We are proud of our extensive, global experience in managing device programmes in the highly-regulated medical device sector, both for proprietary and non-proprietary products.
Our New Product Introduction (NPI) framework has been iteratively developed over many years and is based on the key principles of advanced product quality planning. It allows for experience and learning to be taken from project to project and provides the basis of our structured, risk-based programme management approach, which forms the spine of all programmes run by us.
The NPI process incorporates a deliverables checklist structured in a series of stages, ensuring smooth transition and development at every stage of production. Progress is evaluated by means of a gated review at each stage, which is managed by the programme manager and includes the programme stakeholders. This framework offers transparency to customers, enables them to actively participate and ensures a risk-based progression from early stage design to commercial manufacture.
Our NPI framework recognises that no two products will necessarily follow the same path, and as such, the programme will be customised from product-to-product and customer-to-customer to reflect requirements, risk and other factors. Importantly, the experiences from all projects are captured within Bespak and fed-back into future programmes, ensuring our customers are benefitting from a continually evolving process of best practice.