Medical Design and Outsourcing Archives - Page 25 of 154

J&J used RWE for an expanded indication — and you can, too

Two J&J MedTech leaders shared advice to help medical device developers use real-world evidence (RWE) in FDA submissions.

J&J MedTech’s Biosense Webster ThermoCool SmartTouch [Image courtesy of J&J MedTech]

Real-world evidence (RWE) took a big step forward recently when the FDA approved an expanded indication for a Johnson & Johnson MedTech ablation catheter.

For the first time, the federal medical device safety regulator approved a label expansion based on RWE from a retrospective study of health records documenting off-label use by physicians.

“The clinical evidence used to support the expansion of indications was based solely on an analysis of a dataset comprised of electronic health records from two hospital systems,” the agency said. “The FDA worked closely with the study sponsor to ensure that the RWE resulting from the analysis was both relevant and reliable…

Intricon plans Costa Rica’s first facility for sensor-driven devices

Intricon assembles electromagnetic navigation and other sensor-driven medical devices. [Photo courtesy of Intricon]

Medtech supplier Intricon today announced plans to open Costa Rica’s first facility dedicated to the development and manufacturing of medical devices with microelectronics, biosensors and electromagnetic navigation (EMN) sensors.

St. Paul, Minnesota-based Intricon’s Costa Rica location in Grecia’s Evolution Free Zone is scheduled to open next year. The company will add production jobs in the second half of next year and expects up to 150 employees at the 35,000-f² facility, which has room to expand to more than 150,000 f².

Intricon Costa Rica has hired Jorge Herrera as site manager to lead the project’s design and construction. The company also hired Sofia Vargas as business development manager from CINDE, the Costa Rican firm that helped Intricon with site selection…

Heraeus Medevio appoints new president

Heiko Specht [Image courtesy of Heraeus Medevio]

Heraeus Medevio announced that it appointed Heiko Specht to take over as president of the company from Dr. Peter Reimer.

The appointment went into effect on July 1. Specht has held a number of roles at the contract development manufacturing organization since joining in 2000.

His roles include a number of R&D and business leadership positions. Most recently, as chief commercial leader, he oversaw Heraeus product and portfolio management sales and marketing. That included responsibility for the overall business strategy.

As president, Specth will utilize his experience in strategic leadership, growing market share and continuous improvement at Heraeus.

“Heiko’s experience and success in so many areas of our business gives me every confidence he will lead Heraeus Medevio in continuing to achieve double-digit growth each year,” …

This sensor prototype mimics natural cell membrane function

A team led by MIT researchers designed a sensor that could help screen for hard-to-diagnose cancers or metastatic tumors.[Image courtesy of the researchers/MIT]

A team of engineers at MIT have developed a novel sensor that could detect molecules typically identified by naturally occurring cell receptors.

The prototype sensor can detect an immune molecule called CXCL 12. They say this could help develop a routine screening system for hard-to-diagnose cancers or metastatic tumors. The technology could also be used as a highly biomimetic electronic “nose,” according to an MIT news release.

“Our hope is to develop a simple device that lets you do at-home testing, with high specificity and sensitivity,” said Shuguang Zhang, a principal research scientist in MIT’s Media Lab. “The earlier you detect cancer, the better the treatment, so early diagnostics for cancer is one important area we want…

Find solutions to your most demanding medtech problem at DeviceTalks West

Add some essentials to your toolbox with engineering expertise from our upcoming show in California.

Intuitive President Dave Rosa will give a keynote interview at DeviceTalks West 2023. [Photo courtesy of Intuitive]

In the medical device industry, stubborn problems can cost millions in development expenses and delay the introduction of new life-saving tools and technologies.

That’s why we build our DeviceTalks meetings as a forum where successful medical device engineers, manufacturers and market-builders can share their best practices, providing solutions that help clear hurdles, speed product development and potentially save lives.

DeviceTalks attendees leave our meeting with notebooks full of critical advice and pockets full of business cards. We’ll help fill both at DeviceTalks West, which takes place Oct. 18-19 at the Santa Clara Convention Center in California. You can view the full agenda on our…

Cirtec and Ilika finalize Stereax battery manufacturing deal

Ilika’s Stereax M300 battery with a pen and pencil for scale [Photo courtesy of Ilika]

Battery developer Ilika has signed a 10-year deal for Cirtec Medical to manufacture Stereax batteries in Lowell, Massachusetts.

The two medtech suppliers announced their partnership on the millimeter-scale, solid-state batteries in January. Now, Ilika and Cirtec Medical say they have “concluded contractual negotiations” with the decade-long manufacturing license.

The ultrathin, rechargeable Stereax batteries can enable medical device developers to design smaller implants, wearable devices, sensors and other smart components.

Related: How tiny solid-state batteries enable smaller implants that recharge faster

Select medtech developers have already received limited shipments of Stereax batteries from Romsey, England-based Ilika’s U.K. manufacturing facility.

