Directory of Service
Welcome to the Diagnostics North East
Directory of Service
Here you will find a description of the partner organisations, what it is they do and how they work to help develop, evaluate and support the adoption of diagnostics into healthcare within the NHS. If you are interested in working with any of the partners please contact them via the website links or complete the enquiry form on this website.
Research, Development, Evaluation and Adoption Pathway;
Technology Readiness Level Coverage
Technology Readiness Level Coverage
Aim
Generation of high-quality evidence to demonstrate the potential value of a new diagnostic test and ensuring that better diagnostics are delivered more quickly for the benefit of patients.
Engagement
Although preferable from Technology Readiness Level (TRL) 4 through to 7, the Newcastle MIC will work with companies and researchers from Level 3 where there is good available evidence
Evidence requirement
Minimum published lab data for earlier on in TRL scale, to be used in exploratory Care pathway analysis. Developed prototype or devices available for use in trial or studies, again with published evidence.
In Scope
Primarily focused on In vitro diagnostics but diagnostic devices and monitoring tests may also be in scope too. Particular themes include Ageing and long-term chronic conditions, infectious diseases and personalised / stratified medicine.
Out of Scope
Therapeutics, assay or device development, laboratory validation. Although advice can be given in terms of protocol development, this does not extend to the actual delivery of a clinical trial.
Who you can signpost to if not in scope
MICs, NIHR Office for Clinical Research Infrastructure (NOCRI), Research Design Service (RDS), NovoPath – The Newcastle MRC Node, MedConnect North, Academic Health Science Network (AHSN)
Areas of Expertise
Care Pathway Analysis, early Health Economics, protocol design, data management and statistical analyses to support the development and delivery of clinical studies.
How research projects should be funded
Either self-funded by company or researcher, or as co-applicants or collaborators on a grant.
Who you can help
Main NIHR remit is UK SMEs. Support also provided to academic and clinical researchers. Not limited to UK collaborations, but UK funding may be more difficult to obtain when the lead doesn’t have a UK base.
Partner Organisations
Newcastle University, Newcastle Hospitals NHS Trust
More information
Aim
Acts as an ‘honest broker’ to facilitate collaborations between academia, health and social care organisations, third sector, patients, the public and healthcare industry to improve population health outcomes and generate economic growth across the region. We work with our member organisations including NHS Trusts, CCGs and universities, as well as the regional industry sector, to identify, evaluate, adopt and disseminate transformative innovation.
Engagement
Across the North East and North Cumbria region to support innovation in all its forms within the NHS, social care and the regional healthcare sector.
Evidence requirement
AHSN NENC work with innovators across the NHS who come to us with ideas and we support them through our Innovation Pathway Partners and Tech Transfer partners and therefore don’t necessarily need hard evidence upfront. This includes helping at the ideas stage and whether it is something that is required or can be taken forward (we provide support for prototyping, for example), all the way through to commercialisation (including preparation of business cases) and adoption of proven innovations.
In Scope
Support for all innovative products and services.
Out of Scope
Marketing of products and services to the regional health and care system.
Who you can signpost to if not in scope
Regional business enterprise networks.
Areas of Expertise
Supporting economic growth by identifying, evaluating, and driving the adoption of innovations supporting transformational change; transforming patient safety and quality improvement; improving population health through the delivery of health improvement programmes to drive rapid spread and adoption of proven healthcare interventions.
How research projects should be funded
Either self-funded by companies or innovators, through grants as project partners, through funding for national programmes, or from small awards available from the AHSN to support areas such as prototype development or real world validation studies. Help can also be given to facilitate and support application to funding bodies including Innovate UK.
Who you can help
Academia, health and social care organisations, third sector, patients, the public and healthcare industry.
Partner Organisations
All regional NHS Trusts, universities and other health and social care organisations.
More information
Aim
To improve health and well-being through the delivery, innovation and promotion of precision diagnostics for precision medicine. Specifically: (i) To provide high quality and timely specialist technical services in tissue-based diagnostics to researchers and academics, healthcare providers and industry; (ii) To operate as a successful innovation hub for tissue-based diagnostics including the development of novel prognostic tests and computational pathology and through this, (iii) Facilitate the discovery, refinement, adoption and evaluation of cell and molecular biomarkers for precision oncology and in chronic inflammatory diseases.
