Basic research that generates new knowledge, insights, methods or technologies, but has no immediate health & care application.
[TRL 1]
Developing novel methods and software not targeted at a specific health & care application.
Research and Development (R&D) activities
The R&D lifecycle of a medical device involves the work directed towards the development of an innovation, and/or the improvement of products and processes that are undertaken by researchers (e.g. at an academic/clinical institution or within industry R&D teams).
R&D1: Basic/generic research
Develop generic methods and technology
No dependencies
Business Model (BM) activities
A business model is required to understand the commercial opportunities for the innovation and to plan the sustainable delivery of value. The business model for a medical device addresses how value is created and delivered to patients and healthcare providers. This applies to both for-profit and non-profit endeavours.
BM1: Intellectual property and branding
Understand IP management and contract-related research disclosure agreements
No dependencies
Potential funding sources
UKRI, Wellcome Trust, Leverhulme Trust, Royal Society, Royal Academy of Engineering, Horizon Europe, other charities, companies
Deliverables
-
Generic methods and technology with indicative evidence of performance
Research that addresses a class of health & care problems, developing knowledge, insights, methods or technologies that may underpin innovative solutions.
[TRL 1]
Developing methods and software to address an area of health & care need.
Research and Development (R&D) activities
The R&D lifecycle of a medical device involves the work directed towards the development of an innovation, and/or the improvement of products and processes that are undertaken by researchers (e.g. at an academic/clinical institution or within industry R&D teams).
R&D1: Basic/generic research
Develop applied methods and technology based on available health & care data, following good laboratory practice (GLP) principles with accurate and detailed record keeping
No dependencies
R&D2: Requirements and prior knowledge
Perform scientific literature review on applied methods and technology development based on available health & care data
No dependencies
Health Economics & Service Transformation (HEST) activities
The translation of a health technology innovation to a medical device used in clinical practice requires an understanding of the costs and benefits of the device as well as of how the device will be embedded in the clinical service.
HEST1: Healthcare context (e.g. problem addressed, scale, current QALY/£ cost)
Identify potential areas of health & care application
No dependencies
Regulation (R) activities
The development, manufacturing, marketing, distribution and use of a medical device are governed by a set of laws, standards and guidelines. These regulations are put in place to ensure the safety and effectiveness of the medical device.
R1: Research governance / Ethics
Understand Ethical/HRA approvals & research governance requirements (including contracts and sponsorship) for obtaining existing healthcare data
No dependencies
Business Model (BM) activities
A business model is required to understand the commercial opportunities for the innovation and to plan the sustainable delivery of value. The business model for a medical device addresses how value is created and delivered to patients and healthcare providers. This applies to both for-profit and non-profit endeavours.
BM1: Intellectual property and branding
Consider IP protection (e.g. patenting); record funding and contracts for IP ownership
No dependencies
Potential funding sources
UKRI, Wellcome Trust, Leverhulme Trust, Royal Society, Rosetrees Trust, Royal Academy of Engineering, Horizon Europe, other charities including condition-specific charities, internal translational funding calls, companies
Deliverables
-
Understanding of potential use in healthcare setting
-
Finding / creating indicative evidence from literature or early studies on performance of methods and technology
-
IP protection initiated (if applicable)
Research that draws on existing knowledge, insights, methods or technologies to develop the concept for an innovative solution to a specific health & care problem.
[TRL 2]
Reaching out to stakeholders from STEM, applied health research and clinical practice to provide insights necessary to design and develop an innovative concept for addressing a specific health & care problem.
Research and Development (R&D) activities
The R&D lifecycle of a medical device involves the work directed towards the development of an innovation, and/or the improvement of products and processes that are undertaken by researchers (e.g. at an academic/clinical institution or within industry R&D teams).
