The Rise of Digital Tools During Covid-19

The Rise of Digital Tools During Covid-19

Contents Introduction

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DRUG APPROVALS AND CLINICAL TRIAL CHANGES FROM PINK SHEET COVID-19 Trial Changes Are “Propulsive Force” For Digital Adoption

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How To Use Digital Technology For EU Drug Approvals

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Decentralized Trials Guidance May Reflect US FDA’s Lessons Learned During COVID-19

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VIRTUAL CLINICS AND DEMAND CHALLENGES FROM IN VIVO Extraordinary Times Call For Exceptional Response From Philips’ Connected Care Chief

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Virtual Clinical Trials Find Bigger Voice As COVID-19 Forces Pharma Rethink

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ResMed Ready To Supply Digital Answers To Health Care’s Demand Challenges

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Four Digital Saviors Of Indian Pharma During COVID-19

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BUSINESS STRATEGY CHANGES FROM SCRIP Pandemic Is Enabling Faster Business Transformation, Says Novartis Digital Leader

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DIGITAL HEALTH FUNDING, REMOTE MONITORING AND VIRTUAL TRIALS FROM MEDTECH INSIGHT Rock Health Reports Record Digital Health Funding Of $5.4Bn In H1 2020, Sees Potential For Record-Year Funding

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BIO Digital: Investment Panel Sees Continued Rising Adoption Of Telehealth, Remote Monitoring

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COVID-19: LifeSignals, VitalConnect Get Green Light For ECG Remote Monitoring

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UK NHS Urged To ‘Bottle COVID-19 Spirit’ For Future Health System Change

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Market Intel: Why Telehealth, Digital Therapies Will Provide Mental Health Support Beyond COVID-19 Crisis

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Emergency Clinical Trial Guidance Offers A Peak At The Future Of Virtual Trials: Expert

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Introduction The unprecedented challenges brought about by the novel coronavirus pandemic have brought into focus the use of digital technologies cross the health care spectrum.

For example, experts predict a long-term impact on clinical trials of drugs and medical technology processes from the COVID-19 outbreak. The practical difficulties of collecting information at specific sites during the mobility restriction of the pandemic have acted as a catalyst for mobile collection technologies. The US Food and Drug Administration has made that point in a formal way in its initial guidance for sponsors on how to address issues raised by the outbreak in the context of clinical trials for other products. That guidance noted numerous times that “alternative methods” may need to be considered for monitoring sites, such as “virtual visits.”

The agency is also working on guidance on decentralized trials. Decentralized trials refer to a decentralization of clinical trials operations in which technology – such as telehealth, computers and digital applications – is used to communicate with study subjects and collect data. In fully decentralized trials, everything is done remotely.

The European Medicines Agency has also produced new guidance for pharmaceutical companies wanting advice on the use of digital technology-based tools in drug development and the preparation of marketing authorization applications.

Digital technologies are increasingly being used in clinical trials, for example in monitoring patients’ clinically relevant parameters, digital remote monitoring of drug intake, and electronic patient signatures on informed consent forms.

Technologies that might be used include sensors (ingestibles and implantables), mobile health tools such as wearables for remote patient monitoring, video consultations with patients, health data analytics and digital record systems.

Digital tools are also coming to the fore in the diagnosis and treatment of patients. Aside from the widely reported boon to telehealth providers, such as Doximity and Teladoc, the impact has also been seen in medtech firms. In companies like Philips, the pandemic has seen strong growth in “connected care,” embracing informatics, monitoring and analytics, population health management, and therapeutics. These technologies enable workflows and informatics data to support telehealth. This allows companies to connect with patients and health care services in different care settings.

And as pharma and medtech companies are hoping to emerge stronger from the global lockdown by using digital tools to accelerate its business transformation. Companies with representatives worldwide who were usually on the road visiting healthcare professionals, but were confined to home for months, have had to come up with innovative digital tools for physician engagement and setting new key performance indicators for sales forces.

This eBook brings you a selection of key articles from our publications, ranging from a broad overview of the field from In Vivo to commercial strategy and R&D analysis from Medtech Insight and Scrip and policy and regulatory considerations from Pink Sheet.

Phil Greenfield Editor In Chief| Medtech Insight Informa Pharma Intelligence

3 / September 2020

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COVID-19 Trial Changes Are “Propulsive Force” For Digital Adoption

BY COLE WERBLE Executive Summary Robert Califf, a former FDA commissioner turned Verily Life Sciences exec, is just one of the voice predicting a long-term impact on clinical trial processes from the COVID-19 outbreak.

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Current and former US Food and Drug Administration officials are expressing broad agreement that COVID-19 will likely be a prod to the wider-ranging acceptance of digital health information from clinical trials.

The practical difficulties of collecting information at specific sites during the mobility restriction of the SARS-CoV2 pandemic are acting as a catalyst for mobile collection technologies. The agency has made that point in a formal way in its initial guidance for sponsors on how to address issues raised by the outbreak in the context of clinical trials for other products. That guidance noted numerous times that “alternative methods” may need to be considered for monitoring sites, such as “virtual visits.” (Also see “US FDA Offers More Advice On MidTrial Changes For Pandemic-Impacted Studies” - Pink Sheet, 30 Mar, 2020.)

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The idea that the COVID-19 pandemic will accelerate the use of digital health in clinical trials also has been expressed by several top agency officials, starting with FDA principal deputy commissioner Amy Abernethy.

“In this landscape of COVID-19 we are talking more and more” about digital health “to support our clinical trials structure and distributed clinicals trials,” Abernethy told a March 24 National Academies teleconference on digital health technologies in drug development. “This is a critical place the story is going.”

Center for Drug Evaluation and Research director Janet Woodcock sees a short-term move to more virtual clinical assessments as inevitable, and predicts a longer term impact. That change will be “a very positive thing in general,” Woodcock said during a recent interview. (Also see “CDER’s Woodcock On COVID-19: Missed User Fees Unlikely, But Some Work Will Be ‘Set Aside’” - Pink Sheet, 31 Mar, 2020.)

And that view has been echoed by former top FDA officials as well. Former commissioner Robert Califf (Verily Life Sciences) began the NASEM meeting by calling the FDA guidance on clinical trials during COVID-19 “a special propulsive force to get moving on digital technologies.”

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Leonard Sacks, from the Office of Medical Policy in the Center for Drug Evaluation & Research, agreed with that sentiment, and told the NASEM teleconference that the ability of digital health to collect data remotely is important to decentralized clinical trials and “very pertinent today to the calamity that we face.”

Califf’s successor at the FDA, Scott Gottlieb, has also agreed that the coronavirus outbreak is likely to bring broader adoption of “de-centralized” clinical trial techniques. ( (Also see “US FDA Outlines Wishlist For Decentralized Clinical Trials” Pink Sheet, 13 Mar, 2020.))

Like so much about the COVID-19 pandemic, the adoption of “virtual” trial models may be a case of preparing after the pandemic with steps that business leaders and policy makers will wish they had adopted before – as many ongoing studies may be hopelessly compromised by the inability to follow the planned study procedures amid the outbreak.

And the need to salvage clinical studies will not be itself resolve all the barriers to broader use of digital technology, including the clash of cultures and terminologies that can inhibit the effort. (Also see “Digital Doublespeak: The Language Barrier When Tech Companies Meet Regulators” - Pink Sheet, 9 Apr, 2020.)

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How To Use Digital Technology For EU Drug Approvals

BY IAN SCHOFIELD Executive Summary Early interaction with the European Medicines Agency is recommended if companies are planning to incorporate digital technologies into their drug development plans.

The European Medicines Agency has produced new guidance for pharmaceutical companies wanting advice on the use of digital technology-based tools in drug development and the preparation of marketing authorization applications (MAAs).

Digital technologies are increasingly being used in clinical trials, for example in monitoring patients’ clinically relevant parameters, digital remote monitoring of drug intake, and electronic patient signatures on informed consent forms.

Technologies that might be used include sensors (ingestibles and implantables), mobile health tools such as wearables for remote patient monitoring, video consultations with patients, health data analytics and digital record systems.

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If such technologies are to be used to support product evaluation, approval and post-approval monitoring, and if they are expected to have an impact on the benefit-risk assessment, it is important to ascertain whether they are “in line with, better, or less reliable” than more established methods of data capture, says the guidance, which is in the form of a Q&A. Companies wanting to seek advice on the use of digital technologies can use the EMA’s qualification (validation) or scientific advice procedures during product development, according to the agency. It says “early contacts” are encouraged to help applicants identify the best way of getting such advice “and to advise on the content of submissions.”

The following are examples of digital health technologies that would fall within the scope of the qualification program: digital endpoints, digital biomarkers, electronic clinical outcome assessments (eCOAs) and digital measures.

Early Dialogue Needed Applicants can request qualification advice at any time during the development of the digital technology, but “the importance of early dialogue is emphasized,” the guidance says. As there is much to learn about digital technologies, an iterative qualification process is “a possible and often desirable option for applicants.”

A submission for qualification “should provide insight into the reliability, accuracy, precision, clinical validity, generalisability and clinical applicability of the methodology to be qualified,” the guidance says. The submission should focus on how the technology will provide clinically meaningful data “and not on requirements how to meet technical specifications.”

In the qualification process the EMA will look at “whether the clinical measure taken with the

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technology is fit for the intended use in regulatory decision making during drug development, whether a clinically meaningful interpretation of the concept of interest is possible, and whether or not the underlying method used is reliable and robust.”

The agency also points out that qualification is not required if the digital technology is used in an exploratory way in early trials – for example in proof of concept studies before pivotal development. The need for qualification “arises once the technology is used to support or collect the main body of data that will be considered pivotal to the assessment of the benefit-risk balance of a new medicine.”

Not all aspects of a digital technology will necessarily fall within the EMA’s remit, and there may be “a degree of overlap between the remits of authorities responsible for different parts of the assessment,” for example a medicinal product versus a medical device.

“From the experience so far, when submitting to EMA it is useful to frame the questions and supportive documentation in the context of medicinal product development and subsequent benefit-risk evaluation, as this increases the likelihood of the question being accepted and of the response being relevant,” the agency remarks.

The EMA also notes that while it has no experience of trials that are exclusively conducted remotely or with digital tools, the situation is “rapidly evolving.” The use of digital technologies to supplement in-clinic visits “could support progressive increase of knowledge and trust in digital technologies, if transparency and a strong dialogue and collaboration between scientists, developers of technology, companies and the regulatory network is maintained,” it declares.

A draft guideline on electronic systems and data

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in clinical trials is under development by the agency’s Good Clinical Practice Inspectors Working Group, which focuses on digital data entry and will consider aspects such as audit trails, system validations and electronic informed consent, it notes.

Take-Home Messages In conclusion, the EMA offers five “take-home” messages that companies should bear in mind when preparing a submission for qualification:

• Be focused and specific. Vague or open questions are likely to receive general answers; the document makes suggestions on how to present the information in a systematic manner.

• Frame the questions in a manner relevant to the stakeholders. Because of the possible overlap between different remits, wording a question from the perspective and remit of a given decision-maker “increases the likelihood of the question being accepted, appropriately addressed, and the assessment being relevant.”

• Start interacting early. This allows the relevant experts to be identified and should result in shorter review times by allowing the EMA to provide input on the content, timing and format of the request.

• Provide a draft best practice. The applicant should provide a guidance for implementation of the technology in clinical trials or explain the key points of the methodology that will be used.

• Identify a clear research question. Issues such as the concept involved and details of how it will be used “should form the backbone of the thinking process behind a qualification submission.”

It should also be made clear whether the technology is an alternative to an existing method or is “intended to measure something intrinsically different.”

Data Protection The agency adds that applicants must note the “utmost importance” of ensuring compliance with EU data protection requirements “in light of the sensitive health data processed by the device to be used in combination with the proposed medicinal product.” It is not within the EMA’s remit to assess such compliance, it adds.

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8 / September 2020

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Decentralized Trials Guidance May Reflect US FDA’s Lessons Learned During COVID-19

BY SUE SUTTER Executive Summary Work on guidance that was originally expected in 2020 continues as the agency and industry learn more about the utility and spectrum of decentralized trials as a result of the novel coronavirus pandemic.

The US Food and Drug Administration’s forthcoming guidance on decentralized clinical trials is likely to reflect some of the lessons learned from use of technology to remotely collect clinical data during the COVID-19 pandemic.

Decentralization as an operational approach in clinical research is “here to stay,” Isaac Rodriguez-Chavez, an FDA officer for clinical research methodology, regulatory compliance and medical policy development, said during a panel decision at the Biotechnology Innovation Organization’s recent virtual annual meeting.

“This is the new way, if you will, of collecting clinical data, adding convenience to participants, maintaining safety” and ensuring data quality and integrity, he said.

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Decentralized trials have been “pushed ... to the maximum” during the public health emergency, Patrizia Cavazzoni, acting director of the Center for Drug Evaluation and Research, said during the recent Drug Information Association annual meeting. (Also see “COVID-19 And IP: Companies Are ‘Taking A Chance’ Sharing Clinical Trial Details” - Pink Sheet, 23 Jun, 2020.)

Decentralized Vs. Virtual The FDA had targeted 2020 for release of a guidance on decentralized trials. (Also see “Decentralized Clinical Trials Among Topics Slated For CDER Guidance In 2020” - Pink Sheet, 2 Feb, 2020.) However, much of the agency’s non-COVID guidance development has been pushed to the side while the agency works to address the public health emergency resulting from the novel coronavirus. (Also see “Back To Normal? US FDA Schedules In-Person Meeting But Pauses NonCOVID Guidance Development” - Pink Sheet, 13 May, 2020.)

