UK to boost dementia research funding to £66m by 2015
The UK Prime Minister, David Cameron, has pledged to more than double the funding available for dementia research by 2015.
It is hoped an investment of £66 million will help the UK to become a world-leader in that particular field of research.
The announcement comes just days after a study carried out by the Intellectual Property & Science business of Thomson Reuters found the UK is currently second in the world in dementia research.
Cameron has described dementia as a national “crisis” and said it is his “personal priority” to enhance the understanding of the disease and improve its diagnosis.
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It is thought the £66 million worth of funding, which has increased from £26.6 million in 2010, will go towards researching cures and treatments for the condition.
The extra cash will also help to ensure local health and social services have the resources available to care for dementia patients.
“One of the greatest challenges of our time is what I'd call the quiet crisis, one that steals lives and tears at the hearts of families, but that relative to its impact is hardly acknowledged,” Cameron is expected to say in a speech later today.
“Dementia is simply a terrible disease. And it is a scandal that we as a country haven't kept pace with it.
“The level of diagnosis, understanding and awareness of dementia is shockingly low. It is as though we've been in collective denial,” he will add.
“So my argument today is that we've got to treat this like the national crisis it is. We need an all-out fightback against this disease, one that cuts across society.”
The Prime Minister will continue: “We did it with cancer in the 70s. With HIV in the 80s and 90s. We fought the stigma, stepped up to the challenge and made massive in-roads into fighting these killers.
“Now we've got to do the same with dementia. This is a personal priority of mine, and it's got an ambition to match.
“That ambition - nothing less than for Britain to be a world leader in dementia research and care.”
This is a goal that is definitely achievable for the UK, particularly after the promising findings of the Thomson Reuters study.
The results from the analysis reveal the UK published more research on dementia than any other country except the United States and ranks second in the world after Sweden in citation impact, which is the number of times UK research is referenced in dementia studies around the globe.
Despite its high performance and influence, dementia research capacity in the UK is low when compared to cancer, stroke and heart disease.
For every dementia research scientist there are six who work on cancer.
“Research output and citation impact in scientific literature is an ideal way to measure the quality and capacity of dementia research,” said Karen Gurney, manager of bibliometric reporting at Thomson Reuters and analyst of this report.
“This project illuminated an interesting dementia-research landscape in the UK, where this region is clearly playing an influential role despite its size.”
The research study was commissioned by the UK’s leading dementia research charity, Alzheimer’s Research UK, in an effort to raise awareness and increase investment for the underfunded field.
“The data provided by Thomson Reuters have been extremely valuable in allowing Alzheimer’s Research UK to uncover the facts about dementia research output and quality in the UK,” said Simon Ridley, head of research at Alzheimer’s Research UK.
“We wanted to dig deep into the issue of UK research capacity in this field. The work carried out by Thomson Reuters enabled us to do this and make a strong case for more investment in dementia research.”
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A guide to labelling compliance for medical devices
Small medical device manufacturers often find themselves scrambling to achieve the necessary compliance and validation, risking costly mistakes.
Validating systems and processes including labelling, to ensure they are compliant with stringent regulatory standards is tough and can be expensive. Indeed, compliance with the EU’s Medical Device Regulation (MDR) will cost more than 5% of annual sales, according to 48% of 101 companies polled by the German company Climedo Health, in July and August 2020 about their MDR-readiness.
But if companies bungle the software validation process or put incorrect and uncompliant data on the labels themselves, the penalties are likely to be more severe than just making corrections. Health and safety may be put at risk and fines imposed for failing to comply. When it comes to compliance, they may become overwhelmed with regulations in other geographic regions that focus on device traceability, each with a unique device identifier (UDI-like) component to it.
On the validation front, companies may not be familiar with the software validation process and the multiple tests and documentation necessary for validation are demanding if companies only have a small IT team that is very busy.
Putting a plan in place
MDR-compliant labelling, however, brings with it certain requirements which differ from what is demanded under the FDA’s Unique Device Identification (UDI) system rules. Under MDR, for example, manufacturers must ensure the label specifically states the device is a medical one using an MD symbol in a box. This is only one of many stipulations that usually require redesigned labels.
Small medical device manufacturers who rely on time-consuming and error-prone manual or legacy labelling processes to facilitate these label updates run the risk of mislabelling which can lead to non-compliance. They may have limited staff and no structured processes around roles and responsibilities when it comes to label design, changes and approval. As project leads work toward a compliant labelling process, it is therefore important to establish defined roles and access for each stage of the process.
When dealing with a compliance initiative, up to date, correct and compliant labelling is imperative. This involves having all the relevant label design elements in place to comply with the EU MDR or FDA regulations. Many times, label templates are hard coded, meaning IT must be involved in making changes. And with IT staff often being tasked with multiple mission-critical projects in the organisation, labelling projects can be delayed. For many small medical device manufacturers who have limited resources, finding a solution can be a challenge.
Why labelling in the cloud offers a roadmap forward
Validation-ready cloud labelling solutions have now emerged to ease compliance with regulations and time-consuming validation requirements. These solutions, built with the needs of regulated companies in mind, digitise the quality control processes and facilitate compliant labelling with role-based access, approval workflows and electronic signatures. Outside of compliance, carrying out labelling in the cloud drives scalability and productivity for small medical device manufacturers and boosts overall efficiency.
The latest cloud labelling solutions integrate with other cloud solutions, allowing for seamless functionality and minimising the need for local infrastructure resources and cost.
When it comes to validation, as with many labelling systems, those hosted in the cloud have vendor-supplied documentation that streamlines the process and significantly eases the burden when it comes to installation qualification (IQ). The manufacturer itself has a much lighter burden and a streamlined path to a validated system and process.
A more relaxed software release schedule eases the validation burden on life sciences companies because the software is updated once a year rather than multiple times. This gives them a continuously updated and maintained labelling solution without increasing the validation workload on their IT staff.
The manufacturer would of course need to work closely alongside the vendor and review the documentation, but, if needed, the vendor is able to do much of the work for them, providing not only the full validation acceleration pack but also professional services to assist with the validation process.
While some medical device manufacturers choose to tackle validation on their own, the vendor supplied validation acceleration pack or documentation helps to simplify the process. Consultancy and advice around validation is usually available from the vendor, tailored to the business’s specific needs.
Given the immense hassles of compliance for small device manufacturers, cloud-based labelling systems offer the benefits of a full label management system while easing compliance and validation. This is a future-proof technology. With a cloud-based labelling system, medical device manufacturers can be confident that they are running the most up-to-date software, enabling them to address the fast-changing new regulations and cope with whatever comes their way. And especially in the current pandemic, when face-to-face meetings are still problematic, it is a perfect way to keep labelling operations moving forward.