R&D2: Requirements and prior knowledge
Record device requirements, prior knowledge and evidence of a valid clinical association to inform device specification
No dependencies
R&D3: Concept development and refinement leading to prototype
Create software specification and design for development of prototype (consider whether coding language is suitable for end use)
No dependencies
R&D4: Human factors
Understand and consider human factors that influence the development of the solution
No dependencies
R&D5: Responsible innovation
Understand and consider aspects of responsible innovation that influence the development of the solution (including health equity assessment and strategies for bias mitigation)
No dependencies
Health Economics & Service Transformation (HEST) activities
The translation of a health technology innovation to a medical device used in clinical practice requires an understanding of the costs and benefits of the device as well as of how the device will be embedded in the clinical service.
HEST1: Healthcare context (e.g. problem addressed, scale, current QALY/£ cost)
Understand current and foreseeable specific health & care need
No dependencies
HEST2: Current clinical care pathway (guidelines)
Understand current and foreseeable clinical guidance relevant to the health & care need being addressed
No dependencies
HEST3: Real-world evaluation of clinical care pathway (delivery)
Understand current and foreseeable clinical workflows relevant to the health & care need being addressed
No dependencies
HEST4: Service transformation model (change in clinical care pathway)
Draft how the product may be embedded into the current and foreseeable clinical service (e.g. considering clinical workflows and patient pathways) to inform concept development
No dependencies
HEST5: Value proposition (e.g. expected benefit, cost savings, improving efficiency, improving patient satisfaction) / Target Product Profile
Draft the outline value proposition and target product profile (including logic diagram development); consider competing solutions (existing or currently under development) which may impact the clinical need, guidance, workflows or pathways
- R2: Intended use and device categorisation
HEST6: Health economic analysis to address the value proposition claims (cost-benefit analysis)
Conduct health economics “desk research” (literature review) and conceptualise a preliminary health economic model to inform concept development; consider current and upcoming competing solutions
No dependencies
Regulation (R) activities
The development, manufacturing, marketing, distribution and use of a medical device are governed by a set of laws, standards and guidelines. These regulations are put in place to ensure the safety and effectiveness of the medical device.
R1: Research governance / Ethics
Arrange Ethical/HRA approvals for suitable healthcare development data (including sponsorship)
No dependencies
R2: Intended use and device categorisation
Formalise intended use (based on HEST2/3); understand both Software as Medical Device (SaMD) regulations and risk classification to inform concept development
- HEST2: Current clinical care pathway (guidelines)
- HEST3: Real-world evaluation of clinical care pathway (delivery)
R3: Quality management system (ISO 13485 certification)
Understand requirements around quality management systems (e.g. version control) and the recording of design decisions, data and activities
No dependencies
Business Model (BM) activities
A business model is required to understand the commercial opportunities for the innovation and to plan the sustainable delivery of value. The business model for a medical device addresses how value is created and delivered to patients and healthcare providers. This applies to both for-profit and non-profit endeavours.
BM1: Intellectual property and branding
Consider additional IP protection based on developed concept and freedom to operate; record funding and contracts for IP ownership
No dependencies
BM2: Market size (UK, Worldwide)
Identify the market (i.e. who is going to buy it); understand market size to determine if there is a viable market
No dependencies
BM3: Market share (realistic assumptions)
Understand of market share including analysis of competitors
No dependencies
Health and Care Evaluation (HCE) activities
Health and care evaluation of a health technology innovation involves assessing its safety, efficacy and effectiveness. This assessment is necessary for regulatory approval of the innovation as medical device before it enters the market. It also includes ongoing monitoring of the device once it is being used in clinical practice.
HCE1: Critical evaluation of concept
Collect patient and end user feedback of concept
No dependencies
Potential funding sources
UKRI, Wellcome Trust, Rosetrees Trust, Royal Academy of Engineering, Horizon Europe, other charities including condition-specific charities, LifeArc, NIHR, internal translational funding calls, companies
Deliverables
-
Clearly articulated health & care need
-
Solution concept and draft intended use statement
-
Initial value proposition and target product profile
-
Ethical approval for healthcare data to be used for development and testing in the lab
-
Initial summary of market opportunity (including product/market fit)
Research that develops the proposed health & care innovation and provides initial evidence for the feasibility of the proposed innovation.
