What Employers Should Know About Covid-19 Testing When Bringing Employees Back To Work

What Employers Should Know About Covid-19 Testing When Bringing Employees Back To Work

The COVID-19 pandemic has played out with unexpected twists and turns. The truth is, with a novel infection such as this one, we have to learn as we go along. This has been apparent as we’ve watched public health agencies, state and federal governments and essential businesses respond to the pandemic every step of the way. This is also true for how we track the infection and its immunity.

Employers need guidance on COVID-19 testing. Companies are asking who should we test, when and how often should we test, what do we do with the results and, what kind of testing should we use?

Types of testing for COVID-19

It is important to understand how we test for COVID-19 infection and how we test for presumptive immunity to the infection. There are two different types of tests – diagnostic tests and antibody tests.

  1. A diagnostic test can show if you have an active coronavirus infection and should take steps to quarantine or isolate yourself from others. Currently there are two types of diagnostic tests – molecular (RT-PCR) tests that detect the virus’s genetic material, and antigen tests that detect specific proteins on the surface of the virus.
  2. An antibody test looks for antibodies that are made by the immune system in response to a threat, such as a specific virus. Antibodies can take several days or weeks to develop after you have an infection and may stay in your blood for several weeks after recovery. Because of this, antibody tests should not be used to diagnose an active coronavirus infection. At this time researchers do not know if the presence of antibodies means that you are immune to the coronavirus in the future.

What Employers Should Know About Covid-19 Testing When Bringing Employees Back To Work 1

The FDA is also tracking new diagnostic tests available with alternative methods and benefits.

  • Rapid, point-of-care diagnostic tests use a mucus sample from the nose or throat but can be analyzed at the doctor’s office or clinic where the sample is collected and results may be available in minutes. These may be molecular or antigen tests.
  • At-home collection tests are prescribed by a doctor but allow the patient to collect the sample at home and send it directly to the lab for analysis.
  • Saliva tests allow a patient to spit into a tube rather than get their nose or throat swabbed. Saliva tests may be more comfortable for some people and may be safer for health care workers who can be farther away during the sample collection.

Reliability of these tests have improved and whereas symptomatic testing is usually paid for by medical insurance carriers, there are significant gaps in coverage for other types of testing (see below). Testing for asymptomatic employees (and dependents) is usually not covered. Guidance on diagnostic testing has shifted over the past several months in the United States as more testing becomes available. Most of this guidance, notably, is intended for health care professionals. 

The guidance and use of antibody (immunity) testing is still evolving. There have been more questions around reliability of these tests and the dust has not settled on how or whether employers should leverage antibody (presumptive immunity) testing. 

What does the sensitivity of a Covid-19 test mean?

Sensitivity measures how often a test correctly generates a positive result for people who have the condition that’s being tested for also known as the “true positive” rate. 

A test that’s highly sensitive for current COVID-19 virus infection will flag almost everyone who currently has the virus and not generate many false-negative results. 

For example: a test with 90% sensitivity will correctly return a positive result for 90% of people who currently have the virus, but will return a negative result — a false-negative — for 10% of the people who currently have the virus and should have tested positive.

What does the specificity of a Covid-19 test mean?

Specificity measures a test’s ability to correctly generate a negative result for people who don’t have the condition that’s being tested for also known as the “true negative” rate. 

A high-specificity test for the COVID-19 virus will correctly rule out almost everyone who currently doesn’t have the virus and won’t generate many false-positive results. 

For example: a test with 90% specificity will correctly return a negative result for 90% of people who currently don’t have the virus, but will return a positive result — a false-positive — for 10% of the people who currently don’t have the virus and should have tested negative.

Testing for COVID-19 infection in the workplace

It should be noted that much of the return to work preparedness and business continuity planning involves making adjustments to workplaces, operating procedures, administrative protocols and the requirements for work-from-home versus onsite work. The Occupational Safety and Health Administration (OSHA) points out that employers should continue to implement the basic hygiene, social distancing, workplace controls and flexibilities, and employee training described in this guidance in ways that reduce the risk of workplace spread of COVID-19, including by asymptomatic and pre-symptomatic individuals.

In the OSHA Guidance to Returning to Work [4045-06 2020] employers may consider implementing strategies to reduce risks to the safety and health of workers and workplaces from COVID-19 that include conducting diagnostic testing. “Neither the OSH Act nor OSHA standards prohibit employer testing for diagnostic testing, if applied in a transparent manner applicable to all employees (i.e., non-retaliatory)” the guidance affirms. 

Because of the limitations of current testing capabilities, employers should act cautiously on negative test results. OSHA is quick to point out that employers should not presume that individuals who test negative for COVID-19 infection present no hazard to others in the workplace. 

OSHA also provides guidance and resources for employers and employees  on the control and prevention of COVID-19 by industry. This guidance applies to all workers and employers, while other sections focus on those at lower risk of exposure and those with increased risk of exposure, including workers involved in:

  • Airline operations
  • Border protection and transportation security
  • Business travelers
  • Construction
  • Correctional facility operations
  • Dentistry
  • Emergency response and public safety
  • Environmental (i.e., janitorial) services
  • Farmworkers (developed in partnership with CDC)
  • Healthcare
  • In-home repair services
  • Laboratories
  • Manufacturing (developed in partnership with CDC)
  • Meat and poultry processing (developed in partnership with CDC)
  • Postmortem care
  • Retail operations
  • Solid waste and wastewater management 

Testing asymptomatic employees for infection

According to the May 2020 CDC Activities and Initiatives Supporting the COVID-19 Response and the President’s Plan for Opening America Up Again, testing of asymptomatic individuals is a growing consideration as the role of asymptomatic and subclinical infections in transmission becomes more apparent. 

