Selecting a Contract Manufacturer (CM) is a well thought and time-consuming process. There are many factors that go into making the choice, obvious ones like cost and fit come to the forefront. But one that is often overlooked is the process of onboarding the new project, New Product Introduction (NPI). Transferring all of the knowledge and nuances of your device, a device that you know like the back of your hand, to a new group is an important step to the success of your product. A good Contract Manufacturer will work with you to identify all the potential issues before starting the manufacturing phase. This is why a well thought and planned NPI is key. Valtronic shares with you how we work with our customers and let them benefit from our longstanding experience in medical device assembly to make the NPI process as smooth as possible, thereby enabling the fastest time to market on a solid schedule.
1) Organized and Detailed Documentation
The more organized and complete your documentation is, the easier it is for your new CM to hit the ground running. From BOM’s to schematics, the more detail included and delivered to the CM, the better. This may seem like common sense, but the little details are often the ones that are forgotten when it comes time for assembly which can cause delays. To the creator of the assembly many minor details may seem like second nature. For example, the way a board should be held when connecting to a tester, or the best way to secure a set of wires for mechanical stability. If these small details are not listed on an instruction or document, they will be missed until the start of the build where they will be run into firsthand. No detail is too little! Valtronic processes offer strong support through this phase. Our team will work as an extension of your own team. Our proven methodology, checklists and validation processes make sure nothing gets forgotten.
2) Open Dialogue to identify potential pitfalls before they happen
This goes hand in hand with having complete documentation. Being as straightforward with the history of issues you have encountered is a treasure trove of information. This can be used to get your CM up to speed and may help uncover some of the little specifics that slipped through the documentation. This can also help identify potential pitfalls in the process and allow your CM to brainstorm on ways to avoid them before they ever happen. At Valtronic, we encourage our customers to be onsite for prototype runs to work hand in hand with us, helping to answer questions, trouble shoot issues, and work to complete the first assemblies together. And in the case of production transfers, Valtronic takes all necessary steps to guarantee a seamless transition. This generally involves sending a Valtronic team to your plant to fully understand the manufacturing steps and perform all operations together with your operators.
3) Prototype Runs are key for NPIs
Mentioned above, a prototype run is a must for a smooth NPI. This is vital for a CM working on a new project. Even if the assembly is something that has been in production for years, it is easy important to remember that a new CM needs to familiarize himself with the assembly. A small prototype run of 10-50 pieces lets the new team get a quick course in the assembly of your product. Processes like oven profile creation, cell workstation creation for optimal workflow, tooling verification, and tester troubleshooting, can all be worked out in a small initial run. This way they can have a preconfigured manufacturing process when the large build comes down the pipeline. Furthermore, the customer will get a limited number of samples quickly and thus be able to start clinical testing earlier and accelerate time to market.
4) Perfection is necessary when manufacturing medical devices
This may not seem like much but is immensely important. There is plenty riding on your new CM to complete your assemblies, both for your company and for the lives that your medical device will touch. At Valtronic, we fully understand that. We ask all questions necessary to be thorough as it is paramount to ensure future success. Perfecting details to reach high-quality is a prerequisite when assembling medical devices. If challenges arise, Valtronic’s experienced team takes them up to come up with solutions. The manufacturing of your assembly will improve with each assembly that is completed, and before long, you’ll recognize Valtronic as a true partner and an extension of your own company.