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Are We Together in COVID-19?

A call to proactive action for MedTech and Healthcare

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By Dr. Jesus A. Cabrera, JehanZeb Noor, Gary Barrett | Key contributors Joel Williams, Albert Lim, Nigel Bark

Purpose and overview of our perspectives:

As lessons emerge from the unprecedented health and economic crisis of COVID-19, MedTech and healthcare companies must prepare now for the next 12-24 months. We are presenting no-regret moves for the healthcare value chain, both in the U.S. and outside. This paper provides helpful ideas to the public, to governments, MedTech companies and downstream healthcare provider systems for us to globally overcome the pandemic crisis. The ideas presented can help healthcare providers save many lives through an efficient and effective response from the entire healthcare system, across the globe.

Disclaimer: Our views in this paper are perspectives, which are not intended to contradict or confirm expert, governmental or public opinions. The information in this article is dated to May 4, 2020.

An introduction to the current pandemic

When COVID-19, the disease caused by the virus SARS-CoV-2 (severe acute respiratory syndrome coronavirus-2), was initially detected in December 2019, experienced public health experts did not anticipate that it would rapidly spread into the worst global public health crisis in the last 100 years. The pandemic was initially detected on December 8, 2019, was declared a global pandemic on March 11, 2020, and the Johns Hopkins Corona Virus Resource Center reported more than 3,303,000 global infections and 235,000 deaths on May 1, 2020.

Similar to previous coronavirus outbreaks of this century, SARS CoV-1 and MERS, COVID-19 caught the global community off guard. Its future course remains highly unpredictable. The epidemiology of other serious coronaviruses differs substantially from SARS-CoV-2, so they may not provide a predictive model for the evolution of this pandemic. However, other influenza pandemics may be appropriate comparators. Since 1900, four influenza pandemics have occurred – in 1918-19, 1957, 1968, and 2009-10. Similarities and differences of COVID-19 spread and pandemic influenza may be illustrative of possible scenarios for the course of the COVID-19 pandemic and guide our preparation as a global industry.

The discussion of the spread of COVID-19 in the lay and clinical press has focused on the virus’ emergence in China and its effect on Europe and North America. As the pandemic’s expansion is confirmed in time through more testing or more fatalities in less developed areas of the globe, we must be attuned to the lack of robust healthcare infrastructure and comorbidities such as other infections, malnutrition and chronic respiratory diseases. These added stressors may result in more severe pandemic effects, as happened during the 1918-19 pandemic.

COVID-19 and pandemic influenza – why COVID-19 is dangerous

Though coronaviruses are strikingly different from influenza viruses, the COVID-19 pandemic and pandemic influenza share similarities. First, SARS-CoV-2 and a pandemic influenza virus are novel viral pathogens to which the global population has little to no pre-existing immunity, thereby resulting in worldwide susceptibility. Second, SARS-CoV-2 and influenza viruses are predominantly spread via the respiratory route. Asymptomatic transmission occurs with both viruses as well, thereby contributing to the rapid, undetected spread of each. Finally, both types of viruses are capable of infecting hundreds of millions of people and moving rapidly around the globe.

Differences include the incubation period; the average incubation period for influenza is a short two days; whereas, for COVID-19 it is a longer period of five days. The longer incubation period for COVID-19 allows the virus to move silently in different populations before being detected. 

A second difference is the percentage of the asymptomatic populations for the two infections. Present information suggests the asymptomatic fraction for COVID-19 is 25-80% of all cases, and this may likely change and narrow to the higher end of the range once testing for exposed populations becomes more widespread. Studies that evaluated the historical asymptomatic population for influenza suggest this percentage approached 16% historically. The higher asymptomatic percentage for COVID-19 may assist in the rapid spread of this already highly contagious virus, needing preparation for worst-case scenarios.

Amplifying upon this concept, a recent study found that the SARS-CoV-2 viral load was highest at the time of symptom onset, suggesting that viral shedding may peak before symptoms occur, leading to substantial pre-symptomatic transmission.

