Due to the many regulations in the industry, the design of medical devices presents significant challenges from both engineering and legal perspectives.
The United States medical device industry is one of the largest markets globally, exceeding $110 billion annually.
The most medical device companies are in the states of California, Florida, New York, Pennsylvania, Michigan, Massachusetts, Illinois, Minnesota, and Georgia.
[1] Medical devices are defined by the US Food and Drug Administration (FDA) as any object or component used in diagnosis, treatment, prevention, or cure of medical conditions or diseases, or affects body structure or function through means other than chemical or metabolic reaction in humans or animals.
[2] This includes all medical tools, excluding drugs, ranging from tongue depressors to Computerized Axial Tomography (CAT) scanners to radiology treatments.
Manufacturers are required to develop comprehensive procedures within the FDA framework in order to produce a specific device to approved safety standards.
[3][5] In general, for class I, II and III devices, from the design process until the final FDA market clearance, it can take anywhere from three to seven years.
[8] Premarket Approval is a scientific review to ensure the device's safety and effectiveness, in addition to the general controls of Class I.
[10] Devices are classified into three brackets: Regulations differ by class based on their complexity or the potential hazards in the event of malfunction.
[9][7][6] Examples of Class I devices include hand-held surgical instruments, (elastic) bandages, examination gloves, bed-patient monitoring systems, medical disposable bedding, and some prosthetics such as hearing aids.
[7] Examples of Class II devices include acupuncture needles, powered wheelchairs, infusion pumps, air purifiers, and surgical drapes.
Prior to marketing a Class III device, the rights-holder(s) or person(s) with authorized access must seek FDA approval.
The review process may exceed six months for final determination of safety by an FDA advisory committee.
[17] Common techniques in the area are direct-write nanopatterning techniques such as dip-pen nanolithography, electron-beam photolithography and microcontact printing, directed self-assembly methods, and Functional Nanoparticle Delivery (NFP), where nanofountain probes deliver liquid molecular material that is drawn through nanopattern channels by capillary action.
[18] Additive manufacturing (AM) processes are a dominant mode of production for medical devices that are used inside the body, such as implants, transplants and prostheses, for their ability to replicate organic shapes and enclosed volumes that are difficult to fabricate.
[19] The inability of donation systems to meet the demand for organ transplantation in particular has led to the rise of AM in medical device manufacturing.