Establishing Proper Validation of Extruded Silicone Tubing

Bring your project from the process development phase of manufacturing to a fully validated one.

Shifting Demand for Multi-Layer Ceramic Capacitors Creates a Critical Supply Shortfall for Medical Electronics Needs

MLCC manufacturers are ramping up manufacturing capacity.

Biomedical Balloons: Understanding Their Physical and Mechanical Properties

Learn about the different material options for balloon catheters.

Advanced Extrusion Techniques: How Engineered Extrusion Helps Medical Device Makers Improve Device Designs and Patient Experiences

Advances in hose and tubing manufacturing techniques are supporting new miniaturized devices and wearables.

Adapting Prototyping to Meet Rapid Advances in Medical Device Designs

Rapid prototyping has long played a vital role in the evolution of medical device technology. Effectively applied during a product's early design stages, it can generate...

Design for Inspection: The Key to Lower Cost and Higher Profit Margins

More OEMs than ever before are adopting the concept of design for manufacturability (DFM). However, most don’t realize that inspection can represent 20–40 percent...

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...

9 Tips for Addressing the Documentation Burden of the FDA’s Design Control Regulation

Some of the biggest stumbling blocks encountered by medical device firms on the way to clearance or approval of their devices by the U.S. Food and Drug...

Linear Guides for the Next Generation of Medical Machines

Demand for miniature motion components follows trends. Not too long ago, the motion systems used in medical and lab automation equipment had technical requirements that were easy to...

Micromolding Is Shaping the Future of Drug Delivery

An important movement within the medical device industry is poised to revolutionize the point-of-care (POC) drug delivery market. The goal at hand—making drug delivery devices more...

Design Criteria of Power Supplies for Use in Medical Devices

The third edition of IEC 60601-1 has been in effect since June 2012. It replaces the previous version as a basic standard for medical electrical equipment and describes the general...

A New Alloy for Medical Electronics Applications

History Although the deadline for RoHS compliance for medical device manufacturers is nearly a year away (July 22, 2014), there is more than ten years of testing and in-service data that can be...

The Pursuit of Power for Surgical Instruments

As an increasing number of patients enter the operating room, more and more orthopedic surgeons are becoming orthopedic patients themselves. According to a survey entitled “Occupational Hazards...

Quality Management: Key To Medical Electronics Assembly and Manufacturing

No other industry in the US is under more pressure than medical electronics, and those pressures continue mounting each year for greater innovation and products that are...

Optical Fiber Performance in High-Power Applications

Silica optical fibers are used more and more for delivering laser power in numerous medical applications. Many therapies require the reliable delivery of high laser power to ablate tissue. In...

Risk Assessment for Power Supplies to Comply with IEC 60601-1 3rd Edition

For medical device OEMs seeking compliance to the 3rd Edition of IEC 60601-1 for their power supplies, what is quite clear by now are the regional dates for enforcement,...

Design for Manufacturing: Concept to Reality

Design for Manufacturability (DFM) is a well-established practice, essential in realizing the transformation of new product concepts into mass-produced medical devices. And yet, all too often issues...

Challenges in Design Development: Why Design Controls Make Sense

The time and investment needed to bring an idea for a new medical product successfully to commercial realization can be daunting. In developing new drugs, the costs and timing...