Pear Therapeutics, once a leader in prescription digital therapeutics (PDT or DTx), has recently filed for bankruptcy. In this blog post, we’ll explore the history of the company, its milestones, and the reasons behind its unforeseen downfall, while also shedding light on its competitors in the digital therapeutics market.
Pear Therapeutics: History
Established in 2013 by Dr. Corey McCann, Pear Therapeutics aspired to revolutionize the treatment of various disorders by merging the power of software and medicine. Based in Boston, Massachusetts, the company aimed to develop, manufacture, and distribute FDA-approved software applications that would work in tandem with conventional medications to enhance their effectiveness.
Pear Therapeutics’ Key Achievements
Throughout its existence, Pear Therapeutics managed to obtain three FDA approvals for its products, establishing itself as a significant player in the digital therapeutics industry:
reSET (2017) – The first FDA-approved PDT, reSET is designed for treating substance use disorder. This groundbreaking achievement demonstrated that software could be clinically effective in treating patients.
reSET-O (2018) – A follow-up to reSET, this PDT is aimed at helping patients with opioid use disorder as an adjunct to outpatient treatment. It includes buprenorphine and contingency management, a behavioral therapy approach.
Somryst (2020) – The first FDA-approved PDT for chronic insomnia, Somryst offers cognitive behavioral therapy for insomnia (CBT-I) through a digital platform, making it more accessible for patients who might not have access to in-person therapy.
Partnerships and Collaborations
Throughout its journey, Pear Therapeutics partnered with several industry giants to develop and distribute its PDTs. These collaborations included deals with Novartis, Sandoz, and Blue Cross Blue Shield, among others.
The Path to Bankruptcy: Crucial Factors
Market Penetration and Adoption Challenges
Despite the groundbreaking nature of its PDTs, Pear Therapeutics faced significant challenges in gaining market traction. The healthcare industry is often slow to adopt new technologies, and the novel concept of PDTs faced resistance from both physicians and insurers.
One of the most significant hurdles for Pear Therapeutics was obtaining adequate reimbursement from insurance companies. Many insurers were hesitant to cover the costs of the treatments, which made it difficult for patients to access them.
High Development and Marketing Costs
Developing PDTs is a time-consuming and costly process. Pear Therapeutics had to invest heavily in research, development, and clinical trials to bring its products to market. Additionally, the company faced considerable marketing expenses to promote its PDTs in a market dominated by traditional pharmaceuticals.
Some critics argue that Pear Therapeutics’ management made a series of missteps that ultimately contributed to the company’s downfall. This includes an overemphasis on partnerships at the expense of product innovation, and a lack of clear, focused strategies to address the challenges faced in the market.
COVID-19 Pandemic Impact
The COVID-19 pandemic brought about significant challenges for Pear Therapeutics, particularly in the area of patient access. As healthcare providers struggled to adapt to the new normal, digital therapeutics adoption was deprioritized, and this further impeded the company’s growth.
Competitors in the Digital Therapeutics Space
While Pear Therapeutics was a pioneer in the prescription digital therapeutics (PDT) field, it wasn’t the only company trying to make its mark. Some of the key competitors in the digital therapeutics market include:
Akili Interactive is a Boston-based company that has developed EndeavorRx, the first FDA-approved video game for treating attention deficit hyperactivity disorder (ADHD) in children. EndeavorRx is a digital intervention that aims to improve attention function in pediatric patients with ADHD.
Voluntis, a French digital therapeutics company, specializes in creating software to assist patients in managing chronic conditions. Their flagship product, Insulia, is an FDA-cleared digital therapeutic designed to help patients with type 2 diabetes manage their insulin dosages.
Big Health, a UK-based company, focuses on developing digital therapeutics for mental health. Their two major products are Sleepio, a digital CBT-I program for insomnia, and Daylight, a digital CBT-based program for anxiety. While not FDA-approved like Pear’s Somryst, Sleepio has demonstrated clinical effectiveness in multiple studies.
Omada Health is a San Francisco-based digital health company that offers a suite of digital programs aimed at chronic disease prevention and management. Their flagship program, the Omada Diabetes Prevention Program, is a CDC-recognized digital intervention to help patients with prediabetes make lifestyle changes to prevent or delay the onset of type 2 diabetes.
Click Therapeutics, a New York-based digital therapeutics company, is focused on developing software as a prescription medical treatment. One of their most prominent products, Clickotine, is a digital smoking cessation program designed to help users quit smoking. The company is also working on a digital treatment for major depressive disorder called CT-152, currently in clinical trials.
Pear Therapeutics was a trailblazer in the field of prescription digital therapeutics, achieving FDA approvals and forging partnerships with industry giants. However, the company’s inability to overcome market penetration, adoption, and reimbursement challenges, coupled with high development costs, management missteps, and the impact of the COVID-19 pandemic, ultimately led to its bankruptcy. With multiple players such as Akili Interactive, Voluntis, Big Health, Omada Health, and Click Therapeutics still in the game, it remains to be seen how the digital therapeutics landscape will evolve and what future innovations may emerge.
