AdvaMed Archives - Page 6 of 7 - Medical Design Sourcing

DTW Podcast: CEO Petrovic explains how Insulet is switching people to `Pods

Insulet CEO Shacey Petrovic says she didn’t jump immediately at the chance to join the company.

In an interview with the DeviceTalks Weekly Podcast, Petrovic, who was serving as CEO of a women’s health company when CEO-Patrick Sullivan, her former boss at Cytyc, called her with an offer to serve as Insulet’s chief commercial officer

“I said, `Well, Pat, I’m a CEO now, you know, didn’t you hear?,” she joked.

A chief commercial officer role might be seen as a backward step from CEO, but Sullivan framed the question differently. He told Petrovic that he came out of retirement to take the CEO role and didn’t want to a long stint as CEO. “He said, `This could be your opportunity to eventually run a public company. If it goes well, I need a successor, the technology is remarkable, and together we can fix this problem.’”

A path the CEO role at a publicly traded company was certainly appealing. But Petrovic had more personal reason for the jo…

AdvaMed brass on Biden administration: So far, so good

In office barely two months, the Biden administration is winning high praise from leaders of the medtech trade group AdvaMed.

That applies to the new administration’s use of the Defense Production Act for COVID supplies to its deliberation in choosing someone to lead the FDA. It doesn’t hurt that the $1.9 trillion pandemic relief bill that President Biden signed into law today includes $500 million in general-purpose funding for the FDA. How much of that might be directed to the Center for Devices and Radiological Health, which regulates medical devices, remains to be seen.

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

N.J. appeals court tosses $83M pelvic mesh verdicts against J&J, Bard

A New Jersey appeals court yesterday threw out jury verdicts totaling $83 million in separate pelvic mesh lawsuits against Johnson & Johnson’s (NYSE:JNJ) Ethicon division and Becton Dickinson (NYSE:BDX) subsidiary C.R. Bard.

In both cases, Bergen County, N.J. judges erred by disallowing evidence showing that each company’s mesh product had received FDA 510 (k) clearance, according to the appeals court panel.

In the case against J&J’s Ethicon, a jury had awarded Elizabeth and Tadeusz Hrymoc $5 million in compensatory damages and $10 million in punitive damages after finding the companies liable for violating New Jersey laws on defective design of their ProLift pelvic mesh and failing to warn patients of product risk.

The jury in the case brought by Mary McGinnis and Thomas Walsh McGinnis found Bard liable for design and failure-to-warn defects under the product liability laws of North Carolina, the plaintiffs’ home state, …

Abiomed CEO Michael Minogue appointed as AdvaMed chairperson

Medtech trade group AdvaMed today said it has appointed Abiomed (NSDQ:ABMD) president and CEO Michael Minogue as chairperson of the AdvaMed board of directors, effective immediately.

Minogue will serve as chairperson of the trade association’s board of directors for two years. He has been a member of the board since 2007 and a member of the board executive committee since 2009.

Throughout his tenure at AdvaMed, Minogue has served on several committees, including those overseeing membership, inclusion and diversity, payment policy, ethics and international policy. He was elected as the first chairperson of the newly created emerging growth company council (now AdvaMed Accel) in 2011 and served as the chairperson until 2014. He also co-founded MedTechVets.org, which is served as chairperson until 2019.

Get the full story on our sister site, MassDevice.

Abiomed CEO Michael Minogue appointed as AdvaMed chairperson

Medtech trade group AdvaMed today said it has appointed Abiomed (NSDQ:ABMD) president and CEO Michael Minogue as chairperson of the AdvaMed board of directors, effective immediately.

Minogue will serve as chairperson of the trade association’s board of directors for two years. He has been a member of the board since 2007 and a member of the board executive committee since 2009.

Throughout his tenure at AdvaMed, Minogue has served on several committees, including those overseeing membership, inclusion and diversity, payment policy, ethics and international policy. He was elected as the first chairperson of the newly created emerging growth company council (now AdvaMed Accel) in 2011 and served as the chairperson until 2014. He also co-founded MedTechVets.org, which is served as chairperson until 2019.

