FDA releases BD lock flush syringe facility warning letter

The FDA this week released a warning letter it sent to Becton Dickinson (NYSE: BDX) last month over issues it found at the company’s Franklin, Wisc.-based facilities, which produces pre-filled Heparin and 0.9% sodium chloride lock flush syringes.

The warning letter came from an inspection of the facilities which took place between May 16, 2018 and August 1, 2018, and includes a response from BD that the federal watchdog received on August 21 this year.

Read the whole story on our sister site, Drug Delivery Business News

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Hologic CFO McMahon jumps ship to Agilent | Personnel Moves – August 1, 2018

Hologic (NSDQ:HOLX) said yesterday that its CFO Bob McMahon is leaving to take up a CFO role at Agilent Technologies.

The Marlborough, Mass.-based company said that its current chief accounting officer Karleen Oberton has been lifted to CFO, effective today.

“Bob has made tremendous contributions to Hologic over the last four years, and we wish him all the best in his new role. At the same time, we are excited to promote Karleen to CFO.  She has a deep knowledge of our business and people based on more than 12 years of experience at the company, and has been a great partner to our divisions.  She has been instrumental in our efforts both to drive profitable growth, and to strengthen our balance sheet and cash flows,” chair, prez & CEO Steve MacMillan said in a press release.

Prior to joining Hologic in 2006, Oberton served as senior corporate controller from 2004 to 2006, and acted as Ernst & Young life sceince practice senior audit manager before that.

 BD taps Campion as interventional prez, EVP

Becton Dickinson & Co. (NYSE:BDX) said today it named Simon Campion as its new interventional segment president and exec VP, effective September 4.

Campion came to BD after it acquired C.R. Bard, and has served as the surgery biz worldwide president, the company said. Prior to the acquisition, he led Bard’s surgery business for five years, having joined the company in 2008.

“Simon is a proven leader with deep global experience, a demonstrated focus on results and unique insight and breadth across the BD interventional segment. He is well prepared to drive innovation and cultural initiatives across the peripheral intervention, urology and critical care, and surgery businesses, while continuing to deliver growth as we integrate these businesses into BD,” prez Tom Polen said in a press release.

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 Repro Med lifts Goldberger to board chair, interim prez & CEO

Repro Med Systems (OTC:REPR) said last week it lifted board member Daniel Goldberger to the position of chair and interim prez and CEO

Goldberger joined the board in April, and has previously held positions with companies including Xtant Medical Holdings, Sound Surgical Tech, Xcorporeal and Glucon.

“I look forward to building on the foundation that Andy has laid over thirty years and we appreciate his service. The invention of the Freedom60 has improved the lives of thousands of chronically-ill patients around the globe, and RMS’ portfolio of products has enormous application potential. Andy’s long list of accomplishments has positioned RMS well for strong long-term growth of revenue and shareholder value,” Goldberger said in a press release.

“The prospects for the company are very bright, and we are excited to engage new leadership to embark on our next phase of significant growth,” board member Joseph Manko said in a prepared statement.

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 Philips Canada head Burns to step down, Barnes to step up

Royal Philips (NYSE:PHG) said last week that Jeffrey Barnes is succeeding Iain Burns as Philips Canada prez & CEO, effective immediately.

Barnes serves as a member of Philips NA exec team and is replacing Burns, who retired on July 31. Barnes had previously served as NA commercial leader senior VP.

“Jeff is a proven leader with nearly three decades of experience in working with high-performance, cross-functional teams, and he has worked closely with our North American partners to understand the solutions they need to stay ahead of a rapidly changing industry, helping them to deliver better healthcare for their communities. I am confident that Jeff will build on the exceptional contributions made by Iain Burns to Philips – in Canada, North America and around the globe.  I want to commend Iain for his accomplishments, thank him for his continued commitment to the Canadian business and wish him all the best as he begins to plan for retirement,” Philips NA CEO Vitor Rocha said in a press release.

