Medical Design and Outsourcing Archives - Page 86 of 154

Has the CE mark lost its appeal for novel medical device developers?

Medtech companies are increasingly looking to the FDA instead of Europe’s CE mark when launching novel products, according to a new report.

“Historically, the CE mark has been the preferred route for novel medical technology registration, since its processes were faster, cheaper and more predictable. The situation is now reversed,” wrote the authors of the study, published by Boston Consulting Group and the UCLA Biodesign innovation hub.

They surveyed and interviewed leaders and executives at 102 companies that have achieved registration or approval of a combined 105 novel technologies. A little more than half of the respondents said they are deprioritizing the CE mark relative to FDA approval.

Of the companies surveyed, 90 are headquartered in the U.S. and nine in the EU. One-fifth of the companies are publicly traded.

Industry executives described product registration and approval as “cumbersome and uncertain” under…

This tentacle-like magnetic robot could navigate the lungs

Image courtesy of the University of Leeds

Engineers at the University of Leeds have developed a magnetic tentacle robot to pass through the narrow tubes of the lungs.

Scientists and engineers at the university made a proof of concept for a robotic device that can reach the smallest bronchial tubes to take tissue samples and deliver cancer therapy.

The tentacle robot has a diameter of 2 mm, about twice the size of a ballpoint pen’s tip. Magnets outside a patient’s body guide the tentacle robot into place.

Get the full story on our sister site, Medical Tubing + Extrusion.

Power supply safety standards for home medical devices

Internal medical ac/dc power supplies and external medical ac/dc power supplies have 60601-1 certification for 2 x MOPP (means of patient protection). [Photo courtesy of CUI]

Patients using blood pressure monitors and CPAP devices in non-clinical environments are protected by IEC 60601-1-11.

Ron Stull, CUI

Home medical devices can provide an excellent first line of defense when dealing with health and medical issues, and there is an increased need for at-home care for patients released from hospitals and other healthcare facilities.

The medical technologies used in nonclinical environments range in complexity from simple materials for administering first aid to sophisticated devices for delivering advanced treatment.

Complex at-home electrical medical devices must comply with the stringent IEC 60601-1 safety standards for medical patient protection. They must also adhere to additional requirem…

Eagle Stainless Tube & Fabrication celebrates 40th anniversary

NEWS RELEASE

For 40 years, Eagle Stainless Tube & Fabrication has been supplying stainless steel tubing and other metals to the medical, aerospace and industrial industries. In 1982, Robert Bubencik Sr. and Roy Elliot pulled together a handful of employees to launch a small machine shop in Franklin, Massachusetts. Despite its size and infancy, the founders were committed to building a world-class product manufacturing firm. This remains the philosophy today.

Starting out in a modest rented space, the product quality and customer loyalty produced the success that led to the construction of the current facility in 1987. This facility grew by 40,000 square feet in 1991, which vastly expanded their capacity in fabrication capabilities, including cutting, bending and machining. Eagle bought a second 40,000-square-foot manufacturing facility in 2013, expanding the capacity for warehousing and distribution.

Eagle went from a handful of employees in 1982 to …

How much time and money does it take for FDA 510(k) clearance versus De Novo classification?

If you’re developing a new medical device and want to know how much time and cash it could take to get FDA 510(k) clearance or De Novo classification, a recent report offers some guidance.

Boston Consulting Group and the UCLA Biodesign innovation hub questioned leaders at 102 different companies that have achieved registration or approval of a combined 105 novel technologies. Ninety of the companies are headquartered in the U.S. and nine in the EU. One-fifth of the companies are publicly traded.

Survey questions and interviews yielded detailed cost information for 50 products that successfully navigated the 510(k) pathway at a median cost of $3.1 million and 13 products that won De Novo classification at a median cost of $5 million.

“Cost is dictated by many factors, including but not limited to the inherent novelty of the design, whether clinicals are required, and whether the product consists of software or hardware,” the report said.…

Some analysts are upbeat about Medtronic’s renal denervation prospects

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

Needham & Co. analysts are reiterating their Buy rating for Medtronic stock, saying that renal denervation (RDN) could still be a big opportunity for the medtech giant.

Medtronic (NYSE:MDT) had to continue its Spyral HTN-ON MED trial into this year after failing to obtain the positive results needed to end enrollment early for the potential hypertension treatment.

During Medtronic’s Q3 earnings call in February, CEO Geoff Martha said the company expects to complete the six-month follow-up to ON MED in the second half of this calendar year. It’s the final piece of information Medtronic needs to submit for FDA approval of its Symplicity Spyral device.