Emerging evidence suggests that asymptomatic infections may play an important role in the epidemiology of the disease. Nevertheless, it is important to define the circumstances where testing asymptomatic persons is likely to be helpful in controlling the COVID-19 pandemic. 

The CDC provides further clarification that effective testing programs will focus on (1) persons with an increased likelihood of infection and (2) settings with particularly vulnerable populations, including but not limited to the following: 

  • Contacts of known (symptomatic or asymptomatic) cases. This may include testing of contacts going back one to two weeks before the onset of symptoms, particularly contacts who work with vulnerable populations.
  • Staff of long-term care facilities. Periodic testing and sentinel surveillance in these settings may serve to detect outbreaks early in this setting, where devastating outbreaks are known to occur and to be associated with high rates of asymptomatic infection. 
  • Other healthcare facility workers and first responders. Healthcare facilities may consider testing staff periodically, starting with staff in high traffic, high risk areas such as emergency departments.

Workforce: CDC guidance on “vulnerable individuals”

As workplaces consider re-opening it is particularly important to keep in mind that some employees are at higher risk for severe illness from COVID-19. These vulnerable workers include individuals over age 65 and those with underlying medical conditions (regardless of age). Such underlying conditions include, but are not limited to, chronic lung disease, moderate to severe asthma, hypertension, severe heart conditions, weakened immunity, severe obesity, diabetes, liver disease, and chronic kidney disease that requires dialysis. Vulnerable workers should be encouraged to self-identify, and employers should avoid making unnecessary medical inquiries. Employers should take particular care to reduce vulnerable workers’ risk of exposure to COVID-19, while making sure to be compliant with relevant ADA regulations.

OSHA recommends that employers should identify workers who may be at increased susceptibility for COVID-19 infection or complications and consider adjusting their work responsibilities or locations to minimize exposure. Other flexibilities, if feasible, can help prevent potential exposures among workers who have diabetes, heart or lung issues, or other immunocompromising health conditions. 

Serology testing for immunity to COVID-19

The CDC recently acknowledged that serologic testing may play a role in a back-to-work strategy provided it can be shown that serologic testing can reliably infer immunity. This immunity may not need to be absolute: protection against severe infection may be enough even if immunity against reinfection isn’t reliable or durable. Some employers, and some industries in particular are counting on serologic testing for immunity.

While there appears to be considerable public optimism that serologic testing will allow return to work without the need for PPE or other precautions, there are many unknowns at this early date that limit implementation of serology for this purpose. 

There is a need for high-level consensus on the role of serologic testing in a back-to-work policy. Consensus is also needed on a plan for how to provide documentation of that immunity, be it through federal- or state-based immunity registries, digital proof-of-immunity, or physical documentation such as “immunity certificates”. Despite these limitations, continued interest in the use of serologic testing in a back-to-work policy is likely.

In its most recent guidance, however, CDC Interim Guidance said that antibody test results “should not be used to make decisions about returning persons to the workplace.” 

In light of this CDC guidance, under the ADA (Americans With Disabilities Act) an employer may not require antibody testing before permitting employees to re-enter the workplace. An antibody test constitutes a medical examination under the ADA. An antibody test at this time does not meet the ADA’s “job related and consistent with business necessity” standard for medical examinations or inquiries for current employees. Therefore, requiring antibody testing before allowing employees to re-enter the workplace is not allowed under the ADA.  

Of note the EEOC acknowledges that an antibody test is different from a test to determine if someone has an active case of COVID-19 (i.e., a viral test).  The EEOC has already stated that diagnostic COVID-19 viral tests are permissible under the ADA. The EEOC will continue to closely monitor CDC’s recommendations, and could update this discussion in response to changes in CDC’s recommendations.

What’s covered?

As of this writing, most insurance carriers will cover COVID-19 testing under certain circumstances and employers should factor costs into their plans to include these tests in business continuity planning and execution. Employers should be sure to contact their insurance carrier(s) and understand exactly what is and what is not covered under each of their health plans. Insurance testing for coverage will almost certainly be a moving target, so employers should plan to monitor insurance carrier communications and postings on a regular basis.

Medical insurers typically don’t cover medical services that aren’t ordered by a health care professional, or that aren’t considered medically necessary in fully insured, or through medical insurance administered self-funded plans. As an example, pre-employment testing for job requirements are usually paid by the employer themselves. Some insurers and health plan administrators explicitly exclude surveillance testing for their members.

According to a recent AXIOS article, UnitedHealthcare, for example, says that “we will cover medically necessary COVID-19 testing at no cost-share…when ordered by a physician or health care professional.”

  • BlueCross BlueShield of South Carolina will cover diagnostic tests “when ordered by an attending health care provider and provided at the point-of-care for individuals who are symptomatic and are concerned about infection.”
  • Blue Cross and Blue Shield of Kansas City will cover both diagnostic and antibody tests “with no cost share if you have symptoms consistent with COVID-19 and your physician orders the test.” 
  • BlueCross BlueShield of Mississippi  says it won’t cover tests that are “not medically necessary,” which includes tests for asymptomatic people as part of public health monitoring efforts or screenings for returning to work. 

Not every insurer has added coverage limitations. Aetna, which is owned by CVS, has waived cost-sharing for all diagnostic tests, which “can be done by any approved testing facility.”  

Partnering with employers on COVID-19 testing

Employers are interested in partners who can help them deploy, manage and track testing. If new testing technology enables that, it must have the proper regulatory approvals solidly in place. FDA approval is paramount. Healthtech companies or test provider must remember that there are tremendous liabilities attached to all aspects of this testing- companies are looking for demonstrable reliability and sufficient specificity and sensitivity.