[TRL 3, 4]
Exploring technical options, developing a prototype device and demonstrating the technical feasibility of the proposed innovation via pilot studies in the lab. This may be an iterative process that requires testing of multiple different prototypes.
Research and Development (R&D) activities
The R&D lifecycle of a medical device involves the work directed towards the development of an innovation, and/or the improvement of products and processes that are undertaken by researchers (e.g. at an academic/clinical institution or within industry R&D teams).
R&D3: Concept development and refinement leading to prototype
Collate representative healthcare data; develop an initial prototype (according to good machine learning practice (GMLP) for medical device development if applicable)
No dependencies
R&D4: Human factors
Address human factors when developing the prototype
No dependencies
R&D5: Responsible innovation
Address aspects of responsible innovation when developing the prototype
No dependencies
R&D6: Technical feasibility (pilot demonstration, materials biocompatibility/formulation)
Test the prototype in the lab to evidence technical feasibility; compare prototype performance to existing solutions
No dependencies
Health Economics & Service Transformation (HEST) activities
The translation of a health technology innovation to a medical device used in clinical practice requires an understanding of the costs and benefits of the device as well as of how the device will be embedded in the clinical service.
HEST4: Service transformation model (change in clinical care pathway)
Refine how the product will be embedded into the clinical service
No dependencies
HEST5: Value proposition (e.g. expected benefit, cost savings, improving efficiency, improving patient satisfaction) / Target Product Profile
Refine the value proposition and target product profile
No dependencies
HEST6: Health economic analysis to address the value proposition claims (cost-benefit analysis)
Refine the conceptualised health economic model and identify data to collect
No dependencies
Regulation (R) activities
The development, manufacturing, marketing, distribution and use of a medical device are governed by a set of laws, standards and guidelines. These regulations are put in place to ensure the safety and effectiveness of the medical device.
R2: Intended use and device categorisation
Define the intended use of the SaMD and its target population; identify the correct SaMD according categorisation of the solution and understanding implications
No dependencies
R3: Quality management system (ISO 13485 certification)
Work towards quality management system requirements to ensure accurate audit trail of prototype device development (including design decisions, uses of external plugins/components, etc.); create software in accordance with IEC 62304 (and where applicable ISO/IEC 27001)
No dependencies
R4: Clinical investigation approval
Initialise a technical file (e.g. documented user requirements, software requirements, design decisions, regulatory risk assessments) to be used in the future for clinical investigation approval by relevant regulatory body (e.g. MHRA, EMA, FDA)
No dependencies
R5: CE / UKCA marking
Understand the requirements for regulatory assessment (e.g. UKCA, CE, FDA), for example, with regards to software development standards and clinical investigation standards
No dependencies
Productisation & Distribution (P&D) activities
The innovative technology needs to be manufactured into a regulated medical device product for it to be delivered to the end user (e.g. healthcare provider, patient). This process includes activities around quality control, packaging/labelling as well as distribution and sales.
P&D1: Manufacturing/software-engineering
Seek industry partners (including service providers, suppliers, manufacturers and distributors - also considering start-up formation); understand the IT infrastructure of the health & care environment (including software and hardware); understand Digital Technology Assessment Criteria (DTAC) requirements
No dependencies
Business Model (BM) activities
A business model is required to understand the commercial opportunities for the innovation and to plan the sustainable delivery of value. The business model for a medical device addresses how value is created and delivered to patients and healthcare providers. This applies to both for-profit and non-profit endeavours.
BM2: Market size (UK, Worldwide)
Finalise market size analysis to determine if there is a viable market
No dependencies
BM3: Market share (realistic assumptions)
Finalise market share opportunity (including analysis of competitors)
No dependencies
BM4: Product vs service
Develop a commercial strategy for delivering the device to market (will it be a product or service?)