Lessons learned from past influenza pandemics

Of eight major pandemics that have occurred since the early 1700s, seven had an early peak that disappeared over the course of a few months. Subsequently, each of those seven had a second substantial peak approximately six months after its first peak. Some pandemics showed smaller waves of cases over the course of two years after the initial wave.

The history of past influenza pandemics may provide useful insights into the COVID-19 pandemic:

  • The course of most of these pandemics was not substantially influenced by a vaccination campaign. This points to a stringent need for preparation despite the emergence of vaccines.
  • The course of this particular pandemic also could be influenced by a vaccine. However, a reliable and at-scale vaccine will likely not be available until at least sometime in 2021. And we do not know what challenges could arise during vaccine development that could delay the timeline, and/or introduce the need for another updated vaccine for 2021-22 onwards. In addition, if the virus mutates and retains its lethality, new vaccine(s) will need to be developed.
  • The length of the pandemic will likely be another 12 to 24 months, as herd immunity gradually develops in the human population. Given the transmissibility of the virus, up to 70% of the population may need to be immune to reach a critical threshold of herd immunity to halt the pandemic. Social distancing may not only flatten the curve of the pandemic, but may also delay the time to herd immunity – however, social distancing will protect our healthcare systems.
  • The duration of natural immunity to natural SARS-CoV-2 infection is unknown. Some studies have proven natural immunity, e.g., in South Korea. However, the duration is not yet known.
  • Note that the points above apply if and only if the natural immunity lasts beyond the 12-24 months to extinguish this pandemic (or as mentioned if a vaccine is found) – otherwise it will become endemic to a population.

The observations above lay the foundation for scenario planning preparation as we look ahead.

Potential scenarios of the evolution of the COVID-19 pandemic

Many thought leaders have written and suggested several different scenarios regarding how the COVID-19 pandemic may play out, and some are consistent with what occurred during past influenza pandemics. Only time will tell if one of these scenarios plays out or if another turns out to be true based upon our interventions with development of care, testing and vaccination, or mutations of this virus to a less lethal form. We envision three potential scenarios to consider as an industry.

  • Scenario 1: The first wave of COVID-19 in spring 2020 is followed by a series of repetitive smaller waves that occur through the summer and then consistently over a one- to two-year period, gradually diminishing sometime in 2021. Depending on the height of the wave peaks, this scenario could require periodic reinstitution and subsequent relaxation of mitigation measures over the next one to two years.
  • Scenario 2 (currently appears most likely): The first wave of COVID-19 in spring 2020 is followed by a larger wave in the fall or winter of 2020 and one or more smaller subsequent waves in 2021. This pattern will require the reinstitution of mitigation measures in the fall to drive down spread of infection and prevent healthcare systems from being overwhelmed. This pattern is similar to what was seen with the 1918-19 pandemic. During that pandemic, a small wave began in March 1918 and subsided during the summer months. A much larger peak then occurred in the fall of 1918. A third peak occurred during the winter and spring of 1919; that wave subsided in the summer of 1919, signaling the end of the pandemic. The 1957-58 pandemic followed a similar pattern, with a smaller spring wave followed by a much larger fall wave. The 2009-10 pandemic also followed a pattern of a spring wave followed by a larger fall wave.
  • Scenario 3: The first wave of COVID-19 in spring 2020 is followed by a “slow burn” of ongoing transmission and case occurrence, but without a clear wave pattern.

Whichever scenario the pandemic follows (assuming at least some level of ongoing mitigation measures), we must be prepared for at least another 12 to 24 months of significant COVID-19 activity, with hot spots popping up periodically in diverse geographic areas.

As much as we can hope to glean information to guide us from past influenza pandemics, the world has changed over the last century. There is more frequent travel and faster travel from point-to-point around the globe. Globalization now provides access to remote parts of the world and faster transmission of diseases like this must be anticipated, despite advancements in healthcare technologies.

