Ananya Health wants to bring battery-powered cryoablation to the global fight against cancer

Anu Parvatiyar, cofounder of Ananya Health [Image courtesy of Ananya Health]

Cervical cancer is the fourth most common cancer among women and has a high mortality rate globally, according to the World Health Organization. Screening and effective interventions can reduce cervical cancer deaths, but that access is limited in emerging markets and developing countries.

Ananya Health, co-founded by Anu Parvatiyar, is at the forefront of tackling this global health disparity. The company is developing a cryoablation device that can freeze abnormal cells in the cervix at the point of care, all on a battery-powered system designed to bridge the accessibility gap in regions that typically lack these resources.

Typically, when a Pap smear comes back as abnormal in places like the U.S., doctors refer patients to a specialist at a hospital or larger specialty clinic with the tools and operating space to treat the le…

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How Ambu seeks to hold its top spot in single-use scopes

Ambu CEO Britt Meelby Jensen [Image courtesy of Ambu]

Ambu’s CEO seeks to “Zoom In” on what the Danish company has done best.

More than a year after she took over the corner office at Ambu, Britt Meelby Jensen recalls what brought her into leadership. She already had a seat on the board at the maker of single-use endoscopes, anesthesia and airway management devices, and patient monitoring technology.

“We were in a situation where we saw challenges with declining profitability and we were not able to meet our revenue targets that we had put out to The Street. So it was around that time the chairman asked if I wanted to run the company,” Jensen said during a recent DeviceTalks Weekly podcast interview.

In many ways, Ambu’s challenges stemmed from its success. The Danish company, founded in 1937, launched the Ambu Bag in the 1950s. The self-inflating, manual resuscitator is still a fixture in hospital e…

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The secret behind Intuitive’s surgical robotics success

Dr. Myriam Curet has been instrumental to Intuitive’s success in recent years. [Photo courtesy of Intuitive Surgical.]

Intuitive Surgical has pioneered robotic surgery since the 1990s, continuously driving innovation and collaboration through data to advance patient care.

Teamwork between surgeons and engineers has been a crucial factor behind Intuitive developing effective surgical platforms that solve real-world problems that surgeons face.

Multibillion-dollar companies including Medtronic and Johnson & Johnson — and smaller up-and-comers including CMR Surgical and Vicarious Surgical — have sought to take on Intuitive in the soft-tissue surgical robotics space in recent years, but Intuitive remains the dominant company. An important element of Intuitive’s continued success has been its ability to harness data, collaborate with surgeons, and innovate.

As a practicing surgeon who actively …

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MicroCare promotes Venesia Hurtubise to VP of technology and compliance

MicroCare VP of Technology and Compliance Venesia Hurtubise [Photo courtesy of MicroCare]

Medtech supplier MicroCare today announced the promotion of Venesia Hurtubise to the newly created position of VP of technology and compliance.

Hurtubise has been a technical chemist at New Britain, Connecticut-based MicroCare since 2014. In her new role with the cleaning, coating, lubrication, and infection prevention product supplier, she’ll “be responsible for driving the company’s technological advancements and ensuring regulatory compliance across its global operations,” the company said in a news release.

The company described Hurtubise as strategic and collaborative, crediting her with leadership of cross-functional teams, implementation of technological advancements, and building strong relationships with industry partners.

“We are thrilled to appoint Venesia Hurtubise as…

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Boston Scientific’s Kathryn Unger on how to stand up an ESG program

Kathryn Unger is VP of Environmental, Social and Governance (ESG) at Boston Scientific. [Photo courtesy of Boston Scientific]

Kathryn Unger, VP of Environmental, Social and Governance (ESG) at Boston Scientific, joined the medical device developer and manufacturer in September 2022 to form the ESG team.

“The patient is and must be at the center of everything we do,” she said DeviceTalks Boston in May. “We’re constantly trying to ensure that we have the absolute best patient outcome, from a risk-to-the-patient perspective, period. That has to be our guiding principle, right? However, that’s not an excuse to not improve the design of our medical devices. … There has to be product stewardship that starts before you get to the manufacturing piece. And that design needs to be circular and consider the full life cycle.”

Unger had advice for companies that want to launc…

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Medical device industry ramps up for the CSA Act’s software changes

Change is coming for software development teams at medical device manufacturers through the Computer Software Assurance (CSA) Act.

Carla Neves is quality manager and medical devices product owner at Critical Manufacturing. [Photo courtesy of Critical Manufacturing]

By Carla Neves, Critical Manufacturing

The Computer Software Assurance (CSA) Act of 2022 aims to improve quality and cost-efficiency in validating computer systems for medical device manufacturing. Although it has not been finalized, manufacturers, software developers, and consultants have fully embraced it and are ramping up for implementation.

