Technical insight into engineering approach and design capabilities at phillips medisize

Complex Redesign: The Phillips Medisize design team needed to accommodate dimensional specifications, material properties, operating conditions and compliance with design norms for multiple products, all while maintaining manufacturing capability.

• Delivered comprehensive 3D CAD designs and 2D drawings, including geometric dimensioning and tolerancing (GD&T) for multiple, nominal dimensions of clamps, and valve variants tailored to the OEM’s product range
• Performed structural strength assessments, tolerance stack-up analyses and finite element analysis (FEA) to validate component durability under applied stresses, and optimized part geometries to ensure compatibility with assembly requirements and compliance with performance specifications
• Iteratively optimized designs through multidisciplinary reviews focusing on manufacturing feasibility, assembly automation and efficiency
• Conducted mold flow simulations in conjunction with DfM and DfA assessments to ensure optimal moldability, adherence to quality specifications and streamlined production processes

Regulatory Compliance: Designs had to strictly adhere to standards such as the ASTM BPE (Bioprocessing Equipment Standard) with comprehensive validation documentation to facilitate regulatory approvals

• Ensured full compliance with ASTM BPE requirements that included a thorough, rigorous gasket compression study
• Supplied comprehensive design calculations and validation documentation for quality assurance and regulatory auditing
• Delivered extensive technical documentation and simulation reports, directly supporting the OEM’s internal validation processes, streamlining quality assurance and accelerating regulatory submissions

Structural Integrity Under Stress: The OEM needed assurance that critical parts would withstand bioprocessing conditions, including pressure variations (up to 8 bar) and low temperatures (~4°C), ensuring safety and performance

• Optimized hose barb adaptor designs, focusing on fluid path optimization to improve fluid dynamics and reduce risk for leakage
• Performed detailed computational fluid dynamics (CFD) analysis and FEA simulations under typical process conditions, ensuring functionality and structural reliability
• Developed parametric CAD models incorporating optimized gasket compression profiles for secure sealing

Manufacturing Feasibility at Scale: Transitioning to high-volume production using medical grade resins demanded optimized designs for manufacturability, injection molding and assembly efficiency

• Mold flow analysis was carried out to predict how the resin would behave during injection molding—highlighting potential issues such as air traps, weld lines and uneven fill patterns. By optimizing gate locations, wall thicknesses and flow paths, the team minimized cycle times and material waste while ensuring consistent part quality across high-volume production.
• Early-stage analysis of molding and assembly processes to proactively identify potential failures and prevent delays in development and tooling cycles

Fluid Path Optimization: Adaptors and connectors had to be designed to minimize leakage risks and maintain optimal flow dynamics to meet process specifications

• Adapted incumbent OEM caps to integrate seamlessly with the redesigned clamps, maintaining tight tolerances for leak-proof assembly
• Designed new adaptor variants based on the OEM’s physical samples and CT scans, ensuring precise fit and performance