Investigations of Base Simulation CAD Packages for Initial Regulatory Feasibility Testing in Medical SMEs

The development of medical devices is a complex and highly regulated process, often requiring skilled engineers to conduct advanced analyses for mechanical safety and efficacy. However, med-tech SMEs with limited resources face challenges in navigating these requirements. Industrial designers play a crucial role in making devices both functional and competitive by incorporating ergonomics, aesthetics, and user comfort, and recently basic FEA analysis. To support this, we propose a framework showing how Industrial Designers can utilize basic linear and static simulation tools, allowing for iterative design refinements that align with regulatory standards before significant investment.