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ePTFE for the Cardiovascular Device Industry

October 26, 2018 By WTWH Editor Leave a Comment

For over 35 years, ePTFE has been a mainstay of the cardiovascular device industry. The physical properties of ePTFE make it highly suitable for use in implantable vascular devices. Choosing an ePTFE provider like BD Peripheral Intervention OEM helps ensure a streamlined process and a finished device that meets expectations.

Filed Under: White Papers

Insights Into Drug Delivery Device Manufacturing From Development Through Commercialization

September 28, 2018 By MassDevice Leave a Comment

Biologics and other targeted therapies are creating opportunities for innovative device solutions to meet the needs of the formulations as well as specific patient groups. These therapies may require lower annual volumes, and the device manufacturing strategy must fit commercial expectations at those volumes. Optimal manufacturing solutions should mitigate risk while meeting the quality, financial, […]

Filed Under: White Papers

The Evolving Role of Thermoforming Suppliers in Medical Packaging Design

September 11, 2018 By MassDevice Leave a Comment

Today’s medical device OEMs need thermoforming partners to take on expanded roles in packaging design, development and testing. By providing full-service capabilities, thermoformers can enable optimized sterile medical packaging fit for purpose, which may be more sustainable, and can even play a big part in a device’s functionality.

Filed Under: White Papers

Micro Molding with Bioabsorbables: Not Your Average Thermoplastics

August 14, 2018 By MassDevice Leave a Comment

This whitepaper explores Micro Molding with Bioabsorbables. Across the board with plastics, the rules are different when you mold it so small. But when it comes to bioabsorbable resins, they require a much more extensive and specialized approach than thermoplastics. By learning how processing bioabsorbables differs from thermoplastics, medical OEMs can understand the key factors […]

Filed Under: White Papers Tagged With: MTD Micro Molding

M2M Communication Considerations in Medical Device Development

August 2, 2018 By MassDevice Leave a Comment

Machine-to-machine communication (M2M) refers to the sharing of information between two devices. It is a key component in the rapidly growing “Internet of Things” (IoT), the increasing connectivity of devices in the home, workspaces, industry, and beyond. M2M communication can be as simple as the unidirectional transfer of data or as complex as multiplexed signals […]

Filed Under: White Papers Tagged With: Proven Process

What You Need to Know About the ISO 13485:2016 Update

May 21, 2018 By MassDevice Leave a Comment

ISO 13485:2016: An Introduction The international standard ISO 13485 governs the manufacture of medical devices. The first edition was published by the International Organization for Standardization (ISO) in 1996. The ISO currently reviews standards at least every five years to determine whether they need to be updated. The first update to ISO 13485 was released […]

Filed Under: White Papers Tagged With: Proven Process

Building Safety and Security into Connected Medical Devices

May 4, 2018 By MassDevice Leave a Comment

Medical devices are being designed to encapsulate virtually all of the functionality and complexity within the software. Considering today’s technologically advanced threat landscape, building in safety and security has never been more important. Cyber-criminals are using vulnerable network connected medical devices as a gateway to install malware on hospital networks. It is essential for manufacturers […]

Filed Under: White Papers Tagged With: Green Hills Software

Design for Manufacturing Breakthroughs: Producing Innovative Micro Medical Devices

April 30, 2018 By MassDevice Leave a Comment

This whitepaper explores how medical micro breakthrough designs are produced and how supplier and design roadblocks can be overcome without compromising the original design. By learning how to efficiently work with a molder to produce a breakthrough idea, medical OEMs can save valuable time in their supplier qualification process, decrease costs, increase speed to market, […]

Filed Under: White Papers Tagged With: MTD Micro Molding

LVAD Efficiency and the Criticality of Accurate Blood Pressure Measurement

April 18, 2018 By MassDevice Leave a Comment

What is a LVAD? How does it work? A left ventricular assist device (LVAD), also called a ventricular assist system or VAS, is a mechanical pump that is attached to the left ventricle of the heart to augment the function of the heart’s main pumping chamber. The left ventricle pumps blood from the heart to […]

Filed Under: White Papers Tagged With: Proven Process

Things You Need to Consider When Designing Robots for Commercialization

March 16, 2018 By MassDevice Leave a Comment

When people think of robotics, they often think about warehouses or manufacturing lines, where robots automate multiple processes. But robotics has the potential to reshape the way healthcare is delivered in a variety of applications and locales. While we’re a long way from a robot replacing a physician, there are many opportunities to provide automation […]

Filed Under: Robotics, White Papers

Current Regulatory Landscape for EO Residue Levels in Medical Devices

January 30, 2018 By MassDevice Leave a Comment

One of many crucial steps a single-use medical device takes on its journey from concept to commercial product is sterilization. Ethylene oxide gas sterilization, in particular, is one of the most efficient and effective ways of deactivating bacteria and other potentially dangerous living microbes from medical devices; however, manufacturers must take care to control and […]

Filed Under: White Papers Tagged With: nelsonlaboratories

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