DeviceTalks Boston 2024: Our favorite panels and new additions

Our team picks favorites from our upcoming show, including some new additions to the program.

Leaders from CMR Surgical, the developer of the Versius surgical robotics system, will speak at DeviceTalks Boston 2024. [Photo courtesy of CMR Surgical]

I enjoy reading bookstore staff recommendations. It’s nice to see how people in the know like to spend their time.

But if you asked me to pick my favorite panels on the agenda for DeviceTalks Boston, taking place May 1–2, 2024 at the Boston Convention & Exhibition Center, I couldn’t do it.

In fact, I won’t do it. Sorry, dear reader, I’ve put too much into this agenda to pick one favorite session. Plus, I owe neutrality to our speakers — amazing professionals willing to give up two days to help me create something. That’s a covenant that I cannot violate by selecting a favorite.

But I can put our editorial team on the spot to pick their favorites. And…

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Catheter design was key for the Boston Scientific Farapulse pulsed field ablation system

Boston Scientific Chief Medical Officer Dr. Ken Stein explains how catheter design drives the Farapulse pulsed field ablation system.

This image depicts the Boston Scientific Farapulse PFA system’s Farawave ablation catheter in its flower shape. [Image courtesy of Boston Scientific]

Following FDA approval on Jan. 31, Farapulse from Boston Scientific is now the second pulsed field ablation (PFA) system approved to treat atrial fibrillation (AFib) in the U.S.

Medtronic’s PulseSelect PFA System picked up the first FDA approval in December for the treatment of paroxysmal and persistent AFib.

Boston Scientific’s Farapulse, on the other hand, is indicated for the isolation of pulmonary veins to treat drug-refractory, recurrent, symptomatic, paroxysmal AFib.

Farapulse delivers pulsed field energy using the Farawave ablation catheter, Farastar ablation generator and Faradrive steerable s…

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January 2024 edition: The Leadership in Medtech issue


Opening the brain’s secret back door: A conversation with Synchron co-founder and CEO Dr. Tom Oxley

How Recor Medical won the renal denervation race for FDA approval

Medtech’s biggest personnel moves of 2023

Leadership and innovation in medtech

Creativity, energy, agility — those are three words Recor Medical CEO Lara Barghout used to describe the culture at the world’s first device developer to win FDA approval for hypertension-treating renal denervation (RDN).

You can add persistence to that list. Ever since its founding in 2009, Recor Medical and its team has been pushing to deliver a safe and effective RDN system. The seemingly long odds got longer as larger competitors pulled the plug on their own programs — or in Medtronic’s case, pushed on despite clinical trial failures and won approval shortly after Recor.

Our annual Leadership in Medtech issue of Medical Design &a…

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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…

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How Recor Medical won the renal denervation race for FDA approval

The Recor Medical Paradise ultrasound RDN system uses a water-filled balloon catheter for 360-degree sonification to ablate overactive nerves in the walls of the renal arteries. [Illustration courtesy of Recor Medical]

It’s been a long wait to see the FDA approve renal denervation for treating hypertension.

Recor Medical held a companywide town hall for employees to celebrate winning premarket approval (PMA) for their Paradise Ultrasound RDN system. While they were celebrating, the team learned that the very first commercial procedure had just been completed.

“After a pretty long journey of many years — the rigorous clinical trials that we ran, and all the work that they’ve done —  they were actually seeing, finally, this wonderful result of a PMA,” Recor President and CEO Lara Barghout said. “We hit the ground running immediately. … It was such an incredible, emotiona…

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Boston Scientific wins public funding for $170M ‘Project Black Bear’ expansion

Boston Scientific is planning a $170 million expansion in Maple Grove, Minnesota. [Illustration by Perkins & Will]

Boston Scientific has won $6 million in financial support from Minnesota for an expansion near Minneapolis.

The Minnesota Department of Employment and Economic Development (DEED) awarded the device developer $1.75 million from the state’s Job Creation Fund and $4.25 million from the Minnesota Investment Fund.

That funding will support Boston Scientific’s expansion with a new site in Maple Grove, Minnesota, near Interstate 694 and Highway 169.

The $170 million project — codenamed “Project Black Bear” — includes 400,000 ft² of new R&D labs, office/support space and room for customer-facing training. The site has room for another 150,000 ft² of space if needed in the future.

The builder — Ryan Cos. — plans to complete construction in 2025.


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Medtech vet Sean Gilligan’s tips and red flags for vetting suppliers

AVS Chief Operating Officer Sean Gilligan [Photo courtesy of AVS]

After a career spanning almost three decades at Boston Scientific, Sean Gilligan’s new role at a startup has him working more closely with contract manufacturers and suppliers.