Beginning of March 2023 Bigfoot Medical announced it has FDA clearance for the Android version of the Bigfoot Unity® Mobile App, a necessary component of the Bigfoot Unity® Diabetes Management System. Given that 41 percent of U.S. smartphone users choose Android devices, this clearance enables expanded access to a large group of people with Type 2 diabetes. Bigfoot Unity has been compatible with iOS devices since May 2021.
The medical device landscape is continuously evolving, with companies like Bigfoot Medical revolutionizing diabetes care through cutting-edge technology and artificial intelligence. In this post, we explore the history, achievements, and future prospects of Bigfoot Medical, an industry leader in diabetes management solutions.
Early Days: Laying the Groundwork for Success
Founded in 2014 by Jeffrey Brewer and Bryan Mazlish, Bigfoot Medical was driven by a personal connection to the challenges of diabetes management. Their goal is to create an integrated system that simplifies and enhances diabetes care using advanced technology and AI.
From day one, Bigfoot Medical focused on patient-centric solutions, which has been instrumental in their success and significant progress in the diabetes care sector.
Achievements: Transforming Diabetes Care with Bigfoot Unity™
Bigfoot Medical’s flagship product, the Bigfoot Unity™ Diabetes Management System, is an innovative solution that combines a continuous glucose monitor (CGM), insulin pen caps, and a mobile app to provide a seamless, data-driven experience for those living with insulin-requiring diabetes.
Key achievements of Bigfoot Medical include:
FDA Approval: In 2021, Bigfoot Medical received FDA clearance for the Bigfoot Unity™ System, a major milestone in their journey.
Enhanced Patient Outcomes: The Bigfoot Unity™ System has demonstrated improved glycemic control, reduced hypoglycemic events, and enhanced quality of life for users.
Strategic Partnerships: Bigfoot Medical has formed alliances with industry leaders like Abbott, ensuring technology integration and broader patient reach.
Awards and Recognitions: The company has garnered numerous accolades, such as being named one of Fast Company’s Most Innovative Companies in 2021.
Competition and Market Size: Navigating a Dynamic Industry
The global diabetes care devices market is substantial, with a value of $20.0 billion in 2020, and is projected to reach $38.3 billion by 2030, growing at a CAGR of 6.6% from 2021 to 2030. This significant market size is attributed to the increasing prevalence of diabetes, the need for better management solutions, and rising awareness about diabetes care. In such a dynamic industry, Bigfoot Medical faces competition from various established and emerging players, such as Medtronic, Dexcom, Insulet, and Tandem Diabetes Care, which offer insulin pumps, CGMs, and other diabetes management solutions.
Despite the competitive landscape, Bigfoot Medical differentiates itself through its unique, integrated approach to diabetes care, focusing on providing a seamless, data-driven experience for users. Additionally, the company’s commitment to leveraging AI and machine learning for personalized treatment plans offers a competitive edge that could attract patients seeking tailored solutions for their diabetes management. By continuing to innovate and staying ahead of the curve, Bigfoot Medical aims to secure a significant share of this growing market, providing millions of diabetes patients worldwide with advanced, user-friendly, and effective diabetes care solutions.
Future Prospects: Embracing Continued Innovation
With a strong foundation and proven success, Bigfoot Medical is poised to keep transforming diabetes care. Their future prospects encompass:
Diversified Product Line: Bigfoot Medical plans to expand its product offerings, addressing a broader range of patient needs.
Global Market Reach: The company aims to make its groundbreaking solutions accessible to patients worldwide.
Personalized Medicine: Bigfoot Medical is committed to harnessing AI and machine learning to develop tailored treatment plans for diabetes patients, further enhancing outcomes and quality of life.
Research and Collaborations: The company will continue to work with research institutions, healthcare providers, and industry partners to drive innovation and uncover new ways to improve diabetes care.
Bigfoot Medical’s dedication to enhancing the lives of diabetes patients is evident in their history of innovation and promising future. As they continue to evolve and expand, Bigfoot Medical will undoubtedly remain a leader in the medical device industry, shaping the future of diabetes management for millions around the globe. With a unique approach to diabetes care and a commitment to delivering personalized solutions, Bigfoot Medical is well-positioned to make a lasting impact on patients’ lives and redefine the standards of diabetes care in the years to come.
Digital health in 2023 continues to advance rapidly. Medical devices that utilize digital technology are becoming increasingly popular and offer a wide range of benefits, including improved accuracy, increased convenience, and greater efficiency. In this post, we’ll take a look at the top 10 medical devices revolutionizing digital health in 2023.