Employers need to follow CDC’s and the Occupational Safety and Health Administration (OSHA) guidance for reducing workplace exposure for all employees. All decisions about following these recommendations should be made in collaboration with local health officials and other State and local authorities who can help assess the current level of mitigation needed based on levels of COVID-19 community transmission and the capacities of the local public health and healthcare systems. In addition, specific industries may require more stringent safety precautions. Finally, there may be essential workplaces in which the recommended mitigation strategies are not feasible.

It is important for any test provider   to fully appreciate the regulatory landscape that employers face. This is the time to be a true partner.

What Employers Should Know About Covid-19 Testing When Bringing Employees Back To Work 2

Ronald S. Leopold, MD, MBA, MPH, Physician Consultant

MDisrupt Advisor and Senior Consultant Specializing in Employee Benefits, Medical Cost Solutions, New Medical Technology

As a credentialed and experienced professional, Dr. Leopold brings credibility and a breadth of knowledge as a consultant, client advocate, and marketplace spokesperson. He is an industry thought leader in employee benefits and health and productivity.

Specialties: Medical Costs, High Cost Claimants, New Medical Technologies, Employee Benefits, Heath and Productivity, Population Health Data Analytics, Global Workforce, Generations in the Workforce, Financial Wellness, Thought Leadership, Public Speaking.

At MDisrupt we can help, If you are an employer wanting to deploy back to work protocols and would like expert guidance – please contact us.   

If you are a test developer wanting to access the Employer market we can help you understand the strategies and protocols necessary to be successful.

Talk to us—we can help.

MDisrupt One Year On—A Year of Transformation

MDisrupt One Year On—A Year of Transformation

The only constant in life is change. And nowhere is that more true than in your first year as a start-up.

As many of you know, MDisrupt was founded a year ago because we believed the healthtech world was lacking “medical diligence”. We believed this was the missing link in the market and the reason why so many healthtech startups were stumbling on the path to successfully commercializing their health products.

We originally created MDisrupt to identify healthtech companies who were at risk of becoming the next Theranos, or uBiome. Our hypothesis was that if investors undertook more rigorous medical diligence, they would be able to more easily identify and evade potential investments in companies that were not clinically or commercially viable, or who were not taking the appropriate regulatory path.

Like any start-up in its first year, we had ups and downs, learned a ton and we soon identified our true direction – to play an even more constructive role in the healthcare / healthtech industry than we had originally planned. Luckily we were small and nimble enough to be able to react quickly to the market dynamics and, while some of the changes were tough, they forced MDisrupt into a stronger, better place. I want to share with you the ways we have changed and the lessons we learned along the way. 

Changing Focus – Healthtech Investors Were Not The Primary Customers For Medical Diligence

It turned out that healthtech investors were not our primary customers. There is not really a ‘budget’ for medical diligence in an investment transaction. Tech funds source health subject matter experts from within their network to conduct diligence, whereas, bio and life sciences investors already have health domain expertise on staff.

We soon found that it was the bigger and more established health companies that had utility for our medical diligence services to provide an objective external third party view and address their needs in a range of fundamental areas such as: 

  • Benchmarking: 
    • “How do our clinical standards as a laboratory compare to other clinical labs?”
  • Mergers and Acquisitions: 
    • “We are considering an acquisition and want to understand the new market of the company we are acquiring.”
  • Market Sizing: 
    • “We are launching a new product in a new market and want an objective view of the market size and opportunity.”

Our True Market: Healthtech Truth Seekers Wanting Much More Than Medical Diligence Services

While we had limited traction with investors, one of the most inspiring parts of the last 12 months was meeting the healthtech founders who were determined to build their companies responsibly and cared deeply about building impactful, scalable and data-driven health products. But they did not just want our medical diligence assessments, they wanted access to us and other health industry experts to help them build their health products well in the first place. They were aware of how other healthtech companies had stumbled in their early days and did not want to make the same mistakes. 

These companies wanted our help to solve problems such as: 

  • Should my test be an LDT or an IVD?  Is it a health or wellness product?
  • What is the appropriate regulatory path I should take in the US?
  • How do I find a part-time Chief Medical Officer?
  • How do I access the self-insured employer channel?
  • What is the right strategy for engaging healthcare providers and payors?
  • Help me define a marketing strategy for reaching medical audiences.

Even the investors we engaged with in our early days, started to connect us to healthtech companies in their portfolios. Very soon we were overwhelmed with these types of requests and had to start tapping into our network of colleagues to help us on these projects. We quickly realized that our real market was helping the healthtech founding teams themselves.

Uncovering The Unmet Need: “The Gig Economy For Health Industry Experts”

As we began to reach out to our networks for help on these projects, and with all the press coverage we received when we launched, we were inundated with support from experienced health industry professionals and colleagues. The same key themes emerged: 

  • It is about time someone helped improve standards of health products. 
  • How can I help and get involved? 
  • Can I work for MDisrupt?
  • I want to work with healthtech companies and help them get to market quickly and safely.
  • How can I find the healthtech companies who could use my skills and expertise?

We heard from our client healthtech companies that they were struggling to access the experts they needed and here we were with hundreds of emails from passionate, experienced experts ready and willing to help. That was the moment we realized that the real problem we needed to solve was how we could provide easy access to experienced, vetted health industry experts. We knew then what we needed to build into the MDisrupt platform – a health expert two-sided marketplace. 

