Single-Use Systems: The Future of Biopharmaceutical Processing

See how components suppliers can help therapeutic manufacturers choose the right material for the right application.

First, Do No Harm: Changing Strategies to Prove Your Medical Device Is Safe

Modern evaluation of biocompatibility uses a risk-based approach.

Deciphering Medical Risk with High-Performance Computing

Specialized computational algorithms provide for highly efficient DNA sequence analysis.

Preparing for MDR? Don’t Overlook the Analytical Evaluation Threshold

Medical device manufacturers have a big challenge in preparing for their regulatory device submissions for 2020. In addition to the European Union’s new Medical Device...

How to Protect Patients from Potential Electrical Failure

People and power don’t mix well, and this is particularly true when people are medical patients. Aside from the more usual environment of a medical facility, patients are also...

Got Your Game Plan? The OEM Playbook to Navigating Preclinical Device Testing Under MDR and ISO 10993-1

When the Medical Device Regulation (MDR) replaces the Medical Device Directive (MDD) in 2020, requirements for medical devices in Europe...

3D Printing Fuels the Rise of Point-of-Care Medical Manufacturing

More than 95 percent of point-of-care (POC) professionals expect to see an expansion of POC manufacturing enabled by additive manufacturing, commonly called 3D printing....

High-Visibility Biopsy Needles

Longer life expectancy in conjunction with improved knowledge of cancers has resulted in increased demands for core needle biopsies. Additionally, cancer diagnosis typically occurs earlier and hence biopsy...

3D Printing: Overcoming Anatomical Model Challenges

For years, anatomical models have played important roles in hospitals and healthcare facilities. From educational aids to practice dummies, these models serve many functions for...

EMC Requirements: Pending Changes for the Fourth Edition of IEC 60601-1-2

Electromagnetic compatibility (EMC) requirements for medical devices and systems is defined by IEC 60601-1-2. The fourth edition implementation of this EMC...

New HAI-Prevention Cleaning Protocols Reinforce Need for Material Consideration for Medical Device Housings

As in any industry, new technologies and material choices present new opportunities and challenges for OEMs looking to build brand...

Ensuring a Safe Medical Design

Until recently, developers and manufacturers of medical devices have not been required to consider security in their products. New guidance from the U.S. Food and Drug Administration (FDA) and expanded European...

What's Trending in 3D Printing for Healthcare

In the last three years, there has been an explosion of published content in medical journals related to 3D printing in medicine. This is a great testament to the uptick in innovation and...

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...

Solving the Compliance Puzzle for Medical Startup Companies: The Entrepreneur’s Basic Guide to Understanding Product Regulations & Testing

Often, the last thing first-time and even serial entrepreneurs think about is how the result of...

Chemical Characterization Can Supplement and Support Biocompatibility Testing

Manufacturers producing medical devices that involve patient contact are typically required to perform biological safety evaluations, including biocompatibility...

Designing for Regulatory Approval: What is Important to Regulators in the Approval Process?

Giving attention to regulatory considerations at the earliest stages of product design and development can create a smoother and more successful...

Critical Steps for Developing a Successful Medical Device Interconnect Cable

It seems the biggest ideas get the most attention, and nothing could be more true than when launching a new medical technology, and/or devices. The development time...

Today’s Changing Healthcare Demands Have Big Impact on Power Supply Design Considerations

It is clear that the medical electronics industry has entered an era of dramatic transitions that touch virtually every aspect of the business from...

Standard Security Framework for Medical Device Technologies: A Work in Progress

Collaboration among healthcare technology stakeholders—from device manufacturers and healthcare delivery organizations to healthcare security intelligence...

ISO 80369 Standards for Small Bore Connectors Move Closer to Implementation

After a 20-year effort to establish standards which would minimize the risk of medical misconnections, the pending release of the ISO 80369 series of standards has...

Guide Wire Coatings Put to the Test

Guide wires with a highly lubricious coating are an essential staple of many interventional procedures. In the operating room (OR), you can observe guide wires undergoing multiple passes, constant...

How to Simplify Medical Device Software Integration and Certification

Medical device manufacturers operate in a challenging environment filled with stringent regulatory requirements and industry pressures. With a rise in mainstream...

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...

Best-in-Class Technologies for High Performance, Compliant Mobile Medical Devices

Portable and wearable healthcare devices represent growing, high volume markets for the medtech industry. Patient monitors are evolving from stationary...

Hospital-Grade Standards for Power Cords and Other Power System Components for Global Markets

While a number of countries have standards in regards to overall medical equipment, a few countries have related component requirements (e.g. plugs...

Determining Risks of Nickel in the Heart

Materials scientists at the Friedrich Schiller University of Jena, Germany, have examined implants made of nickel-titanium alloy in a long-term study and have determined that the release of nickel...

Managing Risk in Medical Connectors

Every day, medical device manufacturers are getting better and better at managing risk. They know they have to. Changes have been introduced into international regulatory schemes that impact device design...