A Medical Device Daily

National Health Service (NHS) Primary Care Trusts are to receive £164 billion funding for 2009/10 and 2010/11, UK Health Secretary Alan Johnson reported earlier this month. That represents an average increase of 5.5% over both years, continuing a trend in growth of government investment that has seen funding in the NHS triple since 1997.

Johnson said strong financial management across the NHS has brought the service out of deficit and onto a firm financial footing. He said the service is well placed to meet the challenges of the more difficult economic climate ahead.

Funding will rise to an average of £1,612 per person by 2010/11 compared to £426 in 1996/97. Importantly, trusts will control a greater proportion of funding, with more than 80% of the total NHS budget now allocated directly, allowing them to tailor health services locally to meet local patient needs.

The allocations follow an independent review by the Advisory Committee on Resource Allocation, and are based on what the Department of Health termed "a new, more technically robust formula."

Additionally, a separate formula for what is categorized as "health inequalities" has been developed. It targets areas with the worst health outcomes.

The NHS Operating Framework for 2009/10, setting out NHS priorities for the next year, also was published. The top five NHS priorities in the Operating Framework are:

1) Improving standards of cleanliness and tackling healthcare-associated infections. It is estimated that reducing healthcare-associated infections has saved the NHS £75 million in the last year.

2) Improving access to care through the achievement of the 18-week referral to treatment pledge and improving access to GP services, including at evenings and at weekends.

3) Improving the health of adults and children and reducing health inequalities, by focusing on improving care for cancer and stroke, and paying particular attention to children's health, particularly in the most deprived areas of the country.

4) Improving patient experience, staff satisfaction and engagement.

5) Preparing to respond in a state of emergency, such as an outbreak of pandemic influenza.

Johnson said, "In its 60th year, the NHS is in good shape and treating more patients than ever. We will sustain our investment in the health service over the next two years as the NHS continues to deliver significant improvements against key priorities including better access to primary care, the shortest ever waiting times and a relentless drive to tackle healthcare associated infections."

He added, "During these tougher economic times the NHS, along with the rest of the public sector, will have to make its contribution to delivering greater efficiency. We can be confident that the NHS can continue to provide the improvements and high quality care that patients, public and staff rightly demand."

Start work now under 2010 directive

Medical device manufacturers should start initiating strategies now to comply with the new requirements of the amended European Union Medical Device Directive that take effect in March 2010, Nerac (Tolland, Connecticut) urged in a newly released white paper.

"At stake is maintaining or increasing share in the growing $86 billion market that accounts for a significant percentage of most U.S. medical device companies' profits," wrote Nerac medical device analysts Deborah Schenberger, PhD, and Marco Bafan in the paper titled, "Clinical Literature Reviews: Changes in the European Union's Medical Device Directive Require Manufacturers to Take Immediate Steps to Comply."

They said, "With nearly 8,000 devices on the EU market, it is possible that a backlog of applications as the deadline approaches could bottleneck approvals, with serious implications for sales and profits."

The paper notes that several key changes in the directive will have profound impacts on medical device companies:

Medical device manufacturers must demonstrate safety and efficacy before any device can be sold in any of the 27 EU member nations.

All Class II devices require approvals, meaning thousands of companies that may not have been required to submit clinical data to sell products in the EU now must do so.

If even one significant change has been made since CE approval was granted, the device must go through the approval process again.

If clinical data is missing in the application for an existing device, the product must be withdrawn from the market until compliance is established.

After receiving certification, companies will be required to conduct extensive post-market surveillance as part of their vigilance system.

The paper says one of the most important changes defines which clinical data can be used to demonstrate safety and performance.

Clinical trial testing is one option, though Nerac says it requires "a lengthy, expensive process."

An alternative is a clinical literature review of published data for similar devices. Schenberger and Bafan say conducting the literature review should be the first step to discovering whether an appropriate comparison can be made or whether the company needs to engage in a more expensive meta-analysis or an even more costly and time-consuming clinical trial.

Nerac is a global research and advisory firm for companies developing new products and technologies. Its analysts deliver custom assessments of product and technology development opportunities, competitor intelligence, intellectual property strategies, and compliance requirements through a blended approach that includes review of technical knowledge, investigation of intellectual property, and appraisal of business impacts.