Engagement
The Node operates across the entire translational pathway but with a particular focus on TRLs 1-5. Later phase studies are enabled by the very close relationship we have with the Integrated Laboratory Directorate in the Newcastle upon Tyne Hospitals NHS Foundation Trust (in particular the Department of Cellular Pathology). We work with basic and clinical researchers, NHS departments and industry. The associated Biobank (formerly CEPA Biobank) is a rich resource for products of interest to biotechnology companies in qyuality control and the development of new reagents.
Evidence requirement
This clearly varies depending on TRL but for early phase studies some published data is generally required.
In Scope
Most tissue based research studies, diagnostic tests and assays; somatic genetic analysis; QC products for industry; evaluation of new antibodies and probes.
Out of Scope
Therapeutics and device development
Who you can signpost to if not in scope
NIHR Newcastle In Vitro Diagnostic Co-operative (NIHR Newcastle MIC), NIHR Office for Clinical Research Infrastructure (NOCRI), Research Design Service (RDS), MedConnect North, Academic Health Science Network (AHSN).
Areas of Expertise
Immunohistochemistry and in situ hybridisation; multiplexing; TMA production; digital pathology and computational pathology; assessment of fibrosis (from animal models to surrogate markers in patients); biobanking.
How research projects should be funded
Either self-funded by company or researcher (often through grant funding) or as co-applicants or collaborators on a grant.
Who you can help
Basic and clinical researchers, NHS laboratories, SMEs and larger pharma/biotech companies.
Partner Organisations
Newcastle University, Newcastle Hospitals NHS Trust, Northern Pathology Imaging Collaborative
More information
Aim
To offer a bespoke service to SMEs, National and International Medical Technology Companies, providing guidance and assistance throughout the Medical Technology Research and Innovation Pathway. Our vision is to provide this support in order to generate clinical evidence through research that will expedite the launch of new technologies and services to enhance and improve patient care and positively contribute to the regional economy.
Engagement
The group supports National and International Medical Technology Companies to form partnerships with Academia and the NHS in the North East and North Cumbria region. In addition, MedConnect North supports NHS staff to encourage, drive and develop innovation through research, within their organisation. The team can provide access to world leading NHS consultants across all medical specialities. MedConnect North operates within TRL5-8.
Evidence requirement
The group would not need hard evidence as MedConnect North will support from ideas stage to generate clinical evidence and signpost to relevant organisations for support and development of technology.
In Scope
Support for all new medical technology.
Out of Scope
Medical technology research that cannot be NIHR portfolio adopted guidance can be found here.
Who you can signpost to if not in scope
Regional businesses, AHSN and other partner organisations as relevant.
Areas of Expertise
Collectively the group provides an array of experience and knowledge of the Medical Technology Research and Innovation Pathway and are able to offer advice and guidance throughout the process. They all have experience working in collaboration with Industry to deliver highly successful and valuable clinical research and as such are able to effectively signpost to key organisations throughout the pathway.
How research projects should be funded
Commercial funding, charity or grant funding through national open competition.
Who you can help
SMEs, National and international Medical Technology and Biotechnology Companies, NHS clinicians and Academia.
Partner Organisations
NENC CRN, AHSN, All NHS trusts in NENC, Primary Care organisations in NENC, all regional Universities, NECS, Pharmacies, non-NHS sites and social care settings.
More information
Aim
To a) provide early insights and horizon scanning intelligence in a variety of outputs styles to a number of national bodies; b) develop advanced horizon scanning tools to identify and track new and emerging health technologies (medicines, devices, diagnostics and digital) with the potential to address unmet needs; and c) gathers patient and public insight to i) identify unmet need and ii) support innovation in the health sector.
Engagement
We support pharmaceutical companies with technologies in phase 2 and 3 clinical trials to facilitate access to the NICE technology appraisal process; support the gathering of patient insight around unmet need and innovation development (in partnership with VOICE); we provide both routine and bespoke horizon scanning intelligence on medical devices and diagnostics to national bodies to support expedited access to innovative health innovations and services to NHS patients.
Evidence requirement
We do not require hard evidence. As our primary role relies on intelligence to support understanding prior to the generation of robust evidence. We do however use existing published evidence to support our unmet need and prioritisation work.
