MEDICAL DEVICE AND DIAGNOSTIC TRANSLATION
The Translational Research Initiative Management Team (TRI MT) help researchers achieve maximum impact from their projects, which includes medical devices, diagnostics, sensors and biomarker development, assisting in the translation of medical innovations into a commercial and clinical reality.
The following roadmap provides information on experimental considerations, business development advice and funding opportunities available within The University of Glasgow.
Each stage corresponds with different "Technology Readiness Levels" (TRLs). This is a method for understanding the maturity of an innovation during its acquisition or experimental and testing phases. Each research project is evaluated against the parameters for each technology level and is then assigned a TRL rating based on the project's progress. There are nine technology readiness levels; TRL 1 is the lowest and TRL 9 is the highest.
To find out whether your project is a medical device, what its classification may be, its safety and performance requirements, and specific standards it may need to adhere by, you can use the practical online tool developed by RegMetrics.
For more information on the experimental, business development and funding resources of projects at each maturity stage, and for guidance on how to access them, please see the tiles below.
Key Contacts and Facilities
List of contacts and facilities to support the development of medical devices at UofG.
Key Contacts
- Translational Research Initiative. The TRI team aims to create real world impact through identifying, championing and facilitating the translation of innovative research by providing funding support, training, information and guidance to ambitious research projects.
- IP & Commercialisation Team. The IP & Commercialisation team within Research and Innovation provide a University-wide service to help protect and exploit our intellectual property through licensing and spin-out company formation.
- Contracts Team. The Contracts Team provide a range of services to the University including drafting, reviewing, and negotiating contracts. They offer legal advice for University research and commercial contracts, both pre and post award, including guidance on Non Disclosure and Material transfer agreements (NDAs and MTAs).
List of Facilities
A full list of the research facilities in the College of Medical, Veterinary & Life Sciences can be found here.
The Digital Health Validation Lab |  |
|---|
The Digital Health Validation Lab supports innovators across industry, academia and healthcare. The team can provide secure access to a full spectrum of resources from clinical experts, healthcare and clinical trial services through to regulatory advice and support with clinical adoption to accelerate the development, validation and route to market of digital health technologies.
MVLS Structural Biology and Biophysical Characterisation Facility |  |
|---|
The MVLS Structural Biology and Biophysical Characterisation Facility focusses on macromolecular structure and function characterisations offering a wide range of biophysical techniques and expertise:
- Analytical Ultracentrifugation (AUC)
- Circular Dichroism (CD)
- Fourier Transform Infra-Red Spectroscopy (FTIR)
- Isothermal Calorimetry (ITC)
- Nuclear Magnetic Resonance Spectroscopy (NMR)
- X-Ray Crystallography
- Size Exclusion- Multi Angle Light Scattering (SEC-MALS)
- Microscale Thermophoresis (MST)
- Dynamic Light Scattering (DLS)
- Differential Scanning Fluorimetry (DSF)
- Helix Biosensor
Scottish Centre for Macromolecular Imaging (SCMI) |
|
|---|
The Scottish Centre for Macromolecular Imaging (SCMI) is the Scottish national cryo-electron microscope facility. Equipped with a fully automated JEOL 300 CRYO ARM, and supported by a network of side-entry 200kV microscopes in Dundee, Edinburgh and Glasgow, SCMI offers state-of-the-art equipment for both single particle analysis and cryo-electron tomography.
Protein Production Facility |
|
|---|
The Protein Production Service supports projects across all aspects of the production and purification of recombinant proteins: planning and experimental design, training and assistance with the use of instruments, development of automated purification programs. The facility boasts top of the range ÄKTA purifiers and columns.
Glasgow Polyomics |
|
|---|
Glasgow Polyomics brings together world-renowned experts in the field of omics research encompassing: genomics, transcriptomics, proteomics, metabolomics and lipidomics, as well as bioinformatics and data analysis. The facility offers a comprehensive range of services and consultancy from study design and sample analysis through to data processing and interpretation of results. We have a proven track record in innovation and research, that allows us to deliver world-class research to academic institutions and industry.
Centre for Virus Research Genomics (CVR Genomics) |
|
|---|
CVR Genomics is a team of researchers exclusively dedicated to the development and implementation of high-throughput sequencing solutions applied to viruses. The facility supports CVR researchers, external collaborators and provide resources to the broader virology community. CVR Genomics houses an array of specialised equipment, covering different stages of the sequencing process.