No dependencies
BM5: Spinout vs licence
Develop a commercial strategy (for-profit, or not-for-profit (e.g. via a community interest company)) for delivering the device to market including considerations around setting up a spin-out or licensing out the innovation as academic exit strategy
No dependencies
BM6: Business plan / canvas
Draft an outline business model (consider creating a business canvas)
No dependencies
Health and Care Evaluation (HCE) activities
Health and care evaluation of a health technology innovation involves assessing its safety, efficacy and effectiveness. This assessment is necessary for regulatory approval of the innovation as medical device before it enters the market. It also includes ongoing monitoring of the device once it is being used in clinical practice.
HCE1: Critical evaluation of concept
Create a clinical evaluation plan (CEP) to define the scope and outline the systematic approach of the planned clinical investigation to demonstrate scientific, analytical and clinical validity
No dependencies
Potential funding sources
UKRI, Wellcome Trust, Rosetrees Trust, Royal Academy of Engineering, Horizon Europe, other charities including condition-specific charities, LifeArc, NIHR, Innovate UK, internal translational funding calls, companies
Deliverables
-
Prototype with indicative evidence of performance (demonstrating technical feasibility)
-
Proof-of-concept in the lab
-
Revised value proposition and target product profile
-
Finalised intended use statement
-
Quality management system processes identified and in operation
-
Initial regulatory risk assessment
-
Initial technical file
-
Potential service providers, suppliers, manufacturers and distributors have been identified
-
Revised summary of market opportunity (demonstrating commercial feasibility and competitiveness)
-
Proposed strategy for delivering the innovation to market (including academic exit strategy)
-
Initial outline business model
-
Clinical evaluation plan
Research that further develops the proposed health & care innovation and provides reproducible evidence for its efficacy and safety in a relevant environment.
[TRL 5, 6]
Refining the prototype, developing the product, and conducting a feasibility investigation to generate evidence of health & care relevance and safety in a realistic but controlled health & care setting. This may be an iterative process that requires testing of multiple different prototypes before committing to the final design.
Research and Development (R&D) activities
The R&D lifecycle of a medical device involves the work directed towards the development of an innovation, and/or the improvement of products and processes that are undertaken by researchers (e.g. at an academic/clinical institution or within industry R&D teams).
R&D4: Human factors
Refine the prototype addressing human factors and usability
No dependencies
R&D5: Responsible innovation
Refine the prototype addressing aspects of responsible innovation when developing the prototype (including health equity requirements and cyber security requirements)
No dependencies
R&D6: Technical feasibility (pilot demonstration, materials biocompatibility/formulation)
Refine the prototype addressing findings of lab pilot studies
No dependencies
R&D7: Adapting/extending to achieve health and care feasibility and efficacy
Refine the prototype based on health & care feasibility data and key stakeholder feedback (e.g. patients, end user)
- HCE1: Critical evaluation of concept
- HCE2: Health and care feasibility
- HCE3: Health and care evaluation of safety and efficacy
R&D8: Adapting/extending to achieve health and care effectiveness
Refine the prototype based on health & care efficacy data and key stakeholder feedback (e.g. patients, end user)
- HCE1: Critical evaluation of concept
- HCE2: Health and care feasibility
- HCE3: Health and care evaluation of safety and efficacy
R&D9: Freeze design
Complete R&D activities including the creation of the Device Master List/Record (detailing all processes required to create the device; to include with the technical file) and freeze the design of the refined product
- HCE1: Critical evaluation of concept
- HCE2: Health and care feasibility
- HCE3: Health and care evaluation of safety and efficacy
Health Economics & Service Transformation (HEST) activities
The translation of a health technology innovation to a medical device used in clinical practice requires an understanding of the costs and benefits of the device as well as of how the device will be embedded in the clinical service.
