Are you in safe hands?

The selection of device development & manufacturing partner is critical to the success of any new therapy that incorporates a drug delivery device. There are of course, obvious criteria by which potential suppliers should be measured - their facilities, experience, product range, technical capability, quality assurance procedures and track record are all factors that should be considered. The nature of the relationship is an important consideration. There must be an attitudinal link between the manufacturer and customer, which is based on a mutual commitment to developing and building a long term and profitable relationship. Such a relationship will deliver many benefits including faster development times, effective planning, improved process, productivity and better risk management. Suppliers should be expected to deliver a quantifiable project risk assessment, but equally important, they then need to demonstrate how they can mitigate and manage the identified risks effectively. Consideration should also be given to the structure of the project team. Ideally, both organisations should have complementary teams where a level of technical expertise is matched on both sides. Look for a supplier who can demonstrate a broad range of team working and communication styles that suite your organisation and the stage your development project has reached. The stage of product lifecycle needs to be considered. It is critical that the relationship is built upon a shared agreement of the device's readiness for volume manufacture and a mutual understanding of what elements can be changed. The key selection criteria should be based on a supplier's competencies and demonstrable track record in device development, manufacture and long term supply. Only with a comprehensive understanding of the factors involved are manufacturers able to create devices that are fit for purpose and can be produced cost effectively. Manufacturers should be expected to provide a robust methodology for managing and delivering production effectively throughout the entire life of the product. One such methodology is the Bespak Product Introduction Process (BPIP), the principles of which enable a consistent, repeatable and pragmatic approach to new product introduction and manufacture. BPIP provides for fact based planning rather than reactionary decision making and guides customers through the product development process in an efficient, pain free manner. It also provides a platform for ongoing improvement throughout the lifecycle of the product. Scale of plant is often a consideration that is given less importance, but the effort required to deliver significant increases in volume can be considerable. Customers should demand to see how suppliers will manage production levels effectively and if necessary, cope with unexpected increases and decreases in demand. Regulatory compliance and quality are key factors in any selection process, but 'fitness for purpose' needs to be a key measurement; after all there is little value in appointing a class 10,000 clean room manufacturer when what is required is a non clean-room manufacturing environment. The maintenance of quality should not just sit within the four walls of the suppliers' facility. A robust, qualitative and ongoing assessment of the whole supply chain should be evident. There is little point in controlling quality inside the plant if the standard of the quality systems at supplier companies introduces a higher level of base wastage and compromises efficient manufacture. Finally, customers should be confident that the device manufacturer can not only legislate for peak sales, but can also cost effectively and efficiently manage the inevitable decline in volume as the product nears the end of its life. Conclusion Customers need to choose a partner they can rely on, a partner that will never find itself on the critical path of the project and can work in tandem with customers. Customers also need a partner who can add value at every stage of the product life cycle. Credible manufacturers can guide customers quickly through the regulatory framework and to market safely. And once at market, suppliers should help exploit market opportunities by developing its manufacturing processes to ensure the quantity, consistency and quality of product delivered. The key criteria for assessment 1. What kind of relationship are you looking for? 2. Where is the product in the development life cycle? 3. What is the level of compliance and quality needed? 4. Can they deliver the required compliance standards? 5. How complex is the device? 6. What are the anticipated volumes, throughout the lifetime of the product? Can they effectively manage variation in demand? 7. Can the supplier bring relevant business experience to the relationship? 8. Can they demonstrate success with similar products? 9. Is value being added throughout the product lifecycle? 10. Do they have the tools to manage the lifecycle effectively?