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 Lineus Medical COO Clement moves to CEO spot

Medtech startup Lineus Medical has appointed former COO Vance Clement as its new chief exec as the comapny looks to move out of the R&D phase and into the product launch phase, according to a recent TalkBusiness report.

Former CEO and founder Spencer Jones, who invented the company’s SafeBreak Vascular product will move to a chief technical officer role, according to the report.

“The board made the move so that Spencer could continue to focus on his strengths such as product development, clinical issues and intellectual property. We moved people to their area of strength to match the company’s current focus,” Clement said, according to TalkBusiness.

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BD lifts Bard vet DeFord to CTO | Personnel Moves – June 4, 2018

Becton Dickinson (NYSE:BDX) said last Friday it is lifting former C.R. Bard science, technology and clinical affairs senior VP John DeFord to the role of chief technology officer and exec VP.

Since acquiring Bard in a $24 billion deal that closed last December, DeFord has served as BD interventional segment R&D SVP, the Franklin Lakes, N.J.-based company said.

DeFord originally joined Bard as science & tech VP in 2004, and had previously served life sciences managing director for venture capital fund Early Stage Partners and as prez & CEO of Cook Inc, which is now known as Cook Medical. He also currently serves on NuVasive‘s (NSDQ:NUVA) board of directors, BD said.

“John is a recognized leader with more than 25 years of experience in the medical device industry, with expertise overseeing innovative R&D and technology-based initiatives that have made significant effects on saving and improving lives for patients around the world. He will drive organizational culture, capabilities, products and technology-enabled services to further strengthen the BD innovation funnel, while advancing the world of health through new innovations and solutions for our customers and patients,” prez Tom Polen said in a press release.

 Teleflex global ops SVP Kennedy to retire next year

Teleflex (NYSE:TFX) said last week that its global ops senior VP Thomas Kennedy will retire from the company at the end of next March.

Kennedy will remain in his present position until a replacement is appointed, the Wayne, Penn.-based company said. After a replacement has been named, Kennedy will stay on to aid in the transition.

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 Merit Medical CFO Birkett resigns

Merit Medical (NSDQ:MMSI) said late last month that its chief financial officer and treasurer Bernard Birkett has resigned from the company.

The South Jordan, Utah-based company said that it appointed current accounting VP & corporate controller Raul Parra Jr. as its interim CFO. Parra previously held the position of financial reporting director from December 2009 to July 2012.

Before joining Merit, Parra held the position of auditor with Deloitte & Touche from 2003 to 2009.

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 Integer CFO Haire steps away

Integer Holdings (NYSE:ITGR) said late last month that its exec VP and CFO Gary Haire has separated from the company, effective May 23.

The Frisco, Texas-based company said it has begun a search for a successor, and that until one is found, Jeremy Friedman will serve as interim CFO.

Friedman is currently responsible for the company’s supply chain, environmental, health, safety and security needs, as well as the divestiture of the company’s advanced spinal & orthopedics product line.

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 EctoSense taps McCourt as CEO

Sleep-disorder focused digital health and medical device company EctoSense said last Friday it named Ciaran McCourt as CEO.

Prior to joining Belgium-based EctoSense, McCourt served as CEO of eDiets and Unilever biometric sensor spin out MiLife. He also served as international biz dev director for BiancaMed, which was acquired by ResMed (NYSE:RMD) in 2014.

“We are very pleased to get someone with Ciaran’s depth of experience on board to drive the company’s high ambitions in delivering scalable and clinically validated diagnostics and services in sleep disorder care globally,” co-founder Bart Van Pee said in a press release

“I am very pleased to take up this role with Ectosense operating at the leading edge of developing innovative respiratory diagnostics, beginning in the domain of sleep apnea with the Nightowl device. The device is a perfectly timed step change in sleep apnea screening and diagnosis given its ease of use and cost of delivery just as patients and providers are seeking ever more convenient devices without sacrificing diagnostic efficacy. I believe the engineering, clinical, and design strengths of Ectosense will ensure its place in the new generation of device companies that will improve access to important disease diagnostics and services,” CEO McCourt said in a prepared statement.

