Edwards Lifesciences Archives - Medical Design Sourcing

CAPA doesn’t have to be a four-letter word, Medtronic Quality/Regulatory Director Kathryn Merrill says

[Illustration by Vitalii Vodolazskyi via Adobe Stock]

Medtronic Quality/Regulatory Program Director Kathryn Merrill is a problem-solver’s problem solver.

Right now, the problem she wants to solve is the way device manufacturers approach corrective and preventative actions — CAPA, an abbreviation that can trigger an avalanche of documentation and headaches for medtech engineers.

For five years, Merrill’s been part of a Medical Device Innovation Consortium (MDIC) team developing a new approach to CAPA, stemming out of conversations across the medtech industry and beyond. The goal was to implement improvements in months instead of years and allow teams to be more proactive.

“I’ve been at Medtronic for 26 years and very often we’d say, ‘Hey, I think we’re making this more complicated than it needs to be,'” said Merrill, who is lead co-author of MDIC̵…

Edwards Lifesciences names Secant Group as its supplier of the year

NEWS RELEASE: Edwards Lifesciences Awards Secant Group 2022 Supplier of the Year

Secant Group, a leading innovator in the design, development, and manufacture of implantable medical textile components for medical devices, has been named 2022 Supplier of the Year by Edwards Lifesciences, the global leader in patient-focused medical innovations for structural heart disease and critical care and surgical monitoring.

“We’re thrilled to receive this prestigious award from Edwards Lifesciences. This is a testament to Secant’s rigorous quality standards and multidisciplinary teamwork that enables Edwards Lifesciences to advance their innovative, life-saving devices with our implantable textile solutions. We’re proud to be a long-serving partner of Edwards and look forward to collaborating with them on new solutions for years to come,” said Karen West, CEO, Solesis, parent company of Secant Group.

In 2022, Secant Group was also the first-ever supplier awarded Gold Stat…

The biggest medtech personnel moves in 2022

Some of the largest companies in medtech have promoted, replaced or removed leaders in recent months.

In July, Medical Design & Outsourcing compiled a list of the biggest personnel changes in the first half of 2022. Those included hirings, firings, promotions and retirements of CEOs, presidents and and other business leaders across the medtech industry.

The latter half of the year has brought even more changes. To close out 2022 and prepare for 2023, here are more of the year’s biggest medtech moves — and some updates since the news first broke.

Butterfly Network CEO steps down

Todd Fruchterman

On Dec. 6, Butterfly Network (NYSE:BFLY) announced that it reached a mutual agreement with Dr. Todd Fuchterman to step down as president and CEO. Fruchterman also left Butterfly’s board of directors.

Fruchterman oversaw Butterfly’s development of artificial intelligence-based ha…

Device developers get creative to connect with physicians

Dr. Farzad Azimpour is SVP of Advanced Technology at Edwards Lifesciences [Photo courtesy of Edwards Lifesciences]

Medical device developers have gotten creative in connecting with surgeons and interventionalists during the pandemic.

Leaders from Abbott, Boston Scientific and Edwards Lifesciences shared some of their experiences, challenges and opportunities with attendees of DeviceTalks West in October.

The chief challenge is the number of physicians, nurses and other medical professionals who have left the field during the pandemic.

“The elephant in the room is that everybody is worried about how we’re going to get things to patients,” said Farzad Azimpour, SVP of Advanced Technology at Edwards Lifesciences. “How do we equip the limited capacity that we have right now — from nursing, physicians, everyone — to enable what we have to actually reach patients in a timely and appropriate manner…

Medtech relief efforts begin after Hurricane Fiona hits Puerto Rico

Hurricane Fiona is still dropping rain on Puerto Rico as it moves toward the Dominican Republic, as seen in this Sept. 19, 2022 satellite imagery. [Image courtesy of the National Oceanic and Atmospheric Administration]

Power crews are restoring electricity in Puerto Rico after Hurricane Fiona struck with heavy rains and winds five years after Hurricane Maria made landfall.

Many large medtech companies have manufacturing operations in the U.S. island territory.

Medtronic (NYSE: MDT) has not received any reports of significant damage to its five facilities in Puerto Rico and planned to restart operations today if employees are safe and can report to work, the company told Medical Design & Outsourcing. The company also has a manufacturing facility in the Dominican Republic.

“Given the path of Hurricane Fiona, our teams have been monitoring and are continuing to monitor both Puerto Rico and …

Join us at DeviceTalks West, the World’s Fair of Medtech

Intuitive Surgical CEO Gary Guthart will participate in a keynote interview at DeviceTalks West 2022. [Photo courtesy of Intuitive Surgical]

October’s DeviceTalks West conference is focused on the future.

The best-seller “Devil in the White City” may have darkened the perception of world’s fairs, but these international convocations have long presented visitors with an optimistic and hopeful view of the future, thanks in no small part to new technology. (The next one is scheduled for 2025 in Osaka, Japan, by the way.)

I like to think we’ll be following similar guidelines at the upcoming DeviceTalks West conference, which will be held on Oct. 19-20 at the Santa Clara Convention Center.

