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Advice for building a medtech career inside a big company from BD CTO Elizabeth McCombs

BD EVP and Chief Technology Officer Elizabeth McCombs [Photo courtesy of BD]In the opening keynote for DeviceTalks Boston 2024 today, BD (NYSE:BDX) + EVP and Chief Technology Officer Elizabeth McCombs offered advice for building a medtech career inside a big company.

Reflecting on her 20-year career at Johnson & Johnson MedTech (the world’s second-largest medical device manufacturer) before joining BD, McCombs advised aspiring medtech leaders to strive to deeply understand customers and the clinical state “almost as well as the customer.”

“It’s easy in a big company to get internally focused and get caught up in the technology,” she said in a live interview with DeviceTalks Editorial Director Tom Salemi. “But when we take the time to define an important need and then solve it, that’s where the success comes.”

“We can get ahead of ourselves with our car…

BD warns on some neXus V700 infusion pumps outside the U.S.

BD (NYSE: BDX) + issued an urgent field safety notice in the UK to warn of potential issues with its Alaris neXus V700 infusion pump system.

According to the notice, BD identified that the anti-free flow clamp may not activate when the system door opens. This allows for the potential uncontrolled flow of medication. The issue does not affect to Alaris systems in the U.S.

Free flow as a result of this issue may result in over-infusion. Damage to the pump-based free flow mechanism may not be apparent to the user. Depending on the medication in progress at the time of the free flow, BD says it’s reasonable to expect that an imminently life-threatening situation may arise as a result of the issue.

To date, the company reports one adverse event related to the issue with its neXus V700 infusion pump.

BD reported the issue and advises that clinicians remove the infusion pumps from clinical use with immedia…

BD ups domestic syringe production in wake of FDA warnings on syringes made in China

BD (NYSE:BDX) announced today that it is increasing its U.S. syringe production after the FDA issued warnings related to syringes manufactured in China.

In November, the FDA warned of the potential for device failures with plastic syringes manufactured in China. Failures could include leaks, breakage and other problems. The agency said it received information about quality issues associated with several Chinese syringe manufacturers.

Earlier this week, the agency issued warning letters to three companies, including U.S.-based Medline. The letters describe violations related to the sale and distribution of unauthorized plastic syringes made in China that have not been cleared or approved by the FDA for sale or distribution in the U.S.

In response to the latest developments, President of BD Medication Delivery Solutions, Eric Borin, issued a statement today.

Get the full story at our sister site, Drug Delivery Business News.

Zeus hires new CEO from Becton Dickinson

Paddy O’Brien will become CEO of Zeus on April 1, 2024. [Photo courtesy of Zeus]

Zeus has hired Padraic “Paddy” O’Brien as CEO from Becton, Dickinson and Co. effective April 1, the medical tubing supplier said today.

O’Brien is worldwide president of BD Peripheral Intervention, where he “developed an extensive and consistent track record of delivering durable, sustainable growth while creating a winning culture,” Zeus said in a news release.

O’Brien held management positions at Bard from 2001, rising to the position of global marketing VP by the time of the company’s December 2017 acquisition by BD.

He’ll replace Steve Peterson, who joined Zeus as SVP of global sales and marketing in 2017 and was promoted to president in 2018 and CEO in 2020.

Zeus recently closed its sale to private equity firm EQT, which said it hired O’Brien after an extensi…

BD names new president of BD Surgery

President of BD Surgery Rian Seger [Image courtesy of BD]BD this week announced it appointed Rian Seger as president of BD Surgery, effective April 1.

Seger will be responsible for driving the global strategic, operational and commercial performance of BD Surgery and will report to EVP and President of Interventional Rick Byrd. He replaces Brooke Story who is stepping down to focus on personal matters.

Before becoming president of BD Surgery, Seger was VP and general manager of BD’s Medication Delivery Solutions business unit within the BD Medical segment.

“Rian has more than 20 years of executive experience with proven leadership capabilities that help address unmet needs in health care,” Byrd said in a news release. “Re-joining BD Surgery strongly aligns with Rian’s passion for driving better outcomes for surgeons and patients. With his wealth of experience and a proven track record of delivering results and developing teams, he will be well-suited …

BD initiates IDE trial of stent for treating peripheral arterial disease

The Vascular Covered Stent under evaluation in the AGILITY trial. [Image courtesy of BD]BD (NYSE: BDX) + announced today that it enrolled the first patient in a trial of its Vascular Covered Stent for treating peripheral arterial disease (PAD).

Franklin Lakes, New Jersey-based BD is evaluating the safety and effectiveness of the stent in its AGILITY FDA investigational device exemption (IDE) trial. The self-expanding, low-profile, polytetrafluoroethylene encapsulated nitinol implant is deployed through a delivery system. This system provides controlled stent release, according to a news release.

BD plans for the trial to include 315 patients across up to 40 clinical study sites in the U.S., Europe, Australia and New Zealand. It expects follow-up for all treated patients at various points, starting at one month and ending at 36 months.

