Wednesday, July 15, 2015

Healthwear – Beyond Bracelets and Watches




By Bhargav Rajan
Senior Research Analyst
Healthcare Division, Technical Insights

Frost & Sullivan






When Norman J Holter developed the world’s first ambulatory cardiac monitor, and arguably the world’s first wearable device, it weighed 85 pounds and it had to be worn like a backpack. Since the modern transistor had not been invented then, the electrical data that the device picked up from the patient’s heart had to be transmitted through radio signals. For the very first time, a patient’s electrophysiological activity was recorded while he was mobile, although Holter himself noted that the form factor of his revolutionary device was “not practical”. By the end of his lifetime, he had successfully managed to shrink the device to the size of a briefcase.

Even a visionary such as Holter, who dreamt of a device that would measure cardiac activity on “skiers, parachute jumpers and runners”, would be surprised to find today’s explosive growth and rapid innovations in the field of wearable devices.

The Plateau

Yet, in spite of the pace of innovations, it appears that the field of wearable devices has hit a plateau in the technology adoption cycle. The effusive reception that smart watches and wristbands were welcomed with a few years ago, has been replaced by a bit of a disappointment with their capabilities. Every product launch is preceded with great anticipation and is met with grumbling acceptance of the new product’s incremental improvements. Nearly all forms of wearable devices – wristbands, watches and glasses – have been touted as the “next big thing” in consumer electronics, only to settle down in public memory as a “work in progress”.

A major reason for this adoption plateau is that the current crop of wearable devices does very little other than track physical activity. In other words, wearable devices have become synonymous in the minds of the users - and perhaps developers as well - with activity trackers. Wearables are indeed a great tool for tracking physical activity (FitBit,  Misfit, Moov) and sleep patterns (Pebble, Jawbone), but it would be a great travesty if they end up doing just that. Beyond fitness tracking is an ocean of medical and wellness applications for wearable devices that is yet to be explored.

We have identified emerging and future healthcare applications of next-generation wearable devices, Wearables 3.0, classified under diagnostics, monitoring and therapeutics. The delineation between monitoring and diagnostics is a thin line in the case of wearables. Diagnostic wearables are used to confirm the presence of a particular health condition, an erratic heart rhythm, or brain signals indicative of seizures. Wearable devices used for monitoring measure and store physiological data continuously, usually to gauge the progress of a treatment. Therapeutic wearable devices refer to their use in the treatment of clinical conditions.

Wearables 3.0

Wearable devices are built on a simple technological foundation – record physiological data and use them to monitor the overall well-being of the user. So why limit to just measuring electrophysiological data from the wrist to calculate pulse, or use the gyroscope to measure the steps taken in a day?

Health Diagnostics and Wellness Monitoring

EEG Headsets

A particularly interesting wearable device that is on the cusp of mass adoption is the wearable EEG device. No less than a dozen companies (Emotiv Lifesciences, Neurosky, Interaxon, Advanced Brain Monitoring, Thync to name a few) are developing lightweight, wireless and portable EEG headsets. Designed as simple headbands or helmets, these devices can record the brain activity and wirelessly transmit the readings to a paired phone or a computer. In a manner of functioning, portable EEG headsets work the same way as heart monitors and wrist bands. Continuous monitoring of brain activity can of course provide information about the quality of sleep, but beyond that, it can warn of impending seizures, give insights into mood swings, cognition and emotional states of the user. Given the growing awareness of mental health, wearable brain activity monitors can play an important role in the years to come. Wearable EEG headsets are the foundation on which the promising and much-researched field of brain-computer interfaces rests on.

eLens

Around 2013, just as critics were panning the Google Glass for being “gimmicky”, news tricked out that Google was developing a far more cutting-edge wearable eye device - a smart contact lens or an electronic lens. The lens was supposed to be lined with electronic sensors that could measure the level of glucose in the wearer’s tears and transmit it to a receiver nearby. In rapid succession, companies such as Sensimed and Johnson and Johnson and a host of university research groups revealed that they too were working on electronic lenses. Electronic contact lenses are very much in the prototype stage, and make take a few years to enter the market, but their potential is undeniable. From monitoring glucose levels without drawing blood, measuring the intra-ocular pressure, perform routine eye tests and augment vision, their applications are myriad, based only on the sensors that form the lens architecture.