Viral Testing Development

Viral tests for the presence in patients with symptoms have been established. These tests are PCR-based and test for the presence of the nucleic acids of the virus. Though these tests are widespread and the technology is well-known, the test is still complex and requires specific reagents. At times, access and availability to these specific reagents have been a challenge and have inhibited widespread testing. This testing will be important for surveillance as well as contact tracing to mitigate asymptomatic spread in the community. In addition, cost will be high: wide scale deployment of adequate testing for the U.S. market is estimated to cost $15B per month and will not be a trivial effort to deploy.

Viral Exposure Testing Development

Understanding the level to which herd immunity achieved is going to be critical. Testing our population to understand who has been exposed to the virus will require blood testing to assess for and evaluate presence of antibodies to the virus in these patients. The presence may provide immunity to reinfection; however, the effectiveness and duration of this immunity still needs to be better understood.

Vaccine Development

The complications in developing a vaccine cannot be underestimated. The chart below, published by Callaway (Nature 2020 Apr;580(7805)576-7), shows the various pathways to vaccination development with more than 25 drug companies presently involved in vaccine development. A large group of companies are establishing time lines and models to develop vaccines using strategies that include canonical methods using virus that is attenuated as well as newer molecular methodologies that use nucleic acid and protein based techniques that may lead to a faster time to the bedside with a safe and efficacious vaccine. Whichever method gets the vaccine to patients first, the timeline of getting the vaccine ready to treat hundreds of millions – if not more patients – in terms of manufacturing and distribution, is a daunting task that will take time. Further, with a set mutation rate and the periodic and cyclic nature of this virus, new vaccines will likely need to be developed over time to continue to provide adequate protection. This combined with history of pandemics calls for strong preparation.

It can also be argued that testing is as or more important than the availability of the vaccine because of the long timelines involved and the duration required to deliver the vaccine to large numbers of people, in a safe and controlled manner (e.g., with social distancing), even if a solution were available today. Antibody testing is and will continue to be important to understand what level of immunity has been achieved in pockets of populations – at city, state and national levels. All sophisticated models applied to ascertain social behavioral rules and regulations will only be as good as the completeness and accuracy of the data sets used. Improving sophistication of predictive models is less important than improving our capability to collect high-quality and large-quantity datasets. For example, in the U.S., some analyses show above normal, unaccounted fatalities in February/March. This could mean we might have undercounted initial deaths attributable to COVID-19 in the first two months by 50%, if not more.

Implications for the MedTech industry and supply chain: some ideas and lessons learned

Regardless of the path to testing and vaccinations, the MedTech industry can further and better prepare by taking proactive steps, which might have been unconventional before. Reasonable modeling around current trends suggest that within the U.S. the pandemic will require more than 50 million patient days in various stages of hospitalization before herd immunity will be attained. The path to that outcome (social distancing adherence and healthcare capacity) will largely determine the amount of deaths that result. There are no-regret moves available now to help the situation. For example:

  • To tackle trained staff shortages, hospital networks could deploy nurses/doctors in training/residency. Governments could expedite work permits for doctors and nurses to travel from countries with lesser need for care to regions with unfulfilled need for care. In addition, COVID-19 hotspots could leverage sources of sufficiently trained staff from alternate sources such as NGOs (Doctors without Borders, etc.). Military personnel could also be a source of staffing.
  • MedTech manufacturers could collaborate to decide how to scale-up specialized device making instead of simultaneously trying to produce all their relevant products. This might also lead to more standardization of device fleets, which could further increase the efficiency of providing care. MedTech companies should also allow provisions for releasing/sharing IP. In addition, MedTech companies should show flexibility where possible on commercial terms for providers strapped for cash. In addition, certain MedTech companies might be facing “business-as-normal” technical or regulatory challenges in their ability to supply COVID-related devices. Now is the time to reach across the aisle and request help from peer companies that could help provide supplies to affected customers – so that we always put the patients first without worrying about who retains the business. Arrangements can obviously be made amongst the peer companies and suppliers to protect long-term business interests as well – this is not mutually exclusive.
  • Distributors could redesign hospital deliveries to provide pre-kitting for high occurrence procedures in the continuum of care under COVID-19. This would reduce incidental work in hospitals and allow the providers to maximize their utilization in actual patient care delivery.

