e-ISSN: 2582-5208 International Research Journal of Modernization in Engineering Technology and Science Volume:03/Issue:07/July-2021 Impact Factor- 5.354 www.irjmets.com www.irjmets.com @International Research Journal of Modernization in Engineering, Technology and Science [741] MEDICAL DEVICE FAILURES - IMPACT ON MEDICAL DEVICE & HEALTHCARE INDUSTRY Sai Vidhya Singan *1 *1 Department Of Bioscience & Biotechnology, Banasthali Vidyapith, Banasthali, Rajasthan, India. ABSTRACT Medical devices have revolutionized healthcare industry with enhanced disease prevention, medical diagnosis and treatments. Several regulatory authorities like Food and Drug Administration (FDA) and Center for Devices and Radiological Health (CDRH), ensures safe, effective and high-quality medical devices are accessible to patients and providers. Counterfeit medical devices cause a damaging impact on the authentic manufacturers by replacing the authentic medical devices with fakes ones having compromised quality. The major difference between the counterfeit medical devices and substandard medical devices is that the counterfeit products are deliberately made to replace the genuine ones by authentic manufacturers while the low-quality devices just use cheap raw material to compete with the genuine medical devices in the market. FDA approves the medical devices to use them for specific diseases and treatments on specified populations. However, their use on the non-approved population for non-approved treatments makes them off-label devices which often results in severe detrimental effects on patients. Besides this, software glitches are also the major cause of the medical device failures. While medical devices have successfully provided superior patient and clinician experience, medical device failures and malfunctions have adversely impacted medical device companies, healthcare industry and patients. Keywords: Medical Devices, Counterfeit Products, Off-Label Devices, Software Glitches, Product Recalls. I. INTRODUCTION Now a days, manufacturers of medical devices have to cope with the challenges to make their devices more competitive. The challenges they face include rigorous regulations, lawsuits for product liability along with its implications, and dynamic competition with other manufacturer’s devices. The best way to make product (device) worthy of success is to reduce its risk rate as much as possible throughout its working tenure. Manufacturers follow various top-down as well as bottom-up approaches to identify the potential hazards and risks associated with the device and their possible solutions. These approaches include Hazard and Operability analysis (HAZOP), Fault Tree Analysis (FTA), and Failure Mode and Effects Analysis (FMEA) 1 . These medical devices companies are also known as medical technology firms shortly termed as med-tech organizations. These companies work to produce advanced and innovative medical devices and machines which can enhance the quality as well as extend the human lives. According to various surveys it was found out that the proper use of these medical devices has added almost 5 more years to the expected human lives, reduced the fatalities from heart failures and other heart related diseases to almost half and also caused almost 50% reduction in the hospital stay of the affected patients in USA. The actual problem initiates when these life saving devices starts acting like life threatening devices. Especially, when the manufacturers compromise on the safety of their devices it magnifies the threat. In case of any known hazardous effect because of these medical devices, according to the law, the products’ firm has to take their device back from the marketplace and users to maintain its safety standards. The recalling back of the devices not only directly influence the name of its own organization but also its subsequent competitor organizations manufacturing similar devices because these product recalling events are entirely public 2 . Food and Drug administration (FDA) of the United States and Center for Devices and Radiological Health (CDRH) are responsible for maintaining and regulating all the organizations and manufacturing companies of medical devices, labelling companies, and repackaging companies which sell these medical devices all over the United States 3 . With the passage of time, there has been a tremendous increase in the complexity and innovation of these medical devices. The manufacturing companies are evolving day by day to produce more advanced, life easing and lifesaving medical devices. However, to make sure the functional quality and effectiveness of these medical devices, proper adaptive and regulatory measures are needed to be in place. The flaws of each device vary