Medical e-News Round-Up – Issue 45

This issue covers:

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

This issue covers:

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.

Medical e-News Round-Up – Issue 43

This issue covers:

FDA: 72,000 cases of defib failure

Automated external defibrillators – those installed and ready for use in many public spaces – can save lives when needed, but the U.S. Food and Drug Administration says that since 2005, it has also received 72,000 reports of the devices failing.

The agency said that, based on these incidents, it will strengthen its approval process for external defibrillators and their accessories, including batteries, pad electrodes, adapters and other items.

Automated external defibrillators are portable devices that automatically detect potentially deadly heart rhythm problems in a patient and deliver an electrical shock to restore normal rhythm.

The devices do “save lives,” Dr. William Maisel, deputy director for science, acting director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health, said in an agency news release.

However, the new changes “will allow us to more closely monitor how they are designed and manufactured,” he said. “This will go a long way towards correcting long-standing problems and ultimately improving the reliability of these devices.”

The FDA said it will also carry out inspections of manufacturers’ facilities prior to approving the defibrillators. After approval, manufacturers will have to file annual reports on each device’s performance and inform the agency about any changes made to the defibrillators that affect safety and effectiveness.

The FDA said that devices currently on the market will remain available while manufacturers work to meet the new requirements for the devices, which take effect in mid-2016. New requirements for current, necessary accessories will take effect January 2020.

More at www.webmd.com

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Rigel 62353 analyser powers NHS equipment supplier

Medstrom, a UK medical equipment and service supplier, has improved the electrical testing of thousands of its medical devices using Rigel’s 62353 safety analyser.

The company supplies and maintains electrically operated paediatric cots, bed movers, reactive therapy systems, patient beds, trolleys and carts among other items to hundreds of hospitals and healthcare facilities across the UK. These have to be regularly tested to ensure compliance with IEC 62353, the standard for in-service and after repair testing of medical electronic devices.

The testing work is undertaken by Medstrom’s field service engineers using Rigel 62353 analysers, enabling them to check the electrical safety of equipment to ensure it is safe for use by both patients and staff.

The ability to be able to do this quickly and efficiently means that critical safety tests are completed successfully as an integral part of Medstrom’s after sales support, and dedicated service team, saving time and boosting customer service levels.

Darren Hunt, Medstrom’s technical training manager, said: “The Rigel 62353 is a superb high performance instrument that works extremely well and delivers consistent results. It’s very intuitive, offering a single-button test solution which engineers, who have busy service schedules to complete, really appreciate.

“Test results are easily downloaded to our asset database while the memory and operating instructions are clear, straightforward and easy to navigate.”

European patent applications in medical technology increase

The European Patent Office has published its annual data, which has revealed that medical device innovators remain at the top of the patent protection rankings.

Dr Thomas Prock, a UK, German and European Patent Attorney at Marks & Clerk, says in his article for EMDT that in 2014, more patent applications were filed for medical technology than for any other type of technology, including digital communication, biotechnology and pharmaceuticals.

Figures show an average increase of about 3% per annum in the number of patent filings relating to medical technology over the past ten years while 41% of the European patent applications filed in 2014 in the medical devices field originated from within Europe. Another 39% originated in the USA.

Given that applicants tend to protect their inventions on their “home turf” before seeking patent protection abroad and Europe is a foreign market for US innovators, this data suggests that US research and development activity in medical technology is more intense than in Europe.

Many medical treatment providers are under pressure to reduce invasiveness of treatments and decrease associated recuperation time. While the factors driving the growth in patent filings will be manifold, this pressure appears to be contributing to a healthy culture of innovation among medical technology providers.

He says that we shouldn’t ignore the increasing consumer demand for medical technology – personal healthcare devices are now a source of revenue for many high-tech companies, requiring research and development, leading to patent filings.

As the demands of both consumer and healthcare systems grow, so will the R&D programs developing technology to meet those demands, and the numbers of patent applications flowing from them. Read in full at www.emdt.co.uk

IEC 62353 Guidance Booklet

The new edition of the IEC 62353 standard, which applies to ‘Medical electrical equipment – Recurrent test and test after repair of medical electrical equipment’, covers the general requirements for testing equipment prior to it going into service, after modifications, after repair, and as part of a recurrent testing protocol.