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BD partners with Helmer Scientific to launch drug-dispensing system for refrigerated meds

Becton Dickinson (NYSE: BDX) said today that it’s teaming up with Helmer Scientific to launch a medical-grade refrigerated solution that automatically dispenses medications.

Automated medication dispensing has been a norm in the industry for decades, BD noted, but there hasn’t been a solution that securely dispenses refrigerated drugs. The two companies have co-developed a temperature monitoring system that integrates directly with BD’s Pyxis system.

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

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BD prices $677m in EU-based debt offerings

Becton Dickinson (NYSE:BDX) today priced a set of European debt offerings totaling $677 million.

In the first offering, the Franklin Lakes, N.J.-based company issued $346.3 million (EU €300 million) in 1.401% notes due May 24, 2023 in a public offering between it and The Bank of New York Mellon Trust Company.

Becton Dickinson said that it can redeem the Euro Notes in whole or in part any time prior to April 24, 2023 at a price equal to 100% of the principal amount or at any time on or after April 24, 2023 for the price of the notes plus accrued and unpaid interest.

The company also issued $331.1 million (GBP £250 million) in U.K.-based 3.02% notes due May 24, 2025 in a separate underwritten public offering, according to an SEC filing.

BD specified that it can redeem the notes at any time prior to February 24, 2025 at a redemption price equal to the greater of 100% of the principal amount to be redeemed and a “make-whole” amount described in the notes, plus accrued interest, or at any time after February 24, 2025 with that value plus accrued and unpaid interest.

In March, Becton Dickinson said it closed a $460.7 million offer to repurchase outstanding 3% notes due 2026.

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Hospitals sue BD, distributors, GPOs over alleged safety syringe monopoly

A group of healthcare providers levied a purported class action against BD, its distributors and group purchasing organizations accusing them of running a monopoly on the U.S. safety syringe market.

The lawsuit, brought in the U.S. District Court for Southern Illinois, was filed on behalf of “healthcare providers nationwide” by a group of providers “who have purchased conventional and safety syringes and safety IV catheters directly from the conspiracy and paid above-competitive prices caused by the conspiracy.”

The suit names BD, Premier Inc. (NSDQ:PINC), Vizient, Cardinal Health (NYSE:CAH), Owens & Minor (NYSE:OMI), Henry Schein (NSDQ:HSIC) and “other unknown Becton distributors” as defendants.

“Becton, a manufacturer of devices and supplies, has abused its extraordinary market power to require the use of oppressive, anti-competitive contracts that effectively force above-competitive prices on the market,” the suit alleged. “Defendants have exploited that network of contracts to enter into a vertical conspiracy to restrain trade in the nationwide markets for conventional and safety syringes and safety IV catheters. Using those contracts, Becton has unlawfully conspired with GPOs and distributors to force healthcare providers into long-term exclusionary contracts that restrain trade and inflate the prices of certain Becton products to above-competitive levels.”

Providers are forced to buy BD safety products “or else face substantial economic punishment” due to the defendants’ “tremendous market power,” the suit alleged.

“Defendants have profited greatly from the above-competitive pricing that they have charged for the relevant Becton products,” according to the complaint, filed by Marion Diagnostic Center, Marion HealthCare and Andron Medical Assoc.

“Through their conspiracy, defendants have suppressed competition by preventing Becton’s rivals from obtaining sufficient market shares to bid Becton’s prices down to economically efficient, competitive levels. The conspiracy has also suppressed conventional and safety syringe innovation and safety, placing patients and healthcare workers at needless risk of serious infectious diseases spread by needlesticks and blood-borne pathogens,” the plaintiffs alleged.

The lawsuit seeks a judgment that the defendants violated the Sherman Act, meaning the potential for triple damages, an injunction barring further conspiracy, pre-d and post-judgment interest and legal costs.