Smart inhalers are innovative medical devices that can help patients manage their asthma and other respiratory conditions more effectively. These devices are equipped with sensors that can track the usage of the inhaler, monitor patient symptoms, and provide feedback to help optimize treatment plans.
Wearable glucose monitors are becoming increasingly popular for individuals with diabetes. These devices provide continuous monitoring of blood glucose levels and can alert the wearer when their levels are too high or too low, allowing for more timely and effective management of the condition.
Remote patient monitoring systems enable healthcare providers to monitor patients remotely, reducing the need for in-person visits and improving patient outcomes. These systems typically involve wearable devices that can track vital signs, medication adherence, and other health metrics.
Virtual reality therapy devices are a new and innovative way to treat a range of mental health conditions, including anxiety and PTSD. These devices allow patients to immerse themselves in a virtual environment, providing a safe and controlled space to address and overcome their fears.
Portable ultrasound machines are an exciting development in medical imaging technology, allowing for easier and more accessible imaging in a range of clinical settings. These devices are also more cost-effective than traditional ultrasound machines, making them valuable tools for healthcare providers.
Chison Sonobook 9
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AI-Powered Diagnostics Tools
AI-powered diagnostics tools are changing the game when it comes to early disease detection and diagnosis. These devices can analyze large amounts of data to detect patterns and anomalies that may indicate a health condition, enabling earlier intervention and improved patient outcomes.
Smart pill bottles are an excellent tool for medication adherence, particularly for patients with chronic conditions who need to take multiple medications. These devices can track medication usage, remind patients to take their medication and alert healthcare providers if medication is missed
Robotic exoskeletons are a new and exciting development in the field of physical therapy. These devices can assist patients with mobility issues, providing support and assistance with movement and helping to reduce the risk of falls and other injuries.
Wireless ECG monitors are a convenient and effective way to monitor cardiac health. These devices can be worn for extended periods, providing continuous monitoring of heart rate and rhythm, and alerting healthcare providers to potential issues in real time.
Smart contact lenses are an exciting new development in digital health, allowing for continuous monitoring of a range of health metrics, including glucose levels, intraocular pressure, and other vital signs. These devices could have a significant impact on patient outcomes, particularly for those with chronic conditions. We have seen early pioneers (Alcon+Verily, Mojo) failing to deliver on their promises, but the platform has its potential and the research continues. The most recent advance was when the Ulsan National Institute of Science and Technology (UNIST) scientists led by Dr. Seol Seung-Kwon and Professor Lim-Doo Jeong made a significant step forward in 3D-printed smart lenses.
Medical devices are revolutionizing digital health in 2023, offering patients and healthcare providers new tools to improve patient outcomes, reduce costs, and increase access to care. From wearable glucose monitors to smart inhalers and AI-powered diagnostics tools, the future of digital health looks bright. Are you working on any of the trends above? Do you have a new disrupting healthcare technology in mind? Let us know!
Is digital marketing in MedTech and Pharma similar? Understanding the specifics of MedTech and Digital Health digital marketing is essential to success.
MedTech digital marketing
The four main components of digital marketing in the medical devices industry are digital strategy consulting, digital content creation and management, digital campaign execution, and analytics.
Digital Marketing Consulting involves helping MedTech companies assess their priorities and strengths, optimize their operations and innovation, and develop effective go-to-market strategies.
Digital content creation and management involves producing engaging and informative content for various channels such as email, social media, blogs, webinars, etc. that showcase medical devices’ value proposition and benefits.
Digital campaign execution involves designing and implementing marketing campaigns that target specific segments of healthcare professionals (HCPs) or patients using digital tools such as CRM systems, marketing automation platforms, SEO/SEM techniques, etc.
Digital analytics involves measuring and evaluating the performance and impact of digital marketing activities using data-driven methods such as web analytics, customer feedback surveys, ROI calculations, etc.
Digital consulting is a vital component of digital marketing for medical devices and should be a first step. It helps MedTech companies to:
Define their vision and goals for digital transformation
Assess their current capabilities and gaps
Develop a roadmap and action plan for implementing digital solutions
Align their organization and culture with digital best practices
Digital marketing of medical devices in comparison to pharmaceuticals
Digital marketing for Medical Devices in many aspects is similar to the pharmaceutical industry, however, there are significant differences.
What are the similarities between MedTech and Pharma digital marketing?
Both Pharma and MedTech use digital tools to inform and influence HCPs and patients about their products and services.
Both industries rely on data and analytics to measure and optimize their digital marketing activities.
Medical Devices face regulatory challenges and compliance issues when engaging with their audiences online that are similar to those in pharmaceuticals.
The key differences between Pharma and Medical Devices digital marketing are that:
Medtech companies tend to have more complex products that require more technical expertise and demonstration than pharma companies.
Medtech companies have a wider range of stakeholders to consider, such as hospital administrators, payers, distributors, etc. than pharma companies.
