When it comes to manufacturing medical devices, there's an important factor in choosing a Contract Manufacturer: ISO 13485 certification. While liability for the design failure would rest with the design owner, failures due to wrong material, negligence, etc. would rest on the Contract Manufacturer. Due to such associated risks, companies who plan on manufacturing Medical Devices through a CM must make sure that the CM holds a valid ISO 13485 certification.
The process to ensure successful Medical Device Assembly for Medical programs begin when the program is accepted. When you outsource a Medical Device to a Contract Manufacturer, follow these 6 critical steps to guarantee the success of your program once it's transitioned over to the full-scale assembly phase.
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.
In any industry that elements substantial Original Equipment Manufacturers (OEM's), there is regularly a sub level of suppliers that represent considerable authority in the outline and assembling of segments or, now and again, completed bundled prepared to-ship private name items that are eventually sold under the brand mark of the OEM. Such organizations commonly have broad building and configuration aggregates that can deal with all periods of the product advancement process. Contract Manufacturers almost always control the qualification and acquisition of the raw materials that are used to produce the products they sell to OEM’s. Contract Manufacturers are found in nearly all the major industries you might think of in the world of manufacturing including Medical and Medical Device, Aerospace, Automotive, Appliances, Consumer Goods, Defense, and many others.
Medical Device OEMs are increasingly finding the value in utilizing ISO 13485 Contract Manufacturers in their business for tasks ranging from engineering to final product assembly. While operating in as strictly a regulated industry as Medical Devices, leveraging the capabilities of an experienced and vertically integrated CM can be advantageous in mitigating risks, reducing costs and increasing the efficiency of the overall product cycle. The need for a dedicated full service manufacturer becomes ever more important and beneficial with the mandated high levels of control by the USFDA, which differ between Class I, Class II and Class III devices. Here are three key advantages to consider from using an ISO 13485 Certified Contract Manufacturer.
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.
These days the Medical and Healthcare industries are booming but still susceptible to fluctuations. The Medical industry is heavily impacted by an array of economic and policy factors. An aging global population, growth of emerging markets and health care M&A are just a few examples. Medical OEMs have to deal with the mitigation of these fluctuations in their manufacturing processes. Since the forecast can be unpredictable, OEMs must find ways to match their manufacturing with their demand, all without negatively impacting the bottom line. Ask any Manufacturing Manager, and that person will tell you that this is not an easy task.
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.
These days, everyone knows that time is of the essence when it comes to New Product Development. Marketing comes up with ideas, Management signs off and of course Engineering and Manufacturing groups are left holding the bag on developing, testing and producing the product. And naturally, it was due yesterday. Not everyone in the New Product Development chain truly grasps the challenges that come with ensuring a new design can meet specs at the right price and lead time. Putting the plan together is only half the battle. Another piece of the puzzle is finding someone to do it. Whether its Stainless Steel, Aluminum, Carbon Steel, or Polymers, more often than not you will need to find a machine shop capable of prototype CNC machining.