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Medtronic expands paid family leave benefits for US employees | Personnel Moves – May 1, 2018

Medtronic (NYSE:MDT) today announced expanded paid family leave benefits which the company says will “allow for greater employee flexibility while balancing work and family priorities.”

The new benefits, which went into effect today, cover full and part-time US employees and allow for a “wide range of family care leave needs,” the Fridley, Minn.-based company said. These include time spent with a new child, caring for sick family members or caring for family after a spouse, child or parent is called to active military duty.

“These expanded benefits support our employees and their families in various life stages and make it possible for employees to dedicate their full attention to the people who matter most when needed,” chair & CEO Omar Ishrak said in a prepared statement.

The policy will allow up to six weeks away from work, and comes in addition to maternity benefits for birth mothers. With the addition, when combined with accrued paid time off, a new mother could take leave of up to 18 weeks paid at 100% for the duration, Medtronic said.

The company had previously offered five to seven weeks of paid leave for birth parents and one week for non-birth parents, and four weeks for compassionate leave to care for a terminally ill family member.

“We listened closely to what our employees were saying, and the needs they described. We believe we have created a benefit that goes well beyond current practice in the U.S. and affords Medtronic employees the valuable time they need with their families at critical times in their lives,” chief human resource officer Carol Surface said in a press release.

Medtronic said that currently the policy applies only to regular US employees, but that it is evaluating country-specific employment laws and regulations to “determine opportunities for additional policy changes to apply outside the United States.”

 Becton Dickinson appoints 3 new segment heads

Becton Dickinson (NYSE:BDX) last week announced three new segment president appointments, tapping Alberto Mas to head its medical segment, Patrick Kaltenbach as prez of its life sciences segment and Bill Tozzi as its interventional segment interim prez.

Mas’ appointment will take effect May 29, the Franklin Lakes, N.J.-based company said. Mas will leave behind his previous position as life sciences segment head, which Kaltenbach will take over on May 29. Mas has previously served as prez of diagnostic systems, biosciences and medical surgical systems.

“Alberto is a proven leader who has excelled at every position he’s held at BD. He is the right leader for our largest segment, and I have full confidence he will continue to drive our growth and innovation strategy across the medical segment,” BD prez Tom Polen said in a prepared statement.

Kaltenbach is being lifted to life sciences head from his previously position as Agilent senior VP and life sciences and applied markets group prez, which he held since 2014.

“Attracting an industry leader of Patrick’s caliber to BD is a testament to our life sciences strategy and the segment’s progress toward becoming a transformative partner from discovery to diagnosis. Patrick brings a unique combination of deep experience and knowledge within the life sciences industry and a passion for creating value through innovation and technology. We are pleased to have his leadership as we continue to advance our life sciences Segment,” Polen said in a prepared release.

Tozzi previosly served as integration leader for its acquisition of C.R. Bard (NYSE:BCR), which closed last December. Prior to acting as integration leader, Tozzi acted as medication and procedural solutions prez for six years. Tozzi will replace John Groetelaars who is leaving the interventional segment prez position for an executive position at another company.

“Bill is a seasoned BD executive with a strong track record of success and deep integration experience. Together with the strong interventional segment leadership team driving the business, I am confident we are well positioned to fulfill our potential as a combined company. I would also like to thank John for his dedication and leadership to Bard and BD. I know that everyone at BD wishes him much success in the next chapter of his career,” Polen said in a press release.

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 Minnetronix taps Lindsoe as CFO

Minnetronix said today it named Elissa Lindsoe as its new chief financial officer.

Prior to joining the St. Paul, Minn.-based company, Lindsoe served as SFO of Minnesota-based global manufacturing company Mocon, where she aided the company in its sale to Ametek. Lindsoe served as an independent consultant supporting the transition after the sale, Minnetronix said.

