Advances in Digital Health Devices - 2015 Highlights

Advances in Digital Health Devices - 2015 Highlights

2015 was a busy year in the digital health devices industry. There were many advances in apps and devices designed to improve telemedicine and patient engagement, wearables monitoring chronic diseases, digital devices to assist visual impairment and rapid diagnostics for remote healthcare. This progress was assisted by continued investor interest. A recent year end review by Rock Health reported that in 2015 digital health venture funding topped $4.3B, maintaining a steady 7% of total venture funding while other sectors dipped.


Source: PwC MoneyTree (latest available is through Q3 only); digital health data based on Rock Health data. Note: Digital health only includes U.S. deals >$2M


The prospects for continued advances in 2016 look good. A new wave of digital health innovation is expected, powered by the increasing capability to stream and analyze data.

Here are a few of my favorite 2015 digital health devices:

Telemedicine

Does your child get frequent ear infections? No problem, ear exams can now be performed at home and streamed to a physician for diagnosis. CellScope introduced an ear probe attachment (Oto) that clips over an iPhone camera. The device streams footage of the inside of the ear to an app which can then be analyzed by a doctor on call. 

United Healthcare announced it would begin coverage of virtual doctor visits through Doctor On Demand, AmWell and NowClinic. 

Wearable Monitoring Devices for Patients

 Vital Connect introduced HealthPatch MD, a wearable, connected device that monitors heart activity and other vital signs. Designed for use in out-patient and home settings.

 Biotech Tattoos created buzz with their ability to monitor vital signs through electrical components worn directly on the skin. San Diego's UCSD nanoengineering department plans to take bio tats a step further by combining "bio ink" with a wearable sensor resulting in temporary tattoos that measure glucose levels in diabetics.

Google secured a patent for their prototype contact lens and reader/display unit to monitor glucose levels in diabetic patients.

MIT announced development of a prototype “smart” bandage to monitor wound healing, administer medication and alert a physician if further medical care is needed.

Digital Devices for the Visually Impaired

Be My Eyes smartphone app helps visually impaired people navigate everyday life through the assistance of sighted volunteers.

MIT announced they had completed a prototype for the Finger Reader, a wearable that reads text in real time. The device connects to an Android phone or tablet. Development of a wireless version that works with iPhones is in progress.

Patient Engagement

Minnesota Healthsolutions Corporation, Mayo and Novu received NIH funding to perform a study of the effects of digital health on COPD patient care.

Rapid Diagnostics for Remote Healthcare
Diagnostics for All foundation and Harvard University developed a prototype $2 paper-based microfluidic DNA rapid diagnostic device that can be used anywhere with the aid of a smartphone to read results.

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Panelists and topics:

Operations and Process Control
Marliese Bartz | Principal, Bartz Consulting

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Iryna Clark | Marketing Consultant, InceptPoint Consulting

Business Development
Madhushree Ghosh | Head, Alliance Management, Althea Dx

Patents and IP
Susan Gorman | Principal, Gorman IP Law

Funding
Martin Kleckner | Senior VP, SBDC TriTech

Regulatory
Mark Sarno | President, Vision Biotechnology Consulting

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Digital Tech Meets Healthcare: Great Potential & New Challenges

Digital Tech Meets Healthcare: Great Potential & New Challenges
by Sylvia Norman, PhD, PMP

The Potential
We've all heard about wireless wearable devices that help you track physical activity, eating habits, sleep patterns and weight. Useful tools indeed. More recently though, wireless tech has broadened its focus to include the healthcare market. New digital health devices are being developed that help diagnose disease onset, monitor chronic diseases and improve quality of life for disabled and aging populations.

Here are some of my recent favorites:

The FingerReader - a team at MIT is developing this wearable audio device to help visually impaired individuals read printed or electronic text.

Google Diabetes Contacts - a contact lens being developed by Google and Swiss pharmaceutical company Novartis that will track glucose levels in diabetics.

PEEK Vision iPhone app - brings the ability to diagnose vision impairment to developing countries. This smartphone app scans for visual acuity and can be used to diagnose glaucoma, macular degeneration and cataracts.

The Lively Sensor - San Francisco based Aging 2.0 works with other companies to develop tech products for the elderly. The Lively sensor will help family caregivers remotely monitor whether an elderly parent has taken their daily medication and performed other important tasks.

A Digital Health Forum at the recent 2014 BIO International Convention highlighted the vast market potential for digital healthcare. Panelists discussed benefits like increased patient access to healthcare, decreased medical cost, increased patient engagement, improved chronic disease management and disease prevention.

