During these unprecedented times, medical device professionals have the unenviable task of asking for a pause amid the panic. No matter what the future holds, the facts remain true: inaction will only make it worse. Despite our adrenaline telling us to produce as fast as possible, quality is what matters more than ever right now.
In order to navigate the chaos and support public health, any strategy deployed at this time must leverage applicable exemptions, production procedures that fill needs through innovation, and a comprehensive communication plan across public and private entities.
Outline a Risk-Based COVID-19 Response Plan
Right now, business as usual, is no longer an option. Device manufacturers must move quickly enough to help confront the pandemic, but also remain flexible enough to respond to news and updates that sometimes evolve by the hour.
Response plans must be risk-based and should take immediate actions into account. Three areas to consider are:
- Whether or not your product qualifies for Emergency Use Authorization
- International exemptions
- Downstream effects of pandemic disruptions
The United States has a regulatory precedent for producing diagnostic devices and tests faster than the usual timeline called Emergency Use Authorization (EUA). Through the EUA program, FDA can expedite premarket review to allow devices to enter the market faster in times of immense public need, such as the current crisis.
The global regulatory landscape is currently in flux for all medical device companies, not just those seeking EUAs. Regulatory frameworks are shifting around the world, and existing rules may be evolving. However, most of this depends on where a device is being sold and what type of device is being manufactured. Leveraging the right exemptions may lead to faster market entry.
Notable exemptions related to COVID-19 include:
- China will expedite the registration process for medical protective clothing if they meet standards from Japan, the European Union, or the United States.
- Singapore will exempt specific devices like particulate respirators, protective gear, surgical masks, and thermometers from registration requirements.
- Australia issued an exemption for mechanisms involved in the diagnosis, confirmatory testing, prevention, monitoring, treatment, or alleviation of COVID-19.
Ensure Manufacturing Efforts Are in Line with Public Entity Initiatives
The scale of the COVID-19 pandemic is trapping both public and private organizations. This scenario comes with moments of collaboration and tension between each sector and different entities. While governments explore radical options, medical device companies must maintain clarity as they formulate their own responses.
“Flatten the curve” has been this pandemic’s rallying cry. This phrase refers to the graph outlining the effects of infection below or above the healthcare system’s care capacity. Flattening this curve pertains to slowing the virus’s spread to avoid the threshold.
A unified response to COVID-19 has been lacking as many countries struggle to understand the scale of the crisis and deploy tests to respond to that scale. Medical devices can help bridge this gap. For example, medical devices played an essential role in South Korea’s mitigation process. The country quickly implemented drive-through testing stations and equipped medical workers with throat swabs and remote temperature scanners. Some walk-in centers also took measures to direct patients through newly constructed plastic phone-booth-style tubes to prevent direct contact with medical workers.
The COVID-19 Pandemic Requires Collaboration from All Stakeholders
While we’re currently in the midst of an unprecedented health crisis of global proportions, the medical device industry must look for ways to work closely with regulators, customers, and public organizations for the sake of public health.
The news may be rapid and frustrating, but companies should focus on how they can make the most useful contributions to help control the spread. Short-term efforts may require enhanced production, but long-term initiatives will require sticking closely to regulatory guidelines to ensure that speed doesn’t hinder quality.
The medical device industry faces many uphill battles ahead. The most critical thing to remember, however, is that medical device professionals have a crucial role in the fight against COVID-19. With an agile and well-researched plan and collaboration among stakeholders, medical device companies can contribute to winning the fight.
Jon Speer is the founder and VP of QA/RA at Greenlight Guru, a medical device quality management system (MDQMS) software, and a medical device guru with over 20 years of industry experience. He knows the best medical device companies in the world use quality as an accelerator. That's why he created Greenlight Guru: to help companies move beyond baseline compliance to achieve True Quality.