“How to Optimize Product Development in Life Sciences”

In this episode, Norbert Leinfellner shares his thoughts on how to optimize product development in life sciences. Norbert has a very varied background. He comes from Graz, Austria, and is currently living in the Bay Area, in San Francisco, where he is the Head of PMO at Element Science, a medical devices company in the Bay Area. Norbert is a regular speaker at industry conferences and worked previously in senior program management roles with companies like Siemens, Carl Zeiss Meditec, and Fresenius Medical Care.

He has particular expertise in program management, global organizational planning, cross-functional relationship management, sustaining and value engineering, and all phases of product development in multiple clinical spaces.

Stream or download “How to Optimize Product Development in Life Sciences” below.

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Highlights from “How to Optimize Product Development in Life Sciences”

Norbert, you’ve got a lot of experience under your belt. Tell us a little bit about yourself. How did you end up in the medical devices industry?

Thanks for having me on the show. Yeah, I grew up in Austria, as you said, in Graz, the second largest town in Austria. It has two really nice universities. One in technology, so that’s where I graduated in physics, got my PhD there. I always loved to travel. And so I thought, you know, what do you do with the PhD? So, I thought I’d do some research, and what’s a better place to do research than in Barcelona, in Spain? They have a beautiful campus and beautiful research going on. So, I ended up there in the late 90s, but we also know that in the late 90s what happened?

Maybe you remember, it was the kind of the.com and the industry, especially the internet technology software, everything about technology was just going nuts. And so of course that was also heard in Barcelona. I was intrigued to actually join the industry. So I started a job at a German company, which is big in Austria, Siemens. Siemens is a corporation that is you can think of it as the GE of Europe. It covers all kinds of technology and has a lot of jobs for those that want to enter the workforce. But also those that are there for a very long time. So, it’s a very, very big corporation that promises to give you a career. So, I joined them. And hey, first, it was in Telecom, more about software integration. Yeah, and then I had the chance to join the medical technology industry, especially medical devices and that’s where everything started.

How did your background as a physicist help you in that realm?

That’s a great question. I believe physicists have a very broad education training. They are trained to look at everything, not just on the problem at hand, but also a little bit around. So, they learn very early on to structure the problem, to break it down into smaller pieces, to also be able to explain it well. I think this is something that came in very handy later on. If you listen to two theoretical physicists, they are in their domain and they just go on and on and on.

But as soon as you listen to theoretical physicists talking at a conference, or in class, everything sounds so wonderfully simple. I always admired especially the American physicists when they taught a lesson or, you know, had a show somewhere where they talked about a particular problem. It sounded terribly easy because they know how to break it down, into chunks, and then bring them all together. That is fascinating. I think that is what the physicists bring to the table. It’s the understanding that you have to deal with complex problems, one bite at a time.

Why is the role of the program manager important?

Yeah, program managers are the ones that, I sometimes joke about it, they’re not doing the work that the team does. What they do is they really enable. Those are enablers that help the team do the work really well in a way, that’s also is not only effective but also efficient. So it helps the team members to understand. First of all, again, we’re back to the problem. We have a complex problem to solve. Let’s break it down into chunks. And this is where you can start to do project schedules because a project schedule is nothing else, but a list of tasks with people and dates and, of course, dependences.

So, the program manager does just that, just comes in, understands the problem, the needs that executives have, breaks it down, creates a schedule with them. And then the program manager is there at all times, acting as a glue for the team, bringing the team members together, making them think. I call this, not just creative thinking, but creating thinking. So, he wants to make those people think and do. And then, of course, the rest is just very tactical as you have to be almost like … they call me in my company the one that is herding the cats. It is somewhat true, but this is exactly where the skills come in.

What do you perceive many differences in the rule of the project or program manager?

When I joined the start-up in San Francisco, it was a beautiful little company that works on a very revolutionary device that’s wearable. So, this is everything I ever wanted. Something that the technology marries wearable, medical patient safety, and algorithms, and cloud storage. So, this is what I always wanted. Now, coming from a big corporation that has a huge backbone of infrastructure behind them. Big pockets, they have revenue.

So, what I immediately saw was that a small company, sounded very easy because they have only one problem to solve, one thing to do, and this is to get this product out. It’s one product. It’s not 12 or 50 or 100 products. It is one product and they do not have a product on the market yet. So, this means they don’t have to take care of that product, which in the world of medical devices we call sustaining engineering. You have to make sure that the device can be still manufactured, it works appropriately in the field, it still meets all the regulations; regulations change.

