What is Medical Device Manufacturing?

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  • Written By: Mary McMahon
  • Edited By: O. Wallace
  • Last Modified Date: 18 November 2019
  • Copyright Protected:
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Medical device manufacturing in a branch of the manufacturing sector which is dedicated to the production of devices used in medical diagnosis and treatment, from surgery tables utilized in operating rooms to continuous positive airway pressure (CPAP) machines used by apnea patients to manage their condition. Because the failure of a medical device can have serious consequences for a patient or care provider, medical device manufacturing is closely regulated in many regions of the world. A number of companies specialize in making medical devices or produce medical devices as part of their overall services.

Medical devices can include a wide range of medical equipment, such as cardiac monitors, magnetic resonance imaging machines, prosthetics, fetal heart monitors, anesthesia machines, thermometers, stethoscopes, and surgical instruments. Some nations also classify organisms used in medical diagnosis and treatment, such as bacteriophages, as “medical devices.” Pharmaceutical products, on the other hand, are treated and regulated separately.

A company which works in medical device manufacturing can develop and produce a range of products for medical use. Products must be approved by regulatory agencies before they can be sold, however. Regulatory agencies inspect products to confirm that they are safe, to determine how they can be used, and to see whether or not they adhere to safety standards. Medical imaging devices which use radiation, for example, must be designed with adequate shielding and safety measures to protect patients and technicians from radiation.


Some companies sell directly to hospitals, clinics, and care providers. Because medical devices can be dangerous in the wrong hands, their sale may be restricted to authorized personnel or patients who have prescriptions for specific devices. This is designed to ensure that only people who know how to safely us and maintain medical devices have access to them. Other manufacturers sell to companies which supply medical equipment. Many companies can manufacture custom products by request, as long as these products meet safety standards.

As in other areas of the manufacturing sector, medical device manufacturing is represented by a number of trade associations. These groups work with the government and regulatory agencies to promote safety and ensure that the cost of doing business does not become onerous. These groups can also represent their members in legal suits, and provide networking opportunities to member companies. Members of such trade organizations have access to special publications, annual conferences, legal advice, and other benefits which may be useful to companies working in medical device manufacturing.



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