Basic research that generates new knowledge, insights, methods or technologies, but has no immediate health & care application.
[TRL 1]
Developing methods and materials to address a specific health & care clinical need (or class of).
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
Undertake generic research methods and technology development
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, other charities, companies (e.g. CASE studentships), Horizon – Europe
Deliverables
-
Developed generic method and device idea with indicative evidence of performance in lab-based research
Research that addresses a class of health & care problems, developing knowledge, insights, methods or technologies that may underpin innovative solutions.
[TRL 1]
Adapting lab-based research into methods and / or devices to address a health and care clinical area.
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
Undertake generic methods and technology development of device components, following good lab 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. For wearables and prosthetics this could include examining prior knowledge on toxicity, biocompatibility, and (bio)-degradability of materials.
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 health & care need and identifying if there is a potential area for a healthcare 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 and governance (e.g. HTA, contracts (MTAs etc.), HRA) approvals required for testing of medical devices in pre-clinical and clinical trials
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) freedom to operate and identify / record IP ownership and record funding and contracts for IP ownership
No dependencies
Potential funding sources
UKRI, Wellcome Trust, Leverhulme Trust, Royal Society, Royal Academy of Engineering, Horizon-Europe, Rosetrees Trust, other charities including condition-specific charities, internal translational funding calls.
Deliverables
-
Understanding of potential use in healthcare setting
-
Finding / creating indicative evidence from literature or early studies on performance
-
Understanding of issues around biocompatibility, toxicity and biodegradability
-
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]
Bringing together insights from STEM, applied health research and clinical practice to design and develop an innovative prototype device 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 valid clinical association to inform device specification.• R&D3: Refine technological development of component parts. Basic design and product specifications for prototype.
No dependencies
R&D3: Concept development and refinement leading to prototype
Refine technological development of component parts. Basic design and product specifications for prototype
No dependencies
R&D4: Human factors
Consider human factors in concept design
No dependencies
R&D5: Responsible innovation
Consider responsible innovation in concept design to cover ethically sourced materials, sustainable materials and bias free
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 the current and foreseeable clinical care pathway for the unmet clinical need and the related guidelines for care. This will be needed for the value proposition.
No dependencies
HEST3: Real-world evaluation of clinical care pathway (delivery)
Understand the health and care workflow (i.e. how are the guidelines put into practice) and how the proposed device could fit in. Determine cost of current and foreseeable approach. This will be needed for the value proposition.
No dependencies
HEST4: Service transformation model (change in clinical care pathway)
Initialise preparation for service transformation model which will be required for final business case (i.e. how will current and foreseeable practice need to be changed / be changed by for your device to be used)
No dependencies
HEST5: Value proposition (e.g. expected benefit, cost savings, improving efficiency, improving patient satisfaction) / Target Product Profile
Initialise Value proposition and TPP – what is the expected benefit of the device in terms of costs, patient care. This will be needed for funding applications and the technical file. Consider competing solutions (existing or currently under development) which may impact the clinical need, guidance, workflows or pathways.
No dependencies
HEST6: Health economic analysis to address the value proposition claims (cost-benefit analysis)
Consider current and upcoming competing solutions and initialise health economics “desk research” (literature review) and conceptualise a preliminary health economic model to inform concept development Initialise Health economics “desk research” (literature review) and conceptualise a preliminary health economic model to inform concept development
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 suitable (pre-) clinical testing of concept to be done in D4 if required
No dependencies
R2: Intended use and device categorisation
Formalise intended use (derived from outputs of HEST2/3) to inform concept development before initialising TPP in HEST5. Identify possible device and risk classification and regulatory steps involved for each potential market (see BM2 Based on formalised intended use document.
- HEST2: Current clinical care pathway (guidelines)
- HEST3: Real-world evaluation of clinical care pathway (delivery)
R3: Quality management system (ISO 13485 certification)
Understand the requirements for accurate audit / traceability of prototype device development is in place
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
Development of components of device and initial production process with view to scaling up and regulatory implications for clinical trials. Consider end users requirements in design of full prototype. This may require industry partner engagement (including services providers, suppliers, manufacturers and distributors).