If there is a larger second wave according to Scenario 2 above or the virus mutates to affect other demographics more severely, we expect continued constraints in devices such as infusion pumps, breathing aides (including ET Tubes) and both ICU and non-ICU ventilators. In addition, we see emerging shortages in the next 12 months in devices required for discretionary procedures, given most manufacturers have turned off the spigot for three to six months. Hospitals should signal the reinstatement of discretionary procedures at least two to three months before they need a stockpile of devices for discretionary procedures, and distributors should help aggregate these demand signals for MedTech companies. This assumes that the hospitals can make reasonable assumptions on flattening of curves and reduction in COVID-related demand. In addition, local and state-level governments could also play a role in supporting predictive modeling and stocking for both COVID-19 and discretionary devices for elective procedures.

Views for regulatory and governmental agencies:

Our observation is that global regulatory bodies, including FDA, MHRA and Notified Bodies, such as BSI, have served the needs of patients with increased pace and focused purpose in unprecedented ways. These agencies have streamlined protocols, provided emergency measures and demonstrated pragmatic approaches such as derogation. The agencies could further help with measures such as extending the shelf-life of essential devices in shortages in a safe manner, and standardizing filing/approval protocols globally. Cross-border collaboration has become more important than ever under COVID-19.

More coordination and support are also needed from entities such as the European Union, to make communications even faster. The one-year postponement in the implementation of the Medical Device Regulation (MDR) is a welcome move, and other multinational forums such as the South Asian Association of Regional Cooperation (SAARC) could also look at COVID-19 related measures quickly.

With social distancing and stay-at-home becoming the norm, there has been confusion on what constitutes an essential business in the healthcare value chain. Given global nature of supply chains, governments should coordinate on what are considered essential business related to healthcare and MedTech to avoid unintended disruptions in supply. Even a small component shortage could bring production of critical medical devices to a grinding halt – and this should certainly be further avoided if there are additional waves of virus transmission in the fall of 2020. As some have done already, governments should explicitly lay out rules on pricing and supply terms for medical supplies, and PPE in particular instead of “catching and fining” after the fact. This could help avoid hoarding and price gouging ahead of time. Moreover, governments might want to explicitly direct portions of stimulus funding to certain nodes in the healthcare value chain. For example, small hospitals as well as smaller MedTech companies are starting to struggle and could use support. Lastly, as MedTech companies open their intellectual properties to consortia or licensing to help overcome shortages, governments can layout ground rules on how they would provide protection to those willing to openly license or give away technologies, given the threat of future lost revenues and jobs.

Special considerations for developing countries and emerging markets

When it comes to global care, tailored approaches are needed. Remember, a manual or de-specified device is better than no device. Today, there are several countries in the developing world with very few ICU beds with ventilators. Now more than ever, there is a need to partner with institutions like the Gates Foundation and other global health organizations. MedTech companies can help by adjusting pricing to country-specific economics where possible. This might mean wealthier countries subsidize the less wealthy ones to show respect for human life. While sentiments of nationalism and patriotism can get challenging, countries like Germany are leading the way in donating what they do not need, or flying in critically ill patients from other countries – at least in the short-term. We suggest a needs-based free flow of goods and services (with any excess supply that is not needed for local demand in developed countries), especially to the sub-regions in developing countries and those with health systems at risk in these perilous times. Similarly, we would suggest countries to relax the “made locally” restriction for 12-24 months so patients can be taken care of at the hour of need, without delays.

