Medical e-News Round-Up - Issue 55

This issue covers:

The health care cybersecurity challenge

Growing recognition of the importance of maintaining IT security for interconnected medical devices has prompted a wide range of comment, advice and guidance within the industry.

Only last month the USA Food and Drug Administration (FDA) issued new draft guidance for medical device manufacturers on the use of interoperable devices and the theme has been widely followed up with comment and reaction.

In particular, much of the comment recognises the growing importance of medical products that can securely exchange data and other information, but warns that appropriate safety conditions need to be properly considered.

However, as an extensive article on DOTmed recently pointed out, the increased complexity and connectivity of modern medical devices has made this task exponentially complex for both medical device manufacturers and the FDA.

In the face of this challenge the article argues that health care organizations, including medical device manufacturers, are being driven to adopt a cybersecurity strategy to ensure patient safety. It concludes by saying that while health care organisations can’t prevent a breach from occurring, there are strategies and tactics to help mitigate the potential damage of a breach.

In the circumstances, adopting a cybersecurity risk framework enables organisations to leverage proven processes and maintain an evergreen cybersecurity risk-mitigation strategy. For the full article and advice on setting up a cybersecurity strategy visit here.

Market growth in disposable medical device sensors

The increasing demand for point of care diagnostics and self-health management devices is one of the factors expected to contribute to the growth of the global disposable market in the coming years.

This is one of the findings of a report into the disposable medical device sensors market, which forecasts demand for various patient monitoring and diagnostic devices to 2020.

Overall the global market for disposable medical device sensors is estimated to reach $5,936 million by 2020, growing at a CAGR of 10.3% during the forecast period.

North America is the largest regional segment of the global disposable medical device sensors market accounting for 40.8% of the market in 2014, followed by Europe, Asia-Pacific, Latin America, and the Middle East & Africa.

In the future, China, India, and Brazil are expected to offer significant growth opportunities for market players owing to the rising geriatric population, growing per capita income and changing lifestyles. Other factors in these countries are increasing investments in the healthcare industry by key market players, rising demand for advanced technologies and expansion of private-sector hospitals to rural areas.

FDA looking at safety of refurbished devices

The US Food and Drug Administration (FDA) is seeking more information on medical devices that are refurbished, reconditioned, rebuilt, remarketed, remanufactured, serviced or repaired in order to investigate a number of potential safety issues.

The call for more information comes as manufacturers of devices that are being refurbished by other companies have also requested clarification of their responsibilities when their devices have been altered.

“Stakeholders have expressed concerns that some third-party entities who refurbish, recondition, rebuild, remarket, remanufacture, service, and repair medical devices may use unqualified personnel to perform service, maintenance, refurbishment, and device alterations on their equipment and that the work performed may not be adequately documented,” FDA said. “Possible public health issues arising from these activities include ineffective recalls, disabled device safety features, and improper or unexpected device operation.”

FDA is interested in comments concerning the service, maintenance, refurbishment and alteration of medical devices, including endoscopes, some of which the FDA has recalled in recent months because of contamination issues. Full story is here

Growth forecast for India's medical devices market

The medical devices market in India will rise to $17.6 billion by 2020 from $10.4 billion in 2014, according to a report by research and consulting firm GlobalData.

The report states that although the market will not see the same level of growth as the pharmaceutical sector, it will still undergo significant changes, driven by mounting patient awareness of advancements in medical technology, and an ageing population.

"India's medical device market is one of the fastest-growing, thanks to the country's strong economic growth, improving living standards and large population," said GlobalData's Senior Industry Analyst Adam Dion.

"In addition to benefiting from increased purchasing power within the region itself, the Indian medical devices arena is also profiting from a booming medical tourism market, which is driven by the comparatively low cost of treatments."

In terms of current opportunities within the medical devices arena, ophthalmic devices take up the largest proportion of market share. In 2014, sales for these devices were valued at approximately $3 billion, having grown at a CAGR of 7.3% from $1.98 billion in 2008.

Medical device certification scheme in India

A voluntary certification scheme for medical devices has been introduced in India in a bid to address the lack of quality assurance for products manufactured in the country.

The joint initiative by the Association of Indian Medical Device Industry (AIMED), the Quality Council of India and the National Accreditation Board for Certification Bodies (NABCB) seeks to ensure availability of quality products to end-users.

Pharmaceuticals Secretary V K Subburaj said: "Now, Indian manufacturers can go to the third-party certification agency and certification is voluntary in nature. This will give confidence to manufacturers, consumers and doctors."

Although initially a voluntary scheme, the new Indian Certification of Medical Devices Scheme (ICMED) is regarded as a significant step for the development of the medical devices sector in India, bringing quality, accountability and competitiveness to the sector.

The scheme has two options for certification -- 'ICMED 9000 certification' for low-risk medical devices and 'ICMED 13485 certification' for medium and higher risk devices. Visit here for full details.

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