“We look forward to welcoming Elissa to the Minnetronix team at such an important and dynamic time in our company’s history. She is a proven and accomplished leader who will play an instrumental role in providing financial vision, strategy and leadership as we expand and grow our position in the market,” prez Jeremy Maniak said in a press release.

“Minnetronix is a unique company with an equally unique opportunity to accelerate its impact on the medical device market. I am looking forward to being part of a company with such a bright future and a compelling mission,” Lindsoe said in a prepared statement.

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 Zeus Industrial names Peterson as prez

Zeus Industrial Products said today it named Steve Peterson as its new president.

Prior to moving to the president position, Peterson operated as global head of marketing and sales and senior VP, the Orangeburg, S.C.-based company said. Peterson will report directly to CEO John Winarchick.

Before joining Zeus Industrial Products, Peterson held leadership positions with TE Connectivity, Samsung Electronics (LON:BC94) and General Electric (NYSE:GE).

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 Admedus appoints Oswell as development VP

Admedus (ASX:AHZ) said today it appointed Michael Oswell to the newly created role of development VP, effective May 15.

In the position, Oswell will be responsible for product pipeline acceleration, including 3D surgical solutions and the company’s transcatheter aortic valve replacement project.

Prior to joining Admedus, Oswell held leadership roles with Boston Scientific (NYSE:BSX) and its Guidant subsidiary, as well as Medtronic. His most recent position was as senior program manager at Medtronic’s cardiac rhythm and heart failure operations.

“Michael has a strong track record as a results-driven leader in the medtech environment. He will be an excellent addition to the Admedus leadership team and his technical skill and experience will be an enormous advantage as we look to progress our range of new products in our development pipeline. His background in product development for some of the leading companies in the medtech industry will bring invaluable new perspective to our portfolio of development projects,” CEO Wayne Paterson said in a press release.

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BD to divest stake in Vyaire Medical to Apax Partners in $435m deal

Becton Dickinson (NYSE:BDX) said today it agreed to divest itself of its minority stake in respiratory solutions joint venture Vyaire Medical to joint manager Apax Partners in a deal worth $435 million.

The sale will put Vyaire Medical, which Apax and BD formed in 2016 around BD’s ventilation, respiratory diagnostics, vital signs and AirLife businesses, under direct control by the Apax Funds.

“Since the Apax Funds acquired a majority stake in Vyaire Medical in October 2016, strong progress has been made by the business. A new senior management team led by CEO Dave Mowry has established key functions, delivered operational improvements, upgraded commercial capabilities and made two accretive acquisitions. It was on the basis of this progress, and the promise that we continue to see for the business, that we sought to acquire BD’s minority stake. We would like to thank the BD team for being excellent partners and supporting the company through its history,” Apax Partners partner Steven Dyson said in a press release.

Franklin Lakes, N.J.-based BD said it expects the deal to close by the end of April, and that it expects to record a gain on the transaction at the time of closing, according to a press release.

Vyaire Medical brings in approximately $800 million in annual sales, according to Apax Partners, and is currently active in manufacturing and distributing respiratory and anesthesia and surgical consumables as well as capital equipment for respiratory diagnostics and ventilation.

“We are pleased with the progress our team has achieved over the past 18 months in establishing Vyaire Medical as a focused and leading global respiratory solutions provider with the objective of improving patient outcomes and increasing value for our customers. Our success in standing up Vyaire Medical as an independent company also has been made possible by the support of BD and the contributions from Apax Partners, which has provided our team with a range of capabilities, including the expertise from its Operational Excellence team of dedicated functional specialists,” Vyaire prez & CEO Dave Mowry said in a prepared statement.

Earlier this month, Becton Dickinson said it closed a $460.7 million offer to repurchase outstanding 3% notes due 2026.

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BD sues Cytek over alleged stolen trade secrets


Becton Dickinson (NYSE:BDX) this week filed a suit against Cytek Biosciences, claiming the company stole trade secret information after hiring away a number of its former employees.

