Tag Archives: wearable

Honing Patient Outcomes With WHDs

Posted on by
Reply

On November 01, 2019, San Francisco-based Fitbit, Inc. announced that it has entered into a definitive agreement to be acquired by Google LLC for approximately US$ 2.1 billion. Many believe, though, the value of Fitbit lies in the health data that its wearables capture for its large base of users.

According to the CEO of Fitbit, currently the Fitbit brand supports more than 28 million active users around the globe who rely on these wearable products ‘to live a healthier, more active life.’ With Google’s resources and global platform, Fitbit will be able to accelerate innovation in the wearables category, scale faster, and make health even more accessible to everyone, he added.

The article – ‘The Real Reason Google Is Buying Fitbit,’ published in the Time magazine on November 04, 2019 makes some interesting points, such as the following:

  • The fast-growing healthcare tech space could be worth US$24 billion by 2020, says an estimate from Statista.
  • Although, Google has been working on cardiovascular health, diabetes and more, it hasn’t been publicly pushing healthcare as a business proposition, just yet.
  • Whereas, Google’s rivals, most notably Apple, have embraced healthcare as the next big battleground in the tech world, attracted by the promises of big profits for those who can help simplify a byzantine healthcare system.

Nonetheless, the Fitbit acquisition would facilitate Google’s entry into the Wearable Health Devices (WHDs) market in a big way, alongside other big players, such as, Apple and Samsung.

Driven by the most likely scenario of increasing usage and usefulness of WHDs, several pharma players are sniffing huge underlying commercial opportunity in this space, alongside being demonstrably patient-centric. Thus, my today’ article will deliberate whether or not WHDs will be able to offer a cutting edge to innovative drug marketers, by continually honing patient outcomes. Let me initiate this discussion by fathoming the importance of WHDs in the fast transforming digital world.

The importance of WHDs in the digital world:

‘Mary Meeker‘s 2019 Internet Trends Report’ highlights, about 51 percent of the global population is now connected to the internet, with the majority of users based in China, India and the United States. However, global internet user growth has slowed down by 6 percent and it’s becoming increasingly harder to get the rest of the world online.

In this background, especially - ‘As patients become more involved in making decisions about their health care, research shows, the result is increased satisfaction and improved health outcomes.’Consequently, the report spotlights healthcare digitization where consumer adoption of digital health tools is increasing rapidly. Some of the top areas, in terms of their speed of adoption, were listed as follows:

  • Online Health Information
  • Online Provider Reviews
  • Mobile Tracking
  • Wearables
  • Live Video Telemedicine

This gives a sense of how fast the WHDs are gaining importance for the consumers. Interestingly, Intouch Group also points out that wearables are now being used more to manage a diagnosis rather than just fitness trackers. Adding further, it pointed out – ‘Apple’s ResearchKit is an example of what CEO Tim Cook calls the “democratization of healthcare,” in that it provides health data directly to consumers so they can manage their health.’

A recent study on the scope of wearables: 

The scope of WHDs was aptly corroborated in a recent article – ‘The Rise of Wearable Technology in Health Care,’ published in the JAMA Network Open on February 01, 2019. The paper concludes, the general principle of commercially available ubiquitous wearable computers bodes well for our future ability to measure, track, and understand patient physiological data and behavior both in the hospital and at home.

The ability to capture such data, then applying machine learning to get the evolving health trends and sending alerts to patient accordingly – nurses, and physicians are instantaneously getting empowered to deliver patient outcomes. The fact that the alert can come easily via the patients’ smartphones that a significant part of the global population now carries with them, leading to further democratization of health care.

The Economist  also predicted, by 2020 – 80 percent of the adult population of the world would have a smartphone in their pocket. Therefore, this development opens up an entirely new world of real-time data acquisition, monitoring, and intervention, the paper underscored.

Giving a relevant example, it highlighted: ‘On December 6, 2018, Apple rolled out a software upgrade that turns the Apple Watch Series 4 into a personal electrocardiogram.’ The researchers further added, while WHDs’ fidelity may not yet exactly match medical-grade monitors and devices, these are “good enough” coupled with around-the-clock capabilities, real-time data capture, storage, and analytics and seem likely to provide real value.

