Definitions
Click on the Glossary tab for a brief description of the terms commonly used within the translational toolkit. Click on the Stakeholders tab for more details on the UK-based stakeholders referred to within the roadmaps.
Get in touch with us if you think any key definitions are missing from the glossary.
Glossary
The below provides a short description of potentially unfamiliar terms used across the toolkit. Please also refer to the Resources Database for further information and guidance.
A B C D E F G H I M N P Q R S T U V WA
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Academic exit strategy
It is the process of transitioning a research project or innovation (e.g. healthcare technology) from the academic environment to a commercial setting or practical application (e.g. spin-out company, licencing), to maximise its impact and ensure its sustainability.
B
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Biocompatibility
The ability of a material to perform with an appropriate host response in a specific application.
C
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CE marking
Conformity with European health, safety and environmental protection standards. By placing CE marking on a product a manufacturer is declaring, on his sole responsibility, conformity with all of the legal requirements to achieve CE marking. The manufacturer is thus ensuring validity for that product to be sold throughout the European Economic Area.
Source: GOV.UK
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CEP
Clinical Evaluation Plan. CEP is a technical document that serves as a guide for conducting a Clinical Evaluation of a medical device. A clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance of the device.
Source: European Commission
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Community interest company
A community interest company is a type of not-for-profit company in the UK which is designed for businesses that want to use their profits and assets for the public good.
Source: GOV.UK
D
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DTAC
Digital Technology Assessment Criteria. DTAC is the national baseline criteria for digital health technologies entering and already used in the NHS and social care. It ensures that digital health tools meet the clinical safety, data protection, technical security, interoperability and usability and accessibility standards.
Source: NHS England
E
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Effectiveness
Is the device working well?
Effectiveness, in the health care sector, is the ability of an intervention to have a meaningful effect on patients in normal clinical conditions.
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Efficacy
Is the device working?
Efficacy, in the health care sector, is the capacity of a given intervention under ideal or controlled conditions.
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Efficiency
Is the device working in the most economical way?
Efficiency, in the health care sector, is doing things in the most economical way.
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EMA
European Medicines Agency. EMA is a decentralised agency of the European Union that is responsible for the scientific evaluation, supervision and safety monitoring of medicines.
Source: EMA
F
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FDA
The United States Food and Drug Administration. Amongst other things, the FDA is responsible for regulating medical devices in the United States.
G
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GCP
Good Clinical Practice. GCP is a process that incorporates established ethical and scientific quality standards for the design, conduct, recording and reporting of clinical research involving the participation of human subjects.
Source: World Health Organisation
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Generic research methods
Broad methodological approaches that can be applied across different scientific disciplines, such as statistical analysis, surveys, or lab techniques.
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GLP
Good Laboratory Practice. GLP is a quality system concerned with the organisational process and the conditions under which non-clinical health and environmental safety studies are planned, performed, monitored, recorded, archived and reported.
Source: World Health Organisation
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GMP
Good Manufacturing Practice. GMP is the aspect of quality assurance that ensures that medicinal products are consistently produced and controlled to the quality standards appropriate to their intended use and as required by the product specification.
Source: World Health Organisation.
H
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Health economic analysis
Health economic analysis is the evaluation of healthcare interventions regarding costs and benefits. There are different types of health economic analysis, the choice of which depends on the specific research question, available data and decision context.
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HRA
Health Research Authority. HRA is one of a number of organisations that work together in the UK to regulate different aspects of health and social care research. Its core purpose is to protect and promote the interests of patients and the public in health and social care research.
Source: HRA
I
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Internal translational funding calls
Institutional funding opportunities aimed at moving research discoveries toward real-world application and clinical or commercial use.
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Invasive Medical Device
A medical device that is intended by the manufacturer to be used, in whole or in part, inside the body of a human being.
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IP
Intellectual Property. IP is something that you create using your mind (e.g. an invention, a design of a product, a name of a product or brand, etc.). Copyright, patents, designs and trademarks are all types of intellectual property. For some types you get protection automatically, whereas for others you have to apply for.
Source: GOV.UK
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ISO/IEC
International organisation for standardisation (ISO) and its sister organisation International Electrotechnical Commission (IEC) are organisations that develop and publish international standards. A standard is a document, established by consensus and approved by a recognized body, that provides, for common and repeated use, rules, guidelines or characteristics for activities or their results, aimed at the achievement of the optimum degree of order in a given context. ISO standards cover a wide range of industries and sectors whereas IEC standards cover all electrical, electronic and related technologies.
