Medical e-News Round-Up – Issue 51

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This issue covers:

Interoperability standard for medical devices

The IEEE Standards Association has introduced a new standard as part of its work on enhancing interoperability between emerging eHealth technologies.

The latest standard, IEEE 2410-2015, is called the Biometrics Open Protocol Standard, or BOPS. The primary aim of the new standard is the protection of biometric data. BOPS was sponsored by the IEEE Communications Society and is applicable to data transmission from client device software (running on a smartphone, for example), ensuring that such data is sent to a trusted BOPS server and with an intrusions detection system in place.

The concern over mobile data extends to another standards development project now under way. This is the draft standard for ‘Enabling Mobile Device Platforms to be used as Pre-Screening Audiometric Systems (IEEE P26250)’, which has been announced alongside the draft standard for ‘Bio-CAD File Format for Medical Three-Dimensional (3D) Printing (IEEE P3333.2.5)’.

Meanwhile, a memorandum of understanding between the IEEE and the Regenstrief Institute is aimed at developing standards intended to ensure intercommunication between traditional medical devices and emerging personal medical devices.

As increasing numbers of such devices help to promote a mobile revolution in remote patient care, such standards could prove highly important to a new, emerging care landscape bridging the hospital and the home. Full details at http://findbiometrics.com

New Rigel SafeTest 60 for fast and effective testing of medical equipment

Rigel has introduced a new handheld safety analyser for the routine electrical testing of basic medical and laboratory equipment.

The new Rigel SafeTest 60 is a compact, robust and reliable safety analyser that is particularly well suited to high volume testing demands, with a simple colour coded user interface, push button operation and fast step-through of test routines.

The general purpose tester includes a comprehensive range of safety tests for hospital and medical equipment such as medical beds and chairs, operating tables, hoists, infusion pumps, CPAP’s, centrifuges and other similar equipment that does not require patient lead testing.

As such, the SafeTest 60 is suitable for electrical safety testing to ensure compliance with a range of international safety standards including leakage testing to IEC 60601, IEC 62353, IEC 61010 and NFPA-99.

In addition, to meet the needs of some specific types of equipment, the unit also has the capability to carry out insulation testing in line with IEC 62353 and accurate high current, low energy earth bond testing to both IEC 62353, NFPA-99 and IEC 61010.

In all cases, full manual control means only those specific tests that are required will be carried out, with minimised power breaks and full control of power cycles helping to ensure that testing is carried out quickly and efficiently – without any compromise in accuracy or integrity of testing.

The new Rigel SafeTest 60 is available in a wide range of power supply configurations to meet standard local operating conditions around the world.

Details at www.rigelmedical.com/safetest60

Watch a short video about the Rigel SafeTest 60 electrical safety analyzer

Updated overview of China’s medical devices sector

China now has more than 15,000 medical device manufacturers and the territory has become one of the most important markets for many multinational companies.

This is one of the headline facts from the China Medical Device Industry Handbook 2015, which also reports that the value of the Chinese medical device market reached $41.6 billion in 2014, with a CAGR of 28.4% in the past 10 years.

With this sort of growth China is now one of the most important markets for many multinational companies, with companies such as GE Healthcare, Philips Healthcare, Medtronic, Boston Scientific, and Stryker actively expanding their presence in the country via a series of strategic actions such as mergers and acquisitions, localisation and partnerships.

China’s government has released a series of policies and guidelines to support the local medical device industry in recent years, covering hospital procurement, medical device development and supervision.

However, it remains the case that more than 80% of China’s medical device companies have annual revenues of less than less than $3 million, with the leading local companies, such as Mindray, MicroPort and Unite Imaging, competing with the multinationals. In addition, as well as the local market, Chinese device manufacturers are also expanding global markets mainly in the Middle East, Africa, and South America.

The latest handbook provides a full review of China’s medical devices sector, including government regulations and guidelines, trade data, top companies, key events and healthcare statistics, as well as overviews of the key market segments.

Global growth forecast for wearable medical devices

The Global Wearable Healthcare Market was worth $3.3 billion in 2015 and estimated to be growing at a 17.7% CAGR, to cross $7.8 billion by 2020.

These are the topline findings of a new market research report from Mordor Intelligence, available at www.reportbuyer.com.

The “Global Wearable Medical Device Market – Growth, Trends and Forecasts (2015-2020)” report provides a comprehensive market analysis of all the main wearable device applications, ranging from monitoring blood sugar, glucose, chronic diseases such as heart diseases, diabetes and various other parameters.

Of the four main types of medical and health service solutions targeted by wearable medical devices, comprising of disease management, rehabilitation, health and fitness processes, and patient monitoring and feedback, the latter category accounted for more than 70% of the global wearable medical device market in 2015.

Taiwan seeks medical electronics boost

As part of plans to boost the international competitiveness of Taiwan’s medical electronics sector the country hosted a special forum recently to discuss major trends and developments in the industry.

The ‘Medical Electronics and Devices in Taiwan Forum (MEDiT)’ sought to provide a venue where global medical electronics players could share opinions and establish a cooperation platform which might lead to future business growth.

As part of the proceedings, Dr. Ming-ji Wu, Director General of Taiwan’s Industrial Development Bureau, pointed out that according to Business Monitor International, the worldwide sales of medical electronics totalled $340.3 billion in 2014 and would reach $405.3 billion in 2015.

Dr. Yio-wha Shau, General Director of Taiwan’s Biomedical Technology and Device Research Laboratories, stressed that the medical electronics market in the next decade will be closely linked to population ageing and personalised medicine.