The Challenges
The panelists also pointed out that this promising technology brings it's own set of challenges. Our healthcare reimbursement system, FDA regulatory policies, patient data management infrastructure and patient privacy policies are not ready for digital health. These factors combine to have a negative impact on both digital health innovation and the willingness of health providers to use new digital health technology. A recent blog article by Jean-Luc Neptune, MD provides an informative assessment of current roadblocks to digital health innovation.  

The Future
The convergence of tech and biotech to develop new digital health products has enormous potential to improve the healthcare industry for both patients and providers. Yes, there are many challenges ahead, but dialogues to address them are in progress. For example, possible alternative reimbursement models are being discussed. In June 2014 the FDA released draft guidance to decrease regulation of medical device data systems (MDDS). The FDA stated it "recognizes that the progression to digital health offers the potential for better, more efficient patient care and improved health outcomes. To achieve this goal requires that many medical devices be interoperable with other types of medical devices and with various types of health information technology. The foundation for such inter-communication is hardware and software that transfer, store, convert formats, and display medical device data or medical imaging data." At a recent local regulatory event, Dr. Camille Nebekker, Division of Behavioral Medicine UCSD, discussed the ethical and regulatory challenges presented by digital health. She is currently working with IRB boards to help define and mitigate unique privacy issues for subjects enrolled in clinical trials utilizing digital technology. 

It's an exciting time for digital technology and healthcare. The convergence of these industries brings many new innovations and many challenges. Going forward let's remember this quote from Winston Churchill "the pessimist sees the difficulty in every opportunity; an optimist sees the opportunity in every difficulty."


Dr. Sylvia Norman is the Founder and Principal Consultant at Molecular Diagnostics Consulting.
Molecular Diagnostics Consulting Website
Molecular Diagnostics Consulting LinkedIn Company Page

Just Say Nay to the Naysayers

Just Say Nay to the Naysayers
by Sylvia Norman

"That will never work", "We tried that years ago", "You're wasting your time", "It can't be done". How many times have you heard these comments after presenting an innovative idea? Are they right? Maybe. Should we listen to them? NO! Well, at least not until we examine the real meaning behind the Nay.

There is nothing new about Naysayers. They've been at it for a long time. You've heard the saying "There is nothing new under the sun." Well that was written thousands of year ago. If innovators had believed THAT, the agricultural, industrial, digital and biotech revolutions would never have happened. Luckily, innovators thrive on a good challenge and aren't easily discouraged. The idea for the first Apple computer was rejected 5 times by Hewlett Packard, but that didn't stop Apple co-founders Steve Jobs and Steve Wozniak. They pitched their idea to other companies, assembled their first computers in a garage and the rest is history.

The truth is, sometimes naysayers are right and our idea will fail, but sometimes they are wrong. So what is the best approach when faced with all this negativity? Just say nay to the naysayers, then take a look at the real meaning behind their words. It may be true that some version of your idea was tried in the past. But so what? Did it fail because there wasn't a market for it? Maybe that's changed. Maybe there's a niche market that was never explored. Has new technology been invented that will make it work now? Did the idea fail for lack of funding or because it didn't align with corporate goals? Did it languish for lack of persistence? These are all good questions to ask yourself. They'll help turn the negative into a positive motivation. They'll help you focus on the important questions and maybe even shed light on new inspiration.

In a recent interview, our society's most prolific innovator called on the biotech industry to find innovative breakthroughs in clean energy, access to vaccines, cures for cancer, diabetes, Alzheimer's and other diseases Richard Branson BIO 2014 Interview. Oh and by the way, he mentioned a $20M prize for extracting carbon out the earth's atmosphere to help control climate change. Now that's a clear call to action! In his keynote speech Richard Branson challenged the audience to "innovate in everything you do." A clear call to make creative, positive changes in every aspect of our lives -  professional and personal. So next time you encounter a naysayer, just say NAY then go out and INNOVATE.

New Priorities for Biotech in the Global Market

New Priorities for Biotech in the Global Market
by Sylvia Norman, PhD, PMP

Dr. Trevor Mundel, President of the Global Health Division, Bill & Melinda Gates Foundation provided an inspiring start to the 2014 BIO International Convention forums on Emerging Opportunities in Global Markets. In a plenary session interview with journalist David Brancaccio, he discussed the soon-to-be released 2013 Global Burden of Disease Study. The study focused on the 70 poorest countries of the world and identified infectious diseases (TB, malaria, HIV, childhood pneumonia, etc.) as the highest priority for disease prevention and treatment. Dr. Mundel said that in spite of technological advances in vaccines and diagnostics, mosquito netting for beds remains the most cost-effective intervention against malaria. Why? Current vaccines and diagnostics for infectious diseases do not address the developing countries market need for low-cost products, distribution and long-term ambient temperature shelf life.