Smart Fabrics

One of the disappointments with the current generation of wearable devices is that they are bulky, conspicuous by their design and positioning, and not always fashionable. The most intuitive solution to these concerns is of course to completely integrate the electronics and sensing capabilities into the wearer’s fabric. Enter smart fabrics. Smart fabrics are a class of textiles that can, among other functions, communicate, monitor, transform and even conduct energy. The variety of players who are investing in and actively researching the smart fabrics landscape is staggering and speaks to the potential of the technology. Sportswear experts such as Nike and Adidas, sensor companies such as BeBop Sensors and clothing companies such as AiQ Smart Clothing, Levis and many more along the technology chain are working on intelligent, interactive and functional fabrics.   

eTattoo

Perhaps the ultimate form of technology integration would be to have the wearable devices embedded on to the skin of the user – sort of an electronic tattoo. Firmly in the realm of academic research, these “devices” are actually stretchable skin-like material with electronic Okcircuits and sensors printed on them. These “tattoos” can sense electromyographic signals, measure blood toxicity levels, pick up the precise electrical data from the heart or brain, accurately measure core body temperature and so on. Aided in no small due to the rapid innovations in flexible electronics and ultrathin sensor systems, these skin-hugging wearables may be the final destination that began with an 80-pound wearable device.

Therapeutics

Drug Pumps

A truly niche wearable medical device would be wearable drug injectors, or pumps. As the name suggests, these are body-worn cartridges or reservoirs of essential drugs – monoclonal antibodies, immunoglobulins, biologics and so on – drugs that cannot be administered orally due to pharmacokinetic complications. An effective, and automated, method of delivering medications would be body-worn devices that would subcutaneously deliver medications at pre-set quantities and at the appropriate time. Such wearable devices would greatly benefit patients on chronic medications, such as insulin, and patients with a propensity to forget medications ensuring compliance to prescribed medication. Already companies such Amgen MedImmune and Unilife have wearable drug injectors. Given the wearable injectors are in the interest of the multi-billion dollar biologics market, this class of wearable devices are also likely to be an area to watch out for in the near future. 

Neurostimulation

Electrical stimulation of the brain and the peripheral nervous system has been a clinical practice for several decades now. This involves the use of wired electrodes supplying mild electrical impulses to manage pain, restore hearing, manage and control seizures, tremors and so on. With the advent of wearables, neurostimulation can be made available as over-the-counter use, outside the clinical setting. Belgium-based Cefaly Technology has developed portable headbands that supply micro-impulses that stimulate the trigeminal nerve, as a way of compensating for electrical activity that leads to migraine headaches. Massachusetts-based NeuroMetrix has two wearable products that are designed to provide non-invasive neurostimulation to provide relief from chronic pain caused due to diabetes, sciatica, fibromyalgia, and other conditions.

Enabling Technologies

Throughout the year, Technical Insights, the technology consulting arm of Frost & Sullivan, identifies and profiles innovations in various industries, keeping our finger on the pulse of the global innovation landscape. Of the hundreds of technologies, products and platforms that we write about, we identify 50 technologies that we believe will make a big impact in the following year. When we did this exercise earlier this year, we noticed that no fewer than 10 technologies that made it to our top 50 list were directly driving innovations in wearable devices. Technical Insights’ TechVision 2015 identifies and provides a multi-dimensional profile of technologies such as flexible electronics, smart sensors, smart fabrics, lightweight composites, sensor fusion, cloud computing, neuroprosthetics and brain-computer interface, each of which are key to the burgeoning field of wearable devices.

Beyond Quantified Self

Earlier in the article, I mentioned that the term wearable devices have come to be associated with activity tracking. The plethora of technologies that were subsequently described throws light on the possibilities beyond quantified self. Wearable devices are certain to change the nature of fitness, health monitoring and drug delivery. But even these do not describe the picture in its entirety.
Every aspect of healthcare – surgery, medical imaging, wound care, diagnostics, health informatics, population health management – stands to be benefitted by wearable devices. It would not be an exaggeration to view wearable healthcare devices, or healthwear, as the single biggest enabler of personalized healthcare delivery.

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Bhargav Rajan is a Senior Research Analyst working with the Healthcare Division of Technical Insights, Frost & Sullivan. He tracks innovations in medical devices, medical imaging, clinical diagnostics and healthcare practices. Bhargav holds a Master’s degree in Biomedical Engineering from the University of Florida, Gainesville, and has academic and industry experience in regenerative medicine and tissue engineering. He can be reached at bhargavr@frost.com.  

TechVision is the flagship research service of Technical Insights. The TechVision program profiles and analyzes the growth dynamics of 50 cutting-edge technologies. To know more about these technologies, how they converge with each other and how you can use this information to your growth advantage on our website.

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Look for Bhargav Rajan and other Frost & Sullivan Analysts at our next
Medical Technologies 2016: A Frost & Sullivan Executive MindXchange event.

