“Innovation is core to who we are,” Abbott Medical Devices Group President Lisa Earnhardt says in an interview covering device design, customer needs and diversity in medtech.

Lisa Earnhardt still remembers an important takeaway from the frontline of her first product launch.

The Abbott EVP — who’s group president of the world’s eighth-largest medical device business — was working at Dairy Queen in the summer of 1985 as it debuted the Blizzard. She recalled stressful moments turning the frozen desserts upside down in front of the customer, proving they were so thick they wouldn’t fall out of the container.

“It was the first job I had where I had customers that I recognized,” Earnhardt said in an interview with Medical Design & Outsourcing. “At the end of the day, the customer is always right. Understanding what it means to thrill a customer was a great learning [experience].”

It’s a lesson medtech’s most powerful woman is reiterating as Abbott launches new and improved devices across its portfolio, including innovative systems for cardiac rhythm management, electrophysiology, structural heart, heart failure, vascular therapies, diabetes care, and neuromodulation.

All are meant to get the device, drug, diagnostics and nutritional products manufacturer to its goal of treating 3 billion people around the world by 2030, a 50% increase from Abbott’s 2 billion patients in 2020 when the company set the target.

In 2023, Abbott medical device sales grew 14% to $16.9 billion, helping it rise from No. 10 to No. 8 in MDO’s latest Medtech Big 100 ranking of the world’s largest device companies.

“We truly are in a transformational moment in the medtech industry broadly, and at Abbott we are leaders in this transformation, helping people with some of the most chronic, prevalent diseases like diabetes, cardiovascular care, chronic pain, movement disorders, some of the most challenging conditions,” Earnhardt said. “… Innovation is core to who we are.”

Earnhardt’s medtech career

After her first jobs detasseling corn in rural Illinois and slinging soft serve, Earnhardt earned a degree in industrial engineering from Stanford and then an MBA from Northwestern.

She was a healthcare consultant before joining Guidant in 1996, where she worked for medtech veteran Maria Sainz, succeeding her as Guidant’s cardiac surgery president following Boston Scientific’s 2006 acquisition of the company. A unique blend of attributes makes Earnhardt a strong leader from several perspectives, Sainz said.

“She has this incredible balance of intellect, humanity, leadership and drive,” Sainz told MDO. “… She’s a very caring human being, someone with a special touch, someone that will make sure those who matter feel that she cares, that she is there for you.”

Earnhardt left Boston Scientific in 2008 to be president and CEO of Intersect ENT. She led the implant developer for 11 years and stepped down to join Abbott in 2019, three years before Medtronic bought Intersect ENT for $1.1 billion.

Abbott hired Earnhardt to lead the medical devices business after promoting her predecessor, Robert Ford (now Abbott’s CEO and chair), to serve as president and chief operating officer. The medical device business was and still is the company’s largest segment, bringing in 42% of Abbott’s total revenue in 2023.

“The world needs more leaders like Lisa at the helm of businesses,” former Johnson & Johnson MedTech Worldwide Chair Ashley McEvoy said in an interview, describing her former competitor as “fair and fierce.”

“What I’ve always appreciated about Lisa is her deep belief that innovation’s best years are ahead to improve patient care, and she’s very collaborative to advance the health of the industry,” McEvoy said. “… Lisa is a beautiful ambassador of the industry, because she’s got street cred on engineering, innovation, building cultures, being a good collaborator, getting performance and always being in service of patients.”

While many other leaders of the world’s largest device businesses hold MBAs, Earnhardt’s background as an engineer is unusual among that cohort.

“Engineering is all about problem-solving, and it taught me a methodical way to think about problem-solving,” Earnhardt said. “In medtech, we’re solving some of the most challenging problems we’re faced with in terms of healthcare, and we’re doing it through technology.”

As she sees it, that starts with understanding the needs of the customer — or the consumer, in the case of diabetes patients who manage their own care with increasingly affordable and user-friendly wearable sensors and pumps.

“I always say, ‘God gave you two eyes, two ears and one mouth for a reason.’ It’s listening and observing or watching what’s working — or more importantly, what’s not working — and what we can do to add value,” Earnhardt said.

Expanding healthcare access through device design

The global diabetes epidemic is one of Abbott’s biggest opportunities to reach more patients, with more than half a billion people who could benefit from glucose monitoring.

About 6 million patients use Abbott’s FreeStyle Libre continuous glucose monitoring (CGM) platform, but Earnhardt said a previous product’s “complete failure” paved the way.

