How Abiomed became a major medical device company


AbiomedAbiomed has quickly climbed MDO’s Big 100 list, landing this year at 90th, and it has done so without major acquisitions. Fueling the global medtech company’s growth is a device with unique indications and a patient-centered business strategy.

More than 60,000 patients have been treated using Abiomed’s Impella heart pumps – and every time the world’s smallest heart pump is given to someone, CEO Michael Minogue and his management team get an email.

The email, which contains case information and notes from the physician, is just one way that the company seeks to put patients at the center of their business.

The company’s newly-expanded headquarters doubles as a shrine to their patients. Hanging along the walls of nearly every room and hallway are pictures of people who are alive thanks to Abiomed’s devices. Walking through the facility, Minogue stops at each one and recalls their name and story. He says that despite any obstacles Abiomed has faced in the past, it’s the company’s passion for patients that has propelled them to success.

“Abiomed is a great company because we failed,” Minogue said, referring to a December 2012 FDA decision that forced the firm to take to the more-stringent pre-market approval path after initially marketing the device under a 510(k) clearance. “It’s hard to change the standard of care. But we put the patient outcomes as a priority above everything else – above revenue, above growth. If you do that, you’ll survive and you’ll do well.”

Based in Danvers, Mass., Abiomed (Nasdaq: ABMD) is a disruptive player in the cardiovascular space. In 2016, the company’s headcount rose to 1,000, its revenue climbed to $330 million and they more than doubled the space of their headquarters with a massive expansion project.

A little over a decade ago, the company wasn’t making heart pumps. Instead, they were focused on developing the world’s first artificial heart – a feat that they accomplished in 2001. After Abiomed acquired the Impella technology in 2005, the company evolved from heart replacement to heart recovery – a concept Minogue says is entirely unique to Abiomed.

Recovering a patient’s own heart

When a person suffers an event like a heart attack, the heart muscle stuns itself into hibernation and slows the flow of blood to the rest of the body. This triggers the brain, which is receiving less blood than usual, to try to stimulate the heart to do more work. The kidneys begin to shut down in an attempt to reserve blood flow back to the extremities. It’s a cascade of organ failures.

The purpose of Abiomed’s Impella device is to help restore blood flow and allow the heart to rest. The device, snaked through the femoral or ­­­axillary artery, sits in the heart and spins at 50,000 revolutions per minute, sending blood away from the heart and to the rest of the body.

It’s a minimally invasive procedure that differs dramatically from the standard of care. (Download the full Big 100 list here. )

Traditionally, surgeons have used a procedure called a sternotomy to access the heart. It involves opening the sternum with a saw, spreading the ribs and taking out a chunk of the heart muscle to insert a device.

The patients that Abiomed’s pumps are designed for have had very few options for treatment in the past. They are usually too sick or too high-risk for most procedures and their next step is often a heart transplant.

Abiomed’s pumps are the only products approved by the FDA as safe and effective for high-risk percutaneous coronary intervention and acute myocardial infarction cardiogenic shock. The Impella device is also the only product on the market cleared for heart recovery – a point of immense pride for the company.

Keeping a patient’s native heart is critical, Minogue says, from a clinical perspective and from a financial perspective.

“The reason this technology is growing so much is because maintaining your own heart is the greatest outcome. God is the best engineer and if you can keep your native heart, that’s going to be the best quality of life, that’s going to be the most cost effective,” he explained. “Because these are million-dollar patients if they don’t recover.”

The device can be used for patients undergoing a variety of heart-related conditions. Minogue said Impella has saved the lives of people who have had a massive heart attack and have gone into cardiogenic shock. But it’s also been used to treat kids with viruses that attack the heart. The pump has helped women with post-partum cardiomyopathy or spontaneous coronary artery dissection. Among the thousands of patients treated with an Impella device since it first launched, there is one thing that binds them all together – most of them still have their own heart.

Changing a decades-long standard

One of the challenges still facing Abiomed is that there are a lot of patients that should be using their devices, but don’t have access to them, according to Minogue. The company is constantly working on ways to improve the device to make it easier to use.