HEST4: Service transformation model (change in clinical care pathway)
Refine how the product will be embedded into the clinical workflow / health and care pathway
No dependencies
HEST5: Value proposition (e.g. expected benefit, cost savings, improving efficiency, improving patient satisfaction) / Target Product Profile
Refine the value proposition and target product profile
No dependencies
HEST6: Health economic analysis to address the value proposition claims (cost-benefit analysis)
Refine the conceptualised health economic model and health economics data collection
No dependencies
Regulation (R) activities
The development, manufacturing, marketing, distribution and use of a medical device are governed by a set of laws, standards and guidelines. These regulations are put in place to ensure the safety and effectiveness of the medical device.
R1: Research governance / Ethics
Arrange Ethical approvals for pilot studies in health & care setting
No dependencies
R3: Quality management system (ISO 13485 certification)
Develop device in line with ISO13485 (including QMS) as well as any other applicable standards (e.g. IEC 62304, IEC 82304-1, IEC 81001-5-1, IEC 62366-1, DCB 0129, ISO/IEC 27001), involving industry partners (e.g. manufacturer) as needed
No dependencies
R4: Clinical investigation approval
Refine the technical file (e.g. design decisions, regulatory risk assessments, test methods) for clinical investigation approval
- R&D4: Human factors
- R&D5: Responsible innovation
- R&D6: Technical feasibility (pilot demonstration, materials biocompatibility/formulation)
R5: CE / UKCA marking
Start to collect clinical evidence on efficacy and safety for regulatory assessment (e.g. UKCA, CE, FDA) and if affecting clinical outcomes run the study to accepted good clinical practice (GCP) standards (e.g. ISO 14155)
No dependencies
Productisation & Distribution (P&D) activities
The innovative technology needs to be manufactured into a regulated medical device product for it to be delivered to the end user (e.g. healthcare provider, patient). This process includes activities around quality control, packaging/labelling as well as distribution and sales.
P&D1: Manufacturing/software-engineering
Work with industry partners (including service providers, suppliers, manufacturers and distributors - also considering start-up formation); develop and test the product for integration into health & care environment (including integration into health & care services and IT infrastructure)
- R&D4: Human factors
- R&D5: Responsible innovation
- R&D6: Technical feasibility (pilot demonstration, materials biocompatibility/formulation)
- R&D7: Adapting/extending to achieve health and care feasibility and efficacy
- R&D8: Adapting/extending to achieve health and care effectiveness
- R&D9: Freeze design
P&D2: Testing protocols
Implement a test environment for functional and non-functional testing of the source code (e.g. performance, usability, compatibility, accessibility, security); perform functional and non-functional testing of the product’s source code for verification and validation
No dependencies
P&D3: Safety, compliance, interoperability and usability
Assess Safety, compliance, interoperability, cyber security (ISO/IEC 27001) and usability of the product; review Digital Technology Assessment Criteria (DTAC) requirements
No dependencies
P&D4: Quality control
Conduct quality control of refined product to assess whether it meets the specifications and requirements
No dependencies
Business Model (BM) activities
A business model is required to understand the commercial opportunities for the innovation and to plan the sustainable delivery of value. The business model for a medical device addresses how value is created and delivered to patients and healthcare providers. This applies to both for-profit and non-profit endeavours.
BM4: Product vs service
Review commercial strategy for delivering the device to market (considering refinements of the product/service)
No dependencies
BM5: Spinout vs licence
Review commercial strategy for delivering the device to market (considering refinements of the product/service) as well as the academic exit strategy
No dependencies
BM6: Business plan / canvas
Refine the business model
No dependencies
Health and Care Evaluation (HCE) activities
Health and care evaluation of a health technology innovation involves assessing its safety, efficacy and effectiveness. This assessment is necessary for regulatory approval of the innovation as medical device before it enters the market. It also includes ongoing monitoring of the device once it is being used in clinical practice.