Dr. Nicolas Shammas enrolled the first patient in the study at Trinity Medical Ce…

A high-ranking BD executive is set to retire

Dave Hickey. [Image from BD]BD (NYSE: BDX) + announced today that its EVP and President of Life Sciences, Dave Hickey, intends to retire this year.

Hickey plans for his retirement to go into effect on July 1, 2024. He originally joined BD in 2014, serving as president of Diagnostic Systems. He took over as president of Integrated Diagnostic Solutions in 2019 and began leading the Life Sciences segment in January 2021.

Prior to joining BD, Hickey held a range of executive leadership positions at Siemens Healthcare.

Read: Dave Hickey explains BD’s diagnostics business strategy.

“For over a decade at BD, Dave has demonstrated a strong, strategic and innovative approach, empowering his teams to deliver impactful results through a growth mindset and developing incredible talent and next-gen leaders at BD,” said Tom Polen, chair, CEO and president. “We wish him a…

BD ups guidance but stock dips on mixed Q1 results

BD (NYSE: BDX) + shares fell this morning on first-quarter results that came in mixed compared to the consensus forecast.

Shares of BD dipped 1.2% at $235.92 apiece in early-morning trading today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — rose slightly.

The Franklin Lakes, New Jersey-based medtech giant posted profits of $281 million. That equals 96¢ per share from sales of $4.7 billion for the three months ended Dec. 31, 2023.

BD recorded a 42.2% bottom-line slide on sales growth of 2.6%.

Adjusted to exclude one-time items, earnings per share totaled $2.68. That landed 28¢ ahead of projections Wall Street, where analysts expected $4.73 billion in revenue.

Two of BD’s three segments saw revenue growth. Medical sales ticked up 3.5%, while Interventional revenues grew by 5.2%. Medication delivery, infusion and pharmaceut…

BD, Techcyte collab on AI-based cervical cytology

The digital cervical cytology system used in the partnership. [Image courtesy of BD]BD (NYSE: BDX) + announced today that it partnered with Techcyte on AI-based guidance for cytologists and pathologists.

The strategic collaboration aims to offer an AI algorithm to guide cytologists and pathologists to efficiently and effectively identify evidence of cervical cancer and precancer using whole-slide imaging.

Franklin Lakes, New Jersey-based BD said in a news release that the agreement allows it to deliver a complete solution to reduce the potential for human error and enable greater throughput. This helps labs achieve results with greater standardization, reproducibility and efficiency from a Pap test.

Traditional Pap tests take a sample from a patient and place it on a glass slide evaluated using a microscope. A digital cervical cytology system enables the scanning of the samples. Then comes a review on a computer mo…

BD lays off 111 at biotech reagent plant in California

BD recently informed California’s Employment Development Department that it will relocate its Biosciences division’s reagent manufacturing and R&D operations in San Jose.

The Life Sciences tech giant is laying off 111 workers due to the relocation to other BD sites, according to its WARN letter dated Dec. 12, 2023. The layoffs have been taking place in waves: March 2023, December 2023 and September 2024. All affected employees have received at least 60 days written notice, opportunities to positions elsewhere in BD, and outplacement assistance. Those in full-time roles are receiving severance.

Remaining operations at Qume Drive in San Jose will move to nearby Montecito and Milpitas, with the entire San Jose facility closed by the end of September 2024.

The BD layoffs in San Jose come at the same time that the biotech sector continues to shed jobs. Factors behind the downsizing include not just economic uncertainty but also regulatory shif…

The most important medtech leadership changes of 2023

Former Johnson & Johnson EVP and MedTech Worldwide Chair Ashley McEvoy [Photo courtesy of Johnson & Johnson]

From hirings and firings to promotions, resignations and surprising shake-ups, these were the most important medtech leadership changes of the year.

By Associate Editor Sean Whooley and Managing Editor Jim Hammerand

The leadership change at Johnson & Johnson MedTech was a surprising shift that ended up as the year’s biggest medtech leadership change of 2023.

In October, J&J EVP and J&J MedTech Worldwide Chair Ashley McEvoy announced her resignation from the world’s second-largest device manufacturer. She’s staying on into the first quarter of 2024 while her successor, Tim Schmid, gets settled into his new role.

Schmid, a 30-year J&J vet who was most recently company group chair of J&J MedTech Asia Pacific, said he’s “committed to building ev…

BD inks $85M settlement over Alaris defect disclosure claims

The Alaris infusion system. [Image courtesy of BD]BD (NYSE: BDX) + announced that it filed settlement documents for an $85 million agreement to resolve claims regarding its Alaris infusion pump technology.

The Alaris system has been much maligned over the past few years. Its troubles date back to a Class I recall in early 2020. The recall, which centered around multiple system errors, software errors, and use-related errors, led to a long-term shipping hold on the pumps.

BD’s recall centered around multiple system errors, software errors, and use-related errors.

Get the full story at our sister site, Drug Delivery Business News.