The forthcoming guidance is expected to outline factors that companies should consider when weighing a decentralized trial approach. (Also see “US FDA Outlines Wishlist For Decentralized Clinical Trials” - Pink Sheet, 13 Mar, 2020.)

Rodriguez-Chavez said the agency remains engaged in the topic of decentralized trials and is committed to completing the guidance.

He also explained what the FDA means when it talks about “decentralized trials,” drawing a clear distinction from “virtual trials.”

Decentralized trials refer to a decentralization of clinical trials operations in which technology – such as telehealth, computers and digital applications – is used to communicate with study subjects and collect data, Rodriguez-Chavez said.

In fully decentralized trials, everything is done remotely.

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In contrast, virtual trials are in silico or computer modeling trials that occur during the preclinical phase, he said. Virtual trials do not use real people but, rather, model subjects to assess drug efficacy and the safety at the preclinical level.

“I guess the confusion between the two terms is because in both cases there is use of technology, but the application of the technology for each of these two cases is completely different,” Rodriguez-Chavez said.

Hybrid decentralized trials include elements of both traditional and decentralized trials.

Rodriguez-Chavez described decentralized trials as a patient-centric approach.

“At the end of the day, the biggest advantage of decentralized trials really is added convenience to the participants and being less disruptive … in comparison with, for example, the traditional trial,” he said. “Many of the participants on clinical trials … they have to travel an average of one to two hours to the clinical site. … Convenience to participants is a very important element and that is enabled because of the use of technologies.”

During a separate session of the BIO meeting, Laure Halloran, CEO and president of the Halloran Consulting Group, said COVID is forcing sponsors to follow in the footsteps of orphan drug developers, who long ago learned they need to smooth the path to clinical trial participation for rare disease patients.

“What happened in the weeks after COVID started is going to transform how products should be developed in the clinical phase of development,” Halloran said. “What COVID has done is it’s made people who were really resistant to doing anything where technology was a support and a facilitator have to think differently.”

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“There are so many opportunities to take those lessons and make the patients’ world way easier by employing telemedicine and getting rid of some of the really strict, ‘the doctor must see the patient for the six-minute walk test’ mandates, and think about making it more patient-centric in a bigger patient population,” she said. “The technology’s there, it does not have to be so hard.”

Doing Things Differently, With The FDA’s Blessing The FDA, industry and other stakeholders collectively are learning more about the utility and spectrum of decentralized trials as a result of COVID. Travel restrictions, quarantines and social distancing measures have required sponsors and investigators to come up with new ways of collecting patient data when study participants cannot physically visit a study site. Similarly, they have had to develop plans for delivery of study drugs directly to patients, or to alternate locations, when they cannot visit a clinical site in person.

Through a series of “immediately in effect” guidance updates, the agency has provided a steady stream of advice on how sponsors and investigators can mitigate the impacts of the COVID pandemic on clinical trials. The guidance has addressed a host of issues, including virtual visits with investigators and factors to consider when switching from in-person to remote collection of clinical outcome assessment data.

(Also see “Patient-Reported Data In COVIDImpacted Trials: US FDA Cautions Against Missing Data, Potential Bias” - Pink Sheet, 7 Jun, 2020.)

The FDA’s guidance has been built around several key themes, including prioritizing patient safety, minimizing risks to trial integrity, and documenting of reasons for any protocol changes and deviations. (Also see “Clinical Trial Sponsors Should Consider Changing Data Collection Amid

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COVID-19, US FDA Says” - Pink Sheet, 18 Mar, 2020.)

Clinical trial conduct and oversight seems likely to be one of the key areas where adjustments in the FDA’s regulatory approach necessitated

by COVID may outlast the pandemic. (Also see “BIO 2020 Notebook: FDA’s Hahn On COVID-19 Lessons To Be Learned; NIH’s Fauci On Health Care Disparities; Pfizer’s Young On Forgoing Gov’t Vaccine Funds” - Pink Sheet, 11 Jun, 2020.)

Learning About What Works, And What Doesn’t The COVID pandemic has “been the moment of digital health,” Wade Ackerman, a partner in the Los Angeles office of Covington and Burling, told the BIO meeting.

“Because of a public health crisis we have been as a health care system and as a society sort of pushed to adopt technologies in ways that would have been much more of a step-wise approach” otherwise, he said.

“I think we’re absolutely going to see uptake of some of these things,” Ackerman said. “I think we’re also going to see where it’s not working.”

“We’re also going to learn lessons where maybe it’s not the right place to invest. I think the promise of decentralized trials … the access, the patient-centricity of them, the fact that we can have new and better sources of data, all of that promise is there,” but “just because we’re introducing technology does not always mean things are better.”

For example, limiting data collection to use of a smart phone could exclude study participants who lack access to such technology, Ackerman said, also noting that some people are not going to be comfortable with devices that actively monitor their health.

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Rodriguez-Chavez emphasized the need for verification and validation studies to ensure a digital technology reliably can be used within the specific context of use of the disease, the drug being studied and the study population.

Valerie Paradiz, vice president of services and supports at Autism Speaks, said sponsors considering a decentralized trial approach should “ensure that every step along the way you’re getting patient input.”

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The need for study participants to be proficient in using the study technology is particularly important for retaining participants and gathering the best quality data, she said.

“In my world, the world of autism, you do need to help us know why and how to do it,” Paradiz said.

“And often that can’t just be relayed verbally or in writing. It needs to be supported with images and other kinds of forms of education.”

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Extraordinary Times Call For Exceptional Response From Philips’ Connected Care Chief

BY ASHLEY YEO Executive Summary Roy Jakobs was appointed internally to head connected care at Philips on 28 January, shortly before COVID-19 forced the first of many lockdowns around the world. The disruption prompted a rapid rethink of priorities, which has shown opportunities for lasting health care system change.

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The best-laid plans earn individuals no plaudits when they go wrong, rather it is how well they manage through unexpected events (and even crises) that make the foundations on which future success is built.

Roy Jakobs was head of Royal Philips NV personal health businesses when last autumn he accepted group CEO Frans van Houten’s offer to transfer to the same role at the €4.7bn ($5.3bn) connected care division. It meant Jakobs was moving to the beating heart of outcomes-based, global health care delivery transformation.

Philips’s connected care remit embraces predictive analytics, continuous monitoring, as well as remote and community-based care.

These elements are the future – and increasingly the present – of highquality health care for an ever larger and more demanding patient

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population that now expects consumer-type experiences. Jakobs, 46, seized the opportunity.

Enter COVID-19, circulating quietly but ever more widely in early 2020 from its initial China outbreak center. The full gravity of the SARS-CoV-2 virus were not accepted globally until the city of Wuhan locked down on 23 January. When, five days later, Jakobs started his new role as executive VP and chief business leader of connected care, he was already facing up to the reality that his early weeks would be very different to what he had imagined.

“It’s been quite an introduction,” said Jakobs. The need to rapidly go into firefighting mode gave him a deep understanding of how to work through a crisis and the challenges it presents for health care systems, he said. “For Philips, it showed us how to ramp up and rally all the resources need to respond in an appropriate way.”

While his early plans for the divisions have mostly gone back on the shelf, the journey has not been without excitement, he said. From Jakobs’ angle, the medtech industry and providers were seeing the threat posed by the rapid coronavirus spread through the same lens. “We were having the same challenges, the first of which was how to deal with enormous volumes patients with a new disease, and specifically the need to diagnose, monitor and treat them in the appropriate manner.”

Coping with the extraordinary challenge called for Philips to engage a “triple duty of care.” That meant it was able to look after patients’ needs and those of the hospital systems, safeguard its own staff and continue operations during COVID-19, and protect its business against potential volatility in the economy. It called for an exceptional response to deal with the huge task at hand. “You need extraordinary means to deal with such a challenge,” said Jakobs.

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An Overdue Spotlight On Connected Care Within the connected care portfolio, two elements stood out more than others as tools to control COVID-19. One was Philips’ monitoring capabilities, given that some patients are prone to deteriorating very fast and need to be connected to monitors quickly. The other was patient ventilation, a technology area where Philips sits among the global leaders.

The aftercare needed to improve patients’ outcomes was also critical, as patients often took weeks or more to recover from COVID-19. This was much longer than Philips or the clinicians had initially anticipated, said Jakobs.

Hospitals had to double or even triple ICU capacity, putting huge pressures on the system in terms of the need for nurses, doctors and equipment. And all this while respecting the personal distancing measures recommended by governments to forestall further spread of the disease. It was becoming very clear, very fast, that hospitals needed to accelerate new methods of handling these risks.

“The urgent needs among hospitals include scalability, and how to monitor patient-flow closely over a long period of time. But monitoring is also needed at the patient’s home, where the first signs might be seen,” Jakobs said. Philips can develop the individual support solutions, “but more importantly, we can connect them, and that’s where the hard- and software come together to produce the dataflow from the patient. This is where workflow solutions show their value,” Jakobs said.

Connected care includes monitoring using different care systems, making systems interoperable and using the cloud to make data flow fast. Crucially, patients need to be able to trust that their care is being delivered in the right way. In this sense, COVID-19 has

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effectively showcased what certain technologies can do. “It has presented opportunities to many health systems that have started to realize that connected care is no longer an option,” said Jakobs, observing that crises can drive necessity.

COVID-19 hastened certain realizations about the value of connected care solutions. Where providers had been stalling over new technology adoption and system transformation, they suddenly became more decisive; there was a change in behaviors. “That was a very favorable development, and from the doctors’ and nurses’ perspective, it opened up new ways of diagnosing, monitoring and treating,” Jakobs noted.

In the US, pathologists dealing with the COVID-19 emergency were able to work from home after the US FDA granted a temporary waiver for the use of consumer monitors with Philips’ IntelliSite Pathology Solution. In New York, which was an initial hub of US infections, additional screens were installed in hospitals, enabling pathologists to access digital images of patient tissue remotely.

With the compelling impetus of the virus, telehealth and remote patient monitoring have suddenly come into their own in a very big way.

Teleconsulting was fully recognized for its value in allowing coronavirus patients to receive health care without going to hospital. Patients could use video-assisted modules and surveys, and also sensor-based monitoring for when they entered or left the hospital. In the Netherlands, hospitals and GPs have been able to remotely to screen and monitor patients with COVID-19, based on Philips’ Patient Reported Outcomes Management solution.

COVID-19 Hub Spurs Different Approaches Seeing very quickly that this was a learning environment, Philips set up a COVID-19 Hub as a forum to exchange ideas with industrial partners, governments and clinician experts and to suggest

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new solutions. “I loved seeing the spur given to innovation during the crisis, using what we have already or doing different things,” Jakobs said.

Depending on the region, the coronavirus firstwave peak has largely passed, but SARS-CoV-2 remains the focus of a very vibrant discussion.

Coronavirus is expected to be around for a considerable period, and health systems are still working on the structural consequences of what is a very new disease to the world, said the Philips executive. He said, “We have gone through a big first wave and are seeing the need for structural change for the health system, ahead of a second wave or indeed another pandemic.”

On the positive side, Philips has demonstrated to itself and others that it can scale-up rapidly when needed. That capability – physical and digital – is “here to stay,” said Jakobs. Every player in the health care ecosystem has had to recognize their constraints during this COVID-19 crisis, he said.

But many players have also seen how they can break through traditional boundaries in being able to, say, increase monitor numbers or nurses multi-fold in mere days or weeks.

Philips, for instance, developed a new ventilator, the E30, in four weeks (“a record time”) and it was brought to the market in six weeks. It was an “extraordinary effort” that resulted in the noninvasive and invasive ventilator receiving a US FDA emergency use authorization on 8 April,” said Jakobs. The group planned to produce 15,000 units per week, alongside 4,000 Trilogy and Respironics V60 ventilators per week. It is partnering in this effort with US-listed manufacturing and design partners Flex Ltd and Jabil Healthcare in a bid to expand its assembly lines and strengthen its supply chain. (Also see “Flex Health Outsources To A Medtech Industry In Flux” - In Vivo, 15 Feb, 2017.) “We are talking weeks to develop medical technology where normally, it takes a year or even years,” said Jakobs.

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COVID-19 also called for new ways to maintain support and installations for hospitals. IT installations normally take months to complete, but by adjusting its methods and approach, Philips has been able to install configured solutions in just weeks. Hospitals prefer this in the current environment, where there is a drive to have as few people on site as possible.

“These are the eye openers that we can really build on and learn how to sustain,” said Jakobs.

Going forward, “we want to be able to retain some of the agility we have seen happening at our end and at the customer/hospital end.” One thing is certain: “COVID has been an interesting time for facing new realities.”

Offerings Into The COVID 11 Crisis It is not just Philips’ connected care unit that has played role during the COVID-19 crisis. Other parts of the group have provided diagnostic imaging and services, mobile diagnostic X-ray and mobile ultrasound systems. In fact diagnostic imaging and connected care have both been leveraged significantly.

On the downside, COVID-19 has meant subdued image guided therapy business, as elective procedure volume have been reduced heavily.

In addition, Philips’ sleep business has not been a priority sector, and the group’s consumer business came to a virtual standstill. “Parts of the portfolio have been impacted, but connected care was in the right place to provide the support where it was needed.”