It also provides details of the tests that should be performed under these circumstances and discusses the reporting of the results of your testing and how to evaluate your findings. The standard is intended for use by equipment manufacturers, testing equipment manufacturers, regulatory authorities, equipment suppliers, service personnel and organisational equipment users.

To help, Rigel has published an IEC 62353 (2015) Guidance Booklet which is available at www.rigelmedical.com/

UAE medical appliances’ growth

A Dubai Chamber of Commerce and Industry study indicates that expenditure on medical appliances and equipment in the UAE has experienced a strong increase, valuing the market at around AED 2.87 billion in 2014.

It is also forecasted to increase at a Compound Annual Growth Rate (CAGR) of about 9.78% from 2014 to 2020 as, by then, the value of expenditure will increase to around AED 5.03 billion.

This increase, the study adds, has come in light of the growth in income and population, together with increased awareness about the importance of healthy living across the MENA region and South and East Asia.

This has created demand for medical services and generated potentially lucrative opportunities for Dubai to become the hub for medical tourism for these regions.

The study, which is based on a BMI Espicom Business Intelligence report titled ‘UAE Medical devices report Q4 2014’, discusses opportunities and ways for UAE businesses to benefit from growing demand for medical devices in the UAE and in foreign markets.

It also states that traders in this area can expect potentially robust growth in a range of products within the UAE and across the surrounding regions. More at www.dubaichamber.com/

See us during 2015…

A reminder that you can meet us at several events this year. On April 30th we’ll be at the EBME 2015 Seminar in Milton Keynes, UK. Summer will see us 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 42

This issue covers:

India’s new medical device regulations

A proposed draft of new legislation for medical devices has been released by India’s Health Ministry, according to the website, India Briefing.

The Drugs and Cosmetics (Amendment) Bill is expected to be submitted to the country’s parliament later this year, and would make India’s regulations the same as the European Medical Device Directives.

According to the article…”the new legislation would simplify import procedures and affect change across many areas including: manufacturing, sales, distribution and clinical trial of medical devices.”

It will also establish a Medical Devices Technical Advisory Board. Full details here.

288 success at Hitachi

Leading healthcare equipment manufacturer Hitachi Medical Systems UK Ltd uses Rigel 288 analysers to reduce the time it takes for engineers to test the electrical safety of its ultra sound scanners in service in the UK.

The Rigel 288 enables engineers to quickly check the safety of around 500 scanners while they are in use to ensure compliance with the recurrent and post repair test requirements of the new IEC 62353 standard for medical devices.

Bluetooth technology enables Hitachi’s engineers to carry out cable-free data transfer and safety labelling, without the cumbersome plugging and unplugging of leads and cords.

Wellingborough-based Hitachi Medical Systems is part of the Hitachi Group that designs, manufactures and supplies advanced medical equipment and solutions to healthcare markets worldwide. Roy Cartwright, Hitachi’s technical support manager, said: “We have been impressed with what the 288 offers in term of quality, versatility and ease-of-use.

“Robust and fully functional means the 288 meets the demanding requirements of field testing, while its portability, flexibility and added value features are very good. All in all, it’s an impressive and unique product that makes the job of electrical safety testing a whole lot easier.”

Global refurbished medical equipment market to hit more than $9 billion by 2019

The global refurbished medical equipment market is expected to grow at a compound annual growth rate (CAGR) of 12.5 percent and reach $9.37 billion by 2019, according to a new MarketsandMarkets report.

The market includes operating room, medical imaging, cardiology, intravenous therapy systems, endoscopy equipment, patient monitors, defibrillators, intravenous therapy systems, intensive care and neonatal intensive care units, blanket warmers, autoclaves, suction pumps, sequential compressor devices, stretchers, cath labs, stress test systems, heaters/coolers, dry imagers and beds.