The opportunities with WHDs:

Both from the health and business perspectives, WHDs are opening new vistas of opportunities for all stakeholders in the healthcare space, such as, patients, doctors, care providers and also pharma companies. This was enunciated in several studies, such as one, titled ‘Wearable Health Devices – Vital Sign Monitoring, Systems and Technologies,’ published by Sensors (Basel, Switzerland) on July 25, 2018.

This paper also reiterated: ‘Wearable Health Devices (WHDs) are increasingly helping people to better monitor their health status both at an activity/fitness level for self-health tracking and at a medical level providing more data to clinicians with a potential for earlier diagnosis and guidance of treatment. The technology revolution in the miniaturization of electronic devices is enabling to design more reliable and adaptable wearables, contributing to a world-wide change in the health monitoring approach.’

Thus, a big excitement is currently palpable around the technology related to WHDs. Many more opportunities are expected to unfold for continuation of the ascending trend. With the entry of big global tech giants such as, Apple and now Google, besides scores of small startups, WHDs of many types have started entering into the healthcare, carrying a promise to improving outcomes and creating a unique patient experience in the disease treatment process.

Improves outcomes, creates a unique disease treatment experience:

Echoing many other experts in this area, I also believe that WHDs have covered a lot of ground by now – expanding its usage from fitness trackers to diagnosis of disease and then monitoring the progress both during and after treatment. Current usages of WHDs are mostly for non-infectious chronic diseases, such as diabetes, cardiovascular conditions, sleeping disorders, obesity and treatment compliance, besides others. The list is gradually expected to expand.

Apparently, encouraged by this trend, more pharma players are now moving into this area for significant brand value for augmentation through better patient outcomes – apace with providing a unique disease treatment experience for suffering individuals.

The scope in India:

As WHDs have a close link with both Internet and Smartphone penetration, let me try to weigh the potential of the wearables, in view of the current status of both in the country.

According to the India Internet 2019 Report by Internet and Mobile Association of India (IAMAI), the following three points are indeed noteworthy, besides others:

  • With 451 million monthly active internet users at the end of financial year 2019, India is now second only to China in this regard.
  • Urban India with 192 million users had almost the same number of users as rural India. However, in terms of percentages or penetration, given the disparity of population distribution in urban and rural India, urban India had a considerably higher penetration level.
  • In rural India, a sizable portion does not have access to the Internet, and provides a huge opportunity for growth which will contribute to an increase in the overall Internet population over the next few years, it said.

Similarly, according to the Statista report, for 2017, the number of smartphone users in India was estimated to reach 299.24 million, with the number of smartphone users worldwide forecast to exceed 2.3 billion users by that time, and was projected to be nearly 2.7 billion by 2019.

These numbers speak for themselves on the underlying opportunities of WHDs – both globally and locally. Accordingly, large pharma players have already started teaming up to deliver better patient outcomes, leveraging the value of WHDs.

Pharma players teaming up to deliver better patient outcomes with WHD:

There are several such examples. Nevertheless, to illustrate the point, let me cite one such recent instance of Abbott Laboratories announcing a deal on February 20, 2019 with Novo Nordisk to make diabetes management easier by linking technologies of the two companies. The deal will allow integration of insulin dose data for Novo Nordisk’s pre-filled and connected pens with its ‘FreeStyle’ Libre mobile app and cloud-based system.

‘Abbott’s ‘FreeStyle’ Libre Continuous Glucose Monitoring (CGM) system will read glucose levels through a sensor that can be worn on the back of the upper arm eliminating the need for routine finger pricks. Through the FreeStyle LibreLink app users can capture and view their real-time glucose levels, their eight-hour glucose history, and how their glucose is currently changing on their smartphone.’

Yet another report highlighted, ‘Google sister-company Verily is teaming with big pharma on clinical trials.’ On May 21, 2019, the company announced strategic alliances with the pharmaceutical companies Novartis, Sanofi, Otsuka and Pfizer to help it move more deeply into the medical studies market. The goals for Verily, and its pharma partners, are to reach patients in new ways, make it easier to enroll and participate in trials, and aggregate data across a variety of sources, including the electronic medical record or health-tracking wearable devices,’ the report emphasized.