The elective care side now needs to begin managing its way back to more normal business routines. But COVID-19 has seen social distancing become an ingrained behavior for many, who still view hospitals as high-risk locations. Hospitals are aware of this perception among patients, and

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have reacted by engaging with them before they arrive at the hospital, using telehealth surveys or other forms of dialogue.

This new style of approach does not apply only to COVID-19 patients, but can be extended to cardiac patients, for instance, who, after intervention, are discharged with biosensors provided by Philips that can monitor them at home over a prolonged time and keep delivering relevant data and signals back to the provider.

Global Allocation Of Pandemic Support To ensure its service and solutions reached those areas of the global market where the need was greatest, Philips established its own fair and ethical allocation rules, guided by the WHO Coronavirus Disease (COVID-19) Dashboard.

The “red zones” were given priority, in shipping volume terms. Then, the decision-making became more granular, based on ratios like the number of patients to ICU beds, to gauge the risk of mortality in a given market.

A major pinch-point arrived when both the US and Europe were impacted heavily by the virus during March and April. “That was a difficult time,” said Jakobs, adding that Philips is ramping up further even now. “Across the whole industry we could not cope, and we are still dealing with the demand.” In the first quarter of 2020, Philips spent €100m to ramp up production volumes, in collaboration with suppliers and partners.

Some of the COVID-19 applications will find wider applications in routine health care. Technologies and techniques such as telehealth, remote monitoring, wearables, better use of data flows, and much earlier engagement with patients will gradually become more common. This is partly because consumers and patients have changed.

They realize that no longer do they always need to

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go to a hospital to get good treatment. Neither do they always need face to face consultations, as a lot of care can be done in a virtual way.

The silver lining of the coronavirus is that, for health care systems, certain preconceived ideas about delivery system change have been blown

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away. Attitudes to care have changed, and boundaries that have been in place for a long time have been removed. An unexpected and deeply disruptive global public health episode, ironically, has created the opportunity for new health care behaviors.

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Virtual Clinical Trials Find Bigger Voice As COVID-19 Forces Pharma Rethink

BY ASHLEY YEO Executive Summary The use of virtual, realtime and at-home testing to provide clinical trials data has been steadily gaining the interest of the health care industry. COVID-19 has put this opportunity into sharper focus, says CNS trials technology developer Cambridge Cognition, which is now adding a voice option to its portfolio.

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The adjustments to normal life and business practices brought about

by COVID-19 have reached into every niche, the effects in some areas being more immediately obvious than in others. The consequences are potentially far-reaching for developers of modern health care solutions.

With the closing-off of some activities in the inpatient sector and the refocusing of hospital activity firmly on COVID-19 control measures, routine work on clinical trials has either halted or become severely restricted.

And just as the true value and potential of telehealth and remote patient care to assuring safe and high quality care has been demonstrated during the pandemic, so virtual clinical trials are getting a showcase that was unanticipated Ěś but is proving to be highly useful.

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UK-based Cambridge Cognition Holdings plc, a developer and marketer of digital solutions to assess brain health, is one of the few players active in the specialist field of virtual clinical trials for central nervous system (CNS) patients. CEO Dr Matthew Stork says this part of the health care industry is going through interesting times.

Attention paid by the clinical trials world to virtual, real-time and at-home testing and treatment has been slowly increasing over the past few years.

But in recent months, the benefits they offer have been put into sharp focus by COVID-19. “There are more conversations around experimental clinical trials, and more players doing them,” Stork said.

In the past, drug sponsors would have assessed their products in the clinic, but with some hospital activities having been shut off during COVID-19, many traditional clinical trials were postponed.

Access for vulnerable patients has also been reduced. Unable to test their drugs, major pharma companies and biotechs alike faced up to either stopping their R&D or embracing contingency plans that involve virtual trials.

Companies trying out virtual studies are experiencing the benefits of improved data flow from virtual clinical trials and a richer knowledge for therapy development. While clinic-based trials can produce data at regular intervals, that does not happen multiple times a day. However, CNS disorders can have fluctuations in the disease state over a single day and on different days, Stork noted. “By continuously monitoring the treatment over time, you can track the disease and see the impact of that treatment,” he said.

Wearable passive sensor technology was one of the drivers of digital virtual clinical trials, said Stork. Cambridge Cognition’s work in this area received much impetus after it worked on a project with Takeda Pharmaceutical Co. Ltd. in 2017 using the Apple Watch to develop app-based

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cognitive assessments. Cambridge Cognition was a joint venture partner on that project.

The company’s work in this area has flourished since, and it has developed a suite of modules collecting a variety of data from patients at home or remotely. Medication reminders and at-home patient diaries are among the separate modules available. “We do the modules well,” said Stork, “but they are not unique; the unique part for us is collecting data that is meaningful and correlating it with another data set that is well known.”

A Voice System Applied To Clinical Trials Cambridge Cognition’s ongoing R&D on systems to measure clinical requirements has led it to develop a related program: a voice-based solution that collects data using voice, either via an app, or via a technique that makes a mobile phone give a reminder ring or a call to speak to the individual patient at certain times of the day.

“It’s an R&D program that has progressed to the point where it is already being used by a few big pharma companies to collect data in trials,” Stork said. These methodological trials are showing that the technology works in a clinical environment. So far, data has been collected from 2,800 people, both healthy volunteers and patients with CNS disorders.

The voice information is collected, patients are asked additional questions and the results are parsed. They run it through a cognitive neural network – an AI or machine learning tool that can assess for different levels of cognitive load. Stork explained, “We are looking at whether there are biomarkers for any particular disease state at present, and using the solutions in clinical trials through the voice app.”

Cambridge Cognition is at pre-production stage with the technology. It has a prototype that

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works but is not ready to use it in virtual trials yet. It expects that some virtual trials in the future would be a mixture of touch- and voicebased interactive elements. Stork added that the technology’s multiple speech recognition engines and predictive expectations of what people should typically say and their pattern of speech in a healthy state would give it a very high accuracy.

The project has been running for two to three years, but still needs the necessary validation by regulators. But Cambridge Cognition sees a substantial market opportunity in the future.

While several companies and universities are active in voice-based solutions, only one other company and one university are directly in the field of assessing cognition and working in clinical trials.

in CNS disorders in the world,” he said. The company is “nicely on track” for that, with its four products: CANTAB assessments for cognition; the eCOA platform; digital health solutions for measuring cognition on a day-to-day basis; and now NeuroVocalix, for voice-based cognitive assessments.

The company boasts a 100% satisfaction record with customers using its products. Collecting patient data from clinical trials was expensive and binary, said Stork. “We have a great track record, and get a lot of repeat customers, and old customers coming to us from their new companies.”

Its expertise in CNS disorders was a key differentiator for Cambridge Cognition, said Stork.

Another difference is its focus on providing advice, service and consultancy on how to measure cognition, rather than running trials with staff at hospital sites. Of a staff of 60, 15 have a Ph.D. “That’s a lot of people with secondary degrees,” said Stork.

Recent wins include two contracts worth a combined £1m ($1.23m) from companies wishing to shift from the traditional model of in-clinic assessments to technology-driven solutions that support testing subjects remotely. The first is for an entirely virtual trial designed to gain better understanding of the disease-burden for patients. Patients will complete electronic diaries on an Apple Watch and iPhone, and wear passive sensors to monitor electrodermal activity and heart rate.

The company uses its expertise to run seminars on a variety of clinical conditions. CSO Jenny Barnett, with Cambridge Cognition since 2008, is a frequent panel member at major conferences.

Barnett led the R&D for Cambridge Cognition’s iPad-based medical device, CANTAB Mobile, which is used to test for the first signs of Alzheimer’s disease.

The second is a Phase II study investigating the cognitive impact of a new drug for a neurodegenerative disorder. Patients’ experiences regarding motion and sleep will be collected remotely, mainly virtually, from smartphones, in order to enable high-frequency testing. The data will show natural daily variations and week-byweek disease progression.

A Digitally-Focused Ambition Its combination of skills and expertise has elevated Cambridge Cognition to what Stork believes is the foremost company working in cognitive assessment in the world. “We want to continue that, and become the most digitally focused clinical trials company specializing

More Than Software Cambridge Cognition has validated, precise and reliable research software providing sensitive digital measures of cognitive function for all areas of brain research. “But we’re not just a technology company with nice software,” said Stork, pointing to its 20 years’ experience of clinical trials data

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and 280 clinical trials conducted. At any point in time, the company is running 50 trials to support patient state and disease progression research.

Some 800 universities use CANTAB on a regular basis.

Although based in the UK, Cambridge Cognition only does around 10% of its business there. The balance shifts, but most of its revenue is earned in the EU and US. Its mainstream systems are available in 47 languages, as medtech and pharma companies need to test products anywhere in world. A recent trial was started in Iceland, in Icelandic.

The coming two to five years will be focused on growing core businesses in two markets: the $1bn electronic clinical outcomes assessments market; and the digital health market for CNS. In the eCOA market, 15% of clinical trials are in the area of CNS, which is a £150m that is growing at 20% a year. “There is a lot of growth in the market, with eCOA and digital and then voice,” Stork noted.

Cambridge Cognition has had very good orders inflow this year, said the CEO. Year-on-year order intake in the first quarter of 2020 was up by 23%, and in the first half, four orders of over £500,000 each helped to increase order intake during the period by 88% to £4.9m, the company announced on 30 June. Contracted orders at that date were worth £7.5m.

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Some of the growth is COVID-19 related, and while the fervent hope all round is that a second wave does not take hold later in the year, the digital approach to clinical trials has proven itself to be a valid alternative that should become more mainstream.

COVID-19 And Changed Attitudes To Technology COVID-19 has changed attitudes to technology and in some cases moved customers away from their traditional comfort zones and towards digital tools. So after the pandemic started, Cambridge Cognition was able shift its focus to enable customers to continue their clinical trials as much as possible. Several switched to web-based testing, and there was a lot of interest in placing orders to run full virtual clinical trials.

As the pandemic winds out, clinical trials and assessments in clinics are starting up again now. The end of June and Q3 2020 are shaping up as the “restart.” However, in the search for immediate solutions, and to reduce the chances of similar delays in the future, pharmaceutical companies are showing greater interest in moving to virtual trials, said Stork. One legacy of COVID-19 is that even after the crisis has eased, the value of the virtual route for clinical trials has become more understood as a business option.

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ResMed Ready To Supply Digital Answers To Health Care’s Demand Challenges

BY ASHLEY YEO Executive Summary ResMed’s respiratory device portfolio has put it front and center of the global medtech industry’s efforts to bring COVID-19 under control. UK and Ireland country manager Antoine Valterio tells In Vivo how the company rose to the challenge, and how providers are now seeing digital technologies in a new light.

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Now that peak COVID-19 infection rates have been reached and passed in many countries, governments and health care systems are turning their attention towards managing a sustainable recovery.

Returning secondary care to its pre-crisis activity levels and broad mix of services has become a new priority.

But among the lessons for providers learned during the pandemic, a major one is that digital health care must be central in future challenges of these proportions – and increasingly in routine health care too. Bricks-and-mortar health care and its scarce resources are insufficiently equipped to meet COVID-19-type demand peaks, nor fast-rising “peace-time” health care needs.

Digital technologies have come into their own in recent months, as the experiences of ResMed Inc., a digital health care company active in sleep and respiratory care devices, show. The company’s respiratory

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care portfolio of ventilators, masks and consumables for chronic lung disease patients immediately put it on the front line of COVID-19 control.

The company rose to the challenge, Antoine Valterio, ResMed country manager for the UK and Ireland, said in an interview. “Early in the crisis, we saw in Wuhan that ventilators were in huge demand for treating patients in hospitals,” said Valterio. The company then focused its resources on building as many ventilators it could and getting them out to patients globally.

“In the January to March period, which was the peak of demand, we built 52,000 ventilators – three times what we did a year ago,” he said. The rise was from across the board, in all types of ventilators: noninvasive and invasive models with masks or with tracheostomy tubes, for intubations in the ICU. ResMed’s respiratory division increased its mask production 10-fold during the same period.

It did this while continuing to support its sleep business. The San Diego based group is the global market leader in the production and marketing of CPAP devices and bilevel devices and their masks, and consumables that are used in obstructive sleep apnea (OSA). Up to a billion people may suffer from OSA, according to a January 2020 report in The Lancet.

ResMed has a third division, Software as a Service (SaaS), which is mainly US-focused. This division is growing, with the 2016 acquisitions of SaaS specialists Bright Tree and MatrixCare helping to laying a firmer base on which ResMed will develop its out-of-hospital software services. This makes joined-up care – and moving care from one setting to another – attainable goals.

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Care At Home Will Boost 250 Million Lives Globally Offering more care at home was a major step in bringing all parts of health care together, said Valterio. This capability was a major component to get ResMed to its aim of “reaching 250 million lives globally by 2025,” he said. (Also see “Exec Chat: ResMed’s CEO Mick Farrell Outlines 2025 Strategy For 250 Million Users” - Medtech Insight, 10 Sep, 2019.) The 2018 purchase of US group Propeller Health similarly fits the ResMed philosophy of connecting medical devices and turning the data into actionable information for clinicians. (Also see “Aptar’s Focus On Digital Connectivity Presents New Drug Delivery Opportunities” - In Vivo, 18 Sep, 2018.)

It was widely observed that during the pandemic that patients with non-COVID-19 health care issues were avoiding going to the hospital.

In ResMed’s case, ventilation patients with neuromuscular or COPD issues use their ventilators at home but go to the hospital for check-ups. The fear of infection with coronavirus prevented this for some patients.

