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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…

Medtronic supply chain chief Greg Smith on shortages, suppliers and strategy

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

The heat is on for Medtronic’s global operations and supply chain leader as he forges new links with suppliers the company relies on for innovation, quality and reliability.

For much of his 36-year career in operations, Greg Smith has had to explain to family and friends what the supply chain is and what his job is all about.

“I don’t have to do that anymore,” he said.

It’s no wonder why. Examples of supply chain SNAFUs have intruded on nearly all aspects of our everyday lives since the start of the COVID-19 pandemic, from shortages of masks, test components and toilet paper in the early days to persistent bottlenecks in semiconductors, resins and the many medical and consumer products that use them.

Smith is EVP of global operations and supply chain at Medtron…

ResMed finds a solution to semiconductor shortage, as well as some humor in it

ResMed (NYSE:RMD) can’t go back in time to solve its semiconductor shortage, but it’s found a solution that might be the next best thing — for now.

President and COO Rob Douglas (serving as interim president of Sleep and Respiratory Care at ResMed after Jim Hollingshead left to be CEO of Insulet) offered an update on the San Diego-based company’s supply chain issues as it tries to capture more of the market while Philips works through its recall.

ResMed President and COO Rob Douglas [Photo courtesy of ResMed]

“We’ve been managing a higher than normal rate of decommits coupled with a competitor recall that sucked all the inventory out of our systems and out of all of our customers’ systems as well,” Douglas said Wednesday at the William Blair Growth Stock Conference. “And so there is a huge shortage of devices. … We joke that the head of our supply cha…

‘Catastrophic explosion’ and resin shortage led Medtronic’s supply chain problems

Medtronic CEO Geoff Martha [Photo courtesy of Medtronic]

Medtronic CEO Geoff Martha today said a “catastrophic explosion” in Medtronic’s supply chain for packaging and a shortage of resins were the biggest issues hurting the company’s fourth-quarter performance.

Fridley, Minnesota-based Medtronic (NYSE:MDT) reported about $350 million less in sales than analysts were expecting for the quarter, which ended April 29.

Martha said about 75% of the miss was caused by supply chain issues, 15% by the COVID-19 lockdown in China and the last 10% due to foreign exchange rates getting worse.

Supply chain struggles “came out fast and hard” in the fourth quarter across the company’s businesses, but were most pronounced in Surgical Innovations (SI), Martha said.

“It was three things,” Martha said. “It was semiconductors, which is affecting every…

Texas power grid struggles a year after cold stopped semiconductor plants

Samsung workers at a semiconductor fabrication plant [Photo courtesy of Samsung]A heat wave in Texas took at least six power plants offline Friday with high temperatures forecasted to blaze throughout this week.

A record cold snap in February 2021 took NXP Semiconductors and Samsung chip fabrication facilities offline for weeks, contributing to a global semicondcutor shortage that is still throttling medical device production.

There’s no indication yet that the power grid’s latest struggles will reduce or stop semiconductor production, but the Electric Reliability Council of Texas (ERCOT) has asked residents to curb their electricity use ahead of more heat.

“With unseasonably hot weather driving record demand across Texas, ERCOT continues to work closely with the power industry to make sure Texans have the power they need,” ERCOT Interim CEO Brad Jones said in a news release.

Get the full story at…

Texas power grid struggles in heat one year after record cold stopped semiconductor plants

Samsung workers at a semiconductor fabrication plant [Photo courtesy of Samsung]

A heat wave in Texas took at least six power plants offline Friday with high temperatures forecasted to blaze throughout this week.

A record cold snap in February 2021 took NXP Semiconductors and Samsung chip fabrication facilities offline for weeks, contributing to a global semicondcutor shortage that is still throttling medical device production.

There’s no indication yet that the power grid’s latest struggles will reduce or stop semiconductor production, but the Electric Reliability Council of Texas (ERCOT) has asked residents to curb their electricity use ahead of more heat.

“With unseasonably hot weather driving record demand across Texas, ERCOT continues to work closely with the power industry to make sure Texans have the power they need,” ERCOT Interim CEO Brad Jones said in a news relea…

Medtech CEOs sound off on semiconductor shortage, pushing Biden administration for prioritization

BD CEO, President and Chair Tom Polen [Photo courtesy of BD]AdvaMed continues to push the Biden administration to prioritize medical device manufacturers for semiconductor supplies.

With medtech companies still struggling to source chips amid a global shortage, the industry association held a meeting this week with some of its members and Secretary of Commerce Gina Raimondo to make their case.

“Semiconductor chips are crucial to our industry and to the countless patients who depend on the medical technologies we produce,” AdvaMed President and CEO Scott Whitaker said during the meeting, according to a readout. “In this challenging environment, we simply cannot compete with larger players to gain access to chips.”

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