The company claims that Cytek, which used to service its flow cytometers, began producing its own such devices based off knowledge it gained from former BD employees it hired.

A total of 10 employees are named in the suit, which was filed in the U.S. District Court for the Northern District of California, including scientists, engineers and business people, according to court documents.

“When they left BD to work for Cytek and thereafter, those employees, upon information and belief, improperly retained and misused BD’s valuable, highly confidential, proprietary information, including thousands of confidential and valuable technical files that they had downloaded from BD’s computer systems onto removable storage media while employed by BD,” the company wrote in court documents.

Becton Dickinson said it attempted to recover the devices and files, including reaching out to Cytek for them, but that it has not been able to recover the majority of them, according to court documents.

The Franklin Lakes, N.J.-based company goes on to accuse the former employees of having “improperly downloaded, removed, and failed to return thousands of files with BD’s valuable, highly confidential, proprietary information before departing to Cytek,” which it claims the company used to create substantially similar products.

BD is seeking judicial intervention to hold the company and the individuals who left responsible for the theft, and to prevent any continued development of products it alleges are based off its protected, proprietary information.

Yesterday, Becton Dickinson said it closed the divestiture of its soft tissue core needle biopsy line and Aspira product line to Merit Medical (NSDQ:MMSI) for $100 million.

Medtech CEOs: Hatch’s last stand should be medtech tax repeal


Medical device taxA trio of medical device CEOs are urging Sen. Orrin Hatch (R-Utah), who’s soon to retire after four decades in the Senate, to make permanent repeal of the medical device tax one of his final acts in office.

The 2.3% excise tax on U.S. medical device revenues was in effect for two years before a two-year moratorium began in 2016. It went back into effect at the beginning of this year, although the IRS said this week that it will not enforce any penalties for late payments of the medtech levy. (Last night the U.S. House passed a stopgap budget measure that would put a two-year pause on the tax; Senate Democrats vowed to filibuster over immigration issues.)

Hatch, who spearheaded the effort to push the pause button on the medtech levy in 2015, filed several bills over the years to do away with the tax.

The Salt Lake Tribune last night published an op-ed piece by Fred Lampropoulos, founder & CEO of Jordan, Utah-based Merit Medical (NSDQ:MMSI), Becton Dickinson & Co. (NYSE:BDX) chief Vincent Forlenza and Mike Mussallem, CEO of Edwards Lifesciences (NYSE:EW).

The chief executives, whose companies employ some 4,300 Utahns, wrote that those jobs “are threatened by the return of the medical device tax” and pushed Hatch to make one last effort to kill it.

“The impact of this levy has and will have far-reaching effects on patients, jobs and the economy,” they wrote. “Hatch has been a leader on this issue for years. As chairman of the Finance Committee, he successfully won a suspension of the 2.3% excise tax on medical devices in 2015. But that suspension was only a short two-year reprieve, and as of Jan. 1, the tax returned unceremoniously. We need his help now, at this pivotal moment.

“Since the tax is levied on revenues, not profits, the financial burden is even more devastating on smaller companies, which comprise more than 80% of the industry. Utah is home to over a dozen small medtech companies, and this tax takes a direct hit at the innovation ecosystem in the state. Harming these companies will create a ripple effect throughout the medical technology community, dampening investment in life-saving innovations,” the CEOs wrote.

Medtech companies put the funds that would ahve gone to the tax to good use during the two-year hiatus by  investing in R&D, according to the op-ed.

“With the reinstatement of the tax, companies could be forced to slow development, ending some of these investments and making cuts in their place,” they wrote, estimating the collective hit to R&D budgets at $2 billion.

“There is no one Utahns would rather have in their corner than Hatch. We are proud to have had him represent Utah in the Senate for the past 41 years. I’m sure he would agree with us, however, that he has a final charge to keep. We look forward to seeing him use his skill and passion for helping patients and families win one more fight on behalf of Utah and the nation by acting with urgency to accomplish permanent repeal of the medical device tax,” the CEOs concluded.