The Sunrise System
The Sunrise System defines how we fulfill our client commitments. Grounded in lean principles and customized for each program, the Sunrise System applies the optimal set of tasks needed to bring your devices to market as fast as possible. We use electronic approvals and secure cloud-based document sharing to make it easy for you to interact efficiently with Sunrise.
While Sunrise’s process is nimble, effective, and best in class; process without engineering excellence is like fishing without a hook. The Sunrise System puts accomplished technologists, with many successful product launches under their belts, in charge of all aspects of design and project management giving your project the benefit of years of experience. We continuously measure our performance and make investments to improve the Sunrise System.
The Sunrise System ensures quality by, among other things, taking a System Level view of a device and requiring design reviews with our most senior engineers at critical junctures. This allows Sunrise to identify critical design constraints and apply our full expertise to all of our programs.
The following illustrates our process-driven systems approach to medical device development:
Phase 0: Discovery
The first thing Sunrise will do is work with you to identify where the real challenges are in your device or system; what has been done before and what has not; what is straightforward engineering, what is leading edge; is the technology capable and mature enough to support the market needs? From this Sunrise recommends what if any work is needed in this inital phase to address technical risks and product definition before engaging a full product development effort. This phase is not needed for all projects. It is critically important to validate the capability of the available technology to support the needed performance and requirements before ramping up the implementation effort. Many projects skip this an effort to get the product out the door faster and inevitably end up spending significantly more and taking more time to get to market.
Phase 1: Definition
Market Requirements (or user needs) written from the standpoint of the end users (purchaser, doctors, patients, consumers, servicers...) define the product needs. Sunrise can help organize these design inputs, but you need to fully understand the market needs. Sunrise will work with you to translate your Market Requirements into System Requirements, written in engineering language (unambiguous and testable). Risk management starts in this phase with a hazards analysis to identify the mitigations required to reduce the likelihood of injury. It’s important to feed these hazard-mitigating requirements into the System Requirements before design of the commercial product. Sunrise has years of experience working with clients to make potentially dangerous products safer.
Phase 2: Design
With the requirements understood, the solution is architected to efficiently meet all of the requirements in an elegant and maintainable fashion that is nearly certain to meet all of the System Requirements as well as foreseeable future requirements. The architecture is designed and reviewed by experienced Sunrise system engineers that have implemented many systems over the years and know what works.
Next the subsystems defined by the architecture are specified, designed, integrated and tested to and beyond the required performance by the design team.
Phase 3: Verification & Validation
The design is formally verified to confirm all System and Subsystem requirements are met. For medical devices this means writing test plans and protocols, running and recording the test results and writing test reports.
Given the product meets its requirements, Validation then confirms that the device designed to meet the requirements meets clinical or market need. This is often a clinical study or a limited production release. Sunrise often builds a limited number of devices on-site to support this testing.
Phase 4: Transfer to manufacturing
A benefit of working with Sunrise is the ability you will have to bring your design to the contract manufacturer (CM) of your choosing. Sunrise will support this transition as much or as little as you see fit. Sunrise continues to provide manufacturing support for some devices we designed and launched over 20 years ago. Sunrise encourages clients to choose a CM early in the design phase to allow the CM to provide design for manufacturing (DFM) inputs while the design is fluid. We can help guide the CM selection process, while providing enough design flexibility to allow you to gain competitive bids from multiple CMs.