Augmenting healthcare

Materials World magazine
,
31 Mar 2020

Kristian Debus heads Thornton Tomasetti’s team making advanced design-engineering capabilities accessible. Katherine Williams learns about his career spanning motorcycles to mitral valves.

Kristian Debus has a passion for uniting fields, a can-do attitude and a positive belief in the possibilities of healthcare engineering. He joined Thornton Tomasetti from Siemens Digital Industries Software, where he was Director of Life Sciences, medical devices and consumer goods. However, it wasn’t always healthcare that appealed to him.
 
‘I began my career at BMW. I was working on my master’s thesis in wind tunnel research using one of my favourite subjects – motorcycles. At the same time, I was serving as a photo assistant, mostly for my brother, who has been photographing motorcycles for BMW for almost 30 years now. It was this combination of working on a product from both an engineering and marketing perspective, where I learned that it takes more than great engineering to create a successful product and brand,’ elaborated Debus. 
 
‘However, I was never a very hands-on engineer and was really drawn to computer sciences. When I had the opportunity to dive into computational fluid dynamics (CFD), I jumped on it and fell in love with the concept of simulation. I started out using CFD for process engineering applications, and then had the chance to work on my first biomedical application – a post-doc position at the University of California, Davis, to write code to simulate aortic flow. Since my father had died of a heart attack, I found the idea of simulating cardiovascular flows fascinating, and hoped that one day this could help with diagnostics and maybe even cure heart disease.’
 
With life sciences, just as with motorcycles, you need to understand all the processes, shared Debus. ‘This includes marketing and sales to create a successful product. I left academia to learn the trade from a CFD mesh generation company. From there I learned how professional software is made and about end applications for simulation as well as biomimicry and green-tech.
 
By the time I arrived at CD-adapco (now Siemens), I was focusing on business development and working a lot with sales and marketing. I was also working on biomedical applications on the side and started my own company with three friends. We were developing a cardiovascular diagnostic tool using simulation and big data. Our ideas were spot on from today’s perspective, but the industry was not ready for it at the time.’ 
 
Streamlining clinical testing 
 
Debus sees his current role as supporting the healthcare industry’s transition to being at ease with technologies such as modelling and in silico clinical trials to bring real-world benefits.
 
‘The time it takes to get through the regulatory approval process needs to be reduced in order to make medical device design more cost effective and to deliver results more quickly. To really have an impact, the models have to be accurate and reflect reality. In medical device design, there is no way around complex multi-physics modelling to achieve realism. To shorten the cycle, the industry needs to augment their benchtop tests and clinical trials with simulation. An example of this would be running simulations on implanted devices with anatomical scan datasets to represent a virtual cohort, giving us the ability to mimic an actual clinical trial on a computer. 
 
‘First, we need to augment clinical trials with in silico trials. We need to walk before we run on these often very complex problems. With augmenting, we will initially support clinical trials with new data on how the device performs for a selected cohort, which can educate and guide us in the design of the trial in such areas as patient selection, operating and bounding conditions, material properties and impact and so on. If we can reduce the time and the number of subjects for a clinical trial just by 10%, it would be a huge saving. With time, as credibility and in silico expertise increases, we will minimise the need for animal and human testing.’ 
 
This all sounds like huge progress. But how does it work in practice? Debus explained, ‘After companies have designed their device in the CAD environment, they are still primarily focusing on physical tests. After the benchtop test, or in parallel with it, there is animal testing, then the clinical trials and so on. But a growing number of device developers are starting to support some benchtop testing with modelling, either in-house or through external experts like Thornton Tomasetti.
 
This is the first step in building confidence in the models, but they still need to be validated against the experiments. This means you need to develop suitable material models, along with robust CAD and multi-physics simulation models. As we move towards clinical trial support, we often include anatomical data and, again, validation of the model against the experiment needs to be the primary focus.’
 
What data are the team looking for? ‘That really depends on the stage of the development, the device type and various other factors. For a stent design, for example, we need to fully understand the properties of materials such as nitinol. As we move towards clinical trial support, the vascular tissue properties and anatomy of the blood vessels need to be included. The beauty but also the crux with medical devices is that they are so diverse, which is always interesting, but also challenging.’ 
 
Adopting new methods
 
While areas such as transport have long accepted modelling and simulation, healthcare has been slower to adapt. Debus wants to see change. 
 
‘The time has come for broad adoption of modelling and simulation in the industry. In this regard, we are far behind other industries like automotive and aerospace. If the device manufacturers want to stay ahead of the curve, they need to make an investment in modelling and simulations. This can be done through in-house experts or consultants, which can be more cost-effective and minimises risk. Since the applications are often very diverse, hiring a consultant also offers the obvious advantage of getting results faster and with more certainty. Knowledge transfer then allows you to grow your in-house expertise. That was the natural progression for other industries and the medical industry will likely follow suit. What helps is the support by regulatory agencies. Again, if medical device manufacturers don’t get on board, they risk being left behind.’
 
With so much potential for information and opportunities to improve technology, what is holding his attention at present? ‘The pace of how technology has been advancing is both exciting and startling. It’s really intriguing to think about all the possibilities to improve and innovate medical device design or healthcare in general. The sky’s the limit.’ 
 
But there is a note of caution to his enthusiasm, ‘The bigger problems for the healthcare system are the political and economic pressures. From an engineer’s perspective, we can build a digital twin of you and the medical devices you use or that are implanted in your spine tomorrow - if someone can just figure out how to pay for value and outcome, versus number of procedures. It’s a matter of quality over quantity.’
 
Where can materials improve and assist in this drive for better healthcare? ‘The biggest need for biomedical materials is in the characterisation of pathologic tissues. Specifically, improving our understanding of how diseased tissues differ in mechanical and biological response to healthy tissues.’
 
Time for radicals
 
It seems that Thornton Tomasetti has recognised areas of huge potential in business. The company goal is to change the entire ecosystem of human-centric engineering by providing the right tool for every use case. ‘Like others in the field, I have been passionate about this topic for many years. As early adopters, the software vendors, consultants, regulatory agencies, academics, and medical device makers have pushed to advance this technology into the mainstream,’ said Debus.
 
The company has made a long-term investment in the life sciences and intends to keep developing solutions. ‘The goal is to enable the adoption of in silico trials for clients and to help them all along the way to regulatory submission. We will work with the established leaders in the industry, but also have a specific focus programme from SMEs and start-ups, who tend to be the radical innovators in the industry.’
 
Was a career in medicine ever on the cards for Debus or has he always been a disruptor? Laughingly, he noted, ‘I am not very hands-on. You don’t want to give me a scalpel. Plus, Latin was my least favourite subject in school. You need to know your strengths and weaknesses. I am much better with computers and solving challenging problems. In order to make advances in the life sciences sector, we need all disciplines to come together. After learning how to make great software and how to market and sell it, I think I have finally arrived at the right place at the right time. The medical industry is transforming, and digitalisation is inevitable.’