Dr Shau said: “Taiwan’s medical electronics industry has accumulated many years’ experience in cross-fields integration and ICT manufacturing. “With these advantages, Taiwan can cooperate with leading international medical electronics companies to build up sustainable business models and create win-win business opportunities.” Full report

We’re at Arab Health in January

We’ve recently returned from a very successful Medica show in Germany, where we saw lots of interest in our exciting new product developments.

Our range of new electrical safety testing technology for both general purpose medical equipment and specialist medical devices, including the SafeTest 60, 288+ and 62353+ were the highlight of the Rigel display.

Catch us on stand MD33 in January (25-28th) at Arab Health, Dubai, for a chance to see our exciting new product developments plus our full range of advanced medical device performance analyzers, electrical safety analyzers and vital signs simulators.

More info www.rigelmedical.com/events/

Do you use Rigel Medical equipment? – If you think you may have a story for future e-news bulletins, please let us know by contacting us here.

NEW Rigel 62353 Plus Meets Modern Medical Device Test Needs

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Rigel Medical has introduced an upgraded version of its dedicated tester for the in-service and post-repair safety testing of medical electronic devices in line with the standards required by IEC 62353.

In line with changes in test requirements from manufacturers of 24V DC and 48V DC operated medical equipment such as operating tables and portable lighting installations, the new Rigel 62353 Plus tester is equipped with an extended range of insulation test voltages between 50V DC to 500V DC.

As a result, four separate insulation test voltages are now provided at 50V DC, 100 VDC, 250V DC and 500 V DC to give the latest tester even more flexibility in meeting the routine safety testing needs of medical devices in line with the internationally recognised in-service test standard.

Other special design features include an earth bond “zap” circuit that makes use of preconditioning the contact resistance by using a high current, low energy pre-pulse.

In addition, the new tester can measure and warn of secondary earth paths which are common in hospitals and which may seriously affect the validity of leakage measurements if undetected, potentially leading to false positives and passing medical equipment as electrically safe when in fact they are not.

Improved battery power reduces the downtime between testing and other features include an easy-to-use facility for testing up to two individual Applied Parts from different modules or classes e.g. BF and CF class, in either fully automatic, semi-automatic or manual test modes.

The comprehensive testing capability of the safety tester is supported by a large internal memory for the storage of test results, with stored test data being transferred to PC-based asset management and test records databases for maximum traceability.

The new Rigel 62353 Plus analyser tests in full compliance with IEC 62353 and NFPA 99 or AS/NZ3551 respective local versions.

The new instrument forms part of a comprehensive range of advanced safety analysers, patient simulators, testers and accessories from Rigel Medical, part of the Seaward Group.

Medical e-News Round-Up – Issue 49

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This issue covers:

New Rigel 288 safety analyser is a big Plus for faster medical device testing

The new Rigel 288 Plus from Rigel Medical brings faster and safer testing of medical devices and installed equipment in hospitals and healthcare facilities.

In this new battery powered tester, Rigel’s renowned 288 automated safety analyser incorporates new features to provide enhanced performance and faster testing of electrical safety in accordance with IEC/EN 62353, AAMI/IEC /EN 60601-1, IEC 61010, NFPA-99 and AS/NZ 3551.

The Rigel 288 Plus now offers insulation testing between 50 VDC – 500 VDC to meet the test requirements of low voltage DC power supplies, and because it is the smallest analyser of its type, it is easier to transport from site-to-site by field engineers.

Point to point leakage tests can now be carried out from battery power alone, making the Rigel 288 plus a highly portable instrument for testing leakage, earthbond and insulation without the need of connecting to mains power.

The 288 Plus also features Rigel’s unique earth bond technology, which combines high and low test current to ensure the accuracy of the protective earth path, helping to accurately identify any potential wear and tear and it is the only tester providing automated verification of secondary earth paths and incoming mains configuration.

John Backes, Associate Director at Rigel Medical, said the company has moved to meet the market need to improve the test functionality of the popular 288, delivering faster and safer testing of medical devices and installed equipment. He said: “Our customers wanted even more flexibility by testing medical installations and fixed installed equipment for earth continuity and leakage current using batteries alone. Now they can with the new Rigel 288 Plus.”

Review of key medtech market regulatory changes

In a special review, the trade publication Medical Device and Diagnostic Industry has taken an interesting look at the main regulatory changes in five major medtech markets around the world.

The Global Regulatory Update 2015 provides an overview of the main changes in the medical device markets of India, China, Japan, South Korea and Brazil. All of these countries have seen updates to their regulatory systems of late and the review looks at their future trends and prospects.

In summary the article concludes that the five medical device markets covered reflect major differences regarding ease of market entry and compliance from country to country.

For example, while regulators in Japan, South Korea, and Brazil seem to be moving toward less cumbersome requirements, China’s CFDA apparently has not taken similar steps (yet). In India, meanwhile, the regulators’ efforts to develop a more comprehensive registration process remain a work in progress.

A full copy of the review is available here.

Increase in FDA medical device approval fees

The US Food and Drug Administration (FDA) is raising medical device user fees for fiscal year 2016.

The new rates will take effect starting Oct. 1, 2015 and remain static through Sept. 30, 2016.

Under the Federal Food, Drug, and Cosmetic (FD&C) Act, as amended by the Medical Device User Fee Amendments of 2012 (MDUFA III), the FDA is allowed to collect user fees for medical device submissions or applications in order to supplement the agency’s federally-appropriated funding.

