semiconductors Archives - Medical Design Sourcing

FDA removes dialysis-related products from device shortage list

The FDA has removed two dialysis-related product codes from its device shortage list.

The products — kidney perfusion system (product code KDN) and disposable kidney perfusion set (product code KDL) — had been on the FDA’s shortage list since January 2022.

The agency attributed the shortages to a “shortage or discontinuance of a component, part or accessory of the device” and shipping delays.

As of the May 2023 expiration of the COVID-19 public health emergency, the FDA no longer requires medical device manufacturers to report product shortages, though the agency encourages voluntary reporting of device production interruptions or permanent discontinuations.

The medical device shortages list now only includes five product codes, including automated external defibrillators (AEDs) and two types of oxygenator devices intended for extracorporeal circulation:

BYS: Oxygenators for long-term support (greater than 6 hours), added to…

FDA expects longer AED shortage, reports plans for Abbott HeartMate II discontinuation

The FDA now expects shortages of automated external defibrillators (AEDs) to persist longer than previously estimated, but removed four other product types from its list of medical device shortages.

The agency also added to its list of discontinued devices, including plans by Abbott to stop manufacturing its HeartMate II Left Ventricular Assist System (LVAS) in 2026.

AED shortage update

The FDA said shortages of wearable and non-wearable AEDs (product codes MVK and MKJ, respectively) will likely last through summer 2024. The federal agency updated its forecast last month after saying as recently as October that the shortage would last through 2023.

The FDA said the shortages are due to an increase in demand for the devices as well as a shortage or discontinuance of a component, part or accessory. Those devices have been on the shortage list since July 2022 as the agency required manufacturers to file for premarket approval (PMA) for previously cleared ac…

Stryker CEO Kevin Lobo offers supply chain update after ‘wild year’

Kevin Lobo is CEO and chair of Stryker. [Photo courtesy of Stryker]

The medtech industry as a whole suffered over the past year or so as supply chain issues — namely semiconductors — came to a head.

Midway through last year, Medtronic CEO Geoff Martha labeled it as a problem for everyone as medtech’s biggest names navigated serious shortages of chips and other key supplies.

An industry survey from Deloitte showed that some medtech manufacturers slowed down or halted manufacturing operations after depleting their semiconductor inventories. Nearly 80% of survey respondents reported extended lead times, with some stretching more than a year.

At AdvaMed’s The MedTech Conference on Monday in Anaheim, Stryker Chair and CEO Kevin Lobo explained the low point that his company and the industry hit last year.

“In this industry, we never had to worry about [chip supply] before,” Lobo…

FDA removes more products from medical device shortages list

The FDA removed more products from its medical device shortages list as supply chain issues from the COVID-19 pandemic continue to improve.

The federal safety agency recently removed devices spanning 17 different product codes, including ventilator products

The products removed from the FDA medical device shortages lists in the latest update were:

Ventilation-related products

The FDA removed three ventilation-related devices from the list: non-continuous ventilators (product code: BZD), non-life-supporting continuous ventilators (product code: MNS) and continuous ventilators with minimal ventilatory support for facility use (product code: MNT).

All had been in short supply due to the global semiconductor shortage and good manufacturing practices requirement compliance. Increase in demand was another factor specific to non-continuous ventilators, which had been in short supply since at least August 2020. The shortage of the two continuous ventilato…

FDA removes products from medical device shortage list, reports AED discontinuation

The FDA removed several products from its medical device shortages list and expects the shortage of prefilled saline flush syringes to end soon.

The agency also said Stryker is discontinuing certain automatic external defibrillators (AEDs), a product category for which manufacturers have faced heightened regulatory scrutiny in recent years.

Previously: FDA’s mandatory medical device shortage reporting ends

Relief in sight for prefilled saline flush syringe shortage

Prefilled 0.9% sodium chloride intravenous lock/flush syringes have been in short supply since at least March 2022 due to increased demand. At the same time, supply chain challenges and manufacturing discontinuances have reduced product availability.

These single-use syringes help to prevent blockage of vascular access systems and remove residual medication from the catheter site.

The FDA estimates the prefilled saline flush syringe shortage will end in October 2023. Until then, …

Siemens Healthineers plans new semiconductor factory for photon-counting CT scanner

Siemens Healthineers plans to build a new factory for cultivating crystals used in advanced computed tomography (CT) scanners.[Rendering courtesy of Siemens Healthineers]

Siemens Healthineers announced plans this week to build a factory in Germany for cultivating crystals used to make semiconductors for advanced computed tomography (CT) scanners.

The medtech giant said its existing production facility in Japan is at capacity, and that the new fabrication plant (or “fab”) is scheduled to come online in 2026.

Previously: FDA updates medical device shortage list due to shipping delays and semiconductors

The 9,000-m² Forchheim fab will cost 80 million euros, Seimens said. The company has invested around half a billion euros in its Forcheim operations since 2019.