When asked for a list of the Gates Foundation's top priority biotech products, Dr. Mundel responded:
1) an infection control surveillance device that detects if a person in the room has an infectious disease
2) biomarkers for predicting risk of preterm birth

Poor return on investment (ROI) is frequently cited as a reason for not developing products for use in developing countries. David Brancaccio and Dr. Mundel said that every day 20,000 children die of treatable diseases. The majority of these occur in developing countries where infectious diseases, not diabetes or cancer are the primary cause of disease-related deaths. With a statistic like that, isn't it time for our Biotech industry to realign our priorities and broaden the definition of ROI?

Check out the BIO Buzz Center interview with Dr. Mundel for more information on how Biotech can help prevent deaths from treatable diseases in developing countries.

Biotech Opportunities in Emerging Markets - 2014 BIO Updates

Biotech Opportunities in Emerging Markets - 2014 BIO Updates
by Sylvia Norman, PhD, PMP

One of the highlights of the 2014 BIO International Convention in San Diego June 23-26, 2014 will be the forums on Emerging Opportunities in Global Markets. Marketplace Morning Report host David Brancaccio will kick-off the program with an interview of Dr. Trevor Mundel, President of the Global Health Division, Bill and Melinda Gates Foundation. The 3 day program includes half day sessions on China's biotech industry, Russia's pharmaceutical industry and the biotech/pharma landscapes in Brazil & India. Additional sessions on emerging markets in Africa and the Middle East, updates on patent & regulatory policy trends and trade agreements will round out the schedule.

In recent years, economic woes, political turmoil, regulatory compliance issues and allegations of misconduct have seemingly dimmed the once bright prospects of investing in emerging biotech/pharma global markets. Or maybe not. Just last month Sequoia Capital announced a $530 million investment fund intended to benefit healthcare and technology startups in India: India Tech and Healthcare Startups Investment. In April 2014 the formation of the Brazilian Industrial Biotech Association (ABBI) was announced. This new trade association collaborative between Brazil and leading global biotech companies & institutions has the goal of promoting interaction between stakeholders, policy makers and the public to improve Industrial Biotech R&D funding, regulatory policy and patent legislation. Global partnering with China biotech/pharma and recent US facility expansions to other Asian countries is on the increase.

The 2014 BIO convention program on emerging markets and daily International Market Briefings provide a great opportunity to learn the current status of global market biotech/pharma collaborations. The Exhibit Hall International Pavilions and hospitality receptions will provide welcome opportunities to network and explore synergies between businesses. Stay tuned this week as I explore opportunities to bring global collaborations to my business.

LONGEVITY - Genetics, Diagnostics and a Good Attitude

LONGEVITY – Genetics, Diagnostics and a Good Attitude

This week my mom will be celebrating her 100^th birthday. Relatives and friends will be arriving from all over the country to help her celebrate this momentous occasion. It seems like we hear of people reaching this milestone fairly frequently, but it still has the power to amaze. People who don't even know my mom have asked me to relay their heartfelt congratulations. The most amazing part is that my mom doesn't think she’s “old”. In her mind, she’s at least 20 years younger. Mom keeps up with current events, plays cards, makes new friends and remembers things I've long forgotten. In fact, until 3 years ago, mom was living by herself on a farm, gardening and mowing her lawn. Good health, a sharp mind and a willingness to keep learning new things – isn't that what we all hope for in our senior years?  But how do we make sure we attain that? Can we somehow avoid the diseases that plague many senior citizens e.g. Alzheimer's, Parkinson's, Type 2 diabetes, strokes, heart disease and cancer? Or are we at the mercy of our family genetics?

Recently, we've been hearing a lot about 2 research projects addressing these questions by utilizing advances in genetics and medicine to look for clues to longevity - The Human Longevity, Inc project and The 90+ Study.

The Human Longevity Inc project  - Dr. J. Craig Venter recently announced the goal of his new company, Human Longevity Inc.(HLI), is to sequence the genomes of over 40,000 individuals per year to identify ways to live longer and healthier lives. HLI co-founder Dr. Peter Diamandis apparently agrees with my mom's view of her age, declaring "100 will become the new 60".