Glasgow Precision Oncology Laboratory (GPOL) |
|
|---|
GPOL supports researchers and industry with molecular tests and laboratory experiments to develop novel precision strategies in oncology. This includes tests for discovery work on patient tumours, including Next Generation Sequencing and RNASeq; and experiments to understand models of disease, through defining the genomic mutational landscape and then through providing molecular phenotypes for clinical trials development.
Spatial Transcriptome Facility |
|
|---|
The facility encompasses high calibre instruments including: Nanostring GeoMx for profiling whole transcriptomes form a single FFPE; and 10x Genomics Visium next-generation molecular profiling solution for classifying tissue based on total mRNA.
The Metabolomics Facility (Beatson Institute) |
|
|---|
The Metabolomics facility employs state-of-the-art mass spectrometry techniques to measure small molecule (metabolite) changes in cancer cells, to support cancer metabolism research projects within the Institute.
The Advanced Technology Proteomic Facility(Beatson Institute) |  |
|---|
The Advanced Technology Proteomic Facility develops MS-based platforms and works together with researchers to provide a new level of understanding in tumour biology. We have developed pipelines for the analysis of a wide range of biological samples, from single proteins to the complete proteome of cells, organoids, and tissues.
Flow Cytometry Core Facility |
|
|---|
The Flow Core Facility provides access to a range of Flow Cytometers. Techniques include multicolour immunophenotyping, cell cycle analysis, identification and isolation of fluorescent protein transfected cells, isolation of rare cell populations, analysis of bacteria and parasite populations, apoptosis assays, and functional assays.
Glasgow Tissue Research Facility (GTRF) |
|---|
The Glasgow Tissue Research Facility (GTRF) provides researchers access to a wide variety of consented tissue including pathology archive samples, surplus diagnostic or surgical tissue, bespoke collections of tissue from NHS Scotland patients can be collected as part of cohort studies or clinical trials.
NHS Greater Glasgow & Clyde Biorepository |
|---|
The NHSGGC Biorepository is an invaluable resource for clinical research, providing access to a wide range of human tissue samples including surplus materials from diagnostic and surgical procedures. We can also provide access, with appropriate governance in place, to pathology archive specimens.
Glasgow Imaging Facility |
|
|---|
The facility incorporates imaging technologies that cover whole body imaging (resolution in mm), through conventional wide-field, confocal and multi-photon microscopy (resolution in µm), to high-resolution approaches breaking the resolution limit of light (resolution in nm).
Translational Molecular Imaging Centre (Beatson Institute) | |
|---|
The state-of-the-art facilities and equipment include access to a GE cyclotron, dedicated research radiosynthesizers, a small-animal PET/MRI facility and two clinical GE Discovery Time-of-Flight PET/CT scanners. Within the TMI there is expertise in several key areas of imaging, which is further supported by a wide network of expert collaborators.
Imaging Centre of Excellence (ICE) |
|
|---|
The facility hosts world leading imaging clinical research facilities which provide a nexus for academic, NHS and industrial expertise into brain imaging whilst further strengthening Glasgow’s position as a world leader in precision medicine. most notably, the building includes a 7 Tesla (7T) MRI scanner, an ultra-high resolution scanner which is the first of its kind fully integrated within a clinical site in the UK underpinned by world-leading clinical expertise in stroke, cardiovascular disease and brain imaging. The building accommodates a 3 Tesla MRI scanner and 320 slice/large detector CT.
Glasgow Experimental MRI Centre (GEMRIC) |
|
|---|
Glasgow Experimental MRI Centre (GEMRIC) is a pre-clinical MRI centre situated within the Garscube Campus of Glasgow University. The centre is housed in a custom-designed building containing two Bruker 7 Tesla pre-clinical MRI scanners, along with a fully equipped surgical suite, animal holding rooms and a physics workshop.
Centre for Cognitive Neuroimaging (CCNI) |
|
|---|
The CCNi mission is to understand how the human brain gives rise to complex cognitive functions, in health and disease. The facility boasts expertise in multi-modal imaging and the fusion of different modalities (EEG-fMRI, TMS-EEG). The CCNi also has world-leading expertise in non-invasive brain stimulation, and we develop novel tools to enhance the precision of these stimulation methods
CRUK RadNet Glasgow Centre |
|
|---|
CRUK RadNet Glasgow supports both scientists and clinicians to undertake radiation related research and will build a translational research pipeline by integrating radiation biology into existing projects, obtaining funding for new projects and facilitating preliminary data collection to support new applications. Our multidisciplinary programme encompasses discovery science, preclinical research, imaging, biomarkers, clinical radiotherapy research and clinical trials.