And so we did.  To date we have 58 consultant subject matter experts spanning the healthcare continuum, averaging 10 years’ experience in their discipline. Our expert consultants include:

  • MDs
  • Scientists
  • Market Access Experts 
  • Regulatory Experts
  • Commercial and Channel Strategists 
  • Lab Test Designers 
  • Clinical Trial Designers 
  • Health Economists

Many of these industry experts are still practicing and so are able to provide the most current perspective within their disciplines. They are able to assist healthtech companies in a variety of capacities including: 

  • Experts-in-Residence 
  • Part-Time Chief Medical or Chief Scientific Officer 
  • KOLs 
  • Medical or Scientific Advisory Boards 
  • Consulting Projects 
  • Expert Opinions

Engaging these health industry experts as consultants has enabled us to solidify our mission of helping to bring the most impactful health products to market faster and more responsibly by uniting the healthtech and healthcare industries – benefiting from the best of both worlds.

The Covid-19 Pandemic: An Unexpected Driver In Uniting The Healthcare And Healthtech Worlds 

As we entered 2020 the onset of the coronavirus outbreak changed the world for us all. Never has healthcare, healthtech and science been more in the spotlight than over the past 6 months. Very soon we started to see healthtech companies make significant shifts in their business models to help address the global pandemic. Some examples of these include:

  • Lab testing companies that wanted to shift into developing Covid-19 Testing 
  • Telemedicine companies that had to scale significantly 
  • Instrument companies that had developed products for adjacent industries wanting to move quickly into clinical lab testing 
  • Behavioral apps who pivoted to address mindfulness and stress-management issues arising from lifestyle shifts due to prolonged shelter in place mandates
  • Regulatory and clinical activities for “Back to Work” scenarios – how employers, colleges and schools can bring people back safely

Once again, we have been inundated with requests for health industry experts to help healthtech companies make these pivots and transitions. Increasingly, healthtech companies are seeing the value of having scientific and medical experts as core parts of their teams to help them navigate the new opportunities that the pandemic has brought to the industry.

As Start-Ups Evolve, So Do Their Teams 

Earlier in my career, while working for a start-up, a wise CEO told me that the people that found a company are not always the same people that grow the company, or scale it or take it public.  Teams evolve and different people and skills are needed for different stages of progression. 

MDisrupt was founded by myself and my close friend and colleague Jill Hagenkord, who I nicknamed the “Godmother of Precision Medicine”. We founded MDisrupt with the mission of helping bring the most impactful health products to market faster and more responsibly by uniting the healthtech and healthcare worlds. Today is the one-year anniversary of MDisrupt and, while that mission has not changed, it is bittersweet for me to announce Jill’s departure from MDisrupt. Jill was offered an incredible opportunity that she could not refuse and she is off to pursue her next amazing adventure. I don’t want to steal her thunder by announcing where she is going until she does, so stay tuned for her announcement. I am so incredibly grateful for the blood, sweat and tears Jill poured into MDisrupt working alongside me over the past year and how she helped turn a glimmer of an idea into a business that can truly make an impact for so many companies. Myself, and the MDisrupt community she helped to build, thank her for her dedication, passion and brilliance and we will be cheering her on as she embarks on her next journey.

We have also been lucky enough over the past few months to add some new and incredibly talented people to our team:

Ragan Hart, MS, PhD – Director of Operations and Business Development 
Ragan is an applied health economist, who evaluates clinical genomics and digital health technologies.  Learn more about Ragan Hart

 Dr Pamela Mehta – VP of Medical Affairs 
Dr. Pamela Mehta is a board certified, practicing orthopedic surgeon and the founder of Resilience Orthopedics. Read more about Dr Mehta 

Please join me in welcoming them to the MDisrupt Community!

A New Year, A New Look

As a health product marketer by blood, I believe it is important that a brand is not only representative of your company’s personality but also a critical communication vehicle for your target audiences. We serve both health innovators and our health industry experts equally. Our goal has been to create a brand that resonates with both sectors, keeping the modern feel that the healthtech industry is accustomed to, but enriching this with content written by our experts to address the real issues entrepreneurs may face as they take on the challenges of responsibly building scalable health products.  

 We also wanted to make it easier to showcase some of our experts’ skills and create simpler ways for health companies to find them. So we gave ourselves a rebrand – take a look at our new website, we welcome your feedback. I want to thank Paul Bohanna, our creative and technical director who has worked tirelessly over the past few months to reimagine our brand and build our website. 

A Company Is Only As Good As Its Network of Supporters – Thank You

As with any start-up, the first year is a year of learning, pivoting and identifying new opportunities. But one thing has been clear – we have been blessed with incredible support: from the clients that believed in us and trusted us to work closely with them on their projects, to the network of health industry experts that joined our platform and have been passionate about not only helping the healthtech companies but also helping us directly, advising us, writing amazing blogs for our website and evangelizing our message.

Finally, I want to acknowledge a few partners who have supported us and provided wisdom and guidance from our very first day.  

One year on, I am humbled and grateful for all the support and from the bottom of my heart I thank you all. 

Ruby Gadelrab
CEO

Ascending the Covid-19 Incline—Reform, Reaction and The Long Way Back

Ascending the Covid-19 Incline—Reform, Reaction and The Long Way Back

Confronting the unimaginable: Covid-19, a surmountable challenge

Each day as I get up and go to work, I have to prepare myself mentally in a way that I have never experienced in my 12 years as a UK Doctor. My colleagues and I witness daily, the gravity and devastation that this despicable thief of life has caused—and it is heart-breaking.

Many of us have been personally affected, directly or indirectly by Covid-19 or have lost someone we love and it is nothing short of brutal. There is no doubt in my mind that we will one day all be living in a post-pandemic world that will no longer resemble much of our pre-pandemic one either economically or socially, but I do hold the firm belief that we will once again, reclaim our independent lives, albeit in some alternate form, at the end of this war.

Adapting to the New Normal

Many healthcare professionals share the same concerns and uncertainty as the rest of the public, but in the thick of it as we are now, our primary resolve is to fire-fight our way to global safety.  