As a solution, ResMed accelerated development of its airView app for this category of patients.

The airView telemetry and ecosystem was already available and working well for monitoring sleep patients remotely, said Valterio. “We had been working on a version for ventilated patients, and when we realized what was happening with COVID-19, we brought forward the release of that software to customers by many months.”

Valterio described this as example ResMed’s soft- and hardware efforts coming together to meet the acute needs of the UK National Health Service (NHS) and the European health care provider community. “Clients were able to set up

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virtual clinics, and patients said they appreciated the innovative way in which they could get care without leaving their homes,” he said. airView enables clinicians to log on and monitor patients remotely. They can then trouble-shoot and anticipate potential issues. The technology showed its value in the pandemic, said Valterio.

ResMed also operates the myAir app for sleep patients who are seeking improved outcomes.

Its smart algorithms can provide training and coaching to patients, who can troubleshoot for themselves and seek therapy if needed.

Shift To Digital Tech Valterio sees this as further proof of health care systems’ embracing of digital technologies that deliver better outcomes and maximize the delivery of care in times of scarce health care resources. “COVID-19 effectively accelerated our strategy,” he said. “We saw a shift during the pandemic to digital tools and accelerated the deployment of our software solutions,” by the NHS during the pandemic, he added.

But the benefits of these COVID-19 responses are being carried over into the post-recovery stage for providers. ResMed customers are setting up their own remote pathways using digital health tech to ensure they get back up to pre-COVID-19 levels of service as quickly as possible during the ongoing era of social distancing.

The NHS Long Term Plan also stresses the need for digitization of health care services. Valterio agreed: “Digital health is here to stay, and looking beyond the mid-term recovery, it will continue to provide care to millions of people in the UK and Ireland.” (Also see “The New Culture Club: UK NHS Goes Upstream For Care Delivery And Offers New Chances For Medtechs “ - Medtech Insight, 8 Apr, 2019.)

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Adding To NHS Capacity ResMed has focused on a range of data-enabled, connected care services, allowing it on behalf of the NHS to send devices to patients in their homes, help them operate them remotely, upload the data to the cloud, score it, and use it to make an informed decision about, say, whether a patient has OSA. “By offering that service, we add to the NHS’s capacity to serve patients.”

The company also offers remote CPAP set ups, and replenishment of masks in the home, etc. “If a patient needs a mask, the hospital refers the patient to us and we can dispatch it to their home without the patient leaving home. This model will continue to flourish during this recovery phase,” said Valterio.

Data privacy is an ever-present issue for device companies. But the ResMed country manager has noticed something of a shift in this context. The company (compliant with all relevant legislation, including the EU’s GDPR – General Data Protection Regulation) has seen increasing adoption by the NHS of data-driven software, giving it more flexibility in the use of data that creates clear patient benefits. “We’ve seen that data can be put to good use for patients, but also by the NHS, who can operate their services more effectively,” Valterio said. This should lead to greater acceptance of the use of data.

This change could be an important turning point as the UK passes its COVID-19 peak and slowly returns to a new normal. It could also help the NHS as it recovers from the pandemic and starts to reopen other services. ResMed sees a strong role for itself in helping the provider get back up to speed.

ResMed in the UK established a direct relationship with the UK Department of Health and Social

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Care during the pandemic and contributed to the national response plan. This was not just in the provision of products, but in terms of training materials for the NHS. It also played a role in the COVID-19 strategy and planning of the Association of British HealthTech Industries (ABHI), which offered a consolidated approach for all industry players and as such was a “great ally,” said Valterio. ResMed applauded the efforts of the Ventilator Challenge UK (a cross industries initiative launched early in the pandemic to increase the availability of respiratory support devices in the NHS), while its own drive was to increase capacity to meet the demands of governments around the world.

“We want to the benefits accrued by digital health during this crisis to be institutionalized in the NHS.” – Antoine Valterio The changing needs in terms of ventilator types under the pandemic was monitored by ResMed’s medical team, gathering scientific and clinical

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evidence. COVID-19 continues to be a very dynamic environment. Valerio said the group’s COVID-microsite, offering videos and technical information, had drawn from a variety of sources that could be shared by HCPs in the pursuit of best practice.

ResMed has leaned heavily on its respiratory division in discharging its duty to protect lives during the pandemic. Ventilators were the clear priority, but not at the expense of ResMed’s sleep patients. Valterio said, proudly, that ResMed remained able to oversee multiple priorities in recent months despite being understandably distracted by COVID-19 “We now want to actively support the NHS getting back on its feet as quickly as possible by using digitally enabled services to help it during the recovery,” he said. “We also want to make sure that all the benefits accrued by digital health during this crisis are institutionalized in the NHS, so that it can continue to flourish in the future.”

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Four Digital Saviors Of Indian Pharma During COVID-19

BY VIBHA RAVI Executive Summary From digital marketing to payment systems, electronic solutions are aiding Indian pharma to ensure business continuity during the lockdown.

New guidelines are spurring the adoption of telemedicine. Digital tools are connecting companies to their distribution chains and health care professionals. While some changes are here to stay, others might not stick.

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As private clinics shut down across India, patients could not get to health care facilities due to strict restrictions on movements and hospitals were hit by a government-mandated cessation of elective procedures as well as incidences of COVID-19 among staff. The pharmaceutical industry has witnessed an unprecedented crisis during the pandemic-led lock-down in the country.

Acute and sub-chronic segments saw a sharp dip in sales while the chronic segment also suffered. A report on the impact of COVID-19 on the practice of health care professionals (HCPs) by Cognitrex Consultants and SIHMRACI Educations Pvt. Ltd. showed gynecologists saw a 40% decline in their patient base, while plastic surgeons saw a 90% fall.

An initial assessment by IQVIA estimates that growth in the Indian pharmaceutical market could slide to 1-5% in 2020 from earlier

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predictions of over 10%, against the backdrop of the demand and supply disturbances. (Also see “COVID-19 Disruptions Could Lead To Sharp Slowdown In India Pharma Market” - Scrip, 8 May, 2020.)

haven’t and so have been unable to quickly pivot to them at a time when physical visits by their medical representatives (MRs) are not possible given the lock-down.

Hit by the business disruptions, Indian pharmaceutical companies are now more willing to adopt and invest in digital solutions that will allow them to continue operating during such crises than they were in the pre-pandemic era.

The initial assessment by IQVIA revealed that while 77% of HCPs believe it is important to maintain contact with pharma companies during the COVID 19 phase, only 64% of them were contacted by these companies. The data would have changed since, nevertheless it reveals gaps in digital marketing strategies.

While cloud-based services and data helped continuation of clinical trials, and use of medtech like remote monitoring devices in a health care setup ensured that risk to lives of the medical community minimized, the focus in this article is on the use of digital enablers aiding pharma firms’ sales during the pandemic. (Also see “Coronavirus Pandemic Accelerating Shift To Digitally-Enabled Innovation” - HBW Insight, 2 Jun, 2020.)

Most companies are using simpler tools like text and WhatsApp messages as well as emails to communicate directly with HCPs while webinars are being organized to provide HCPs with updates in their fields of specialization along with information on the relevant products of the sponsor.

Digital modes of communication between a company and its distribution chain, its field force and HCPs, and HCPs and patients, have helped.

While some of the tools or practices might be here to stay, others are unlikely to entirely stick after conditions return to normal, say experts.

In Vivo delves into four such solutions that have helped the industry maintain business continuity.

Digital Marketing Unlike certain developed markets, companies in India depend to a significant extent on prescriptions by HCPs, given that there are multiple companies selling a generic drug. The traditional reliance on HCPs has resulted in a model which leverages a large sales/field force to drive sales.

While some companies have invested substantially in digital marketing tools, others

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“A vast majority of pharma still believes that the crisis is short-lived, and life will go back to normal very soon. Hence, they are not yet convinced about digital transformation which is capital intensive in companies that do not have that infrastructure. Companies that do, are also still making half-baked attempts at engaging customers online with the belief that their sales forces will return to the market soon enough,” said Salil Kallianpur, a former executive vicepresident at GlaxoSmithKline PLC in India who now runs a digital health consultancy. (Also see “COVID-19 and What Doctors Expect From Pharma In India” - Scrip, 1 Jun, 2020.)

“Companies are taking a multichannel rather than single channel approach during this time.

However, in a country like India where labor costs are economical, companies have always maintained a substantial field force and this is unlikely to change in the near future despite the current challenges,” said Anup Soans, a former

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industry professional who is currently a digital media enthusiast and author of multiple books.

“Information has always been available to HCPs, whether it’s via a website or product brochures, however access and attention have been deficient,” he observed.

Dr Vivek Shetty, joint replacement surgeon and consultant orthopedic at P D Hinduja National Hospital in Mumbai, said that a few companies like Zydus group’s Cadila Healthcare Ltd. have sponsored webinars and it came to a point where two to three were being organized every day, but he feels that this strategy has run its course as fatigue for the medium has set in.

Digital modes of marketing are more likely to find favor among the newer generation of HCPs while the older generation might find it difficult to adapt, experts say.

Online Pharmacies And Consulting Platforms Online pharmacies like Netmeds, 1 mg, Medlife and PharmEasy offer customers the convenience of door-step delivery. Along with deep discounts, delivery has been a draw for customers who worry about exposure to COVID-19 during a physical trip to the chemist.

Medlife serves customers in 29 states and 4,000 cities fulfilling over 25,000 deliveries daily. CEO Ananth Narayanan recently told local media that the online pharmacy is looking to hire delivery staff as there has been an up to 200% upsurge in the number of orders, while deliveries are at 6070% of what it used to fulfill.

In fact, demand has surged to an extent where online pharmacies are now cutting marketing spends and even offering lower discounts to customers as they are assured of sales. Strong growth has been forecast for the e-pharmacy market in India.

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Digital platforms like Practo, Lybrate, Ask Apollo and Just Doc have helped HCPs who run private clinics to keep consultations going at a time when clinics are shut or patients are unable to reach them due to restrictions on movements. Even online pharmacy 1mg, which now also offers remote consultations, has seen a quantum jump in the number of paying customers.

RedSeer Consulting has upped its estimate of the global digital health market to $25bn in FY25, compared with its pre-COVID-19 estimate of $19bn, with medicine delivery continuing to comprise a large share of the market. India’s digital health market will expand to $4.5bn in this fiscal year, compared to $1.2bn in FY20, the consultancy said.

While regulation is still developing, most leading e-pharmacies claimed to transact with customers through offline pharmacies and comply with the current laws. (Also see “India Pharma 2020: Trends That Can Change Business Tempo” - Scrip, 8 Jan, 2020.)

Digital Payment Solutions Digital payment gateways within teleconsulting and online pharmacy apps as well as independent digital payment apps have kept transactions within the health care system going.

Normally, private clinics prefer cash payments, but patients are insisting on using digital apps since the lock-down has made cash withdrawals difficult. The Cognitrex-SIHMRACI study shows Google Pay and Paytm are preferred while internet banking is barely used.

Apart from this, digital solutions are also being adopted in the pharmaceutical distribution chain.

A recent service by AIOCD-AWACS offers stockists of pharmaceutical companies the option of using a digital payments system instead of physical checks that are currently in use.

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Apart from avoiding visits to a bank or ATM to physically deposit the checks, the free service also helps avoid charges on bounced checks and payments made via cards. Additionally, reminders are sent to stockists to maintain an account balance in line with the credit limit assigned to them by a clearing and forwarding agent (CFA) appointed by the pharmaceutical company.

“Normally, a CFA has post-dated checks given by stockists based on the credit limit fixed for each stockist. If a CFA sells products of 50 pharma companies and supplies to 50 stockists of each company and there are two to three billing cycles in a month, which is generally the case, the CFA has to deposit 5,000-7,500 checks at a bank in just one month,” Rakesh Dave, president of market research agency AIOCD AWACS, said.

“Imagine the hardship of doing so these days and the time taken for a check to clear. Instead of that, we have details of each stockists’s current account details on our portal, a CFA raises an invoice, the stockist gets an alert and dues are cleared smoothly,” he added.

Stockists of some top pharmaceutical companies like Sun Pharmaceutical Industries Ltd., the Indian subsidiary of Abbott Laboratories Inc., Mankind Pharma Ltd. and Cadila Healthcare are using this service and more are exploring the option driven by operational continuity concerns, he added.

Teleconsulting Telemedicine is not new to the country, with Apollo Hospitals’ Apollo Telemedicine Networking Foundation having been set up in 1999, however telemedicine practice guidelines issued by the government on 28 March have helped drive its adoption during the nationwide lock-down.

So far operating in a regulatory grey area, telemedicine has gained credence as registered medical practitioners are free to consult patients

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via phone, video, and chat applications including telemedicine platforms and WhatsApp. The guidelines, formulated by the government think tank NITI Aayog, were notified under the Indian Medical Council (Professional Conduct, Etiquette, and Ethics Regulation, 2002).

Experts say teleconsulting has helped to keep sales going during the current lock-down when new prescriptions dropped. IQVIA’s survey of 500 HCPs during 5-9 April, showed that while HCPs use multiple channels of communicating with customers, telephone calls and WhatsApp are preferred.

