Features

Features : Medical
Improving Outcomes: 3D Printed Models for Simulating Surgery

The Department of Neurological Surgery at St. Louis University has partnered with the university's School of Engineering to begin quantifying how advanced manufacturing practices such as 3D printing can enhance the training as well as the surgical practice for neurosurgeons. The...

Features : Medical
Device Combines Ultrasound and Photoacoustics to Improve Imaging

In collaboration with various companies, scientists at the University of Twente's MIRA biomedical research institute have recently developed a prototype for a handheld device that combines ultrasound technology with photoacoustics.

Features : Medical
MES as a Single Source of Truth: Achieving Regulatory Compliance at Sparton

A couple of years ago, contract manufacturer Sparton Corporation faced increasing demand for high-quality, highly complex products that were delivered as quickly as possible. The multisite contract manufacturer serves highly regulated end markets, including the medical...

Products : Medical
New Products: March 2017 Medical Design Briefs

PRODUCT OF THE MONTH — High-Strength Alloy

Foster, Putnam, CT, has introduced compounds for medical device components that require high strength, yet cannot use metals or traditional reinforced plastics. The Nanomed MAX® compounds, based on an alloy of meta-xylene diamine polyamide (MX...

Features : Medical
Medical Device Tax: Goodbye and Good Riddance

When the controversial medical device excise tax was introduced more than seven years ago as part of the Affordable Care Act, industry criticized it as a “jobs killer” and predicted that such a tax would essentially wipe out investment in R&D.

Features : Medical
High-Quantum Efficiency Photocathodes for Medical Diagnostics

Detection of a single photon is a requirement for many research and medical applications, such as fluorescence imaging, single molecule imaging, and luminescence applications. The sensitivity required for single photon detection has traditionally been provided by a photon...

Features : Photonics/Optics
Ultrafast Lasers for Medical Manufacturing

Ultrafast or ultrashort pulse lasers offer unique material processing possibilities, because the laser’s pulse duration is less than the target material’s conduction time. Essentially this means that cold machining of parts is possible — with material being removed by sublimation. This...

Features : FDA/Regulatory
Quality Assurance: Risk Mitigation for Lithium-Ion Battery Packs

Safety and reliability are the key concerns when determining the right power source for a medical device. Lithium-ion (Li-ion) batteries are often considered for their higher energy density, lighter weight, longer cycle life, superior capacity retention, and ability to withstand a...

Features : Medical
Medical Plastics: Meeting Today’s Changing Requirements

Today’s medical device designers and OEMs are challenged to meet a wide, and sometimes conflicting, range of requirements. These targets stem not only from regulatory restrictions, but are equally likely to arise based on market perceptions, pressures to contain costs, and the changing...

Features : Medical
Advanced Sealing Technology Enables the Next Generation of Insulin Delivery Devices

Diabetes is not only one of the most common chronic diseases, it is also complex and difficult to treat. Insulin is often administered between meals to keep blood sugar within target range and at mealtimes based on the number of carbohydrates to be ingested. A...

Features : Medical
Project Management: Four Trends to Follow in 2017

We are living through an era of profound change. Technology is affecting this change in ways unthinkable only a decade ago and none more so than in the medical device industry. A tour of life sciences conferences over the past year revealed a number of technological advances that are now driving...

Features : Medical
3D Printed Lens Enhances Images in New Ultrasound Device
Nanyang Technological University
Singapore
http://media.ntu.edu.sg

Scientists from Nanyang Technological University (NTU), Singapore, have developed an ultrasound device that produces sharper images through the use of 3D printed lenses. With clearer images, doctors and...

Products : Medical
New Products: February 2017 Medical Design Briefs

PRODUCT OF THE MONTH — UV LED Curing System

Excelitas Technologies, Waltham, MA, has expanded its OmniCure® product line with a higher power UV LED curing system for fiber optic coatings. The new OmniCure AC8225-F+ features a custom optical design that provides optical performance...

