What is a Medical Device OEM?

Statistical Process ControlA medical OEM is an acronym for an Original Equipment Manufacturer that produces medical devices. Medical OEMs are an important part of the medical device manufacturing industry. Because medical devices come in a wide range of instruments, apparatuses, implements, objects, implants, machines, even software or types of material, the medical device manufacturing industry is a vital sector of the economy. One that provides services and products utilized by and in support of global healthcare systems. The medical OEM functions similarly as other OEMs, but there are a number of FAQs that define its unique role in the medical device industry. Specifically:

What is a Medical Device OEM?

A medical device OEM manufacturer designs, engineers and manufactures complete products and systems. Some OEMs also manufacture sub-assemblies or component parts. Other manufacturers purchase these and assemble them into their products. It is not unusual for OEMs to perform all of these functions: parts manufacture, sub-assembly, and final production.

Such a wide range of medical devices constitutes the medical device manufacturing industry, one that continues to expand to meet the demand of global populations. Medical OEMs produce the instrumentation and equipment specifically designed for diagnoses and treatments of patients worldwide. Whether it’s surgical instrument trays or implants, simple tongue depressors or advanced imaging systems, medical device OEMs plays an important, if not vital, role in the healthcare industry.

What is the Meaning of OEM?

An Original Equipment Manufacturer (OEM), broadly defined, is a company that produces components for itself, or for use by another company (sometimes referred to as a VAR, i.e., value-added reseller) to sell or incorporate into another product for resale. A component can be a part or finished product depending on the needs and specifications of the reseller. OEMs provide Contract Manufacturing (CM) services for developers, designers, entrepreneurs, individuals, and companies who do not have the capacity or production means to manufacture a device or component. This is a particularly common method of production in the medical device industry. OEM CMs can manufacture, assemble, package and ship on behalf of their clients.

What is a Medical OEM?

A medical OEM is a company that manufacturers medical related equipment or devices, finished or component parts. Because of stringent regulatory oversight of the medical device industry, medical OEMs offer a broader range of product services such as validation and verification, design and engineering, etc., in conjunction with their manufacturing capacity.

What is Medical Device Outsourcing?

Outsourcing is the practice of one company contracting out operational activities and services to another company. It is a method which allows one company to cut operational and manufacturing costs by contracting those functions to another company to perform for less. As a business model and market, global medical device manufacturing outsourcing is a standard practice in the industry. Outsourcing can include any number of services that range from product testing to design and development to production, packaging, and distribution.

What is Own-Brand Labeling?

An OBL, or Own-Brand Labeler, is a practice where products are manufactured by an OEM and then sold under the name, trademark or brand label of another company. OBL is also referred to as a Private Labeler, and in the UK by statute as “Virtual Manufacturing.” In the medical device industry, OBLs are not part of or involved with the manufacturing of a particular device from an OEM. The responsibility of the design, validation, and verification, production, manufacturing, and packaging are provided by the OEM. The OBL then purchases the components or finished products from OEMs to market and sell under their own name.

If you want to learn more about medical device OEMs, read a former blog post What is a Medical Device Contract Manufacturing Service Company?