Conducted among over 2,300 doctors in 16 Indian cities between 24 March to 2 May, the CognitrexSIHMRACI study shows that among the general practitioners surveyed • 60% communicated with their patients over the phone • 22% via mobile applications (apps) like WhatsApp, Google Duo and Facebook messenger • 15% through live video calling apps like Zoom, Skype and Microsoft Teams On the other hand, hematologists interacted with patients on the phone 45% of the time while 35% were contacted via mobile apps and 20% through live video apps.

In fact, state governments have been urged to drive telemedicine use. Tweets from twitter handles of several state governments have shown or mentioned such consultations even in remote areas. With a physician-population ratio of 7.6 per 10,000 of population against the 10 per 10,000 recommended by the World Health Organization, telemedicine’s potential in India is huge.

“Teleconsulting is a useful tool, especially for senior citizens and for those who have had

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surgical procedures recently. It’s particularly handy now for other patients as well who need follow-ups – in fact, my colleagues tell me that they’re likely to continue with this practice as it saves time and money for patients,” said Dr Vivek Shetty of P D Hinduja National Hospital.

However, it’s important that they have already met the medical professional earlier and a physical examination has been done, he said.

Setting up good teleconsulting facilities needs large investments, which is easier for larger hospitals to do rather than smaller set-ups.

Besides, patients’ unfamiliarity with technology is a barrier to adoption, he added.

Dr Rakesh Ranjan, consulting neurosurgeon at Aditya Birla Memorial Hospital and Jupiter Hospital in Pune, agrees, saying it’s easier done at hospitals where payments are handled smoothly and the patient-doctor interaction is recorded, but it’s not feasible if proper data cannot be maintained, which is important from a legal point of view. It also doesn’t work if payments can’t be made by patients remotely.

So, while telemedicine will not “substitute physical visits completely, more people will be forced to adopt it in some form.”

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Pandemic Is Enabling Faster Business Transformation, Says Novartis Digital Leader

BY ANDREW MCCONAGHIE Executive Summary Novartis has accelerated its digital ambitions during the worldwide lockdown period, working with partners such as Doximity on engaging doctors and Science 37 on virtual trial tech.

While the COVID-19 pandemic will undoubtedly hit some biopharma companies harder than others, Novartis AG wants to make sure that it emerges stronger from the global lockdown by using it to accelerate its business transformation.

The company’s chief digital officer Bertrand Bodson says the pandemics’s enforced restrictions have made the company’s employees more determined to push ahead with digital innovations across the business, from clinical trials to healthcare professional interactions with reps.

He told Scrip: “Many things that we had planned to take a couple of years to get into full motion have happened in two months.

Everybody, including the regulators, have come together on this, and so we have been able to change gears strongly.”

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On the commercial side, Novartis had 30,000 representatives worldwide who were usually on the road visiting healthcare professionals (HCPs), but have been confined to home for the last two months or more.

This required a wholesale and rapid change in how this frontline team’s performance was assessed, and a more streamlined approach to getting educational and promotional content signed off internally.

Bodson said Novartis looked at how it could adjust rapidly and meet the genuine needs of patients and HCPs. He points to a very rapid and positive approach taken by its local team in China as a great example where new digital models have been adopted at speed. Novartis has 3,000-4,000 reps in the country who have been unable to provide face-to-face updates and clinical information during the lockdown period.

“We changed literally in a week, and the team in China set about creating new KPIs (key performance indicators) for the [salesforce] team,” he says.

Bodson said Novartis had been able to respond proactively to the lockdown because of the significant investment in many different digital initiatives it has put in place over the last two to three years.

These include a joint venture launched with China’s internet giant Tencent in November 2019, an online chronic disease management platform for heart patients. The service provides daily health indicator monitoring and assessment through voice and image recognition and interaction and is embedded within the country’s well-established WeChat social media platform.

During the lockdown period, this service saw visitors increase hugely to 1.2 million visitors, an “intensity” of interest that Bodson said was unprecedented.

The company is also using WeChat to communicate with China’s HCPs, and took this channel one stage further by working with TenCent to introduce rep-triggered emails. From there it could engage via KOL-led webinars, using content tailored to specialists and sub-groups of interest.

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Novartis then built on the experience, putting together digital toolkits and expanding the approach to South Korea and Japan, countries which are also generally eager to embrace digital innovation in communication.

“We had many of the tools in place, but we needed to get consent to be able to reach doctors, and to do MLRs (medical/legal/regulatory) and approval of content in a much, much faster way,” Bodson added.

He said the company’s employees had been galvanized by the challenges of the pandemic, and by the belief that theirs is an important mission.

“Nobody asked for this crisis obviously, but we want to take all the positives that are coming from it and extrapolate them for better times ahead.

“My job now is to make sure that all this sticks… and to keep designing experiences for doctors or patients in partnership with regulators. It really makes sense on the back of having proven that we can do this [during a pandemic].”

Bodson said this kind of progress had been mirrored in other parts of the business, including clinical trials, although he admits that the latter cannot become fully ‘virtual’ in most cases.

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Telemedicine: Doximity Reporting Surge In Demand Novartis has been able to accelerate its digital transformation via multiple tech partnerships across its business, including with Amazon, Microsoft and clinical trial specialists TrialSpark and Science 37.

In telemedicine, it teamed up with San Franciscobased Doximity, which has become one of the biggest online platforms in the US or doctors.

Amit Phull, medical director and head of strategy at Doximity, told Scrip the firm had seen a significant spike in engagement on Doximity since the onset of the pandemic.

That includes Doximity Dialer, an app which allows physicians to connect with patients securely using their cell phones.

“Prior to the pandemic, we were facilitating about one million calls a month. Now, we are averaging about one million calls a day,” he said.

He added that the service’s newsfeed, which delivers custom-curated medical news and research based on each member’s specialty and clinical interests, had also seen a 60% jump in engagement since the crisis began.

The company also launched a new telemedicine offering on 5 May, called Dialer Video. This enables doctors to video call their patients in a

reliable and secure way, directly from their own smartphone, and Phull said over 100,000 HCPs are already regularly using the service.

Doximity is just one among several digital health platforms which have seen their use explode during the pandemic, other notable names including Teladoc and Livongo. Nevertheless, concerns about issues such as data and privacy, and the depth and quality of their service remain long-term questions.

Further Acceleration Away From Face-To-Face Rep Contacts?

This rapid acceleration towards digital communication raises the prospect of also fastforwarding the existing trend of physicians being reluctant to have face-to-face meetings with industry reps.

However Bodson said that there would always be a place for reps, particularly in newly launched brands. He claimed the sales data from the industry frontline show that these newer brands have struggled during the lockdown period compared to better established rivals across therapy areas.

“I can see [in future] the rep being a very nice orchestrator, but hopefully giving more ammunition to the teams to be able to be more personalized [in their communication] for HCPs and patients.”

Sign-up to a free trial for more recent coverage from Scrip

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Rock Health Reports Record Digital Health Funding Of $5.4Bn In H1 2020, Sees Potential For Record-Year Funding

BY MARION WEBB Executive Summary Digital health funding is on track for the largest funding year ever amid the COVID-driven demand for telehealth and remote monitoring of patients.

However, a large second wave of the pandemic could reverse that trend.

US digital health companies raised $5.4bn in venture capital funding in the first six months of 2020, driven by skyrocketing demand for on-demand health care services and disease monitoring. As a result, digital health is on track for the largest funding year ever.

Digital health funding in the first half of this year exceeded first half figures for the last nine years and was $1.2bn higher than the first half of 2019, according to venture capital Rock Health’s midyear report. (Also see “BIO Digital: Investment Panel Sees Continued Rising Adoption Of Telehealth, Remote Monitoring” - Medtech Insight, 11 Jun, 2020.)

Digital companies are now on track for seeing the largest funding year ever. (Also see “VC Deals Analysis, H1 2020: Medtech Funding Stays Apace, Cardiovascular Is King” - Medtech Insight, 1 Jul, 2020.)

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This, according to Rock Health, is surprising to investors and companies alike given that after raising $3bn in the first quarter, venture funding hit the brakes in April when COVID-19 started spreading globally. However, in May and June, investment saw an uptick again, which Rock Health attributes in part to loosened digital health government regulations, a COVID-driven surge in demand for digital health solutions and reduced volatility in the public markets.

“The reversal [updtick in May and June] was significant,” according to Rock Health researchers Nina Chiu, Alex Kramer and Aditya Shah. The researchers noted that overall digital health funding in the second quarter was $2.4bn, or 33% higher than the $1.8bn quarterly average for the prior three years. An average deal size in the first half of 2020 was $25.1m, well above the previous record of $21.5m set in 2018.

Mega Deals Eleven $100m-plus mega deals led the way for digital health funding in the first half with five deals occurring in May and June.

Among the leaders was Amwell, which raised $194m in May to meet the rising need for telehealth services during the COVID-19 pandemic.

Corporate venture capital funds also stepped up their investments during the digital health rebound in May and June, completing 76 transactions in the first half of 2020 with 28 transactions being done in May. Rock Health noted that corporate venture capitalists – rather than waiting for the return of normalcy – may view this crisis as an opportunity to accelerate bets on digital health companies that will help them navigate the post-COVID world.

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During the first half of 2020, health systems accounted for 34% of all corporate venture digital health transactions, making them the largest single source of corporate venture participation.

M&A, IPOs Mergers and acquisitions remain the most common source for liquidity for digital health investors, the researchers wrote.

Notably, 52% of the acquirers were digital health companies this year, as many companies are looking externally to buy more capabilities and talent.

Among the notable deals during the first half of this year were Teladoc, which bought InTouch Health for $600m in stock and cash in January to expand its provider-facing capabilities for its telemedicine platform.

United Health Group’s Optum is in late-stage talks to buy AbleTo for $470m to expand its virtual behavioral health capabilities. Health Catalyst bought Able Health for $27m in February to enhance its quality and regulatory measures capabilities amid Able Health’s SaaS application, which automates measures reporting.

After a grim outlook for initial public offerings at the end of the first quarter of 2020, a surging stock market and skyrocketing adoption of telehealth may have paved the way for several companies to go public.

Amwell raised $194m in a series C round in May after raising $365.4m in a series B round in 2018 and $81m in 2014, putting it in a good position to go public this fall. Its competitor Teladoc reported 41% year-over-year revenue growth and a 92% increase in new users on its first-quarter earnings call, bolstering its rising stock price.

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Amwell, which raised $1.1bn in the first half of 2020, ranks among the companies that led the trend for on-demand health services followed by monitoring of disease firms, which raised $831m in total – putting both categories on pace to exceed the 2019’s totals by 100%.

Telemedicine companies – which Rock Health defines as companies that leverage synchronous or asynchronous virtual care technology – raised $926m in the first half of this year. A survey of more than 1,000 seniors on Medicare Advantage, conducted between 16-18 May by the advocacy group Better Medicare Alliance, also showed that 91% of beneficiaries that used telehealth services reported “high favorability for telehealth.”

The pandemic has also led to an uptick in funding for companies that offer tech-enabled solutions for behavioral health to help people deal with rising COVID-related issues such as anxiety and depression.

In the first half of this year, digital behavioral health companies have received $588m in funding. Most of the funding in this segment during the first half of 2020 went to companies that provide solutions to help providers remotely treat acute or chronic conditions or digital therapeutics that themselves are treatment. One example is Headspace.

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But despite the uptick in digital health funding in the first half, Rock Health researchers cautioned that the uncertainty of the ongoing pandemic makes it difficult to make predictions about the financial markets for the remainder of the year.

“A potential second wave of the virus could quickly reverse the second-quarter public market rebound in private digital health investment. While the pandemic appears to have stoked investors’ appetite for digital health companies, in particular, their focus could shift in a longer-term economic downturn,” the researchers wrote.

Rock Health expects that macroeconomics turbulence will continue to drive enterprise buyer, consumer and investor interest in digitizing health care in a way to offset the negative effects of a recession as they did in the first half of 2020. Also, not all digital health companies will fare the same.

“Start-ups who sell to providers and employers may face stiffer headwinds than those of other categories,” Rock Health said.

For more information on funding and M&A activity, visit Medtech Insight’s VC deal tracker and M&A tracker.

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BIO Digital: Investment Panel Sees Continued Rising Adoption Of Telehealth, Remote Monitoring

BY MARION WEBB Executive Summary BIO Digital investment panel sees strong investment opportunities in telehealth, remote monitoring and converging digital products.

An investment panel at the BIO Digital virtual health care conference agreed that the COVID-19 epidemic will impact the investment environment throughout 2020 -- but to what extend remains to be seen.

All four panelists agreed that investments in telehealth, remote monitoring and data-driven technologies, which have seen unprecedented adoption during the pandemic by consumers and health providers alike, will continue to rise.

Digital health funding was off to a great start in the first quarter of 2020, with a record $3.1bn invested across 107 deals. That’s more than 1.5 times the total funding in the first quarter of any previous year, according to a report from venture capital firm Rock Health.

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The first quarter of 2020 was the second-largest quarter in terms of total funding, and 57% greater than the average quarterly funding across 20182019. Investors expected a more challenging fund-raising environment in 2020 after venture investment in digital health slowed to $7.4bn in 2019 from $8.2bn in 2018, but no one could have predicted the new territory that the COVID-19 pandemic created.

“What we’re seeing is that COVID will undoubtedly impact the investment environment throughout 2020,” said panelist Ruoxi Chen, an associate at US-based private equity investment firm Warburg Pincus.

“We’re at a very strange place right now – on the one hand, you’ve got 40 million Americans who are unemployed. You’ve got social unrest. You’ve got potential and question marks [about] whether there will be a second wave for the pandemic.