Financial challenges are increasing the global interest in low-cost refurbished medical equipment and growing privatization in the health care sector is also driving the market. But at the same time, the market is restricted by the lack of standard policies for the sale and use of refurbished medical equipment and a public institutional stance against purchasing the equipment.

In 2014, North America made up most of the global market, followed by Europe, but the Asia-Pacific region is projected to gain momentum and grow at a CAGR of 13.7 percent from 2014 to 2019. That is being driven by privatization, reduced reimbursement rates, a growing population base and an increase in low budget hospitals and clinics.

The emerging markets, including India, Brazil, and Mexico hold great potential for refurbished medical equipment companies. Medical tourism is growing in those regions and there is also an increase in the population bases and privatization.

As of 2014, the global refurbished medical equipment market was dominated by GE Healthcare (UK), Philips Healthcare (Netherlands), and Siemens Healthcare (Germany), which together accounted for about 41% of the market. www.dotmed.com/

Total capability at EBME

Rigel Medical will be showcasing its advanced range of electrical safety analysers and vital signs simulators, which provide accurate solutions for testing medical devices and equipment, at EBME (30th April 2015) in Milton Keynes.

Event details at www.rigelmedical.com/events

New technologies will cut healthcare costs

In a report issued by market research firm IBISWorld, industry analyst Sarah Turk predicts that burgeoning digital technologies will pay substantial dividends for healthcare by 2020, both reducing healthcare costs and improving access to care.

She focuses on three key modalities in her report: telehealth, mobile health (mHealth), and interoperability.

Telehealth technology may help “mitigate the burden of the projected shortage of 20,400 primary care physicians by 2020,” Turk says. She notes that while many healthcare providers already engage in telehealth, the technology’s potential “has yet to be fully harnessed”.

Similarly, she says, mHealth—the “use of mobile applications and devices to exchange medical information, data or to provide clinical services”—will also transform healthcare information technology. Combined with the rise of telehealth, mHealth will move healthcare away “from relying on inpatient care and … toward outpatient, namely in-home, patient-monitoring services.”

However, for these advances to occur, the healthcare industry must overcome the challenge of interoperability. Due to the lack of “interoperability standards for medical equipment and related software,” Turk says, “the implementation of new technology may pose … an arduous task for healthcare providers.”

More at www.ibisworld.com

Check your Pulse

Finally, make sure you collect your copy of the latest edition of The Pulse, Rigel Medical’s medical industry publication. We look at the new edition of IEC 62353 which applies to ‘Medical electrical equipment – recurrent test and test after repair of medical electrical equipment’ and answer some of your questions in our regular ‘Question Time’ slot.

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 41

This issue covers:

Medical Device Tax facing the axe

The U.S. medical device tax is the issue that won’t go away. Elected officials and medical device companies began railing against Obamacare’s medical device tax before it even became law and have complained about it ever since it did.

Now with a Republican majority in Congress and bipartisan support from legislators in states that host major medtech firms, it appears the 2.3% tax may be axed from the Affordable Care Act by the end of March, according to a report in the political news website thehill.com.

Paulsen and Rep. Ron Kind (D-WI) said they expected lawmakers to replace the money lost in a repeal, the Hill report said.

Senator Orrin Hatch (R-UT), who last April called the levy a “stupid, dumbass tax,” does not believe a “pay-for” will be necessary to get Paulsen’s bill passed. The incoming chair of the Senate Finance Committee, Hatch proposed his own repeal bill last year.

Sens. Al Franken and Amy Klobuchar (D-MN.) have also long opposed the tax, and medtech companies have paid lobbyists significant sums of cash to pressure Congress to repeal it.

More at www.qmed.com/news

Passing the test in Tel Aviv

One of the largest hospitals in Israel uses Rigel Medical’s range of testers and analysers to improve the testing and calibration of biomedical devices.

The move allows The Herzliya Medical Center (HMC) to simplify testing procedures as part of an in-service planned preventative maintenance programme overseen by its Biomedical Department.

This has seen improvements in the speed and ease by which electrosurgical units (ESU), vital signs monitors, infusion devices and defibrillators among other items of medical equipment are maintained and checked for electrical safety and performance accuracy.