M
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Market potential
The estimated ability of a product to achieve commercial success, based on market size, demand, and competitive landscape.
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Medical Device
A medical device is any apparatus, appliance, software, material or other article, intended by the manufacturer to be used for medical purposes.
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Medical device distributors
Medical device distributors act as intermediaries between medical device manufacturers and healthcare providers such as hospitals. They have in-depth knowledge of the specific needs within healthcare providers, and have access to networks to ensure a timely and efficient distribution of the device to the right place.
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MHRA
Medicines and Healthcare products Regulatory Agency. MHRA is an executive agency, sponsored by the Department of Health and Social Care that regulates medicines, medical devices and blood components for transfusion in the UK.
Source: GOV.UK
N
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NICE
National Institute for Health and Care Excellence. NICE evaluates new health technologies for NHS use, considering clinical effectiveness and value for money. They also produce useful and usable guidance, helping health and care practitioners deliver the best care.
Source: NICE
P
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Productisation
The process of turning a concept, service or a tool into a commercial product
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Proof-of-concept
A demonstration or pilot study that validates the feasibility or potential effectiveness of a product, idea, or intervention.
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Prosthetics
Artificial devices used to replace missing body parts, improving mobility and function for individuals with limb loss.
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Prototype
An early sample or model of a product used to test concepts and functionality before regulatory approval or mass production.
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Public partnership
A term to collectively describe ways in which patients, service users, carers, communities and members of the public work with researchers, and health and care professionals, in the creation and use of health and care research.
Source: NIHR Public Partnerships
Q
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QALY
Quality-adjusted life year. A measure of the state of health of a person or group in which the benefits, in terms of length of life, are adjusted to reflect the quality of life. One QALY is equal to 1 year of life in perfect health.
Source: NICE
R
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Risk classification
Medical devices are classified based on their inherent risks to patients, users and others. The classification system (from low to high risk) is based on the device’s intended use, potential harm, and the degree of invasiveness.
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RoI
Return on Investment. RoI is a metric that estimates the profitability of an investment.
S
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SaMD
Software as Medical Device. Software programmes that are intended to be used for medical purposes and which are independent of a physical device.
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Service transformation model
In healthcare, service transformation describes the process of redesigning and improving the delivery of services to achieve better outcomes for service users. A service transformation model provides a structured approach on how to achieve the above.
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Spin-out company
A start-up company that was created based on intellectual property (IP) generated through research at a university.
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Sponsorship
A clinical trial sponsor is the individual, company, institution or organisation who takes responsibility for the initiation, management, and financing (or arranging the financing) of that trial. The sponsor is responsible for ensuring that a clinical trial complies with the legislation and Good Clinical Practice.
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Stakeholder
Anybody with an interest, or stake, in a business, organisation or project.
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STEM
Science, Technology, Engineering and Mathematics
T
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Test houses
Test houses are specialised facilities or organisations, providing essential support and infrastructure to test various aspects of a healthcare intervention. This includes, for example, tests of safety, performance and regulatory compliance.
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TPP
Target Product Profile. A TPP is a document that outlines the desired ‘profile’ or characteristics of a product that under development. TPPs include, for example, information on the intended use, target populations, commercial considerations as well as safety and efficacy-related characteristics.
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Translational research
The process by which basic scientific research is translated into practical applications in clinical settings or real-world contexts that benefits individuals, communities and society as a whole.
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TRL
Technology Readiness Level. The term originated from NASA’s TRL system, which was developed to assess the maturity of technology components for space missions. The TRL system assigns numerical values from 1 to 9 to indicate the readiness of a technology, with 1 being at the lowest readiness and 9 being at the highest readiness. The concept has been adopted and extended beyond NASA and space technology, including translational research. In translational research, readiness levels are used to assess the maturity of scientific discoveries or innovations in the context of their potential translation into practical applications, such as new therapies, diagnostic tools, or medical devices.
U
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UKCA marking
UK Conformity Assessed marking – Conformity with the applicable requirements for products sold within Great Britain.
Source: GOV.UK
V
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Value proposition
The value proposition is a statement that articulates the unique value and benefits that a product or service promises to deliver to its future customers. It also communicates why the product should be chosen over alternatives.
W
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Wearables
Electronic devices worn on the body that monitor health metrics or support medical treatment (e.g. smartwatches or fitness trackers).