The medical device industry is one of the most complex and rapidly evolving sectors of the health sciences field. Dynamic innovation in medical devices has helped better healthcare both in terms of people’s quality of life and their longevity; however, while the value of these devices to humanity is undeniable, differences in the regulatory policies surrounding their approval in different countries have caused the industry to become extremely complex in terms of global market access. The disconnect between different countries’ existing regulatory policies and the international demand for medical device products illustrates the need for open, effective cross-border communication, not only to advance innovation and improve patients’ lives globally, but also to increase access for underserved populations, especially in pandemic times.
The regulatory classifications and even the specific definitions for medical devices can vary widely depending on one’s location in the world. The World Health Organization (WHO) defines a medical device as, “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.” Examples of medical devices include glasses, stethoscopes, pacemakers, glucose meters, and syringes, to name just a few. Every single field in healthcare uses medical devices in one way or another, whether in the actual treatment of a patient, in data intake from research, or in improving patients’ quality of life. However, the timeline for these devices’ integration into the market ranges significantly country to country.
Several different classifications exist for medical devices, with some variance depending on the country where the device is being created or utilized. Typically, classifications rank devices from those presenting the least amount of risk to those presenting the most risk in terms of their function on human health; however, while this principle may seem straightforward, each country has its own system for defining what makes a medical device more or less hazardous. The differences among definitions and classifications barely scratches the surface of the complexity of regulatory policies across the world, as other factors such as quality assurance, clinical trial processes, and even how the product is labelled can all change the timeline and process for introducing a medical device in a new market.
Regardless of one’s place in the world, the need for effective regulatory policies is undeniable; almost every country has its own rules for ensuring that companies are held to specified standards for public health safety and that consumers can have a sense of security in obtaining the product they need. Simultaneously, regulatory bodies and the policies they put in place are constantly adapting to keep pace with the global market and public health safety concerns, from innovations in medical devices themselves to shifting public health concerns like the COVID-19 pandemic.
In light of the COVID-19 outbreak, many countries’ regulatory bodies have worked to accelerate, and sometimes bypass, the timelines for their own regulations in order to expedite the process for testing, treating, and developing a vaccine for the virus. The United States, with the biggest research market in the world, is quickly becoming one of the countries most severely affected by Covid. The need for a response to combat this critical, time sensitive situation has led the FDA to utilize the Emergency Use Authorization (EUA) to fast track these innovations. The typical timeline for a medical device product to enter the United States market averages between 3 and 7 years, with testing of the product averaging 2 to 3 years. Since the COVID-19 outbreak, however, the FDA has worked to expedite their normal review process in order to ensure the safety of the United States’ citizens, while still working to maintain the efficacy of the product itself.
One of the most notable efforts to accelerate the rate at which innovations reach the market is the increase of testing kits for COVID-19. For example, Hologic, a medical device company based in Massachusetts, was granted EUA for its testing kits; the kits have been in use since the FDA approval on March 16th by medical professionals all over the country, and with them up to 1,150 test results can be processed in a single day to help track and catch the spread of the virus earlier on. While medical device companies like Hologic are working as fast as they can to help diagnose COVID-19 cases, with a predicted 600,000 kits to be distributed in the month of April, treatment and vaccination for the virus is still in the process of expedited approval to ensure its efficacy and safety for the population not only in the US but around the world. Collaboration between different countries is clearly needed not only to help stop the spread of COVID-19, but also to ensure that we will be better prepared to act as a global community if and when another pandemic occurs. Particularly important is ensuring that underserved populations are better prepared for such an event.
The global importance of medical devices in healthcare is undeniable. Without these innovations, the world would be unrecognizable for the worse. While the medical device industry continues to create groundbreaking devices that can increase longevity and improve the quality of human life, the importance of adapting to the varied regulatory policies between different countries is equally critical amid viral pandemics like COVID-19. The future of communicative, cross-border collaboration presents monumental opportunities for ensuring better access to medical devices for people all over the world, giving hope to the further advancement of humanity and the defeat of COVID-19 and viruses like it.
- Dr. Hope
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Sources
Commissioner, O. of the. (2020, March 16). Coronavirus (COVID-19) Update: FDA Issues Diagnostic Emergency Use Authorization to Hologic and LabCorp. Retrieved March 31, 2020, from https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-diagnostic-emergency-use-authorization-hologic-and-labcorp
Institute of Medicine (US) Committee on the Public Health Effectiveness of the FDA 510(k) Clearance Process; Wizemann T, editor. Public Health Effectiveness of the FDA 510(k) Clearance Process: Balancing Patient Safety and Innovation: Workshop Report. Washington (DC): National Academies Press (US); 2010. 5, The Global Framework for Regulation of Medical Devices. Available from: https://www.ncbi.nlm.nih.gov/books/NBK209785/
Commissioner, O. of the. (2020, March 16). Coronavirus (COVID-19) Update: FDA Issues Diagnostic Emergency Use Authorization to Hologic and LabCorp. Retrieved March 31, 2020, from https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-diagnostic-emergency-use-authorization-hologic-and-labcorp