Medical e-News Round-Up - Issue 34

This issue covers:

Better design tests needed for medical devices, say engineers

A new report featured in The Engineer magazine says that the medical technology sector needs better ways of demonstrating the safety, effectiveness and performance of its products.

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, 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.

Multi-Flo doubles infusion pump testing capacity

Rigel Medical's Multi-Flo high performance analyser doubles infusion pump test capacity, saving time and delivering productivity improvements through instantaneous high accuracy flow measurements.

Available in single or multi-channel configuration, the Multi-Flo channels can be tested simultaneously across a range of 10 μL (microlitre) to 1,500 mL per hour and the results stored in the instrument’s large internal memory. With a sampling rate of 1Hz, the Multi-Flo can accurately detail any variations in flow or pressure, providing a real-time picture of the quality of infusion.

Fast, accurate and instantaneous flow measurements are provided, even at low rates, enabling the user to test twice as many infusion devices within the same time period when compared to other volumetric-based analysers.

The direct flow measurements, are directly comparable with tests using the traditional scales method but without the manual handling and evaporation problems associated with it. The Multi-Flo also offers faster set-up times and improved data recording - tests have shown that on typical low flow rates, users can cut testing times by up to 50%, providing significant annual cost savings.

The easy-to-use stand-alone analyser enables manufacturer specific test routines to be programmed and automatically executed, with readings stored automatically in a large internal memory. This removes the need for manual recording of data, reduces duplication of work and cuts the risk of manual data errors.

To meet the requirements of IEC 60601-2-24, the Multi-Flo also provides accurate back pressure simulations, occlusion alarm monitoring and bolus (PCA) measurements. A large colour screen presents the data in both numerical and graphical format, giving the user the flexibility to monitor acquired volume, flow delivery profiles, pressure changes and bolus volumes. More at www.rigelmedical.com/multi-flo

New FDA programme for medical devices that address unmet medical needs

The U.S. Food and Drug Administration has proposed a new programme to provide earlier access to high-risk medical devices that are intended to treat or diagnose patients with serious conditions whose medical needs are unmet by current technology.

The proposed Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions ("Expedited Access PMA" or "EAP") programme features earlier and more interactive engagement with FDA staff, including senior management and a collaboratively developed plan for collecting the scientific and clinical data to support approval.

These are features that, taken together, should provide patients with earlier access to safe and effective medical devices.

EAP is not a new pathway to market, but rather a collaborative approach to facilitate product development under the agency's existing regulatory authorities. While other existing device programmes have focused on reducing the time for the pre-market review, EAP also seeks to reduce the time associated with product development.

"We are excited to offer a proposed programme for expedited access for certain high-risk medical devices," said Jeffrey Shuren, M.D., Director of the FDA's Center for Devices and Radiological Health.

"The programme allows manufacturers to engage early and often with the agency. We expect most devices involved in the process will be in the pre-clinical trial phase."

More at www.fda.gov

India's medical device industry facing 'severe challenges'

According to a study from The Associated Chambers of Commerce and Industry of India (Assocham), India's $3.5 billion worth medical device industry is facing severe challenges of inadequate quality standards coupled with huge reliance on imports, time delays and other related hassles.

This is hindering new product development as the 'Access to Healthcare: Indian Perspective' study notes: "Unfavourable duty structure for imports and exports is another significant impediment in the growth of the domestic medical devices' industry as higher import duties for raw materials than finished goods has established an 'import-export anomaly' whereby devices manufactured in India become expensive owing to high raw material costs making them uncompetitive against low priced Chinese goods."

Mr D.S. Rawat, Secretary General of Assocham said while releasing the findings of the chamber's study: "[India] does not provide any incentive on setting up medical device production bases to encourage medical device manufacturing, as such significant steps to overcome these anomalies are imperative to boost the domestic medical device industry thereby reducing our high dependence on exports.

"There is an urgent need for a single window clearance system to spur growth in new product development as the limitation of medical device falling under preview of the Drugs and Cosmetics Act, 1940 has been the major deterrent in the medical devices' sector growth," said Mr Rawat.

"Low research and development (R&D) spends, lack of innovation promotion including low medical device funding from Department of Science and Technology/Department of Biotechnology, inadequate quality standards and others are significant challenges faced by the industry."

More at timesofindia.indiatimes.com

Check your Pulse

The latest edition of Rigel Medical's medical industry publication, The Pulse, takes an in-depth look at what’s involved in infusion device testing and the advantages of using automatic flow analysers.

In her article, product specialist Katherine Summers explains flow measuring principles and current testing methodology before covering the important considerations needed to achieve reliable and accurate test results.

The latest industry news are also included along with a look at a ground breaking project in Poland where a new generation of cardiac surgery robots utilise portable analysers to improve electrical safety testing during product development.

Look out also for the regular section where John Backes, Associate Director, replies to readers’ questions on medical device testing. Download a PDF copy at www.rigelmedical.com/pulse