bottom line, two common methods are to reduce the size of the workforce or to divest from direct manufacturing responsibility. Also, gone are the days when an employee stays with a company until they retire. As a result of these factors, many medical device companies are losing valuable experience. Eric Hinrichs, retired from Ethicon, Johnson & Johnson, discusses what a company can do to address this knowledge drain.
The thread of risk management connects every piece in the quality management system and guides the manufacturer in quality related decision-making throughout the lifecycle of the device. In Part 3 of his article series on risk-based postmarket surveillance (PMS) in the age of EU MDR, Jayet Moon discusses how quality risk management and PMS are natural partners. He also examines the five elements for which the PMS system should be on the lookout.
As we say goodbye to 2020, the end of which couldn’t come soon enough, it is fitting to look at how to build a voluntary quality culture in our “new normal” work environment.
WHITE PAPERS & CASE STUDIES
Look, Ma! I Solved These Wearable Device Challenges
Wearable medical devices bear expectations of medical-grade efficacy, plus consumer-grade comfort and aesthetic appeal. Micro molded thermoplastic parts help OEMs live up to these expectations.
Effective dock-to-stock programs ensure optimal outcomes by identifying risks up front, setting clear timelines, and assigning unambiguous responsibilities to all shareholders.
Quality by Design (QbD) principles help to facilitate design of products and processes that maximize the product’s efficacy and safety profile, while enhancing product manufacturability. A proposed roadmap to utilize QbD principles in conjunction with design control requirements (21 CFR 820.30 and ISO 13485) for design and manufacture of drug-device combination products based on sound science and risk management is presented.
It 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. 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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
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.