COVID-19 has thrown the medical community into a frenzy. Hospitals are struggling as the disease spreads faster than companies can produce masks, ventilators, and tests.
And right now? Medical device professionals have the unenviable task of asking for pause amid the panic. No matter how bad it is or how bad it might get, here’s the truth: heedless action will make it worse. Despite the adrenaline telling us to produce as fast as possible, this is the moment when quality matters more than anything else.
With a strategy that leverages exemptions, production procedures that innovate to fill needs, and a communication plan that works across public and private entities, you can navigate the chaos and support public health.
Develop a risk-based COVID-19 response plan
Business as usual is not an option. Medical device manufacturers need to move fast enough to confront the pandemic but remain flexible enough to respond to news and updates that evolve day by day and sometimes by the hour.
Your plans must be risk-based and should account for immediate actions to be taken, such as authorizations you may need to apply for as soon as possible, as well as long-term reactions to international exemptions and difficult-to-predict second-order effects.
Determine if you qualify for Emergency Use Authorization
In the U.S., there’s a regulatory precedent for manufacturing diagnostic devices and tests faster than usual: Emergency Use Authorization (EUA). With an EUA, the FDA can expedite premarket review and help manufacturers get devices to market faster in times of sudden, immense public need.
Most of the current demand is around personal protective equipment (PPE), ventilators, respirators, and in vitro diagnostic (IVD) tests. If you can either pivot existing diagnostic tests to test for COVID-19 or adapt manufacturing processes to fill equipment shortages, an EUA is worth considering.
On January 31, 2020, the U.S. Health and Human Services (HHS) secretary declared a public health emergency and authorized the emergency use of IVD tests. After these initial declarations, authorizations for emergency PPE and emergency ventilator and ventilator alternatives followed.
To qualify, devices still need to meet what’s called a “may be effective” standard. This standard requires less evidence, but the FDA will still perform a risk-benefit analysis to determine whether authorizing the device is worthwhile. The FDA will also determine whether there’s an alternative option available that’s already been cleared/approved, so there still needs to be a gap in the market before you can justify filling it.
In terms of timelines, the FDA analyzes requests on a “case-by-case basis,” but is “prepared to issue EUAs expeditiously (e.g., within hours or days).” Once the public health emergency is over, those authorizations end and companies either have to pull the devices from the market or put them back to their originally authorized use.
Companies such as Thermo Fisher, Roche, Everlywell, and Abbott are currently producing COVID-19 tests. Thermo Fisher projects the company will be able to produce about 5 million tests a week in April, and Abbott received an EUA for a point-of-care test that can produce results in minutes.
Examine international exemptions
The global regulatory landscape is in flux for all medical device companies, not just the ones seeking EUAs.
Regulatory approaches are shifting quickly across the world, and rules may be changing for your devices, depending on where you’re selling and what you’re manufacturing. You might be able to get market entry faster and start selling devices sooner if you look for and leverage the right exemptions.
Exemptions related to COVID-19 have been issued by regions around the world, ranging from China to Australia and beyond. Here are three of the most notable:
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 certain devices, such as particulate respirators, protective gear, surgical masks, and thermometers, from registration requirements.
Australia issued an exemption for devices involved in the diagnosis, confirmatory testing, prevention, monitoring, treatment, or alleviation of COVID-19.
Emergo by UL, a global regulatory consulting team, is keeping readers up to date on these shifts on their blog.
Plan against the downstream effects of pandemic disruptions
Even if you’re not in the position to get an EUA or use an exemption, your company still needs a COVID-19 response plan. The industry as a whole will be under immense strain. The effects of this strain will be hard to track and predict.
Consider the impact on clinical trials. With travel and clinic restrictions in place, trials are going to become increasingly difficult to complete for numerous reasons.
If patients can’t travel, they might miss trials, and/or your trials might be under attended.
Test protocols may have to change to allow for at-home visits and telemedicine.
IRB review and approval will likely be delayed.
Consider, too, the impact social distancing will have on your team if working remote. Without the proper collaboration tools, previously workable processes will worsen and might become unmanageable.
If your team relies on paper, travel restrictions and delivery delays will make it difficult to get physical signatures.
Without a centralized communication system, important documents and messages can slip through the cracks, causing delays and rework.
Legacy systems don’t always offer varying permissions levels, meaning you might not be able to maintain appropriate security levels as you collaborate online.
With the support of a purpose-built solution, however, your team has the foundation for success. Greenlight Guru, the only quality management software for medical devices, centralizes your entire document management flow into a single cloud-based system, with permissions that you can tune to your team and security that keeps your data safe.
Garwood Medical Devices, a medical equipment manufacturer, found that using Greenlight Guru enabled them to keep working efficiently: "We are making progress on our product design. Surprisingly, we are actually more ‘Greenlight Productive’ working from home than in the office."
