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.

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Startup vies to get blockchain adoption in pharma off the ground

[Image courtesy of Pixabay]

Blockchain may be arguably one of the most hyped technologies in recent memory, but the distributed ledger technology better known for its role in cryptocurrency may have significant potential in the pharma supply chain, clinical trials and beyond.

A blockchain-based initiative known as PharmaLedger has won support from prominent companies like Pfizer, Novartis, Merck & Co., Bayer and AstraZeneca.

In 2019, the FDA launched a pilot program supporting the Drug Supply Chain Security Act with the support of IBM, KPMG, Merck & Co. and Walmart.

The pandemic’s disruption of the pharmaceutical supply chain further spurred industry interest in exploring blockchain to improve logistics networks, as the Harvard Business Review observed.

Overall adoption of blockchain in pharma or the enterprise at large, however, remains at a nascent stage.

Blockchain in…

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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…

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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.”

Get the full story at our sister site, Medical Design & Outsourcing.

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Intuitive eyes sole-source suppliers as it expands capacity

Intuitive Surgical CFO Jamie Samath [Photo courtesy of Intuitive Surgical]Top executives at Intuitive Surgical (Nasdaq: ISRG) have sole-source suppliers on their minds as they ramp up manufacturing capacity in the face of continued supply chain challenges.

The robotic surgery technology developer’s growth and mindfulness of supply chain resiliency could bring new opportunities for Intuitive’s suppliers — along with competition from others who want in.

Sunnyvale, California–based Intuitive had just more than 10,500 employees at the end of March, CFO Jamie Samath said today on a conference call to discuss Intuitive’s first-quarter financial and operating performance. That employee count is up 26% from the same time a year before, and of the 2,100 new employees, he said about 900 work in manufacturing.

Get the full story at our sister site, Medical Design & Outsourcing.

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Intuitive eyes sole-source suppliers as it expands capacity

Intuitive Surgical CFO Jamie Samath [Photo courtesy of Intuitive Surgical]

Top executives at Intuitive Surgical (Nasdaq: ISRG) have sole-source suppliers on their minds as they ramp up manufacturing capacity in the face of continued supply chain challenges.

The robotic surgery technology developer’s growth and mindfulness of supply chain resiliency could bring new opportunities for Intuitive’s suppliers — along with competition from others who want in.

Sunnyvale, California–based Intuitive had just more than 10,500 employees at the end of March, CFO Jamie Samath said today on a conference call to discuss Intuitive’s first-quarter financial and operating performance. That employee count is up 26 percent from the same time a year before, and of the 2,100 new employees, he said about 900 work in manufacturing.

The company spent about $95 million on capital expenditures in the first …

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How medtech is tackling supply chain challenges

A host of medical device companies with manufacturing in Puerto Rico found their supply chains impacted by Hurricane Maria in 2017. It was a harbinger of what was to come. [Image is public domain]Join us at DeviceTalks Boston on May 10-11 to hear how medical device companies are propping open supply lines and ensuring a steady flow of products to customers in a constantly changing world.

Sharing best practices is more important than ever because supply chain challenges aren’t expected to diminish post-pandemic. That’s because superstorms, fires, droughts and other extreme events driven by climate change are already straining the industry’s supply chain — and it could get a lot worse.

(Go to DeviceTalks Boston’s site to register!) 

Over the two-day meeting we’ll hear how companies large and small are adapting to new demands, including:

How Viant and Vapotherm combined forces to meet unforeseen demands brought on by the COVID-19 pandemi…
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How medtech is tackling supply chain challenges

A host of medical device companies with manufacturing in Puerto Rico found their supply chains impacted by Hurricane Maria in 2017. It was a harbinger of what was to come. [Image is public domain]

Join us at DeviceTalks Boston on May 10-11 to hear how medical device companies are propping open supply lines and ensuring a steady flow of products to customers in a constantly changing world.

Sharing best practices is more important than ever because supply chain challenges aren’t expected to diminish post-pandemic. That’s because superstorms, fires, droughts and other extreme events driven by climate change are already straining the industry’s supply chain — and it could get a lot worse.

(Go to DeviceTalks Boston’s site to register!) 

Over the two-day meeting we’ll hear how companies large and small are adapting to new demands, including:

How Viant and Vapotherm combined forces to meet unforesee…
Read more
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FDA proposes new cybersecurity, supply chain and inspection laws for medical device manufacturers

Ventilators were in high demand during the first peaks of the COVID-19 pandemic. (Image from Raumedic)

The FDA today offered a slate of proposed laws for Congress to consider along with the agency’s $8.4 billion budget request for fiscal year 2023.

The legislative wish list includes several proposals that would affect medical device developers, manufacturers and distributors, including cybersecurity requirements for medical devices, mandatory supply chain reporting, remote inspections for FDA-regulated facilities and the destruction of dangerous imports.

Medical device cybersecurity

One proposal would require medical device manufacturers to design cybersecurity into their devices, such as the ability to update and patch software in a timely manner. Manufacturers would also need to provide cybersecurity assurance in premarket submissions, include a Software bill of Materials that tells patients …

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Pharma supply chain facing a perfect storm

Image courtesy of Felix Mittermeier on Pixabay

The tensions facing the global supply chain have been building in the pharmaceutical industry since even before the pandemic began, said Apurva Saraf, CEO of privately-held Cosette Pharmaceuticals (South Plainfield, New Jersey), in a recent interview.

About five years ago, China, a central producer of active pharmaceutical ingredients (APIs), began shutting down tens of thousands of factories as a result of environmental infractions.

After the SARS-CoV-2 virus emerged in Wuhan, additional factory closures constricted production further.

There was a “rolling effect” when the pandemic began in China and later spread to Italy and New York and New Jersey in the U.S. — all critical areas for the pharmaceutical industry, Saraf said.

Repeated stringent lockdown measures in countries such as China, Italy and India reduced the flow of dru…

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5 key steps for building a secure cold chain to maintain vaccine and therapeutic stability 

Cold chain image courtesy of Thermo Fisher Scientific

COVID-19 vaccine development and rollout were crucial to gaining control of the pandemic. When the success of these efforts became dependent on the ability to maintain lower than typical temperatures during distribution, the importance of reliable and continuous cold chain solutions for mRNA-based formulations was thrust into the spotlight. Beyond pandemic mitigation measures and outside of COVID-19 control, vaccines and therapeutics are increasingly leveraging the power of temperature-sensitive cells, proteins, and nucleic acids in preventing and treating disease. With the pharmaceutical industry shifting toward using biological molecules as medicine, there’s a need to emphasize cold chain logistics and access to innovative, reliable cryogenic solutions.

Pharmaceutical products containing biologically active components often require adherence to special …

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How the cloud tools behind Google Maps and Photos can advance medtech

Alissa Hsu Lynch is Google Cloud’s global lead for medtech strategy and solutions. [Photo courtesy of Google]

Alissa Hsu Lynch leads medtech strategy and solutions at Google Cloud, previously serving in executive roles at Johnson & Johnson and Bausch Health.

As part of Medical Design & Outsourcing‘s ongoing series of conversations about the cloud’s contributions to the medical device industry and its future, Lynch offered her perspective from the Alphabet (NASDAQ:GOOGL) subsidiary’s cloud-computing business. The following exchange has been edited for clarity and length.

MDO: What are some surprising and inspirational examples of what cloud computing enables with regard to medical device/drug development, manufacturing and capabilities/performance?

LYNCH: First is using data and artificial intelligence (AI) to quickly respond to emerging crises. COVID-19 accelerated …

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