In Scope
Our focus is on supporting a fuller understanding of the innovation landscape into which any new innovation (pharmaceutical or medical technology) will fit, by using a variety of tools and methods to collate a plethora of relevant intelligence.
Out of Scope
Therapeutics and medical technology development, evaluation, regulation or market access support.
Who you can signpost to if not in scope
NIHR Newcastle MIC, NIHR Office for Clinical Research Infrastructure, Research Design Service, MedConnect North, AHSN.
Areas of Expertise
The centre has extensive experience developing tools and methodologies to provide horizon scanning and soft intelligence. We have experience of presenting this intelligence in a number of outputs (market analysis reports, pipeline analysis, evidence briefings, technology briefings, patient insight reports, web-based dashboards) for a variety of purposes and a number of national bodies. We also have experience in the development of advanced horizon scanning tools, including ScanMedicine a web-based ‘self-service’ tool which allows users to access global data about health technologies and visualise and explore results in a dynamic fashion. For further details contact us by email (info@io.nihr.ac.uk).
How research projects should be funded
Either self-funded by company or researcher (i.e. through grant funding); in some circumstances as co-applicants or collaborators on a grant.
Who you can help
SMEs, national and international biotechnology and pharmaceutical companies, health and social care organisations, policy and decision makers, academia, clinicians, the public and healthcare industry.
Partner Organisations
We work closely with the Accelerated Access Collaborative (AAC), and other national bodies such as NHS E&I and NICE, to support accelerated access of new innovative health technologies and services to NHS patients.
More information
Aim
Newcastle Hospitals aims to provide local excellence and global reach through compassionate and innovative healthcare, education and research.
Engagement
Newcastle Hospitals will work with researchers from proof of concept to the provision of clinical trials, adoption into the NHS and post adoption evaluation.
Evidence requirement
Ideally there should be some evidence to support your technology, although we are able to support with advice from the earliest stage of development.
In Scope
Development, evaluation and adoption of all medical technologies including invitro diagnostic and all phases of pharmaceutical development including virtual clinical trials, early-stage research including help in the development of technologies as key opinion leaders.
Out of Scope
Animal studies.
Who you can signpost to if not in scope
Researchers within other hospitals and academic institutions including Newcastle University, NIHR MedTech and In Vitro Diagnostic Co-operatives, NIHR Office for Clinical Research Infrastructure (NOCRI), Research Design Service (RDS), MedConnect North, Academic Health Science Network (AHSN).
Areas of Expertise
In the top 10% of best performing Trusts in the UK and provides the widest range of specialist services including transplantation, genetics, rare cancers and hosts the Great North Children’s Hospital. Expertise in laboratory medicine includes the provision of over 11 million tests per year. All laboratories are compliant with and accredited by the HTA, MHRA and UKAS accreditation services.
How research projects should be funded
Commercial, charity or grant funding through national open competition.
Who you can help
Support is provided to academic and clinical researchers, SME’s through to large international companies.
Partner Organisations
NHS Hospitals, regional and international academic institutions, Academic Health Science Centres, ARCs, MedConnect North, Academic Health Science Network (AHSN), Northern Health Science Alliance (NHSA).
Aim
One of the Russell Group Universities, Newcastle University is dedicated to providing a high quality learning environment for students and an innovative location for researchers. It commits to being a world class, research-intensive university that builds upon its distinctive attributes. These features include a broad disciplinary base but at a scale that allows it to act cohesively: the integration of education with research and engagement, a portfolio of world-leading research clusters and independent scholars, the provision of real-world test beds for innovation, and deep regional and global partnerships.
Engagement
Newcastle University has a strong tradition of working for the public benefit through the co-creation of knowledge in partnership with external collaborators. As a civic university, its regional engagement is integral to ensuring that its academic and professional activities have economic, social and cultural benefits. It works with local and national government initiatives to deliver inclusive, place-based growth. Newcastle University will work with companies and researchers from Technology Readiness Level 1 where a sound theoretical case can be made.
Evidence requirement
From theoretical through to those technologies that have been refined and are ready for human trials, input is available for collaboration across the research pathway.