This infrastructure enables the kind of efficient collaboration and streamlined document and risk management companies need to make risk-based decisions and innovative medical devices. In times of crisis, you have to move rapidly without losing track of everything as you scale to meet demand. Legacy solutions, rather than modern solutions that match your pace, can impede your processes and prevent progress from being made.
four companies innovating to fulfill global supply shortages
The state of medical supplies is dire.
Medical suppliers are trying to buy hand-sewn face masks from boutique stores, and physicians are reusing one mask over the course of a day. Even the Centers for Disease Control and Prevention (CDC) is recommending, as a “last resort,” that people modify bandanas and scarves into masks.
A PPE shortage will be devastating for healthcare workers, the immune-compromised, and the population at large. A shortage of PPE can create a negative feedback loop as clinicians without adequate protection treat patients, get infected, and become vectors for the spread of the disease.
Medical device manufacturers and research groups are stepping up to fill these gaps.
Surfacide is protecting frontline healthcare workers with new technologies
One of the worst aspects of this crisis is that healthcare centers become riskier over time. As infected patients cycle in and out, hospital beds, equipment, and rooms can all become new breeding grounds for the virus. This threatens other patients and healthcare workers who touch a contaminated surface.
This problem predates COVID-19. Surfacide, a company that develops UV-C emitters, first encountered a variation of the coronavirus, called MERS or Middle East respiratory syndrome, and honed their technology’s ability to eliminate it, which proved to be highly successful.
The Surfacide device works almost like a magic wand if you aren’t familiar with the science.
The ozone layer blocks most UV radiation coming from the sun, but it blocks UV-C rays entirely. As such, no organism on earth has felt UV-C exposure. Until now. Surfacide harnesses this energy and delivers concentrated doses to targeted objects, effectively destroying pathogens at the genetic level.
Surfacide President and CEO, Jeff Veenhuis, spoke with Greenlight Guru founder Jon Speer on an episode of the Global Medical Device Podcast explaining how the effectiveness of this method surprised even him: “We were a little shocked by just how easily it eradicated that coronavirus.”
University of Iowa researchers studied the successes coming from Surfacide and found that the technology would be effective at combating COVID-19, too. Between this research and their experience with MERS, the Surfacide team has a powerful technology for disinfecting healthcare settings and unique, real world data to back it.
Surfacide is embracing the opportunity and scaling rapidly so they can help frontline healthcare workers, as well as their patients, in surge centers, ICUs, and ERs around the world. Veenhuis said that such scale required a purpose-built QMS. “If we tried to implement it in a paper system, we’d never get there.”
“If it weren’t for Greenlight Guru,” Veenhuis continued, “it would probably take us a month or two, maybe even more, to scale up. Because all our documents are at our fingertips, we’re instantly ready to go with everything we need to produce at a high quality level for a highly technical product.”
With Greenlight Guru streamlining their workflows, Surfacide can scale their manufacturing processes and document flows. The immense need demands rapid change but even then, Surfacide can use Greenlight Guru to easily add things on the fly or collaborate with third-party suppliers.
Nectar is rapidly producing ventilators
Ventilators have become a focal point. For patients infected with COVID-19, ventilators are essential for helping them breathe and eventually recover. The number of ventilators available, however, even accounting for emergency stockpiles, is scant.
One study, using data from the U.S. Department of Health and Human Services, said the maximum number of people America could currently ventilate is 160,000. The study predicted 865,000 residents would need hospitalization during a moderate pandemic, and 9.9 million would require hospitalization during a severe pandemic—far outstripping supply.
The medical system, however, was not equipped with a surplus of ventilators prior to the pandemic. Now that this shock to the system is upon it, the industry is turning to manufacturers that can innovate new ways to produce fast, cheap, reliable ventilators.
Darren Saravis, CEO of medical device manufacturer Nectar–a Greenlight Guru customer–is one of the leaders pushing for new ventilator designs. He started a new organization, called BreathDirect, and designed a ventilator that costs half the price of a traditional ventilator.
His design meets minimum specifications for a ventilator, meaning it can handle 90% of patients who are critically ill with coronavirus at a much cheaper cost. It also uses locally sourced parts, so it isn’t dependent on an increasingly fragile global supply chain.
Saravis projects BreathDirect can produce 3,500 ventilators per week in May and 40,000 per month by June.
MIT is creating open-source medical device designs
Despite innovations in medical device production, ventilator supplies will also be limited by availability of medical device designs. This is why MIT created an open-source solution.
The MIT Emergency Ventilator, or E-Vent, Project aims to research how hospitals can safely adapt manual resuscitators to work as low-cost substitutes for ventilators. Manual resuscitators are already in widespread use, making them an effective opportunity for this alternative use.
MIT will release hardware, control strategies, electronics designs, and animal testing results as open-source resources. The goal is to equip medical device manufacturers with the designs they need to facilitate unprecedented production goals.
Already, people are taking up the call.