Features : Medical
From the Editor: A Cure for the U.S. Medical Innovation Ecosystem

As 2016 came to a close, the U.S. House of Representatives overwhelmingly approved the 21st Century Cures Act by a vote of 392–26, and the Senate passed it by a vote of 94–5. The Act, which was strongly supported by the device industry, is the result of a two-year effort to...

Features : Medical
Silicone Pump Segments for Medication and Feeding Pumps

They are vitally important, make therapy possible, and they have become an integral part in hospitals or home-care settings: medication and feeding pumps supply patients with essential medication and nutrition. It is not only the right electronic and mechanical components that are crucial...

Features : Software
Building an Integrated Home Health Monitoring System

Among the challenges faced by the healthcare sector is a population that is growing older. The elderly population is expected to grow significantly over the next 20 years. Having an independent lifestyle is highly desired by elderly people, but independence for older adults often comes with...

Features : Software
Enhancing Performance and Safety of Medical Implantable Devices with Multiphysics Simulation

At St. Jude Medical, ventricle assist devices are developed to improve the lives of patients with heart failure. Numerical simulation is used...

Features : Medical
Design Validation and Regulatory Requirements

Design validation is one of the most important aspects of the design and development process for medical devices. It is at this stage that the medical device manufacturer confirms that the device...

Features : Medical
Mari: Precision Technology for Successful Surgery

Besides radiotherapy and chemotherapy, the standard procedure for treating brain tumors includes the surgical removal of all or some of the growth. This surgery calls for precision and perfection — both from the surgeon and the instruments, because knowledge and skill alone do not determine the...

Products : Medical
New Products: January 2017 Medical Design Briefs

PRODUCT OF THE MONTH — Magnetic Hyperthermia System

MSI Automation, Wichita, KS, has introduced a magnetic hyperthermia system for the magnetic heating of nanoparticles. The system is designed for developing the proper thermal response of nanoparticles used in conjunction with drugs for...

Features : Medical
MDUFA IV: Shorter Review Times, More Consistency, and More Oversight

The reauthorization of the Medical Device User Fee Amendments (MDUFA) brings more pressure for FDA to shorten its review times back to “historical norms” and to provide more consistency in the review process. And after the success of an independent review authorized in...

Features : Medical
The Next Industrial Revolution and What It Could Mean for Medical Device Manufacturing

The next industrial revolution is on its way. It is bringing innovative technologies that are available and proven and placing them in the modern manufacturing plants. The cloud, the Internet of Things, mobile computing technology, embedded computing, advanced...

Features : Medical
Silicone Adhesives for Medical Device Assemblies

Medical device assemblies present unique challenges beyond those associated with manufacturing and assembly of products for consumer and industrial applications. While sharing the need for ensuring reliable, robust seals or bonds with these industrial applications, medical applications are subject...

Features : Test & Measurement
Validating IFUs for Reprocessed Medical Devices

Incidents of nosocomial or healthcare acquired infections (HAIs) and bacteria that have become resistant to antibiotics (“superbugs”) are a concern for U.S. FDA. These ongoing incidents have heightened FDA’s attention to manufacturers of reprocessed medical devices. Manufacturers need to...

Products : Medical
New Products: December 2016 Medical Design Briefs

PRODUCT OF THE MONTH — AC/DC Power Supply

Power Partners, Athens, GA, has released a new AC/DC power supply from its medical open frame/u-channel product line. The BF-rated-output PPWAM360 series is designed to deliver 360 W in a high power density 4 × 6 in. footprint with 90–264 V...

Features : Medical
Real-World Evidence: Next Steps for the NEST Coordinating Center

FDA has awarded the Medical Device Innovation Consortium (MDIC) $3 million in seed funding to establish the coordinating center for the medical device National Evaluation System for Health Technology (NEST). The funding will also be used to set in motion the group’s first...

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