What can your potential CMO actually do for you in a practical sense? You’ve heard their company aims, you know where they’re based, and you know that they are at the very least capable of manufacturing medical devices. But what services can you expect your manufacturer to provide? While some manufacturers will only provide one or two of these, more successful and well-rounded companies will often provide all of the medical manufacturing services available. Again, if you want to ask about these services when vetting companies to partner with, their answers will steer you away from less competent ones and towards a company you can truly trust.
Cleanroom Manufacturing
This may not need to have been stated – to expect cleanroom manufacturing from a medical manufacturing company is like expecting a baker to make bread. If it’s not there, there’s obviously something wrong. However, cleanroom manufacturing is no simple service. If you’re creating and producing a medical device, a precisely maintained and operational cleanroom is going to be integral to not just producing the device, but ensuring a sterile and environmentally-controlled area in which it is made. We typically expect a good CMO to maintain a couple of cleanrooms per ISO 14644:2015.
R&D/Prototyping
You’ve got a concept, but you’re unsure of how to build it precisely. That’s where the R&D department comes in. Companies will maintain entire divisions of their organisations dedicated solely to the groundwork of the product. Not only this, but these manufacturers are constantly using these wings to conceptualise, innovate, and test out new products and novel ideas. Manufacturing organizations would not go far without their own team dedicated to exploring new systems to reduce cost or wasted time. Does the company you’re working with have a prototyping department?
Product Development
Your device will go nowhere fast if one hand is not communicating with the other – which is why many successful manufacturers maintain product development in-house. They make sure that your product is managed entirely through a singular guiding team of experts. Project management is a service designed to make sure there is optimal communication and cohesion. Ask your CMO if they manage your project from start to finish.
Material Selection
Especially with medical devices, material selection is the most important part of the process. Sub-optimal materials will ensure poor performance and failure, so companies will offer services and maintain teams dedicated to sourcing and selecting the best materials for the parameters of your project. Does your CMO have the necessary experience to identify the best materials for a specific project?
Medical Adhesives
In a similar vein, medical adhesives must be selected with the utmost of care and experience – particularly with medical equipment and devices that are intended to stick to the skin. How much breathability must be present with the device? Will it need a powerful adhesive to compensate for a heavier frame?
Product Certifications
Another important quality to look for in your CMO is whether they actually have the capacity to certify your medical device when it is produced. As we all know, medical manufacturing is stringent and beholden to strict legal requirements. Does your CMO partner have the capability to legally CE mark your product?
Outsourced Operations
How often does your CMO outsource their own operations? Many successful companies know that they have highly skilled workers and quality production facilities – allowing them to be outsourced to other companies looking to make use of their expertise.
Quality
While this is one of the more nebulous of the above services – it should probably be at the forefront of your mind. Notwithstanding the other services that the CMO offers, how are their products? How reliable are they? What is their longevity? What is their reputation? These are the kinds of questions about the quality of their products and services that you should always keep in mind.
For the previous blog in this mini-series, which looks into the differences between local vs global medical manufacturing partners, please CLICK HERE.
To see our next blog in this mini-series, which looks into which applications are available within medical manufacturing, please click here.