Some healthcare professionals also share the cynicism that many members of the public express about the way our various governments have handled certain aspects of this Covid-19 war. It is undeniable that many positive strategic steps have been taken, such as the rapid deployment and reinstatement of retired healthcare workers, the Herculean effort of everyone involved in the development of the UK Nightingale ITU hospitals – massive temporary hospitals put together in a matter of days to help increase capacity where regular hospitals struggle to admit any more patients – and the active campaign to protect the NHS and global health systems aimed at ‘flattening the curve’ through staying at home, to save lives, have all been pivotal and impressive. However, crucial delays in implementing a hard lockdown, PPE shortages for frontline staff, inadequate levels of testing and the procurement of antibody kits which fail to meet trialled standards have all been hot topics of debate amongst health professionals and our society at large. In response to this, I believe we will see some very significant reforms to our post-pandemic healthcare systems, striking changes within our economy and alterations in our social behaviours that are likely to be long-standing.

Lockdown V Liberty 

My colleagues and patients regularly ask my views on our current state of lockdown. The essential  move to severely curb movement amongst the population has been a globally challenging phenomenon, taking its toll financially, physically and emotionally on every individual. It is, however, the only measure that has been shown to reduce the spread of this highly contagious virus as it clearly deprives Covid-19 of the opportunity to pass from person to person. Hard lockdown has been, and still is, a fundamental step in our fight at the coal face of this pandemic but I am not convinced it can continue in its current form until a vaccine or treatment is established. The impact on the physical and mental health of the population and the socio-economic consequences of a long-term hard lockdown would likely be extensive and far-reaching. The evidence requires detailed evaluation in an effort to find a safe and workable balance in the months ahead.

This does not mean lockdown should be lifted at this phase, while death rates continue on an incline, without careful consideration as to how this should happen. If we are too impatient and take action prematurely, this would put us firmly back to square one, if not worse, as saturation points start to be reached within our hospitals. There is an infectivity index (R0), which measures how infective the virus is among people- our aim is to see this become R0 <1, which is what containment and staying at home should achieve and has been successfully reached in many countries. Anything above R0 >1 will result in an exponential growth in case numbers and this would be catastrophic. 

So, what happens after lockdown is slowly lifted? My view is that Covid-19 will continue to exist among us but we will likely step down the ladder from a pandemic state —> epidemic —> virulence levels. We will still be at risk but the probability of contracting this virus will be much lower as the number of cases declines through isolation and social distancing and we would need to exercise sensible limitations to our movements until such a time that the vaccine and treatments emerge.

If the lockdown release is too abrupt, we risk a secondary surge in cases similar to that seen in China last week in its northern borders with Russia – this was thought to be due to an influx of  overseas Covid-19 positive people into China, after which the border was quickly closed and further quarantining was mandated.

I agree with those who express the view that this pandemic will have a permanent effect on general social behaviours.  Personally, I believe there is likely to (or at least should)  be a graded exposure back to mobilising the public to essential activities first, then close family mixing and finally, over time, a more full social interaction.

It is hard to imagine that our social landscapes will ever see the dense aggregation of people that we have previously enjoyed and indeed I suspect that concerts, cinemas and even restaurants that can’t maintain safe social distancing may well need to wait for their lockdowns to be lifted until such a time that vaccines and treatments are more established. This all remains uncertain for now and the coming weeks will be telling as government strategists look at ways to safely rehabilitate us back to our functional lives. 

Collateral Damage—the Forgotten Victims of Covid-19

There is a growing concern amongst healthcare professionals that there is a risk of declining health in non-Covid-19 patients who suffer from other chronic conditions which have been eclipsed by this  pandemic. The fear is that there will be significant consequences if these patients cannot access their healthcare providers or are fearful of attending hospitals over prolonged periods of time. Patients shielding (where extremely vulnerable individuals are advised to minimise all interactions with others and stay home while having access to priority food supplies and other vital services), limited access to health services resulting from Covid-19 surges, cancelled procedures and treatments, delayed presentation and non-surveillance of chronic health conditions will all contribute to the mass grave of the Covid-19 era. 

As primary healthcare providers, we are still able to see many patients (albeit mainly virtually) but access to all our patients needs to improve to prevent an increase in non-Covid-19 mortality over time. Primary care has been forced to digitise at an unprecedented speed with the rapid scale-up and introduction of telemedicine through the use of video consulting, electronic prescribing and other digital applications that enable a more flexible remote working capability. What we can see is an enabled primary care provider that can continue to offer access and services virtually so as to minimise the risk to both healthcare professionals and patients during the pandemic The NHS and private sectors have also harmonised in an unprecedented way with private hospitals and clinics committing their facilities, staff and equipment for the use of NHS patients  Together, they have shown some impressive resolve and flexibility, which will hopefully outlive this viral war and improve national healthcare well after it no longer faces such a colossal challenge. 

Reviving the Economy—the healthcare implications

Our economy will need some serious attention in the coming weeks, not least because at a critical point, and once infectivity is R0<1, the non-Covid 19-related morbidity and mortality caused by a long-term and deep financial depression in our country may potentially outweigh the risk of Covid-19 related tragedies at that junction.

This is a veiled outcome for us all to imagine from where we are all at now but there has been considerable modelling based on Wuhan data and other research to identify the most appropriate way back to some socio-economic ‘life’. One study in the Lancet by Prem, Lui et al. highlights a number of approaches that are being trialled to achieve a return to graded social mixing and with the aim of enabling some socio-economic recovery. They acknowledge their modelling needs further research and analysis but their projections suggest that premature and sudden lifting of interventions could lead to an earlier secondary peak, which could be flattened by relaxing the interventions more gradually

So, to avoid the risk of provoking a second wave of the virus spreading, and a subsequent early second peak, we may need to be prepared to accept a relatively slow approach to lifting the lockdown.

