Design & Testing

Beware of FDA Multisite Inspections

Recently, I came across an FDA regulatory situation you do not see too often. On the same day, FDA sent two teams of field investigators into two geographically different sites of the same company to...

Cadence Rebrands to Reflect Commitment to Innovation

Cadence, Inc., a provider of vertically integrated contract manufacturing solutions to the medtech and pharma markets, is excited to announce a significant milestone in the company’s...

Seeing Is Communicating

The Eyegaze Edge system developed in collaboration with NASA is an eye-tracking technology that makes 'talking' possible for people who can’t.

Inside Story: Trends in Packaging and Sterilization

Eurofins Medical Device Testing (MDT) provides a full scope of testing services. In this interview, Eurofins’ experts, Sunny Modi, PhD, Director of Package Testing; and Elizabeth Sydnor, Director of Microbiology; answer common questions on medical device packaging and sterilization.

New Products and Services

See the new products and services, including Dri-Air Industries' new dryer for plastics, the MicroDryer Series (MD); Thomson Industries' advanced controllability options to its Electrak ® LL line of long-life electric linear actuators; Instron's next-generation Autoinjector Testing System; more than 40 different thermally conductive greases available from EpoxySet; a series of low-profile pull type clapper solenoids from Magnetic Sensor Systems; and more.

A Look at Vaporized Hydrogen Peroxide as a Sterilization Option

The changing regulatory landscape and innovation of medical products is driving an interest in additional options for medical product sterilization. Read on to learn what this means.

From the Editor - AI: A “Transformative Force” in Medtech, But Hurdles Remain

AI is poised to make a major impact on the medtech market by enhancing precision in diagnostics, personalizing treatment plans, and streamlining manufacturing processes. Read on to find out what Editor and Director of Medical Content Sherrie Trigg thinks about the matter.

Addressing Challenges in Primary Packaging Testing for Medical Devices

Developing and evaluating primary packaging for medical devices continues to be an area ripe for innovation, with ample opportunity to improve existing processes. Read on to learn more about the topic.

MEDevice Boston, an MD&M Event

MEDevice — formerly BIOMEDevice — is a meeting place for engineers and business leaders from medtech, biotech, and pharma, to inspire and collaborate on the next life-changing medical device. Read on to learn more about the event.

Why Standardization Matters in Pulsed Electric Field Generation for Clinical Electroporation

Pulsed field ablation is a nonthermal method of tissue ablation technology that uses high amplitude pulsed electrical fields to create irreversible electroporation in tissues. Read on to learn more about it.

Inside the OEM: Becton Dickinson (BD)

Becton Dickinson (BD), a global leader in medical technology for many years, is strategically positioned to drive innovation, operational excellence, and sustainable growth. Read on to learn more about BD.

Regulatory

What government group was formed to study medical devices and recommend legislation, ultimately leading to the 1976 Medical Device Amendments?

Overcoming Challenges in Material Selection for 3D Printed Medical Devices

In this season, we are taking an in-depth look at Printed Health: Transforming Medicine with Advanced Manufacturing, and this episode will focus specifically on...

Vantedge Medical Completes Strategic Acquisition of Hobson & Motzer

Vantedge Medical, a portfolio company of Aterian Investment Partners, has acquired Hobson & Motzer, Inc. Founded in 1912 and based in Connecticut, Hobson is a manufacturer...

ANSI/AAMI ST24 Updated to Reflect Technological Changes

As leaders in the medical device industry seek ways to optimize the application of ethylene oxide (EO) sterilization, it is more important than ever to ensure that medical device...

Space Station Germ Testing Improves Wastewater Monitoring

A technology developed for NASA to identify pathogens inside spacecraft turned out to be beneficial for wastewater surveillance on Earth.

Videos of the Month

See the videos of the month, including one on drug-loaded 3D-printed films that could change cancer treatments forever; one on CELMoDs, which are designed to attack cancer in a novel way, by binding to a regulatory protein called cereblon, which then triggers the degradation of key cancer-driving proteins; one on the bridge recombinase mechanism, a precise and powerful tool to recombine and rearrange DNA in a programmable way; and one on immune cells called regulatory T-cells.

Video Spotlight on Products and Services

See which products and services the video spotlight is on, including Dotmatics, an integrated scientific informatics platform that supports research and development activities; an autoinjector testing system featuring precise measurement and control capabilities; BD’s Physiojet disposable autoinjector; testing software that takes over the test sequence with determination of the results; Stevanto Group’s technology centers; and more.

How Advanced Drug-Delivery Systems Are Improving Healthcare

Innovative reusable drug-delivery devices are transforming the administration of high-dose biologics by enabling self-administration of challenging drug formulations. These devices support high viscosity and larger injection volumes, enhancing patient comfort and adherence. Read on to learn more.

Packaging and Processing: Life Sciences Industry Strives to Become More Sustainable

The pharmaceutical industry’s pivot toward sustainability reflects a broader movement in global business practices where environmental responsibility is not just a choice but a business imperative. Read on to learn more.

Enabling CDMO Success Through Intelligent Testing Capabilities

While mechanical testing may play a small role in the total scope of CDMO competencies, a poorly equipped solution can result in significant issues with time management, data integrity, and root cause analysis. Investing in highly capable testing systems should be considered a long-term investment and serve to showcase a commitment to quality for potential clients. Read on to learn more.

From the Editor - FDA Releases Draft Guidance for Drug-Delivery Devices

At the end of June, FDA released a draft guidance that is designed to facilitate and streamline development of stand-alone devices and combination products by improving the consistency of drug-delivery performance information included in applications and submissions. Read on to learn more about it.

The Politics of Health: How Global Elections Will Impact on Life Sciences

The global landscape for medical technology, biotechnology, and life sciences is on the cusp of seismic change.

Product of the Month

See the product of the month: Linxens' NFC tag that is integrated directly into the polymer matrix of the medical device.

Videos of the Month

See the videos of the month, including one on research that pioneers transformative approaches to intuitively control prosthetic devices; one on how medical professionals can map the radiation dose within the body, giving them new data to guide treatments in real time; one on a new smart material that is activated by both heat and electricity; and one on what bats can teach us about co-existing with viruses and preventing severe disease.

From the Editor - Medical Robotics: Report Reveals Clinician Expectations

From the Editor discusses Robocath -- a company that designs, develops, and markets innovative robotic solutions to treat cardiovascular and neurovascular diseases -- and how it has published a new report exploring current and future expectations for the use of robotics in interventional medicine. Read on to learn more.

Five Breakthrough Medical Technologies Set to Transform Patient Care in 2024

A new report from Clarivate Plc, London, UK, offers a predictive analysis of high-growth medical technology markets poised to generate over $1 billion in value or achieve double-digit growth within the next five years. The report, “Medical Technologies to Watch in 2024” underscores critical areas of significant investment. Read on to learn more.

Advanced Medical PCB Tech: Precision Cleaning Challenges

With the evolution of PCB materials to meet the stringent demands of medical device applications, the challenge lies in effectively removing contaminants without compromising the integrity of delicate components. Read on to learn more about the process.

Device Delivers Gene Therapy for Lung Disease

Drug-delivery researchers have developed a device with the potential to improve gene therapy for patients with inherited lung diseases such as cystic fibrosis. In cell culture and mouse models,...