“We made a conscious decision in favor of the Forchheim site. Here we are building the world’s first photon-co…

FDA updates medical device shortage list due to shipping delays and semiconductors

Medical device shortages persist due to shipping delays and semiconductor availability, the FDA said last week in an update to its medical device shortage list.

The updated medtech products in short supply include radiological devices, general plastic surgery devices, cardiac diagnostic and monitoring products, general ICU/ hospital products, specimen collection supplies and ventilators.

Philips Invivo MRI breast biopsy grid plates

Philips product shipping delays caused a shortage of magnetic resonance imaging (MRI) breast biopsy grid plates used with breast biopsy/localization trays, surgical guide needles and specialty magnetic resonance coils.

Those Philips Invivo MRI breast biopsy grid plates have been on the shortage list since October 2022 after imaging facilities notified the FDA of the shortage in July. The FDA said it does not know how long the shortage will last, but said it “is still compiling and evaluating data on manufacturing and pro…

Biden reportedly plans to block AI chipmaking exports to China

President Joe Biden’s administration may soon restrict AI chipmaking exports to China. [Image courtesy of Biden for President]

President Joe Biden’s administration plans to restrict U.S. exports of artificial intelligence semiconductors and manufacturing equipment to China, Reuters reported over the weekend.

Citing confidential sources, Reuters said the Commerce Department plans to publish new regulations next month, requiring licenses for certain exports of AI chipmaking equipment and AI computing chips.

Semiconductors and artificial intelligence are increasingly valuable tools for medical device developers and manufacturers as smaller sensors, connectivity tech and algorithms to collect and crunch more data than ever before.

RELATED: 5 steps to help medical device makers deal with semiconductor shortages

The Commerce Department said it is “taking a comprehensive approach…

New semiconductor design boosts AI computing efficiency

The NeuRRAM chip [Photo by David Baillot for the University of California San Diego]

Medical devices could one day get a boost from a new energy-efficient semiconductor designed with AI computing in mind.

Stanford engineers have developed a new resistive random-access memory (RRAM) chip called NeuRRAM that does AI processing within the chip’s memory, saving the battery power traditionally spent moving data between the processor and storage.

“The data movement issue is similar to spending eight hours in commute for a two-hour workday,” Weier Wan, a recent graduate at Stanford leading this project, said in a news release. “With our chip, we are showing a technology to tackle this challenge.”

They say their compute-in-memory (CIM) chip is about the size of a fingertip and does more work with limited battery power than current chips. That makes the new chip a potential space-saver for medical de…

FDA adds AEDs and other medical devices to shortage list

An automated external defibrillator (AED) [Photo by James Rein]

The FDA has added automated external defibrillators (AEDs), chest drains/suction canisters and autotransfusion systems to its list of medical devices in short supply.

AEDs — including wearable and nonwearable versions of the devices — are expected to be in limited supply for at least the rest of 2022, the FDA said. The agency cited both an increase in demand for AEDs and the global shortage of semiconductors used in the devices.

“The FDA continues to work with federal partners and other stakeholders to help mitigate challenges associated with semiconductor shortages,” the FDA said in yesterday’s update to the device shortage list. “In addition, the FDA has issued guidance documents, including enforcement policies, regarding circumstances where manufacturers may consider modifying their devices because of supply chain …

Five steps to help medical device makers deal with semiconductor shortages

[Photo by Vishnu Mohanan]

Medical device manufacturers are increasingly pessimistic about the supply of semiconductors, according to Deloitte’s latest survey of the industry.

Some said they’ve slowed down or halted manufacturing operations after depleting their semiconductor inventories, and nearly 80% of survey respondents reporting extended lead times, with some stretching more than a year.

“More than 75% of our most-recent survey respondents said that their customers have turned to alternative types of treatment for their patients,” Deloitte’s Stephen Bradley and Bill Murray wrote in a new report. “As a result, some hospitals and health systems are looking into alternate products, new usage strategies or treatment options.”

The Advanced Medical Technology Association (AdvaMed), which continues to push for the medical device industry to be prioritized fo…

Supply Chain EVP Greg Smith sees fewer suppliers in Medtronic’s future

Greg Smith is Medtronic’s EVP of global operations and supply chain [Photo courtesy of Medtronic]

All eyes are on Medtronic’s global operations and supply chain leader as he works to modernize its operations and scrutinize suppliers.

EVP of Global Operations and Supply Chain Greg Smith sees fewer suppliers in Medtronic’s future, he said in an interview this week.

Smith spoke with DeviceTalks Editorial Director Tom Salemi in his first published interview since joining Medtronic (NYSE:MDT) in April 2021.

Smith was previously EVP of U.S. supply chain at Walmart and SVP of global operations at Goodyear Tire & Rubber Co. His more than three decades of experience also includes time at ConAgra Foods, United Signature Foods, VDK Frozen Foods and Quaker Oats.

Around the same time that he joined Medtronic, semiconductors and resins were in short supply following the February 2021 cold s…