Transitioning to risk-based validation after more than 20 years of document intense compliance will likely dominate medical device software operations for many years to come, as will building out the manufacturing execution system (MES) infrastructure to support it and developing the innovations that t…

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Outset Medical CEO Leslie Trigg and the beginner’s mindset

Outset Medical Chair and CEO Leslie Trigg [Photo courtesy of Outset Medical]

The home dialysis developer’s CEO discusses leadership, leaping before you look and making medtech for the home and hospital.

Eight years after becoming the CEO of Outset Medical (Nasdaq:OM) and two years after going public, Leslie Trigg says the medtech developer is finally at the starting gate for home dialysis.

It hasn’t been easy. The COVID-19 pandemic made it unsafe to train nurses in person, even as hospitals used the Tablo hemodialysis console in hallways and waiting rooms to clean patients’ blood. The pandemic also disrupted Outset’s supply chain. For example, it increased transportation costs for its single-use cartridges made by a contract manufacturer in Southeast Asia.

Last year, Outset had to put new shipments on hold while working through issues with the FDA.

And when she first go…

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October 2022 Issue: Women in Medtech

Rachel Ellingson is driving Zimmer Biomet toward new tech

What Laura Mauri learned from a ‘firestorm’ in her first months at Medtronic

How Medline maintains quality while innovating and growing

How a wrist-worn device treats essential tremor

Diversity in medtech: 2022 markedly the best for women in medtech

Diverse executive teams bring more innovation to medtech Diversifying the executive suite is more than just a push for representation — it helps bring more diverse ideas to the table to innovate for more than half of the global population.

The leadership gap in the medical device industry closes slightly every year, but women still account for less than a quarter of executive roles, according to our annual analysis in this Women in Medtech edition of Medical Design & Outsourcing.

Women hold just 23% of executive roles at the top 100 medical device companies, up 2 percentage points since 2021. After Accuray and Ambu appointed f…

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Diversity in medtech: 2022 markedly the best for women in medtech

This year has been one of the most formative for women in medtech leadership roles as representation in the C-suite has reached a new high.

Just 23% of the top executives at the world’s 100 largest medical device companies are women, according to an analysis of Medical Design & Outsourcing‘s annual Big 100 ranking of the top revenue-generating medtech companies.

While that number is up 2 percentage points from 2021, the average composition within the top 100 companies is also up slightly to 22%.

This year has been one of the most formative for women in leadership roles. There were 50 new C-suite appointments. However, 2020 seemingly started the shift in leadership diversity. That year, 37 women moved into C-suite roles in the top 100 companies, followed by 34 new appointments in 2021. Overall, women have moved into 121 new roles in the last three years.

“The fact that the management teams are now tapping into this in 2020 and…

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How medical device companies can better protect themselves from lawsuits

Getting hit with lawsuits isn’t an if, but a when for medical device developers and manufacturers. A veteran Greenberg Traurig lawyer shares advice for staying secure.

[Image from Pixabay]

As with pharmaceutical companies and health providers, medtech is emerging from the COVID-19 pandemic with a great deal of goodwill, says Ginger Pigott, a Greenberg Traurig shareholder. Pigott has seen the industry’s improved image helping device companies with juries, mock juries and the litigation process in general.

But don’t bet on the trend lasting.

“I’ve been practicing for 30 years, and it goes in that cycle all the time,” Pigott said in a recent interview with Medical Design & Outsourcing. (Pigott will moderate a panel about building startups to last at DeviceTalks West, Oct. 19-20, 2022 in Santa Clara, California.)

In fact, Pigott suspects the present economic unc…

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How Medline maintains quality while innovating and growing

Lara Simmons is Medline’s president of quality and regulatory affairs. [Image courtesy of Medline]

Medline President of Quality and Regulatory Affairs Lara Simmons offers insight into  innovation and quality as the company grows.

When Lara Simmons joined Medline in 1991, she began by performing packaging validations.

At the time, Medline was bringing in $250 million in sales per year, and the company’s quality assurance team had only about nine members.

In 2021, the Northfield, Illinois–based company reported more than $20 billion in annual revenue. And there are now around 1,800 people in Medline’s quality organization around the world.

“You don’t get that kind of growth if you don’t have rock solid quality,” Simmons said in an interview with Medical Design & Outsourcing. “You can win customers on price and promises. But, you lose them on ba…

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How this inside-out vascular access system simplifies catheter placement

Gabi Niederauer is president and CEO of Bluegrass Vascular Technologies. [Image courtesy of Bluegrass Vascular Technologies]

Bluegrass Vascular Technologies is making catheter placement procedures for dialysis and chemotherapy easier and safer using inside-out technology, explains CEO and President Gabi Niederauer.

Bluegrass Vascular Technologies has figured out a way to make a catheter sheath go inside the body and back out for easy catheter placement in standard access procedures.

The San Antonio, Texas–based company’s Surfacer Inside-Out access system facilitates catheter insertion into the central venous system. The company designed it for use in patients with upper body venous occlusions or other conditions that preclude central venous access by conventional methods.

One of the challenges of having a catheter in the body for weeks or months for dialysis or chemotherapy is the risk of blood…

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