Project Aether, a collective mission formed by Dragon Innovation, Prodct, LLC, Cooper Perkins, and Greenlight Guru, is leveraging MIT’s designs. Using MIT’s work as a proof of concept, Project Aether will produce ventilation devices that are as simple as possible while still helping to address the COVID-19 crisis.
Many coronavirus cases don’t need full-featured ventilators, so these simpler devices can free more sophisticated ventilators for use in those advanced, critical cases. A stop-gap like this can help medical centers significantly increase capacity so the sickest patients can be prioritized for treatment.
With the backing of experienced manufacturers, Project Aether can design a device that weathers regulatory approval and user validations.
Medline is scaling mass produced masks
Masks are facing a similar shortage. Without the right protective equipment, medical workers risk of infection from the people they’re trying to help. If masks remain limited and medical workers can’t work, then hospital capacity will suffer even more strain.
These limitations don’t have an easy solution. A global pandemic threatens the supply chains that keep even local healthcare systems running.
In the U.S., for example, of the hundreds of millions of surgical masks and respirators the American healthcare system buys each year, a mere 5% of the former and 30% of the latter originate from American manufacturers.
Charlie Mills, CEO of Medline, spoke with President Trump about Medline’s efforts to address this shortage. The company is producing about 100,000 masks per day and plans to triple production in only a few months. Medline is accomplishing this via a company they acquired called MEDISISS, which Greenlight Guru COO Jason McKibbin cofounded in 2001.
In his discussions with President Trump, Mills echoed a strategy many other medical device manufacturers will likely be following: “A lot of our other business is medical, but not related to [COVID 19], so as that drops off, hopefully this will pick up the slack and we’ll have the capacity to do a lot of other things.”
Coordinate medical device manufacturing efforts with public entity initiatives
The scale of the pandemic is ensnaring both private and public organizations.
There will be moments of tension and collaboration both between the public and private sectors and among different public and private entities. Governments are exploring radical options, so medical device companies will need to seek and maintain clarity as they formulate their own responses.
“The curve” is worldwide and flattening efforts must be too
“Flatten the curve” has become a rallying cry around controlling the pandemic. The phrase refers to a now-famous graph that shows the effects of infection below or above the healthcare system’s capacity. Flattening the curve, reducing the spread so it doesn’t reach this threshold, is essential to holding back some of the pandemic’s worst, exponential effects.
More tests and treatment mean a better understanding of the virus’s spread and a better ability to design resource allocation and response strategies. This is especially important in countries like the United States, which struggle to formulate federal-level strategies that reach across regions. That fragmentation worsens when it’s on a global scale.
“The curve” shows why the pandemic requires a swift, as well as strict, response. If countries can react quickly enough, they can avoid the worst damage. Doing so, however, requires working closely with public and private entities across the world—a worthy but difficult endeavor.
Seek transparency, no matter how elusive
A united response to COVID-19 has been lacking. Many countries struggled to understand the scale of the problem and deploy the tests necessary to measure and predict that scale.
As the crisis worsened, some countries, like Singapore and Taiwan, were able to act quickly and convince citizens to follow suit. In other regions, public-private coordination has been more difficult.
Worse than any single country, however, is the state of the global supply chain and the lack of transparency and collaboration between nations.
Though China, for instance, is now receiving some praise for its strict reaction to control the virus’s spread, many are still skeptical as to whether the virus has, in fact, been contained.
Italy, one of the world’s hardest-hit countries, has also levied criticisms at the EU and its member states for their slow response time.
Medical devices can stem the tide
South Korea has proved it should be the world’s model when it comes to flattening the curve. As reported in the New York Times, the country intervened quickly, tested early, traced cases, and asked the public for support.
At its peak, South Korea found 909 new cases in a single day, but after a week, they cut the number of cases in half. The country pressed on, and cases kept dwindling.
Medical devices played an important role in the mitigating process.
South Korea implemented drive-through testing stations and equipped medical workers with throat swabs and remote temperature scanners. Some walk-in centers took measures to direct patients through newly constructed plastic phone-booth-style tubes in an effort to protect medical workers from direct contact.
Outside of medical centers, the New York Times also reported that large buildings in South Korea, such as offices, hotels, and restaurants, are using thermal-image cameras to identify fevers.
South Korea is a prime example of what medical devices and medical device companies can do to be effective against this disease. The WHO urged other countries to learn from South Korea, but manufacturers can only work as well as their governments enable them to.
Coronavirus pandemic calls for collaboration amongst all stakeholders
We’re in the midst of an unprecedented global health crisis. This crisis calls on the medical device industry to work closely with customers, patients, regulators, and public organizations for the sake of public health. The news will be fast-paced, and much of it will be disappointing, frustrating, and dispiriting.
The key, however, will be for companies to focus on how they can make the most effective contributions to control the spread of the virus and save lives.
Short term, that might mean ramping up production to new levels; long term, that might mean sticking closely to regulatory guidance to ensure that speed doesn’t destroy quality, creating even more problems in the future. No matter what, medical device professionals will have an essential role to play in the fight against COVID-19.
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