HCE1: Critical evaluation of concept
Perform health & care risk assessment
No dependencies
HCE2: Health and care feasibility
Conduct investigation of the product to generate evidence of health & care feasibility
- R4: Clinical investigation approval
HCE3: Health and care evaluation of safety and efficacy
Conduct investigation of the product to generate evidence of health & care efficacy and safety (based on risk classification)
- R4: Clinical investigation approval
Potential funding sources
UKRI, Wellcome Trust, Rosetrees Trust, Royal Academy of Engineering, Horizon Europe, other charities including condition-specific charities, LifeArc, NIHR, Accelerated Access Collaborative (SBRI Healthcare), Innovate UK, internal translational funding calls, companies, venture capitalists
Deliverables
-
Final product (frozen development/design)
-
Approvals and access in place for real-world healthcare dataset
-
Revised value proposition and target product profile
-
Conceptual health economic model with preliminary data
-
Ethical approval for pilot studies in health & care setting
-
Development process according to ISO13485
-
Revised technical file
-
Functional and non-functional testing completed
-
Relationships have been established with potential service providers, suppliers, manufacturers and distributors
-
Revised strategy for delivering the innovation to market (including academic exit strategy)
-
Revised outline business model
-
Evidence of utility in a health and care setting
Investigations that evaluate the proposed innovation in a health & care setting, providing actionable evidence of its efficacy, effectiveness and safety in a patient population.
[TRL 7]
Embedding the product in a real-world health & care setting and conducting a pivotal study to demonstrate safety and generate evidence of stakeholder value.
Health Economics & Service Transformation (HEST) activities
The translation of a health technology innovation to a medical device used in clinical practice requires an understanding of the costs and benefits of the device as well as of how the device will be embedded in the clinical service.
HEST4: Service transformation model (change in clinical care pathway)
Refine how the product will be embedded into the health & care pathway by integrating collected evidence
No dependencies
HEST5: Value proposition (e.g. expected benefit, cost savings, improving efficiency, improving patient satisfaction) / Target Product Profile
Refine the value proposition and target product profile by integrating collected evidence
No dependencies
HEST6: Health economic analysis to address the value proposition claims (cost-benefit analysis)
Develop the health economic model/case based on the preliminary modelling and collected evidence
- HCE4: Health and care validation of safety and efficacy, effectiveness
Regulation (R) activities
The development, manufacturing, marketing, distribution and use of a medical device are governed by a set of laws, standards and guidelines. These regulations are put in place to ensure the safety and effectiveness of the medical device.
R4: Clinical investigation approval
For any clinical investigations that may affect the outcome of a patient, refine and submit the technical file (e.g. design decisions, test methods, and regulatory risk assessment to standard ISO 14971) for MHRA approval for pivotal clinical investigation of final product (to get exemption for clinical investigation of a non-CE/UKCA marked device)
No dependencies
R5: CE / UKCA marking
Prepare application for regulatory assessment (e.g. UKCA, CE, FDA)
No dependencies
Business Model (BM) activities
A business model is required to understand the commercial opportunities for the innovation and to plan the sustainable delivery of value. The business model for a medical device addresses how value is created and delivered to patients and healthcare providers. This applies to both for-profit and non-profit endeavours.
BM4: Product vs service
Review commercial strategy for delivering the device to market (considering refinements of the product/service)
No dependencies
BM5: Spinout vs licence
Review commercial strategy for delivering the device to market (considering refinements of the product/service) as well as the academic exit strategy
No dependencies
BM6: Business plan / canvas
Refine the business model
No dependencies
BM7: Investment required and RoI
Assess commercial viability to confirm that the development, distribution and maintenance of the software is financially sustainable (including return-on-investment analysis); seek company or venture capitalist funding
No dependencies
Health and Care Evaluation (HCE) activities
Health and care evaluation of a health technology innovation involves assessing its safety, efficacy and effectiveness. This assessment is necessary for regulatory approval of the innovation as medical device before it enters the market. It also includes ongoing monitoring of the device once it is being used in clinical practice.