Tuesday, July 14, 2015

Facilitating Drug Development:
Optimizing the Person-Provider Encounter



By Frederick A. Curro, D.M.D. Ph.D.
Director, PEARL Clinical Translational Network
Clinical Professor, New York University






The Affordable Care Act (ACA) has broadened the responsibility of health and healthcare to include the person as well as when they become a patient. It has also widened the perspective on how we view health and healthcare recognizing that they are dependent variables where the outcome of one affects the outcome of the other. It can be viewed as a continuum where the person may experience becoming a patient many times in the course of their life but for the most part their health would be dependent upon what they do as a person.

This movement from healthcare to health and away from disease management has the person becoming an active participant in the outcome of their own healthcare. This concept of shared responsibility has the patient responsible for their compliance to both their health and healthcare. Medications can no longer be a substitute for a lifestyle that brought on the condition without the patient becoming more aware of lifestyle changes to possibly avoid the condition in the first place. The ACA has caused the present healthcare system to be introspective. Considering what the fixed variables would be in a new healthcare paradigm the person/patient encounter is the single most important aspect that one can consider to be a starting point. Other aspects of health and healthcare such as cost of drugs and drug development can be affected by this encounter if they are considered as dependent variables in an integrated system. 


Integrating the principles of clinical research with clinical practice to conduct person-centric clinical trials is one way of optimizing the person/patient encounter for an integrated system. Such a system can reduce drug development costs, facilitate the dissemination of current information to optimize clinical practice by closing the scientific gap from bench to practice, and provide an infrastructure for quality assured data that can be used for decision making purposes and incorporated in the “big data” concept.


Raising the person/patient/provider from an observational encounter to the level of a quality assured data point translates the medical encounter to a usable data point for best practice, submission to regulatory agencies for phase III and IV clinical studies, and creates an audit trail for both the provider and person/patient. It also provides a means for transparency and health care literacy. The audit trail for the provider can be used to lessen multiple claims that contribute to cost increases and fraudulent claims. The audit trail for the person keeps the person/patient informed to maintain a level of continued compliance to reduce further complications and/or to increase the treatment outcomes.


The missing component from many health care programs is an infrastructure that connects patients/persons with providers and third party payers. All of these moving parts should be in sync to optimize the efficiency of the system. Point-of-care quality assured data can lower the developmental costs for pharmaceutical companies to conduct clinical studies, provide meaningful patients that would be on the medication with a known medical history. Patients would be informed for their assessment and input, and side effects would be more interpretable to providers reporting the effects of the medication as the patient’s medical history would be transparent. In addition, patient compliance on the use of the medication would be improved as they have a vested interest under the concept of person/patient-centered care, recruitment costs to a study would be reduced to a minimum, and the data generated by the providers would be more readily accepted by the profession at large. 


Improving the person/patient encounter to a quality assured data point reduces the intensity and costs of oversight and the data can be cross referenced by many of the healthcare partners. This model proposes to integrate many of the steps in health and healthcare that are currently discrete and make them continuous and dependent upon each other so that the system is optimized and readily utilizable by the profession and the person/patient. The process would contribute to lessening the scientific gap by facilitating information transfer to the practitioners. 


Frederick A. Curro, D.M.D., Ph.D.
 

Frederick A. Curro is currently a Clinical Professor at New York University where, under the auspices of an NIH grant he and two colleagues built and directed “Practitioners Engaged in Applied Research & Learning” (PEARL) a Practice Based Translational Network. PEARL conducts person-centric clinical trials to improve health and healthcare delivery and conducts comparative effectiveness clinical studies for best practice.

Curro’s pharmaceutical career has included positions as Vice President of GlaxoSmithKline; Corporate Vice President of Clinical, Medical & Regulatory Affairs at the Block Drug Co. Inc.; Head of Reed & Carnrick Pharmaceutical, a division of Block Drug; and Executive Director of Clinical Operations & Research at Transkaryotic Therapies (TKT) Inc. of Cambridge, MA.


Curro was also a former Professor and Chairman, Department of Pharmacology at Fairleigh Dickinson University and has held faculty positions at the University of Texas at Houston and SUNY/Buffalo. His clinical expertise is in pain management.
 

Building Engagement Through Analytics




By Shawn Miller
Director of Market Analytics
Philips Healthcare North America








Let’s help our Medical Device organizations build engagement through powerful analytics.   In other words, let’s not just provide data, but rather, help drive action planning to improve top line performance.  But how do we do that? 
First – let us define and use a common terminology:

Analytics – industry data and market intelligence related to market size, trends, growth, market share, win/loss, “visibility” (percentage of deals your sales team sees), competitive analysis and related information
Engagement – understanding and action based on the data
You want your clients to be engaged in your output – your clients or stakeholders being senior management including marketing and sales leadership and the sales organization down to the individual Account Manager.