In exchange, the FDA is expected to use the additional revenue from user fees to conduct more efficient, timely, and transparent reviews.

The standard fee for a premarket application, product development protocol, biologics licensing application, premarket report, and BLA efficacy supplement, is set at $261,388 each for FY 2016. Fees for other submissions are calculated as varying percentages of that amount.

The US Advanced Medical Technology Association (AdvaMed) is lobbying for additional legislation, such as the FDA SOS Act, to exempt FDA user fees from sequestration measures.

Full story here

Strong market for medical device electronics predicted

A new market report looks at the future of the integrated circuits market in wireless portable medical devices (WPMDs).

The global analysis and forecast review predicts that the global integrated circuits market in WPMDs is projected to grow at a compound annual growth rate of 13.5% during the forecast period of 2014 to 2019.

The growth of the global ICs market in WPMDs is driven by factors such as the increasing use of ICs in application areas such as ECG/EKG monitor, heart rate monitor, and blood pressure monitor, among others. In the global market, the Power IC (PMIC) and driver IC segments are expected to be the highest revenue-generators and drive the market in the coming years.

In this report, the global ICs market in WPMDs has been broadly classified on the basis of type into Power IC (PMIC), driver IC, and logic IC. The PMIC and driver IC segments together accounted for a market share of 74.9% in 2014 and are projected to grow at CAGRs of 13.3% and 14.2% respectively, during the given forecast period.

Watch a short video about Rigel Medical and our products

Dates for your diary

Rigel’s US-based electromedical test specialists will be out and about at forthcoming trade shows.

You can catch up with all the latest Rigel developments and product introductions at the Florida Biomed Symposium (1-3 October, booth 321) to be held at the Disney Colorado Springs Resort, Orlando, Fl. Also in October, Rigel will also be attending the MD Expo (21-23 October, booth 114) at the Redrock Casino, Las Vegas.

Jack Barrett, Rigel’s US based representative will be happy to meet you at either or both events. Full details at www.rigelmedical.com/

Do you use Rigel Medical equipment? – If you think you may have a story for future e-news bulletins, please let us know by contacting us here.

Medical e-News Round-Up – Issue 48

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This issue covers:

New bill will make distinction between devices and drugs in India

A medical device makers body in India has welcomed new medical device legislation that it says will enable the industry to serve the needs of Indian patients in a better way.

The Drug and Cosmetics Bill is awaiting passage through India’s Parliament and for the first time would include specific regulations for medical devices and would address the marketing approval process for the medical device industry.

AdvaMed, the Advanced Medical Technology Association of medical device manufacturers said that currently out of the 14,000 types of medical devices that exist, only 22 are on the government’s list and even these are currently treated in the same way as drugs.

The body said that the Bill is a benchmark legislation as it outlines a regulatory system that is appropriate for medical devices and is broadly harmonised with international regulations.

Sanjay Banerjee, Chair of AdvaMed India, said: “The Bill is historic because it creates a distinction between drugs and medical devices for the first time in India’s legislative history.

“We believe that by establishing an appropriate regulatory framework for medical devices, it will enable industry to better address the needs of Indian patients.

“The obfuscation of the two categories in India has created ambiguity about safety standards and quality control, and limited the ability of the medical device industry to address issues of access, availability, affordability and safety,”.

“It will ensure quality of medical devices, patient safety and remove bottlenecks to easy availability. It will grow domestic manufacturing capacity, allow domestic industry to compete globally and incentivise international industry to invest and ‘Make in India’.” More information at www.business-standard.com

Uni-Therm ensures electrosurgical devices remain in spec

Investment in advanced test instrumentation from Rigel Medical is helping a specialist supplier of veterinary and medical equipment verify the performance and safety of important electrosurgical devices.

Bristol-based Freelance Surgical Ltd. is an established and market leading medical equipment company specialising in the supply of operating and ITU equipment, as well as other medical supplies, to veterinary practices and hospitals.

As part of a rigorous quality control policy the company is using an advanced Uni-Therm unit from Rigel Medical to ensure that all equipment remains compliant with the relevant medical device standards and performs within required specifications.

The Uni-Therm carries out a range of tests in line with the IEC 60601-2-2 type testing standard for electromedical equipment, using its unique load bank and current measurement technology to stimulate the behaviour of body tissue.

As a result, the instrument can accurately analyse the performance of all types of surgical generators across a wide range of impedances, including those operating at high current levels.

The Uni-Therm enables the Freelance Surgical engineers to upload the power distribution curves of different items of equipment for automatic comparison against preset power curves over time and to manufacturer’s specifications.

Upper and lower limits of performance can be established and tolerances refined to ensure that operational norms are maintained.

Steve Griffiths, service manager at Freelance Surgical, explained: “Users of specialist electromedical devices should understand that more rigorous analysis and testing is required than that provided by conventional portable appliance testing.

“The simple to operate technical capabilities of the Uni-Therm mean we can reliably and regularly analyse devices, monitor the results over time and identify any changes to performance that should be rectified.

“This higher level testing means we can give customers much more comprehensive service reports, alongside the confidence that their important electromedical equipment continues to be fit for purpose.” More at www.rigelmedical.com/uni-therm

Click here to see the Uni-therm in action and to download your free guide to Electrosurgery

FDA encourages improved access to medical devices

The US FDA has introduced new measures to reduce the time and cost of clinical trials associated with new medical devices while maintaining patient protections.