The first shipmen…

Quest International achieves ISO 27001 information security certification

NEWS RELEASE: Quest International Achieves ISO 27001:2013 Certification, Proving Its Commitment to Cybersecurity

Quest meets strict ISO criteria in delivering a secure, resilient Information Security Management System for post-sales service support for OEMs

IRVINE, Calif., August 2023 — Quest International, a leading global post-sales service support partner for Original Equipment Manufacturers (OEMs) and an IT managed services provider, announced that it has received ISO 27001:2013 certification from the International Organization for Standardization (ISO). The only globally recognized certifiable information security standard for Information Security Management Systems (ISMS), ISO 27001:2013 has auditable requirements to encompass the overall management of information security, including cybersecurity protections.

“With ISO2700:2013 certification, Quest is certified as a responsible and trustworthy steward of client data as well as third-party information,” …

Scientists report wearable breakthrough in electric control of DNA

In what they believe is a wearable breakthrough, researchers stimulated engineered cells to control insulin expression in mice. [Illustration by Nathan Devery via Adobe Stock]

Researchers at ETH Zurich in Switzerland say they’ve made a wearable breakthrough, developing an electrogenetic interface to enable transgene expression in human cells.

They call their work DART, for direct current (DC)-actuated regulation technology. It uses power “to generate non-toxic levels of reactive oxygen species that act via a biosensor to reversibly fine-tune synthetic promoters,” they said in a paper published in Nature Metabolism.

“We designed an electrogenetic interface consisting of genetic components that render human cells responsive to DC-triggered electrostimulation and enable exclusive, DC-adjustable transgene expression,” the researcher said.

The researchers bel…

Hemco launches new UniFlow SL fume hood

NEWS RELEASE: New UniFlow SL Fume Hood

Hemco’s UniFlow SL fume hood [Image courtesy of Hemco]

The new SL series of high-performance laboratory fume hoods are constructed totally, interior and exterior, of chemical resistant, flame retardant, lightweight composite resin for a fume hood that will outlive the competition.

This non-metallic fume hood has an interior fume chamber that is molded one piece seamless with all corners coved and a slotted VaraFlow baffle system for superior airflow uniformity. All hardware is of chemical resistant PVC.

The SL fume hood features a 54” height with an extended front post to accommodate additional service fixtures and electrical services. This fume hood is available in 48”, 60”, 72”, and 96” models with a 30” depth.

The SL fume hood is equipped with a vapor-proof LED light fixture, light switch, and counterbalanced vertical sliding safety tempered glass sa…

Wearable and implantable medical devices tap humans as a power source

MIT’s glucose-based battery uses the body’s own sugar to generate electricity, which could power implants and sensors. [Image courtesy of MIT]

By Brian Santo for Mouser

Wearable medical devices and implants are becoming more prominent in a wide range of applications such as health monitoring devices and biomedical implants, which provide continuous measurements of biomarkers and medical diagnostics. Based on growth of the elderly population and insights garnered from the pandemic, the shift to the development of wearables and biosensors has increased the need for real-time health monitoring, personalized medicine and point-of-care technology (POCT).

Over the last decade, advancements have been made in the development of next-gen medical wearables and implants using the latest technologies that make using them cheap and readily available. What typically took hours for diagnostic testing at a medical facil…

3D-printed COVID-19 breath test takes two breaths and one minute

Researchers have developed this 3D-printed breath test for COVID-19. [Photo courtesy of Washington University in St. Louis]

A 3D-printed COVID-19 breath test delivers results within 60 seconds from just one or two breaths, according to Washington University in St. Louis researchers.

It’s the same team that recently developed an air monitor that can detect the COVID-19-causing SARS-CoV-2 virus in the air within minutes.

Researchers from the McKelvey School of Engineering and the School of Medicine used the same ultrasensitive biosensing technique for the breath test.

The small, portable and adaptable device could help fight the airborne virus as at-home rapid tests increasingly report false negatives for new SARS-CoV-2 variants. Most COVID-19 transmission is still pre-symptomatic and asymptomatic.

The researchers envision their device being used for rapid diagnosis by doctors or to scr…

Ahead of Medtronic RDN’s FDA review panel, analysts place their bets

The Symplicity Spyral renal denervation system delivers radiofrequency energy via a catheter to the nerves leading to the kidneys, which help regulate blood pressure. [Image courtesy of Medtronic]

Analysts expect good news for Medtronic and its renal denervation (RDN) therapy for hypertension when the FDA review panel meets later this month.

RDN therapy could be a life-saver for millions of patients with high blood pressure — and a billion-dollar business for Medtronic if it wins FDA approval after two failed trials in the past decade.

The world’s largest medical device company is looking for a win after the latest RDN pivotal trial fell short of expectations, a disappointing result in a year with many other challenges. Medtronic’s revenue slipped 1% in fiscal 2023 (which ended on April 28, 2023), and net income dropped by 25% year-over-year as the company cut costs with early retirements, la…