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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.

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.”

Medical device manufacturers buy about 1 percent of the world’s semiconductors, the trade group has said. That small share is difficult for the industry to leverage wit…

FDA releases MDUFA V details after industry negotiations

The FDA today released details of its agreement with the medtech industry for reauthorization of the Medical Device User Fee Amendments (MDUFA).

If passed by Congress and signed into law, it would be the fifth version of the Medical Device User Fee and Modernization Act of 2002. AdvaMed lauded the framework earlier this month after regulators and industry representatives negotiated updates to the program, which collects fees from applicants to fund FDA review.

The FDA’s Center for Devices and Radiological Health and Center for Biologics Evaluation and Research will work with companies submitting products for faster, more efficient reviews and decisions without sacrificing product safety or effectiveness, the FDA said in the 38-page MUFDA V commitment letter. For example, the agreement sets the goal of making 510(k) clearance decisions within 128 calendar days for applications received in fiscal year 2023 and reducing that time to 112 days within two years.

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FDA releases MDUFA V details after industry negotiations

The FDA today released details of its agreement with the medtech industry for reauthorization of the Medical Device User Fee Amendments (MDUFA).

If passed by Congress and signed into law, it would be the fifth version of the Medical Device User Fee and Modernization Act of 2002. AdvaMed lauded the framework earlier this month after regulators and industry representatives negotiated updates to the program, which collects fees from applicants to fund FDA review.

The FDA’s Center for Devices and Radiological Health and Center for Biologics Evaluation and Research will work with companies submitting products for faster, more efficient reviews and decisions without sacrificing product safety or effectiveness, the FDA said in the 38-page MUFDA V commitment letter. For example, the agreement sets the goal of making 510(k) clearance decisions within 128 calendar days for applications received in fiscal year 2023 and reducing that time to 112 days within two years…

Integer’s longtime board chair set for departure; replacement named

Bill Sanford will retire as chair of the Integer Holdings (NYSE: ITGR) board of directors at the end of the company’s annual shareholder meeting on May 18, the company said today.

The Plano, Texas-based medical device outsource manufacturer said its board plans to appoint former AdvaMed CEO Pam Bailey as the next chair. Bailey has served on Integer’s board since 2002 and “has been an integral part of developing the strategic direction of Integer,” Integer President and CEO Joe Dziedzic said.

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

Integer’s longtime board chair set for departure; replacement named

Bill Sanford will retire as chair of the Integer Holdings (NYSE: ITGR) board of directors at the end of the company’s annual shareholder meeting on May 18, the company said today.

The Plano, Texas-based medical device outsource manufacturer said its board plans to appoint former AdvaMed CEO Pam Bailey as the next chair. Bailey has served on Integer’s board since 2002 and “has been an integral part of developing the strategic direction of Integer,” Integer President and CEO Joe Dziedzic said in a news release.

“On behalf of the Integer Board of Directors, I wish to thank Bill for his immense contribution and insightful leadership over the past 22 years serving on the Integer board, including his 14 years as board chair,” Dziedzic said. “Bill has positioned the company to continue executing our strategy to deliver sustained outperformance and laid the groundwork for a smooth board chair transition.” Read more

How medtech and pharma are responding to Russia’s invasion of Ukraine

[Image from Pixabay]

Medtech and pharma companies continue to support Ukraine relief efforts following Russia’s invasion.

Previously, the World Health Organization announced that it was sending “essential medical supplies” to Ukraine — including its first shipment of 36 metric tons of supplies for trauma care and emergency surgery and other health supplies — to meet the needs of more than 150,000 patients. Medical device and pharmaceutical companies have taken various actions for support efforts, ranging from matching employee contributions and sending supplies to suspending operations in the region.

Get the full running list of life science companies and their efforts on Medical Design & Outsourcing.

FDA, medtech industry groups reach MDUFA V deal

According to reports, the FDA and medtech industry groups came to an agreement on a medical device user fee deal.

Regulatory Affairs Professionals Society (RAPS) reported that, while details are still being negotiated, the FDA reached an agreement on principle on a framework for the Medical Device User Fee Amendment (MDUFA V) on Monday (March 7) and will make the deal public once all details are ironed out.

An FDA spokesperson told RAPS that daily meetings are ongoing to negotiate details of the commitment letter before the draft agreement is published for public comment in “the near future.” After that, there will be a public meeting and the delivery of final recommendations to Congress, the spokesperson said.

RAPS reported that, if enacted, the agreement would double current user fee spending. Even with the doubled fee, the report stated that industry groups “are optimistic the deal will help their companies bring new products to mark…

How medtech and pharma are responding to Russia’s invasion of Ukraine

[Image from Pixabay]Medtech and pharma companies continue to support Ukraine relief efforts following Russia’s invasion.

Previously, the World Health Organization announced that it was sending “essential medical supplies” to Ukraine — including its first shipment of 36 metric tons of supplies for trauma care and emergency surgery and other health supplies — to meet the needs of more than 150,000 patients. Medical device and pharmaceutical companies have taken various actions for support efforts, ranging from matching employee contributions and sending supplies to suspending operations in the region.

Get the full running list of life science companies and their efforts on Medical Design & Outsourcing.

How medtech and pharma are responding to Russia’s invasion of Ukraine

[Image from Pixabay]

Medtech and pharma companies continue to support Ukraine relief efforts following Russia’s invasion.

Previously, the World Health Organization announced that it was sending “essential medical supplies” to Ukraine — including its first shipment of 36 metric tons of supplies for trauma care and emergency surgery and other health supplies — to meet the needs of more than 150,000 patients. Medical device and pharmaceutical companies have taken various actions for support efforts, ranging from matching employee contributions and sending supplies to suspending operations in the region.

Below is a running list of life science companies and their efforts. This is a developing story and will be updated as companies release information.

3M: Suspending all business in Russia.

Abbott: Donating $2 million to humanitarian organizations to support Ukraine and refugees; donating …

Medtech companies extend support to Ukraine humanitarian efforts

Photo by Yehor Milohrodskyi on Unsplash

Medical device companies are continuing to make contributions to support the humanitarian emergency in Ukraine following Russia’s invasion of the country last month.

Last week, Henry Schein, Siemens Healthineers, Conformis, Roche, Medicom and Philips announced initiatives to support the crisis, which included matching employee donations, sending supplies or donating money to support families in Ukraine. The World Health Organization also announced that it was sending “essential medical supplies” to Ukraine — including its first shipment of 36 metric tons of supplies for trauma care and emergency surgery and other health supplies — to meet the needs of more than 150,000 patients.

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

Medtech companies extend support to Ukraine humanitarian efforts

Photo by Yehor Milohrodskyi on Unsplash

Medical device companies are continuing to make contributions to support the humanitarian emergency in Ukraine following Russia’s invasion of the country in late February.

Last week, Henry Schein, Siemens Healthineers, Conformis, Roche, Medicom and Philips announced initiatives to support the crisis, which included matching employee donations, sending supplies or donating money to support families in Ukraine. The World Health Organization also announced that it was sending “essential medical supplies” to Ukraine — including its first shipment of 36 metric tons of supplies for trauma care and emergency surgery and other health supplies — to meet the needs of more than 150,000 patients.

Johnson & Johnson (NYSE: JNJ) is one of the latest companies to announce its support of Ukraine. The New Brunswick, N.J.-based company said it is donated $5 million to s…