Should your medical device company partner with a CDMO – a contract design and manufacturing organization? Medical device companies are increasingly turning to CDMOs because of the range of benefits and commercial advantages they offer. We’ll explore the main reasons for choosing a CDMO in this blog.
What is a Medical Device CDMO?
A CDMO offers end-to-end services throughout the entire medical device product lifecycle, from the development of the initial concept through all stages of the design process through to the creation of a working prototype ready for testing and clinical trials. CDMOs often also offer regulatory support and, as the name suggests, they can manufacture your medical device when it is ready to be launched into the market.
There are two additional points to highlight. The first is the difference between a CDMO and a CMO. A CMO is a contract manufacturing organization and is the more traditional type of setup. However, a traditional CMO lacks the design and development expertise that is crucial to many projects and medical device companies.
The second point to highlight is the importance of choosing a medical device CDMO. CDMOs are not unique to the medical device industry, but the medical device industry is unique. Therefore, it is essential to choose a CDMO with a proven medical device track record.
The Benefits of Choosing a Medical Device CDMO
CDMOs are the ideal choice for a range of companies in the medical device industry, including start-ups, academic spin-offs, OEMs (original equipment manufacturers), and large international corporations. Here are the main benefits of choosing a medical device CDMO for your product, project, and/or company.
Focus
By partnering with a CDMO, you will have more time to focus on your core areas of competence, whether that’s ideation, product research, market development, raising finance, etc.
Time to Market
You will benefit from an accelerated time to market by working with a CDMO that has a ready-to-go team, established processes, and relevant experience.
Easier and Less Costly Scale-Up
When you are ready to scale up production to meet the growing demand for your product, you can do so without having to make a massive investment in technology, equipment, infrastructure, or personnel. Your CDMO partner will already have all of that in place, allowing for a more controlled, efficient, and cost-effective increase in production.
Specialist Knowledge
By partnering with a medical device CDMO, you will get access to specialist knowledge. This includes product-related knowledge such as materials, minimally invasive medical devices, advanced catheter technologies, sensors, etc. It also includes process knowledge and experience, including validation, testing, sterile packaging, labeling requirements, manufacturing methods, etc.
Advanced Capabilities
Your CDMO will also give you access to advanced capabilities, from design innovation expertise to prototype production to manufacturing.
Regulatory Expertise
On-tap regulatory knowledge is another important benefit of working with a CDMO. At Arrotek, for example, we start work on compliance at the earliest stages of the product development process, and we continue that work on compliance throughout the entire product lifecycle. This approach reduces the risk of approval setbacks, warning letters, product recalls, and other regulatory challenges.
Certifications and Audits
A medical device CDMO will have a ready-to-go Quality Management System (QMS). Your CDMO should also have a valid ISO 13485 certification and FDA audit certification.
DFM
DFM stands for design for manufacturing (or design for manufacturability). It involves designing a product in a way that not only delivers the required performance characteristics but can also be commercially manufactured, i.e., efficiently manufactured profitably with minimal quality risks.
Design Transfer
Design transfer refers to the process of handing over the project from the design team to the operational team responsible for manufacturing the product. When you work with a CDMO, those teams will be within the same company, making the design transfer process more streamlined and reducing the risk of errors.
Optimised Processes
A CDMO will have experience ensuring manufacturing processes are fully optimized.
Resource Availability
Many medical device companies struggle with resource availability issues, especially start-ups, although larger organizations can face similar problems. This is where internal resources are overstretched leading to delays and other project challenges. Working with a CDMO will resolve your resource availability issues.
Cost-Effective
Partnering with a CDMO is a cost-effective approach to designing, developing, and manufacturing your medical device product. It is also easier to budget and plan.
Flexibility
The best medical device CDMOs offer flexibility in working arrangements to ensure their services align with the varied needs of different customers. At Arrotek, for example, we offer as much flexibility as possible, including operating on a time and materials basis when required. This approach lowers the initial financial outlay and reduces project risks for our customers.
Knowledge Exchange
As medical device products become more advanced, there is an increasing need to access specific and often highly niche expertise to resolve problems and progress projects. Going out to find that expertise from a standing start is difficult and time-consuming. A CDMO will already have relationships with other specialist companies, facilitating faster knowledge sharing and keeping the timeline of your project on track.
Entire Product Lifecycle
Finally, working with a CDMO means you will benefit from dedicated support through the entire product lifecycle. The CDMO will continuously learn, adapt, and improve, benefiting your product and its success in the market.
Arrotek – a Leading Medical Device CDMO
Arrotek is a leading medical device CDMO with a proven track record, extensive minimally invasive medical device design capabilities, and advanced manufacturing operations in Ireland, the USA, and Central America. To discuss your requirements and the benefits of partnering with us as your CDMO, please get in touch with us today.
