We've shared the importance of having an NPI, or New Product Introduction, division when integrating your technology to a Contract Manufacturer–you can read about that here. However, for this blog post, we're going to focus on how the critical steps taken during the on-boarding phase within a NPI group will drive the success of Medical Device projects down the road.
The term "Medical Device," is a broad term that can have a few different meanings. Depending on how the device will be used, there are different classifications to determine quality assurance that is associated with the device's manufacturing. Classifications of Medical Devices refer to Class I, Class II, and Class III which differentiate the level of risk associated with the device as well as the level of regulatory controls required during manufacturing.
Regardless of their classification, Medical Devices have touched every person's life in one way or another. And whether or not they have specifically saved our own lives, it's safe to assume they have saved the life of someone we love. This is how important our company treats the manufacturing of Medical Devices and this sentiment is felt through each and every person who works on our Medical Device projects within our organization.
The Quality System is the backbone of a successful and repeatable manufacturing system. The strongest companies employ a QMS that oversees all facets of the contract manufacturing operation. With these systems in place, products can be built repeatably each and every day, dramatically reducing the chance of discrepant products ever reaching the customer destination.
Any company can claim to have experience in design engineering, but if that company doesn’t have any experience on the manufacturing side of things, then there really is no hard evidence that your machine can even be manufactured. Apart from manufacturing experience, how can you rest assured that a Contract Manufacturer will be able to execute your break-through technology?
All across the United States, Medical Device OEMs are looking for a pool of competent suppliers to help in the manufacturing of their Medical Devices. Medical Devices require a different level of manufacturing process documentation and traceability than do their counterparts in less regulated industries. Companies like PEKO Precision Products have years of experience in this kind of Medical Device Contract Manufacturing. This level of sophistication requires the Med Device OEMs to choose a supply chain that can also adhere to these strict requirements. The ISO 13485 standard is a very good way OEMs can initially assess whether a supplier has a Quality System even capable of dealing with the requirements. In plain English, the ISO 13485 directs companies to do things like establish/document a Quality system for Medical Devices, create Management Requirements, and Identify resource requirements. Suppliers in the Machining, Sheet Metal Fabrication, Contract Assembly and other areas still must prove that these systems are in place when applying for their 13485 Certification. Suppliers like these have validated process control that account for value added quality methods. Medical Device Contract Manufacturing with CNC Machining, Sheet Metal and Assembly is certainly a difficult animal. Suppliers in this category are much different from the mom and pop shops with quick turnaround and a few machines.
Combining Robust Systems and Vast Experience for Medical Precision Machining
Today's modern machine shops serve a broad list of manufacturing industries. Each has their own specific demands but there are very few that require the attention to detail that the Medical industry demands. From unique capability requirements like clean rooms and multi axis machines to specific regulatory requirements, Medical OEMs have to make sure their supply base is capable of producing parts that comply with prints and paperwork. Today's best ISO 13485 Medical Machine Shops must exhibit specific characteristics to show OEMs that they can be a value asset to their supply chain.