The Marathon, not the Sprint—Uniting for the Win

No one knows how Covid-19 behaves in the long term – we just do not have that insight but an immense amount of research is being undertaken globally and each day we are more informed, more empowered and ever closer to overcoming this pandemic. For now, however, it remains an elusive and unpredictable nemesis. 

I know patience is being tested and it feels like nothing will be the same again but we should try to accept that we are in this for the medium term at least and that we may well emerge with a few positive reflections and adjusted ways of living that, while may not be the same, will still enable us to have our capacitated lives back.

In the meantime, I should say that every single health professional, researcher, and key worker I have encountered has been beyond dedicated and committed to helping us all out of this with the least possible number of casualties and, whatever our political or personal views, for now we are fully united in our fight to shepherd our nations up the incline, to the summit and down the other side safely.

Thank you To All Our Healthcare Colleagues on The Front Line

Please know that I, and many of my colleagues are deeply affected by what we are seeing each day at work, horrified at how unrelenting and unkind this criminal virus is and humbled by seeing other colleagues fearlessly approach the most risky of situations without a second thought to their own safety in order to help someone else. I am optimistic and hopeful that if every person does their bit, people stay at home and give us the time we need,  we will be able to emerge from this and hopefully have some answers. 

I want to express deep gratitude to everyone who is fighting the good fight and sympathy for anyone who has been affected directly or indirectly, or who has lost someone they love to the horror of this disease. Every single person who is staying at home for us, is a warrior in this war.

Dr Rasha Gadelrab

Dr. Rasha Gadelrab

MDisrupt Guest Blogger: Dr. Rasha Gadelrab, MRCGP MBBS BSc (Hons), NHS GP & Chief Medical Relations Officer

Dr. Rasha Gadelrab is a portfolio NHS GP, Quality Improvement Manager and a clinical Covid-19 contingency lead in a North London Practice. She is also the Chief Medical Relations Officer of www.myhealthspecialist.com. Since completing her medical training, she has dedicated her career portfolio to clinical medicine, medical education, digital innovation and healthcare quality improvement activities in order to improve patient care.

If you are a health tech founder looking for guidance on building or growing a healthcare savvy product team, talk to us—we can help.

How Healthcare and Healthtech Should Unite to Combat the COVID-19 Crisis

How Healthcare and Healthtech Should Unite to Combat the COVID-19 Crisis

We’re facing unprecedented times as we gear up to confront the reality of COVID-19, both on the economy and within the healthcare system. As cases continue to rise, sorting through misinformation on the virus has become more vital than ever. Fortunately, the healthtech and healthcare industries have never been ones to stand immobile or on the sidelines when the public’s health is at risk. With each passing day, great steps have been made to better inform the public of actionable recommendations they can make to combat the growing COVID-19 crisis, including a passionate movement to increase efforts on the current and most significant challenge: production and distribution of clinically valid diagnostic tests.

And with the current climate, anxiety and trepidation abound showing an uptick in claims surrounding the coronavirus pathogen. There is no more prevalent time for rapid dissemination of scientifically valid research to help educate and appease the public than now. With more people staying at home and practicing “social distancing,” the market has become a flooded landscape of companies either suffering or taking advantage of nervous individuals. Although there is an opportunity to help stabilize the health market, the greatest potential is in partnering tech with patient care to promote evidence-based information and valid actionable recommendations to the many facing the COVID-19 pandemic. 

The first step is understanding  which are some of the most reliable resources available – which include more than constantly refreshing the CDC website – in fact, the CDC provides a variety of webinars to address updates for private sector partners, including frequently asked questions about the virus.

In addition, several credible sites ranging from OSHA to the New York Department of Health are regularly updated, sharing protective tips and FAQs. If you’ve recently reviewed the USDA’s response or visited the WHO’s website, you’ll find similar levels of information. But as the government continues to struggle over the shortage of diagnostic tests and the stresses facing the healthcare system, new opportunities are emerging.

How Healthcare and Healthtech Companies Have Risen to the Challenge

The healthcare and healthtech industries have responded to the call for increased action to combat COVID-19 across various fronts. This has taken the form of amplified production of kits, reagents and supplies, therapies, and preventative-care products. We’ve seen many companies rise to the occasion to address the severity of gaps in COVID-19 preparations. 

Test Kit Suppliers 

Building a health product responsibly takes careful orchestration between medical, commercial and regulatory teams and can often take years for commercialization and scale.  However in response to the crisis, the FDA has expedited the process to approve new COVID-19 kits under the new Emergency Use Authorization (EUA) guidelines. This has allowed a number of health companies to quickly mobilize and create tests that have made it to market in a matter of weeks

The severity of the situation has since been emphasized as the CDC has announced the allowance of commercial testing facilities to develop and distribute COVID-19 tests as of February 29th – with companies like Thermo Fisher offering state-of-the-art pathogen detection kits for both real-time PCR and Applied Biosystems QuantStudio 5 assay systems. As the CDC has repeatedly announced their challenges in improving the availability of tests, Thermo Fisher’s increased production is alleviating the scarcity in kit supplies. 

Several other companies have also  developed current COVID-19 test kits and begun making them more accessible to meet the growing and urgent demand.  Their quick response has steadily reduced kit shortages. This list of companies grows each day and includes: 

In recent weeks, Cepheid has released a COVID-19 test with an analysis 4x faster than standard kits with an improved 45 minute turnaround. Their test, now available, has been primarily distributed to hospitals first. 