Medtech companies have more opportunities to leverage digital health and digital therapeutics (DTx), such as connected devices, apps, sensors, etc. that can enhance their value proposition and customer experience than pharma companies
Outsourcing digital marketing services in the MedTech industry
Medical device companies may look for different services or support when deciding to outsource digital marketing, depending on their needs and goals.
Some possible services or support are:
Quality assurance: ensuring that the digital marketing activities comply with regulatory standards and best practices.
Content production and management: producing digital content or products such as websites, apps, videos, etc. that showcase the features and benefits of medical devices.
E-commerce: setting up and managing online platforms that allow customers to order and purchase medical devices easily and securely.
Virtual sales channels: creating and maintaining digital tools that enable sales reps to communicate and demonstrate medical devices to HCPs remotely.
Data analytics: collecting and analyzing data from digital marketing activities to measure performance, optimize campaigns, and generate insights
Generally, smaller MedTech companies may need more comprehensive and flexible services and support than larger companies, as they may have less experience and capacity for digital marketing. Larger companies may need more specialized and customized support than smaller companies, as they may have more complex and diverse needs for digital marketing.
Some possible factors that influence digital marketing service requirements are:
The type and complexity of medical devices that the company produces or sells.
The level of expertise and resources that the company has internally for digital marketing.
The scope and scale of digital marketing activities that the company wants to undertake.
The budget and timeline that the company has for digital marketing outsourcing.
The skillset of MedTech digital marketer
Some of the skills of a digital marketing expert from pharma are transferrable to provide medical device digital marketing services too. For example, both sectors require:
Knowledge of regulatory requirements and compliance standards.
Ability to create engaging and informative content for different audiences and channels.
Proficiency in using various digital tools and platforms to design, execute, and measure campaigns.
However, there are also some differences between pharma and medical device digital marketing that may require additional skills or adaptation. The key differences are that:
Medical device customers have different expectations and needs than pharma customers. They may be more interested in product features, benefits, demonstrations, or testimonials than in disease mechanisms or outcomes.
Medical devices are more diverse and complex than drugs. They can range from tissue grafts to prostheses to digital devices and apps. They may also have different modes of action, indications, or usage scenarios.
Medical devices may have shorter product life cycles than drugs. They may face more competition or innovation from other players in the market. They may also require more frequent updates or upgrades.
Therefore, a digital marketing expert to excel in the Medical Devices industry may need to understand the nuances of device marketing and how to tailor their strategies accordingly. MedTech digital marketing specialist has to learn about the specific types of devices they are marketing and how they work, who they serve, and what value they offer. Finally, digital marketer in MedTech industry has to be flexible and agile in responding to changing market conditions and customer feedback.
Regulatory requirements for medical device digital marketing
Regulatory requirements for medical device digital marketing vary depending on the type of device, the market, and the channel. Some of the general requirements are:
Medical device digital marketing must be truthful, accurate, and not misleading.
Medical device digital marketing must comply with the relevant laws and regulations of each country or region where they operate.
Medical device digital marketing must respect the data privacy and security of customers and users.
Some examples of specific regulatory requirements for medical device digital marketing are:
The Medical Devices Regulation (MDR) applies since 26 May 2021 in the European Union. It sets out new rules for placing medical devices on the market, including requirements for clinical evidence, post-market surveillance, labeling, and advertising.
The In Vitro Diagnostic Devices Regulation (IVDR) applies since 26 May 2022 in the European Union. It replaces Directive 98/79/EC and introduces new classification rules, conformity assessment procedures, performance evaluation requirements, etc. for in vitro diagnostic devices.
You can read a lot about MedTech. There are websites (like disrupting healthcare), news resources, and companies focused on one thing. MedTech. But what is MedTech? What does a MedTech company do? Is Medtech in a hospital or can you have it at home, on your wrist, or inside your body?
To make your journey into the world of MedTech easier, let’s discuss basic facts about MedTech.
What is MedTech?
It is just an ugly abbreviation. MedTech stands for medical technology. And as you can guess there are very many technologies in the medical sector.
What are medical technologies?
MedTech is a very wide subject, but it can be categorized into three categories.
In-vitro Diagnostics (IVDs)
Digital Health Solutions and Digital Therapeutics (DTx)
What are Medical Devices?
Medical Devices is yet another very wide term in the MedTech world. It covers any product, service, or solution used to prevent, diagnose, monitor, or treat people. As you can now understand, it can be literally anything, an instrument, appliance, software, implant, reagent, material, or even a service for processing some vital data. Under Medical Devices, you will find all known gadgets of the medical profession, syringes, needles, stethoscopes, big machines to perform X-Ray or MRI, or the special chair in your dentist. Wheelchairs and canes, and hospital beds are also medical devices. And of course, everything that can be put on or in your body in medical procedure – sensors, cardiac pacemakers, and so on.
