Medical Design and Outsourcing Archives - Page 19 of 154

Navigating thermally induced dynamics when developing miniaturized medical devices

Examples of mismatched materials of varying thermal dynamics, cured at various temperatures, causing warpage, cracking and potential breakage. The results are based on the forces that are present during matching and the assembly processes. [Photo courtesy of Promex]

Understanding and managing thermally induced dynamics during assembly and use is essential as devices become increasingly integrated and miniaturized.

By Dave Fromm, Promex

Some complexities of integrating miniaturized components, such as microelectronics, into increasingly small medical devices are obvious. Examples include the precision required to position and align components with the requisite accuracy, or the identification of critical-to-function dimensions and methods that control and check assembly steps.

A more hidden and often overlooked complexity is the thermally induced dynamics that occur when producing assemblies at micros…

The Future of Medical Device Development: Honeywell’s Spectra UF BIO Fiber Solution for Cardiovascular Applications

By Zachary Murnane, Medical Fiber Global Business Manager, Honeywell

The rise in heart valve disease and other cardiovascular conditions has led to a growing demand for minimally invasive devices and technologies. In addition, medical devices need to meet specific tissue response and durability criteria for the biomedical structures to elicit proper biologic responses. This means that medical devices need to be small and flexible to enable minimally invasive surgeries while also being strong and durable so they can last for the full life of the patient. The use of ultra-high molecular weight polyethylene fibers like Honeywell Spectra UF BIO can play a significant and useful role in the development of biocompatible medical devices, particularly in the field of cardiovascular applications such as heart valves.

What is Honeywell Spectra® UF BIO Fiber

Spectra® UF BIO Fiber is a product portfolio that falls under the Honeywell medical grade fi…

How Ambu seeks to hold its top spot in single-use scopes

Ambu CEO Britt Meelby Jensen [Image courtesy of Ambu]

Ambu’s CEO seeks to “Zoom In” on what the Danish company has done best.

More than a year after she took over the corner office at Ambu, Britt Meelby Jensen recalls what brought her into leadership. She already had a seat on the board at the maker of single-use endoscopes, anesthesia and airway management devices, and patient monitoring technology.

“We were in a situation where we saw challenges with declining profitability and we were not able to meet our revenue targets that we had put out to The Street. So it was around that time the chairman asked if I wanted to run the company,” Jensen said during a recent DeviceTalks Weekly podcast interview.

In many ways, Ambu’s challenges stemmed from its success. The Danish company, founded in 1937, launched the Ambu Bag in the 1950s. The self-inflating, manual resuscitator is still a fixture in hospital e…

Superior Sensor expands CPAP pressure sensor family

NEWS RELEASE: Superior Sensor Technology Expands CPAP Pressure Sensor Family to Drive Better Patient Synchrony New CP Series Sensors Offer Faster System Response Time and New Safety Measures for PAP Devices, Providing a Higher Quality Patient Experience Los Gatos, CA, September 27, 2023 – Superior Sensor Technology today announced two new CP Series pressure sensors for Positive Airway Pressure (PAP) devices used in sleep apnea, COPD, Asthma and home ventilator applications. Based on Superior Sensor’s highly integrated CP Series dual pressure sensor architecture, the new CP202 and CP302 closed loop control functionality and overpressure indicator enable manufacturers to easily upgrade their PAP devices to offer a better patient experience. The integrated closed loop control feature typically cuts the pressure response time by 50%, enabling the PAP device to more efficiently synchronize to the patient’s varying breathing patterns to reduce sleeping disturbances, further …

CUI releases medical grade dc-dc converter with 2:1 input voltage and extended temperature range

NEWS RELEASE: CUI Releases Medical Grade DC-DC Converter with 2:1 Input Voltage and Extended Temperature Range

CUI’s PTP15 medical grade DC-DC converter {Image courtesy of CUI]

Tualatin, OR. [September 27, 2023] CUI Inc, a Bel group company, today announced the release of its PTP15 Series—a 15 W, 5 Pin DIP isolated dc-dc converter, specialized for medical instrumentation and home medical supplies.

Offering 4000 Vac isolation or 5600 Vdc isolation with a 2:1 input voltage range, the series is compliant with the IEC/EN 60601-1 and EN 55011 Class A safety standards without external components. Housed in an industry standard 2″ x 1″, encapsulated, board mountable package, the converter can be used in temperature ranges from -40 up to +100°C and features output over current, short circuit and overvoltage protections.

Though specialized for the medical field, the PTP15 series is also suit…

Surface Solutions Group introduces sustainable, compliant GlideMed medical device coating

NEWS RELEASE: Surface Solutions Group to Introduce Sustainable, Compliant GlideMed™ Medical Device Coating at MD&M Minneapolis

CHICAGO, September 26, 2023 – ISO 13485 certified Surface Solutions Group, LLC (SSG), a leading provider of coating technologies for the medical device industry, today announced that it will be showcasing its GlideMed™ sustainable, compliant coating along with its 12 other coating solutions in Booth #3226 at the Medical Design & Manufacturing Conference & Expo (MD&M) in Minneapolis on October 10-11, 2023.