So, usually, when you have a lot of products on the market, you own that liability, you have to take care of the products. For a small company, that would be a huge distraction. Imagine that half of the people have to be working in sustaining engineering. So, anyway, coming to a small company, it looks like paradise. There’s one thing to do. Everybody knows what to do. There’s one marching order. It’s a small team. There’s no fluff. Right? And if you are well-founded, then we take that kind of risk out of your head a little bit and focus on the work. So this is what I thought would happen.

However, I came in with my experience, I thought I can help this company get to the next level. I know everything about project portfolio management. I know how to do proper project risk management. I know how to do schedules and I showed them everything I know. Now what I didn’t know was they didn’t want to know about this. So, didn’t really ask for it. Okay. What I needed to do is to organize the work, to make sure that milestones are met, and that the end goal is met in a way that, it’s still kind of achievable.

So, it comes down to being much more tactical than I thought it was and it would be. And this is also very nice because it’s the herding cats, and that can be a lot of fun. Right? So I put all my strategic and all my big corporation kind of toolbox thinking on the side for a little bit and started to really understand what are people exactly working on, how can I help them, how can I make them work a little better, how can I show them maybe to when they do a meeting, maybe do the meetings a little bit more efficient, faster, easier. And then when it comes to scheduling and reporting, let me do that. I know how to do that.

So with the CEO, I have this personal connection, where I said, you know “Let me take care of all the reporting, people should just do the work and let me do the kind of the herding.” That was the big, big difference. In a big corporation, very often, you very typically operate in a matrix. And so sometimes it’s much easier to pull resources from here to there, do this and go back, and when you have a need because you’re stuck very often you have the funds to just get help. In a smaller company, you just don’t have the funds. You have to be much more creative, but this is what I really like about this world.

How can companies, large or small, best manage these kinds of “black swan”, catastrophic events?

Yeah, that’s a great question. Risk management is also very different between small and large. Very typically, you look at your internal risks more than you like to determine external risks. I learned that for a smaller company, especially for start-ups that have very little help to build up their own supply chain or to recruit consultants. They just don’t have that financial flexibility or maybe the internal skills to do that. But what I learned, especially in a small company, is that you have to manage your external risks much better.

We have very, very good examples these days. We all think about the supply chain these days, I mean, almost on a weekly basis we get calls from our suppliers saying that we cannot deliver this part anymore because the material for it is not sourceable anymore. So, we have to change the material but this means there is a delay in getting you the part and so on. Let’s not even talk about the chip shortage and microprocessors. Those we cannot source as much as we would like to. So managing external risks becomes incredibly important.

So, now let’s talk about the black swans. Let’s talk about the animal first. The black swan is an animal that is very rare and there was a time, hundreds of years ago when nobody believed it existed because every swan was white. Now, there was this one guy, he was a Dutch explorer, I believe, Willem de Vlamingh. In the late 1600s he went to Australia and he saw a black swan. This was the first time where the world actually woke up to the idea. Oh, there could be something like a black swan. So, they’re actually more likely than unlikely.

So coming back to the project management role. This is how you need to start thinking. You think of very rare events. You think “Oh, tomorrow, we cannot get this microprocessor or this one part”. This is just a very otherwise standard part that is in a catalogue and you can order. Now, a black swan event, this part disappears from one day to the other, what do you do about it? So, this is something that the project managers maybe, a few years ago didn’t think about as much. So, black swan events weren’t in our kind of toolbox. So, now we get much better.

The pandemic thought us that we cannot rely on the supply chain. It’s very difficult to hire the talent with need. We have 27 open positions. Try to fill those in the Bay Area quickly. It’s very, very difficult. So, the pandemic was one of the black swan events that change our thinking and we see other global events happening these days that can equally create those black swan events. So, I would suggest that program managers, and their team of project managers, maybe sit down and start thinking about “Okay, everything we have assumed so far in our world, in our schedule, in our resource planning, in our milestone planning, is there anything internally or externally that can look like a black swan?”

Maybe it’s a white swan with a black head. And by the way, those exist, I saw them when I went to a conference in Orlando last year. I saw a white swan with a black head. So, coming back to project management. They do exist. So, how can you prepare for it? It’s a little bit difficult to think of medications for it. But you will be surprised if you sit down with your team in a quiet moment and talk those risks through with the team. They will come up, with a very, very creative way to think about mitigations and that is a wonderful thing to do. So, I would recommend everyone to sit down and think a little deeper. And think about the black swan that you probably never saw. But one day you will see it.

Show Notes

Connect with Norbert on LinkedIn

*Bonus*

If you’d like to explore this topic in more detail, download our complimentary guidebook Pharma Project Management in the “New Normal” at corasystems.com/pharmaspeed

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