Minogue has also been president and CEO of Abiomed for 17 years. Prior to joining the company, he held numerous leadership roles at General Electric M…

Feds to spend $1.6B to expand COVID testing, domestic manufacturing

(Image from the CDC)

The Biden administration announced plans today to expand COVID-19 testing across the country, boost domestic manufacturing of tests and testing supplies and increase virus genome sequencing to detect virus variants.

The departments of Health and Human Services and Defense will jointly invest $650 million to expand testing for K-8 schools and underserved congregate settings, such as homeless shelters, directly through new regional coordination “hubs.” The move will also include working with laboratories, including at universities, to collect specimens, perform the tests and report results to the relevant public health agencies for up to 25 million additional tests per month.

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

AdvaMed wants input on Biden pandemic DPA use

AdvaMed reacted to President Joe Biden’s plan to use the Defense Production Act (DPA) to tackle the pandemic with some cautionary words.

In a letter responding to Biden’s 200-page COVID-19 plan, the medtech trade group asked for collaboration and urged the president to consider the industry’s experience with DPA orders issued by former President Trump.

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

Biden’s COVID-19 response will make manufacturers busy

(Image courtesy of Biden for President)

Manufacturers of vaccine supplies and personal protective equipment can expect more work as the new Biden administration rolls out its plans to combat the COVID-19 pandemic.

In one of his first official acts as president, Joe Biden announced a plan to “fully use” the Defense Production Act to ramp up production of testing supplies, masks, face shields and other PPE, with an eye toward boosting American manufacturing to reduce reliance on other countries. The president also announced his intention to invest $25 billion in a vaccine manufacturing and distribution plan that will provide vaccines to all Americans, free of charge.

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

Biden’s COVID-19 response will make manufacturers busy

[Image courtesy of Biden for President]Manufacturers of vaccine supplies and personal protective equipment can expect more work as the new Biden administration rolls out its plans to combat the COVID-19 pandemic.

In one of his first official acts as president, Joe Biden announced a plan to “fully use” the Defense Production Act to ramp up production of testing supplies, masks, face shields and other PPE, with an eye toward boosting American manufacturing to reduce reliance on other countries. The president also announced his intention to invest $25 billion in a vaccine manufacturing and distribution plan that will provide vaccines to all Americans, free of charge.

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

Medicare to cover breakthrough devices

FDA-designated breakthrough devices will have Medicare coverage the same day they are approved, under a final rule issued this week by the Centers for Medicare and Medicaid Services (CMS).

The Medicare Coverage of Innovative Technology (MCIT) rule will provide national Medicare coverage as early as the same day as FDA market authorization for breakthrough devices and certain diagnostic tests. The coverage would last for four years, during which CMS would specify what additional data, if any, would be needed to maintain coverage after the four-year coverage period expires.

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

Medtech takes a stand on D.C. rioting

The medtech industry has joined other business and industry groups in condemning Tuesday’s siege of the Capitol in Washington, D.C. by supporters of President Donald Trump.

The National Manufacturers Association called for Vice President Mike Pence to invoke the 25th Amendment to remove President Donald Trump from office. The Business Roundtable tweeted a call for an end to the violence and for a peaceful transition of power to President-elect Joe Biden’s administration.

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

CMS agrees to cover ‘breakthrough’ medical devices

Medicare patients will have coverage for medical devices the FDA designates as breakthrough technology under a proposed rule released this morning.

Once the Medicare Coverage of Innovative Technology (MCIT) final rule goes into effect, national Medicare coverage will begin on the date of a breakthrough device’s FDA market authorization would begin and continue for 4 years.

The proposed rule, scheduled to be published September 1 in the Federal Register, has been under discussion for years and would remedy a nationwide patchwork of Medicare coverage for such devices. Currently, a breakthrough device may be covered in one state or area of a state and not another, depending upon a local coverage determination made by a Medicare administrative contractor.

The MCIT pathway would be voluntary and device manufacturers would notify the Centers for Medicare and Medicaid Services if they want to use this coverage option.

“This coverage pathway d…