By doing so, the FDA is helping to ensure that manufacturers will be more likely to conduct their clinical studies in the USA, enabling patients to have earlier access to innovation.

Writing in a blog on the FDA’s website, Ben Fisher, Director, Division of Reproductive, Gastro-Renal, and Urological Devices, in the Office of Device Evaluation at the Center for Devices and Radiological Health, said: “One way the FDA can reduce the time and cost of a clinical trial is to determine if publicly available clinical data for medical devices with which we have considerable experience can be leveraged to develop a less burdensome clinical trial design.

The FDA has also established a strategic priority of strengthening the clinical trial enterprise. This includes finding ways to streamline clinical trials so that fewer resources are required to bring a new device to the market.

Ben Fisher said: “Through strengthening the clinical trial enterprise, we hope to encourage manufacturers to study new and important medical devices in the USA, helping us fulfil our vision of providing patients with high-quality, safe and effective medical devices of public health importance first in the world.” Full details at www.fda.gov/MedicalDevices/

China issues more standards for medical devices

In an effort to ensure the continued safety and effectiveness of medical devices, the China Food and Drug Administration (CFDA) has made a number of changes to the country’s regulatory framework for product certification.

The CFDA has recently issued a further 90 industrial standards for medical devices. Of these, 14 are to be mandatory standards concerning inter alia haemodialysis and laser corneal refractive therapy equipment and will come into effect on 01 January 2017. The remaining 76 recommended industry standards concern implants for surgery, medical electrical equipment, in vitro diagnostic reagents, and equipment for dentistry and will come into effect on 01 January 2016.

These new 90 standards are in addition to the 120 industry standards already announced in July 2014 and bring the total number of medical device standards to over 700. Although most of the guidance is similar or equivalent to the European harmonised standards, some versions incorporate local variations.

Demand for medical devices is increasing in China, especially in the wealthier urban areas, and the total value of the Chinese medical device market is estimated at over $17-billion.

Hong Kong regulators issue list of medical device standards

Regulators in Hong Kong have published a new list of recognized standards applicable to medical devices as the region moves toward more formal oversight of its device market.

The Hong Kong Medical Device Control Office’s (MDCO) list is intended as a reference for in-country representatives (Local Responsible Persons) in order to demonstrate safety and effectiveness of their manufacturers’ products.

The MDCO list includes standards from the International Standards Organization (ISO) and International Electrotechnical Commission (IEC). MDCO has included ISO 15223 for medical device symbols.

In the introduction to the new list, the MDCO notes that not all requirements for listing a device may be addressed by recognised standards, especially for new types of devices and emerging technologies. In these cases, other supporting documentary evidence should be submitted for evaluation, which may involve relevant industrial or factory standards.

Find out more at www.mdco.gov.hk

Do you use Rigel Medical equipment? – If you think you may have a story for future e-news bulletins, please let us know by contacting us here.

Medical e-News Round-Up – Issue 47

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This issue covers:

Market report charts growth of medical devices

A specialist industry report looks at growing demand for medical devices. The ‘Europe Medical Device Market Outlook to 2018’ provides a comprehensive analysis of industry aspects including, market size by production value of medical devices market in Europe.

The demand for medical devices has been growing owing to a mounting awareness for early diagnosis and treatment of countless disease states in European countries. Other factors propelling the escalating demand for medical devices are the ageing populace, growth in the number of better informed patients and the accessibility of enhanced technologies.

The report also entails market share analysis and company profiles of major players operating in the medical devices market in Europe. A future analysis, trends and developments, government regulations and segmentation by application have also been discussed in the industry research report. Full details are available here.

Growth in Chinese medical device regulatory framework

As China’s medical device market rapidly develops, the China Food and Drug Administration (CFDA) is working quickly to update its standards and certification framework.

It is reported that recently, the CFDA issued a further 90 industrial standards for medical devices. Of these, 14 are to be mandatory standards and will come into effect on 01 January 2017. The remaining 76 recommended industry standards include medical electrical equipment and equipment for dentistry and will come into effect on 01 January 2016.

These new 90 standards are in addition to the 120 industry standards already announced in July 2014 and bring the total number of medical device standards to over 700.

With an estimated value of over $17-billion the Chinese medical device market is the world’s fourth largest with many opportunities for overseas companies.

Although most of the guidance is similar or equivalent to the European harmonised standards, careful attention must be paid to the version adopted and any local variations. The full article on China’s growing regulatory framework is here.

 

International medical device standards explained

One common source of misunderstanding in the medical device industry is the method the various national regulatory systems use to identify standards.

An informative article on MedDevice Online explains the classification system for medical device standards and how the various regulatory bodies in different countries work together across international boundaries.

The article explains how a particular region or country has a standards organisation that may adopt an international standard, and in some cases they modify it or place limitations on it. In addition, the medical device authorities in the region or country may recognise the standard, but there is no obligation to do so. The situation in the USA, European Union and Canada is used to illustrate these points. More details here.

New German website for Rigel

Rigel Medical German language website is now up and running, providing further support for its international customers through added value resources and online tool-kits.

www.rigelmedical.de provides sections covering the company’s range of advanced electrical safety analysers and vital signs simulators along with technical datasheets and brochures. Additional guides and manuals will be available in future as the website expands and develops further.

The site includes enhanced search and navigation features providing ease of access to in-depth information on the Rigel range and help users to identify the right electrical safety tester for their requirements. Users can contact Rigel Medical direct for enquiries on all products and register to receive a regular e-mail newsletter giving details of new instruments and technical developments as they are announced.