“It was complicated to use, it didn’t have the impact we had thought, and the team went back and soul-searched,” Earnhardt said. “[They] came forward with some principles to have an impact on the way that people manage their diabetes: We need to make it easy to use, we need to make it affordable and accessible to the millions of people who can benefit.”

To cut manufacturing costs at scale, Abbott designed its FreeStyle Libre products for high-speed, automated fabrication and assembly while investing hundreds of millions of dollars to upgrade and expand its manufacturing operations, including a new factory in Ireland.

Abbott designers joined the transmitter and receiver for a one-piece sensor that’s more efficient to make and easier to use, for example, and for the latest-generation FreeStyle Libre 3 designed a one-piece applicator instead of two pieces. All these efforts paid off with a device that sells for half the price of competing sensors.

“We worked in partnership with a number of external vendors on the automation piece, and it’s been a game-changer for us as a business and a game-changer for the field of diabetes,” Earnhardt said. “… It’s set up very intentionally from the very beginning of the development process.”

Now, Abbott’s launching Lingo, an over-the-counter, wearable CGM sensor for real-time glucose readings. The goal is to use machine learning algorithms and Abbott’s trove of more than 50 billion hours of glucose data to help users predict how their activities affect blood sugar levels so they can make appropriate changes.

“This is a powerful example of not just how healthcare and consumer technology are coming together, it’s an amazing example of how we’re able to move to what I truly consider healthcare, and it’s going to be an amazing example of how we can leverage the power of AI,” Earnhardt said, displaying a Lingo sensor on her own arm.

Another Abbott product tapping AI is its Ultreon intravascular imaging software, which uses optical coherence tomography to help interventional cardiologists visualize plaque inside a patient’s artery for more efficient and accurate stent placement.

“You wouldn’t necessarily think about that as innovating for access,” Earnhardt said, “but to the extent that we can democratize procedures and make it easier and more predictable for more clinicians to be able to utilize the technology in a more efficient fashion, that has global impact.”

She called out other innovations like the AVEIR dual-chamber leadless pacemakers, the Abbott Volt pulsed field ablation system for cardiac ablation, the bioabsorbable Esprit BTK drug-eluting scaffold for peripheral artery disease, and the Eterna rechargeable spinal cord stimulation system for pain relief.

MDO Min-Vasive Medtech Series: Watch an on-demand interview with Abbott AVEIR Chief Engineer Matthew Fishler about minimally invasive device design

“We just announced we’re launching a trial for treatment-resistant depression utilizing deep brain stimulation (DBS),” she said. “That’s a huge unmet need, a very difficult condition. We think there’s a really compelling application of DBS for that. The list goes on and on.”

Expanding access through diversity

Another opportunity to reach more patients is to increase gender, racial and ethnic diversity within the medtech industry and Abbott, where women make up 46% of the company’s global workforce and 42% of its managers.

“At Abbott, I’m surrounded by talented women [but] we still have work to do,” Earnhardt said. “It’s ensuring you’re recruiting the right talent, developing the talent, retaining the talent, even recruiting and developing the talent before they’re ready to be hired at a company like Abbott. We have a program starting at the high school level focusing in particular on girls and minorities in STEM, and part of that is making sure we have the right pipeline of talent and they get interested in an industry like medtech.”

Asked for advice for other women in medtech, she encouraged them to always keep learning and challenging themselves, and to trust in themselves and their experience.

“Sometimes that self-doubt comes in, probably more so with women. … That self-doubt voice needs to be put aside,” Earnhardt said. “You are where you are because you’ve demonstrated your abilities. You’ve demonstrated your potential.”

And asked for advice more broadly for everyone in medtech, she said time with customers is time well spent, whether that be informal ride alongs and observations in clinical settings, or more structured activities like market research, focus groups and advisory boards.

“Hearing directly from patients who are impacted [is] incredibly motivational, not just understanding what the needs are in the mind, but feeling it in the heart,” Earnhardt said.

“Oftentimes the interactions we have — whether it be our commercial organizations or our clinical teams and our R&D engineers — tend to be with the clinicians or the physicians using our products, and those are incredibly beneficial and make a huge difference,” she later continued. “But … it’s amazing when you hear from [patients] how we might be able to make their lives easier or provide more reassurance or give them more information so they can control their own health. It’s powerful.”

Finally, she emphasized the importance of “being authentic to who you are.”

“It helps build trust,” she said. “Trust is the foundation for all relationships. It’s the foundation for strong collaboration, for building world-class teams. Work is hard enough, so being yourself is the easiest thing to do.”

This story was originally posted on Sept. 23, 2024, and updated on Sept. 30 with comments from Ashley McEvoy.