World Health Organization defines a Medical Device as, “any instrument, apparatus, implement, machine, appliance, implant, in-vitro reagent or calibrator, software, material or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purposes of:
- Diagnosis, prevention, monitoring, treatment or alleviation of disease
- Diagnosis, monitoring, treatment, alleviation of or compensation for an injury
- Investigation, replacement, modification, or support of the anatomy or of a physiological process
- Supporting or sustaining life
- Control of conception
- Disinfection of medical devices
- Providing information for medical purposes by means of in-vitro examination of specimens derived from the human body and which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.”
In health care delivery, the medical device manufacturing industry plays a major role. Medical devices are being used by physicians in treating many illnesses and conditions along with the medication. As there is a possibility of occurring adverse events with the use of medical devices, there is need for testing the performance of the medical device prior to their use. Sources say FDA has received more adverse event reports from devices used in cardiovascular and neurological diseases than from drugs in 2008.
Approval for the use of medical devices takes a long time as the regulations are very stringent for the conduct of device trials. In the US, it takes five to ten years for the approval and in Japan it takes an additional five to ten years. Lack of proper standards for conducting device trials and strict regulations has affected the approval of medical devices. In 1993, the European Committee for Standardization published standard EN 540 which defines the standards for conduct of medical device trials. Later International Standards for Organizations (ISO) joined with the European Committee for Standardization and developed the standards in more elaborated way under two parts: ISO 14155 Part-1 and ISO 14155 Part-2.
ISO 14155 discusses the Step-by-step methodology, record-keeping, reporting requirements, Ethical and legal approval requirements; Steps to construct a protocol, Risk assessment, Case report forms and Instructions for preparing a final report. It also defines procedures for conducting medical device clinical investigations and protects the human subjects, ensures proper scientific conduct, and assists all the individuals involving the conduct of device trial.
A medical device trial costs $5 to $10 million in United States and Japan. In India the cost of these device trials would be one tenth of the cost in Western countries. As Asian countries contain huge population with large patient pool and less cost than the Western countries, India, China, Korea are becoming a hub for these device trials.