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

Dr. Laura Mauri faced a monumental moment with former Medtronic CEO Omar Ishrak shortly after she joined the company as VP of global clinical research and analytics.

It was late 2018, and Mauri — who’s now an SVP and the chief scientific, medical and regulatory officer at Medtronic (NYSE: MDT) — was in a meeting about the safety of a product.

A drug-coated balloon for lower leg angioplasty offered long-lasting relief to patients who had pain when walking, but outside investigators had questions about whether the device increased patient mortality, Mauri told DeviceTalks Editorial Director Tom Salemi in a new interview.

“This created kind of a firestorm,” she said. “I had experienced firestorms like that in the past and other subject areas and been really involved. But what surprised me about that was the response of the company.”

After the meeting, Ishrak asked Mauri for her thoughts.

“I started to talk about the details of what we might do and what our plan might be,” Mauri said. “And he said, ‘No, no, no. What do you really think? Because if, if there’s a problem here and we need to stop, we’re ready to do that.’”

That interaction from her first months at Medtronic still sticks with her.

“It wasn’t just all about calculating the balancing of risks and all. It really came down to, ‘Is there a value here for patients?’ And that to me was really reinforcing that I was in the right place for what I wanted to do,” Mauri said.

How Laura Mauri landed at Medtronic

Mauri’s parents were first-generation immigrants from China and Italy. Her father was an engineer, and her mother, a librarian, was diagnosed with lung cancer when Mauri was in high school.

“Living through that with her and her experience was really impactful for my decision to take my interests and apply them to medicine,” Mauri said. “Even before that, though, I had some sort of indication that I was interested in medicine. Whenever there was an emergency in the house or first aid was needed, other people in the family fainted at the sight of blood, and somehow I just found I had an interest and aptitude for jumping in those situations.”

After completing her undergrad studies at Harvard College, she earned her M.D. from Harvard Medical School and a master of science in clinical epidemiology from Harvard School of Public Health. She started practicing medicine at Boston’s Brigham and Women’s Hospital with a residency in internal medicine and fellowships in cardiovascular disease and interventional cardiology as new drugs and medical devices offered improved cardiac care.

“That connection between biology and science and then seeing things move really rapidly from bench research to understand what the targets were to seeing how these were working in clinical settings, I had firsthand experience with that,” she said, recalling her time rotating through the cardiac care unit and seeing how heart attack care improved first with medication, then with stents and eventually drug-eluting stents.

“While I was practicing, I always had a combination of that practical experience and really enjoying working with patients and working with teams in the procedural setting, [developing] better and better technologies and the personal satisfaction of being able to actually change the course of somebody’s illness that dramatically and quickly,” she said.

After 15 years of clinical practice in interventional cardiology and running research programs in clinical trials, she said she was drawn to Medtronic by its global reach and range its products and expertise.

“The range of expertise that exists within the company to bring new things forward was really exciting,” She said. “That opportunity to extend the impact to healthcare leadership was really interesting.”

Two years after joining Medtronic, she was promoted to SVP and chief clinical and regulatory officer, joining the company’s executive committee. This April, she became chief scientific, medical and regulatory officer.

“With this appointment, we’re enabling a patient-centered approach to healthcare technology innovation at every stage of the product lifecycle,” Medtronic Chair and CEO Geoff Martha said when announcing Mauri’s latest promotion. “Dr. Mauri’s expertise and leadership connects medical and scientific intelligence, ensuring we have a clear appraisal of the medical and scientific landscape as we make investment decisions, and helping to deliver effective and reliable innovations for patients and healthcare providers.”

Changes from Medtronic’s reorganization and the COVID-19 pandemic

Following Medtronic’s recently completed reorganization into 20 operating units (OUs), Mauri has a team that works with the OUs and also has employees inside the OUs.

“We have a central team that is shared services and centers of excellence around clinical medical and regulatory, but then the work on the specific programs for clinical trials or regulatory submissions or the chief medical officers that do work is all within the operating units and that’s through an indirect organization,” Mauri said. “When we think about how to move the needle for Medtronic, we want to think about it in totality.”

RELATED: Medtronic’s Design for Reliability and Manufacturability after the reorganization

Mauri believes many of the changes in how Medtronic and other companies conducted trials during the COVID-19 pandemic are going to become permanent.

COVID boosted remote technology out of necessity. Technicians can now make programming changes to ventilators for intensive care patients without entering the room for their safety.

“Whether it’s in the surgical suite with our surgical programs, avoiding the need to have somebody turn off your pacemaker when you go into an MRI setting, or the remote interrogation of devices that can happen directly from a patient through a phone, these are all things that I think are important and the measured benefits are to the healthcare system and the experience for patients as well,” Mauri said.

Another example is the adoption of remote methods for clinical research, with more focus on what data can be easily and reliably collected directly from patients through an app rather than hospital visits.

One pandemic surprise was enrollment increased for some trials — such as renal denervation procedures for hypertension — despite all the COVID-related challenges because Medtronic reached patients directly through social media.

“Patients had more time at home, they were interacting more with us without going to the hospital,” she said. “We could do a lot of the screening to check their interest in eligibility for the trial before they even had to go to a hospital location. Those are becoming the ways of working in clinical research.”