Tim Gee, Principal, Medical Connectivity Consulting, was kind enough to write-up the first sessions at our Everywhere Healthcare event last week at CTIA Wireless I.T. & Entertainment event in San Diego. What follows is Tim's notes from the session (including some commentary from him in parenthetical asides.)
Brian Dolan, co-founder and editor of MobiHealthNews kicked off the event by highlighting some of the key wireless health stories that MobiHealthNews has published over the past several months. MobiHealthNews' most emailed story to date is an interview with Scott Eising, director of product management for Mayo Clinic's Internet Services. Another hot story was Aetna's repurposing online content through an iPhone app. Last week, MobiHealthNews ran a story about Safeway and their practice of providing financial bonuses to employees maintain a "healthy" BMI, lower cholesterol, or improve their health in other ways. Another article of note described CardioNet's plans to extend its business model beyond ambulatory cardiac arrhythmia diagnostic testing to chronic disease management. This past summer, MobiHealthNews reported on Best Buy's push to become a channel for providing wireless health to consumers. At TEPR+, Brian reported on comments made by FDA scientist Don Witters. During his presentation, Don suggested that the iPhone could indeed meet the legal definition of a regulated medical device.
The first session following Brian's presentation was a panel discussion, titled "Meet the Wireless Health Leaders." The panel included Kent Dicks, CEO, MedApps; Don Jones, VP, Health & Life Sciences, Qualcomm; Mike Srivathsa, VP, Corventis; David Inns, CEO, GreatCall/JitterBug; Jon Linkous, founding CEO American Telemedicine Association; and Rob McCray, Chairman, Wireless-Life Sciences Alliance moderated the session.
Rob noted that the panel intended to represent the wireless health landscape. Rob characterized the wireless health opportunity as a way to target under served populations -- the uninsured in the US, in addition to those in developing markets around the world. Don Jones described wireless health as the ability to present the right information and interaction, with the right person (patient or provider), in the right place and at the right time. He suggested that "monitoring" itself does not play a big role presently, but noted that numerous sensor technologies are coming to market. He characterized these medical sensors as "accessories" -- a term with important FDA regulatory implications.
Rob asked the ATA's Jon Linkous to list the key questions that concern taking health care services outside the walls of the hospital. Jon noted that wireless health is transformative, compared to typical evolutionary technology advancements in health care. He noted that Congress is struggling with this transformation, especially in the context of health reform. Questions include whether reform will leverage wireless health through reimbursement, or whether it will quash the market through cuts in care expenditures. The FTC is also looking into the implication of wireless health and how it impacts the delivery of health care across the borders of both states and countries.
Jitterbug's David Inns talked about the self pay market in health care. The 65-year-old and older demographic represent a majority of health care costs, Inns said. The iPhone is a great product, but it is not going to make an impact on that demographic. This group requires considerably more customer service and support than typical consumer electronics products, Inns said. The Jitterbug platform is growing through the addition of "services," as opposed to "apps" or new hardware accessories.
MedApps' Kent Dicks noted that in his wireless health experience, the market was (and is still) dominated by large call centers who call patients daily to ask them if they've taken their medications, done their exercises, and so on. He noted that a key factor for chronic disease management is patient compliance.
Mike provided an overview of the Corventis platform. Corventis' patients only wear the company's disposable sensor for about a week at a time. Both the device and a back end server provide data analysis. The sensor talks to a gateway that connects to the Internet to reach a web-based application. The U.S. is Corventis' largest market, but because it is a self-pay market, they are expanding to international markets with affluent populations, including Canada, Mexico, the Middle East, Europe and Asia.
Rob noted that Corventis' PiiX sensor targets episodes of care. He asked the group about chronic disease management. David reported that Jitterbug targets prevention -- the price points are affordable, the value proposition is attractive. Jitterbug's services costs between $25 and $50 per month. MedApps' Kent Dicks said his company's tactic is to align with PHRs like Google Health and Microsoft HealthVault. He said consumers are not going to head to Walgreens to buy a $600 weight scale to send data to an Internet app. They target much lower cost products. MedApps targets the B2B side of the market -- employers and payors. These groups are looking for ways to control their increasing health care costs. MedApps, then, goes through these B2B channels to reach the consumer market.
