Dr. Shrinidh Joshi, freelance medical device consultant at Kolabtree, the freelance platform for scientists, shares his tips on what to consider when choosing a contract manufacturing organisation (CMO).
According to a 2019 survey by Accenture Life Sciences, 91% of medical device manufacturers plan to expand their use of CMOs over the next three years. The same survey found that on average, one in five manufacturers work with over 100 external partners, including CMOs and contract development and manufacturing organisations (CDMOs). Both large and small companies regularly work with these organisations and there is a growing pool of CMOs for them to choose from.
Outsourcing is a powerful tool for medical device companies because it frees-up manufacturer’s time and resources to focus on other activities like marketing products, communicating with stakeholders, expanding into new markets or creating new designs — activities to help grow their businesses. Medical device companies can outsource almost all parts of the process, from design, to manufacture, to packaging to testing and when doing so it is vital to outsource the right tasks, to a company that can help you achieve your objectives.
There are many reasons for turning to a CMO to help with your manufacturing process. Commonly, companies choose a CMO to save upfront costs — a CMO means there is no need to invest in large amounts of equipment. These organisations can help produce technical files that will strengthen your hand when submitting an application to a notified body (NB). CMOs are not just for small businesses — even large medical device firms may prefer to outsource their manufacturing processes for particular products or markets.
Choosing the right organisation
According to a report by IQ41 Research & Consultancy, the medical contract manufacturing global market is estimated to be worth $97.2 billion by 2026. With the market growing, there is an increasing number of CMOs at the disposal of medical device companies.
It is important to be diligent when choosing a CMO because working with an organisation that lacks the necessary knowledge of the industry can delay your project, put you behind schedule, and lead to costly rework. It is good practice to reach out to these organisations at the earliest opportunity, because recruiting one later down the line can mean revisiting and reworking previous elements that are not to their standards, such as particular design features. This means making a considered decision on an important topic early in the process, which may be challenging for smaller businesses.
It can help to outsource some of the decision-making processes to a freelancer with experience of working with CMOs, who can help you shortlist and decide. If you hire a freelance medical device consultant, they can even help with some of the product development aspects of your project, such as compiling technical documentation.
Speciality and focus
When it comes to CMOs, no one size fits all. As well as varying in physical size, these organisations differ in their focus. Generally, there are two types of CMO to choose from: organisations that are vertically integrated and have a broad focus, and smaller CMOs with a narrow or singular specialism. Choosing the right CMO means knowing their precise focus as well as understanding how the organisation will fit into your wider project.
If you want to outsource a particular task, there are smaller organisations that provide specific services. For instance, the STS Medical Group specialises in manufacturing protective clothing and surgical customised procedural kits (CPTs). If you are working on multiple projects at a time, it can make more sense to work with a vertically integrated CMO that covers various elements, such as design, packaging and testing. For example, DeviceLab Inc is a full-service medical device product development company that covers industrial design, prototyping, manufacturing, product testing and FDA regulatory consulting.
Knowledge and understanding
Once you have decided to recruit a CMO for your project and you know the type of organisation that you want, the next step is choosing one with the right qualifications. It is important that the CMO has extensive medical industry experience and facilities that are certified for medical-grade device production. The priority is always quality — does the organisation meet the required standards for what you need and, if not, why?
While CMOs can operate in other areas of manufacturing without being ISO 13485 certified, this standard demonstrates that their management system meets medical device manufacturing standards. Therefore, when producing scalpels or any other medical device, ISO 13485 is non-negotiable. If you are selling your device in the US, you should also check to see that the organisation is an FDA registered medical device establishment that qualifies it to manufacture and sell on the American market.
It is important to know that CMO has a strong grasp on the complexities of medical devices and will be able to deliver your project on time. Do they know what a good device design involves? Will they be able to select the right materials for your application? Do they already know whether your device will require biocompatibility or an ISO test? Questions like these are important for understanding the knowledge of your CMO.
CMOs that lack this knowledge may sometimes offer a low upfront price and then extend the deadline. To avoid this, you should always be clear about your objectives and try to agree on specific targets on delivery. Remember to ask for the results of any customer satisfaction surveys from their previous clients. Most CMOs will keep a record, and these should tell you the kind of projects that they have previously worked on and how successful they have been. Customer testimonials will also show whether or not the organisation met its deadlines.
If the information you want is not in these documents, don’t be afraid to ask the CMO — when did it last miss a deadline? Why was this? Who will be covering the expenses? The hallmark of a good CMO is that it will be open and honest with you from the start.
With 91% of manufacturers expanding their use of CMOs over the next three years, outsourcing is a clear trend among medical device companies. When choosing a particular organisation to collaborate with, there are several things to consider. You should always check what type of organisation the CMO is and what its focus is, it is important that you decide whether it has the qualifications and experience needed to take your project on.
