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.
Bringing a new Medical Device to the market? How will you tackle the commercialization process? Are you a start-up that has stakeholders and investors on edge pestering when your final product will hit the market? If yes, then you'll benefit from outsourcing your medical equipment to a Contract Manufacturer.
There are many benefits of outsourcing to a Contract Manufacturer and when a company is trying to bring a medical device to market, there's a lot at stake because the medical industry requires additional tests and processes before a Medical Device can be brought to market. We wrote a blog on the extra elements required for Medical Device Development a few months ago, read more on that here, and for this post, we'll highlight the expected benefits medical device companies can expect when outsourcing to an experienced CM.
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 have a new video that explains our New Product Introduction and Development Processes. Check it out below!
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.
How mature is your design, and what is your main focus in preparing your build for the next phase? We've broken down the three main indicators we look at, as a Full-Service Contract Manufacturer, while assessing a customer's design: Cost, Quality, and Delivery. Read on to find out where you should be focusing your efforts, and where we see most customer's trying to focus their efforts on.
In manufacturing, we are used to major projects taking months from prototype to production. Without fail, this involves weekly meetings with internal personnel like managers, operations personnel, floor managers purchasing and of course, the customer. This usually means getting half a dozen people in the room to solve problems, delegate and usually make some committee decisions. Heck, we struggle to cut an hour off the setup time for a part but have six folks with ties sitting in a meeting for an hour to discuss it. We all know this isn't the most efficient way to communicate. Do we even know if it's effective? Is this just our comfort zone? Here at PEKO we are well aware of the costs associated with getting so many people in the room for an hour each time.
Topics: Contract Manufacturing
From the Program Management team to the corporate executive team, it's absolutely critical that a communication line is established with the customer, when it comes to Contract Manufacturing. The CM should be proactive in their efforts to ensure that inevitable manufacturing concerns can be remedied with the customer as soon as possible.
Larry Fast gets it exactly right , and admirably puts his money where his mouth is towards getting kids into manufacturing. For too long manufacturing jobs have had an optics problem..."dirty, dingy, layoffs" is the sentiment. Decades ago, one could find a nicely paying job down at the local factory which promised a nice pension at the end of service. Times have changed and the past thirty years has reflected an education system that pushed kids away from manufacturing to pursue jobs in more "glamorous" fields. We've been told "America is a service economy now" as if that's a good thing. Can we really afford to sell each other coffee and insurance for the next 100 years?
Once production has begun, and is in full-effect, a great CM will have a team of experienced, competent and trained individuals to carry out the assembly and integration. These trained professionals will be supported by their supervisors, tools and techniques, along with a manufacturing system that ensures the team's success. For most programs, the technicians will be trained specifically for the product, while the tools and workstations will be optimized for optimum build quality and efficiency. PEKO's team works tirelessly to use efficient and effective techniques for customers' assembly processes.