In the medical device manufacturing industry, the manufacturer of record is who the regulatory authorities consider to be the product manufacturer. Since multiple companies and suppliers are involved in designing and manufacturing medical devices, it’s important to distinguish who’s liable for the device early on. That way, the FDA knows who to hold accountable if questions arise.
Key Points
- It’s important to document criteria expectations before choosing a manufacturer of record.
- When talking about the manufacturer of record, you are referring to the medical device company developing your product, not the suppliers that manufacture the components of your device.
- It’s common for medical device manufacturing companies to use external suppliers for technologies not available at their facility.
- All medical devices manufactured in the United States are grouped into three broad but distinct classes.
- A detailed contract agreement is crucial for business operations and for regulatory requirements.
Steps for Selecting a Manufacturer of Record for Your Device
Defining a medical device manufacturer of record is easy. Choosing the right manufacturer is more complicated.
Determine the Criteria
The first step to selecting a manufacturer of record is determining your supplier criteria. Start by listing your requirements—important factors like their capabilities, expertise, processes, certifications, price and delivery terms, and intellectual property protection. Take note of everything important to you. Then, you can start evaluating potential suppliers.
Claim Ownership
If you’re using multiple suppliers to manufacture your device, claiming ownership of the product is tricky. From a regulatory perspective, the device owner is the manufacturing company, not the device’s component supplier. When multiple component suppliers are selected, those companies act as proxies to the main product’s owner.
The medical device company becomes the “manufacturer of record,” or entity that regulatory authorities consider the manufacturer. So when you refer to the manufacturer of record for your device, you’re talking about the medical device company developing your product, not the suppliers that manufacture your device’s components.
Define Intellectual Property
Once you’ve selected the manufacturer of record, product ownership seems straightforward—your medical device company is the manufacturer of record, so they own everything, right? The simple answer is no.
It’s common for medical device manufacturing companies to use external suppliers. For example, an external supplier that offers 3D printing, rapid prototyping, or injection molding has its own intellectual property.
Understanding who owns the intellectual property used to manufacture your medical device is crucial, since it may be challenging to change your product in the future if the intellectual property is owned by a separate supplier from your manufacturer of record.
Understand Manufacturing Regulatory Compliance Classifications
Next, make sure you’ve chosen a manufacturer of record that understands manufacturing regulatory compliance classifications.
Every medical device manufactured in the United States is grouped into three broad but distinct classes: Class I, II, or III.
- Class I devices are the most common classification, constituting over 47% of approved devices on the market today.
- Class II medical devices offer more complications than Class I because of the increased risk for patients or device users. They’re subject to closer evaluations and stricter design, manufacturing, testing, and labeling standards.
- Class III devices make up the smallest number of devices, with only 10% falling into this classification category. Class III includes many complex instruments like smart medical tools, life support systems, and invasive devices.
Before moving to the next step, ensure that your device’s manufacturer of record helps you determine which class your product falls under based on FDA requirements.
Create a Contract Agreement
Once you’ve defined your criteria, claimed ownership, considered intellectual property, and determined your device class, it’s time to formalize and document your expectations with a contract agreement. The formal agreement should include detailed expectations, quality criteria, ownership clarification, defined deliverables, a determined review period, definition of escalation, and path changes. A well-defined contract agreement is crucial for both business operations, but it’s also important for regulatory requirements.
Remington, an Experienced Medical Device Manufacturer of Record
Remington works alongside other suppliers to develop unique device components, but our team completes the final assembly, sterilization, and packaging so that when your product is submitted to the FDA for approval, we’re considered your manufacturer of record.
Leveraging the Power of Our Intellectual Properties
Unlike other medical device companies, Remington doesn’t use external suppliers for 3D printing, rapid prototyping, and injection molding. We complete these innovative processes in-house, making it seamless to update your medical device design in the future.
Our Rapid Prototyping Services
Remington’s rapid design process for medical devices begins with our digital design team building a prototype simulation that creates an interaction between the interface and user. We can prototype almost every aspect of your product in a user interface, from a simple interaction to a detailed representation of your device.
Our Injection Molding Services
The Remington team uses injection molding for large scale plastic part production. Our injection molding machines are scalable and capable of meeting your needs as they arise. We use raw materials and inject them into cavities where the molten plastic sets to fit the mold. Following the mold cycle, the plastic cools before being ejected from the mold. Our innovative injection cycle process typically takes seconds, and the cooling process is managed efficiently by a Remington molding technician.
To learn more about what makes Remington a high-quality medical device manufacturer of record, contact us today.
