The Sunrise Approach:
Medical device manufacturing has unique challenges from a regulatory and quality standpoint. We transfer designs to you or contract manufacturers (CMs) that have mastered medical device manufacturing for similar devices. We maintain relationships with many CMs so that we know the appropriate ones for a given device and business plan. Once the design has been transferred, we provide continued assistance to make sure the build proceeds smoothly, while monitoring all quality, cost and delivery targets.
Careful CM Selection
We include considerations for manufacturing from the earliest stages of design, starting with the technology in terms of scalability, long term parts availability, cost, and manufacturing challenges. As part of the design process, we maintain a Design History File (DHF) which is compliant with FDA regulations. Our proven manufacturing transfer process allows an FDA compliant CM to create a Design Master Record (DMR) from the DHF. We then support the CM to validate the manufacturing processes and line including development of in-process tests and test fixtures from pilot through full production.
You can get all under one roof design and manufacturing services for perceived management simplicity; but be conscious of where you may be compromising. Selecting the best team for your challenge is often better served by choosing the A-team for User Research, Industrial Design, the A-team for Systems, Electronics and Software, the A-team for Mechanical Design, and the A-team for Contract Manufacturing. Find the best solution partners to get the optimal design to meet the project and business needs, and the most appropriate manufacturing solution enabling the fastest time-to-profit. Sunrise has worked with many CMs over many years and can help guide your CM selection process, while providing enough design flexibility to allow you to gather competitive bids from multiple CMs.