 

 

Do you use Rigel Medical equipment? – If you think you may have a story for future e-news bulletins, please let us know by contacting us here.

 

Specialist Tester Ensures Electrosurgical Devices Remain Fit For Purpose

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Investment in advanced test instrumentation from Rigel Medical is helping a specialist supplier of veterinary and medical equipment verify the performance and safety of important electrosurgical devices.

Bristol-based Freelance Surgical Ltd. is an established and market leading medical equipment company specialising in the supply of operating and ITU equipment, as well as other medical supplies, to veterinary practices and hospitals.

The company’s extensive range of specialist equipment ranges from orthopaedic power tools and flexible endoscopy instruments to general operating theatre medical equipment and pre-hospital equipment.

As part of a rigorous quality control policy all items supplied are safety and function tested prior to dispatch in the Freelance Surgical service centre.

For electrosurgical devices and power generators, the company is now using an advanced Uni-Therm unit from Rigel Medical to ensure that all equipment remains compliant with the relevant medical device standards and performs within required specifications.

Electrosurgical equipment uses high frequency electricity to produce enough heat to enable surgeons to cut tissue or seal bleeding vessels during operations. The sophisticated devices work by using the body as a conductor and to ensure the highest levels of patient safety, it is critical that the performance of surgical generators is verified on a regular basis.

At Freelance Surgical, the company’s service team uses the Uni-Therm as part of the regular service, repair, testing and analysis of electrosurgical devices and associated diathermy instruments used in veterinary practices.

The Uni-Therm carries out a range of tests in line with the IEC 60601-2-2 type testing standard for electromedical equipment, using its unique load bank and current measurement technology to stimulate the behaviour of body tissue.

As a result, the instrument can accurately analyse the performance of all types of surgical generators across a wide range of impedances, including those operating at high current levels.

The Uni-Therm enables the Freelance Surgical engineers to upload the power distribution curves of different items of equipment for automatic comparison against preset power curves over time and to manufacturer’s specifications.

Upper and lower limits of performance can be established and tolerances refined to ensure that operational norms are maintained.

Steve Griffiths, service manager at Freelance Surgical, explained: “Users of specialist electromedical devices should understand that more rigorous analysis and testing is required than that provided by conventional portable appliance testing.

“We are dealing with important operating theatre equipment and it is therefore vital that the highest levels of safety and performance standards are maintained.

“The simple to operate technical capabilities of the Uni-Therm mean we can reliably and regularly analyse devices, monitor the results over time and identify any changes to performance that should be rectified.

“This higher level testing means we can give customers much more comprehensive service reports, alongside the confidence that their important electromedical equipment continues to be fit for purpose.”

Product features of the Uni-Therm include a built-in memory, automatic test sequencing, and comprehensive data management facilities – all supported by a large full colour screen display of step-by-step operating instructions to ensure the correct connection and testing of the device under test.

More at www.rigelmedical.com/uni-therm and www.freelance-surgical.co.uk

Medical e-News Round-Up – Issue 46

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This issue covers:

USA votes to repeal health law’s medical device tax

A Republican-run House committee has voted to repeal a 2.3% tax on many medical devices that helps pay for President Barack Obama’s health care overhaul.

The Ways and Means Committee’s mostly party-line 25-14 vote came with Republicans complaining that the levy costs jobs and stifles innovation.

“It’s like putting sandbags on the wings of the Wright Brothers as they try to figure out how to fly an airplane,” said Rep. Patrick Meehan, R-Pa. Democrats say those claims are exaggerations and complained that Republicans have offered no savings to cover the $24.4 billion in lost revenue the repeal would cost over the coming decade.

The bill was “the obvious effort of Republicans to essentially piece by piece, if they can’t do it entirely, to repeal” Obama’s health law, said Rep. Sander Levin, D-Mich.

The GOP-led House has voted three times to repeal the medical device tax since it was enacted in 2010 and the Senate approved a repeal in 2013, though on a non-binding vote. Senate Finance Committee Chairman Orrin Hatch, R-Utah, has introduced a repeal bill in his chamber that has garnered some Democratic support, but no vote has been scheduled.

The tax, which took effect in 2013, does not apply to consumer items like eyeglasses and pregnancy test kits. More at www.dailymail.co.uk

Going Deutsch – New German website for Rigel

Rigel Medical’s German language website is now up and running, providing further support for it’s international customers through added value resources and online tool-kits.

www.rigelmedical.de provides sections covering the company’s range of advanced electrical safety analysers and vital signs simulators along with technical datasheets and brochures. Additional free application information guides and product manuals will be available in the future as the website expands and develops further.

The site includes enhanced search and navigation features providing ease of access to in-depth information on the Rigel range and help users to identify the right electrical safety tester for their requirements. Users can contact Rigel Medical direct for enquiries on all products and register to receive a regular e-mail newsletter giving details of new instruments and technical developments as they are announced.

Medical device technology outpacing regulation

While healthcare services and products are highly regulated throughout their life cycle – from product development to market entry, distribution and post-market supervision – medical regulators have begun to address the question of whether e-health products are caught by these existing regulatory frameworks, which in many cases have yet to finalise their positions.

Regulators are tussling with a need to balance the benefits that come from increased access to health information for patients with the risks that arise from a reduced reliance on physicians in diagnosis and treatment. On the other hand, the lack of a clear regulatory framework itself risks inhibiting new market entrants and limiting the interoperability of products.