Conclusion:

It seems clear that in the rapidly transforming digital world, many drug companies are realizing the criticality of making their business operations sine qua non with the evolving trend is essential. This is not just for the organization progress, but also for long-term survival of the business. In the midst of this exciting technological environment, the potential value of WHDs to deliver better patient outcomes is being brought to the fore, primarily by the pure tech companies.

Figuring out the magnitude of the new opportunity, several pharma companies have thrown their hats in the ring, primarily in the form of collaborative deals. This ushers in a new phase in the healthcare space. Mostly because, such initiatives will have to be patient-centric for providing a unique patient experience with the drugs, in the disease treatment process. As India too, is taking rapid strides for penetration of digital technology in its ‘Health for All’ initiatives, the use of WHDs for better and cost-effective patient outcomes isn’t a pipe dream, any longer.

The evolving scenario, therefore, opens yet another door for the pharma players to grow their business, not just with drugs offering differential value, but also by making even a ‘me-too’ drug perform better, leveraging the potential of WHDs, effectively. From this perspective, continuously honing patient outcomes with WHDs, appears to be a unique tool for pharma marketers to make use of – in search of excellence.

By: Tapan J. Ray   

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.

 

Prescription Digital Therapy Now A Reality

Posted on by
Reply

The pursuit of offering ‘prescription digital therapeutics’ or ‘digiceuticals’ by Big Pharma, to ensure better clinical outcomes for patients, has apparently come to fruition now.

On April 18, 2018, by a media release, Novartis announced that the Sandoz Division of the Company has entered into collaboration with Pear Therapeutics to commercialize and continued development of digital therapeutics, designed to effectively treat disease and improve clinical outcomes for patients.

The collaboration brings on to the table, a synergy between Sandoz expertise in launching and commercializing various disease treatments, with Pear’s leading experience in digital therapeutics design and implementation. This deal has attracted attention of many. Mainly because, any pharma player will, for the first-time, detail a digital therapy treatment directly to the medical profession, and seek their prescription support.

It is worth noting that Pear’s flagship digital therapeutic – reSET is the first USFDA-cleared mobile medical application with both a safety and efficacy label to help treat patients with Substance Use Disorder, in September 2017. According to published reports, several studies have established that it is two-times more effective than conventional in person therapy sessions. Interestingly, the rate of treatment efficacy increases even up to tenfold, in refractory patients.

Just the beginning of a long run: 

The above market launch of a digital therapy by Novartis signals just the beginning of a long run in changing in the disease treatment archetype for better outcomes. Incidentally, prior to this announcement, on March 1, 2018, the same Company had announced, “Novartis and Pear Therapeutics to collaborate on prescription software applications aimed to treat patients with schizophrenia and multiple sclerosis.”

The media release underscored:“Psychiatric and neurodegenerative diseases place a heavy physical, mental and economic burden on patients and their families. With widespread adoption of digital devices, prescription digital therapeutics could potentially play an important role in future treatment models for a range of diseases with high unmet medical need”.

The scope and potential:

An article titled – ‘Digital therapeutics: Preparing for takeoff’,published by McKinsey & Company in February 2018, captures its scope succinctly. It says, “digital therapeutics tend to target conditions that are poorly addressed by the healthcare system today, such as chronic diseases or neurological disorders. In addition, they can often deliver treatment more cheaply than traditional therapy by reducing demands on clinicians’ time.”

A separate McKinsey interview article, titled ‘Exploring the potential of digital therapeutics’, published in the same month, elucidated the potential of digital therapy equally well.  It highlighted:“A digital therapeutic is an intervention based on software as the key ingredient, which has a direct impact on a disease. This is what distinguishes this category from the broader term digital health. We will see digital therapeutics and digital diagnostics integrate into the health system…”

‘Prescription digital therapy’ are not just ‘Fitness and Well-being’ Apps:

Prescription digital therapy are not just to monitor a person’s general fitness level against pre-identified parameters, and overall well-being. Whereas, digital therapeutics help patients to regularly and consistently monitor relevant and tailor-made disease related data - in real-time to detect behavioral, lifestyle and requisite biological changes on a daily basis. However, this is not ‘a so well-realized necessity’ today, especially, in the treatment of certain serious disease conditions, to ensure significantly better clinical outcomes for patients.

