Prototype Development Tests Device Functionality
Millar's Prototype Development process supports converting concept visions into functional pressure-sensing prototype components. Once a Proof of Concept design has been approved, Millar can provide full-scale, sub-component prototyping services to test device functionality during pressure sensor integration. At this stage, our objective is to secure a stable design, complete initial design control documentation, and determine production volumes for lab and clinical trials testing.
Millar Uses Multi-Phase Prototype Development
Design Sprints Dictate Deliverables
Each design sprint is outlined in the project's Statement of Work, completed during the Proof of Concept phase, that captures the goals, estimated time and materials, and deliverables for each Prototype Development effort. Deliverables might include drawings of a proposed design, the build of prototypes or iterative prototypes, or prototype testing and evaluation. Each design sprint brings the prototype toward a final design lockdown. Some tasks are minor modifications of existing designs and only require a single design sprint, while others may introduce new design elements or processes and require iteration to achieve the desired size, performance, sensor selection, or other characteristics.
Customer Testing Follows Flexible Approach
Millar is flexible in the way we work. As in the Proof of Concept stage, our partners can test any iteration of a prototype in their own benchtop or animal studies. These prototypes also can be deployed for early IRB approved clinical feasibility testing. In addition, Millar's 50-year history in the pre-clinical life sciences market provides our OEM partners with the opportunity to tap into a network of potential university test locations that can facilitate animal studies if they don't already have networks of their own. As with any stage, Millar is also available to provide full in-house testing when the client is running lean to conserve capital and make it to the next funding round.
Design Lockdown Leads to Final Prototype
Throughout the Prototype Development phase, Millar documents all the prototype details, including drawings, bill of materials (BOM), and manufacturing processes and specifications. Millar has design expertise for compliance with IEC 60601 and AAMI BP-22 and can support customers as they are working through these compliance requirements and initial product testing. As the design moves toward finalization, this documentation also is finalized, which will save time when you are ready to scale up and move into Manufacturing Development. Millar operates its own full Design Control system in compliance with FDA and CE Full Quality Assurance standards, which provides seamless documentation integration into the customer's own Design Control process.
Case Study
Codman Microsensor® ICP Transducer Revolutionizes TBI Treatment
Codman, now part of Integra LifeSciences, reached out to Millar OEM Solutions in 1990 to develop a better method for measuring intracranial pressure (ICP) in patients with traumatic brain injury (TBI). Millar's patented strain-gauge technology in the Codman Microsensor® ICP Transducer gives medical practitioners the precise, reliable information they need to intervene quickly and relieve brain-damaging pressure. To date, Millar has manufactured more than 1.1M units for Codman that have revolutionized TBI treatment.
Previous Step: Proof of Concept
Millar's Proof of Concept phase tests design and integration pathway assumptions made in the Discovery stage, exploring multiple design concepts and iterations, selecting a final design, refining design options, and developing initial documentation with specifications. Come learn more about Millar's Proof of Concept process.
Next Step: Manufacturing Development
When a product enters design freeze, your project will move on to the next step in Millar's OEM Solutions Integration Process -- Manufacturing Development -- to define the critical processes that will affect your product's overall cost and successful production. Come explore Manufacturing Development.
Contact Millar
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)