To become a Medical Device and be used in a healthcare setting, an object or service has to meet certain regulations to ensure its safety and reliability.
What is In Vitro Diagnostics?
In vitro means literally in the glass. In vitro diagnostics (IVD) is any diagnostic procedure taken outside of the patient body. It is a non-invasive test made on a sample taken from your body, used to determine the status of a patient’s health. The sample can be blood, urine, tissue, or saliva. COVID-19 tests are IVDs. IVD never comes into direct contact with a person, they provide information based on scientific measurement of the sample. IVDs are not used for treatment, they are supposed to inform patients and healthcare professionals to make decisions.
What is Digital Health?
Digital Health covers all tools and services that combine information and communication technologies in prevention, diagnosis, and treatment. Digital Health plays an increasingly important role in healthcare. It allows for gathering and analyzing health data on an unprecedented scale, allowing scientists to discover patterns and insights. Digital Health speeds up and facilitates research and development of new therapies. It also allows remote monitoring of vital signs, early prevention and diagnosis, and at-home or ambulatory treatment. Finally, there are specific Digital Health solutions called Digital Therapeutics (DTx). Digital Therapeutics is usually Software as Medical Device – or in layman’s terms software application, that can be prescribed and used as medicine. There are more and more such DTx available, we have been covering examples such as Deprexis and NOCD.
What is MedTech – summary
Now, you know what is MedTech! It is any technology that is used in healthcare. MedTech covers Medical Devices, In vitro Diagnostics and Digital Health Solutions. On disrupting.healthcare we discuss MedTech with a focus on Digital Health on the exciting journey to improve the health and well-being of patients around the world.
MoovCare claims to be the first application of its kind. It allows controlling lung cancer treatment based on reports on outcomes submitted by patients via web or mobile-connected devices. It enables the early identification of relapse or complications requiring rapid and specific care. According to the clinical data from the III phase randomized study on 300 patients as presented at ASCO, this mHealth application provides direct benefit in terms of prolonged survival.
The main advantage of using the app in lung cancer therapy is early detection of relapse, which is symptomatic and typical for lung cancer. This allows optimal treatment and in turn increases of survival rate among patients.
An additional effect of the app is improved treatment compliance (observance of scheduled visits, lower number of inopportune phone calls, lower number of imaging). All this at a comparatively very low cost of less than 10 000 USD versus 265 000 USD per one CT-scan for Lung Cancer.
How does MoovCare work?
MoovCare is being “prescribed” to ambulatory patients. Patients are asked to fill in the web-based form each week, self-assessing 12 clinical parameters and having a free text field to enter any information they consider of importance. Data are securely passed and processed within the application. An algorithm behind MoovCare analyses the data provided and in case of any anomaly detected reports it to the oncologist and hospital dashboard. Based on the alert from Moovcare healthcare providers can contact patients and take any necessary action. Company and research behind MoovCare.
MoovCare is a product of Sivan Innovation. Founded in 2014 in Jerusalem by Daniel Israel, Sivan Innovation is an Israeli E-health start-up and R&D company. The research presented at ASCO has been conducted by Dr. Fabrice Denis at the Cancer Institute of Western France
MoovCare is a perfect example of how digital innovation, mHealth, and IoT trends are positively impacting healthcare and patient outcomes. We look forward to seeing more of such innovations coming not only from startups such as Sivan innovation but also from Big Pharma companies with their vast R&D resources.
Internet of Things (IoT), sometimes called also Internet of Everything, is a concept of enabling Internet-based connection between computing devices embedded into everyday objects. Internet of Things is already technically feasible and applied in multiple scenarios. With wider adoption, Internet of Things brings revolutionary changes to existing processes in most, if not all industries..
Internet of Things applications are impacting all three stages of health care: prevention, diagnosis and treatment. Wearable sensors and quantified self software embedded in smart-watches are good example of using Internet of Things in Healthcare for disease prevention and healthy lifestyle promotion. Going forward, wearable or digestible connected sensors are part of diagnosis useful especially in remote areas and in chronic conditions.
As for the treatment itself, connected packages and medication dispensers such as CleverCap, MedMinder or Philips Lifeline are used to improve patients adherence to the treatment. A step forward from adding connectivity to packages is putting it directly on medication. Proteus Digital Health, a company backed by Novartis and Oracle has already received FDA market clearance in the United States and a CE mark in Europe for its wearable and Ingestible Sensor devices.
Video: Proteus Digital Health – Your Health, Powered By You
Internet of Things in Clinical Environment: MBANs
MBAN stands for Medical Body Area Network and is a concept of low power network of body sensors worn directly or in close proximity to the patient. MBAN is connecting to the hub via LAN of health care facility (ie. hospital). MBAN allows constant monitoring of patient’s health parameters while in the facility, even while moving. Outside of the facility, MBAN may also serve patient – for example by connecting blood sugar level sensor with insulin injection pump.
