Our process

Whether we’re designing a low-cost, disposable item or a complex, fully functional device, every project we undertake follows a rigorous development process designed to manage risk, cost and time effectively, delivering brilliant products in the most efficient way possible.

Incorporating systematic testing and verification and accredited to ISO 13485, our process is supported by first-class project management, detailed documentation and clear, direct communication.

The product development process is divided into three stages – definition, creation and production.

Definition

The development process begin by looking at the desired final outcome. We work closely with our clients to understand their business goals, user needs and target markets, as well as any manufacturing requirements and constraints. This allows us to generate a comprehensive specification that will guide the development process.

Human Factors

Human factors research looks at how the user will interact with the finished product. Incorporating input from end users and industry experts, competitor research and a review of the relevant regulatory requirements, we create a product specification that will ensure the perfect fit between user, product and use environment.

Concept Generation

To generate the original ideas that are the first step towards innovative, exciting products, we combine meticulous research with creative strategies including brainstorming sessions and interactive workshops. Ideas are then developed, challenged and assessed for risk before the strongest are refined into fully fledged product concepts.

Proof Of Principle

The output of the concept generation stage is put through its paces via our technology demonstrator system. Risk reduction is the primary focus, with proof-of-principle prototypes used to assess the areas of highest risk and provide proof of concept before moving forward.

Creation

Once a concept has been proven and selected, product creation proceeds through a process of design testing and verification that covers usability, ergonomics, function, materials and regulatory compliance. Reaching the goal of a robust and fully tested pre-production design, ready for transfer to manufacture, typically involves three distinct prototyping phases.

Alpha Prototype

Designed to test the basic functions of the product, the alpha prototype provides crucial feedback in the early stages of development.

Beta Prototype

Designed to look and work like the finished product, the beta prototype has all key features in place and allows more sophisticated testing and end-user trials.

Pre-Production Prototype

Created using the same processes intended for volume manufacturing, this final prototype verifies that the product meets the specification and can be manufactured efficiently.

Production

We work with your chosen manufacturer – or can help you select new manufacturing partners – to address costs and processes before delivering the complete design files and documentation necessary for volume production of the finished product.

​Transfer To Manufacture

We oversee pilot production and, where applicable, volume production and these stages are supported by a final round of testing and verification. All of the necessary design files, documentation and test files are delivered on completion of this phase.

Post Launch Support

Even after the goal of bringing the finished product to market has been achieved, we can provide ongoing support through obsolescence management, advice on supply chain refinement, software support and updates, and the development of a next-generation product.

Our process

Our rigorous ISO 13485-accredited process is designed to manage risk, cost and time, with quality management and accountability built into every stage.

BSI certificate