CVR Bioinformatics |
|
|---|
CVR Bioinformatics is a group of computer-based researchers embedded in the MRC-University of Glasgow Centre for Virus Research (CVR). The facility has expertise in novel analytical approaches, high-throughput sequencing, and data analyses. The facility works to support CVR researchers and external collaborators, perform independent research and provide resources to the wider virology community.
Bioinformatics Core (School of Infection and Immunity) |
|
|---|
The facility supports bioinformatic projects across Sii and has expertise with omic data analysis, visualisation and communication, training, and assistance with methods, costing and grant writing.
Bioinformatics & Data Science (Beatson Institute) |
|
|---|
The facility provides support to scientists at the Institute, covering a range of research projects that require large-scale exploratory data analysis, advanced statistics and mathematical modelling and provide insights that advance our understanding of cancer biology.
Robertson Centre for Biostatistics |
|
|---|
The facility has expertise in the design, conduct, analysis and interpretation of clinical trials and epidemiological studies and in the development of novel informatics technologies to support their conduct in biostatistics, health informatics, data processing and management, software development, project management and project development.
Social and Public Health Sciences Unit |
|
|---|
At MRC/CSO Social and Public Health Sciences Unit, we conduct high quality research that has a real impact on health and wellbeing, and on reducing health inequalities – both at home and across the globe. The facility has key expertise is database development, data collection and analysis, project, and data management.
Health Economics and Health Technology Assessment (HEHTA) |
|
|---|
The facility is dedicated to delivering research that has direct impact on clinical practice, population health and health policies, both nationally and internationally. Methodological expertise includes economic evaluation alongside trials, decision analytic modelling, evidence synthesis, population health economics, precision medicine, global HTA, medical statistics and qualitative evaluations.
Glasgow Clinical Trials Unit (GCTU) |
|---|
The GCTU has expertise in the design, conduct, analysis and interpretation of clinical trials and epidemiological studies and in the development of novel informatics technologies to support their conduct in biostatistics, data processing and management, software development, project management and project development.
Drug Screening and Resistance Hub (CRUSH) |
|
|---|
CRUSH strives to address pandemic preparedness providing access to the specialist knowledge and facilities of the CVR for partners in all sectors of industry and academia. CRUSH is a fully integrated hub with access to bespoke biocontainment facilities and the expertise to support small animal model studies of high consequence viruses, including SARS-CoV-2. Proximity to the CVR’s virology expertise, viral genomics and computational biology capabilities further strengthens the CRUSH offering.
Glasgow University Microbiome Initiative (GUMI) |
|
|---|
GUMI is a collection of researchers and clinicians from across the University of Glasgow and NHS Greater Glasgow and Clyde with a passion for microbiome research. In bringing together experts with diverse skillsets and interests in microbiome research under this umbrella, we aim to facilitate collaboration and increase both discovery and translational microbiome research across human and animal health and the environment.
Centre for Data Science & AI |  |
|---|
The Centre for Data Science and AI will facilitate the initiation and expansion of sustainable collaboration across disciplines, industries, public, and government to promote impact generation from research.
Stage 0: Discovery Research
The earliest stage of a research project. Fundamental discovery research takes place, and preliminary data is collected to establish the feasibility of an idea.
Experimental
Assessment and review of scientific findings (identification and validation of technology), foundation for characterising this new technology (TRL 1).
Business Development
- Opportunity Audits (hosted by the TRI MT) provide understanding of the opportunity landscape. These are helpful discussion-based sessions, where researchers can receive expert advice from experienced consultants on the development of their project and the next steps towards creating impact through their research.
- Enterprise Courses and Industry Events will be regularly available throughout the year.
- The Public Engagement team can help support engagement with the wider community with funding, training and resources.The MVLS Engagement with Research Fund is open to all MVLS staff and postgraduate research students. It offers flexible awards of up to £2,500 to support research-related public engagement activity and skills development.
- The ScotPEN Wellcome Engagement Award (SWEA) scheme offers funding of up to £100,000 for public engagement with Wellcome funded research.
Stage 1: Ideas and Identification
Following successful preliminary data collection, further studies are conducted to solidify the research hypothesis, characterise the preliminary device prototype and design and evaluate its critical components.
Experimental
Development of experimental design; characterisation of preliminary product by exploring prototypes and identifying and evaluating critical technologies and design features/components required (TRL 2).
Gaining preliminary user feedback on device prototypes and design (or assay components via prototypes and screening) is also recommended. For devices, milestones could include demonstrations of in vitro efficacy, preliminary ex vivo or in vivo efficacy and safety demonstration. For assays, sensitivity and specificity with spike/recovery studies in the appropriate matrices could be completed (TRL 3).
Business Development
- Opportunity development reviews, Licensing/invention disclosures and Tech Transfer referrals (RIS).
