The global contract manufacturing market is cluttered. There are literally hundreds of thousands of contract development and manufacturing organizations with varying levels of qualifications. So how do you select one to manufacture your custom medical product?
At the most basic level, you need a contract development and manufacturing organization (CDMO, or contract manufacturer) with the experience and physical capabilities to handle your job. If your CDMO lacks these attributes, you could have high failure rates, cost overruns and subpar quality measures.
Digging a little deeper, you need a contract manufacturer to do three things:
- Reduce risk
- Speed production
- Limit costs
We’ll discuss what to look for in a CDMO so your product gets made within your budget and on time.
Current challenges in device manufacturing
No matter what you want to create, your CDMO needs to understand the challenges inherent in medical device manufacturing. Current challenges include:
Increased cost and supply issues. Supply chain disruptions in recent months have increased the cost to develop and manufacture just about anything, including medical devices. An experienced CDMO will quickly identify potential issues with sourcing supplies and seek ways to reduce costs while still bringing your product to market on a reasonable timeline.
Government regulations. Government regulations change frequently, and new programs are introduced often. If your CDMO isn’t well versed in the various regulations, your costs could increase or your product could be delayed going to market. The right CDMO should have plenty of experience navigating the regulatory arena so you don’t get held up by bureaucratic red tape.
Risk exposure. Your CDMO should reduce your company’s exposure to potential risks by adhering to risk mitigation throughout the entire development process. They should follow ISO 9001 standards. By following these standards and streamlining the production process, you’ll end up with a device or component ready for production.
Your CDMO should help you manage regulatory and supply issues while addressing future risk in the development of an item. But there are other key factors to consider when selecting a contract manufacturer.
Characteristics to look for in a contract manufacturer
You don’t want to hire a contract manufacturer that looks at your job as a “one-and-done” endeavor. You need a long-term partner that will become a de facto arm of your company. You’ll enjoy greater communication and better understand your own goals and requirements as well as your CDMO’s capabilities.
Additionally, some CDMOs may be too big for you. Your project may get lost among myriad projects of bigger brands. On the other hand, small CDMOs may not have the capabilities you need, and they may outsource much of the work to subcontractors you don’t know.
The Goldilocks solution is a CDMO that can handle at least 80% of your processes in-house. It also should be able to handle varying volumes of orders and not require you to order more than you need to meet a minimum run. If you have more product than you need, you’ll have to consider warehousing and logistics over a multiyear period, which increases your production cost.
Another important consideration is the CDMO’s knowledge of current technologies used in medical device manufacturing. The manufacturer should be up to date in the latest methods and have employees who are highly trained and capable of making quality products.
Key takeaways
There are many factors to consider when partnering with a contract manufacturer to build a medical device or product. The most important things to consider are your CDMO’s vendor relationships, ability to get products to market quickly and respect for your budget.
Supply chain management
If the pandemic taught us nothing else, it showed just how fragile the global supply chain can be. Your CDMO must maintain strong vendor relationships that allow your product to get made even when materials are hard to source.
Speed to market
Experienced CDMOs get products to market faster. In the medical device industry, it’s vital you get to market quickly, so you need a partner that can help you do so quickly and efficiently.
Managing costs
The CDMO you choose should keep your budget in mind and work to reduce costs if at all possible. If you find you’re consistently going over budget, you may not have the right contract manufacturer.
A true partner for medical device manufacturing
Cenmed Enterprises has a long history of helping medical device companies bring products to market. From design and prototypes to sterilization, shipping and packaging, our custom manufacturing capabilities will help you achieve your vision.
Contact us to learn more about our contract design and manufacturing services.
