Monday, November 14, 2022 9:38:49 AM
Five minutes on Google:
Medical Device Shortages During the COVID-19 Public Health Emergency
FDA statement
"The FDA publishes a device shortage list to provide transparency to the American public, particularly those who use or purchase medical devices. The list fulfills a statutory obligation under section 506J of the FD&C Act and reflects the categories of devices the FDA has determined to be in shortage at this time and will be maintained and updated as the COVID-19 public health emergency evolves. The presence of a device type on this list does not necessarily indicate that patient care has been affected."
https://www.fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/medical-device-shortages-during-covid-19-public-health-emergency
How is the semiconductor shortage affecting medtech?
Deloitte Posted: 28 Jun. 2022
"Semiconductors, and their integrated circuits, act as the brain for millions of products—from smartphones, to automobiles, to laptops, to medical devices. However, these once inexpensive and plentiful silicon chips have been in short supply for more than 18 months, and medical device companies are suddenly competing with virtually every other manufacturing sector for limited inventory. Many medtech manufacturers are making difficult decisions to help ensure they can continue to meet the needs of the market. Some of them are likely to implement new (and often more expensive) strategies to keep their production lines moving."
https://www2.deloitte.com/us/en/blog/health-care-blog/2022/how-is-the-semiconductor-shortage-affecting-medtech.html
How the Supply Chain Upheaval Became a Life-or-Death Threat
NYT 12/09/2021
"A maker of medical devices can’t keep up with customer demand as the shortage of computer chips puts it in competition with bigger companies with more clout."
"ResMed has struggled to buy enough chips, Mr. Farrell said, constraining its ability to make a range of vital equipment — from ventilators used by Covid patients to breathing devices that sustain premature infants."
"The company is “producing less than 75 percent of what our customers need,” Mr. Farrell said."
https://www.nytimes.com/2021/12/09/business/supply-chain-medical-device-shortages.html
Medtechs face supply chain disruptions from semiconductor shortage
"The global semiconductor chip shortage is causing delays, order cancellations and other supply disruptions at medtech companies, according to a study commissioned by AdvaMed."
"Deloitte, which conducted the survey, found all respondents have experienced some level of disruption to their chip supply chain, with delays ranging from two weeks to more than one year."
"Evidence of the impact on medtech emerged over the summer, when ResMed cited the shortage of semiconductors as a reason it will be unable to meet all the demand created by the recall of devices by its competitor Philips."
"ResMed CEO Mick Farrell said he is calling suppliers and saying: “Look, this component can go into a cell phone or a car, or it can go into a medical device that literally gives someone the gift of breath. Please prioritize our part of the supply chain.” "
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