- RIS: legal advice & IP (initial IP search for patentability and file provisional patent);
- TRI MT: information on Non-disclosure agreements and material transfer agreements.
- The Public Engagement Team can help support engagement with the wider community with funding, training and resources.The MVLS Engagement with Research Fund is open to all MVLS staff and postgraduate research students. It offers flexible awards of up to £2,500 to support research-related public engagement activity and skills development.
Discovery Research Grant Funding
Discovery Research Grant Funding
Internal Translational Research Funding:
Translational Funding Calls such as:
- WT ECD: Early Concept Development, enhance the link between discovery science and innovation and promote the translation of scientific research to health impact. 3-4 months. TRL 1 - 3.
- BBSRC IAA: Impact Accelerator Account, early stage translational projects to take them on the next steps along the translational pathway. Facilitate impact agendas including forging and strengthening collaborators. 6 - 12 months, TRL 2 - 4
- MRC IAA: Impact Accelerator Account, aims to accelerate the transition from discovery science to the early stages of therapeutic/biomarker development. 6 - 12 months, TRL 2 - 4.
- When assessing project potential, the TRI review panel look at a variety of different aspects of the project, please see the TRI Translational Research video.
External Translational Funding:
Stage 2: Early Concept Validation
At this stage, the project focuses on device prototype and design optimisation, and demonstration of activity and efficacy through in vivo and ex vivo testing.
Experimental
Optimisation and demonstration of activity and efficacy. For devices, this can include the collection of user feedback on prototypes to refine design. Bench testing, ex vivo and non-GLP in vivo testing can also be carried out as well as the initiation of animal model development if necessary and the identification of non-clinical and clinical studies.
Examples of milestones for device translation can be the establishment of a regulatory and clinical strategy or a non-GLP in vivo efficacy demonstration. Assay demonstrations can involve the integration of critical technologies and components (including hardware and software) and establishment of quality control reagents and testing (TRL 4). Milestones for this could be the determination of a regulatory strategy.
Research governance and ethics support:
- UofG Research Governance,
- Research Regulation and Compliance team,
- Ethics committee for non-clinical research involving human subjects,
- Research involving humans
- MHRA regulations: is your product a medicine or a medical device?
Possible regulatory standards: e.g., CE, ISO, GMP, GLP, MHRA, MEDDEVs, CHEATA.
Business Development
- The TRI Management Team (TRI MT) and the IP and Commercialisation team, have published an informational video on Non-disclosure agreements and material transfer agreements.
- Projects can significantly benefit from potential collaborations between the PIs, NHS, ICE, nodes, CIZ, and industry partners.
- The TRI MT provide feedback & support, as well as Enterprise Bootcamps and Training.
- The Public Engagement team can help support engagement with the wider community with funding, training and resources.The MVLS Engagement with Research Fund is open to all MVLS staff and postgraduate research students. It offers flexible awards of up to £2,500 to support research-related public engagement activity and skills development.
Translational Research Funding
Internal Translational Research Funding:
Translational Funding Calls such as:
- WT ECD: Early Concept Development, enhance the link between discovery science and innovation and promote the translation of scientific research to health impact. 3-4 months. TRL 1 - 3.
- BBSRC IAA: Impact Accelerator Account, early stage translational projects to take them on the next steps along the translational pathway. Facilitate impact agendas including forging and strengthening collaborators. 6 - 12 months, TRL 2 - 4.
- MRC IAA: Impact Accelerator Account, aims to accelerate the transition from discovery science to the early stages of therapeutic/biomarker development. 6 - 12 months, TRL 2 - 4.
When assessing project potential, the TRI review panel look at a variety of different aspects of the project, please see the TRI Translational Research video.
External Translational Funding:
For External Translational Funding Opportunities, please visit the TRI Funding Calendar.
External funding can also be sourced from:
- MRC DPFS,
- BBSRC FoF,
- Innovate UK,
- NIHR i4i.
Stage 3: Concept Progression
At this stage, the project focuses on feasibility and efficacy studies. After characterisation is concluded, the medical device is ready to be manufactured.
Experimental
Advanced characterisation of product and initiation of manufacturing. Continuation of feasibility and efficacy studies. Exploration of potential manufacturing options and sustainability (reproducible processes amenable to GMP), performance testing and finalize quality control criteria. (TRL 5).
Research governance and ethics support:
- UofG Research Governance,
- Research Regulation and Compliance team,
- Ethics committee for non-clinical research involving human subjects,
- Research involving humans.
