Global Medical Device Updates
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Worldwide Medical Device Regulatory Updates
As medical device quality assurance and regulatory affairs professionals, it can be challenging to stay on top of changes happening in our industry. Few people have the time to read lengthy articles these days and although many online newsletters exist, they are often packed with PR releases, ads or unrelated information. That\'s why we started this blog for QA/RA professionals in the medical device and IVD industry. The idea is to give you short updates on quality and regulatory topics that may be of interest to you. No fluff, just straight to the point. We hope you\'ll enjoy the content.
Mobile Health Sector to Reach $23 Billion by 2017
PricewaterhouseCoopers and mobile operator industry association GSMA expect global mobile health revenues to hit $23 billion by 2017, with the biggest markets in Europe and the Asia-Pacific region.
A new report recently issued by the two entities, Touching lives through mobile health: Assessment of the global market opportunity, projects that European and Asia-Pacific markets will each make up 30% of global mobile health market share, followed by North America (28%), Latin America (7%) and Africa (5%).
Monitoring services—particularly those for aiding chronic disease management and ageing, will constitute about 65%, or $15 billion, of the global medical health market, followed by diagnostic services and healthcare system strengthening services, according to the study. Mobile operators will reap nearly 50% of the growing mobile health market, whereas medical device manufacturers, app developers and healthcare providers will account for the remaining market share.
However, this level of growth depends highly upon global regulators developing effective market authorization requirements that take into account the nature of mobile health products rather than just pigeon-holing these products into regulatory systems designed for more conventional medical devices. PwC and the GSMA acknowledge that regulatory support—as well as acceptance of mobile health devices by healthcare practitioners and consumers—is essential to the realization of the study’s projected growth rates. Although regulators in the US and other highly developed markets have taken initial steps toward developing a more nuanced approach to mobile medical technologies, substantive policies regarding mobile health have yet to fully materialize. Until they do, these study projections should be taken with a healthy grain of salt.
Markets: Worldwide
Date: March 8, 2012
UK Unveils Long-term Telehealth Campaign
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.
Markets: Europe
Date: December 14, 2011
InMedica Report: Global Telehealth Market to Top $1 Billion by 2016
The worldwide market for telehealth products and services will reach more than $1 billion by 2016—and may reach $6 billion by 2020—according to a new study by medical electronics market research provider InMedica.
InMedica researchers cite factors such as efforts to curtail health care costs by reducing hospital visits and lengths of stay particularly for chronic diseases as key drivers of the telehealth and remote medical technology sectors.
Telehealth technology subscriptions from patients are expected to increase most dramatically for monitoring and treatment of congestive heart failure, as well as for chronic obstructive pulmonary disease, diabetes and hypertension.
The US remains the most advanced market for telehealth products and services, according to InMedica, while the European Union has taken steps to expand use of such devices among its populace as well.
Date: September 23, 2011
FDA Mobile Apps Workshop: Can App Developers Meet Medical Device Requirements?
Can minimally-staffed software application developers getting into the medical device sector reasonably be expected to comply with the same FDA requirements as medical device manufacturers?
That was one issue addressed during the FDA’s public workshop on its mobile medical applications draft guidance held September 12th and 13th, 2011. In panel discussions covering how medical apps should be regulated according to the risks they pose and their intended uses, Qualcomm senior director of government affairs Robert Jarrin argued that low-risk apps should be exempt from FDA regulation, and that ambiguous definitions in the agency’s guidance on mobile medical apps can cause difficulties and confusion for software developers. He also questioned the feasibility of requiring one- or two-person app development teams taking on the task of implementing quality management systems in order to satisfy FDA requirements.
But app developers targeting the US medical device market had better prepare for just such a requirement, according to AdvaMed director of technology and regulatory affairs Bernie Liebler. “What do you have in place to guarantee software quality?” he argued. “It’s very difficult—even after validation, software can be buggy.”
Liebler suggested that requiring software developers to have quality systems in place or abide by some kind of recognized standard would not be unreasonable, echoing the FDA’s guidance recommending that “all manufacturers of all mobile apps that may meet the definition of a device follow the Quality Systems regulations (which include good manufacturing practices) in the design and development of their mobile medical apps and initiate prompt corrections to their mobile medical apps, when appropriate, to prevent patient and user harm.”
Just such an approach was taken by MedApps, a remote health monitoring technology developer. MedApps CEO Kent Dicks explained that his firm undertook quality system implementations not only to meet potential regulatory requirements but also (and just as importantly) to attract investors.
Going forward, medical app developers aligning their products more closely with medical devices had best get used to the idea of quality system implementation, both to satisfy regulators and effectively raise capital.
Markets: USA
Date: September 14, 2011
Finally, Draft FDA Guidance on Mobile Medical Apps
Highly anticipated draft guidance on mobile medical applications has been published by the FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER).
Targeting specific subsets of mobile medical device applications, the guidance should help answer some longstanding industry questions of how—or whether—US and other regulators would approach such devices. The guidance could furthermore serve as a template for other medical device market regulators determining how to establish requirements for this burgeoning sector of the device industry.
The guidance focuses on mobile applications that either function as accessories to medical devices currently regulated by the FDA; transform a mobile communication device into a regulated medical device via attachments, sensors or other medical capabilities; or allow users to input patient-specific data in order to obtain patient-specific results, diagnoses or treatment recommendations for use in clinical settings.
Regulatory requirements manufactures of such devices may need to address depend on their devices’ classifications. According to the guidance, Class I mobile medical devices would have to comply with the following components (General Controls) of the Code of Federal Regulations:
- Establishment registration and Medical Device listing (21 CFR Part 807)
- Quality System regulation (21 CFR Part 820)
- Labeling requirements (21 CFR Part 801)
- Medical Device Reporting (21 CFR Part 803)
- Premarket Notification (21 CFR Part 807)
- Reporting Corrections and Removals (21 CFR Part 806)
- Investigational Device Exemption (IDE) requirements for clinical studies of investigational devices (21 CFR Part 812)
Manufacturers of Class II mobile devices would need to meet the General Control requirements listed above, as well as Special Controls and, in most instances, Premarket Notification requirements.
Class III device manufacturers would need to meet General Controls and Premarket Approval (21 CFR Part 814) requirements.
The guidance also spells out FDA expectations that mobile medical application distributors will work with manufacturers in the event that corrections and removal actions need to take place.
The FDA plans separate draft guidances to address the following related issues:
- Wireless safety issues
- Classification and submission requirements for clinical decision support software
- How quality systems apply to software
- Regulation of mobile applications that analyse or interpret data from multiple medical devices
The FDA is accepting written comments on the proposed rules for mobile medical applications for 90 days following publication of the guidance in the Federal Register.
Markets: USA
Date: July 19, 2011
IBM Survey Finds Growing Consumer Demand for Mobile Health Devices
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.