And when you put all those pieces together for investors, there is just increased uncertainty, which makes it harder to price risk.”

But Chen also pointed to a disconnect between the factors above and the current equity markets.

“When you look at the equity markets, you couldn’t tell that any of these circumstances are actually present,” he said, noting that he was shocked to see the Nasdaq up 80% and the S&P 500 remaining flat.

On 9 June, the Nasdaq composite hit 10,000 for the first time ever, closing at a record high with tech companies Apple and Amazon shares hitting all-time highs. The S&P 500 Index fell 1.2%. That comes after the stock markets began to rapidly decline in mid-February, when the COVID crisis hit.

However, sellers’ expectations around valuations haven’t changed.

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“What we’re finding is that generally very strong businesses do not need to put themselves up for sale at the present moment or raise capital ... [they] will wait for a better market environment or window,” Chen said.

Private Equity Market Remains Competitive Rock Health had a diminished outlook for initial public offerings and mergers and acquisitions in 2020. “An impending recession will diminish public investor appetite for IPOs,” the report said.

Chen, however, finds that there is ample opportunity for investments. In this he echoes David Rubenstein, co-founder of the Carlyle Group, who recently said that his firm and other private equity companies have a “fair amount of dry powder,” or cash.

Chen said Warburg has a $19bn private equity fund and is actively pursuing investments in companies that are at the intersection of health care, technology and pharma services, he said.

On the digital side, companies that have a software or software-as-a-service business model are the most resilient.

“Those are highly recurring business models, multi-year contracts, very high renewal rates and incredibly sticky services,” he said. “In this sort of market environment and backdrop those are still seen as very critical services for companies … business models that have those characteristics are going to continue to be incredibly resilient.”

Investors, however, are now also facing other obstacles.

For instance, the pandemic has made it more difficult to have face-to-face meetings, which Chen sees as being critical for investors to build trust with leadership teams and to align strategies.

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“While Zoom [virtual meetings] has come a long way, there are some limits,” Chen said, adding that not being able to meet in person will dampen investments on the private equity side this year.

Sales cycles are becoming longer, because sales representatives are no longer able to physically meet with health providers in hospitals. Recent financial announcements from orthopedic companies show this has hurt sales of medtech products. And many hospitals are also now facing capital constraints because the pandemic has led patients to put elective services and procedures on hold. (Also see “Orthopedic Roundup: Zimmer Biomet, J&J, Smith & Nephew, Stryker Hope For Post-COVID Recovery As Elective Surgeries Restart” - Medtech Insight, 13 May, 2020.)

“2020 will be a lost year for some companies, but the horizon looks a lot brighter beyond that,” he said. (Also see “Device Week, 17 May 2020 – COVID-19 Impact On Q1 2020 Earnings In Orthopedics; Highlights From HRS 2020” Medtech Insight, 17 May, 2020.)

Rising Adoption Of Telehealth Among the bright spots is the wide adoption of telehealth and telemedicine during the pandemic.

Many insiders believe that regulatory flexibilities introduced during COVID-19 will remain in place beyond the crisis and that telehealth will become a regular part of health care delivery.

What has changed as a result of the pandemic, is a willingness by customers and health providers to adopt new technologies, said Thomas Kluz, senior investment manager at Qualcomm Ventures.

“I think in the last six to 12 weeks we’ve accomplished what we would have hoped to accomplish over the next two to three years, so there’s been an accelerant on a willingness to adopt novel technologies, and where I see that the most is at the end-user level,” Kluz said.

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He added that many technology entrepreneurs believe that their technology or AI is the “best in class,” but what has changed in the last 12 weeks is that “customers are listening to the pitch about the AI solution, because it’s clearly solving a critical need.” He added that users are at a “point of desperation, because ‘brick-and-mortar’ is no longer the end-all, be-all,” he added.

He pointed to digital health company Tyto Care, which is powered by a Qualcomm chip and backed by Qualcomm Ventures. Tyto Care markets a handheld device that allows for the remote examination of the ears and throat. It also listens to the heartbeat and lungs and is used by both health providers and consumers. (Also see “TytoCare Raises $50M Amid Rising Demand To Remotely Monitor COVID-19 Patients” - Medtech Insight, 8 Apr, 2020.)

Moderator Wainwright Fishburn, a partner with the law firm Cooley LLP, cited a patient survey that suggests that almost 60% of the patient population have expressed comfort with using telehealth to interact with practitioners. Onethird said they would be willing to seek a new practitioner if their current practitioner was not accessible via telehealth.

What does this mean for investment trends in the next 18 to 24 months?

Jessica Zeaske, a partner at Echo Health Ventures, said she’s been looking for a disruption in health care delivery. The rising use of telehealth expedited by the pandemic puts the patient’s need at the center of health care, which she said offers advantages for patients, providers and insurers.

“We are seeing the necessity of that now,” Zeaske said, adding that the rising use of telehealth will make health care more affordable, which is critical during this time of high employment. She sees

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telehealth as a way to open up access to care and make it more convenient for consumers.

“Just as retail was driven by this [consumer online shopping] 10 years ago, we’re going to see the cost of [telehealth] actually be the driver going forward,” she said. (Also see “The Rise Of Digital – Deloitte Offers COVID-19 Recovery Strategies For Medtechs” - Medtech Insight, 22 Apr, 2020.)

Kluz echoed that there is a trend toward consumer-minded health care, citing technologies like TytoCare that empower consumers by allowing them to take more control over their care. (Also see “Start-Up Spotlight: Tyto Care Brings Medical Exams To Homes” - Medtech Insight, 24 Dec, 2019.)

Health care has lagged behind technology companies in offering consumers enabling technologies, Kluz said. He noted that Qualcomm recognized early on that its technology innovation was powered by consumers, not by enterprises.

He gave the example of 5G, the fifth-generation technology standard for cellular networks, which cellphone companies began deploying worldwide in 2019. Kluz said the development of 5G was driven by consumers demanding “faster and better internet enterprises.”

He also believes that some of the lessons learned during the pandemic will have a lasting impact, giving the example of Tyto Care, which became a technology use case during the last few weeks.

“We’re actually seeing a convergence of best-inclass, upper-echelon technology use cases and the health care practicalities coming together … I

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think it’s just the tip of the iceberg. I think there’s a lot more interesting AI, Internet of Things and other innovative things that will spin out of 5G.” Digitization Of Clinical Trials Chen also considers telehealth a hot spot for investment, saying that provider groups are now embracing telemedicine as a complementary service to office visits.

Warburg will continue to look for investment opportunities in the area of tech-enabling digital health services and tools. That said, he noted that life science companies are “woefully behind the adoption of technology.”

Chen further anticipates that digital health solutions will be used to help digitize clinical trials, conduct site-less or patient-centric clinical trials, and even commercialize drugs because physicians are no longer willing to meet with pharma reps face-to-face. And innovative tech solutions that can capture clinical trial data, riskbased monitoring, real-world evidence faster will be in high demand.

“If we think about the enormous costs and complexity of clinical trials … it now takes about two and a half billion dollars of development costs and R&D to get every successful drug approval,” Chen said.

There is an expectation that consumers and providers who use telemedicine for the first time will remain long-term users. Surveyed investors anticipate growth in remote monitoring, symptom checkers and triage tools, according to Rock Health’s report.

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COVID-19: LifeSignals, VitalConnect Get Green Light For ECG Remote Monitoring

BY MARION WEBB Executive Summary Two California-based ECG remote monitoring companies see rising demand for their solutions during the COVID-19 crisis.

Two California-based makers of electrocardiogram (ECG) remote monitoring patches have been given the go-ahead to sell their devices in key markets.

Fremont-based LifeSignals said it received the CE mark for its Biosensor Patch 1A, clearing the way for marketing in Europe, while San Jose-based VitalConnect said it obtained emergency use authorization (EUA) from the US Food and Drug Administration to bring its ECG VitalPatch into hospitals for monitoring COVID-19 patients.

Under the EUA, VitalConnect’s VitalPatch will be used to detect changes in the QT interval in COVID-19 patients who are being treated with drugs such as hydroxychloroquine or chloroquine. These drugs, especially when combined with azithromycin, may cause life-threating arrythmias or irregular heartbeat.

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In a letter to VitalConnect, the FDA concluded that “based on bench testing and reported clinical experience,” the VitalPatch may be effective for remotely monitoring and detecting QT interval changes in COVID-19 patients who are 18 years or older and taking drugs; but cannot be used for critical care patients. Conventional ECG measures QT interval on a 12-lead device during various time points by health care workers entering the room.

“Our vital sign monitoring is especially useful for COVID-19 patients either in or outside the hospital while our cardiac monitoring solution is ideal for arrhythmia detection,” Peter van Haur, CEO of VitalConnect told Medtech Insight. He added that VitalConnect had more than 10,000 patches ready for shipping and has the capacity to build “tens of thousands a month.”

The VitalPatch already received clearance from the FDA as a Class 2 wearable biosensor for monitoring 11 physiological vitals – body temperature, heart rate, heart variability, respiratory rate, blood oxygen saturation levels, single-lead ECG, body posture, fall detection, activity such as steps, blood pressure and weight – in real time, continuously for seven days. The EUA is temporary and for treating COVID-19 patients.

In February, VitalConnect partnered with CorVitals to provide patient monitoring and heart rhythm analysis in a comprehensive platform called Vista Solution 2.0. The company sells its patches to hospitals, long-term care facilities and for monitoring patients at home after they have been discharged from the hospital. The patch is designed to wirelessly transfer data to a thirdparty device and can be integrated with an electronic medical record system, said van Haur.

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European Launch for LifeSignals LifeSignals said it will start marketing its Biosensor Patch 1A in Europe on 18 May through a network of partnerships with OEMs and telehealth software providers to specialist hospital facilities.

The interoperable biosensors can be “whitelabelled,” customized and integrated into client systems according to their requirements, the company said. The majority of European clients that are in discussions for integrating the sensors are located in the UK and Italy. The estimated cost of the BioSensor is $20-$45, depending on features and functionality, LifeSignals said.

The company also plans to submit EUA-supporting documents with the FDA this month to market the patch and app either directly to consumers or through a third-party provider. It has already received FDA clearance for a two-lead and heart monitoring patch for hospital and ambulatory use.

LifeSignals has had a limited introduction of its FDA-cleared patch thus far, but has also landed CorVitals as one of its customers, Surendar Magar, CEO and co-founder of LifeSignals told Medtech Insight earlier.

BioButton Meanwhile, another remote monitoring device maker, BioIntelliSense announced the introduction of its new BioButton to remotely monitor temperature, respiratory rate, heart rate at rest, body position, sleep and activity for 90 days on a single, disposable on-body sensor.

The Denver, CO-based start-up received FDA clearance in 2019 for the BioSticker, a barbellshaped device that sticks to a patient’s chest for up to 30 days continuously.

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“The introduction of the BioButton device, in combination with the BioMobile applications and enterprise triage dashboards, represents a significant advancement in making continuous medical-grade monitoring reliable, effortless and cost-effective,” said James Mault, CEO of BioIntelliSense.

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The company teamed up with UCHealth to begin clinical testing of the BioSticker starting with postoperative and diabetic patients.

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UK NHS Urged To ‘Bottle COVID-19 Spirit’ For Future Health System Change

BY ASHLEY YEO Executive Summary Residual resistance to digital health care solutions in the UK NHS disappeared “almost overnight” when COVID-19 compelled the rapid adoption of new tools to meet the surge in demand and cope with supply challenges.

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Adoption of digital technology tools by the UK National Health Service was impressively rapid – “almost overnight” – when COVID-19 struck, in the view of Association of British HealthTech Industries digital lead Andrew Davies. What prompted such a change, when nothing comparable in NHS technology adoption, has been seen before? he asked during the association’s webinar on the NHS’s planned care restart, post coronavirus.

This spirit of readiness to embrace positive change is to be welcomed, says industry. “If we can bottle it, we should use it in all aspects of the health and care service moving forward,” said Louise Jopling, of the Academic Health Sciences Networks (AHSNs), the 15-member organization that acts as a bridge between industry and the NHS to facilitate innovation adoption locally and nationally.

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The pandemic forced the notion that existing routines and methods would fail to produce the required results for patients. “There had to be a rapid deployment of new platforms, but also a need to support the staff who were suddenly going to be using them as the new norm,” she said. Online training of staff became a role for the AHSNs. Elsewhere, the networks rapidly amassed some 200 market-ready innovations that could be deployed in COVID-19 control efforts, including those for online triage, remote monitoring, virtual consultations, infection control and diagnostics.

Under the pressure of coronavirus, some 99% of UK primary care practices are now using video consultations.

In the secondary care sector, hurdles to restarted activity remain in place, however. Some 500,000 operations have been cancelled in the UK. One third of the membership of the Royal College of Surgeons of England is not yet able to restart planned surgery, and one quarter does not have access to a “COVID-lite” site, said the college’s incoming president Neil Mortensen.

“Technology has made a huge impact,” Mortensen said, with face-to-face consultations down by

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some 75%. Multi-disciplinary team meetings have also arrived in a big way, which is good for team building and co-working, he said.

Meanwhile, supplies of health care products is becoming easier, including for personal protective equipment.

But a considerable problem is emerging in cancer care. Cancer waiting lists remain high in some parts of the UK but while some trusts have long waiting lists, others have been able to rely on the independent sector to share the burden. (Also see “UK Medtech Industry Seeking More Clarity On Restart Of Elective Procedures” - Medtech Insight, 7 Jul, 2020.)

