As businesses fight just to survive the pandemic-driven economic freeze, the medical device industry is facing unique regulatory challenges. At the same time, the industry has seen some unprecedented opportunities as well. Medical device and personal protective equipment manufacturers rely heavily on healthcare facilities. They regularly need clinical data to test, improve, and plan products. Almost every medical device must undergo rigorous testing at a health care facility before getting regulatory approval.
With the healthcare industry fighting an unprecedented crisis, it has become all but impossible for medical device makers to collect clinical data. And this great disruption is affecting consumers and PPE suppliers in the USA alike. Medical device makers are finding it increasingly difficult to make data-based decisions about their products and supply chains. Regulatory challenges have become more prominent than ever — both in the U.S. and EU. Here are the most notable challenges for the industry amid the coronavirus pandemic.
Approval delays in EU Countries
The Medical Device Regulation (MDR) rule of the European Union requires manufacturers to conduct post-market clinical follow-up studies. These studies are aimed at demonstrating the safety and performance of medical devices. But due to the virus outbreak, delayed clinical trials have substantially disrupted the process. Besides, the European Commission adopted in April 2020 a proposal to postpone the application data of MDR for one year.
While reporting requirements for medical devices have been delayed, manufacturers must keep their supply chain data ready for submission by March 2021. The European Commission also revised its standards to speed up the production of medical face masks, gloves, and other medical equipment.
Emergency regulatory changes in the US
Regulatory agencies in the U.S. are revising standards and rules as a response to the worsening public health crisis. The Food & Drug Administration issued Emergency Use Authorization for medical devices, including COVID-19 diagnosis kits and PPE. This will have a significant impact on how the PPE suppliers in the medical industry operate amid the crisis. Under the EUA, the FDA has the power to authorize the rapid emergency use of certain devices.
As a response to the shortage of medical devices and PPE, the FAD has collaborated with manufacturers to improve the supply chain. The regulatory agency has also issued new guidelines on ventilator devices pertaining to EUA. Non-medical manufactures can enter the medical device industry under the new guidelines provided to adhere to safety and quality criteria.
Shortage & exemptions for COVID-19 related devices
The regulatory environment is rapidly transforming as the healthcare industry battles the coronavirus. Medical device makers and personal protective equipment manufacturers must adapt to ensure seamless supply to front-line workers. One industry that has faced the most remarkable impacts is the ventilator industry. It has seen both unprecedented shortages and entry of new players. There is still a global shortage of ventilators. Automobile industry players like Tesla have entered the ventilators industry to help address the supply chain issues.
The rapid transformation in medical device regulation is not limited to the U.S. and Europe. It has largely become a global phenomenon. Countries like India, China, and Brazil too are making remarkable changes in rules and standards.
Transformation in PPE manufacturing
The pandemic has more than anything else exposed to the unpreparedness of the PPE industry during a health crisis. Almost all kinds of PPE required to fight the pandemic are still in short supply in the U.S. and elsewhere in the world. Be it sanitizers, face masks, gloves, or other products, manufacturers have been struggling to meet the soaring demands. The global supply chain disruption also adversely affected the initial response to the virus outbreak. New import tariffs and export restrictions imposed by countries are making the crisis even worse.
The surge in medical device funding
Government funding agencies worldwide are increasing grants to scale up medical device production. In the U.S., for instance, the National Science Foundation has granted a substantial amount of money to numerous research projects related to medical devices. US Congress has also revamped the national funding program to speed up COVID research and medical equipment production. The National Institute of Health is also announced funding measures to encourage research. Such schemes and measures have helped many medical device manufacturers to launch ambitious projects.
The pandemic is far from over. Medical device manufacturers must work in collaboration with government agencies, industry peers, health care providers, and customers. We are in the middle of a rapidly changing landscape in the healthcare and medical supply industries. While scaling up demands is crucial keeping safety and quality in mind is more important than ever. Medical device manufacturers must stick to their commitment to delivering solutions that guarantee safety.
At Co-Defend, we are closely watching the shifting healthcare landscape. We directly connect our customers with top medical and personal protective equipment manufacturers across the world. Being one of the leading bulk PPE suppliers in the USA, we are committed to delivering quality under all circumstances.