Manufacturing Development Phase

Manufacturing Engineering Assessment Defines Production Approach

When your prototype enters the design freeze stage, Millar engineers determine how to streamline production and evaluate what custom equipment or tooling might be needed to improve manufacturing. We have been manufacturing clinical products for over 50 years and fully understand what it means to design for efficient manufacturing and assembly. Our know-how and ability to understand the full process ensures we are always moving forward to get your product closer to commercial manufacturing.

Millar's manufacturing engineering team performs process characterization studies or initial engineering studies to provide detailed guidance on the manufacturing process. This includes supplying feedback on component specifications and standard operating procedures to support quality and supply chain processes.

Manufacturing Process Development Sets Strategy

Millar understands how to support reduced cost, increased quality, and reliable manufacturing processes. We've been doing it for 50 years. Our OEM Solutions team works closely with our partners to determine the manufacturing strategy that will deliver the required level of validation and timeline for releasing prototypes for use in Design Validation Studies, Safety Testing, Standard Compliance and Clinical Trials. Millar develops and validates manufacturing processes according to our partner's Quality Management System (QMS), as agreed upon in the Statement of Work. In this phase, staged volume requirements are planned, including processes defined for scaling up, equipment validations, and characterization studies.

Process Qualification Plan Supports Regulatory Submission

Through the product development process, Millar can provide recommendations on the best regulatory path for FDA/CE submission, develop a process validation plan, and provide various levels of support for design control and risk management analysis. We can tailor our approach based on your internal capabilities. However, when it comes to sensor-enabled products, we recommend relying on Millar's expertise for full sensor testing and test method validation design. 

Millar can execute on the process validation plan to complete the installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) processes where required. We support PFEMA and DFEMA documentation processes and can provide testing sample size recommendations based on the appropriate risk index.