The Rigel 288 automated safety analyser, Uni-Therm electrosurgical generator calibrator, Uni-Pulse defibrillator analyser, Multi-Flo infusion pump analyser and Uni-Sim combination vital sign simulator are among the Rigel Medical products the hospital’s uses for compliance with standards including IEC 62353 IEC/EN60601-1, VDE 0751-1, AS/NZS 3551, AAMI, NFPA-99, MDA DB 9801-2006.

Director of the Biomedical Department and engineer Tamim Jaber said that turning to Rigel Medical met the HMC’s ‘real life biomedical’ requirements, providing the first opportunity to bring all aspects of biomedical testing within a single software solution (Rigel’s Med-eBase) and to generate reports and certificates for all devices under test.

France medical devices market worth over $20 billion by 2020, says report

A new report estimates that the size of France’s medical devices market is expected to reach approximately $20.8 billion by 2020.

The ‘CountryFocus: Healthcare, Regulatory and Reimbursement Landscape – France’ report identifies the trends in the healthcare market and provides insights among other matters on the demographic and regulatory landscape, and healthcare infrastructure of France.

It has been prepared using data and information sourced from proprietary databases, secondary research and an in-house analysis by GlobalData.

The positive trends in the country’s healthcare market can be attributed primarily to an increasingly elderly population, universal healthcare insurance, and a high degree of access to healthcare facilities.

In 2012, France’s population was approximately 65 million, but the growth rate is decreasing steadily – possibly due to a negative balance between the mortality and birth rates, and a low net rate of immigration. Domestic policymakers are also wrestling with the problems of a Eurozone crisis, a declining working population and an increasing elderly population.

The scope of the report includes an overview of France’s medical devices market, including the market size, market segmentation, key drivers and barriers. Analysis includes details of the regulatory agencies and the approval processes for new medical devices while there’s an overview of the opportunities and challenges for growth that exist in the healthcare market. More at www.cnbc.com

Search for pioneering healthcare innovators

Sir Bruce Keogh, NHS England’s Medical Director, has launched the NHS Innovation Accelerator programme.

Together with hosts UCLPartners and The Health Foundation, NHS England is inviting healthcare pioneers from around the world to apply to develop their tried and tested innovations across parts of the NHS.

The programme will focus on the conditions and cultural change needed to enable the NHS to adopt innovations at scale and pace, aiming to improve outcomes and give patients more equitable access to the latest products, services and technology.

Applicants should be experienced innovators in healthcare who are currently leading or working on new technologies, services and processes that have the potential to make a real difference to patient outcomes.

The programme will offer successful candidates a range of support to develop and spread their innovations across parts of the NHS, such as access to international leaders in healthcare development and established networks through high calibre mentors including Lord Ajay Kakkar, Lord Ara Darzi, Sir John Tooke and Sir Sam Everington.

Sir Bruce Keogh, NHS England’s Medical Director, said: “Britain has made a significant contribution to medical science and humankind.

“The Innovation Accelerator will build on our enviable history of discovery and innovation by embracing cutting-edge healthcare innovators from around the world to improve patient care while reducing costs and providing better value for the taxpayer.”

Details at www.england.nhs.uk

Improved safety analyser makes for faster testing

The improved battery powered 288 analyser from Rigel Medical delivers faster and safer testing of medical devices and installed equipment.

The 288 is one of the most recognised electrical safety analysers on the market today, renowned as the smallest, most compact tester of its type in the world. It incorporates unique technologies and features to provide enhanced performance and improved electrical safety testing of equipment to the appropriate standards including IEC/EN 62353 and IEC/EN 60601.

While most conventional testers rely on mains power, the improved battery powered 288 retains operational integrity, even without mains connection, due to standard AA battery power compatibility. This provides greater user flexibility and makes it quicker to complete in-service testing of point-to-point leakage as well as earth continuity and insulation resistance.

And because the 288 does not require a lengthy power cord to operate, there are no trailing cables to cause potential trip hazards, making it even safer and more convenient to set-up and use on-site. Further time saving benefits are achieved because the analyser’s battery power back-up avoids the need for lengthy boot-up times between tests.

Up to 10 individual patient leakage circuits can be checked in a single test routine, while a further benefit is the ability to automatically warn users of incorrect test set-ups, helping to avoid incorrect readings – it is the only tester of its type providing automated verification of secondary earth paths and incoming mains configuration.

The 288 forms part of a comprehensive range of high performance biomedical test equipment supplied by Rigel Medical. You can find out more at www.rigelmedical.com/288

Watch out for us in 2015

Don’t forget you can catch Rigel at several events this year. March (29 – 31) will see us at MD Expo Nashville before returning to Europe for the EBME seminar (30 April 2015) in Milton Keynes, UK.

Summer will see us at June’s AAMI Conference & Expo (5 – 8 June 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 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 40

This issue covers:

New advanced interface for device testing

A new approach to medical device testing in hospitals is available following the launch of an advanced interface developed by Rigel Medical and EQ2.

The move sees the Rigel Medical 288 electrical safety analyser integrated with EQ2’s clinical equipment management system HEMS to provide a fully automated, highly accurate and easily portable system for capturing and documenting medical device safety records.

A new module has been incorporated into EQ2’s HEMS Enterprise software to make it fully compatible with the automated Rigel analyser.

This module – the EQ2 Rigel SA Interface – enables the biomed engineer to harness the 288’s full capabilities to capture valuable information at the point of testing in a hospital or healthcare centre before sending the data automatically to the HEMS system to complete safety checks and link to the medical device’s inventory, test library and performance history.

John Backes, Associate Director at Rigel Medical, said the international and domestic hospital markets are key areas of growth and we have partnered with EQ2 to provide an advanced testing solution for this sector.

He added: “EQ2 has simplified the user interface experience while delivering accurate and robust interoperability with the Rigel 288 was a key to our interest in EQ2.

“EQ2 has delivered on their vision with the release of this simple, intuitive interface to our Rigel 288 – a perfect complement to our great safety analysers.”

India opens up investment opportunities

India’s Department of Industrial Policy and Promotion (DIPP) will allow 100% foreign direct investment (FDI) in medical devices as part of a strategy to reduce imports and promote local manufacturing for global markets, which will be worth over $400 billion in 2015.

Over the past few months, the government has eased FDI rules in defence and construction to promote domestic manufacturing as PM Narendra Modi made a pitch for ‘Make in India’ and boost investment and economic activity.

The proposal on medical devices will be a carve-out of the FDI policy in pharmaceuticals, said an official, adding that there will be no need for government approval in this segment.

India currently imports over 70% of medical devices, these fall under the purview of the Drugs and Cosmetics Act. FDI in the sector is governed by the same rules as that for pharmaceuticals or medicines. Though the government allows 100% FDI in pharmaceuticals, companies are required to comply with certain conditions.

Read more at timesofindia.indiatimes.com

Specialist electro medical equipment services from Calibrationhouse

The expanded Calibrationhouse now has the capability to provide full calibration, repair and service for all types of electro medical equipment including oscilloscopes, diathermy testers, defibrillator testers, infusion device analysers, occlusion testers, NIBP and other types of patient simulators.

In addition, in compliance with IEC 60318 and BS EN 60645, the company has the ability to undertake the specialist calibration and servicing of dedicated audiology equipment including audiometers, sound calibrators and acoustic ear instrumentation.

Calibrationhouse is accredited to ISO9001:2008 and ISO17025:2005 with service, calibration and repairs of all types of electronic equipment being undertaken with assured traceability to national UKAS standards.

This service is provided both at the company’s advanced technology workshops and also via a specialist on-site calibration service enabling work to be carried out on customer premises to minimise downtime for vital equipment.

Specialist calibration, service and repair expertise is provided by Calibrationhouse to a range of NHS trusts and private healthcare providers for medical test equipment manufactured by a wide range of suppliers including, Rigel, Fluke Biomedical, Bio Tek, DNI Nevada, Metrohm and others.

Further details on Calibrationhouse on 0191 587 8736, via info@calibrationhouse.com or at www.calibrationhouse.com

Eastern Europe restructures growth strategies to focus on medical devices sector

As governments in Eastern Europe restructure their growth strategies and focus on attracting investors outside of the European Union in response to the Eurozone crisis, the region presents ample opportunities for investors in high value-added industries such as the medical devices sector.

Many companies within the region are unable to fulfil the demand for more sophisticated equipment. The majority of new medical device equipment is therefore imported.

New analysis from Frost & Sullivan,

Profiles of Key Eastern European Medical Device Manufacturers, finds that the market was worth $5.40 billion in 2013 and is expected to grow at a CAGR of 3.1 percent between 2014 and 2018. Poland, Czech Republic and Hungary afford the highest scope for medical device investments.

“Easy access to a quality workforce as well as an uncomplicated registration process in comparison with other countries encourages manufacturers to invest in Eastern Europe,” said Frost & Sullivan healthcare senior research analyst Parthasarathy Raghava. “The emergence of private healthcare facilities has created an added revenue stream for the medical device market.”

More at www.news-medical.net

And finally…Arab Health 2015

Don’t forget you can see us at Arab Health (Z1B12), where the world’s smallest all-in-one vital signs solution will be the highlight of our display of medical device analysers, electrical safety testers and simulators.

Rigel’s hand-held vital signs simulator Uni-Sim – capable of undertaking six synchronised vital signs parameter tests simultaneously – has been linked with the new PULS-R SpO2 simulation finger to provide improved vital signs simulation and measurement.

Associate Director John Backes said: “Arab Health is a key show and this year we look forward to using it as the perfect platform to launch our world leading, all-in-one vital signs simulator solution to the important Middle East market.”

Further details on our events page, 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.

Rigel and EQ2 partner to launch new automated interface

A new approach to medical device testing in hospitals is available following the launch of an advanced interface developed by Rigel Medical and EQ2.

The move sees the Rigel Medical 288 safety analyser integrated with EQ2’s clinical equipment management system HEMS to provide a fully automated, highly accurate and easily portable system for capturing and documenting medical device safety records.

A new module has been incorporated into EQ2’s HEMS Enterprise software to make it fully compatible with the automated Rigel analyser.

This module – the EQ2 Rigel SA Interface – enables the biomed engineer to harness the 288’s full capabilities to capture valuable information at the point of testing in a hospital or healthcare centre before sending the data automatically to the HEMS system to complete safety checks and link to the medical device’s inventory, test library and performance history.

John Backes, Associate Director at Rigel Medical, said the international and domestic hospital markets are key areas of growth and we have partnered with EQ2 to provide an advanced testing solution for this sector.

He added: “EQ2 has simplified the user interface experience while delivering accurate and robust interoperability with the Rigel 288 was a key to our interest in EQ2.

“EQ2 has delivered on their vision with the release of this simple, intuitive interface to our Rigel 288 – a perfect complement to our great safety analysers.”

EQ2 is the first Rigel authorised provider of automated CMMS – Rigel interfaces. Vishal Malhotra, EQ2 Director of Development, said: “With this first release, EQ2 and Rigel prove that complex interoperability can be accomplished through good system design to be stunningly simple for the customer to use.”

The Rigel 288 features a compact Bluetooth barcode scanner, enabling devices and equipment to be quickly and easily identified, while test results can be stored internally and printed wirelessly to a small battery operated printer. Users also have the facility to select from a range of pre-set test programs or develop their own customised routines.

EQ2, based in Burlington, Vermont, U.S. is global supplier of healthcare and clinical equipment management systems.

Rigel Medical 288 stars in new online video

Rigel Medical has produced a new online video to showcase the advantages of its 288 electrical safety analyser.

The 288 is one of the most recognised electrical safety analysers on the market today and features a lightweight design, earth bond technology and an internal memory to make it a valuable tool for a vast array of test applications.

In a move to improve the support and service Rigel provides to customers, the video explains more about the benefits of this highly versatile analyser and demonstrates how biomed engineers can take advantage of the product’s compactness and portability for comprehensive, high performance in-service testing.

The video is available at www.rigelmedical.com/288

Medical e-News Round-Up – Issue 39

This issue covers:

Faulty NHS equipment kills 300 people a year

More than 300 patients a year are dying due to faulty NHS equipment, according to an article in the Daily Mail about a report from the Institution of Mechanical Engineers.

The report says nearly 5,000 people were left seriously injured last year after using faulty equipment including pacemakers, MRI and CT scanners. In the highest annual total of deaths since records began, 309 patients died last year in ‘adverse incidents’ linked to medical devices.

In total, there were 13,642 incidents relating to faulty equipment reported to health officials. Medics have also been forced to delay life-saving operations because their machines and tools don’t work.

Patients also suffered delays and injuries after issues with incubators, wheelchairs, artificial limbs, syringes and specialist beds.

The report says boosting the number of engineers in hospitals would help cut the number of deaths and injuries, and warns that while technology is leading to huge advances in healthcare, it remains dependent on the work of biomedical engineers to fix and maintain it.

There are concerns that a lack of engineers to maintain equipment might be exacerbating the problem with the report calling for the introduction of a Chief Biomedical Engineer at each NHS trust.

Dr Patrick Finlay, of the Institution of Mechanical Engineers, said: “Government and the NHS need to take urgent action to prioritise the role engineers play in hospitals and trusts.

“Technology is leading to huge advances in healthcare, but this technology is dependent on the work of biomedical engineers who are inadequately recognised and in short supply in most hospitals.

“Clinicians and engineers need to work in partnership to ensure that advances in medical technology are applied in the best interest of patients. The benefits of hospitals having a designated chief biomedical engineer responsible for healthcare technology are clear.”

Read in full at www.dailymail.co.uk

Rigel comments: This and other similar reports once again highlight the urgent need for regular testing of health equipment, says John Backes, associate director – Rigel Medical. “There is always a need to ensure devices are regularly checked and tested as people’s lives could be placed at risk by faulty or failing equipment.

“This is the latest report of problems associated with medical devices, so it’s vital they are properly checked and maintained. Testing these medical devices and other items including AEDs is easy, relatively inexpensive yet vital. Owners and operators could benefit by using the latest generation of easy to use, portable and lightweight analysers to quickly and easily verify the safe operation and functionality of equipment.”

This includes the Rigel Medical Uni-Pulse defibrillator analyser, which features advanced measurement technology, the battery powered analyser offers both manual and automatic test programs for the safe testing of all mono-phasic, bi-phasic and pulsed waveform defibrillators and AEDs.

Republican knives out for Obama’s medical devices tax

News agency Reuters reports that republicans in the U.S. Congress will move to avoid a medical device tax imposed less than two years ago under President Barack Obama’s healthcare law.

The 2.3% excise tax on sales of most medical devices sold in the United States helps fund the law, known as Obamacare, and applies to products ranging from bedpans to heart pacemakers. It took effect in January 2013 and is projected to raise about $30 billion a year in government revenue over 10 years.

Though no full-scale repeal of Obamacare is expected, even with the Senate now under Republican control, the move against the tax is part of efforts to gradually chip away at the law.

The recent mid-term elections will elevate Republican Senator Orrin Hatch, a long-standing opponent of the tax, to the chairmanship of the tax-writing finance committee in the Senate.

“The senator will continue to examine and support every viable opportunity to permanently repeal Obamacare’s onerous tax on medical devices,” said his spokeswoman Julia Lawless.

In 2013, the Senate approved a symbolic resolution calling for repeal of the tax, with more than 30 Democrats joining Republicans in support of the non-binding measure.

Opposition to the tax is also widespread in the House of Representatives, so there is a strong chance it could be repealed. Republicans held the majority there even before the elections and voted on 50 occasions to repeal all or part of Obamacare. More at www.reuters.com

Video star

The Rigel 288 has become one of the most recognised electrical safety analysers on the market today. Its unique, earth bond technology and use of internal memory make it a truly valuable tool for every biomedical test professional.

Now, in a move to boost the support and service Rigel provides to customers, a new online video has been produced explaining more about the benefits of this highly versatile analyser and demonstrates how biomed engineers can take advantage of the product for comprehensive, high performance in-service testing. Watch in full at www.rigelmedical.com/288

Tap into £1m of R&D funding

Companies in Wales with a medical project it feels is risky, can now bid for funding to research and develop the project

.

Risky projects may be difficult for companies to take forward and develop – Innovate UK is looking to help these projects, where the majority of the project activities take place in and around the South Wales medical technology cluster.

Up to £1 million is on offer through our new Launchpad competition, along with a programme of business support. We’ll also help applicants raise more external finance to help fund and commercialise the project.

Medical technology is one of Wales’ major industrial strengths. There are around 300 life science businesses in the country, including rapidly growing small businesses. Many of these are in South Wales.

The aim of the Launchpad is to help companies clustered there to go further and faster towards commercial success. We want to draw investment and people into the area and to encourage networking and collaboration.

The competition is now open with the deadline for stage 1 video submissions/applications on midday on 10 December 2014. More at https://ts.catapult.org.uk

Rigel analyser leads the way in dialysis machine testing in Japan

Nikkiso Co Ltd, the leading manufacturer of dialysis machines and related devices in Japan, is using the Rigel Medical 288 automated safety analyser to improve biomed electrical safety testing.

The move has led to improvements in testing procedures as part of an in-service annual safety check programme for its machines installed at hospitals and healthcare facilities throughout the country.

The portability of the 288 is a benefit to Nikkiso’s team of over 100 technicians who are able to take advantage of a single solution to quickly and easily complete both earth bond and leakage testing on the dialysis machines. Rigel’s unique earth bond test circuit ensures accurate measurements at low currents which have resulted in a drastic reduction in size and weight of the Rigel 288.

It remains the industry’s smallest automatic safety analyser, providing fast and accurate testing of patient, enclosure and earth leakage as well earth continuity and insulation resistance. Its compact design and user friendly interface is particularly beneficial for the technicians involved in testing, providing improved portability and ease-of-use during completion of electrical safety checks.

Satoru Kawarabayashi, Marketing Manager at Nikkiso, said: “The 288 is an excellent instrument, providing a fast, cost effective reliable testing solution. The engineers, in particular, find it easy-to-use and appreciate the fact that it’s compact enough to carry around with them.

“It incorporates a good range of features for a tester of its size, while the connectivity benefits are particularly impressive. The user-friendly screen, featuring a simple step-by-step test diagram, is also easy to understand and follow.

“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 audit purposes.”

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.

Arab Health sees regional launch of smallest all-in-one vital signs solution

The world’s smallest all-in-one vital signs solution will be the highlight of the Rigel Medical display of medical device analysers, electrical safety testers and simulators at this year’s Arab Health (Z1B12).

Rigel’s hand-held vital signs simulator UNISIM – capable of undertaking six synchronised vital signs parameter tests simultaneously – has been linked with the new PULS-R SpO2 simulation finger to provide improved vital signs simulation and measurement.

UNISIM can check NIBP, SpO2, ECG, temperature, IBP and respiration functionality in a single test, while 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.

Also showing will be the MULTI-FLO infusion pump analyser, which leads the way in high and low flow, occlusion, back pressure and bolus measurement and meets the requirements of IEC 60601-2-24.

Featuring variants of one, two and four independent channels, each MULTI-FLO channel can be tested simultaneously across a range of 100 μL (microlitre) to 1,500 mL per hour with results stored in the instrument’s large internal memory. With a sampling rate of 1Hz, the analyser accurately details changes in flow and pressure rates, providing a real-time picture of the quality of infusion.

Associate director John Backes said: “Arab Health is a key show and this year we look forward to using it as the perfect platform to launch our world leading, all-in-one vital signs simulator solution to the important Middle East market.”

The UNI-THERM, which provides fast testing of all leading electrosurgical devices, providing accurate results as it quickly and automatically guides the user through test procedures, and the UNI-PULSE defibrillator analyser will complete Rigel Medical’s display.