Presentation by Marta Gaia Zanchi, founder, Medinnovo at www.bio2devicegroup.org
Marta Gaia Zanchi, founder of Medinnovo, a medical innovation consultancy firm, www.medinnovo.com, gave a talk on “Wireless Health: Needs, Applications, Challenges, and Devices” on November 1, 2011 www.bio2devicegroup.org. Marta began her talk by defining the challenges of the current health care system, spiraling costs, aging of theUS population, rise of chronic diseases like obesity rates, growing healthcare inefficiencies, and shortage of qualified healthcare professionals. When one considers the challenges, the solutions become obvious and should include providing affordable solutions to manage aging and chronic conditions, move care outside the hospital environment, provide transparency of clinical outcomes, and bridge the last mile through novel health care delivery strategies, focusing on prevention through devices and services that enable and facilitate healthy behaviors. Wireless health is “the provision of health services and information via mobile technologies” (WHO, 2011), aimed aimed at helping people live healthier and longer while making healthcare more affordable.
Several factors drive the emerging Wireless Health market and these are the increasing and changing consumer demand, the tremendous advancement of medical technology and of wireless communications technologies. Mobileis outstripping fixed broadband, and the ubiquitous smartphone is becoming the “hub” for many wireless health devices recently available or announced. Also societies are changing – we are living in a highly – we are living in highly networked society, where the social motivators of wireless health technology drive adoption and motivate users.
Wire Health applications include fitness products, wellness diagnostics, remote patient monitoring and more – spanning the entire spectrum of health needs. Other applications include, components of education, awareness building, medical data access, drug authentication and tracking and so on. Wireless Health has a global reach and initiatives are ongoing in virtually every continent.
While there are great opportunities, there are also many challenges. Wireless technology is not mainstream, there is minimal funding going into such technology, the field is highly fragmented. While some of the technology is cutting edge, it often does not align with the problems. Initiatives are often technology is deployed in small scale, there is limited evidence base proving efficacy and cost effectiveness (with several, noteworthy exceptions) and the field is little standardized. The key barriers worldwide include, misaligned priorities, lack of knowledge, and policies and legal challenges that vary by geographic market. In theUS, the overburdened health system and limited understanding of the field and responsibilities means that the funding is poorly allocated and creates reimbursement challenges. Also, US physicians are today viewed as “providers of services” in the hospital, and are little incentivized for adopting wireless technologies whose adoption is still relatively low and consumer driven.
There are other questions like who would own the data; the patient, care provider, or insurance agency? FDA has only recently stepped up and has released the very first mobile application draft in July of 2011. Currently it is very narrowly focused, but it is a start. There are about 12,000 medical applications out there and about 3000 of them need 510(K), says FDA. Defining viable regulatory challenges for companies in this area will depend upon the specific intended use which applies to Wireless Health devices as it does to any other FDA-regulated medical device and which regulates the device classification, and the FDA’s perception of risk associated with the device. For instance if we consider the goal of a simple weight scale, it is to measure weight by the individual and it requires no FDA involvement. If wireless app is tagged on, then FDA might get interested. If the app is linked with management of some chronic conditions, then the scale would become critical to the support of the patient’s life and there would be much higher level involvement of the FDA. Therefore depending on the goal of the technology, (who gets the information, and if the information is used to drive a simple behavior versus to make clinical decisions, the regulatory challenges change.
Network availability will also define how this industry takes shape, and so will the evolution of the currently available standards – there is a lot of activity in software, for example, which is a critical component of most Wireless Health technologies. Also the risk of connected health devices in the IT networks of hospital organizations are little understood and managed – the Connected Health Safety Initiative initiatives, co-chaired by Dr. Zanchi and Dr. Geetha Rao, promises to address the issue by developing a framework for collaborative management of safety and providing a basis for self-regulation of some elements of a connected healthcare system.
Opportunities abound in the space even for non-traditional players, for example those developing enabling technologies – batteries, sensors, digital medias, displays, and so forth. Convergence of several industries is key to the success of the market. For instance, Intel is in this space, Walmart is trying to fill the gap for distribution channels for wireless, and service providers like Verizon, AT&T, and Sprint will also play a key role. The development of integrated platforms of health, for storage of data and to extract meaning out of it, will be necessary and the field is still in search of a definite solution. Innovators should also explore opportunities (and will likely encounter a different set of challenges) for deployment of wireless health technology at global level.
Zanchi went on to give many interesting examples of a diverse range of technologies in this arena. Proteus Biomedical Raisin Personal Health Monitor, a wireless-enabled adhesive sensor technology was recently cleared by FDA and works with iPhone; in the future, it will connect with chipsets onto pills to track medication adherence. MobiSante has created the smartphone-based ultrasound imaging system MobiUS, capable of doing ultrasound in the field and sending the image via cellular or WiFi to hospital for diagnosis. The current cost of $8000 is less than an order of magnitude lower than traditional systems, and MobiSante expects to halve it over time. Duo Fertility Monitor helps couples trying to conceive and includes a wearable sensor that measures body basal temperature, taking up to 20,000 readings every day. It can be plugged into a computer via USB port and the data can be transferred to the hand-held reader which would give a visual display of the fertility status and forecast, thereby helping couples conceive in a private, affordable way. Monica AN24 is a small wearable fetal heartbeat monitor that records raw abdominal electrophysiological signals for women during labor and delivery. BodyMedia FIT Armband is on-body monitoring system that tracks calories, sleep quality, steps, and physical activity and transfers the information to BodyMedia’s online Activity Manager to help in weight management. CATRA, an invention of MIT’s Media Lab uses a smartphone with a custom app, and a $5 device that clips on to various brands of smartphones for detection of cataract – without the need of a physician to be present to interpret the results, thus lowering the barriers to testing and extending the reach to remote and low-income regions.
Wireless health is a nascent field, still taking shape. It will grow thanks to the collaborative efforts and convergence of many industries. For technology in this area to scale, it will require that the technology focuses on the problem. Several challenges need to be overcome, and overcoming them will require important shift in priorities, incentives, and in the value chain. Yet, business opportunities abound and the benefits will be tremendous: we will gain better understanding of diseases and Wireless Health will radically change for the better the delivery of health care by providing affordable, effective solutions to manage our health.