The 90+ Study - The University of California, Irvine 90+ Study compiled physical, cognitive and questionnaire data from 1600 retirement community residents over the age of 90. In a recent interview, Dr. Claudia Kawas revealed a few surprising results e.g. taking vitamins didn't contribute to longer life, moderate alcohol consumption (2 drinks/day) increased longevity, exercising just 15 minutes per day and keeping socially active also contributed to extended life expectancy. The 90+ Study has been granted an extension to include PET and MRI scan experiments to study Alzheimer's and other forms of dementia in this population.

How will sequencing genomes and PET/MRI scans help unlock the secrets to longevity? Understanding the genes and biological pathways contributing to diseases like Alzheimer's, Parkinson's, Type 2 diabetes, strokes, heart disease and cancer will help physicians find more effective ways to diagnose and treat these diseases. Molecular diagnostics and personalized medicine will play a primary role in this effort by providing medical tests that physicians can use to monitor the health of aging patients and determine the best course of prevention or treatment of age-related diseases.

It's important to keep in mind that advances in longevity genetics, diagnostics and medicine won't translate into eternal youth anytime in the near future. We can still expect to acquire certain diseases, gain weight, move slower and look older as we age. That's where the good attitude comes in. Mom wakes up every day looking forward to what new surprises and challenges life will bring her. In fact, I'm sure that attitude is at least partially responsible for her longevity. Happy 100th Birthday, Mom!

The Ambitious Goal of Harmonizing Global Biobanking

Biobanks have become an essential tool for advances in genomics and biotechnology.  Access to large specimen collections with associated patient genotypic and phenotypic data is especially important to biomarker discovery for cancers and genetic diseases.  There are numerous biobanks in existence, but no internationally-accepted governance process is currently available to standardize the many ethical, legal and social implications (ELSI).  Some of these issues include ensuring high quality samples and  data, appropriate patient consent, secure de-identification & storage of patient data and standardized practices for patient phenotype characterization.  Harmonization of biobanking operational procedures and policies is key to the ability to share specimens and associated data (1). 

Patient Privacy and Consent Issues

While there is general consensus on the need to address the issue of patient privacy, there is a general lack of consensus on implementation.  The “broad consent” model has been adopted by many biobanks in an attempt to solve the problem of making samples available for multiple projects.  However, some experts argue these are not really informed consents since aims of future projects cannot be specified (2).  Broad consents leave patients vulnerable to loss of control over their biological samples and so may result in decreased donor participation.  A “dynamic consent” model has been proposed which would allow donors to extend or revoke consent for new projects via a web-based system (2).

Ownership of samples is a hotly debated issue with the most well-known examples being the cases of Henrietta Lacks and John Moore.  In the US, the debate has centered on whether donated samples can be viewed as property (3).

Ursin et al. (4) provide an enlightening glimpse of how study patients perceive privacy and consent.  Their focus group results revealed that patients are primarily concerned with self-determination (control), harm, respect, freedom, confidentiality and discretion.  The most interesting insight was that patients view consent as the expectation that their sample will be treated with respect.

Securing Data-Linked Sample Information

The ability of biobanks to share patient data between multiple studies requires absolute assurance that sensitive patient information is protected. This includes secure de-identification methods as well as secure storage of genotypic and associated phenotypic data.  Tracker detection, anonymization of data sets and statistical blurring of query results are proposed technical strategies for preserving donor anonymity while allowing access to biobank information systems (5).

Progress in Global Biobanking Harmonization

Progress towards the goal of harmonization has been accelerated in Europe by initiatives funded by the European Commission.  These harmonization projects include Promoting Harmonization of Epidemiological Biobanks in Europe (PHOEBE), Biobank Standardisation and Harmonization for Research Excellence in the European Union (BioSHaRE-EU) and the International Society for Biological and Environmental Repositories (ISBER).  The BBMRI (Biobanking and Biomolecular Resources Research Infrastructure) consortium was formed to improve accessibility and interoperability of existing European biobank collections.  This consortium consists of 54 members with 225 associated organizations (mostly biobanks) from over 30 countries (http://bbmri-eric.eu/).  The preparatory phase of BBMRI is complete and implementation under the European Research Infrastructure Consortium (ERIC) is scheduled to begin in 2014.  Harris et al. (6) provide a comprehensive review of biobanking infrastructure, bridging and harmonization efforts in Europe.  Numerous other international organizations and initiatives are already in place to aid in the development of global biobank harmonization (1).  Although global harmonization of biobanking remains a daunting task, recent progress made by international organizations and initiatives suggest this ambitious goal is attainable.

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