The Pharmaceutical Medical Devices: An Updated Review
Medical Devices Used for medical purposes
Keywords:
Regulatory review and decision, preclinical research, clinical trials, product introduction, postmarketing monitoring, and medical deviceAbstract
ABSTRACT
A medical device refers to any object or substance, including instruments, machines, appliances, implants, reagents for in vitro use, software, materials, or similar articles, that is designed by the maker to be used for one or more particular medical purposes, either alone or in combination, for the benefit of human beings. Medical devices are often categorised according to the level of danger they pose. The specific categorisation of a medical device based on risk is contingent upon its intended function and usage. The inception of a novel device often starts with a conceptualisation by a medical professional or bioengineer, aimed at addressing a medical issue. If the proposal is deemed feasible and viable (proof of concept), a first iteration of the apparatus, referred to as a prototype, will be constructed. The prototype device will undergo a series of preclinical testing, followed by redesigning, and further rounds of preclinical testing of the redesigned version. This iterative process will continue until the design has been developed and tested to a level of readiness suitable for manufacturing and subsequent human testing. Preclinical animal experiments are undertaken with the aim of generating substantial data about the safety and efficacy of innovative technologies and medicines. In the realm of medical device research, the need of clinical trials is not universally mandated, since their implementation depends upon a comprehensive evaluation of potential risks. Post-marketing surveillance refers to the systematic and on-going process of monitoring the safety of a medical product subsequent to its commercial distribution.
References
REFERENCES
WHO, medical device-full definition. Available at: https://www.who.int/medical_devices/full_deffinitio n/en/. Accessed on 22 July 2020.
Medical device & diagnostics. Available at: https://cdsco.gov.in/opencms/opencms/en/Medical- Device-Diagnostics/Medical-Device-Diagnostics/. Accessed on 22 July 2020.
How medical device development from prototype to regulatory approval works?. Available at: https://schmitprototypes.com/how-medical-device- development-from-prototype-to-regulatory- approval-works/. Accessed on 22 July 2020.
Cooper T. Understanding prototype development phases for medical products. Available at: https://www.meddeviceonline.com/doc/understandi ng-prototype-development-phases-for-medical- products-0001. Accessed on 22 July 2020.
Bench testing important for patient safety, successful device development. Available at: https://www.healio.com/news/cardiology/20120225/ bench-testing-important-for-patient-safety- successful-device-development. Accessed on 22 July 2020.
Medical device testing strategies and implementation. Available at: https://www.einfo- chips.com/blog/implementing-medical-device- testing-strategies-a-high-level-overview/. Accessed on 22 July 2020.
Whitepaper medical device simulation. Available at: https://www.asme.org/wwwasmeorg/media/resource files/aboutasme/standards_certification/whitepaper_ medical-device-simulation. Accessed on 22 July 2020.
Sunghee P, Schaer TP. Preclinical animal models. Academic entrepreneurship for medical and health scientist. 2019;1(3):20.
New regulations for medical devices in India, applied clinical trials. Available at: http://www. appliedclinicaltrialsonline.com/new-regulations- medical-devices-india. Accessed on 22 July 2020.
IISO 14155:2011, clinical investigation of medical devices for human subjects, good clinical practice. Available at: https://www.iso.org/standard/45557. html. Accessed on 22 July 2020.
Medical device clinical trials. Available at: https://cdn2.hubspot.net/hub/149400/file- 646377456-pdf/docs/mc-n-med-dev-trials-compare- with-drug-trials. Accessed on 22 July 2020.
Premarket approval (PMA), FDA. Available at: https://www.fda.gov/medical-devices/premarket- submissions/premarket-approval-pma. Accessed on 22 July 2020.
How to submit preclinical data to ODE. Available at: https://www.mddionline.com/stub/how-submit- preclinical-data-ode. Accessed on 22 July 2020.
WHO, implementation of adverse event reporting for medical devices, India. Available at: https://www.who.int/bulletin/volumes/98/3/19- 232785/en/. Accessed on 22 July 2020.
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