Video: Medical Body Area Networks (MBANS) should expand patient monitoring
Internet of Things and Big Data
With wider adoption of connected wearable sensors and MBANs the amount of available relevant real world evidence becomes so huge, that medical research may, at least partially, shift its paradigm from experimental to statistical approach. Instead of setting up costly trials and recruiting patients with specific conditions, investigators will be able to perform analysis of existing data gathered from already diagnosed and treated population.
Video: Data analytics: Changing the practice of medicine
According to the research quoted by NHS over a fifth of patients with diabetes will have experienced a largely avoidable hypoglycemic episode whilst in hospital. Wearable technology may help doctors to detect deterioration early and act without delay. NHS England hopes, that connected sensors will be used to monitor health of people with long term conditions such as diabetes, heart failure, liver disease or asthma. The information gathered by wearable technology will be uploaded directly into patients’ records through the digital health services platform.
Nowadays, NHS maintains highly successful application (50 million hits per month) NHS Choices, that allows UK citizens to search and register for GP visit, book prescription and register for other services. NHS Choices provides also preliminary symptom checker, medical knowledge database and health related news promoting healthier lifestyle.
From the pharmaceutical marketing perspective embracing wearables in healthcare clear opportunity. Wearable (but also ingestible and implantable) devices and sensors will provide us with valuable real world evidence.With the mass adoption of such sensors assessment of treatment efficiency and drug safety will improve on unimaginable scale. Use of wearables in healthcare may also greatly impact treatment adherence (making patient to take medication as and when prescribed). In general, it moves medicine from population-based to individual data based, truly personalized healthcare.
Technology providers seeing vast business opportunity are joining those efforts. Then, they go back seeing how hard it is to operate in strictly regulated market.We all may remember how Google’s Larry Page and Sergey Brin were discussing their work on sensor contact lenses for diabetes (with Novartis/Alcon) and longevity medicine project of Calico. Their learning was in Sergey Brin’s words:
“Generally, health is just so heavily regulated. It’s just a painful business to be in. It’s just not necessarily how I want to spend my time. Even though we do have some health projects, and we’ll be doing that to a certain extent. But I think the regulatory burden in the U.S. is so high that think it would dissuade a lot of entrepreneurs.”
For pharmaceutical companies and healthcare providers this regulatory burden is given for their core business. For them, raise of wearable devices and mobile health applications raises some issues. Our smartphones, fitbits, jawbones and misfit shine wearables are not meant to be medical devices. Data acquired by wearables may not be accurate as they do not hae to be. They are not designed to the clinical and healthcare standard – there are no backup systems if the battery goes down, if user switches the phone in silent mode etc. Today wearable technology for pharma is still not good enough to bet patients safety on it. FDA’s guidance allows wearables in healthcare only as general wellness, low risk devices.
The solution may come from the alliance of pharma and technology. Novartis with Google and Qualcomm, UCB with MC10, GSK with Medidata have chosen this direction. Another may be innovative startups companies willing to align with regulatory and compliance burden for a benefit of entering profitable niche leftover by more established players.
K-message believes that finally wearables and more generally, the internet of things will change and shape the future of healthcare and pharmaceutical industry. If you know or, even better, make a product or service intended to be a part of this future we will be happy to cover your story.
Quantified self, mHealth and wearable technology. While you could hear about those trends in the past, the tipping point has been reached at the CES 2014. What was supposed to be the future is our present much faster than industry expected. Enterprise market is again far behind consumers. Health care industry tethered by regulations just cannot catch-up quickly enough.
At K-message however, we can take a look at the forefront of the consumer technology and assess its possible impact on the industry, and our focal point – pharmaceutical marketing. But first, let us define what we are talking about.
What is quantified self? Who wears technology? What is mHealth?
Quantified self (QS)
Quantified self (QS) is a trend of personal data collection via technology. The idea is to acquire data on person’s state, actions and performance using wearable technology and/or mobile applications.
Wearable technology is a description of any electronics that one can wear. It may be something with a sensor for quantified self purposes, but it can be also a T-shirt with LEDs intended just to look nice. From quantified self perspective, wearable technology is a trend that enables the whole movement by devices that can capture personal data.
mHealth is a general term for usage of mobile devices (mobile phones, smartphones, tablet computers etc.) in connection to medicine or health care. mHealth includes providing information to the patients or HCPs, but also collecting patients data.
Is Quantified Self big and mature enough to have an impact on health care industry?
The topic is huge. On the Quantified Self Guide – a website that collects different Quantified Self applications, there are 505 different tools listed at the time of writing this article. Of those 65 are tagged with medicine and 124 with fitness category tag. Wearable technology was main topic of CES 2014. If you look around in the office of any healthcare corporation (or, even better, on the jogging path) in the developed world, you will notice wearable sensors in form of bracelets, chest bands or small items in the shoes used by increasingly high population. Users of the smartphones install “measuring” applications on their devices.