In Scope
Support is provided for academic input into medical technology and pharmaceutical development, provision of samples. Newcastle Clinical Trials Unit (NCTU) supports the design and development of high-quality clinical trials and clinical studies. These studies investigate the efficacy, effectiveness and efficiency of therapeutic, complex and service-level interventions. NCTU provides support to a wide range of trial types including Phase III and IV pharmaceutical trials, device trials and surgical trials, as well as those of service organisation & delivery, and of complex interventions aimed at behaviour change amongst professionals, patients and members of the public. NCTU supports both single- and multi-centre trials, working with investigators from across the UK and internationally. Capacity and expertise also is being developed in early phase trials, in particular Phase II. In addition to clinical trials, NCTU supports studies employing a range of quantitative and qualitative research methods in preparation for the design and conduct of a future trial (including systematic reviews, feasibility and pilot studies, and the development and validation of patient reported outcome measures), as well as methodological studies relating to trial design, conduct and data interpretation.
Out of Scope
Clinical hospital trials although we work closely with Newcastle upon Tyne Hospitals (NUTH), within Newcastle Health Innovation Partners, and Newcastle University staff include clinical academics with honorary NUTH contracts, who can provide these links. Our clinical academics are frequently chief investigators/principal investigators on clinical trials sponsored by NUTH.
Who you can signpost to if not in scope
Researchers within other academic institutions, NHS Hospitals including NUTH, MedConnect North, Academic Health Science Network (AHSN), NIHR Newcastle In Vitro Diagnostic Co-operative (NIHR Newcastle MIC), NovoPath – The Newcastle MRC Node.
Areas of Expertise
Newcastle University has wide range of expertise across academic disciplines including laboratory bench science, translational research, experimental medicine, clinical research, engineering, pharmacy and laboratory services including biobank resources for prospective collaborators.
How research projects should be funded
Commercial, government (MRC, NIHR, Innovate UK), charity or grant funding through national open competition.
Who you can help
Support is provided to national and international academic and clinical researchers, SMEs through to large international companies.
Partner Organisations
Regional and international academic institutions including other Russell Group Universities, NHS Hospitals, Academic Health Science Centres, ARCs, International Centre for Life, Northern Genetics Service, MedConnect North, Academic Health Science Network (AHSN), Northern Health Science Alliance (NHSA).
More information
About
Northern Medical Physics and Clinical Engineering (NMPCE) is a Clinical Directorate of Newcastle upon Tyne Hospitals NHS Foundation Trust (NuTH). Our activities, in the fields of medical physics and clinical engineering, include providing clinical and scientific services, professional advice, teaching and training, and research and development. Our customers include acute NHS Trusts in the North East and North Cumbria, research funding organisations and national agencies. We employ a multi-disciplinary workforce including scientists, engineers, technologists and AHPs, who provide services in the community, in the acute sector and for national programmes.
We provide over 40 distinct services categories of: clinical diagnostic services; mobility and rehabilitation services; quality assurance services; professional advisory and consultancy services; clinical engineering services; research, development and innovation; teaching and training. Directly relevant to Diagnostics North East are those shown below encompassing healthcare technology evaluation, translational clinical engineering, regulatory advice and healthcare informatics.
In addition to legislation and regulations that apply to NuTH as a whole, many of our services must conform to particular requirements. These include legislation associated with ionising and non-ionising radiation and medical devices. Our professional advisory services include providing advice on applicable legislation to NuTH and other organisations, and our quality assurance services assist NuTH and other organisations to demonstrate required standards of quality.
We provide national services to NICE (External Assessment Centre for medical technology; one of five centres nationally) and to Health Education England (the academic element of two Scientist Training Programmes, in conjunction with Newcastle University). We also support the NIHR Medtech and In–vitro diagnostics Cooperative (MIC), one of four such research infrastructure organizations nationally which support evidence generation for novel diagnostics.
More information
https://www.newcastle-hospitals.nhs.uk/services/medical-physics/
Aim
The service provides independent assessment of the clinical and economic evidence for adopting innovative medical technologies (devices, diagnostic and digital) into the NHS.
Engagement
We combine skills in Health Technology Assessment, observational research and device development to provide an EAC to the NICE Medical Technologies Evaluation Programme (MTEP) (link to NICE HTA guidance) and offer similar services directly to other stakeholders.
Evidence requirement
There is an expectation that CE mark status will have been given or due within one year of assessement.
In Scope
Health technology assessment of devices, diagnostics and digital technologies.
