Product Development

Planning

We follow a documented design and development process to keep development projects under control and ensure compliance with applicable regulatory requirements, including ISO9001 and 21 CFR 820 (FDA) requirements for design control. The key to success and compliance is planning. We will prepare a project plan which identifies all the key tasks, who is responsible for them, when they will be performed, and how they will be verified. The plan is updated continuously and is available to you throughout the project to monitor progress and hold us accountable for our performance.

Specification Development

The first task in a development plan is establishment of product requirements. You can provide us with detailed specs or we can prepare these documents for your approval based on broader inputs from your marketing team. Often requirements evolve as the project progresses and poorly understood constraints become more clearly defined. We recognize this as a natural part of development and our process is designed to adapt readily and stay in control when the requirements change.

Design

We then organize the design activities to reduce unknowns as early as possible. You will see this principle reflected in numerous ways in our practice, for example we tackle the most difficult technical uncertainties by simulations or lab studies in the design stage rather than while verifying a prototype (no “build it and see”), we build every prototype using production processes so that the design converges earlier, and we source and test key components from production suppliers with the first prototypes rather than during a much later manufacturing transfer phase. Our goal is to minimize the risk of significant course changes, and if they do occur, to ensure that the dollars spent up to that point were used efficiently.

We will hold design reviews at planned intervals, to ensure that design is thoroughly checked and constraints are understood consistently across all participants in the design process. This is particularly important when responsibilities are shared across organizational boundaries.

Prototyping

Unlike most product development firms, we assemble the prototypes in-house using the same equipment and processes which will be used in production. This has many benefits — prototypes are more reliable and consistent, more can be produced at reasonable cost to make testing more efficient, and process validation begins earlier and becomes a more natural part of the design process.

Further, our development engineers work directly with manufacturing to take their designs through prototype builds and process development. This ensures that they have a deep understanding of manufacturability constraints and they design products that are optimized for production right out of the gate.

Verification testing

Throughout the design process, samples undergo ongoing verification testing against the established specifications. This may involve a variety of test methodologies including bench measurements, use-case simulation, environmental stress testing, etc.

Another important part of verification testing is safety, EMC, and other regulatory testing, to demonstrate compliance with national or international standards. Pergamon has extensive experience applying these standards in design, and managing the test and certification process through nationally recognized testing labs.

Validation

Design validation is performed on the final design to provide objective evidence that the device meets its intended use. This includes an evaluation of actual test results as well as a re-evaluation of the specifications in their final form. Process validation goes a step further by confirming production processes are capable of producing devices which can consistently meet specifications. We can participate in your validation process by providing selected inputs, or provide complete formal validation reports at your request.

Production Transfer

This refers to the process of transferring manufacturing data from the design team to the manufacturing team and subsequent approval and release. Even in a tightly-coupled environment like Pergamon’s, having a formal production transfer process remains a critical last step to ensure quality before you introduce your product to the world.