What are the numbers? Runtastic, a mobile app dedicated to track running performance has recorded 60 million downloads worldwide and 25 million registered users on Runtastic.com. Similarly targeted device and app Nike+ platform claims 18 million users. Fitbit.com, the website that allows to see the results of tracking with Fitbit range of devices according to Quantcast has around 2 million users from the U.S. only. Quantified Self is definitely mass market now and it will not fade away. Instead it seems it will get more devices and applications as the tech industry embraces it.
Quantified self: dangers versus benefits
From the pharma marketer perspective quantified self may be even more disruptive than the raise of social media (which, by the way is still not accommodated properly). As it gives more knowledge to the user it takes away control from the HCPs. Fitness trackers are obviously beneficial as they encourage the best prevention against disease – exercise and movement. On the other hand the trend brings some risks with it.
Interpretation of the data gathered by the device or application, even if supported with some mHealth resource filled with scientifically proven knowledge may lead to wrong decisions. Innocent life-logging app that counts calories intake may lead to starvation, or at least to non-balanced diet for some users who want to lose weight too quickly (not mentioning here eating disorders). A non-calibrated blood pressure and pulse tracker may put people with cardiovascular issues at risk (I cannot breath but the reader says I can still run…). The device alone can affect users health by allergy (that happened with Fitbit Force recently), heat, permanent exposure to radiation. There was also at least one occurrence when using activity tracking device, and competing for better score was connected with a tragic death of one too motivated biker. In pharmaceutical industry there is a lot of pressure put on the patient data privacy. Quantified self puts those data in open, sharing the very personal information on the activity publicly, sometimes without informing user about it. This was a real case when Fitbit.com allowed public to see users who were logging their 30 minutes very active sexual encounters. What is fascinating in Quantified Self movement is how the application can change focus from empowering by giving the knowledge to the patient to enslaving by enforcing control over users behavior. In one of the quantified self business use cases, not related to health care, a QS device called Hitachi Business Microscope worn by office workers was mapping their communication patterns within organization, pinpointing unnecessary meetings, organization social graph and communication issues.
If we take it to the field of pharma marketing, QS may be seen as a great tool to improve patient compliance or to provide personalized healthcare, but also as a menace of higher insurance rates for any misbehavior – be it sitting too long on the couch or having one drink too much.
Quantified self and EHR, EMR and PHR solutions
One of the promising features of the quantified self is possibility to include the data acquired by sensors directly into electronic health records systems (EHR). Electronic Health Record is not exactly what industry widely embraces as EMR – electronic medical record. Although the data gathered, stored and processed in EHR are more or less the same, the source is different. EMR can include only data provided by medical institutions and healthcare professionals. EHR is open to any source of data. It includes what can be gathered from EMR, but also accepts patient input, quantified self devices and applications feeds and other sources. A specific range of EHR, that includes only data provided and managed by the user (in this case – patient) is Personal Health Record (PHR). The most renowned solutions of this kind are Google Health (decommissioned) and Microsoft Health Vault, but there are also other providers.
This brings new opportunities as we get really Big Data in EHR, but also some risks. Data in EHR and PHR cannot be really trusted, as they come from not validated sources and can be contradictory. The sampling (how often you take a data point) is not standardized and quality of the input is questionable. Nowadays, adoption of EHR and PHR is very limited, as is their functionality and usability. However with the growth of the quantified self we can expect rising importance of such hubs for the medical information.
Quantified self and regulatory compliance: HIPAA and HITECH
Quantified self movement adoption is nowadays limited to developed nations, and the biggest market for those solutions is in the United States of America. There are two regulatory bodies in the US that overlook quantified self devices and applications. For non-medical use the main authority is FTC. Privacy and access to the health related data is regulated by HIPAA and HITECH regulations.
HIPAA Compliance Checklist
Have you formally designated a person or position as your organization’s privacy and security officer?
Do you have documented privacy and information security policies and procedures?
Have they been reviewed and updated, where appropriate, in the last six months?
Have the privacy and information security policies and procedures been communicated to all personnel, and made available for them to review at any time?
Do you provide regular training and ongoing awareness communications for information security and privacy for all your workers?
Have you done a formal information security risk assessment in the last 12 months?
Do you regularly make backups of business information, and have documented disaster recovery and business continuity plans?
Do you require all types of sensitive information, including personal information and health information, to be encrypted when it is sent through public networks and when it is stored on mobile computers and mobile storage devices?
Do you require information, in all forms, to be disposed of using secure methods?
Do you have a documented breach response and notification plan, and a team to support the plan?
If you answered no to any of these questions you have gaps in your security fence. If you answered no to more than three you don’t have a security fence.
