Clinical Engineering Phase
Once the manufacturing process for your product has been developed and validated during Manufacturing Development, Millar can start producing prototypes at the volumes required to meet your Design Validation (DV), Verification & Validation (V&V), safety testing and clinical trial requirements. Our production team and full-scale manufacturing capacity are fully activated in the Clinical Engineering phase to support your submission process, regulatory testing and clinical trial schedules.
Millar Uses Multi-Step Clinical Engineering
Manufacturing Capacity Accommodates Flexibility
Millar's ultimate goal at the Clinical Engineering stage is to meet your initial production demands for validation testing and get your device through regulatory submission and approval as efficiently as possible. In fact, our Clinical Engineering and Manufacturing Development phases can overlap during the OEM Solutions Integration Process based on your needs and timelines. Millar's flexible manufacturing capacity allows us to scale up or down, from early pilot builds to large clinical trial volumes, depending upon your specific needs.
Validation and Testing Volumes Finalize Processes
At this point in the process, you'll have one or more production lines dedicated to your clinical product builds and manufacturing your product to production build standards. All steps and parts of your production process are finalized with product documentation released and suppliers confirmed. If required, Millar can take full responsibility for the supply chain and leverage our long-standing supplier relationships.
Millar can build quantities to meet customer testing purposes, including biocompatibility, electrical safety, and animal studies, ranging from hundreds of units to thousands, based on our partner's own validation requirements and those of the regulatory agencies. When you get to clinical trials, we'll be prepared whether you need units for under 100 patients or more than 1,000.
Millar Supports OEM Solutions Partners
During this phase, we understand our partners will be working through internal processes in tandem with our efforts. From GLP studies, regulatory submission, sterilization and shipping validation to design control processes, Millar is here to provide support you every step of the way. With an approved clinical device on the market, we have worked through all the steps required to get a product through the regulatory approval process and can step in as a resource when needed. Our goal is to help you get to market faster and reduce your overall development costs.
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: Manufacturing Development
Millar's Manufacturing Development phase in the OEM Solutions Integration Process defines the critical processes that impact the overall cost and successful production of your product, executing the process validations which seamlessly feed into your design control effort. Come learn more about Millar's Manufacturing Development.
Next Step: Commercial Manufacturing
After completing Clinical Engineering, your project will move on to the next step in Millar's OEM Solutions Integration Process -- Commercial Manufacturing -- where we offer full-scale contract services that comply with all current standards for medical device manufacturing. Come explore Millar's Commercial Manufacturing.
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)