Gilligan is the chief operating officer at Amplitude Vascular Systems (AVS), which is developing a new intravascular lithotripsy system for treating severely calcified arterial disease.

He joined the Boston-based startup in March 2023 after a 29-year career at Boston Scientific. He started in 1994 as an engineer in Ireland and moved his way up to VP of program management and R&D, leading the portfolio for a large part of the interventional cardiovascular business.

“I had my fingers on a lot of different areas. I wasn’t in the weeds dealing with too many suppliers — we had a whole supplier engineering group [of] experts who had expert rel…

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The best medtech innovations of 2023

Recognize this medtech innovation? It was one of the nominees for the Galien Foundation’s 2023 Prix Galien USA Awards. [Image courtesy of Boston Scientific]

The Galien Foundation’s 2023 Prix Galien USA Awards recognized a first-of-its-kind cancer diagnostic and other medtech innovations.

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

“The outstanding quality of the submissions is a testament to the promising future of the life sciences industries,” said former Johnson & Johnson CEO and Chair Alex Gorsky — one of the awards jurors — in a news release announcing the nominees. 

Last year’s winners included Cala Health, Abbott, Edwards Lifesciences and Roche. (See all of 2022’s nominees here, including many that were nominated again in 2023.)

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RWE tips from Boston Scientific Peripheral Interventions CMO Dr. Michael Jaff

Dr. Michael Jaff is chief medical officer and VP of the Boston Scientific Peripheral Interventions business. [Photo courtesy of Boston Scientific]

Real-world evidence (RWE) is a transformational concept for medical device design and engineering, says Dr. Michael Jaff, the chief medical officer and VP of the Boston Scientific Peripheral Interventions business.

“Every really great technological advancement in the vascular space has come from a physician’s recognition that they would like to be able to do something safely and effectively for their patients, but the technology does not exist,” Jaff said in an interview with Medical Design & Outsourcing. “They find their way to an engineer, someone really smart takes that concept builds a prototype — off to the races. And it has time and time again transformed the way patients can be cared for.”

RWE leverages modern data coll…

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These devices are the top targets of lawsuit-related advertisements

Surgical mesh products continue to drive medical device lawsuit spending. [Photo via Adobe Stock]

Spending on advertisements related to medical device lawsuits this year is on track to exceed last year’s tally.

That’s according to figures provided by Washington, D.C.-based X Ante, which uses data from ad intelligence firm Vivvix. X Ante supplies reports on medical device lawsuit ad spending to the Advanced Medical Technology Association (AdvaMed), which is calling for new federal regulations of mass tort advertising to protect device manufacturers from lawsuits bankrolled by third-party funders.

For the first half of 2023, $6.2 million worth of legal ads targeted five kinds of medical devices:

Pelvic mesh: $3.5 million Hernia mesh: $1.9 million CPAP machines: $532,000 Physiomesh: $262,000 Military earplugs: $54,000

Spending on the top five device categories totaled just under $11 mil…

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Boston Scientific’s Farapulse PFA system is poised for FDA approval, analysts say

The Farapulse system’s Farawave single-shot ablation catheter expands inside the patient to deliver energy for treating AFib. [Image courtesy of Boston Scientific]

Boston Scientific’s Farapulse pulsed-field ablation (PFA) system likely hit its primary endpoints, according to Needham analysts who say that means the technology is poised for FDA approval.

Boston Scientific has already said it expects FDA approval of Farapulse next year, but has not yet shared results from its ADVENT pivotal trial.

That data is set for release on Aug. 27 at the 2023 European Society of Cardiology (ESC) Congress. The device developer started that trial in March 2021 and stopped enrolling patients in June 2022.

Based on the trial’s adaptive design with a varying number of possible patients — 350, 450, 550, 650 or 750 — and the timing of enrollment, the Needham analysts say they suspect Boston Scientifi…

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Boston Scientific ramps up Farapulse manufacturing with new site

The Farapulse pulsed-field ablation system’s Farawave catheter (pictured) uses an energy field generated by the Farastar to treat atrial fibrillation. [Image courtesy of Boston Scientific]

Boston Scientific plans to increase production of its Farapulse pulsed-field ablation (PFA) system with a second pulse generator manufacturing site.

“Demand for the platform far exceeds our ability to supply thus far,” Boston Scientific Chair and CEO Mike Mahoney said on yesterday’s earnings call.

He soon after shared that the device developer “just recently received GMED approval for a manufacturing approval to actually manufacture this in Minnesota.”

Paris-based GMED is a notified body designated by France for conformity assessment under the EU Medical Devices Regulation (MDR).

Farapulse Inc.  secured CE mark approval for the system before being acquired by Boston Sci…

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