HCE4: Health and care validation of safety and efficacy, effectiveness
Conduct pivotal clinical investigation to confirm efficacy, health & care effectiveness and safety in line with ISO14155; usability study for regulatory purposes (IEC62366) based on final product; write a clinical evaluation report (CER) to summarise the results of the clinical evaluation plan process
- R4: Clinical investigation approval
HCE5: Real world evidence post-launch
Initialise plans for post-market surveillance and clinical follow-up
No dependencies
Potential funding sources
UKRI, Wellcome Trust, Royal Academy of Engineering, Horizon Europe, other charities including condition-specific charities, LifeArc, NIHR, Accelerated Access Collaborative (SBRI Healthcare), Innovate UK, internal translational funding calls, companies, venture capitalists
Deliverables
-
Revised value proposition and target product profile based on collected evidence
-
Early health economic model
-
Revised technical file (including revised regulatory risk assessment)
-
Partnerships have been formed with key stakeholders (e.g. suppliers, service providers, manufacturers, distributors/customers)
-
Revised strategy for delivering the innovation to market (including academic exit strategy)
-
Revised business model
-
Clinical evaluation report
Activities that finalise the regulatory approvals, and the commercialisation, implementation and scaling-up strategies for the health & care innovation.
[TRL 8]
Obtaining regulatory approvals, and finalising the business model and commercial strategy to attract funding for implementation and adoption.
Health Economics & Service Transformation (HEST) activities
The translation of a health technology innovation to a medical device used in clinical practice requires an understanding of the costs and benefits of the device as well as of how the device will be embedded in the clinical service.
HEST4: Service transformation model (change in clinical care pathway)
Finalise how the product will be embedded into the health & care pathway by integrating collected evidence
No dependencies
HEST5: Value proposition (e.g. expected benefit, cost savings, improving efficiency, improving patient satisfaction) / Target Product Profile
Finalise the value proposition and target product profile
- HEST4: Service transformation model (change in clinical care pathway)
- HEST6: Health economic analysis to address the value proposition claims (cost-benefit analysis)
HEST6: Health economic analysis to address the value proposition claims (cost-benefit analysis)
Finalise full health economic analysis
No dependencies
HEST7: End-user business model / Procurement case
Refine end-user business model / procurement case for the product (including needs assessment, cost-benefit analysis, implementation and adoption strategies)
No dependencies
HEST8: NICE Health Technology Evaluation
Consider adoption of the product into policy and/or guidelines as a routine method or approach; prepare proposal for NICE Early Valuation Assessment; prepare for DTAC certification
No dependencies
Regulation (R) activities
The development, manufacturing, marketing, distribution and use of a medical device are governed by a set of laws, standards and guidelines. These regulations are put in place to ensure the safety and effectiveness of the medical device.
R5: CE / UKCA marking
Finalise technical file (e.g. design decisions, regulatory risk assessments, clinical evaluation report); submit technical file for regulatory assessment (e.g. UKCA, CE, FDA) or self-declare product (risk class dependent)
- HCE5: Real world evidence post-launch
Productisation & Distribution (P&D) activities
The innovative technology needs to be manufactured into a regulated medical device product for it to be delivered to the end user (e.g. healthcare provider, patient). This process includes activities around quality control, packaging/labelling as well as distribution and sales.
P&D5: Scale-up
Plan scale-up of production (including support and maintenance)
No dependencies
P&D6: Production and distribution
Get Digital Technology Assessment Criteria (DTAC) accreditation (if appropriate)
No dependencies
Business Model (BM) activities
A business model is required to understand the commercial opportunities for the innovation and to plan the sustainable delivery of value. The business model for a medical device addresses how value is created and delivered to patients and healthcare providers. This applies to both for-profit and non-profit endeavours.
