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How COVID-19 changed medical device clinical trials forever

The success of remote clinical trial oversight opens the door to hybrid approaches and creates new possibilities for the future of trials. DeviceTalks [Image from Unsplash] Because of the pandemic, virtually overnight, all players involved in medical device clinical trials had to pivot to virtual monitoring to keep trials going. What impact did remote trial oversight have on the quality, safety, and costs of clinical trials? What are the implications for the future? A panel of experts from across the clinical trial ecosystem discussed these topics on a recent episode of DeviceTalks Tuesdays, sponsored by IMARC. Panelists included Hamish Baird, clinical research president at Remington-Davis; Brandy Chittester, president of IMARC Research; Xavier Lefebvre, global VP of medical and regulatory operations at Medtronic; and Dr. Eric Kolodziej, corporate VP and global head of quality and regulatory affairs at Hologic. Go to our sister site Medical Design & Outsourcin…

How COVID-19 changed medical device clinical trials forever

The success of remote clinical trial oversight opens the door to hybrid approaches and creates new possibilities for the future of trials.

[Image from Unsplash]

DeviceTalks

Because of the pandemic, virtually overnight, all players involved in medical device clinical trials had to pivot to virtual monitoring to keep trials going. What impact did remote trial oversight have on the quality, safety, and costs of clinical trials? What are the implications for the future?

A panel of experts from across the clinical trial ecosystem discussed these topics on a recent episode of DeviceTalks Tuesdays, sponsored by IMARC.

Panelists included Hamish Baird, clinical research president at Remington-Davis; Brandy Chittester, president of IMARC Research; Xavier Lefebvre, global VP of medical and regulatory operations at Medtronic; and Dr. Eric Kolodziej, corporate VP and global head of quality and regulator…

SCOTUS preserves assignor estoppel in Minerva Surgical v. Hologic patent case

The front of U.S. Supreme Court in Washington, D.C. (Adobe stock photo)

The U.S. Supreme Court, in its Minerva Surgical v. Hologic ruling today preserved the legal doctrine of assignor estoppel — that inventors who sell patent rights can’t turn around and sue over the validity of the patents.

However, Justice Elena Kagan, in her opinion for the majority, did say that the doctrine has limits.

Get the full story on our sister site Medical Design & Outsourcing.

SCOTUS preserves assignor estoppel in Minerva Surgical v. Hologic patent case

The front of U.S. Supreme Court in Washington, D.C. [Adobe stock photo]

The U.S. Supreme Court, in its Minerva Surgical v. Hologic ruling today preserved the legal doctrine of assignor estoppel — that inventors who sell patent rights can’t turn around and sue over the validity of the patents.

However, Justice Elena Kagan, in her opinion for the majority, did say that the doctrine has limits.

The convoluted case involves the NovaSure system for abnormal uterine bleeding that Csaba Truckai invented in the late 1990s, filing for a patent assigned to his company Novacept. Hologic eventually acquired Novacept in 2007 and got claims added to the patent in 2015. Months later, Hologic sued Minerva Surgical — the new company Truckai had founded — for patent infringement. Minerva Surgical makes the Minerva Endometrial Ablation System, touted as an improved device to treat abnormal uterine bleeding.

In…

MedTech 100 roundup: Industry climbs again

The medtech industry built off a strong performance two weeks ago with another uptick in the midst of an up-and-down year.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — finished the week (June 18) at 110.64 points, producing a 0.9% rise from the 109.63-point mark set one week prior (June 11). In all, the industry has risen 3.4% over the past two weeks.

The recent upswing provides a welcome sight after the industry’s progress came to a halt with a -1.4% dip earlier this month. The index looks poised to pick up again as it nears the high points registered when April brought the industry’s all-time best performance.

Even with some recent setbacks, medtech’s performance continues to reflect an overall rebound from the struggles brought on by the COVID-19 pandemic, too. The industry has registered an 19.8% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus a 78.1% increase from the …

Hologic completes $795M Mobidiag acquisition

Hologic (NSDQ:HOLX) today announced that it has completed its $795 million acquisition of diagnostic developer Mobidiag Oy.

France-based Mobidiag develops PCR-based tests for acute care conditions, including gastrointestinal and respiratory infections, antimicrobial resistance management and healthcare-associated infections. Its Amplidiag and Novodiag platforms can deliver results in 50 minutes to two hours.

Marlborough, Mass.-based Hologic announced the deal in April when it said it would make a cash payment of approximately $714 million for Mobidiag’s equity and net debt of approximately $81 million.

“Closing the acquisition of Mobidiag enables us to become a broader, more diversified global diagnostics leader,” Jan Verstreken, international president at Hologic, said in a news release. “Together, we can accelerate development and adoption of Mobidiag’s innovative products globally and drive Hologic’s growth.”