In an interesting article www.lexology.com, legal firm Freshfields Bruckhaus Deringer LLP take a look at what’s happening in some of the key markets around the world.

Testing times at Maquet

Maquet, one of the world’s leading suppliers of equipment for operating theatres and intensive care units, uses Rigel 288 to enable medical equipment service engineers to meet the in-service and post-repair test demands of the IEC 62353 standard for in-service testing.

Among the medical equipment and applied parts regularly checked for electrical safety by Maquet engineers are surgical workplace equipment such as operating tables and lighting systems, ventilators and cardio pulmonary machines.

The Rigel 288’s large internal memory facilitates the storage of test results for safety audit and traceability purposes. Test data can be stored for downloading to a PC or output on site via a dedicated print module.

Maquet engineers utilise this facility to print out test results immediately after testing has completed, supplying hospitals with a complete electrical safety record of their equipment at the end of every visit.

Medical device connectivity market to $33.5B by 2019

According to a report by Transparency Market Research, the medical device connectivity market is growing due to the fact that integrating data derived from healthcare devices into electronic medical records (EMRs) saves time, improves patient care, and eliminates transcription errors.

The ‘Medical Device Connectivity Market (wired hardware, wireless hardware and software) – Global Industry Analysis, Size, Share, Growth, Trends, and Forecast 2013 – 2019’ report states that at an astounding CAGR of 37.8% from 2013 to 2019, the global medical device connectivity market is projected to grow from US$3.5 billion in 2012 to US$33.5 billion by 2019.

The key components of medical device connectivity are software, Bluetooth hardware, wired hardware, WMTS hardware, wireless hardware, and Wi-Fi hardware. Wired hardware was the largest segment in 2012, accounting for a 40% share of the medical device connectivity market.

The major end users of medical device connectivity are home health care, hospitals, and others. Hospitals were the largest end users of the medical device connectivity, with home health care identified as a segment having immense growth potential.

Geographically, the global medical device connectivity market comprises four key regional segments: North America, Europe, Asia Pacific, and Rest of the World. North America is the largest market for medical device connectivity, accounting for a 62% share of the overall market in 2012.

The increasing penetration of EMRs in countries such as the U.K. and Germany is estimated to drive the medical device connectivity market in Europe. More at www.onlinetmd.com

Do you use Rigel Medical equipment? – If you think you may have a story for future e-news bulletins, please let us know by contacting us here.

Metrawatt announces acquisition of Seaward Group

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Metrawatt International GmbH has announced the purchase of the UK electrical safety testing specialist, the Seaward Group.

Seaward will now become part of the GMC Instrumentation Division, a group of separate specialist T&M manufacturing businesses based in Germany, Switzerland and the USA and with a global international sales network.

The Nuremburg-headquartered Metrawatt is a worldwide market leader in the development and manufacture of test products and systems used in the electrical, energy and related sectors.

The County Durham-based Seaward Group is a highly successful manufacturer of electronic test and measurement instruments used in the appliance testing, bio medical, renewable energy, electronics manufacturing and utility markets.

The directors of both businesses believe that there is a very good synergy between the two companies in terms of product ranges, geographical spread and main markets served.

Under the terms of the deal, the Seaward Group name and its brands will remain intact and manufacturing will continue at the company’s operation in County Durham.

Rod Taylor, founder of Seaward, said: “This is a very positive development for both companies, bringing new opportunities in terms of enhanced technical capabilities and stronger global market presence.

“Seaward has been very successful as an independent T&M business, but developing a global presence is a significant challenge and being an important part of a larger multinational group brings the opportunity for the business to achieve this much more quickly and effectively.

“Our presence in the UK will remain as strong as it always has been. In fact, one of the attractions of linking up with GMC means that Seaward can make the most of the high global growth potential of its products without losing its brand identity or the core values that have contributed to the company’s success.”

Within its product portfolio, the Seaward Group manufactures instrumentation products under the Seaward, Clare, Cropico, Rigel and Seaward Solar brands.

Market leader in the UK portable appliance testing (PAT) sector, export has become an important and growing feature of the company’s development in recent years, representing 50-60% of turnover. Seaward now supplies products to over 60 countries across the globe, recently breaking into Japan, China and a variety of South American countries.

Dr Hans-Peter Opitz, chairman of Metrawatt International, said: “We are delighted to have added Seaward to our portfolio of instrumentation companies.

“There are parts of the world and specific markets where Seaward products are already strong that have the potential for GMC growth, and, similarly, there are areas where GMC’s presence can now provide a platform for expansion of Seaward’s technology.

“The prospects for both Seaward and the enlarged GMC Instrumentation Division are therefore very bright and we look forward to a successful future together.”

Metrawatt Inernational also owns GMC-I-ProSys in Skelmersdale, a manufacturer of current probes and voltage measurement instrumentation.

As part of the new arrangements Rod Taylor, founder of Seaward in 1982, has announced his retirement from the business. The new managing director of Seaward is Andrew Upton, who joined the company as sales director in 2006. Andrew was formerly Vice President of Seaward Group USA and returned to the UK earlier this year.

Medical e-News Round-Up – Issue 45

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Advanced healthcare to drive Europe’s medical device market

The medical device market in Europe is expected to grow over the coming three years, driven by increasingly advanced healthcare and an ageing population, according to a new report.