Digital therapeutics can ensure making a favorable change in patient behavior, which is not merely as efficient as administering medicines, but could also ensure greater effectiveness than conventional medications. Further, it assists patients to better understand, manage and control several disease conditions, and more importantly, sans any untoward side-effects.

Besides, with digital therapy, the required treatment interventions will reach patients faster than traditional treatment processes. Both the patient request and the medical response for the same can be quickly exchanged, together with relevant data support, through smartphones or other wearable digital interfaces – either in the form of voice or text or both. I shall dwell on this later in the article. Thus, digital therapy may not require patients to meet the doctor every time a need arises.

Moreover, fitness and wellbeing Apps do not require marketing approval from a country’s drug regulator. Mostly because, they help monitoring general and generic fitness parameters, capturing some low-risk changes. Whereas, a custom-made prescription digital therapy would necessarily require such regulatory nod.

In tandem, various studies are also being conducted on wearables, such as an Apple Watch, as an interface. The following are examples of some of these studies:

Digital therapy study with Apple Watch as an interface:

In February 2017, Takeda Pharmaceuticals U.S.A. and Cognition Kit Limited, announced a collaboration to pilot the use of a specially designed app on an Apple Watch wearable to monitor and assess cognitive function in patients with Major Depressive Disorder (MDD).

In November 2017, they presented results from ‘Digital Wearable Technology Study’ in patients with MDD. The observational study involved 30 participants, aged 18-65, with a clinical diagnosis of mild to moderate depression who have been prescribed antidepressant monotherapy for MDD.

The study also evaluated feasibility and participant compliance with measures of mood and cognition on wearable technology; and compared measures of mood and cognition on wearable technology using traditional neuropsychological testing and patient reported outcomes on depression symptoms at 6 weeks. Participants were provided with an Apple Watch on which brief cognitive and mood tests were administered daily.

The researchers observed that patients were compliant with the wearable Apple Watch device on a daily basis to evaluate mood (95 percent) and cognition (96 percent). The study also demonstrated that abbreviated daily assessments delivered through the wearable Apple Watch device corresponded with objective Cambridge Neuropsychological Test Automated Battery (CANTAB) cognitive tests and full-length patient reported outcomes, PHQ-9 and PDQ-D, assessed during weeks 1, 3 and 6. No adverse events were reported in the study.

According to another report, this user interface with Apple’s smart-watch versions 2 and 3 is now being used in a number of studies for chronic conditions, such as Parkinson’s disease – combining biometric data with user input. Again, in February 2017, Johns Hopkins University announced a project to use the smart-watch for research on possible triggers of epileptic seizures.

When used as an interface with prescription digital therapy, the provision of e-SIM and GPS in Apple Watch Series 3, I reckon, would also help patients to immediately communicate with the remote therapy centers using the same device, anytime – as and when the patients want.

Digital therapy initiatives in India:

Initiative on digital therapy has already started rolling in India, as well. Its pace is also quite encouraging. For example, Wellthy Therapeutics is building a patient centric solution for diabetes through digital intervention and management. On February 20, 2018, the Company, reportedly, shared the interim results of an ongoing real-world pilot to evaluate the effectiveness of the Wellthy Diabetes Smartphone App (WD). The results were shared at the 11th International Conference on Advanced Technologies and Treatments for Diabetes (ATTD 2018) in Vienna, Austria.

The data demonstrated how the use of WD improved glycemic control. On completion of 16 weeks, participants showed a reduction in their HbA1c by (-0.61%) on average, with 61.5% of participants having showed significant reduction in their HbA1c with an average of (-1.17%) reduction.

Conclusion:

As indicated in my article titled, ‘Digiceuticals: A Force Multiplier to Contain Chronic Diseases’, published in this blog on October 23, 2017,prescription digital therapies are primarily of two types – one for “medication augmentation” and the other for “medication replacement.”

Be that as it may, prescription digital therapyimproves clinical outcomes for patients by manifold. It also shows potential to take over from traditional treatment with medicines in several serious and virtually crippling ailments, mostly related to human behavior and lifestyle, such as a host of chronic diseases, and without causing any side-effects.

Thus, prescription digital therapy is now a reality. It has come to stay for long – can’t be wished away, any longer.

By: Tapan J. Ray

Disclaimer: The views/opinions expressed in this article are entirely my own, written in my individual and personal capacity. I do not represent any other person or organization for this opinion.