MD&M attendees are invited to meet with SSG’s team and learn more about GlideMed™, a water-based, low friction coating for medical devices. Available in No PTFE and Low PTFE formulations, it is free from any PFOS, PFOA, solvent and hexavalent chromium (hex chrome) compounds. Developed using established, proven coating technology, it is a biocompatible, environmentally friendly coa…

RWE tips from Boston Scientific Peripheral Interventions CMO Dr. Michael Jaff

Dr. Michael Jaff is chief medical officer and VP of the Boston Scientific Peripheral Interventions business. [Photo courtesy of Boston Scientific]

Real-world evidence (RWE) is a transformational concept for medical device design and engineering, says Dr. Michael Jaff, the chief medical officer and VP of the Boston Scientific Peripheral Interventions business.

“Every really great technological advancement in the vascular space has come from a physician’s recognition that they would like to be able to do something safely and effectively for their patients, but the technology does not exist,” Jaff said in an interview with Medical Design & Outsourcing. “They find their way to an engineer, someone really smart takes that concept builds a prototype — off to the races. And it has time and time again transformed the way patients can be cared for.”

RWE leverages modern data coll…

Resonant Link and Cirtec partner on implantable medical devices

Resonant Link and Cirtec Medical have entered into a strategic partnership to serve developers of implantable medical devices.

The two medtech suppliers said today that the partnership will combine Resonant Link’s next-generation wireless power technology with Cirtec Medical’s product design, development and manufacturing expertise to “offer medical device makers the best technology, fully integrated components, and faster time to market.”

The companies have already been working with each other for years, said Resonant Link CEO Grayson Zulauf.

“This partnership is really an extension of the close collaboration, transparency, and mutual respect we already have,” he said in a news release. “Cirtec is known for providing advanced medical device technologies, engineering, and contract manufacturing services, and we are thrilled to add our wireless power capabilities to their suite of off-the-shelf and custom medical device solutions.”

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Johnson & Johnson MedTech plans manufacturing facility in Costa Rica

Johnson & Johnson MedTech will build a 200,000-sf² manufacturing facility in Alajuela, Costa Rica, the medical device developer said today.

It’s the largest investment J&J MedTech has ever made outside the U.S., according to Procomer, the agency that promotes Costa Rican exports.

J&J MedTech — Johnson & Johnson’s medical device business — said the plant will manufacture products across its franchises, with an emphasis on heart rhythm solutions and orthopedics. The new plant will also have space for shared services and will assess and support demand for product across J&J MedTech’s portfolio, which includes DePuy Synthes, Biosense Webster, Cerenovus, Ethicon and Johnson & Johnson Vision.

Construction starts this year on the facility, which will add around 3,000 new jobs in the region over the next three to five years, the company said.

“Nearly 300 million patients are treated with Johnson & Johnson MedT…

The secret behind Intuitive’s surgical robotics success

Dr. Myriam Curet has been instrumental to Intuitive’s success in recent years. [Photo courtesy of Intuitive Surgical.]

Intuitive Surgical has pioneered robotic surgery since the 1990s, continuously driving innovation and collaboration through data to advance patient care.

Teamwork between surgeons and engineers has been a crucial factor behind Intuitive developing effective surgical platforms that solve real-world problems that surgeons face.

Multibillion-dollar companies including Medtronic and Johnson & Johnson — and smaller up-and-comers including CMR Surgical and Vicarious Surgical — have sought to take on Intuitive in the soft-tissue surgical robotics space in recent years, but Intuitive remains the dominant company. An important element of Intuitive’s continued success has been its ability to harness data, collaborate with surgeons, and innovate.

As a practicing surgeon who actively …

3D-printed ventricles made from fiber-infused gel ink mimic heartbeats

The tissue-engineered 3D ventricle model. Image credit: Harvard SEAS

Researchers have found a way to use fiber-infused ink to 3D-print a functional heart ventricle that mimics the beating of a human heart.

The team included researchers from Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) and the Wyss Institute for Biologically Inspired Engineering at Harvard University. They reported on their new hydrogel ink infused with gelatin fibers in a paper published in Nature Materials.

This fiber-infused gel (FIG) ink allows heart muscle cells printed in the shape of a ventricle to align, beating in coordination like a human heart chamber.

“People have been trying to replicate organ structures and functions to test drug safety and efficacy as a way of predicting what might happen in the clinical setting,” said Suji Choi, research associate at SEAS and first author on the pape…

Synchron’s plan to beat Neuralink in the neuroprosthetic BCI race

Synchron Chief Commercial Officer Kurt Haggstrom [Photo courtesy of Synchron]

Competing brain-computer interface (BCI) developers Synchron and Neuralink both announced big news this month as they move their dueling neuroimplant technologies forward.

The device developers each have FDA investigational device exemption (IDE) for their experimental BCIs. They’ve also got billionaires backing their R&D and regulatory efforts, with Neuralink owned by Elon Musk and Synchron funded by Jeff Bezos and Bill Gates.

This month, Synchron announced the completion of patient enrollment in its COMMAND clinical trial. Two weeks later, Neuralink announced the start of recruiting for its own clinical trial, the PRIME first-in-human study.

With BCI technology advancing as one of the hottest spaces in medtech innovation, Synchron Chief Commercial Officer Kurt Haggstrom discussed the competitive landscape and…