Qualcomm's Don Jones opined about the kind of cell phones that will be used for wireless health: both consumer phones, in addition to specialized devices with sensors (or the ability to talk to sensors). Uptake of these devices will be driven by the particular application. Body area network (BAN) radios are now Bluetooth, with the market moving to low power Bluetooth LE when it's available, but eventually Don said he sees multimodal BAN radios in consumer devices. In the mean time, there is a place for specialized gateway devices, he said.
Rob asked ATA's Jon Linkous: "Is the iPhone a medical device?" If you look at the AirStrip application, there's no question that is a medical device, Jon said. A device that helps a patient measure the steps they take a day (pedometer), however, isn't a medical device, he said. (That is a debatable proposition, depending on marketing claims and how the manufacturer manages their product). Jon expects that eventually there will be health care oriented products sold to consumers that won't be regulated by the FDA. (It seems to me that recent trends in the FDA are going in just the opposite direction.) Don notes that being regulated by the FDA is not necessarily a bad thing, and can be a good thing in the U.S. He noted that the Pill Phone, basically a mobile app version of a book still sold in bookstores, is not a medical device. The Pill Phone's creator, however, got FDA clearance anyway and sold it through Sprint, Verizon Wireless and AT&T. The carriers have since noted that without FDA clearance, they would not have touched the product. Jon noted that the FDA's key focus is on patient safety and efficacy.
Since Corventis was taking a look at international markets, Mike discussed international regulatory approvals. Corventis has two products that they have run through approval processes. As long as you have either an FDA clearance or European CE mark, Mike said, approvals in other international markets are much easier -- some will even accept the FDA or CE outright.
Qualcomm CEO Paul Jacobs noted in his keynote earlier in the day that the current FCC position about managing broadband and the Internet precludes creating a quality of service for things like medical device data. Offering a customizable computer as a consumer cell phone introduces a lot of variables and regulatory challenges for use as a medical device.
Does wireless health reduce healthcare costs? Jitterbug's David Inns noted that there are some very simple things the industry can do to improve outcomes and reduce care. He noted that their service of an RN by phone service has resulted in reduced health care costs. Patients have leveraged the RN calls as an alternative to a physician or ER visit.
What will get consumers into Best Buy to purchase a specialized phone to support wireless health? The issue is not the technology or making the products (both already exist), the question is who drives demand? David noted that health care providers, payors or perhaps employers could eventually drive that demand. Another question: Is Best Buy a health care brand or channel? Will consumers want the Geek Squad setting up their elderly parent's wireless health system? Qualcomm's Don Jones noted that this is where simplicity comes to the fore. Products and business models that are very simple will have a greater likelihood of success. The examples Don used preclude the need to deal with Best Buy or anyone -- the device comes via the mail or UPS and is applied and used by the user themselves -- which simplicity makes possible.
Will wireless health be cellular or WiFi-based? Don said he has weekly conversations with medical device manufacturers who think their products will leverage home broadband connections and Wi-Fi. What they forget is the $300 installation cost. These systems have a 50 percent installation failure rate with consumers. And you also have ongoing service and support issues. This approach is a poor match for the target demographic, the "silver tsunami." Don suggested that the complexity of the broadband/Wi-Fi approach is an argument for using cellular connectivity. (However, complaints about the iPhone's current exclusivity to AT&T's network, often stemming from coverage limitations, demonstrate that cellular connectivity is not a panacea.)
What about privacy concerns and wireless health? The ATA's Jon Linkous said this was a bogus issue, and that he could put on a white lab coat and go into any hospital in San Diego and come out with a dozen medical records. Many people in Washington D.C. as well as consumers, do not have a realistic or informed perception of privacy issues, Jon said.
A question from the audience was: When will wireless health really break out, with appropriate reimbursement and a regulatory framework? Jon said that the day is coming soon when those challenges are finally overcome.
