Matters of the Heart

In August of last year, Abiomed Europe GmbH opened its expanded European headquarters at Neuenhofer Weg in Aachen after four years of modernization. Abiomed develops and produces the Impella heart pump in Aachen, the smallest heart pump in the world, which Dr. Thorsten Sieß invented in Aachen in the 1990s. These heart pumps are as small as the tip of a pencil and are temporarily inserted into the heart to support or take over its pumping function for blood circulation. To date, more than 250,000 patients worldwide have benefited from this special life-saving technology.

Dr. Thorsten Sieß founded Impella Cardiotechnik GmbH with Dirk Michels and several other co-founders in 1997. A few years later, the American medical technology group Abiomed took notice of the Aachen-based startup and acquired it in 2005. Since then, the Aachen site has been expanded to become Abiomed's European headquarters under the executive management of Thorsten Sieß and Dirk Michels.

Another chapter in the Impella and Abiomed corporate history was written at the end of last year, as Johnson & Johnson, the world's largest healthcare products provider, acquired Abiomed Inc. However, Abiomed continues to operate as an independent company within Johnson & Johnson's medical technology segment.

Dietrich Hunold and Siba Fitzau from the RWTH Alumni Team spoke with Thorsten Sieß and Dirk Michels about their exciting research, the company history, and memorable personal experiences with their company.

Dear Dr. Sieß, Dear Mr. Michels, You have been on the road a lot in the last few months…

Dr. Thorsten Sieß: ... yes, and this won’t change. In fact, we’ll be even busier in the future. We are here today on a flying visit, so to speak.

 

The many trips you’ve been on lately have a particular reason.

Dr. Thorsten Sieß: In addition to the tasks of day-to-day operations, we were acquired for the second time at the end of last year; this time, by the largest supplier of medical technology and pharmaceuticals, namely Johnson & Johnson. Post-merger integration is not something that takes place overnight. That's where we, as the people in charge, have to provide a lot of support. Acquisition is one thing; integration is another. We want to do both successfully for the benefit of our patients.  

 

When people say their company has been bought out, it often has a rather negative connotation. However, I assume that it is different in your current case.

Dr. Thorsten Sieß: I'll even go back a step. After all, we already experienced this once in 2005. The prospective buyer at the time, Abiomed, needed a cutting-edge product. They were looking for a product just like our Impella technology. And we were looking for financial stability and greater access to the market. As a small startup, you're only scratching the surface of the market, at most, but you’re not really getting in. So it really was a win-win situation. Even back then, integration was not easy and it was not something that just happened by itself. Mr. Michels and I traveled back and forth many times and learned that trust can only be built by working together and not just by talking about it.

Dirk Michels: I think you have to look at it from two angles. One is the rational one, as just described; that is, the reasons why it is a good thing. From that perspective, the case is very clear. After all, the two companies’ cultures are very similar. And secondly, it is another step toward financial stability for us, especially being listed on the stock exchange. Looking at all that, Johnson & Johnson is a perfect fit. But there’s no denying it: you also have to consider the emotional aspect. The merger certainly affected people – including us – in 2005, and it does so today. Many employees here have come to us because they have previously been affected by a company’s post-merger rationalization measures. These people are afraid. They see the merger in a negative light for now. It is our task to work with them, to approach them personally. So you have to see the rational and emotional side of things. It's about people, our employees, who we care about.

 

You just emphasized personal conversations with employees. I imagine this was more difficult during the pandemic.

Dr. Thorsten Sieß: We actually managed that quite well; we were always ahead of the curve, so to speak. Because we had worked back and forth across the Atlantic before, video conferencing was nothing new to us; we recognized that it was an important tool early on. As it happens, on the day we were first told to stay home, we had just introduced a new system. We were then very quickly able to talk to each other, communicate, and work together in a different way. So it was a stroke of luck that we didn't have to build these communication structures from scratch.

We had also already converted some parts of the company to being paperless at an early stage. Of course, there are situations and jobs where you must be on-site at the company. After all, you can't build a heart pump virtually. So we depended on colleagues here to ensure that production could continue.

