When developing laboratory instruments for the IVD sector, time is precious, budget is constraint, compliance is non-negotiable, and risks must be systematically managed. At HSE•AG, where we bring automation to the life sciences, modeling and simulation (M&S) is one of the hidden engines driving our success. Modeling and simulation can for example include whole system’s behavior, focus on modules and also predict outcomes of applications and workflows.
But what exactly does M&S bring to the table in a highly regulated environment like the European In Vitro Diagnostic Regulation (IVDR)?
Modeling for speed and agility
At the start of a development project, it’s important to explore a broad solution space, and not commit to a single approach too early. It is prohibitively expensive and time-consuming to develop and test multiple concepts experimentally but modelling offers an efficient alternative. A key part of this process is rapidly evaluating the physical working principles underlying a new instrument concept. At HSE•AG, we use simple analytical or lightweight numerical models for this purpose.
These models guide the early concept selection, enabling fast and informed decision-making. As we progress into the feasibility and development phase of the project, these models are refined into detailed simulations that support technical de-risking and a performance-driven design. Simulations of sub-systems can be combined into a digital twin that allows us to analyze and optimize the system behavior. Once the first instrument prototypes are available, we often the digital twin to optimize process parameters and to design compensation algorithms. The digital twin evolves and accuracy and reliability of the instrument improves.
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Cutting-edge simulation models guide early concept selection and support technical de-risking and performance-driven design.
Confidence through model verification and validation
Crucially, we treat model verification and validation as an integral part of the development process. Early in the project, we compare simulation results with experimental data from functional models and prototypes to confirm that the model behavior matches reality.
This alignment builds confidence – both in model predictions and in the decisions they inform. From experience, any development program benefits from a strong collaboration and exchange between modeling and experimental activities.
Covering the simulation landscape
One of the challenges we face is the wide variety of applications and simulation tools required to support a diverse range of IVD instrument projects. From fluidics and heat transfer to electromagnetics and optics, choosing the right modeling approach requires both experience and judgment.
With a small dedicated in-house team, we amplify our capabilities by partnering with CADFEM, one of the leading simulation companies. This gives us access to a large pool of expertise, the latest tools, and on-demand consulting, tailored for the challenge at hand.
Guiding experiments, not replacing them
If we do not develop the nth iteration of a design, functional models and experiments will not be replaced – however, we use simulations to sharpen and direct them. Simulations help us predict which design aspects matter most and where the critical thresholds lie. This allows us to be selective and strategic in our experimental work.
The benefits? Reduced development effort and a higher-performing product. At the same time, the transparency of the simulation model gives us detailed insight into the physical effects at work, deepening our understanding of the system – vital for risk management under IVDR.
The transparency of simulation models deepens our understanding of the system – vital for risk management under IVDR.
A digital trail supports traceability
One of the quiet superpowers of simulation is documentation. As regulatory requirements grow more stringent, M&S provides a traceable, data-backed story for design decisions. The models we build today become digital assets for future regulatory submissions, internal knowledge, and lifecycle support.
The essence of this article
Modeling and simulation guide early concept selection and support technical de-risking and performance-driven design.
The strong collaboration and exchange between simulation results and experimental data builds confidence and enables informed decisions.
Simulations reveal which design aspects are most important, reduce development effort, and provide a higher-performing product.
Curious how simulation could help your next development challenge? Let’s talk.
As a global systems engineering provider with a proven track record in life science and diagnostics, we recognize your need for innovative IVD products. We are committed to integrating simulation in the product development process.
At HSE, we ensure the products we design not only meet but exceed market demands, focusing on innovation, de-risking, and regulatory compliance to support your success.
Contact Philipp Hahn and discover how our deep application knowledge and technical expertise can help you achieve compliant, performance-driven IVD instruments.
Modeling and Simulation Expert Philipp Hahn
Philipp Hahn is a Senior System Engineer at HSE•AG and holds a PhD in mechanical engineering from ETH Zurich. He has been the Technical Lead in a variety of IVD instrument development projects and established and leads our numerical simulation team.
Philipp has almost 10 years of experience in systems engineering and design, microfluidics, and in vitro diagnostics.
Prior to joining HSE•AG in September 2022, he held positions as a Research and Development Engineer at Sensirion and as a Microfluidic Instrumentation Scientist at Fluidic Analytics.