Another key couple of observations are for the governments of various developing countries: first, study and accept devices and therapies that can help your citizens even if these deviate from your normal usage patterns and preferences (e.g., consider non-ICU ventilators where ICU beds or ventilators might be in shortage); second, while testing levels and identified infection numbers might be low, accept that the virus is pervasive and has already penetrated local populations. Prepare both your stockpiles and care providers to be ready for case numbers that are manifold compared to what has been identified. The emergence and effects of the virus will become transparent over time in any case, regardless of the pathway taken. It is also understandable that proactive detection and measures are extremely difficult in highly populated, high density, and low resource-available countries. Regional entities like the African Union could play a prominent role in driving cohesiveness in the approaches to the continent’s COVID-19 response. Reaching out to global MedTech companies to help prepare for the next 12-24 months can be a key source of insight, equipment and resources for these key regional entities.

The role Smiths Medical is playing

As a global medication management solutions company with a complementary vital care portfolio, we are focusing on serving healthcare providers across the continuum of care for COVID-19, and for prior chronic diseases – both in markets where we traditionally have a strong footprint (e.g., the U.S. and Europe) and our distributor markets (e.g., Africa, Middle East, Latin America and Southeast Asia). We are summarizing what we have learned, given our role, which might be of assistance to other MedTech companies:

  1. Be decisive and take action – given the uncertainties and surges in demand, be willing to take financial risk and scale up production in areas that will potentially face device shortages – despite uncertainty. Also invest in tools that enable training and troubleshooting remotely to support telehealth. Relying on prior methods of forecasting and training delivery will lead to disruptions.
  2. Redeploy workforce – from discretionary procedure devices to must-have ones, delay longerterm strategic projects, or even efforts around areas like margin management.
  3. Partner collaboratively – invest in joint ventures and consortia that address device needs for the current surge, and potential surge under a larger second wave in Scenario 2 discussed earlier. Most companies are willing to help in these times and share their experienced workforce.
  4. Create a dedicated team to manage crisis – having a Tactical Team to connect the dots crossfunctionally will help tremendously, even if you have strong internal collaboration to start with normally.
    These approaches have helped us provide robust solutions and devices as a company as we support the global treatment of COVID-19 across the continuum of care, as summarized in the picture below:

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  1. Be thoughtful – show gratitude to frontline coworkers and protect them through PPE, policies and benefits. Plan ahead and think of putting social distancing and protective measures back in place 2-3 weeks before the next flu season in the fall of 2020 (or as suitable in your geography). Other essential businesses, suppliers and care provider networks should consider the same.

How we behave and partner in this crisis will determine our individual and collective legacies. While not perfect, the creativity and spirit in the COVID-19 response has been tremendous. It is our belief that the human species will learn new approaches to excellence coming out of this crisis – whether these relate to telehealth, social and health policy, or regulatory affairs, amongst other topics. We hope the views shared in this paper will push our response and collaboration forward. Next steps may include the formation of an industry consortium to address some/all identified planning points, especially around preparation for upcoming waves with more commonly provided products. A consortium could also consider sponsoring development of a generic product offering that could service high demand areas and/or developing countries. Smiths Medical would be interested in leading or joining such an endeavor.

We believe in the resilience and creativity of our human race to overcome this crisis, and we thank all the heroes in the shape of frontline care providers and production/healthcare workers who are going above and beyond to keep our response system running. The entire world owes you all deep gratitude.

The authors and key contributors would like to thank several internal and external experts and academic who assisted by generously sharing their input. The views in this paper are the authors’ only. They do not represent the views of Smiths Group or Smiths Medical.

Authors: Dr. Jesus A. Cabrera is the leader of clinical affairs, JehanZeb Noor is the overall global business leader, Dr. Gary Barrett is the global leader of regulatory and quality. Key contributors: Joel Williams is the business leader for the Americas, Nigel Bark for EMEA and Albert Lim for APAC – all at Smiths Medical.