Reportbuyer’s Europe Medical Device Market Outlook to 2018 states that the industry is mainly comprised of equipment such as orthopaedic, dental, respiratory and ophthalmic devices manufactured in Germany, France, the UK, Italy and Spain. Indeed, Germany was highlighted as a major contributor to the exportation of medical devices between 2008 and 2013, while the compound annual growth rate (CAGR) for the industry as a whole on the continental bloc was 2.6 per cent.

The report says that demand for medical devices is on the increase because of a need for early diagnosis and treatment of diseases, an ageing population, better informed patients and enhanced technologies. It also explains that rising incidences of chronic diseases such as diabetes and hypertension should further drive the market in the coming years and predicted a CAGR of 3.9 per cent between 2013 and 2018.

This comes after MarketsandMarkets predicted that the portable medical device market will grow at an estimated CAGR of 9.51 per cent from 2014 to 2020, potentially creating further opportunities for exporters. Details at blog.mic-cust.com/

Wearable medical device market growing

The medical device industry is keeping up with a more tech-savvy population by developing technology that is not only mobile but wearable, with companies having devices in development that can sense and measure vital signs and health functions.

With the industry focusing on advancing these devices, the global market for wearable medical devices is projected to reach $5.8 billion in 2019, according to market research retailer ResearchMoz.

As the market for wearable health care devices increases, companies should invest in coding and marking technologies and track and trace solutions that can help brand technology precisely and deliver help protect against counterfeiting.

Wearable medical devices are increasingly being used to help health care professionals monitor patients’ heart rates, blood pressure and more. The market for these kinds of portable medical technology is likely to become more valuable as applications expand into sports and fitness as well as home health care.

While wearable medical devices are still relatively new in the medical world, they are on the fast track to growth as major tech companies like Google and Apple enter the market, IDG News Service reported. More at www.videojet.com/

Free IEC 62353 guide

A free guide covering the electrical safety testing requirements of the IEC 62353 international test standard is available from Rigel Medical.

‘An introduction to electrical safety testing in accordance with IEC 62353’ provides an insightful overview on electrical safety, the definitions of a medical electronic device, the IEC 606001 standard and a summary of the IEC 62353 publication including the 2014 additions.

One of the most significant additions to the 2014 edition is the recommendation to test to IEC 62353 at the final production line stage and before equipment goes into service. This will allow recurrent testing to be directly comparable with factory tests, providing easier observation of any variations.

New for the IEC 62353:2014 edition were a number of suggested tests to help manufacturers identify any requirements for isolating a particular equipment leakage current. Advice about this issue is covered in the guide.

Also included is a section on the benefits of the latest range of battery powered electrical safety analysers, which provide a fast and accurate solution for compliance with international and local safety standards. Visit www.rigelmedical.com/IEC62353 to download the guide.

Asian device market set to leap to $15B in 2017

A survey of the top 100 makers of medical devices in Asia indicates the industry will reach the $15 billion mark in 2017, a huge leap from a market of just $2 billion in 2012.

In addition to the top 100, Research and Markets also focused individually on the device markets in India, Japan and South Korea, all three major ones. Japan, in fact, has the second largest in the world, behind only the United States.

As for Asia, the research company said the overall device market was growing by more than 10% a year to meet the demand driven by higher incomes and living standards in several of the leading countries on the continent.

In Japan, the device market is expected to increase by a compound annual growth rate of 2.9%, its value rising from $30.2 billion just two years ago to $34.9 billion in 2018. South Korea has Asia’s third largest market for devices, behind Japan and China, but is expected to expand by a compound rate of 7.7% by 2018, up from $5.1 billion in 2013.

India has one of the globe’s 20 largest device markets despite a per capita spending rate of less than $3 for the products. The industry’s value has suffered because of the depreciation of the rupee, the national currency, but in actual growth terms is expected to be one of the world’s fastest growing over the next 5 years. Read more at www.fiercepharmaasia.com

Make a date

Don’t forget you can catch Rigel at June’s AAMI Conference & Expo 2015 in the USA, and then in the autumn at the MD Expo, Las Vegas (21 – 23 October). The last event of the year will be MEDICA, the world leading medical trade fair, from the 16 – 19 November.

Full details at https://www.rigelmedical.com/events

 

Do you use Rigel Medical equipment? – If you think you may have a story for future e-news bulletins, please let us know by contacting us here.

 

Medical e-News Round-Up – Issue 44

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First medical device testing lab for India

India’s first medical device testing laboratory is expected to come up in Gujarat by the end of this year. The Gujarat Food and Drugs Control Administration (FDCA) has initiated the process to establish a biocompatibility and medical device testing lab in Vadodara.

FDCA had raised the demand during a meeting with Engineering Export Promotion Council (EEPC), set up by the ministry of commerce and industry in Ahmedabad, for a medical device testing laboratory in the state.

HG Koshia, commissioner, Gujarat FDCA, said: “This will be the first government owned medical devices testing laboratory in India.

“The lab will help medical device manufacturers – who are paying a hefty sum for their products to be tested by international testing agencies – become self-reliant. It will be an affordable option for the medical device industry in the country.”

More at timesofindia.indiatimes.com/

Optical company sees the benefits of Rigel Uni-Therm

Field engineers at Olympus KeyMed Ltd use the Uni-Therm analyser for improved in-service testing of electrosurgical devices. These items of equipment use electricity to produce enough heat to enable surgeons to cut body tissue or seal bleeding vessels during operations.

The Uni-Therm units are used to allow automation of the performance testing of Olympus’s electrosurgical equipment, resulting in greater efficiencies.