Regulatory standards to keep in mind: e.g., CE, ISO, GMP, GLP, MHRA, MEDDEVs, CHEATA. Pivotal study: demonstrate device/diagnostic safety and efficacy with patient population (used to gain regulatory approval).
Business Development
Researchers should consider seeking advice on:
- Global market competition,
- Legal advice & Intellectual Property,
- Non-disclosure agreements and material transfer agreements (visit the TRI informational video page for more information),
- Business plan advice (identify supply chain and/or manufacturing partners),
- Public Engagement.
Translational Research Funding
Internal Translational Research Funding:
Translational Funding Calls such as:
- BBSRC IAA: Impact Accelerator Account, early stage translational projects to take them on the next steps along the translational pathway. Facilitate impact agendas including forging and strengthening collaborators. 6 - 12 months, TRL 2 - 4.
- BBSRC EwI: Excellence with Impact, Projects aligned with ‘Understanding’, ‘Identifying and/or ‘Enabling’ themes underpinning the MVLS Impact Strategy and with BBSRC key strategic research priorities or enabling themes. TRL 5 - 8.
When assessing project potential, the TRI review panel look at a variety of different aspects of the project, please see the TRI Translational Research video.
External Funding:
Opportunities and support:
For more opportunities, see our TRI Funding Calendar.
Investment Possibilities:
VC, Angel investment.
Stage 4: Scale-Up of Concept
After finalising the device prototype and receiving all necessary approvals, the product is ready for to be manufactured in a scalable way.
Experimental
Regulated production (scalable and reproducible), regulatory submission (design freeze) and clinical data. Shelf life and product stability studies, package finalisation and sterilization validation should also be considered for potential product release. In vitro diagnostic (IVD) devices: use, safety and management (TRL 6).
Scale-up initiation of GMP process validation and further clinical trialling (e.g., phase II). Milestones can assays used to assess product quality and critical outcomes in clinical trials and/or in animal efficacy studies (TRL 7).
Research governance and ethics support:
- Research governance office,
- Ethics committee for non-clinical research involving human subjects,
- Research involving humans.
Comply with regulatory standards e.g., CE, ISO, GMP, GLP, MHRA, MEDDEVs, CHEATA.
Translational Research Funding
Internal Translational Research Funding:
Translational Funding Calls such as:
- BBSRC EwI: Excellence with Impact, Projects aligned with ‘Understanding’, ‘Identifying and/or ‘Enabling’ themes underpinning the MVLS Impact Strategy and with BBSRC key strategic research priorities or enabling themes. TRL 5 - 8.
- When assessing project potential, the TRI review panel look at a variety of different aspects of the project, please see the TRI Translational Research video.
External funding:
- MRC DPFS,
- SE/Innovate UK,
- BBSRC FoF,
- NIHR i4i,
- Scottish Enterprise SMART:Scotland Grants,
- advisors/consultants, industry engagement.
For more opportunities, see the TRI Funding Calendar.
Investment Possibilities:
Venture Capital (VC), Angel investment.
Stage 5: End Goal/Exit
Device manufacturing is scaled up, feasibility, pivotal and post-market studies are confucted to ensure efficacy and safety.
Experimental
Feasibility, pivotal and post-market studies, post-market testing for long term effectiveness and potential adverse effects. Device/diagnostic registration, manufacturing scale-up. Reverse translation to adapt for new uses.
Finalise GMP manufacturing, submit for market approval and post-market testing and surveillance strategy plan (TRL 8 - 9).
Business Development
- Spin out/start-up company, exit: sold in entirety for one-off deal to a company.
- Licences: drug released / NHS.
- Public Engagement.
Funding Opportunities
Investment:
- Venture Capital,
- Angel investment.
Translational Research Projects
Many projects have been successfully translated with the help and support of the TRI; some of which are described in our case studies.
Previously funded translational projects can be found below each of our funding opportunities.
For further advice, please see our Applying for Translational Research Funding Video.
Medical Devices Updates & Further Information
Recent updates and further information published by the UK government and MHRA on the regulation of medical devices in the UK.
UK approved bodies for medical devices
On the 30th of January 2024, the UK Government and the MHRA published the updated list of the UK approved bodies for medical devices.
The list includes the following companies:
BSI Assurance UK Ltd (0086)
DEKRA Certification UK Ltd (8505)
LNE-GMED UK Limited (8521)
Scarlet NB UK Ltd (8536)
SGS United Kingdom Ltd (0120)
UL International (UK) Ltd (0843)
TUV Rheinland UK Ltd (2571)
TUV SUD BABT Unlimited (0168)
INTERTEK MEDICAL NOTIFIED BODY UK Ltd (8532)
More information can be found here.