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Clinical Needs of strategic priority as defined by national healthcare organisations


Department of Health (DH)

The Department of Health (in England) is committed to improving the quality and convenience of care provided by the NHS and social services. Its work includes setting national standards, shaping the direction of health and social care services and promoting healthier living. They do this by:

  • Setting and communicating the strategic direction of the NHS and social care.
  • Ensuring that public money is spent wisely and efficiently.
  • Monitoring the standard and safety of health and social care services.
  • Developing new policies in collaboration with patients, communities, health and social care staff, the voluntary sector and other government departments.

The DoH also work with the Technology Strategy Board to define needs that can be responded to under the SBRI scheme, details on this can be found on either the TSB or Health KTN web portals. The TSB Innovation Platforms can have DoH requirements as a central theme linked as well to a major global challenge.

National Institute for Health Research (NIHR)

The National Institute for Health Research (NIHR) is developing improved services and support to realise the vision of the NHS as a world class environment for collaboration with industry. It has prime responsibility for driving through new systems and processes to accelerate and improve the quality of research undertaken with businesses. Examples of work complete or underway includes:

  • Model Agreements - developed in consultation with industry to help speed up contract negotiations.
  • Common costing templates.
  • Simplified high quality ethics approvals.
  • Establishment of the Comprehensive Clinical Research Network - helping identify experienced clinical researchers relevant to medical technologies.
  • Establishment of Healthcare Technology Co-operatives (HTCs) – building UK clinical capacity in defined areas of clinical need.
  • Establishment of more local networks, through Academic and Health Science Networks – bringing local excellence together to improve clinical practice and engage with local industry.

NIHR is also the home for the Invention for Innovation programme which is open to industry collaborative applications.

Also importantly, the NIHR has recently established the NIHR Office for Clinical Research Infrastructure, in recognition of the complexities involved with clinical studies and trials for medical technologies.

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NIHR Office for Clinical Research Infrastructure (NOCRI)

The NIHR Office for Clinical Research Infrastructure (NOCRI) has been set up to help ensure that clinical research carried out in the UK becomes easier, better and faster:

  • Easier by sign-posting for investigators a clear path through NOCRI.
  • Better by promoting the highest quality research environment.
  • And faster by catalysing more rapid set up, delivery and translation of research into clinical practice.

NOCRI has been established to help the life sciences industry to find the appropriate experts, facilities and technologies within the NIHR clinical research infrastructure to best support their research. The NIHR clinical research infrastructure brings together expert individuals, working in dedicated facilities, using cutting-edge technologies. All NIHR infrastructure is embedded within, or works closely with, the National Health Service. The infrastructure is there to support researchers and investigators carry out high quality industry-sponsored, industry-collaborative and non-commercial clinical research for the benefit of patients. More information and contact details can be found at the following website.

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The National Institute for Health and Clinical Excellence (NICE)

NICE is the independent UK organisation responsible for providing UK guidance on the prevention and treatment of ill health. NICE provides guidance on the clinical and cost effectiveness of selected new therapeutics and devices in three areas:

  • Health technologies guidance on the use of new and existing medicines, treatments and procedures within the NHS.
  • Clinical practice guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.
  • Public health guidance on the promotion of good health and prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector.

NICE is well known for its evaluation for new and existing drugs, but is also now actively engaged with the evaluation of medical devices and diagnostics. Businesses (any business can submit topics for consideration) can propose topics (products and services) for NICE consideration via its website. Not all devices need to go through this route, but having NICE guidance may enhance a product’s position in the UK market. NICE issues guidance, it does not rule or recommend that a Trust must use a specific device or treatment.

All NICE technology appraisals and recommendations are published, and current guidelines can be reviewed as a source of information for device development and market and competitor analysis.

In recent ministerial announcements, there is growing emphasis on measuring uptake of NICE approved devices or drugs to ensure adoption where relevant, is being implemented.

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National Innovation Centre

The National Innovation Centre (NIC) homed within the NHS Institute for Innovation and Improvement, has a role of interfacing with businesses to determine the appetite of English Trusts for proposed innovative technologies and services. It provides a portal based system which businesses can enter their details into, and gain feedback on the attractiveness of their proposition. For the most attractive propositions, there is potential for direct NIC support to introduce the technologies to key Trusts and potential for Proof of Concept funding where further investment is needed to gather evidence of the value to the NHS.

The NIC has gone through changes during the last 6 months, so an updated portal is currently being developed but the NIC is still open for business.

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Statements of Clinical Need (SOCN)

The Statements of Clinical Need initiative has been a web-based database and discussion forum established by the Health Technologies KTN, providing a virtual community of healthcare professionals, industrialists, and academics – indeed, anyone with an interest in developing new and improved healthcare technologies. It was incorporated into the NHS National Innovation Centre and its website, but as that is undergoing some restructuring, the original data are still available off-line via the KTN.

The initiative aimed to provide a simple and efficient way of defining and, ultimately, finding solutions for clinically significant problems. Through the website, clinicians and other healthcare professionals can contribute their experience right at the very start of the R&D process, by recording problems, issues and deficiencies relating to current treatments or technology, and describing exactly what they need to improve patient care.

Users can record clinical needs quickly, either directly online or through a fax-back form. To stimulate problem-solving across a range of technical disciplines, the website asks that Statements of Clinical Need clearly define the problem, without necessarily indicating any particular solution. They are then collated in a central database or directory of need, which users can review and respond to with their individual problems. Researchers can use the statements to stimulate focused discussions about the major inadequacies of healthcare technology.

Note: if there is difficulty accessing this site, please refer back to the KTN as the content is still available but is becoming somewhat dated.

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