Are you under pressure to control your design, development, and manufacturing costs without sacrificing quality, timelines, and safety? You are not alone. As a result, many OEMs today focus on outsourcing as a competitive strategy to benefit from lower operation costs, speedier time-to-market, and higher quality assurance. Here are 7 good reasons to partner with a medical device CDMO.
1. A CDMO allows you to focus on your core business
Is your ambition to maintain a strong position in your core business area? Do you, however, want to expand your product portfolio? We know design and development aspects outside of the core technology for your medical device can be challenging. This is where a CDMO with design and development capabilities can be a great asset to your team. A CDMO with the capabilities to take on those challenges will allow you to focus on your core business while at the same time helping you reduce the time and cost of bringing your new product to market.
2. Scale up without investing by using a CDMO
Do you need to increase manufacturing capability, scale production volume, or add new components to your production? If so, you are most likely faced with tough decisions and costly investments in production equipment and other resources. Outsourcing design, development, and manufacturing to a reliable CDMO enables you to scale your production in a controlled manner and according to your own plan and bring new products to market without taking the expense of ownership.
3. A CDMO can help you speed up time to market
Bringing new medical devices to market requires attention to risk assessment and a strong regulatory and compliance strategy. With their complex geometries, today’s medical components often require optimized manufacturing design, advanced surface treatments, and high cleanliness. This also demands validated production processes and advanced verification. The right CDMO can provide you with the skilled professionals required to accelerate your time to market and avoid unnecessary costs.
4. A CDMO provides the specialization you may lack
The dedicated expertise, knowledge, and specialization you can find in a full-service CDMO are extremely valuable to many OEMs. CDMOs have qualified engineers dedicated to specific areas in the design, development, and manufacturing process. These processes may include design optimization, plating or coating, over-molding, adhesives work, sterile packaging, or labeling, to mention a few. The insights a specialized CDMO can provide can make or break a successful product launch.
5. Use a CDMO for testing your medical devices
Complex designs often require a combination of different test technologies. A full-service CDMO has its own accredited test lab to carry out advanced testing of your medical devices. Your product can be tested at any step of the manufacturing process, from design, development, and prototyping to assembly and packaging. This provides a great deal of flexibility and cost-efficiency to you as an OEM. Tests may include function testing, mechanical pressure response, or package seal testing.
6. Rely on your CDMO for quality assurance
As the need for medical devices increases, regulations evolve and become stricter and more complex, and competition more intense. As an OEM, you must navigate the highly regulated framework required by the FDA or similar authorities in the EU or other markets. When partnering with a CDMO with extensive regulatory requirements knowledge, you can rely on them for quality assurance. They will ultimately focus on the right things: patient safety and high product quality through dedication to critical details.
7. A CDMO takes care of the product life cycle
A full-service CDMO can drive the product life cycle through all of its phases – analysis and documentation, clinical trials, planning and execution of process customization, initial production, and commercial manufacturing. With the right partner, you can rely on your CDMO to support you with the design, development, manufacturing, and distribution of your medical device until the end of product life.
A committed CDMO to the European, US, and Chinese markets
We leverage our capabilities in Europe, the U.S., and China. As a committed global CDMO, we offer complete performance and vertical integration to leading OEMs worldwide.
Are you looking for a reliable CDMO and a strategic partnership? Contact us today, and together we will find out if your needs align with our competencies.