Reagent Suppliers

As the COVID-19 crisis has grown, demand for reagents and testing supplies has surged. Fortunately, companies such as Promega manufacturers have answered the call of the CDC in improving access to critical components needed for diagnostic test production. Already, Promega has begun accessing their stored inventory and ramping up production of the key materials and reagents necessary for meeting the demand of diagnostic tests. Their focus has meant fulfilling much-needed orders by adding additional work shifts, paying overtime, and even diverting work on other projects to prioritize COVID-19 efforts. Reagent supplied Qiagen has also joined its ranks, aiming to increase its contribution 4-fold.

Monitoring and Screening 

In an effort to better monitor changes in COVID-19 progression, technology companies such as Alibaba have developed open-source platforms that update in real-time. They’re joined by other platforms supported by Johns Hopkins COVID-19 Global Dashboard and Bing’s COVID-19 Tracker. With the private sector quickly responding to the gaps by the public sector, we’re seeing market-driven innovation that’s improving the general public’s access to reliable information.

For example, a quick review of commonly searched keywords shows an increase in symptom checks, adding to the current pitfalls in amatuer diagnostics. However, leading innovators like Buoy Health have worked to develop a systematic online screening tool that rapidly assesses symptoms related to COVID-19, alongside the Cleveland Clinic’s. Their tool arrived shortly ahead of Apple’s symptom triage tool, featuring a CDC-approved symptom flow within Siri voice assistant

Telemedicine

While historically the healthcare world has been slow to adopt telemedicine, the COVID-19 crisis has shone a light on the benefits of remote medicine during contagious pandemics. Telemedicine has now become a key tool enabling the public to maintain social distancing practices while still accessing healthcare. This has been facilitated by the Trump Administration’s initiative to expand CMS’s telehealth accessibility. For individuals looking for online resources, you can also access Doctor on Demand, featuring an online symptom assessment.

Medical Equipment and Supplies

Health and tech companies have also responded to help with delivering preventative measures.  With healthcare professionals on the frontlines in our hospitals and doctor’s offices, we’re seeing mass shortages of personal protective equipment, or PPE, as large quantities of protective masks have been purchased by the anxious public. Although most low-grade masks work best for those already ill, the N95 respirators and surgical masks shown to protect against airborne particles are in low supply. Earlier this month, Jack Ma of Alibaba has also improved availability and distribution of N95 masks by pledging to send 1.8 million masks to Asia, which has since been expanded to Africa, Europe and the U.S. including protective suits, ventilators and thermometers.  

Additionally, to improve funding, Biogen has also donated $10 Million to non-profit organizations working during the crisis, including donating medical equipment to supplies to Partners HealthCare in Massachusetts and local hospitals.

Clinical Trials and Therapeutic Development

Other government efforts  to develop treatment options for severe cases have teamed up with pharmaceutical company Roche. Currently, their arthritis drug Actemra has already been in use by Chinese authorities to address COVID-19 cases, however the need for establishing clinical validity is pressing. To tackle the feasibility, the FDA has partnered with Roche to initiate a randomized, double-blind, placebo-controlled phase 3 clinical trial to study Actemra for patients hospitalized with severe COVID-19 induced pneumonia. This comes on the heels of Japanese drug Favipravir, used to combat the flu, which has been shown to be effective in treatment in both Japan and China after a series of clinical trials with over 340 patients. However, the Japanese health ministry has stated that its efficacy is reduced in severe cases and would require government approval before it can be used to treat COVID-19 cases.

The greatest challenge for potential treatments remains the time necessary for evidence generation to assess the safety and efficacy – though we’ve seen various pharmaceutical companies announcing breakthroughs in their viral research efforts (such as companies like Regeneron, and drugs such as Chloroquine). During this time it can seem like grasping for straws may give the appearance of progress, but devotion to clinical validity is the only way to halt the progression of the viral pathogen. Various companies, such as Benchling, have donated funds and resources to research labs working to develop diagnostics, vaccines, and treatments. Reify Health has also begun offering funding for companies utilizing clinical trials for COVID-19 therapies and treatments.

Healthcare and Healthtech Can Make A Difference Together.

Desperate times call for more collaboration and uniting industries to bring together skills to solve health problems both quickly and responsibly.  Despite the urgency health companies feel to bring products to market quickly, it’s important not to take shortcuts in evidence generation so that products are proven to work and are safe.  Healthtech companies have the advantage of technology and agility. Healthcare experts understand how to build medically viable products and navigate the regulatory path. The most critical thing a healthtech company can do is engage health industry experts early and often in the process of bringing health products to market. 

At MDisrupt, we have over 50 Health Industry experts many of whom are dedicated to offering their time and skills to assisting companies combating the COVID-19 crisis. These include physicians, regulatory and commercialization experts .  Most notably a number of pathologists in our network have offered to donate their time to provide CLIA lab medical director services to labs who need assistance. Talk to us, we want to partner with you to contribute to building solutions for this crisis together.

Combatting Misinformation related to COVID-19: a Primer for Healthtech Companies and Consumers

Combatting Misinformation related to COVID-19: a Primer for Healthtech Companies and Consumers

As a Pulmonary & Critical Care Physician who has a passion for finding digital technology solutions to our health care problems, as well as 5 years of experience helping healthtech companies in the SF Bay Area, I have evaluated many and led the adoption of several platforms in my practice.  Through involvement with Health 2.0 SF, I have mentored founders with solutions that have the ability to re-shape the practice of Medicine.  Below I share my observations on the tsunami of COVID-19 information we are deluged in.

