News: Medical e-News Round-Up - Issue 24

This issue covers:

MEPs divided ahead of vote on medical devices

A vote in the European Parliament's Environment, Public Health and Food Safety (ENVI) Committee over the EU's proposed new medical devices regulation has been postponed until September to give lawmakers more time to work on compromise amendments.

The European Commission has tabled new rules for the approval of medical devices following a series of health scandals including a high-profile case in France involving faulty breast implants, the so-called PIP scandal.

But MEPs are divided as to how far the proposal should go in harmonising the way medical devices should be approved in future. Some committee members are worried that the new EU approval system will be too bureaucratic, while others argue stricter rules are needed to protect patients from faulty products.

Faced with political deadlock, the Parliament’s ENVI Committee decided to postpone the vote until 18 September, leaving enough time for MEPs to work on compromise amendments.

Holger Krahmer, a German MEP from the liberal ALDE group, who is shadow rapporteur on the proposal, said: “There is no doubt we need an efficient system of market access for medical devices that satisfies the highest possible safety standards in order to serve the needs of patients. I believe that there is a lot of room for improving the current system.”

More details at www.euractiv.com.

Better design tests needed for medical devices, say engineers

A new report says the medical technology sector needs better ways of demonstrating the safety, effectiveness and performance of its products.

The ‘Establishing high-level evidence for the safety and efficacy of medical devices and systems’ report examined the engineering model for assessing safety, which it said has been built by dialogue between industry and regulators.

Medical device developers could adopt methods from the engineering sector to help improve assessment where the kind of trials used to test new drugs are not appropriate, according to the report from the Royal Academy of Engineering.

The UK’s strong research base and the NHS mean the country is well placed to generate the necessary high-quality evidence for such devices, said the report, which was produced following a roundtable discussion on the topic that brought together clinicians and engineers from healthcare, industry and academia.

Sir Alasdair Breckenridge, chair of the Medicines and Healthcare products Regulatory Agency, said: “As medical devices become more complex, their regulation needs to keep up with the underlying science.

‘The current devolved European regulatory system requires a drastic overhaul to reflect these changes and collaboration between engineers, clinicians and regulators will become even more important.”

The report, published in collaboration with the Academy of Medical sciences, focused on the problem of testing medical devices when randomised controlled trials (RCTs) are not possible or appropriate.

Devices, unlike medicines, are increasingly used as one aspect of complex treatments where it is difficult to create a control group. The report said that, with appropriate design and guidance, meaningful trials for medical devices can and should be undertaken.

It found that a similar collaboration between clinicians, device manufacturers and patients could lead to a framework for medical devices to establish hazards, safety requirements, and ensure they are designed to meet real clinical need.

Jack for US

Jack Barrett has joined Rigel Medical as its US-based National Business Development Manager, responsible for sales and marketing activity across North America and brings more than 30 years management experience to this new position.

The North American medical devices market is one of the largest in the world and Jack Barrett will be drawing on his experience of working for both distributors and manufacturers to develop new business for the company’s high performance analysers, simulators, testers and accessories.

He will be expanding market coverage and support for the brand as well as looking to develop new OEM, independent service organizations and distribution commercial opportunities.

John Backes, Associate Director – Rigel Medical, said: “Jack’s management background and extensive sales experience will be a major asset as we continue to grow our business throughout Canada and the USA.

“It is a particularly exciting time for him to join us as we continue to see demand from all sectors for high quality medical device testing products, support and expertise.”

You can contact Jack at the Seaward Group USA, 6304 Benjamin Road Suite 506 Tampa FL 33634. Tel: 813-886-2775 Fax: 813-886-2754. Email: sales@seaward-groupusa.com.

US slow while positive outlook for EU

Slow going in the United States was a recurring theme in medical device companies' Q2 earnings reports. Several medical device companies reported earnings for the second quarter of 2013 in July, and while sales were all over the board, one trend that can be garnered from their results is that many are seeing business struggle in the United States.

Johnson & Johnson experienced a flat performance in the US, where sales of its diabetes care products plummeted 23.1% while Covidien's U.S. device sales dropped 4%, and the company is looking at restructuring.

These were among several leading companies reporting poor results, which were blamed by Johnson & Johnson’s CEO Alex Gorsky on a number of factors.

He cited declining hospital admissions and in-patient procedures, while Philips CFO Ron H. Wirahadiraska blamed sequestration and healthcare reform adding that he didn't expect conditions in the US to improve anytime soon.

Meanwhile, across the Atlantic, there’s a more positive outlook for the medtech market in Europe where there’s 5% annual growth. The recession may have hit some member states particularly hard, but there is still a lot of potential for development in hot-spot countries such as the UK, Switzerland, France and Germany.

IEC 62353 LinkedIn forum and FREE guide download

John Backes - Associate Director, Rigel Medical, is asking LinkedIn IEC 62353 forum members to come forward with what they see as the single most important issue affecting their organisation about implementing, or not implementing IEC 62353 in the approach to preventative maintenance? Your views are welcome, so join John in the forum here.

A free booklet on the benefits of testing to IEC 62353 is also available from Rigel, to download your free copy click here.