“The ease-of-use is important because we’re asking physicians that have been treating patients for the last 40 years in a certain way, we’re asking them to do something new on one of the sickest patients in the hospital,” he said.

In one room in the company’s Heart Recovery Institute, there is a model used to simulate Impella’s set-up and administration process. Two months ago, Minogue set up the pump in one minute and twenty seconds – and he is quick to say that he isn’t the fastest at the company

Speed and comfort are extremely important, as Minogue pointed out – some patients get Impella while doctors are still performing CPR on them.

“It’s got to work, it’s got to be quick, easy, reliable and [healthcare workers] have got to feel confident,” he said.

One of the ways that they work to improve their devices is by thumbing through the emails they get every time a patient receives an Impella device. Each Monday, the staff gathers to look at the cases that offer opportunities to improve – whether it involves changes to training protocols or fixing something in the software that controls the pump.

The company also spends a “tremendous amount of money” on a registry of data. In the U.S. database, they have information from more than 60,000 patients that they use to identify best practices and ways to boost outcomes.

The company will even set up live cases to stream into a large auditorium at Abiomed’s headquarters, so that engineers and scientists can chat with doctors about what works and what doesn’t work.

“Adoption is a function of training, data and time,” Minogue said, adding that the company is deliberate in its pace. “There’s a lot of regulation, there’s a lot of scrutiny on physicians. They have to make sure that, as a company, you get great outcomes for patients. You don’t try to go at a pace that eliminates the ability to control that.”

Moving forward, Abiomed is developing new pumps for different patient populations – such as the Impella 5.5 and the Impella BTR, which are designed to support patients with heart failure. Minogue envisions that the Impella family of devices will be used with other adjunctive therapies, such as stem cells or immunosuppressants.

The company is also prototyping devices that could be used to calculate cardiac power and help heal the heart just as you would any other muscle. Using real-time information in what Minogue referred to as “smart pumping,” an algorithm could be used to wean the heart back from its hibernation state as it grows stronger.

Ultimately, Minogue said he sees a future without sternotomies and without heart-and-lung machines.

Growing a successful medtech company

Abiomed is aiming to be the fastest-growing, GAAP-profitable medtech company that improves the standard of care, Minogue said. To accomplish this, the company has to strike a balance between financial stability and growth.

“Financially, our discipline has allowed us to be profitable in an earlier stage, have no debt and have a very strong cash position,” Minogue said. “But that happens when you focus on those things. It’s a lot of work and it means that you defer investing in things like [building an expansion] until you get to a certain level.”

Hanging outside of Minogue’s office is an excerpt from the book, Blueprint to a Billion by David Thomson, which he said helps to reinforce their business strategy.

“The bottom line is not about the coolness of the brand, the positioning of the business or the pedigree of the CEO. Those can be important inputs; however, it is exponential revenue growth that makes a great company — so long as the management team ethically seizes the opportunity that it creates to achieve profitability, maintain positive cash flow, and produce high return on capital,” the quote reads.

Lining the walls of the main hall in Abiomed’s headquarters are the company’s values – recovering hearts and saving lives; leading in technology and innovation; growing shareholder value; and sustaining a winning culture.

Under the plaques that describe each value sit conference rooms, each named after a patient whose life has been saved with an Impella device. One room is named after the first patient in the U.S. to be treated with Abiomed’s Impella 2.5 heart pump.

“Without any exaggeration, he went from being couch-bound to playing golf with me in Puerto Rico at one of our national meetings – and he beat me,” Minogue said.

If you ask Minogue what has fueled the growth of his company over the years, he will say it is a relentless focus on patients and their hearts.

“We’re not talking about one less day or half a day in the ICU. We’re talking about someone being able to stay alive and potentially go home with their own heart.”

(See the best minds in medtech live at DeviceTalks West, Dec. 11–12 in Orange County, Calif.)

NEW! Technology Track at DeviceTalks Boston

textadimage These featured panels at DeviceTalks Boston will explore the state of R&D at major medtech firms, as well as the latest trends when it comes to developing combination products, neuromodulation devices, robotic systems and women's health technology.

View Technology Track Featured Sessions

Register today to save. Use code TECHTRACK to save an additional 10%.

Speak Your Mind