Every Contract Manufacturer has something distinctive to offer, but whether or not they are a good fit for you depends on what you hope to get out of the project. Price is and always will be a key consideration when selecting the ideal contract manufacturer for your project, but other qualities are just as crucial for building a successful and long-lasting partnership. The ideal partner for an OEM is a (contract) manufacturer who is willing to collaborate with your company to better comprehend and accomplish your ultimate aim target.
Here are some of the key considerations to keep in mind while selecting a contract manufacturer,
Capabilities
Utilizing resources you don’t already have in-house is one of the key reasons you might decide to outsource manufacturing to a contract manufacturer. To create your desired component, any manufacturing company you might consider should at the very least have the necessary infrastructure, machineries and expertise. However, this information is not enough to make a decision regarding a manufacturer. Gather as much information as you can about any extra capabilities that would enable you to consolidate your vendor base. Additionally, inquire about other services like assembly and Design for Manufacturing and Assembly (DFMA). The right contract manufacturer may offer benefits you hadn’t thought of.
Experience and Know-how
Manufacturing is more than a set of skills when it comes to complex products or highly regulated sectors such as medical devices. Along with relevant industry experience, the ideal partner should also have complementary skills to your key talents. For instance, some businesses specialize in specific fields, like the medical or industrial, while others are general manufacturers. You can check to see whether a possible partner has preferred status with top OEMs and vendors for industry experience and expertise.
Adhering to Industry Standards Increases Success Rate
In order to guarantee the timely delivery and success of your product, managing the manufacturing processes of a medical device or component calls for legal experience, familiarity with the FDA regulatory environment, and a strong compliance programme. Different compliance processes apply to medical devices classified as Class I, II, and III. The FDA medical device classification of your product will determine which OEM service provider to use. Some might exclusively deal with the production of Class I, II, or III medical devices. Knowing what classification your item falls under and selecting an OEM who only works with that classification will help the process forward by adding more experience and expertise.
Capacity
When searching for the ideal contract manufacturer, you need to ensure that the business you choose has enough capacity to deal with the scale of your undertaking.
Are you going to be this business’s biggest customer or one of the smallest clients? Both extremes can be cause for concern. Will this be the first time the business has handled a project of this size if you are the biggest client? Will you receive the attention you require if you are a start-up company? Additionally, checking if the company has enough room at the company’s facilities for storage and assembly. Employees committed to your project, or personnel shared with other projects, is an important consideration.
Location
Where exactly will all of this work be completed? However, if some sub-components are outsourced, it may be developed in multiple locations. The location of the final assembly and testing is the true issue, then. Location is frequently considered as domestic vs offshore, which has a wide range of implications in terms of politics, linguistics, shipping, and cost.
Beyond that, though, geography can also affect how comfortable you are, as you may occasionally want to be able to travel to the factory to observe the business in-person or to speak with your project manager in person.
Financial Stability
OEMs search for potential manufacturing process disruptions when they perform risk assessment analyses on potential contract manufacturers. Unrealistic expectations, equipment failure, improper inventory management, subcontractor delays, a lack of raw materials, a natural disaster, and other circumstances can all contribute to interruptions. The worst-case situation is that the chosen manufacturer (or their suppliers) may fail to operate because of financial instability and payment delays to vendors. So it is safe to make sure that company has been around for a long time and enquire about their previous projects and clients.
A Partner for Market to Design
From the idea stage to the product’s launch, a company that offers contract manufacturing services for medical devices can give clients advice and help them find ways to make their product successful. Teams from engineering and manufacturing provide their clients decades of experience and knowledge. The ability to oversee production and provide consultation throughout the whole process enables all parties to take advantage of improvement possibilities as they arise. These contributions can help you overcome the most difficult development hurdles for your medical device, from managing regulatory compliance issues to using pre approved manufacturing materials and methods.
Meeting Contract Manufacturing Deadlines
Speed to market is one of the persistent focuses for medical device companies while choosing a contract manufacturing partner. The contract manufacturer should be able to provide examples of the business processes and practices that have been put in place to meet and maintain aggressive production schedules for your specific medical device.
In order to guarantee the seamless transition of a programme from concept to design, gesco healthcare has time tested processes and capabilities in place. You’ll see that we are able to respond to unforeseen customer-driven changes thanks to our adaptable system during the manufacture, testing, and delivery of your medical device.
There are a lot more questions you may (and should!) ask a potential contract manufacturer, but if these are on your list, you can rest assured that your screening process is well-supported.
In the end, any good contract manufacturer will adapt to your needs to serve you better.