Out of Scope
Evidence generation and technology development.
Who you can signpost to if not in scope
Health Technology Consultancy (see entry below) AHSN, the NIHR Newcastle MIC.
Areas of Expertise
40 Years of national device evaluation.
How research projects should be funded
Commercially funded, grant funded.
Who you can help
Researchers and industry involved in the development of health technologies.
Partner Organisations
AHSN, NIHR Newcastle MIC, Newcastle Hospitals NHS Foundation Trust, Newcastle Univeristy, NICE.
More information
Aim
The service provides independent assessment of the clinical and economic evidence for adopting innovative medical technologies (devices, diagnostic and digital) into the NHS.
Engagement
Industry, hospital departments, healthcare providers, researchers.
Evidence requirement
Dependent on the nature of the request.
In Scope
Medtech (devices, diagnostics, digital).
Out of Scope
Non medtech.
Who you can signpost to if not in scope
NICE, AHSN, Medicines Delivery Catapult, Newcastle University and other academic institutions.
Areas of Expertise
Physiological measurement technologies; rehabiliation technologies; electronic design, mechanical design; investigator brochure for clinical trials of medtech, regulatory technical files.
How research projects should be funded
NHS core service funding or for industry and academic collaborations via commercial or grant funding.
Who you can help
Researchers and industry involved in the development of medtech.
Partner Organisations
NIHR Newcastle MIC, Newcastle Hospitals NHS Foundation Trust, Newcastle University, AHSN.
More information
Aim
One of eight Academic Health Science Centres in the UK, bringing together world-class research, education and clinical practice for the benefits of the region, our aim is to become the most integrated and innovative academic health science partnership in the world by 2025, to discover, develop and deliver new solutions in healthcare.
Its Partners are:
- Newcastle University
- Newcastle upon Tyne Hospitals NHS Foundation Trust
- Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust
- Newcastle City Council
- Academic Health Science Network for the North East and North Cumbria
Engagement
NHIP thinks globally and acts locally across the city/region and engages a wide range of stakeholders which includes patients, staff, citizens, students, industry, local and international collaborators.
Evidence requirement
Academic Health Science Centres are designated by NHS England and NHS Improvement and the National Institute for Health Research for demonstrating excellence in health research, health education and patient care.
In Scope
Integrated programmes of work in research, education, people and joint programmes that support economic growth.
Out of Scope
Activities that do not provide new value to NHIPs 2025 mission.
Who you can signpost to if not in scope
Refer to the existing programmes of work and complementary work in Partners and collaborators that do not fit NHIP 2025 mission.
Areas of Expertise
World-class expertise in designated areas of research, education and innovation.
How research projects should be funded
NHIP is funded via an assessment of the added value of collaborations where new value is created and where the sum is greater than the individual parts.
Who you can help
Patient care, citizen health, staff, academia, health and social care organisations, third sector, and industry.
Partner Organisations
NHIP Partner organisations, regional, national and international collaborators.
More information
Aim
Coordinating capability and ideas across sectors and can provide unique access to laboratory facilities and biobanking designed to accelerate the development, implementation and use of diagnostic tests.
Engagement
The Innovation Laboratory is able to engage with collaborators at any stage of technology readiness level.
Evidence requirement
Aiming to provide support over a large range of technology readiness levels means our evidence requirement is flexible. The later readiness levels will require more supporting evidence.
In Scope
Assay and device development (research use only and in vitro diagnostic), laboratory validation, access to biobank samples, clinical evaluations, protocol development.
Out of Scope
Therapeutics, regulatory affairs.
Who you can signpost to if not in scope
MICs, Regulatory affairs consultancy, NovoPath, Academic Health Science Network (AHSN).
Areas of Expertise
Assessment of analytical validity (limit of detection, cross-reactivity etc.), in-context evaluations, assay development, collection of clinical diagnostic material.
How research projects should be funded
Either self-funded by company or researcher, or as co-applicants or collaborators on a grant.
Who you can help
Industry (pharma & biotech), academics, clinicians, NHS laboratories, private laboratories, contract research organisations.
Partner Organisations
The host organisation is Newcastle Upon Tyne Hospitals NHS Foundation Trust, partners include the NIHR Newcastle In Vitro Diagnostics Co-operative.
More information