Medical Device R&D Simulation Services

Any cardiovascular, neurovascular, or peripheral device would benefit from simulation services. These include transcatheter mitral and tricuspid valve replacement devices, coronary and peripheral stents, braided or self-expanding stents, stent grafts, embolization coils, flow diverters, aneurysm occlusion devices, and septal or left atrial appendage (LAA) occluders.

Through the FEops acquisition, Materialise has strengthened its medical image analysis capabilities with simulation technology. The FEops FEA experts performing these services combine an exceptionally strong academic background (PhD in biomedical engineering) with 15+ years of simulation experience in the medical device industry.

Materialise offers a unique combination of advanced simulation expertise, patient-specific anatomical modeling, and a strong understanding of device development and regulatory requirements. Materialise does not approach simulation as a purely theoretical exercise, but builds and validates models that support concrete decisions in design optimization, worst-case definition, fatigue testing strategy, and clinical adoption.

Results from simulation services can be used to build regulatory evidence, such as characterizing in vivo loading conditions and stress and strain distributions, and identifying worst-case scenarios for fatigue testing. The use of simulation has quickly become the norm in medical device design as regulatory bodies, including the FDA, increasingly accept in silico and simulation-based results for clinical evaluation — ranging from first-in-human (FIH) and early feasibility studies (EFS) to the submission of investigational device exemption (IDE) and pivotal trial preparation.

Examples of simulations we perform include, but are not limited to:

• Structural mechanics/finite element analysis (FEA)
• Computational fluid dynamics (CFD)
• Fatigue analysis (in vivo, bench, virtual cohort, worst-case condition assessment)
• Deployment simulations to compare designs and evaluate performance across anatomies
• Device-tissue interaction analysis (contact, apposition, anchoring, and force assessment)
• Durability assessment (hydrodynamic performance testing support)
• Delivery system simulations
• Preoperative planning from first-in-human case to routine clinical use, including workflows compatible with reimbursement pathways (learn more about this service here)

The accuracy of medical device simulations depends on model quality, relevant input data, sound assumptions, and — most importantly — rigorous validation. Depending on the development stage, validation may rely on literature, bench testing, animal data, and at later stages, such as EFS and early human implantation data. In all cases, simulations are essential for defining physiologically relevant and worst-case conditions for fatigue testing.

Yes! Simulation can tremendously reduce the number of costly physical tests and even animal studies in many different ways. For example, by verifying your prototype with a realistic in silico setup and making design changes based on the outcome, assessing two potential device designs with simulation to define which to continue, or identifying fatigue risk upfront with in silico tests. All scenarios lead to fewer bench or animal tests, thanks to smarter design iterations based on computational modeling and simulation. Moreover, the simulation strategy to support very long fatigue testing can be discussed and verified with the FDA and other regulatory bodies upfront.

It depends on the project, but typically around 1 – 4 months. Projects are usually split up into smaller parts to accommodate the dynamic and fast-paced nature of medical device R&D. It is ideal to start during the design phase, in parallel with initial prototyping and bench testing.

Yes, each project is analyzed on a case-by-case basis. We'll develop simulated scenarios according to your device, needs, and R&D questions.

At a minimum, a sketch (drawing) of the device. Then, we can incorporate material and mechanical testing. Anatomical models are already in our database, either patient-specific or built to reflect statistics (e.g., using ADAM services). We can also start from patient data you provide, such as a CT scan of an animal or a human.