“An article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose. Typically, the purpose of a medical device is not achieved by pharmacological, immunological or metabolic means.”(1) The term medical device differs from a drug because a drug can achieve its actions by pharmacological, immunological, or metabolic means.
Market Trend For Medical Devices
In 2013, the medical device market reached approximately $363.8 billion with an annual market average growth of 18.41% from 2010 to 2020. (5) “The top 10 medical device markets by sales revenue in 2012 were the United States (36.3%), Japan (9.9%), Germany (7.0%), China (4.3%), France (4.1%), UK (3.0%), Italy (2.6%), Russia (2.1%), Canada (2.1%), and Brazil (1.6%).” (5)
The top 10 companies for medical devices sold in the United States are provided below with the percentage of revenue:
Class I: These type of devices are considered low risk. These include surgical instruments and tongue compressors. (2)
Class IIa: These type of devices are considered low-moderate risk. Examples include hypodermic needles and suction equipment. (2)
Class IIb: These type of devices are considered moderate-high risk. Examples include lung ventilator, orthopedic implant, and blood bags. (2)
Class III: These type of devices are considered high risk. Examples include heart valve, implantable defibrillator, or a shunt. (2)
Approval Process For Medical Devices
The process for medical device approval is a very complicated process. Medical devices are approved by the Food and Drug Administration (FDA).
The first step in the approval process includes the concept and design process, which is when “the innovator works out the details of the design and manufacturing of the new device. At this stage, many innovators partner with medical device companies, which perform a detailed market analysis in determining which devices to support.”(4)
The next phase includes animal testing. A medical device is tested on animals before it can be studied on humans. (4)
The third phase includes performing clinical trials on medical devices. Generally, for class III devices, clinical trials are conducted to determine the efficacy and safety. (4)
The fourth phase includes a review process by the FDA based on the animal testing and clinical trials for medical devices. Most class I and class II medical devices do not undergo a review process by the FDA if they are low risk and if they are similar to already previously marketed medical devices. Class II devices undergo a process known as 510(k) review, which focuses on whether the medical device is equivalent to already an existing device on the market. However, for class III devices, manufacturers must submit a PMA (premarket approval process) application. (4)
Next, a class II medical device is considered cleared if it meets the 510 (k) review process requirements and a class III medical device is considered approved by the FDA if it is proven to be safe and effective for human use. (4)
Finally, the FDA conducts post-marketing assessments for malfunction of medical devices. (4)
(1) Medical devices: definition. World Health Organization. Accessed from:
http://www.who.int/medical_devices/definitions/en/ . Accessed November 3, 2018
(2) Regulation of medical devices: a step-by-step guide. World Health Organization. 2016 Accessed from: http://applications.emro.who.int/dsaf/emropub_2016_EN_18962.pdf ?ua=1&ua=1&ua=1 . Accessed November 3, 2018
(3) Classify your medical device. FDA (Food and Drug Administration. Accessed from: https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/ClassifyYourDevice/ucm2005371.htm . Accessed November 3, 2018
(4) Jin J. JAMA patient page. FDA authorization of medical devices. JAMA.
2014;311(4):435. Available from: https://jamanetwork.com/journals/jama/fullarticle/1817798 . Accessed November 3, 2018
(5) Liao S, Ramakrishna S, Teo WE, Tian L, Wang C. Introduction. Medical devices: regulations, standards and practices .Waltham, MA. Elsevier. 2015. Available from: https://books.google.com/books?id=B5SZBgAAQBAJ&printsec=frontcover&dq=medical+devices&hl=en&sa=X&ved=0ahUKEwju_Om1y7jeAhVSbK0KHaLgB3UQ6AEIMDAB#v=onepage&q=medical%20devices&f=false . Accessed November 3, 2018