The relationship between OEMs and CDMOs in the medical device industry has changed remarkably. The increased need for reliable and safe medical devices along with a rising interest in strategic partnership drives the demand for specialized CDMOs. But what exactly is a CDMO? What are the benefits of partnering with one? And what should you consider before choosing your CDMO? Find the answers and more in this blog post.
What is a CDMO of OEMs in the medical device industry?
CDMO is short for Contract Development and Manufacturing Organization. As the name suggests, it is an organization that provides development and manufacturing services. Full-service CDMOs take responsibility for all steps throughout the development and manufacturing process. They guide customers from concept, design, and development to regulatory, prototyping, and testing and through validation, manufacturing, and delivery. However, many CDMOs also take on customers looking to outsource only certain parts of their development and manufacturing process.
What is the difference between a CMO and a CDMO?
CMO is short for Contract Manufacturing Organization. And so, the difference between a CMO and a CDMO is the development part. Medical device and OEM companies contract CMOs to manufacture medical devices or components. Many companies find themselves outsourcing to a CMO for various reasons, usually because a CMO is a more effective solution than investing in their own production. The OEMs find it more economical and efficient to outsource than invest in competence, equipment, and resources by themselves.
A CDMO does not only handle the outsourced manufacturing of medical devices. They also handle all of the innovation and development work that occurs prior to manufacturing. While a CMO is viewed as a tactical provider with the manufacturing capacity needed to complete a project, a CDMO is considered a strategic partner with expertise in areas that the medical device companies seek. This has made CDMOs more appealing to medical device companies and OEMs and given them an advantage over the traditional CMOs.
What are the benefits of partnering with a CDMO?
Developing and manufacturing medical devices is a multifaceted and complicated process – and also the reason more medical device companies are relying on CDMOs. It is often a multi-year, multi-million dollar undertaking. On top of that, medical device companies must navigate the highly regulated framework required by the FDA or similar authorities in the EU.
Partnering with a CDMO can be a great resource, offering numerous benefits that allow you to focus on your core business while reducing time and cost.
Scale your medical device production without investing
If you need to increase manufacturing capability, scale production volume, or add new medical devices to your production, you are faced with tough decisions and costly investments in production equipment and other resources. Outsourcing development and manufacturing to a CDMO enables you to scale your production and bring new products to market without taking the expense of ownership. You can run leaner and more efficiently, knowing that your development and manufacturing are carried out by a CDMO that has these areas as its top focus.
Speed up time to market for your medical devices
Bringing new medical devices to market also requires attention to risk assessment and a strong regulatory and compliance strategy. Today’s medical components with their complex geometries often require optimized design for manufacturing, advanced surface treatments, and high cleanliness. This also demands validated production processes and advanced verification. The right CDMO can provide you with the skilled and experienced professionals you need to accelerate your time to market and avoid unnecessary costs.
Benefit from the expertise of dedicated professionals
The dedicated expertise, knowledge, and specialization you can find in a full-service CDMO are extremely valuable to many medical device and OEM companies. CDMOs have qualified engineers, experts, and professionals dedicated to specific areas in the development and manufacturing process. A dedicated CDMO can provide you with insights and innovation that can make or break a successful product launch to the medical device market.
What should I consider when partnering with a CDMO?
The first thing to look for is a strategic CDMO with capabilities and a view on partnership that align with your needs. Do they have the strategic resources that you need? Do they have the technical expertise and qualified engineers that you seek? Are they specialized in the market segment that your company focuses on?
Reading tip: How we specialize to supply components to the biggest healthcare companies
Next, look at their equipment and facilities. What are their investments in automation, robotics, and spaces such as cleanroom production and testing laboratories? Do they have the manufacturing capacity that you need? Are they prepared to invest in increased capacity as your business grows? Are they able to take your product to market quickly, cost-effectively, and successfully?
Reading tip: Are you looking to outsource cleanroom production of medical devices?
As a medical device company or OEM, you are aware that the medical device market is characterized by a rapidly changing healthcare environment. This demands a CDMO that is highly responsive, committed, and flexible – while at the same time delivering exceptional quality. Does your intended CDMO partner understand your market and medical technologies? Can they solve complex problems and deliver quality that is second to none? Do they have the expertise, knowledge, and experience required to develop and manufacture best-in-class products?
Reading tip: Quality in the medical device industry
Finding the right CDMO is difficult and should not be taken lightly. To find out if your needs align with Elos Medtech’s dedicated competencies, check out our website.