What Is Contract Manufacturing?

What Is a Contract Manufacturing Agreement?

A contract manufacturing agreement for medical devices establishes a service arrangement between a medical device company and a contract manufacturer. The purpose of this agreement is to set the terms of the device’s production, yearly quantities, pricing, quality standards, and delivery.

When a business is looking for a manufacturing agreement for a medical device, key facilitators approach various contract manufacturers that specialize in medical devices. Then, providers quote bids on the costs based on labor, tooling, and materials. After the bidding process, the client selects their contract manufacturer (CM).

Types of Contract Manufacturing

For successful, high-volume contract manufacturing, reputable medical device companies offer a variety of in-house services, including:

Rapid Prototyping

As a specialized manufacturing service for medical devices, rapid prototyping creates high-quality parts that match 3D models of a new medical device design. Medical device prototyping is crucial for design validation and improvements. The process helps medical device manufacturers identify and develop the production components required to transition from research and development to full-scale production.

In-House Tool Shop

At Remington, we’re more than just your average medical device manufacturer. We build high-quality devices with our in-house tool shop, starting from the ground up and focusing on all aspects of your product. We use a wide range of precision tooling processes, like:

CNC Milling
Wire and Sinker Electrical Discharge Machining (EDM)
Swiss Screw Machining

Our in-house tool shop gives us the opportunity to become familiar with your device, ensuring accurate form and functionality.

Manufacturing

Contract manufacturers specializing in medical devices have a vast array of advanced equipment and high-level expertise to assist companies with manufacturing high-quality products. Well-known manufacturers have large facilities where they take on projects of all sizes and handle medical device manufacturing processes in house, including design, manufacturing, packaging, and managed sterilization.

Packaging and Sterilization

Full-service medical device contract manufacturers provide you with everything you need for medical sterilization and packaging. Companies often create a package design and test it to ensure it’s the right fit for your product. Once the device’s packaging meets your expectations, experts conduct onsite medical device sterilization and packaging processes in a regulated ISO Class 8 clean room. By offering design, packaging, and sterilization solutions at our facility, you get a streamlined process that prevents time-to-market delays.

Product Lifecycle Management

The lifecycle management of your medical device is about more than just getting your product on the market. Once your device is available, there’s still consistent work to be done. From design strategy to product launch and beyond, once you find a quality contract manufacturer, you get a lifelong partnership with an experienced company that supports your device for years to come.

When you work with a quality provider, you won’t have to worry about the design details of your device. With a partner like Remington Medical, your job only gets easier.

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Benefits of Contract Manufacturing Services

The advantages of working with contract manufacturers for medical devices include:

A More Cost-Effective Process

Medical device companies that use contract manufacturing services benefit from working with a partner that already has expertise. Knowledge of the manufacturing process and having the right equipment mean the manufacturing services provider can make products faster and with lower overhead.

A Closer Focus

By relying on contract manufacturers to design and create medical devices, pharmaceutical companies have more time to put toward their core competencies, giving them a closer focus on the market. Freeing up these resources also allows companies to reach out to new markets.

Streamlined Distribution

Many contract manufacturers ship directly to their customers, giving them a whole new edge. This cost-saving benefit allows more supply chain freedom.

Improved Scalability

Every business is looking for ways to grow. With contract manufacturing, companies gain access to services that can be scaled up or down to fit their needs. Key facilitators can miss out on opportunities because of a lack of supply to meet demand.

Questions To Ask a Contract Manufacturer

Selecting the right contract manufacturer for your medical supply needs requires due diligence. Going with the manufacturer that offers the lowest price may put you at a disadvantage when demand is high. When searching for a suitable contract manufacturing partner, be sure to keep these questions in mind:

Are They Compliant With All Industry Standards?

Ask your manufacturer if they are ISO 13485:2016 compliant. This specifies requirements for quality management systems and requires all medical devices meet regulatory standards.

Are They Capable of Protecting Your Intellectual Property?

Ask about the data systems employed by the manufacturer and what security solutions they have in place to protect your intellectual property. An excellent medical manufacturer should prioritize safeguarding your information from day one.

Is Their Pricing Structure Transparent?

A good contract manufacturer will quote you an accurate price from the start. Feel free to ask for references and similar case studies to make sure they won’t sneak in hidden costs after signing a contract.

What Is Their Turnaround Time?

Turnaround time is critical when working with medical devices. Making sure that a contract manufacturer can deliver your supplies on time will help keep your patients and staff happy.

Are They Financially Viable?

Don’t be afraid to ask questions about the overall financial health of a particular manufacturing business. You want the partnership to last for years, and verifying the financial stability of a contract manufacturer can assure you about their long-term staying power.

What Is Their Customer Service Process?

A solid contract manufacturer will dedicate a professional to overseeing quality control and serving as your point of contact throughout the manufacturing process. Your contract manufacturer should offer services that extend beyond final production.

Working With a Contract Manufacturer You Can Trust

At Remington Medical, we complete all device manufacturing processes in house. With more than 90,000 square feet of production space, our team handles projects of all sizes. By holding ourselves accountable for all aspects of your product’s manufacturing, we have total control of your device’s quality and efficiency, from prototyping and packaging to product launch and lifecycle management.

With Remington handling your medical device manufacturing processes, you get: