Medical e-News Round-Up Issue 50

This issue covers:

We're at Medica with new products

Advanced new safety testing technology for both general purpose medical equipment and specialist medical devices will be featured at this year’s prestigious Medica show.

Electromedical test specialist Rigel (Hall 11, Stand A14) will be showcasing its latest product developments which are designed to make electrical safety testing and patient simulation fast and cost-effective without compromising on accuracy.

The company’s latest new product introduction is the SafeTest 60, an entry level safety analyser which has been purposefully designed for more basic and general purpose medical equipment testing where simplicity of testing is of the essence.

The new SafeTest 60 tests in accordance with IEC 60601, 62353 and 61010 including equipment, earth and touch leakage as well as insulation and earth bond testing. It is suitable for the safety testing of a wide range of equipment used in hospitals and healthcare facilities such as, electronic beds and hoists, as well as infusion pumps, CPAPs and centrifuges.

Also on display for the first time will be Rigel’s new ‘Plus’ range of testers. These new testers see the well-established Rigel 288 and Rigel 62353 instruments relaunched as the 288+ and 62353+ models, incorporating special battery-powered leakage tests to enable testing to the full range of international standards to be carried out without compromise on portability or speed of testing.

These new hand held instruments also feature special low voltage insulation tests (at 50V and 100V) in line with growing manufacturer's test requirements for 24VDC and 48VDC operated devices such as operating table, lights and mobile X-rays.

The full Rigel range of products including patient simulators, ventilator testers and performance analysers will also be on display at Medica.

Medtech sector forecast to 2020

A medical technology industry report claims that the sector has now returned to pre-recession levels and is likely to do so into 2020.

The fourth edition of the annual EvaluateMedTech World Preview says global medtech sales reached $375.2 billion in 2014 and are forecast to grow by $.1% each year to reach $477.5 billion by 2020.

Alongside the medtech annual preview, the pan-European trade association Eucomed reports the USA as the largest medtech market in the world, accounting for almost 40% of sales, followed by Europe at 28% and Japan and China at 9% and 5%.

This ranking is not likely to change significantly, with the exception of China, which is poised to overtake Japan and, according to some analysts, may be the second largest medtech market in the world by 2020.

Full details on how the medical device industry will look in 2020 are provided here

New Rigel 62353 Plus meets modern device test needs

Rigel Medical has introduced an upgraded battery powered 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.

The new Rigel 62353 Plus tester is equipped with an extended range of insulation test voltages between 50V DC to 500V DC in line with changes in test requirements from manufacturers of 24V DC and 48V DC operated medical equipment.

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.

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.

Find out more about the Rigel 62353+ here

Report says US fast-track bill will include medical devices tax repeal

Committees in the US House of Representatives are considering proposals to repeal several key Affordable Care Act (ACA) provisions, including the medical device tax, as part of a congressional budget tool called a reconciliation bill.

Leaders in the US medtech industry see the tax as an unnecessary drag on research spending and technology innovation, which a recent report suggests could reduce overall healthcare spending.

The two percent tax levied against gross profits in the medical device industry is one of the provisions that a reconciliation bill on ACA provisions is poised to repeal.

One of the principal arguments against the tax is that it limits funding for research and innovation. Medtech leaders have long insisted that innovative technology improves patient care and a white paper recently released by medical sector technology trade body AdvaMed indicates the same technology could also reduce healthcare spending.

For a full report on the medical device tax situation, see Medical Device Online

Watch a short video about the Rigel Multi-flo infusion pump analyser

Debate on medical device quality control in India

The medical device industry in India has made recommendations to the country’s Department of Pharmaceuticals (DoP) to set up a centre of excellence to develop, scale up and validate appropriate technologies for the quality assurance of medical devices in the country.

The Indian healthcare sector claims the move will complement DoP recommendations to the Indian Government to have a national list of essential medical devices, setting up new medical device clusters and reducing import duty as a part of the national medical device policy. There have also been calls for a global harmonisation policy of medical device standards.

Sushobhan Dasgupta, president, NATHealth says, "There are attempts from certain quarters to incorporate India marking for all medical devices distributed in the country. Imagine a situation where all countries mandated their own country marking; you would end up in a situation where there wouldn’t be enough space on the device packaging to incorporate the details. This will be a burden on both the local and foreign manufacturers."

Setting up centres of excellence to develop, scale up and validate technologies for quality assurance will complement the concept and agenda of setting up of medical device clusters to help boost the growth of the medical device industry in India. "Ireland has adopted this concept and has become the hub of medical device production in the world. However, cluster locations should be carefully chosen based on the availability of the required infrastructure," Dasgupta suggested.

The full article and interview on medical device quality control and standards is available here

Overseas growth wins export award for Seaward

Seaward’s growing success in international T&M instrumentation markets, including electromedical testing, has been recognised with a prestigious business award.

In the 2015 UK Insider Made in the North East awards to acknowledge the top manufacturing businesses in the region, Seaward Group, which includes Rigel, was rewarded with first place in the export category.

While the company continues to perform strongly in UK markets, the award was made in response to the company’s expanding overseas focus.

Export sales now account for around 50% of the company’s turnover and grew by 20% in the last year.

Andrew Upton, Seaward Managing Director, said: “We are delighted to have received this award and it reflects highly on the efforts and commitment of everyone involved in the business.

“We’ve always had a strong overseas market presence and the much improved performance in the last few years reflects our success in adopting a much more strategic approach to our export business.”

The Insider judges were particularly impressed with the fact that increased exports have led to an increase in the Seaward workforce, as well as the overseas expansion of operations with offices now established in Florida and Malaysia.

Made in the North East Award