Hologic previously said that …

DTW Podcast: Getting to the heart of Boston Scientific’s peripheral business; How Hologic sees trials changing

In this week’s episode of the DeviceTalks Weekly Podcast, Boston Scientific peripheral business EVP Jeff Mirviss explains why the specialty’s name doesn’t really reflect the importance of arteries, veins and other critical “highways” in the body.

Mirviss explains where the peripheral business is headed, and why Boston Scientific is uniquely positioned to address the business.

He also shares lessons learned over his 20-plus years at Boston Scientific including the challenges presented by the Guidant acquisition and the necessary spirit infused by CEO Michael Mahoney.

Also on this week’s podcast, Eric Kolodziej, corporate VP and global head quality and regulatory affairs at Hologic, about how clinical trial management is changing. What role will real-world evidence play going forward, and how will Hologic and others follow up on the record number of EUA’s issued over the past year by the FDA.

Kolodziej will be part of a panel of regulato…

DTW Podcast: Getting to the heart of Boston Scientific’s peripheral business; How Hologic sees trials changing

In this week’s episode of the DeviceTalks Weekly Podcast, Jeff Mirviss, executive vice president of Boston Scientific’s peripheral business, explains why the specialty’s name doesn’t really reflect the importance of arteries, veins and other critical “highways” that his business group is addressing.

Mirviss explains where the peripheral business is headed, and why Boston Scientific is uniquely positioned to address the business.

He also shares lessons learned over his 20-plus years at Boston Scientific including the challenges presented by the Guidant acquisition and the necessary spirit infused by CEO Michael Mahoney.

Also on this week’s podcast, Eric Kolodziej, corporate vice president and global head quality and regulatory affairs at Hologic, about how clinical trial management is changing. What role will real world evidence play going forward, and how will Hologic and others follow up on the record number of EUA’s issued over the past yea…

Hologic launches $20M women’s health equity initiative

Hologic this week announced an effort to improve healthcare for Black and Hispanic women in the U.S.

Project Health Equality (PHE) will focus initially on how Black and Hispanic women experience healthcare in different regions of the country and on making meaningful, sustainable improvements, according to the Marlborough, Mass.-based company. Hologic’s partners in the $20 million initiative are:

Get the full story on our sister site, Medical Design & Outsourcing.

Hologic EPS trails the consensus forecast

Hologic (NSDQ:HOLX) posted second-quarter results today that trailed the consensus forecast, but the company forecasts a strong third quarter fueled by strong COVID-19 test revenue.

The Marlborough, Mass.-based company posted profits of $1.09 billion, or $2.38 per share, on sales of $1.54 billion for the three months ended March 27, 2020. Sales growth in the quarter was 103.4% year-over-year for a 40.3% bottom-line gain.

Adjusted to exclude one-time items, earnings per share were $2.59, three cents beneath the consensus forecast of $2.62 per share on sales of $9.9 million.

“Hologic posted very strong financial results in our second fiscal quarter in line with our guidance,” said Steve MacMillan, the company’s CEO. “Organic revenue doubled, driven by strong recovery and momentum in our base businesses, as well as our continued response to the COVID-19 pandemic. And earnings per share more than quadrupled.”

The company is upb…

MedTech 100 roundup: Industry roars back

In the blink of an eye, the medtech industry exited its spring slump and neared its all-time best performance levels.

MassDevice‘s MedTech 100 Index offered signs of a rebound last week and has built on that momentum, registering a final tally of 109.39 points on April 9. That represents a 2.9% increase from the 106.26-point mark set a week prior (April 2).

The industry’s rebound has been impressive, given that just over one month prior, the index had dropped to 102.16 points (March 8), having just set its all-time best of 110.96 on Feb. 15. Medtech companies had no seen that degree of a fall since October 2020.

Improvements highlight the secure position the industry has nestled into a year on from the height of the COVID-19 pandemic’s impact on medtech, as the industry has produced an 18.5% rise from the pre-pandemic high of 92.32 (set on Feb. 19, 2020), plus a 76.1% increase from the mid-pandemic low of 62.13 (March 23, 2020).

The overall …

DTW Podcast: Herrera on how military lessons led to Medtech career; Ulmer ready to redo landmark FDA survey

Derek Herrera and Kwame Ulmer are featured on this week’s DeviceTalks Weekly Podcast.

In this week’s podcast, Derek Herrera explains how a serious battle injury he received while leading Marines in Afghanistan led him to build a career in medtech.

Herrera has founded two companies – Spinal Singularity and Habit Camera – to create devices that can improve and save the lives of people who need help the most. Herrera also explains how his military training is serving him so well in medtech and how the medical device industry would benefit from including more veterans in its workforce.

We’ll also hear from Kwame Ulmer, principal at Ulmer Ventures and a lecturer at UCLA Anderson’s School of Management, about an effort his helping to lead to update the landmark study compiled by Josh Makower in 2010. The study blasted a regulatory process that it called “unpredictable, inefficient and expensive.”

Its finding led to introspection and changes, according to…