Worldwide Medical Device Regulatory Updates

The UK Department of Health has undertaken a campaign to expand the use of mobile medical devices and services to cover three million patients over the next five years.

Launched in collaboration with the National Health Service, industry and professional partners, the campaign entails deploying mobile medical devices to three million patients through 2016. The campaign’s work plan remains in early stages of development, however, according to E-Health Insider.

Because the capital investments required for establishing telehealth systems can be prohibitively high, according to the NHS, the Department of Health will consult industry to identify ways to address cost issues.

The campaign follows an effort the Department of Health began in 2008 to assess how telehealth would impact the NHS and British social care services; that assessment concluded that proper implementation of telehealth systems could result in 15% fewer A&E visits, 20% fewer emergency admissions, 14% fewer routine or elective health care visits and 14% fewer inpatient hospital stays.

If those predictions hold up, the case for governmental involvement in driving adoption of mobile medical devices becomes compelling. 

During the US Food and Drug Administration’s two-day public workshop on its Mobile Medical Applications Draft Guidance held September 12 and 13, 2011, attendees and FDA officials wrestled with the issue of how to classify applications that serve as accessories to medical devices.

FDA policy advisor Bakul Patel and Bryan Benesch, determination officer at the Center for Devices and Radiological Health’s (CDRH) office of compliance, reiterated the agency’s general purpose approach that an accessory’s classification typically aligns with that of its associated device during a panel discussion on connecting accessories to devices. However, Benesch and other panelists acknowledged that the issue of apps connecting to multiple devices with different classifications—not covered by the FDA mobile app guidance—does not fit neatly within that approach. Given how varied accessory-device configurations can be, regulators will require a much more nuanced approach in this area, but the details of such an approach need hashing out.

Bradley Thompson, attorney at law firm EpsteinBeckerGreen, suggested intended use statements from the manufacturer or developer of an accessory—what the manufacturer is saying about the app and how the app is being marketed—as one criterion to be taken into account in order to determine the proper level of regulation. Furthermore, the FDA should focus on classifying accessory apps based on their functionality rather than their technology, Thompson argued, in order to avoid overregulation.

Jorge Valdes, chief technology officer at glucose sensor product developer Dexcom, made a point of distinguishing between apps that simply move data between sources or devices and those that actually analyze that data. FDA regulators should focus on where in the process analysis of medical data is occurring, according to Valdes. Apps and devices only providing displays of data should be kept on a low-risk, low-regulatory pathway while still complying with quality system requirements.

Expected treatment outcomes should also factor into how the FDA regulates medical device accessories, argued Marc Anderson of the Juvenile Diabetes Research Foundation. Particularly in challenging cases involving apps and accessories connect to multiple devices, he said, focusing on the intended or expected outcomes for patients treated via those configured systems should figure significantly in how those systems are classified.

Following the panel discussion, the FDA appears hardly closer to forming a viable regulatory process for apps as accessories to medical devices. The agency is accepting comments on all aspects of its proposed approach to regulating medical apps until October 19^th—enough time, perhaps, to get a firmer grip on how to deal with the accessories-to-medical-devices issue.

A new survey by the IBM Institute for Business Value indicates high satisfaction rates among patients and caregivers using mobile medical devices, as well as growing willingness to spend money for such devices.

The survey of more than 1,300 consumers of telehealth products in the US and UK found that 93% of respondents are satisfied with their devices’ basic functionality, and that 80% of respondents would be willing to pay up to $100 out-of-pocket for their devices. A sizable minority (35%) of respondents also expect to pay monthly fees for using such devices within the next two years.

In terms of how consumers are using mobile medical devices, half of survey participants reported using their devices to manage known health problems; IBM found that within the next two years, however, 30% of participants anticipate using such products for preventative health uses like physical activity.

Ease of use dominated respondents’ list of criteria for selecting mobile health products, cited as the most important factor by 96% of participants. More than three-fourths of respondents cited price as a key factor, followed by feature set (54%) and customer support (42%).

Of paramount interest to mobile medical device manufacturers, no doubt, is the finding that 71% of patients and caregivers taking part in the survey reported that their physicians’ opinions determined their choice of telehealth product. Product endorsements from health care provider groups were accordingly viewed as more influential by respondents than endorsements from insurers, regulators or consumer advocacy groups.

IBM identifies an emerging competitive landscape between medical device manufacturers and consumer electronics makers in the telehealth market. Although the latter group has a stronger foothold among end users due to its established retail presence, its distribution efforts among health care channels will take time and effort to set up. Medical device firms, conversely, have more experience with health care providers, but will have more work to do in terms of addressing consumer rather than practitioner product requirements.