This event will bring together executives from Abbott, Boston Scientific, Edwards Lifesciences, Intuitive, Johnson & Johnson, Medtronic, Outset Medical, Penumbra, Shockwave, Zimmer Biomet and many …

The 24 best medical device innovations of 2022

The Galien Foundation recently announced its nominees of medical device innovations for its 2022 Prix Galien USA awards.

There are 24 medical technologies nominated for the annual award this year, up from 18 nominees in 2021.

The Galien Foundation’s annual Prix Galien awards highlight devices, biotechnology and pharmaceutical products designed to improve the human condition.

Nominees need to be FDA-approved for the market within the last five years and show major potential to affect healthcare. The winners will be announced in October at the Prix Galien USA Awards in New York City.

This year, the foundation nominated 24 medical device innovations, 22 biotechnology products and 33 pharmaceutical agents. The devices range from an intraocular lens to a bariatric stapler.

“Every year, evaluating and recognizing the amazing submissions that come through for the Prix Galien Awards is one of the greatest honors,” said Dr. Sue Des…

EPA flags high-cancer-risk EtO sterilization facilities across the country

This map of Richmond, Virginia, shows the EPA’s estimated cancer risk for the area surrounding Sterilization Services of Virginia’s EtO plant. [Image courtesy of the EPA]

The EPA today identified nearly two dozen U.S. cities where commercial sterilizers using ethylene oxide (EtO) contribute to an elevated cancer risk for residents of surrounding communities.

EtO is used on about 20 billion medical devices each year — or about half of all sterile medical devices — and in some cases it’s the only option. The FDA is seeking safer ways to use EtO and alternative means of sterilization in an effort to reduce EtO emissions due to its cancer risk, particularly blood cancers and breast cancer.

“Exposure over the course of a lifetime (24 hours a day for 70 years) to EtO at concentrations expected to be found near some commercial sterilizers can increase a person’s risk of developing cance…

These 10 medtech companies’ stocks performed best in 2021

(From Ishant Mishra on Unsplash)

Following a year like no other in 2020, 2021 was when many looked to rebound — including the medtech industry.

A number of medtech companies followed up a challenging, pandemic-enveloped year with impressive performances. Plenty of them had already proven in 2020 that they were capable of a quick bounce-back.

Here are 10 medtech companies that saw their stocks soar even higher in 2021:

(This list includes members of the MassDevice MedTech 100 Index of the world’s largest medical device companies. Performance is measured in stock price change from Dec. 31, 2020, to Dec. 31, 2021.)

Get the full story at our sister site, MassDevice.

Edwards Lifesciences misses on Q4 earnings as omicron hammers hospitals

Edwards Lifesciences (NYSE:EW) posted fourth-quarter earnings at the end of trading today that fell short of the consensus forecast on Wall Street, but reaffirmed its outlook for 2022.

The Irvine, California-based heart device company reported profits of $335.3 million — or $0.53 per diluted share — on sales of $1.33 billion for the three months ended Dec. 31, 2021, for a bottom-line gain of 8% and sales growth of 12% compared with Q4 2020.

Transcatheter aortic valve replacement (TAVR) sales grew to $872 million for the quarter, up 12 percent despite the “pronounced impact on hospital resources in December” from the omicron variant of COVID-19, said CEO Mike Mussallem, who cited the delta variant wave in the company’s third-quarter results.

TAVR sales outside the U.S. grew about 20 percent on an underlying basis in Q4, and Edwards Lifesciences said it continues to project that the global TAVR opportunity will double to $10 billion by 20…

Edwards Lifesciences stock slides on Q3 financial results

Edwards Lifesciences (NYSE: EW) reported third-quarter financial results today that exceeded Wall Street’s expectations on profits but narrowly missed on sales.

The Irvine, California–based cardio device company reported earnings of $340.1 million (or 54¢ per share) off sales of $1.31 billion. That’s a 4.6% increase from Q3 2020’s earnings of $325.2 million (52¢ per share) off sales of $1.14 billion.

Edwards reported TAVR sales of $858 million, which were up 15% from the same three months a year ago. Edwards said transcatheter aortic valve replacement (TAVR) sales would have been higher if not for continued pressure on hospitals from COVID-19. The company said TAVR sales outside of the U.S. grew approximately 20% on a year-over-year basis.

Get the full story at our sister site, MassDevice.

September 2021 Issue: Our latest Medical Device Handbook is out!

Making medical devices: Everything you need to know

The innovation-fueled evolution of drug eluting stents

Dexcom CEO Kevin Sayer says G7 will be ‘wonderful’

Getting the inside scoop behind top medtech innovations

Autumn is upon us, and it is once again time to sip a pumpkin spice latte — or a pumpkin beer — and crack open our latest Medical Device Handbook.

Once again, we’ve reached out to experts across the industry to curate dozens of “what is” and “how to” types of articles that cover a breadth of categories: components, drug delivery, manufacturing and machining, materials, product design and development, regulatory, software, sterilization services and tubing.

As the years go by, I’m proud that we’re including more insights from the major medical device companies in each succeeding issue. This time around, we spoke to experts involved in some of the major industry innovations of the past decade:

Now VP of R&D …