Building engagement
Here are some things I have learned to build engagement:
 

  1. It’s like playing golf.  You need to keep score, you need immediate feedback and you need to provide your organization with a good scorecard.    Examples would be providing quarterly market size and share data, providing quarterly win/loss and visibility metrics, customer satisfaction data, etc.
  2. Don’t “high 5” too early.  Have a great quarter?  I would argue the bigger question is, “how did you do bumped up against the market?”  That is, if you grew 5% in a particular segment, and the market grew 10%, you lost.  You lost market share.  You may have “high 5’d” each other for a great quarter that met plan, but you lost to your competitors.  So include in your analysis, not just company performance, but company performance compared to market performance.   This is hard to do in practice because sometimes the data just isn’t available.  More on that below.  And this analysis should be provided at regular intervals; I recommend quarterly.
  3. Execute.  I have seen a lot of people over-promise and under-deliver when it comes to providing data and analytics.  For example, we have been promising “dashboards” to the field sales organization for several years but have not yet been able to provide a workable solution.  This sounds simple, but I’m more convinced than ever that execution, doing what you say you will do, is a skill and an art that less and less people have.     You’ve heard the adage, “Under promise, over deliver”.  This is true with analytics.  Promise something you can’t deliver and you and your team will lose credibility.
  4. Don’t say “No” twice.  You can say it once – “No, I don’t have that information now”.  Or no I can’t figure it out.  I once had a manager say, “figure it out, or I’ll find someone who can” (he eventually tried with an outside consultant and the consultant failed).  But the point is valid – say no…once…that’s OK, but caveat it with “I’ll figure it out”.   Find the data.  If you don’t have the data, put together a budget, an RFP and do the research.  If that won’t work, which is often the case for market sizing efforts, figure out a way to model or forecast it.
  5. Go to Vegas.  If you don’t know the answer, model it.  There are great skills to be learned in Vegas.  Poker and black jack are about estimating, and making educating judgments and betting based on the odds and your likelihood of winning.  This isn’t much different from estimating in business and building robust models based on outcome probabilities.  My Dad taught me poker and chess, and there are embedded life lessons and skills I use every day in building market models and planning.
  6. Discuss it, don’t just send it.  Email is not a great forum for sharing complex data.  Even simple data can be often misinterpreted because it is read quickly and often not understood in context.  It’s OK to send it out initially, but setup a meeting to discuss it, especially if it is new data or new analysis.  It will take more time on your part, but there is tremendous value in the discussion
Following these straightforward guidelines will make a dramatic difference in the credibility and usefulness of our analytics and market intelligence functions.  So go ahead, play some golf, gamble in Vegas and learn not to say “No” and then apply these skills to your analytics and see what amazing things happen!

Shawn Miller is the Director of Market Analytics at Philips Healthcare.   Shawn has held a variety of positions in Marketing, Sales, Market Analytics, Market Intelligence and IT.  He doesn’t play golf, but he does play chess, poker, likes betting on horses, build models and gives lots of “high 5’s” when company performance exceeds market performance.

    Top Companies Disrupting Healthcare In 2015



    By Reenita Das
    Partner and Senior Vice President
    Healthcare and Life Sciences

    Frost & Sullivan





    Healthcare is the worlds largest industry today - it is three times larger than the banking sector. After lagging behind for almost five decades, this industry is revitalizing and transforming itself faster than any other vertical.


    Improving the healthcare system requires simultaneous pursuit of three aims (commonly referred to as the Triple Aim): enhancing the experience of care, bettering the health of populations and reducing per capita costs of healthcare. For this to happen, some major seismic shifts will need to take place. Today healthcare is about the following:

    • Wellness
    • Prevention
    • Consumer centric and integrated
    • Participatory: patients helping other patients
    • Personalization & Precision
    • Outcomes
    • Engagement
    • Digitization
    • Consumerization
    • Interoperability
    • Continuum of Care

    Through Frost & Sullivan’s research, we have identified nine areas that are expected to see the most disruption and transformation within the eco system. The list above discloses the areas that will be targets for disruption. Companies that provide solutions addressing the needs in the following areas will be the winners to come.

    Our team of analysts and myself constantly place bets on new companies. In the following chart, Frost & Sullivan unveils their 2015 list of the top contenders in this space.



    Figure 2 lists the top 10 companies disrupting healthcare in 2015- 2016 and the impact of their interference within the industry.

    Stay tuned for the next update on the top 10 non-healthcare companies invading and disrupting the healthcare spectrum.


    This content was written with contribution from Venkat Rajan, Global Director with Frost & Sullivan’s Visionary Healthcare Program.

    Look for Reenita Das, Venkat Rajan, and other Frost & Sullivan Analysts at our next Medical Technologies 2016: A Frost & Sullivan Executive MindXchange event.