Quantified self and regulatory compliance: FDA guidance on medical mobile applications
For medical mobile applications relevant authority is the FDA. The Agency considers mobile phone as a medical device as soon as it meets one of the following:
It works expressly for medical purposes and offers medical or health-related apps
It acts as an effective accessory or component to aid medical health
While assessing medical mobile applications the FDA applies the same risk-based approach as for other medical devices. The guidance document provides examples of how the FDA might regulate certain moderate-risk (Class II) and high-risk (Class III) mobile medical apps. The guidance also provides examples of mobile apps that are not medical devices, mobile apps that the FDA intends to exercise enforcement discretion and mobile medical apps that the FDA will regulate in Appendix A, Appendix B and Appendix C. For many mobile apps that meet the regulatory definition of a “device” but pose minimal risk to patients and consumers, the FDA will exercise enforcement discretion and will not expect manufacturers to submit premarket review applications or to register and list their apps with the FDA. This includes mobile medical apps that:
Help patients/users self-manage their disease or condition without providing specific treatment suggestions;
Provide patients with simple tools to organize and track their health information;
Provide easy access to information related to health conditions or treatments;
Help patients document, show or communicate potential medical conditions to healthcare providers;
Automate simple tasks for healthcare providers; or
Enable patients or providers to interact with Personal Health Records (PHR) or Electronic Health Record (EHR) systems.
The quantified self will gain more importance in the healthcare industry. However, there are still some issues to be addressed before embedding them in the marketing strategy. Before building your own application or choosing one from the market consider them carefully.
Tracking versus privacy
Regardless of HITECH privacy considerations, the pharmaceutical company has to be extremely careful about patient data privacy. It has to be absolutely clear to the patient and the organization, that all data are owned by the user of the application and not the company. You need to have users’ direct consent if you are going to aggregate, store, process, or use the data in any way.
Your quantified self-application or device will gather data in connection to patients’ health. Therefore it is important to achieve possibly high level of accuracy and ensure the integrity of this data. It should be also clearly stated what are limitations of the sensors and technology used.
Fallback in case of failure
You need to make sure that in case of failure or loss of the device, patients will still be able to be treated or diagnosed with a fallback solution.
If your application allows data exchange with EMR, make sure it uses open standards, so that it can be used regardless of the health care provider chosen by the patient. This applies also to interoperability with PHR solutions.
Clear guidance for the interpretation of data
Make sure that the data gathered and provided to the patient are not subject to misinterpretation. There should be a clear explanation of the result provided, and if not possible the instruction should point the patient to the HCP who will be able to interpret the data. Even the best result on the application should not encourage patients to be not compliant with the treatment ordered by his doctor.
Co-operation with HCPs
If every patient comes to his GP with gigabytes of life-logging data, there is no time for a proper diagnosis. Valuable information will be hidden in the noise like a needle in a haystack. Not to mention different UIs of the applications and general annoyance with non-standard requests coming out of the blue. To avoid this you need to provide HCPs with clear instructions on what to look for and make sure they will know it at the first glance. Think about a separate dashboard for the physician or even better – distribute the app through the trained HCPs.
Example of quantified self in pharma marketing: Eli Lilly’s Talking Progress.
Talking Progress (this name applies for UK & Ireland markets) is an application available for iOS and Android, that was presented by Claire Perrin on the recent Social Media in the Pharmaceutical Industry conference in London. Talking Progress is dedicated for adults suffering from depression. Using this app patient can record his/her mood to produce progress charts which can track the recovery and help inform discussions with the doctor. It is extremely important, as one of the symptoms of depression is lack of focus and gaps in the memory.
The app also contains useful hints and tips about lifestyle changes as well as information on causes of depression and treatments. Talking Progress Features:
Educational information about depression
Healthy living advice
Medicine reminder alarm
Together with an app Lilly provides a booklet for the patient and small information desk stand for the HCPs. Embedding quantified self elements (diary and note pages) with mHealth features (educational information, lifestyle advice and compliance reminder) makes this app a perfect companion for patients suffering depression. Providing HCPs with the information pack (they are supposed to “prescribe” an app) guarantees that the data gathered via the app will be used and understood by the doctor.
Quantified self in pharma marketing – an opportunity for everyone
It looks like the quantified self movement will stay with us for longer. Lilly’s example described above shows that properly used it may be beneficial for all – patients, HCPs and pharmaceutical industry. We can without doubt add payers to the list. Correctly applied quantified self is great way for prevention via changing lifestyle habits, increasing disease awareness and improving patient’s adherence to the prescribed treatment. Will we use this opportunity? Quantified self may save lives and money. It seems that even regulatory bodies are up to date with the trend, so the only thing missing is pharma marketers involvement. Do you plan to include quantified self and mHealth elements in your brand strategy?
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