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.

Ascending the Covid-19 Incline—Reform, Reaction and The Long Way Back 1

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
Combatting Misinformation related to COVID-19: a Primer for Healthtech Companies and Consumers 2

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.

Combatting Misinformation related to COVID-19: a Primer for Healthtech Companies and Consumers 3

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 4

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.

Bridging the Cultural Divide Between Healthcare and Healthtech 5

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.

The Formula for Widespread Adoption of Health Products that Every Investor and Health Tech Entrepreneur Needs to Know.

The Formula for Widespread Adoption of Health Products that Every Investor and Health Tech Entrepreneur Needs to Know.

Building a health product or service that will gain widespread adoption requires a long term plan and thoughtful orchestration between your Medical Affairs and Commercial teams. While we show you the formula below, each step of strategy and execution are intertwined over time as milestones are achieved. 

 This formula is well-known and well-established for traditional healthcare investors and entrepreneurs, but may be less familiar to those from the tech industry. Health tech entrepreneurs are often tempted to skip a step or delude themselves into believing that their product will be so impactful that the medical industrial complex will not require evidence of safety and utility. They are wrong. None of the steps we outline below can be skipped. Instead, entrepreneurial creativity and technology can and should be harnessed to achieve these milestones more quickly than ever before. Combining innovative experts from health and tech increases your chances of getting widespread adoption more quickly.

 The necessary steps for widespread adoption of a health product.

Above: The necessary steps for widespread adoption of a health product.

Define Your Product’s Intended Use.

Your company will need a statement that clearly describes what the device/test/software is testing, the technology it relies on, why the testing is performed, acceptable sample types (if relevant), and who is or is not an appropriate test subject. This statement guides the performance specifications and development process. It also determines the risk level and complexity of the product, which impacts the regulatory requirements. It is the “North Star” that provides clarity to the product, marketing, medical/scientific affairs, legal, regulatory, and engineering teams.

 Meet Regulatory Requirements for Market Entry (this is about the device/test/software itself)

  • Analytical Validity: The device/test/software must accurately detect the analyte when this substance is present (analytical sensitivity) and not indicate that it is present when it is not (analytical specificity).
  • Clinical Validity: The test must accurately detect the disease or condition when it is known to be present (clinical sensitivity) and not indicate that it is present  it when it is not (clinical specificity).

Demonstrate Proof Points Necessary for Widespread Adoption (this is about the intervention)

 Interventions can be medicinal, surgical, or behavioral. Whatever category the intervention falls into, it  must be valid, beneficial, and impactful relative to cost and alternatives.

  • Clinical Utility: Based on the results of the device/test/software, there is an intervention that has been shown to be safe and effective in the test population.
  • Health Economic Model: There is a budget impact, cost effectiveness, or similar model to estimate the relative health and economic benefits of the intervention.
  • Prospective Outcomes Research: How safe and effective is the test and intervention in real people in real time? This can be established with a randomized clinical trial or real-world evidence collection. It is possible to negotiate Risk Sharing Agreements (eg, Coverage with Evidence Development) with forward-thinking payers to obtain conditional payment for this study.
  • Professional Society Guidelines: It is important to have a credible, external, academic medical champion(s) for your health product. Involve this person deeply in all steps described above so that they understand the product and the data to support its adoption into medical professional society guidelines. For liability reasons, most physicians adhere to society guidelines most of the time, so these guidelines are key to acceptance and adoption. A champion who is a research scientist, while he or she may be credible and highly accomplished, is not sufficient;  medical training and scientific training are drastically different and provide very different perspectives on the viability of a health product.
  • Select the Right Market Access and Commercial Strategy: If it is desirable to get a test covered by insurance, that requires a somewhat different path than self pay or institutional pay. However, all paths will require specific evidence presented in the right way to the right channel at the right time. Even for a self-pay strategy, consumers will bring the results of a health product to their healthcare provider. Failing to earn the trust of the healthcare community is a common oversight for health tech companies. It is important to close the loop on the customer experience as they interact with their care providers. 

    The medical community is THE most skeptical audience a marketer can encounter.  Those in this sector are trained to make data-based decisions. Knowing this, there is an art and a science to timely communication with this audience and showcasing data-driven messages using the appropriate media, channels and spokespeople. Healthcare marketers know how to effectively communicate with medical audiences through a sophisticated combination of engaging their internal medical affairs colleagues, KOLs (Key opinion leaders), and medical societies. They are also experts at generating appropriate marketing materials that can sway even the most cynical medical audiences, 

Every health tech company wants widespread adoption for its health product and, as you can see, there is a path to getting there. There is also a community of healthcare experts who would love to help. MDisrupt is the conduit.

The Formula for Widespread Adoption of Health Products that Every Investor and Health Tech Entrepreneur Needs to Know. 6

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.

Every health tech company wants widespread adoption for its health product. There is a community of healthcare experts who would love to help you. Talk to us—we can help.