The new European Union (EU) Medical Device Regulation (MDR) will impact medical device manufacturers’ product-development timelines. All companies intending to sell their devices in Europe must understand the new MDR and how it differs from the previous directives, especially in terms of new biocompatibility standard requirements. Download the white paper to learn more…
This case study shares insights from engineers at Abbott Technologies on how they use multiphysics simulation to model left ventricular assist devices (LVADs) to improve the outlook and quality of life for patients with heart failure. Read on to learn how simulation software allowed Abbott to evaluate the structural integrity of the external controller of […]
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.
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, […]
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.
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 […]
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 […]
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 […]
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 […]
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, […]
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 […]