Manufacturing Development Phase
Millar's Manufacturing Development phase defines the critical processes that impact the overall cost and successful production of your integrated medical device. After reviewing the prototype designs, entering design freeze, and suggesting modifications for manufacturing efficiency, Millar can further streamline the process by providing guidance regarding required verification and validation testing from our in-depth experience moving OEM products, as well as our own, through Manufacturing Development.
Multi-Step Manufacturing Development
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.
Quality Alignment Streamlines Process Path
The qualification and verification processes are all outlined through the Quality Agreement that is put in place early during this phase. This ensures we achieve alignment between Millar and our partner's QMS system requirements and defines each company's level of responsibility throughout process qualification. This is a critical component of the Manufacturing Development phase and supports a streamlined path to clinical engineering. Millar's experience bringing our own products to market and achieving and maintaining regulatory compliance in the US, EU and Japan make us ideally suited to assist you through your own submission process.
OEM Solutions Partner Revolutionizes TBI Treatment
A medical device manufacturer reached out to Millar OEM Solutions in 1990 to develop a better method for measuring intracranial pressure in patients with traumatic brain injury (TBI). Since then, we have manufactured nearly one million patented strain-gauge pressure sensors that have revolutionized TBI treatment.
Previous Step: Prototype Development
Millar's Prototype Development phase tests device design functionality during pressure sensor integration to secure a stable design, complete initial design control documentation, and determine production volumes for lab and clinical trials testing. Come learn more about Millar's Prototype Development process.
Next Step: Clinical Engineering
After completing Manufacturing Development, your project will move on to the next step in Millar's OEM Solutions Integration Process -- Clinical Engineering -- where we ramp up production, ensuring you hit your test timelines and have product available for clinical trials. Come explore Clinical Engineering.
Millar OEM Solutions has been collaborating with our partners for years to help create breakthrough products that shape the future of medicine. Contact us today to collaborate on your next project. We welcome your questions and ideas. US Headquarters T: +1 832.667.7000. Toll Free: 800.669.2343 (US Only)