With cancer screening put on hold as a result of the coronavirus, and people with suspected cancer reluctant to visit their doctor, there could be a 20% rise in cancer-deaths within a year, due to COVID-19. That is according to research published on 29 April by DATA-CAN: The Health Data Research Hub for Cancer, hosted by the AHSN, UCLPartners.

At the peak of the pandemic in the UK, the number of cancer referrals were down by almost two thirds. But there is evidence that patient confidence is returning, said Mortensen.

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Market Intel: Why Telehealth, Digital Therapies Will Provide Mental Health Support Beyond COVID-19 Crisis

BY MARION WEBB Executive Summary In this second part of a two-part series focusing on mental health tech, Medtech Insight highlights behavioral digital health companies that have attracted investors’ attention. Part one focused on transcranial magnetic stimulation.

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Mental health has taken center-stage during the ongoing COVID-19 pandemic crisis with millions of people flocking to digital technologies such as teletherapy and therapy apps to help them cope with mental stressors.

Many experts believe that the digitization of health care and behavioral health, which has seen lightning-fast adoption among consumers and providers during the pandemic, enabled in large part by the removal of regulatory barriers, will drive innovation and investment opportunities.

According to venture capital firm Rock Health’s midyear report, in the first half of 2020, digital behavioral health companies received $588m in funding, up from $539m in 2019 (compared with 2017, were $273m was distributed), putting 2020 on track for the largest funding year ever. (Also see “Rock Health Reports Record Digital Health Funding Of

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$5.4Bn In H1 2020, Sees Potential For Record-Year Funding” - Medtech Insight, 15 Jul, 2020.)

“We are bullish on the opportunity for telemedicine to play an important role in the treatment of behavioral health concerns,” Rock Health’s venture associate Chipper Stotz told Medtech Insight. “There is a really unique opportunity for digital health companies to really plug into this problem we have today to support patients with telemedicine from the comfort of their own home to offer evidence-based care that can be standardized and modularized in a way that allows not only providers and patients to track outcomes [but also] refer that back to health plans.” (Also see “Telemedicine Is Riding High, Hopes For More Provisions In ‘Phase Three’ COVID-19 Stimulus Package” - Medtech Insight, 25 Mar, 2020.)

Ralph Judah, managing director of health global markets at Deloitte Consulting LLP, agrees.

“I’m very bullish about the ability to intervene at a critical time, and not for somebody to have to wait until they get a physical appointment with a psychologist or a psychiatrist in order to have their problems and concerns addressed,” Judah told Medtech Insight.

Stotz said the pandemic has worsened a mental health crisis that has already existed. He cited a recent study by Mental Health America that said that nearly 100,000 Americans have reported anxiety or depression as a result of the pandemic.

Demand for virtual health skyrocketed especially during the months of March and April when many doctor’s offices shut down to prevent the spread of infection of SARS-CoV-2 and started telehealth consulting or alternative options for in-patient visits.

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“The uptick in funding is, in part, driven by the renewed interest from doctors who are recognizing the problem that has really always existed, but has been exacerbated by the COVID crisis,” Stotz noted.

The Rock Health report showed that much of the funding distributed in the first six months of 2020 went to digital behavioral health companies that either offered virtual platforms to facilitate remote monitoring for acute and chronic conditions or digital therapeutics that provide users with clinical interventions.

Mental Health Funding The largest rounds so far in 2020 were raised by three companies – Headspace, Inc., Mindstrong Health and Lyra Health – which raised 54% of the entire behavioral health funding round.

Santa Monica, CA-based mediation app maker Headspace raised $47.7m in equity and debt in February and raised another $93m in a series C round in June. The company said earlier this year it wants to grow its direct-to-consumer business, but also expand into the business-to-business segment.

The company’s app is used in several clinical trials, including one at the University of California San Francisco to measure the meditation’s app impact on work stress. Headspace’s chief science and strategy officer Megan Jones Bell told CBS News in June that Headspace is also working on a “separate program that’s developed in collaboration with patients, physicians, patient advocacy groups” that will be clinically validated for US Food and Drug Administration clearance.

Jones Bell didn’t say for which indication, but regulatory clearance would give the start-up the credibility and validation to set itself apart in the smartphone mental health space.

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In July, Headspace also announced it joined forces with Snapchat to bring mediations to the app itself via Snap’s new Mini applications. “Headspace Mini,” rolled out on 20 July, allows Snapchat users to join into meditations.

San Francisco-based Mindstrong raised $100m in a series C round in early May, which it plans to use to scale its business.

The company partners with national and public payer organizations to offer its digital platform to its members. Its focus is on patients with severe mental illness such as schizophrenia, major depressive disorder and obsessive-compulsive disorder. Mindstrong’s in-house clinical team of therapists, psychiatrists and care coordinators connect with users via messaging, video or phone conversations to deliver virtual care. The company also offers video chats via their in-house psychiatrists to help members with medication management, according to their website.

The smartphone app also allows members to monitor their own mental health symptoms through AI-powered digital biomarkers that can track changes in mental health symptoms, such as stress and mood. It does so by tracking a patient’s smartphone behavior, such as how a patient scrolls and types. The company conducted a study with the Kadima Neuropsychiatry Institute to determine which smartphone feature would be the best predicators for a user’s mood, anxiety and cognitive assessments in patients with major depressive disorder and bipolar depression. When the markers indicate a problem, it triggers an alert to the member’s clinical team.

“People living with a serious mental illness will tell you that managing their symptoms isn’t one of those things that fit neatly into business hours or can be deferred because of COVID-19,” Mindstrong’s CEO Daniel Graf said in a statement.

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“The combination of our technology and our inhouse clinical team puts us in a position to unlock a unique solution that increases access to care and improves health outcomes.”

Burlingame, CA-based Lyra Health, which partners with companies to offer their employees personalized mental health treatments through its network of providers, closed a $75m series C round in March. The funding will be used to expand its platform technology and network of evidence-based mental health providers, the company said.

Mental Health Issue Survey Among US Employees Lyra Health has a network of more than 3,000 mental health providers that it matches with employees and spouses and children based on their individual needs. Employees and covered dependents start off by accessing Lyra’s digital platform and entering symptoms, which are used to build recommendations for treatment. The patient can then schedule an appointment with a matched provider online.

Joe Grasso, clinical director of partnerships at Lyra Health, said the company has seen an 84% increase in weekly care registrations from midMarch to May and added more than 620,000 new members to the population eligible for Lyra benefits.

“We expect the need for mental health care to continue growing due to COVID-19 and the racial justice movement,” Grasso said.

He pointed to a recent study Lyra Health conducted with National Alliance of Healthcare Purchaser Coalitions that surveyed more than 12,000 US-based employees who receive health insurance through their employer that found 83% of Americans experience mental health issues.

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Meanwhile, 40% of survey participants said they don’t believe their employer cares about their mental health, beyond being productive at work.

“The findings of the study are eye-opening – including the fact that many of these employees have struggled to access mental health treatment with only 14% stating that they have spoken to a mental health professional during this time of turmoil,” Grasso said.

While Lyra Health has partnered with more than 40 companies, it signed nine new customers since the COVID-19 shutdowns began including big employers such as Starbucks, Morgan Stanley and Asurion. He said six new customers are slated to be added for the third quarter.

Among other notable companies in this space is San Francisco-based Big Health.

Big Health developed two major digital health apps, Sleepio and Daylight, to help users manage poor sleep and anxiety, respectively. Big Health raised $39m in a series B round in June, which was backed by Glide Health and Morningside Ventures with participation from Samsung NEXT and prior backers Kaiser Permanente and Octopus Ventures. The company plans to use this funding to grow its distribution channels and marketing efforts.

Big Health’s Daylight app Both digital health apps use cognitive behavioral therapy (CBT) techniques and solicit feedback from users to deliver personalized therapy. The Daylight app aims to reduce mental health issues such as worry and anxiety.

On 28 July, Big Health published positive results from a six-week long randomized controlled trial comparing the digital CBT Daylight app in 256 participants with moderate-to-severe symptoms of generalized anxiety disorder (GAD) to a control

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group of individuals with anxiety that may have received other treatment (including possible pharmacological intervention)for their anxiety during this time period, but were not using the Daylight app.

Four weeks after the intervention period, 71% of Daylight users in the study achieved remission of GAD compared to 33% in the control group. The improvements achieved with using the Daylight app lasted six months following the intervention, which coincided with the beginning of the pandemic when many people had heightened anxiety. The study results were published in July in the medical journal Depression and Anxiety.

Peter Hames, CEO and co-founder of Big Health, told Medtech Insight that this is the latest study of a total of 13 published randomized controlled studies.

The company’s apps have seen a huge upswing in demand since April when it – along with other companies such as Headspace and digital health company Omada – offered their platforms for free to help individuals cope with mental stressors during the pandemic.

“We have signed up 6.5 million lives to access our solutions globally,” Hames said. That included large employers such as Nike, McDonalds, Target, Home Depot and Comcast, the UK’s National Health Service, as well as payers such as the Boston Medical Center. CVS Health is also now offering both products to its employees.

But Hames said that the platform is no longer being offered for free to the community as it was intended for use in the “first few weeks of the pandemic to help those with the most need.”

However, he said, a side effect of the pandemic is more employers are recognizing the need to provide mental health offerings for their

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workforce, and he believes that Big Health can be a part of the solution.

“As employers try to get back to some [resemblance] of new normality, then we’re having a lot more conversations with employers about how we can provide help to their population base,” he said.

He also agreed with Stotz and Deloitte’s Judah that the pandemic has uncovered a problem that has been around for a long time. Hames noted that 70% of people get no help at all with chronic mental health issues and of the remaining 30% who get care, most rely on pharmacotherapies such as antidepressants that can have sideeffects.

“There has been a great acknowledgment as a result of people being isolated of the value of digital health solutions that can be accessed from wherever you are … the biggest thing for me it’s made mental health a topic that’s unavoidable, which I think is a positive thing,” Hames said.

Another start-up, Hims & Hers, also gained traction for its mental health app during the crisis.

The company started out by building its business around the de-stigmatization of disorders such as erectile dysfunction and sexual health, then moved into the mental health space with anonymized group therapy and guided meditation sessions. In late July, it also introduced a new service that connects people with providers who can prescribe and manage common medications for depression and anxiety.

Reuters recently reported that the company is exploring a public debut which could raise its valuation to more than $1bn.

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The Rise Of Teladoc Since the pandemic, mental health providers in hospitals and private practices have also started using telehealth offerings or significantly expanded their telehealth capabilities, including mental health offerings, as a way to continue to serve their patients and recoup lost revenues.

Among the leading vendors in that space are publicly held Teladoc Health, Amwell and Doctor on Demand, which all reported unprecedented growth since the pandemic hit.

Teladoc connects patients with health care providers associated with hospitals, health systems, physician practices and health plans, through a highly flexible technology platform used to complete millions of telehealth visits. It derives most of its revenue from subscription access fees.

On 29, July, the company reported it ran 2.8 million virtual visits in the second quarter of this year, a more than three-fold rise from the same period last year. During the second quarter, Teladoc’s total revenue rose 85% to $241m and global revenue subscriptions access fees revenues rose 64% year-over-year, the company reported.

On 1 July, Teladoc completed the buy-out of virtual care provider InTouch Health for $600m and with that expanded its offerings to InTouch Health’s 450 hospital clients.

The company covers more than 450 medical subspecialties, but behavioral health has been a strong growth driver due to the rising use and upselling of mental health services to existing customers.

Taladoc’s CEO Jason Gorevic told investors during the second-quarter earnings call on 29 July, “while general medical visits continue to

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exhibit significant growth, demand for specialist care, including dermatology and mental health, continue to grow even faster.”

“We’re seeing tremendous demand for mental health visits in particular as visit volumes have grown sequentially in every months of the year based on the business-to-business and directto-consumers sides of the business,” he said.

“BetterHelp, our direct-to-consumer mental health offering, is exhibiting accelerating traction and continues to significantly outperform our expectations.”

Gorevic also told investors that the “pandemic has accelerated the widespread adoption of virtual care, and added, “I’m confident there’s no going back.”

The telehealth sector has been largely driven by eased government restrictions on telehealth use such as waived licensing requirements which allowed telehealth companies such as Talkspace and BetterHelp to provide teletherapy across state line, removed previous barriers of location to receive telehealth services for Medicare beneficiaries, and provided reimbursement parity for providers.

The Trump administration on 3 August took a big step to expand virtual visits including mental health under Medicare with an executive order to direct the departments of Agriculture and Health and Human Services, and the Federal Communications Commission, to join forces for building the infrastructure to support telehealth in rural communities beyond the pandemic.

(Also see “Telehealth: Trump EO Would Extend Payments, While CMS Proposes Permanent Rule” Medtech Insight, 5 Aug, 2020.)

But there are still many unanswered questions that could block widespread adoption in the future with reimbursement and privacy of data

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ranking high on that list. (Also see “Telehealth Act Introduced In US House Would Eliminate Geographic Originating Site Restrictions” Medtech Insight, 17 Jul, 2020.)

But Gorevic remains optimistic for growth. For 2021, he forecasted a 30%-40% revenue growth for Teladoc, noting that in the first half of 2020, the company onboarded 15 million new paid members in the US alone, including 8.5 million in the second quarter.

