Addressing Material Changes and Safety in Medical Devices

Strategies for assessing risk, streamlining testing, and managing documentation for maintaining product safety.

Product of the Month

See the product of the month: Amada Press System’s WH-2A, a 13-axis CNC dual-point coiling machine designed for ultra-fine wire coil processing for medical guidewire formation.

The New Medtech Frontier

The next phase of medical device innovation will be defined by systems that are not only responsive but also autonomous and personalized. Read on to learn more.

3D Printed Cardiac Patch Helps Repair Heart Defects

An interdisciplinary research team from ETH Zurich and the University Hospital of Zurich has developed a novel three-dimensional heart patch for intraventricular implantation. Read on to learn more about it.

Product Focus: Fluid Handling/Pumps/Valves

See where the product focus is this month: Fluid handling, pumps, and valves, including Clippard's isolation valves with a hit-and-hold option; Raumedic AG's expanded portfolio of biopharmaceutical transfer tubing; Festo's expanded line of compact grippers; and more.

New Products & Services

See the new products and services, including EPIGAP OSA Photonics GmbH's surface-mount device (SMD) shortwave infrared (SWIR); Moticont's linear voice coil servo motor; Dart Controls' high-performance pulse width modulation (PWM) controller for 12–48-V battery powered equipment; a compact, fullservice RTD sensor from Burns Engineering; and more.

Wearable Sensor Could Help Patients with Bipolar Disorder Track Medication Levels Through Sweat

Although lithium is highly effective to treat bipolar disorder, the chemical has a narrow therapeutic window — too high a dose can be toxic to patients, causing kidney damage, thyroid damage, or even death, while too low a dose renders the treatment ineffective. Read on to learn how a wearable sensor may thwart this issue.

Researchers Develop Ultrasound-Based Wireless Charging Technology for Implantable Medical Devices

A research team led by Prof. Jinho Chang at DGIST has developed an ultrasound-based wireless charging technology capable of rapidly and efficiently charging the batteries of implantable medical devices. The technology has achieved world-class energy efficiency, fully charging a commercial battery within two hours, even inside the human body. Read on to learn more.

At-Home Melanoma Testing with Skin Patch Test

Melanoma testing could one day be done at home with a skin patch and test strip with two lines, similar to COVID-19 home tests, according to University of Michigan researchers. The new silicone patch with star-shaped microneedles, called the ExoPatch, distinguished melanoma from healthy skin in mice. Read on to learn more.

3D Printed Implant Helps Repair Spinal Cord Injuries

A research team at RCSI University of Medicine and Health Sciences has developed a 3D printed implant to deliver electrical stimulation to injured areas of the spinal cord offering a potential new route to repair nerve damage. Read on to learn the details of the 3D-printed implant and how it performs in lab experiments.

SiC Power Delivery for ‘Big Iron’ Medical Devices

SiC MOSFETs can operate efficiently at much higher switching speeds than silicon devices and can withstand high applied voltages as well as high operating temperatures. Read on to learn what this means for "big iron" medical devices.

Medical Devices Are Booming — But Can the Supply Chain Keep Up?

While demand surges, so do design and development challenges. Today’s medical devices are not only expected to be smart and connected, but they must also operate flawlessly in high-stakes environments where safety, reliability, and regulatory compliance are non-negotiable. Read on to learn what this means.

No More Lost Sponges: RFID to Optimize Surgical Suite Efficiency and Safety

Retained surgical items are not as rare as many believe. These mistakes are a small but critical piece of the larger challenges of managing the availability and use of a wide range of surgical instruments and other items. Radio frequency identification (RFID) technology has emerged as one of the most effective tools for solving these challenges. Read on to learn how.

Designing Resilient LSR Supply Chains Through Vertical Integration

As devices grow smaller, smarter, and more user-centered, materials like liquid silicone rubber (LSR) play a bigger role in enabling performance, comfort, and compliance. From implantables to connected wearables, LSR is helping engineers meet growing design and usability demands. Read on to learn more.

Genetic Testing Device Detects Rare Mutations

Researchers have developed a portable device capable of detecting rare genetic mutations from a single drop of blood. The instrument was shown in lab experiments to quickly and accurately test for a genetic condition called hereditary transthyretin amyloidosis, which can cause heart problems. Read on to learn more.

Bioimaging Device Holds Promise for Eye, Heart Conditions

A new bioimaging device can operate with significantly lower power and in an entirely non-mechanical way. It could one day improve detecting eye and even heart conditions. The device uses a process called electrowetting to change the surface shape of a liquid to perform optical functions. Read on to learn more.

Conductive Polymer Improves Sensor-Based Devices

Scientists have produced a new, powerful electricity-conducting material that could improve wearable technologies, including medical devices. The new technique uses hyaluronic acid applied directly to a gold-plated surface to create a thinner, more durable film, or polymer, used to conduct electricity in devices like biosensors. Read on to learn more.

Smart Wound Monitor Poised to Improve Chronic Infection Care

Researchers have developed a wearable wound monitoring device with integrated sensors that could reduce infection risks by minimizing the need for frequent physical contact. The proof-of-concept device is designed for reuse, making it more cost-effective and practical than disposable smart bandages and other emerging wound monitoring technologies. Read on to learn more.

LED-Based Imaging System Could Transform Cancer Detection

Researchers have developed a prototype imaging system that could significantly improve doctors’ ability to detect cancerous tissue during endoscopic procedures. This approach combines light-emitting diodes (LEDs) with hyperspectral imaging technology to create detailed maps of tissue properties that are invisible to conventional endoscopic cameras. Read on to learn more.

Paper-Based Devices Diagnose Malaria in Asymptomatic People

Devices made with cheap strips of paper have outperformed two other testing methods in detecting malaria infection in asymptomatic people in Ghana — a diagnostic advance that could accelerate efforts to eliminate the disease, researchers say. Read on to learn more.

MD&M Midwest 2025, an MD&M Event

Returning to the Minneapolis Convention Center this October, MD&M Midwest 2025 is where the region’s medtech leaders gather to explore, collaborate, and solve the toughest engineering challenges in medical device development. Read on to learn more about it.

From the Editor: Rebuilding Trust in Medical Devices

A recent report from MasterControl delivers a sobering statistic: more than 8 in 10 physicians (82 percent) have questioned the quality or safety of the medical products they prescribe. For medical device engineers and designers, that figure should be a wake-up call. Read on to learn what Editor and Director of Medical Content Sherrie Trigg thinks about the matter.

Shaping the Future: Honoring the Next Generation of Women Leaders in Medtech - Debbie Teodorescu

The 2025 Medical Rising Star Award recognizes Dr. Debbie Teodorescu, a physician-engineer whose career bridges patient care and technology development. Read on for a full interview with her.

The Power of the Plasma Pen

Plasma pens integrated into production lines provide targeted plasma treatments that reduce failure rates by improving adhesion and bonding in various critical applications. Read on to learn more about their powers.

2025 Rising Star Awards Winners

SAE Media Group’s Women in Engineering: Rising Star Awards program shines the spotlight on trailblazers who not only excel in their respective domains but also stroke the flames of inspiration in others. This year’s awards program features six categories: Aerospace/Defense, Automotive/Transportation, Electronics, Manufacturing/Materials, Medical, and Robotics, Automation and AI. In this special section, you’ll meet the winners in all six categories.

Regulatory

What consumer technology device became the first FDA-approved over-the-counter (OTC) assistive hearing device for adults with mild to moderate hearing loss?