Consort Medical
 

NPI Policy

Bespak designs and manufactures drug delivery device components (such as metered dose inhaler valves or “pMDIs”, inhaler actuators and autoinjectors) and other medical product componentry (such as medical check valves and in-vitro diagnostic cartridges).

Our core business process for New Product Introduction (NPI) provides the management and governance for the introduction of these product components, from design and development through to clinical and commercial manufacture, to agreed levels of quality and regulatory compliance. This provides our customer the confidence that the products we design, develop and manufacture meet their needs and the needs of the patient or end user.

New Product Introduction encompasses all of the functions within Bespak and a Stage Gate process is embedded within the business to provide a standardised approach. Stage gate reviews, overseen by senior management, are performed at the end of each phase in order to decide if the criteria to exit and progress to the next stage has been fulfilled. In addition, stage gates provide overall governance and alignment of the programme portfolio to the business strategy.

The NPI process is aligned to the relevant industry regulatory standards; this is embedded as product and manufacturing process requirements for the new or improved products through the key NPI stages: concept evaluation, detailed design and development, verification and validation and design transfer into manufacturing, through to product launch.

Our Programme Management team manage the NPI Programme Portfolio and generate monthly Key Performance Indicators (KPI) data on key programmes and the programme portfolio as a whole as a means of measuring performance and driving continuous improvement in the NPI process.