Teladoc and diabetes coaching company Livongo Health, Inc. announced on 5 August they have agreed to merge in an $18.5bn cash and stock deal, which is expected to drive revenue of 30%40% for the combined company over the next two to three years, Teledoc CFO Mala Murthy told investors in an earnings call on 5 August.

“I recently shared the virtual stage with US HHS Secretary Alex Azar,” Gorevic said during the earnings call, “and when asked about virtual care Secretary Azar said, “I think we’d have a revolution if anyone tried to go backwards on telemedicine.

This is now an embedded part of our health care system.”

Boston-based Amwell raised $194m in a series C funding round in May, led by Allianz X and Takeda and reportedly confidentially filed for an initial public offering. The company told CNBC in May that it has seen a 1,000% increase in visits amid the pandemic, and even higher in some places.

San Francisco-based Doctor on Demand secured $75m in a series D financing round in July. The financing round was led by equity firm General Atlantic with participation from existing investors.

The company said it will use the funds to expand access to virtual care. Doctor on Demand said on 8 July it more than doubled its covered lives in the last six months, covering more than 3 million virtual visits.

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Untapped Opportunities Stotz foresees untapped funding opportunities in areas that remain underserved in the digital behavioral health sector.

“Things like eating disorders, obsessive compulsive disorder, post-traumatic stress disorder that are not only incredibly pervasive to people’s lives, but also costly for health plans to cover their members who have these conditions,” he noted.

More recently, Rock Health has also been interested in the pediatrics space, noting that many behavioral health concerns emerge during childhood adolescents.

Teladoc is also exploring this opportunity. In April, the telehealth giant began working with Cincinnati Children’s Hospital Medical Center in a pilot program to develop the first telehealth platform for pediatrics.

get it started. Some clients had trouble finding privacy at home and were “hiding in the closet” or calling her from the car.

Telehealth is also no substitute for the one-on-one human connection.

“I think there is something about being in the same space and having that connection,” Oneal Mas said. “It [teletherapy] takes that physical connection out of it … I really appreciate that and I think that clients do to … they told me they can’t wait to see me in person.” Also, she finds that for some patients with serious mental illness, teletherapy is simply not the right solution.

With coronavirus cases spiking again in many parts of the US, including in San Diego, Oneal Mas is still not offering face-to-face meetings in her practice. But she does offer patients, who feel comfortable with the idea, outdoor private sessions with protective masks and social distancing rules enforced.

Teletherapy Pros And Cons While digital technologies offer many advantages for patients, such as real time help from the convenience of their home, it also poses unique challenges.

Oneal Mas expects that in the future, most patients will return to see her face-to-face. But she plans to still offer teletherapy for a small number of clients who prefer it.

Patty Oneal Mas, a licensed couples and family therapist, in private practice in San Diego, CA, said she first started using teletherapy in her practice during the lockdown in March via the telemedicine platform Doxy.me.

“I think the ratio is going to be 90% in-house and 10% telehealth,” she said. “Probably for some of my clients, telehealth is a nice option. I had someone move to Northern California and I now I can still see her through telehealth.”

She was pleasantly surprised by the positive response by patients. For some of her clients, such as people with social anxieties and looking for flexibility in scheduling appointments, teletherapy offered a good alternative.

Deloitte’s Judah believes that the pandemic will accelerate the emphasis on early detection and prevention of mental health issues forward by ten years to 2030 and transform the health care industry as we know it. (Also see “The Rise Of Digital – Deloitte Offers COVID-19 Recovery Strategies For Medtechs” - Medtech Insight, 22 Apr, 2020.)

But there are also cons in telehealth. Among them are technical glitches, such as with Wi-Fi access, which interrupted the flow of sessions or couldn’t

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“We’re seeing two things happen in behavioral health that are supporting this change,” Judah said.

There is already a major cultural change driven by the younger generation, particularly by the Generation Z, to publicly discuss mental health issues, breaking down long-held social stigmas.

He also feels that younger people are more willing to engage in teletherapy and digital therapeutics.

Though companies such as Lyra Health’s Grasso would disagree.

“We see a lot of member interest in virtual mental health care options – especially now as a result of COVID-19 – but it’s person, not age-specific,” Grasso said.

Judah, however, has observed that Deloitte’s clients’ sensitivity to behavioral issues has been heightened by the pandemic, “simply because it’s more pronounced and more urgent.”

“This situation has stressed employees … working from home, trying to care for children at home or sick loved ones is putting a lot of pressure on employees that is going to get the attention from human resource departments,” he said.

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The de-stigmatization of mental health issues combined with scientific breakthroughs could drive low-cost access to mental health services. He also anticipates that mental health will be more integrated with primary care to address issues early and will be covered by insurance.

There is tremendous potential for digital technology to transform mental health. With more than 10,000 apps now crowding this market, it can be difficult for both providers and patients to decipher which ones are truly backed by science and effective. And in many cases, the research to support that these tools are effective is lacking.

The FDA announced in April it would relax certain premarket requirements for computer programs and mobile apps that support the treatment of conditions such as depression, anxiety and insomnia to address mental health needs during the COVID-19 crisis. But it has no regulatory requirements for low risk general wellness apps.

“It’s incredibly hard for patients to discern with just the plethora of options available on the App Store who is and who isn’t providing evidencebased care, the more outcomes and clinical vigorous validation that companies can provide can really help patients navigate to the right ones to care for them and help health providers and health plans to find who to work with,” Stotz said.

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Emergency Clinical Trial Guidance Offers A Peak At The Future Of Virtual Trials: Expert

BY FERDOUS AL-FARUQUE Executive Summary The current pandemic has accelerated the US FDA’s perspective on conducting remote clinical trials. The agency has published an emergency guidance to allow sponsors to continue their work, which a former FDA official says is an indication of where the agency is headed post-COVID-19.

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When the US Food and Drug Administration published an emergency guidance last month on how sponsors can continue to run clinical trials during the current COVID-19 pandemic, it also signaled the direction the agency is taking to allow broader use of tools to conduct trials well beyond the current crisis, according to an industry expert.

The FDA in July released the broad “FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Public Health Emergency.” The document outlines how sponsors currently conducting clinical trials can use tools such as remote-monitoring technologies and adjust trial protocols to allow studies to continue.

However, the guidance holds more significance than just what’s written on its pages, says Wade Ackerman, a partner in the Los Angeles office of law firm Covington & Burling.

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Ackerman, who also served as an FDA lawyer and was senior FDA counsel on the Senate Health, Education, Labor and Pensions (HELP) Committee, said based on his experience he suspects the guidance reflects thinking the agency had already cleared for a broader future guidance on remote clinical trials.

While the FDA previously said it was working on clinical guidances, such as one being developed by the agency’s drug center to allow digital tools for remote or virtual clinical trials, COVID-19 spurred the agency to get a guidance out sooner to help sponsors trying to figure out how to continue their trials, especially since patients are unable to visit clinical sites.

When the pandemic hit, Ackerman says it’s likely the FDA took the ideas that were already agreed upon by a working group that was developing virtual clinical trials guidances and published them to help sponsors continue to operate.

“What I suspect happened based on my experience with FDA … is they had thinking that they thought was baked enough to put out in an emergency setting,” Ackerman told Medtech Insight. “That’s what you got in this temporary guidance: a preview of what they were thinking, but tailored to COVID.” While the temporary guidance is limited in terms of the topics it addresses, he says what it does address is likely to be part of a permanent future guidance on virtual clinical trials.

Focus On Patient Safety Ackerman notes the temporary guidance only addressed existing clinical trials and offers stopgaps to keep current trials going to ensure people already enrolled on a therapy are not pulled off of them and addresses how to appropriately do safety monitoring of patient, as

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well as collect data that can be used for a product submission.

“What FDA is most concerned about [in the temporary guidance] is patient safety from a monitoring perspective,” he said. “At least when patients go in to the clinic to see investigators, the investigator can more easily check the patient for potential adverse events.”

Ackerman noted that the guidance states sponsors can collect data remotely, but they need to go back to their institutional review boards to update protocols and document deviations.

One key issue the guidance doesn’t address is how the FDA intends to decide whether the tool used to collect the data is sufficient to ensure the data being collected is valid. Ackerman has faith, though, that the issue will be addressed in any future permanent virtual trial guidance.

“In the longer run you’d want to see FDA talk more about what does the sponsor need to do to ensure that the data collected is considered valid by the agency, and that data can be used for regulatory purposes,” he said.

Ackerman said the issue has already come up in the clinical trial space as sponsors are using realworld evidence data to support their products for approval, but the FDA has pointed out gaps in the data.

“This guidance is all about how do you get through COVID. I wouldn’t say it’s on the cutting edge of how we’re going to do remote clinical trials and use digital technologies to better do that,” he said. “I am more excited to see the permanent guidance when it comes out.”

Ackerman advises clients in the digital health space, including developers of software as a

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medical device (SaMD). Since April, most of the questions he’s received are about what sponsors can do when patients can’t make regular site visits. Even if they can do telehealth visits, in some cases they are required by protocol to so some on-site visits. However, for a lot of his SaMD companies, virtual clinical trials have been the norm.

“Sometimes [not having on-site visits] wasn’t an issue,” said Ackerman. “One client had a digital therapeutic and it was something the patient could use in the home and have an app that followed patient’s well-being, and that kind of trial wasn’t affected. It varies case by case and FDA seems to recognize that.”

To Validate Or Not To Validate?

One of the key issues around virtual trials is whether the tools being used to collect data will be accepted by the FDA, especially in clinical trials using remote-monitoring devices to evaluate a new drug. In past industry conferences, FDA officials have encouraged makers of wellness products not overseen by the agency to get their product validated so they can be used for collecting clinical trial data.

“We get questions all the time whether a digital tool has really been reviewed by FDA for the purpose it’s being used in the drug trial,” Ackerman said.

He noted that the Apple Watch, which came on the market more than five years ago, has been reviewed by the FDA and has received two de novos to determine if a patient may have certain heart risks, but it hasn’t been reviewed for use in collecting data for a drug trial. In such situations, his clients are unsure of whether the agency will accept the data they collect with the watch.

“Generally our advice to clients is, if the digital tool has gone through CDRH [the FDA’s Center

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for Devices and Radiological Health], that is going to give CDER [the Center for Drug Evaluation and Research] some level of comfort that someone at the agency has looked at the tool, has validated it for what it’s intended to do,” Ackerman said. “You still have to think about whether it’s being used in a way that CDRH didn’t really think about.”

Ackerman says for wellness devices that haven’t been validated or gone through some review process, the question is: Will the FDA rely on such a device to collect and store data in a clinical trial, and will sponsors be willing to take that risk?

Another question to ask is whether makers of products used to collect clinical trial data may consider getting their products reviewed by the FDA because there’s a market for them.

“This comes up all the time, it’s not just the Apple watch,” Ackerman said. “There are so many digital tools where CDRH may have reviewed them but maybe didn’t review them exactly how the drug sponsor would want to use them.”

He says sponsors would have to ask how close the device is to being accepted by the FDA to collect valid data and whether there may be a step that could be added to the trial protocol to fill in any potential data gaps.

Ackerman says sponsors should discuss all these issues with the FDA before they start clinical trials to ensure the clinical trial data they collect will be accepted by the agency. He also hopes such questions are addressed in longer term clinical trial guidances from the agency.

More Clarity On Devices In Drug Trials Ackerman went on to say there are companies that are focused on developing remote clinical trial devices, such as apps that can be put on smartphones and wearable technology to remotely monitor patients in drug trials, but there’s frustration that the CDER does not have

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a pathway to clear such devices for use in clinical trials.

“They’re having a lot of problems when they go knock at Johnson & Johnson, Pfizer, Merck and Bayer ... and getting their R&D programs to adopt them,” he said.

One solution, Ackerman says, could be for the CDER to encourage such device makers to reach out to the CDRH to get their product approved, but the problem remains that they don’t have any regulatory experience to make that happen.

I’ll be curious to see if a future guidance will recommend such companies should go to CDRH to get their product reviewed for use in a clinical trial,” Ackerman said. “I think they would have to.

I think the threshold question is whether it should be considered a device or not because not every digital tool in a trial should be a device, especially if it’s just collecting and tracking the data.”

Mother Of All Inventions Ultimately, Ackerman says COVID-19 has pushed regulators, industry, patient groups and health care providers to accelerate the culture to adopt tools that will allow virtual clinical trials.

“In so many ways, COVID kind of forced forward some of these innovations and also people’s trust that some of these alternative methods could work,” he said. However, he also cautioned that there’s a lot of work left before the full potential of such trials can be realized.

“There’s this general feeling that adoption of telehealth and digital tools that will allow for virtual clinical trials will democratize clinical trials, where not everyone will have to live within 30 or 50 miles of major academic medical centers, where many of these trials take place,” Ackerman said. “While it’s true many of these virtual trials may open up geographic diversity, I think there are some real challenges we’re going to have to work through around the use of technology.”

He acknowledged that a lot of people don’t have smartphones or tablets that could carry SaMD products, or patients may not have the education or technical know-how to use the technology.

Meanwhile, the technology requires access to strong internet broadband that may not be available to them.

“Those are all issues that need to be addressed

by FDA, and hopefully they will address them,” Ackerman said.

That being said, Ackerman says sometimes there are ways around the need for hi-tech to allow clinical trials to continue under COVID-19, including simply using phone calls to get updates from patients. He’s also seen trialists partner with home-care providers and traveling nurses where the nurse can collect the necessary trial data, but that raises the question of whether the nurses can be considered clinical investigators and if that will be allowed by the FDA.

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