BM6: Business plan / canvas
Finalise the full business model
No dependencies
BM7: Investment required and RoI
Confirm commercial viability of the product; seek company or venture capitalist funding
No dependencies
BM8: Marketing and promotion
Refine a sales and marketing strategy based on business model
No dependencies
Health and Care Evaluation (HCE) activities
Health and care evaluation of a health technology innovation involves assessing its safety, efficacy and effectiveness. This assessment is necessary for regulatory approval of the innovation as medical device before it enters the market. It also includes ongoing monitoring of the device once it is being used in clinical practice.
HCE5: Real world evidence post-launch
Refine and finalise plan for post-market surveillance and clinical follow-up
No dependencies
Potential funding sources
NIHR, Accelerated Access Collaborative (SBRI Healthcare), Horizon Europe, other charities including condition-specific charities, internal translational funding calls, companies, venture capitalists
Deliverables
-
Finalised value proposition and target product profile
-
Full health economic analysis
-
Finalised technical file (including revised regulatory risk assessment)
-
CE/UKCA marking
-
DTAC accreditation (if appropriate)
-
Full business model
-
Product ready for deployment
-
Sales and marketing plan
-
Post-market surveillance plan
Activities that lead to product launch, and evaluation of the real-world effectiveness and safety of the innovation, to avoid harm and inform future developments.
[TRL 9]
Collecting real-world evidence and using it to avoid harm and further refine the technology and its application. This may inform product improvement and may require additional regulatory approval.
Health Economics & Service Transformation (HEST) activities
The translation of a health technology innovation to a medical device used in clinical practice requires an understanding of the costs and benefits of the device as well as of how the device will be embedded in the clinical service.
HEST7: End-user business model / Procurement case
Monitor end-user business model / procurement case for the product; ongoing health economic analysis
No dependencies
HEST8: NICE Health Technology Evaluation
Obtain NICE Health Technology Evaluation recommendation (if appropriate)
No dependencies
Regulation (R) activities
The development, manufacturing, marketing, distribution and use of a medical device are governed by a set of laws, standards and guidelines. These regulations are put in place to ensure the safety and effectiveness of the medical device.
R6: Post-market surveillance (PMS) and post-market clinical follow up (PMCF)
Collate post-market clinical evidence on safety and performance; update clinical evaluation report regularly and maintain quality management system
- HCE5: Real world evidence post-launch
Productisation & Distribution (P&D) activities
The innovative technology needs to be manufactured into a regulated medical device product for it to be delivered to the end user (e.g. healthcare provider, patient). This process includes activities around quality control, packaging/labelling as well as distribution and sales.
P&D5: Scale-up
Implement scale-up to meet market demand
- P&D6: Production and distribution
P&D6: Production and distribution
Launch and distribute product (including strategies for communication and training processes to increase acceptability by end users)
No dependencies
Business Model (BM) activities
A business model is required to understand the commercial opportunities for the innovation and to plan the sustainable delivery of value. The business model for a medical device addresses how value is created and delivered to patients and healthcare providers. This applies to both for-profit and non-profit endeavours.
BM8: Marketing and promotion
Implement the sales and marketing strategy (including customer outreach activities and advertising)
No dependencies
Health and Care Evaluation (HCE) activities
Health and care evaluation of a health technology innovation involves assessing its safety, efficacy and effectiveness. This assessment is necessary for regulatory approval of the innovation as medical device before it enters the market. It also includes ongoing monitoring of the device once it is being used in clinical practice.
HCE5: Real world evidence post-launch
Conduct post-market surveillance and post-market clinical follow-up of the product to collect data on long-term effectiveness, safety, potential adverse effects, and usage of the device
No dependencies
Potential funding sources
NIHR, Accelerated Access Collaborative (SBRI Healthcare), companies, venture capitalists
Deliverables
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End-user business model / procurement case
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NICE Health Technology Evaluation recommendation (if appropriate)
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Initial release version of the product has been manufactured and deployed
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Updated clinical evaluation report with post-market surveillance and post-market clinical follow-up data