Misinformation Avalanche

Fortunately: scientists, epidemiologists, and physicians are not facing anything new when confronting the copious amount of misinformation people bring to them.  People over the span of time, without credible background knowledge on a subject, have been prone to follow movements based on an erroneous understanding of causation vs correlation or fear-based propaganda that fits their political ideology.  The epitome might be the Anti-Vaxxing crowd, many of whom are already lining up against any possible future Coronavirus vaccine.  COVID-19 has brought upon an onslaught of media and social media activity: with the ability to spread helpful information on these channels has come an unprecedented manner to spread misinformation that at minimum confuses (what is fact vs opinion), often shapes (opinions and behaviors), and occasionally kills.

Already related to COVID-19 we have seen the home-remedy folks, conspiracy theorists, and racists rush to create fake news or propaganda to satisfy a fearful base.  To counter this deluge of bad information, Twitter, Google and Facebook are launching campaigns within their platforms to fight it back; and even CNN’s Dr. Sanjay Gupta has a new Podcast that has content to educate and combat against misinformation.  As part of the health community, please be careful what you re-tweet or share: consider the source (CDC, WHO, local hospital medical leaders are reputable), do not under-analyze preliminary scientific (typically not peer-reviewed) data, and keep in mind that certain knowledge is not concrete, as scientists continue to unravel  this disease.   Slow down and fact check!

Developing Healthtech in the World of COVID-19

Healthtech founders, including ones I mentor, are facing an existential dilemma: push forward with their platform in a badly damaged economy with fewer VC and consumer dollars; or tailor their platform to help solve a need in our current pandemic, and hope the buy-in and funding will come.

For either approach, I describe the Quadruple Aim that leaders in hospital systems need from health technology.

The Quadrupal Aim
MDisrupt Quadrupal Aim

Briefly, all solutions must begin by being able to either improve the patient or clinician experience.  A platform aimed at improving the experience for either patients or clinicians must lead to mutual benefit: an improved patient experience must not come with a worse clinician experience, or vice versa.  Concomitantly, a new platform that can help lower costs will only be successful by leading to improved outcomes and patient/clinician experience.  Patients will and must always come first.

It is impossible to understand the nuances of the Quadruple Aim (when considering your consumer and purchasers: patients, clinicians, hospital/government administrators) without a domain expert who understands medical affairs (your product and your consumers).  Everything within the Quadruple Aim needs to be in sync for there to be success of a new platform. 

If the solution, for example, is aimed at improving patient outcomes related to COVID-19 then this requires validation – a level of evidence that demonstrates that the data obtained from the platform is accurate, and that the added data is effective in its goal relative to doing nothing (or versus the standard of care).  The solution also must be easily integrated into the workflow, for patients to use (ex: how many smartwatches are worn consistently; asking consumers to perform manual data entry into an app is not typically sustainable) and/or for clinicians to access seamlessly.  A bad patient or clinician experience ensures a futile effort.  The process is lengthy and complicated, and it needs to be kept in mind that each particular locality will have variable needs during this pandemic.  Talk to medical professionals near you with boots on the ground.  If it will take over a year to perform a fast-tracked clinical trial on a vaccine and therapies, and until March 21st to see Google create its Coronavirus resources; then it will take time even for a digital platform to apply the scientific method to identify the problem within the pandemic to solve, and then testing of the platform for meaningful outcomes.

It Takes a Village

What is not misinformation is that with every known major societal disruption there are opportunities that rise through the ashes and lead to fundamental change.  There are multiple areas impacted by COVID-19 that need solutions, including the supply chain, population management, consumer facing tools, and back-office.  When tailoring a platform to meet the needs of our Coronavirus pandemic, an honest assessment must be first made of whether anyone on the team has experience in epidemiology, pulmonary, and/or infectious diseases.  Product development and management in Tech requires a different skillset and experience base than for Health. There are no short cuts for understanding the disease; or clinician and patient behaviors, attitudes, and needs. You will need a team, including domain experts and experienced healthcare product managers: talk to us, we are here to help.

Sachin Gupta MD, MDisrupt Guest Author

Sachin Gupta MD, FCCP, ATSF, Physician Consultant

MDisrupt Guest Author

Dr. Gupta is a thought leader in Healthtech and a Consultant through his roles previously at Kaiser Permanente and Health 2.0 SF, where he co-developed the “Project Zygote” pre-accelerator curriculum for entrepreneurs in digital health. Clinically he is in private practice now and a known expert in rare lung diseases, early technology adopter, and patient advocate. He is an editor for the monthly California Thoracic Society Inspirations, as well as the CHEST Physician newsletters, and an active member of the Pulmonary Hypertension Association.

Specialties: Pulmonary, Critical Care, Clinical trials, Digital Medicine, Rare lung disease, Physician education, Patient education, Medical Affairs.

If you are a health tech founder looking for guidance on building or growing a healthcare savvy product team, talk to us—we can help.

Bridging the Cultural Divide Between Healthcare and Healthtech

Bridging the Cultural Divide Between Healthcare and Healthtech

Bridging the Cultural Divide Between Healthcare and Healthtech 3

From Healthcare to Healthtech

Jill Hagenkord talks about her transition from Healthcare to Healthtech and shares the lessons she learned. In this podcast Jill shares some of the cultural differences she observed between the two industries and the ways that healthtech companies can collaborate with healthcare experts to create clinically and commercially viable health products that can scale.

jill hagenkord

Jill Hagenkord, MD

MDisrupt Guest Author

Jill is a board-certified pathologist with subspecialty boards in molecular genetic pathology and a fellowship in pathology/oncology informatics. She brings expertise in health product strategy, coding, coverage, reimbursement, medical and regulatory affairs, health policy, clinical laboratory medicine, population health, provider education and patient engagement.

Accessing the self-insured employer channel correctly takes special expertise. If this channel is key to your commercial strategy, talk to us—we can help.