Medtronic’s Symplicity Spyral device delivers energy to the ner…

Johnson & Johnson is bringing the world’s first drug-eluting contact lens to market

Johnson & Johnson has a potential alternative to eye drops with its drug-eluting Acuvue Theravision contact lens.

As far back as the early 1960s, researchers toyed with the idea of delivering medication through contact lenses.

Johnson & Johnson Vision (NYSE:JNJ) Director of Clinica Science Dr. Brian Pall told Drug Delivery Business News that patents back then disclosed how a soft contact lens of hydrogel material could be an effective vehicle for delivering medication to the eye.

Get the full story at our sister site, Drug Delivery Business News.

Making biomedical data computable

Vik Nagjee is the vice president of product at nference [Photo courtesy of nference]

Cloud computing can power quantum leaps in human health.

Vik Nagjee, nference

A state-of-the art platform that supports real world evidence (RWE) and health economics and outcomes research can enable breakthroughs at an unprecedented scale.

This is achieved by making the de-identified, transformed information contained within the electronic medical record (EMR) available for data science and analysis at the aggregate and patient level. Add multi-modal data sources such as imaging and electrocardiograms as well as novel data assets like digital pathology and omics data to enrich the EMR data to provide a truly longitudinal view of the patient, and you have the beginnings of a world-class platform.

The keys are privacy preservation, harnessing longitudinal data, data enrichment and a data science platform.

P…

How the hospital may become a new market for CGMs

Dexcom G6 transmitter

Following a breakthrough nod for Dexcom, CGMs may become a key part of hospital care.

As the early stages of the COVID-19 pandemic required action in many forms, continuous glucose monitors became an unexpected part of hospital care.

The FDA issued temporary guidance in April 2020 allowing for increased remote monitoring of hospital patients to limit contact with hospital staff and opportunities for COVID-19 transmission. That guidance extended to CGMs for the remote monitoring of people with diabetes.

Use of the technology in hospitals has always been of great intrigue for Scripps Whittier Diabetes Institute Corporate VP Dr. Athena Philis-Tsimikas, an adult endocrinologist who has been in practice for around three decades and has watched the development of CGMs since about 1999.

“[CGMs are] what we’ve been using to manage patients as I became more involved in having resp…

FDA warns of cybersecurity risk in certain medical device software components

[Image from Pixabay]

Kathryn Burke, Emergo by UL

The U.S. Food and Drug Administration (FDA) has issued a cybersecurity alert to medical device manufacturers regarding vulnerabilities that have been identified in the Axeda agent and Axeda Desktop Server.

The FDA alert noted that all versions of Axeda agent and Axeda Desktop Server are affected. The agent and desktop server are owned and supported by computer software company PTC and are used in a number of medical devices across several medical device manufacturers.

Get the full story here at the Emergo by UL’s blog.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MedicalDesignandOutsourcing.com or its employees.

Teamvantage acquires MMD Medical

Custom contract manufacturer and injection molder Teamvantage has acquired medical device manufacturer MMD Medical.

Forest Lake, Minnesota-based Teamvantage and Brooklyn Park, Minnesota-based MMD Medical did not disclose terms of the deal in their announcement this week.

Teamvantage said the combination could add significant value for customers with the additional scale and capacity, operational efficiencies and expanded access to major medical customers.

“Teamvantage is on a strong growth trajectory, and this partnership enhances our ability to provide creative solutions for our customers’ unique manufacturing challenges and compete in the global marketplace,” Teamvantage CEO Dave Hemink said in a news release. “MMD Medical’s capabilities and processes are very complementary to the Teamvantage platform, providing a fully integrated, single source with differentiated precision manufacturing capabilities to serve a broad base …

Synopsys updates Simpleware 3D image processing software

The Shoulder CT Auto Segmenter in Simpleware AS Ortho [Image courtesy of Synopsis]

Synopsys recently announced version T-2022.03 of its Simpleware 3D image processing software, which is used in life science and advanced materials and manufacturing applications.

Improvements in the new version of Simpleware announced by the Mountain View, California-based company earlier this month include:

Simpleware AS Ortho Shoulder CT Auto Segmenter

The Shoulder CT Auto Segmenter has fully automatic AI segmentation of shoulder CT scans; segmenting of the humerus, scapula and clavicle; automatic positioning of anatomical landmarks; and automatic region-of-interest detection to speed up inference.

2D Contour Measurements

2D contour creation from straight lines, splines, and active contours, and D-shaped contours for computing dimensions of D-shaped annulus make this an effective tool when used in conjunction with…