Dirk Michels: In addition, it must be said that we implemented an incredible number of measures; for example, we set up our own test center as early as September 2020. We tested every employee there free of charge. Staff can still get free self-tests at the front desk now. We took a number of measures to make sure that our staff could feel comfortable here. That's what our employees all said, too: If there's one place where they feel safe, it's at work! We even picked them up by cab when they couldn’t come by public transport. We managed to get everyone through the pandemic safely, and we were able to go about our business without any restrictions.

 

Let’s leap back in time to the past. Dr. Sieß, you invented the Impella heart pump. How did it come about?

Dr. Thorsten Sieß: At that time (the early 90s), you could not study medical engineering, but you had the opportunity to attend specialization lectures. My future boss, Professor Paul Reul at the Helmholtz Institute, told me in a lecture about a development in the USA called a “HEMO pump.” That was a pump at the tip of a catheter, miles away from what we can do today. But it was the first of its kind. That totally fascinated me. I originally wanted to work in aerospace and was working on a mini turbine at the time. That fit the picture quite well. So I applied and said: Mr. Reul, I would like to work here. I then practically submitted my own DFG application. It was approved and I was employed there for four years for my doctorate.

 

A research project like this is one thing, but turning it into a commercially viable product is another. How did you come to found a startup?

Dr. Thorsten Sieß: Such a path is never straightforward. When you work scientifically at a university, it's often publish or perish. Of course, I was also required to publish academic work. And because of my publication, the Helmholtz Institute came to the attention of the Director of Business Development at Eli Lilly Corp, later Guidant. They were looking for a completely implantable, long-term supportive pump, a liver cirrhosis pump, so it was to be for a totally different indication. They had a rough idea of what it should look like - a highly complex system with an integrated battery, controller etc. And, of course, they also needed a pump, but that didn't exist yet. Then they came to us. We started this project alongside others. Then Eli Lilly spun off its technology division to Guidant, which was then interested in commercializing this technology with us. Then the only question was: Where do we do it all? Do we choose Silicon Valley, where Guidant was based, or do we do it here locally? Guidant saw how well we are networked here and their CEO at the time said: Let's take a look in Germany and see if we can find the venture capital and match money there. That was quite the challenge for him.

Guidant's idea was to gain market access by developing a new therapy. We are all familiar with heart-lung machine surgery. But now, when you're operating on the coronaries – which are the vessels on the outside of the heart – you don't have to go into the heart. There is actually no reason to shut down the heart. So, at that time, the idea was to let this heart continue to beat, and then operate on the coronaries - without a heart-lung machine - which is no easy feat. It's kind of like fixing the engine on your car while it is running. This is only possible if you have the right technology. And as far as coronaries are concerned, Impella provides this technology. That's how we came together.

I have to be honest: It wasn’t all plain sailing. The first product was not so successful. If you're a startup and you're not making money yet, your lifeline is in the bank. The money will then last for ten months. Then you need to gather money again. And you need to convince investors that it is still worth investing in the technology. In addition, if you then determine that the first market appearance didn't work out so well, then it becomes difficult at some point. We had a lean period like this, but we learned from it: Never try to do two things at once as a startup, for example, establish a new technology and a new therapy. When all was said and done, we successfully overcame this difficult time.

 

You have to have nerves of steel…

Dr. Thorsten Sieß: Not only that. You have to believe in the cause. I will say this much about the insolvency at this time: We restarted with all the employees we had to send home. We did not lose a single person. Everyone, really everyone, believed fully in the cause.

Dirk Michels: We've had situations where we both felt that we would end up becoming our next customers ourselves. You worked until five o'clock in the morning, splashed a little water in your face, then you went on. To cut to the chase: I guess you have to be a little crazy.

