Medical Device Development

It is rightly a central concern of regulators that a manufacturer shall be able to demonstrate that, before placing a device on the market, a number of very basic criteria are met:

• A medical device must be effective and beneficial.
• A medical device must be as safe as is reasonably achievable.
• A medical device must provide the services claimed, and only the services claimed.
• The manufacturer must be able to provide comprehensive evidence that the claims for a device have been met.

Crucial to all of these factors is the creation of a comprehensive statement of requirements for the device. It is no good attempting to define a device's functionality after it has been built, as, by that stage, it is likely that some of the conceptual and design ideas will have been inadvertently overlooked. Quite apart from possibly compromising a device's safety, retro-fitting specifications makes no business sense. A clear concept of a device's purpose from the outset is crucial to controlling development and managing costs.

The completed specification of a complicated device will not be determined at the outset of a project. To refine understanding of the principles of a device or perhaps of how it is best deployed it will be necessary to experiment.

The tools and techniques that we use for requirements engineering provide firm a foundation for compliance with regulatory demands. They allow the integration of hazard analysis, validation and verification into the development lifecycle and enable the production of electronically signed documents with appropriate design history, whose evolution can be managed through a change management mechanism tailored to observe a chosen process.

Our page on software for medical devices describes how we use these tools and supplement them with modelling to develop software in a reliable and cost effective manner.