New PRODUCT DEVELOPMENT PROCESS OVERVIEW
Our NPD process includes at various points all of the design and engineering services we offer, and the extent to which this entire process is executed depends on the customer. We present this to you, the prospective client, so we can start off “speaking the same language” with regard to CSE’s value proposition and the resulting scope of work. Shown below is our product development diagram, complete with phases of work and review stage gates.
In the case of a client company that is a startup with no established processes and little to no engineering staff, we would recommend following this process from start to finish in order to efficiently develop a viable product. In the case of a company with existing engineering staff, but that needs help with a robust design and development stage, we would provide those services that the company is missing. In either case, our process assumes the presence of business/marketing staff, as well as either a manufacturing department or a contract manufacturer.
Of course, the process shown below is just a “most rigorous case” that starts the discussion. It can be pared down to a more expedited process, or a concurrent process can be developed wherein (for example) key components are tested very early in the process in order to narrow down options proactively, for example. Starting with the most rigorous approach and purposefully simplifying as needed ensures that critical elements of the process are not neglected.
FDA-regulated medical device companies: We are accustomed to working under ISO 13485-compliant quality systems, and although we aren't yet ISO 13485 certified, we can work within your QMS. We try to make clear where our process is specifically in compliance, i.e. by pointing out the start and end of Design Controls.
Note: The process diagram and written overview shown here are meant to paint a general picture of our approach, and should not be considered a Statement of Work applicable to any actual project. Each project will be planned individually.
The primary goal of the Definition phase is for you, the client, to define the “What” and “Why” of the project/product. Define what the end result or output of the program needs to be. Determine the scope of the project in terms of time, cost & performance. Explain why the project/product is an idea worth pursuing, and determine any “gates” in the project at which the viability of the pursuit is evaluated. CSE will help you with the project/product definition to develop high level objectives and requirements for the project/product.
The planning phase is the period during which the client and CSE will determine how the product objectives will be met. CSE will help you with the idea generation, resource planning, and patent strategy in order to help enable the development process. CSE will guide the client through an evaluation of any current products or competitive products against the defined product objectives to guide the development process towards a successful business strategy.
3. Conceptual Design
Starting with the original concept and exploring market opportunity and alternative design concepts, we'll help you to arrive at the optimal product specification (Design Input). CSE specializes in generating innovative design concepts from jointly-developed requirements and specifications, achieving your desired cost/benefit balance by keeping an eye on the array of critical, cost-driving details down the line and navigating the conceptual and detail design process proactively. Top-down and bottom-up risk analyses are conducted in this stage, in order to control business and safety risk and to provide that quantified risk information as a factor for concept down-selection. Subsystem architecture and multi-discipline engineering approaches are defined in this stage... another specialty of CSE. We approach multi-discipline design in a highly-concurrent manner. The conceptual design phase is repeated, if necessary, to arrive at a single concept design that can meet the requirements.
4. Detail Design
The goal of detail design is simple: To produce a complete and verified Design Output from the Design Input and concept design. CSE has significant experience with optimizing cost of manufacturing of parts using various process, such as molding, sheetmetal fabrication, and machining. We will provide a document package that completely meets the specifications (Design Input) in order to ensure predictably manufactured components and systems.
5. Prototype Build and Test
In this stage, we will help with (or completely manage) the build, qualification testing, and validation testing of production-intent prototypes of the product. Qualification testing verifies that the product, when tested in controlled conditions, exhibits performance that matches the product specifications. Validation testing proves that the product, when tested in intended-use conditions, meets the user/stakeholder requirements (required for FDA Class II and Class III medical devices).
At the end of this phase is the Design Transfer Review, where we establish a complete document package suitable for formal release to a manufacturing organization, be it internal or outsourced (or ISO 13485-compliant design transfer, if applicable).
6. Product Launch
Post-transfer/release to manufacturing, we will provide support to initial manufacturing efforts and product launch. We will provide ongoing support for tooling changes, maintenance of risk analyses, design changes, and re-verification and re-validation/qualification of the design if warranted. We will also provide support to deal with customer complaints and remediation and technical issues.