After finishing my studies in the US, I came back and a friend of mine said: “I'm doing student research with someone right now who wants to start a company. It might be something you’d be interested in”. In October 1997, I went for an interview. Before that, I had applied to other companies in a very traditional way and also had a very conservative view of things myself. During the interview, I found out that not only did the job I was applying for not exist yet, but the company didn't even exist. There wasn’t even any money to start the company yet. Two months later, however, Mr. Sieß called me and said: “Come on, let's get started now!” It's in my nature to do crazy things sometimes. I was so drawn to it all. In addition, Mr. Sieß has a quality like no other in the company: an innate sympathetic power of persuasion that what he does is the holy grail, so to speak. You really switch off rationality; you're totally inspired by him.

Then, on December 23, 1997, we founded the company. The decision to start the company was the best decision of my life. The team was an incredible conglomeration of like-minded people, equally crazy, equally inspired. A key component of this success was really this collection of 40 or 50 people, a core of personnel since the 2002 bankruptcy, who all thought alike, who were really united in their goal, and who did not put self-interest first.

 

What are the technological and strategic goals now? How much further are you going to go with the Impella pump?

Dr. Thorsten Sieß: We have a pump here on the table in front of us; this is the Impella CP. That's where we are today with variant 11. We are always improving our products based on feedback from the market and further research developments. Systems are becoming more compact, better, and more intelligent. In terms of size, we can't make a miniature blood pump like this any smaller. That's why we started looking at new systems more than 20 years ago, at the same time as we were working on the current Impella technology. We asked ourselves where we really had to be small. We have to be small where we want to be in the patients' bodies. So now, if we could manage to build a pump that we can compress down wherever we go in, and then open it up again in the body, it can pump just like a much larger device. The Impella ECP is exactly that development. It was also a development that brought all the pain as well as the ups and downs with it. We lost this technology in between; then we bought it back again. Now we have it in clinical trials.

Dirk Michels: There are four things to concentrate on: “Smaller” is still the way in which we need to go. “Smarter” – that's where digitization comes in. The next one is “longer support life,” meaning that the product functions not only over days or weeks but over months and years. The last thing is that we're looking at our approach to therapy a little bit more holistically, as it hasn't been as focused on the heart thus far. Patients who have a heart problem often have other problems as well, whether it's lung problems or kidney problems. Therefore, our developments also go into supporting such organs as well. So those are the four directions of development that we're working towards at the moment. These cover our future developments, where we have incredible potential. We are not short of ideas.

 

Let’s focus on the Aachen site for a moment. There is a lot of construction going on here. Apparently, the location here is “safe”, so to speak.

Dirk Michels: We were an American company, and we still are. The main location is in America. It must also be said, of course: Our product was invented in Aachen, was built in Aachen, and goes out from Aachen into the whole world. We feel a great need to keep this technology in Aachen and to leave a mark here that remains in place. What does that mean? You see the building here, which we bought a few years ago. We have a building of 7,000 square meters of floor space, a large production space in the lower area with about 800 square meters of clean room. Then we bought another building here, where we have another 4,500 square meters, primarily laboratories and offices. Now we are expanding even further. Around 140 million euros will be invested in expanding our production site. We will use it to build another 5,000 square meters of space, which is primarily clean room. And we will triple the current clean room space. Of course, this includes parking spaces in the new parking garage and the like. This should be completed by 2026/27. That's the time plan right now. This will certainly then create more jobs; we are already hiring 15 people a month at this site. And that will continue for the time being.

 

And the proximity to RWTH ...

Dr. Thorsten Sieß: ... we still maintain that we benefit from it. We always have five to seven students in the research area who are doing a bachelor's or master's thesis or internships. And these often include young people whom we take on afterwards because we have also gotten to know them. Mostly these are people with intrinsic motivation.

Dirk Michels: Of course, we also support RWTH with scholarships.

Dr. Thorsten Sieß: This proximity to the site is important to us. This goes so far that we are allowed to use RWTH laboratories in certain projects if we do not have the necessary equipment on site. This works great.

We should emphasize again: We don’t just build heart pumps. We also support clinical research with a lot of money. Everything ultimately has to be based on evidence in the long term. The point is to show what can be achieved with the appropriate cardiac support. We like to talk about products, but the research is at least as important as they are.

 

Dr. Sieß, Mr. Michels, thank you very much for the detailed interview.  

– Author: Dietrich Hunold