What is a Medical Device Contract Manufacturing Services Company?

lab with petri dishThere’s little doubt that the medical device manufacturing industry is expanding worldwide and contract manufacturing services a large part of it. Over the past several decades, the industry, and the contract manufacturing sector has met the challenges of ever-increasing demand and reshaped medical technology. There are near 5,800 companies employing over 350,000 people in the industry. Last year, the United States alone accounted for nearly half –45 percent of sales—of the $413 billion global market for medical devices. With the industry growth rate at 5 percent annually, projected sales by 2022 will be approaching $530 billion. As the global market for medical device manufacturers increases, so will the need for more companies and people in the industry. Expect the role of contract manufacturing to play an even greater part in the years ahead.

A Little Bit About Contract Manufacturing Services

Contract manufacturing is a form of outsourcing in which a company produces whole products or a single part a larger product. This is true in the medical device industry, as well. OEM (Original Equipment Manufacturer) of medical devices are companies that, in general, focus on a particular area of expertise, such as molding, assembly, or R&D design. Medical device contract manufacturing is the system by which a manufacturing company makes medical devices or components of medical devices that can be later sold by another company.

Medical device contract manufacturers often specialize in a certain process or task and can offer expertise from frequent practice of their manufacturing. Service or services for customers, clients, and inventors of medical devices include product concept and development, process validation and verification, production, or highly specialized manufacturing, packaging. They can even manage the supply and delivery to the end customer.

OEMs can also provide specialized facilities that are essential for the manufacturing of medical devices. On-site medical labs are necessary for all phases of production, from design to manufacturing. These labs afford engineers with the chance to validate and verify new products and allow for any design changes that may be necessitated as needed. Cleanrooms are also required to ensure the manufacture of medical devices is free of contaminants. A cleanroom utilizes advanced filters, specialized clothing, and even hermetically seals the workspace.

What is Medical Device Contract Manufacturing?

To be certain, the term “medical device” covers a broad range of products. They can be found in the operating room, labor and delivery, nursing homes, intensive care units, home health care, sleep labs, your local pharmacy, and many other places. Nevertheless, all medical devices sold in the U.S. are regulated by the FDA (Food and Drug Administration). By FDA definition a medical device is “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory” that’s recognized as a pharmaceutical or supplement, intended as a diagnoses, cure, or preventive treatment of a disease, with the intention to affect the structure of a human or animal body. The regulatory policy for these devices is strict and follows a three tiered classification system, i.e., Class I, II, and III.

When You Need an Experienced OEM Contract Manufacturer

As an OEM contract manufacturer, BMP Medical provides services for the medical device industry. Its area of specialty produces highly precise plastic consumables used in devices and diagnostic kits. BMP Medical will work with its customers through all phases of production. We offer state-of-the-art injection blow molding capabilities to produce an array of IVD & IV components, sample preparation devices, and lateral flow technologies. We can offer design consultation, engineering, drawing, R&D, tooling, mold development, computer automation, and statistical process control for mid-tier products. Our facility is equipped with a Class 8 clean room for manufacturing, packaging, and assembly needs.

As a single source provider, BMP is geared to meet all regulatory requirements for medical device engineering. Sterilization services, custom packaging, pad printing, DNase/RNase free manufacturing, and process validation services to support any complex product development cycle are all available to BMP’s customers. The company has established the most rigorous quality control standards possible; especially for Class 1 medical device approval and 510K filing specifications.

Finally, to meet the needs of our clients and customers, BMP offers manufacturing facilities in Massachusetts and Asia, we can service any complex project requirement worldwide. Our devices have assisted a wide variety of industries ranging from diagnostic, laboratory, and research to biomedical, clinical, medical, and pathology devices. BMP is both ISO 13485 and 9001:2008 compliant, and conforms to standards set by the FDA, cGMP, LPA, ANSI, AAMI, and SPE. This is why, as an OEM of medical devices, pharmaceutical and medical companies have looked to BMP Medical to manufacture their medical devices for over 30 years. If you have any questions, feel free to contact us!