The testers enable engineers working at sites across the UK to accurately measure the performance of each device and complete high frequency leakage, high current, power distribution and patient return plate alarm testing.

Compliant with IEC 60601, the high performance Uni-Therm is capable of verifying and calibrating the electrosurgical equipment while guiding the engineer through all test procedures automatically and most of all safely.

Olympus is a leading manufacturer of advanced optical and digital equipment for the healthcare and consumer electronics sectors, leading the way in designing endoscopy and microscopy products among others.

Martin Wallace, head of field service, said: “The Uni-Therm incorporates an excellent range of features for a tester of its size, while the added value benefits, like improved connectivity and ease-of-use, are particularly impressive.

“The ability to import and export data is also a particularly beneficial feature, enabling us to store test information which can then be easily retrieved and used for quality control purposes at a later date.”

UK NHS open to global innovation

A worldwide call has been launched for innovators to partner with local health and care systems in trialling new technologies, digital services and other innovations with the potential to deliver big benefits to patients and taxpayers alike.

The National Health Service England (NHS) and the UK Government are calling for expressions of interest from innovators from any sector in the UK and overseas who want to test their ideas to deliver health services in better ways at scale, and in a real clinical setting.

The announcement is the latest stage of implementing the NHS Five Year Forward View, which set out additional steps the NHS will take to accelerate innovation in better ways of delivering health and care. It also builds on the UK Life Sciences Strategy and the NHS ‘Innovation Health and Wealth’ Proposals.

Too often, new technologies have been tested alone, in isolation from complementary innovations in how NHS services are delivered, limiting the value they produce. This programme will address this shortcoming of previous approaches.

Innovators from industry, the voluntary sector or the NHS itself are therefore being asked to put forward new technologies that, working in combination with innovations in health and care delivery, could offer better outcomes for patients as well as better value for taxpayers.

For example, this could mean equipping patients with wearable technology, combined with new patterns of working for clinical and nursing staff which aim to help patients manage long-term conditions, address any potential problems as early as possible, and help keep them out of hospital.

Life Sciences Minister George Freeman MP said: “The NHS Test Bed programme is about unlocking the potential of the world’s only fully integrated health system as the ultimate platform for assessing the real value of innovations. By doing this we open the door to making the UK once again the best place in the world to invest in and develop medical innovations.” Read in full at www.england.nhs.uk/

New German website

Rigel Medical is targeting further growth and support for its international customers with the launch of a new German language website.

The dedicated site at www.rigelmedical.de provides sections covering the company’s range of advanced electrical safety analysers and vital signs simulators along with technical datasheets and brochures. Additional guides and manuals will be available in future as the website expands and develops further.

The site includes enhanced search and navigation features providing ease of access to in-depth information on the Rigel range and help users to identify the right electrical safety tester for their requirements.

IMDRF proposes QMS principles for software as a medical device

In recent years, general-purpose devices such as personal computers, smartphones and wearables have enabled the proliferation of ‘software as a medical device’ (SaMD) products.

Now, the International Medical Device Regulators Forum (IMDRF) is considering a new document that explores how quality management system (QMS) principles can apply to software as a medical device (SaMD) development.

The move will see traditional manufacturers follow these principles for medical devices as well as any good software engineering practices that may apply. While many QMS principles that apply to traditional medical devices translate to SaMD, companies developing these products will also need to make some additional considerations:

User-based risks: Is the SaMD product appropriate for all intended users? For instance, are there risks posed by visual acuity for an elderly user, or for patients with peripheral neuropathy?

Application-based risks: Should a SaMD application be available on any device, or should it be restricted to certain devices in such a way that it could help to mitigate user risk?

Device-based risks: Is a device with a smaller screen such as a smartphone adequate for the intended application, can a smaller screen display a large set of information without losing the information or making it cumbersome to the users in a way that could affect patient safety.

Environment-based risks: Is continuity of use (and therefore, safety) of the SaMD product compromised when there are environmental disruptions (e.g., what happens with use interruptions, background noise and loss of network connectivity during use, etc.)

Security-based risks: Analysis should include evaluating the security threats to SaMD product software code during manufacturing, maintenance and in-service use. Analysis can also include intrusion detection, penetration testing, vulnerability scanning and data integrity testing to minimize system and patient risks.

Developers should also consider the risk posed by the platform or operating system (Windows, Mac OS, iOS, Android, etc.) a SaMD product is connected to including, designing SaMD products that take into account ‘unanticipated upgrades to the underlying platform’.

More at www.raps.org/

Connect to the benefits of the world’s smallest all-in-one vital signs solution

Discover all the advantages of the world’s smallest, high performance all-in-one vital signs solution with the simulation finger and hand-held UNI-SIM simulator combination.

The compact Rigel PULS-R universal SpO2 simulation finger can produce accurate SpO2 simulations in 1% resolution from as low as 30% using the pre-programmed manufacturer specific R-curves. It can also be configured to meet customer specific R-curves via a simple-to-use configuration tool. This improves the detection of degrading and inaccurate SpO2 probes, reducing incidences of failure and providing the user with peace of mind.

When linked with the UNI-SIM vital signs simulator – capable of undertaking NIBP, SpO2, ECG, temperature, IBP and respiration functionality tests simultaneously – it provides improved and customised vital signs simulation and measurement. Administration time is also reduced as the data recording and storage is undertaken directly and automatically. More at www.rigelmedical.com/uni-sim

Do you use Rigel Medical equipment? – If you think you may have a story for future e-news bulletins, please let us know by contacting us here.