A "Particle" of Prevention Is Worth a Pound of Cure
The Significant Benefits of Premarket & Postmarket Particulate Testing of Cardiovascular Devices

Considerations for Third-Party Reprocessing of Single-Use Medical Devices
Reusing single-use devices that have been safely reprocessed by a third-party reprocessor can enable healthcare providers to maintain high-quality patient care while saving on costs and reducing medical waste. Validated functionality testing must be paired with validated cleaning, disinfection, and steril...

Current Regulatory Landscape for EO Residue Levels in Medical Devices: What Manufacturers Need To Know Now and What May Be on the Horizon
The goal for medical device manufacturers that use EO sterilization to minimize patient exposure to EO residues and (and EO derivatives) from their devices and ensure that the levels of residual EO, ethylene chlorohydrin (ECH), and ethylene glycol (EG) pose the least amount of risk possible to the patient ...

EO Residue Levels in Medical Devices
Sterilizing medical devices via ethylene oxide gas is an effective and common practice within the industry. EO gas is active at a relatively low temperature compared to other methods, such as steam, and it is compatible with plastics, polymers, and many products that are not compat¬ible with other steriliz...

Choosing Colorants for Medical Devices
Colorants are often added to the substrates and material components of medical devices with the primary intent of improving the usability of the devices. For instance, color coding can assist users in matching devices or sizes together when multiple options are available. Colorants can also be used to bran...

Selecting & Justifying Sample Sizes: Where to Begin?
Within our industry, we have seen several approaches to selecting samples sizes; this paper will not cover all of the approaches, but it is a guide to give medical device manufacturers and pharmaceutical companies a good starting point for determining their own ideal sample size.

Could Lean Product Development Get You to Market Faster?
Every manufacturing engineer is familiar with The Machine That Changed the World: The Story of Lean Production. First published in 1990, this classic book was the first to detail the Toyota Production System from which the principles of Lean Production were derived. The authors predicted that Lean Producti

Advancements in Clear High Barrier Packaging Materials
Clear high-barrier materials are an excellent alternative to traditional aluminum foil. Manufacturers enjoy the ability to easily inspect packaged product through the use of vision systems, metal detectors, and manual visual inspection. As a marketing tool, clear materials allow for product differentiation

Challenges with MEMS Pressure Sensor Integration in Medical Devices
This white paper discusses the need for pressure sensor integration in medical devices with a focus on applications, different pressure sensing technologies, MEMS sensor options, and considerations during the encapsulation and integration process. It highlights the need for an experienced partner to help stre

New Catheter Based Devices and Procedures Driving Hemostasis Valve Innovation
The viability of new interventions dependent on more robust componentry Today’s hemostasis valves are a vexingly difficult engineering challenge. Beyond the minimum requirements per ISO 11070 and ISO 10555 for pressure and vacuum decay, emergent invasive catheter therapies are demanding muc

Validating Medical Device Assembly, Packaging, & Sterilization
Medical device packaging and sterilization validation are required for FDA 510(k) submissions yet are often causes of delay. Sterile packaging validation is a vastly misunderstood topic in its own right but becomes even more complicated when considering it involves the additional coordination of manufacturing

Fiber and Textile Innovations Pave the Way for Device Advancement
Much of the advancement of the MIS market can be attributed to technology developments in the materials science and textile processing industries, as evidenced by a partnership between biomaterials leader DSM and Secant Medical, a leading designer, developer and manufacturer of biomedical structures. The c...

Regenerez™: How the Incorporation of Regenerative Materials Will Advance Biomedical Textiles
To explore the recent trends and the future direction for the development and commercialization of biomedical textiles in regenerative medicine, it is necessary to look at some areas in which their uses are expanding as well as an ongoing success story in which a material is moving from bench top to market...

Designing Functional Fabrics for Today’s Heart Valves and Beyond
Heart valve disease affects nearly 5 million Americans, a figure that is expected to double in the next 25 years. The most advanced of these cases require heart valve surgery. Prosthetic heart valves are designed to restore function to a damaged heart valve and ultimately prevent heart failure. Textiles ar...

Implantable Fabrics Revolutionize Neurovascular Devices
In the neurovascular device segment, development is focused on minute, precision devices delivered via micro-catheters. The overarching challenge is to create components that maximize performance within a minimal deliverable profile. That’s where biomedical textiles come in. Specifically, biomedical textil...

Win Big in Sports Medicine Device Design
With the convergence of the increasing active and aging population as well as continuing surgeon adoption of arthroscopic procedures, there is an increased demand for minimally invasive sports medicine and arthroscopic treatments. This demand is evident due to the fact that according to the 2009 American A...

Biomedical Textiles Advance Development of Orthopedic Implants
This whitepaper discusses the changing demographics of orthopedic patients, the versatility of biomedical fabrics and the advances in implantable biomaterial textile technologies in the development of orthobiologic innovation.  

The Role of Material Selection in Biomedical Textile Device Design
Biomedical textile structures are increasingly prevalent as critical components in a broad range of medical devices. Device designers are challenged in exploring material selection in component design, optimizing the development process, and ultimately defining the form and function of the device. This whi...

The Future of Woven Biomedical Textiles in Next-Generation Devices
One of the most interesting trends in medical device development is the rapid growth of woven biomedical textiles for use in key device components. As the pace of innovation in the device industry accelerates, engineers are discovering how woven structures allow them to expand their design’s portfoli...

The Importance of Regenerez Antimicrobial Activity
The role of the biomaterial may be crucial to preventing or reducing the severity of a device-associated infection.

Regenerez Degradation and Release Kinetics White Paper
Implantable biomaterials play a critical role in medical applications such as, cell therapy, regenerative medicine, tissue replacement, and biomedical devices.

Regenerez Elastomeric Properties White Paper
Elastomers serve in a variety of medical applications including tissue engineering and implantable devices due to their ability to bend and stretch, mimicking native tissue.

Regenerez : A Next-Generation Material for Bioresorbable Coatings
Coatings consisting of natural and synthetic origin play a major role in the world of medical devices both from a functional and a biological perspective.

Sanavita Ortho Case Study
SanaVita Medical sources raw materials and performs packaging process validation for new biodegradable orthopedic device.

Sanavita Spinal Case Study
SanaVita Medical manages reverse-engineering, reduces time to clinical evaluation for spinal tether implant.

Enhancing Electrode Properties With Laser Restructuring
An advanced surface engineering technique improves the performance of implantable electrodes.

Opportunities for Complying with the European MDR
The MDR includes a series of requirements that can have profound implications for medical device companies. Companies that are not prepared to have compliant systems, processes and products by the implementation date may find themselves unable to market their products in the EU after May 2020.

CYLINDRAFlow™ Manifolds: Simplifying Processing Applications
Nordson MEDICAL has announced a new manifold that makes assembly and operation simpler compared to products currently used in the industry.

Polymer Solution Casting: Enhanced Performance from a Single-Piece Device
Nordson MEDICAL is the world's leading contract manufacturer of cardiopulmonary vascular cannulae, catheters, and specialized medical tubing for a wide range of clinical applications. The key is our Avalon polymer solution casting technology, which allows us to design and manufacture custom tubing with fea...

Experimental characterization of adhesives for dimensioning and computation of medical micro adhesive bonds
Adhesive technologies at the micro scale are becoming more and more important in the field of medical engineering. This is strongly influenced by the increasing amount of miniaturized medical devices. In addition, many medical devices could not evolve their full functionality without the use of adhesive techn