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 freedom to operate; record funding and contracts for IP ownership and consider if additional IP protection is needed based on concept development
No dependencies
BM2: Market size (UK, Worldwide)
Identify the market understanding of 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
Gather and analyse initial feedback from stakeholders on relevance of solution
No dependencies
Potential funding sources
UKRI, Wellcome Trust, Royal Academy of Engineering, Horizon Europe, Rosetrees Trust, condition specific charities, LifeArc, internal translational funding calls, companies
Deliverables
-
Clearly articulated health & care need
-
Solution concept for development along with a draft of an intended use statement for prototype
-
Development of component parts initiated
-
Ethical approval for pre-clinical testing in D4
-
Initial summary of market opportunity
Resources
Roadmap-specific Resources
Research that develops the proposed health & care innovation and provides initial evidence for the feasibility of the proposed innovation.
[TRL 3, 4]
Development of full prototype and use of previous research and generation of pre-clinical data to develop proof of concept. 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
Undertake full prototype development and pre-clinical testing (including comparison to existing solutions - aiming to show improvement or equivalency) in laboratory models, including in-vivo models if required
No dependencies
R&D4: Human factors
Include human-centric design principles in prototype
No dependencies
R&D5: Responsible innovation
Ensure the materials are suitable for use in humans. Ensure prototype design meets regulatory requirements, is sustainable in design, is sourced from ethically verified materials and its manufacture is can be audited. This can be done by an external test house.
No dependencies
R&D6: Technical feasibility (pilot demonstration, materials biocompatibility/formulation)
Determine safety (bio-compatibility / bio-degradability / formulation / toxicity) of device is suitable for use in a clinical setting by testing in model systems. This can be done by an external test house.
No dependencies
R&D7: Adapting/extending to achieve health and care feasibility and efficacy
Adapt prototype based on pre-clinical data and key stakeholder feedback to ensure health and care feasibility (design input) i.e. after performing HCE activities in D4
- HCE1: Critical evaluation of concept
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 and update preparation for service transformation model which will be required for final business case (i.e. how will current practice need to be changed / be changed by for your device to be used)
No dependencies
HEST5: Value proposition (e.g. expected benefit, cost savings, improving efficiency, improving patient satisfaction) / Target Product Profile
Refine Value proposition and TPP – what is the expected benefit of the device in terms of costs, patient care. This will be needed for funding applications and the technical file.
- R2: Intended use and device categorisation
HEST6: Health economic analysis to address the value proposition claims (cost-benefit analysis)
Refine the 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.
R1: Research governance / Ethics
Prepare ethics and research governance (including sponsorship) applications for clinical investigation / feasibility studies in T1 – T4 stages
No dependencies
R2: Intended use and device categorisation
Determine device categorisation and necessary regulatory approvals required. This will determine if a clinical investigation is required for CE marking.
No dependencies
R3: Quality management system (ISO 13485 certification)
Ensure accurate audit trail / traceability of prototype device development is in place (inc. device materials, design iterations and equipment uses) for example by working towards the ISO13485 standard for quality management systems
No dependencies
R4: Clinical investigation approval
Initialise a technical file (incl risk assessment), determine the documentation required for MHRA notification of a clinical investigation
No dependencies
R5: CE / UKCA marking
Understand the requirements for Regulatory Approvals (e.g. CE / UKCA / FDA / other). Ensure requirements for clinical investigation standards are met.
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
Optimise the full prototype (if applicable) for human use and refine production methods for preclinical testing. This may require industry partner engagement (including services providers, suppliers, manufacturers and distributors).
No dependencies
P&D2: Testing protocols
Develop testing protocols for the full prototype in pre-clinical models and understanding of protocols for the final product required for clinical investigations
No dependencies
P&D3: Safety, compliance, interoperability and usability
Test prototype components to determine material safety, electric safety and bio-compatibility
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 UK, EU, US or worldwide and the relevant regulatory pathways required for each market to feed into HEST4
No dependencies
BM3: Market share (realistic assumptions)
Finalise market share assumptions to feed into HEST4
No dependencies
BM4: Product vs service
Initialise plans for delivering the device to market - will it be a product or service
No dependencies
BM5: Spinout vs licence
Initialise a commercial strategy for delivering the device to market (set up spin out or license out innovation or develop as not-for-profit (e.g. via community interest company) as academic exit strategy)
No dependencies
BM6: Business plan / canvas
Initialise business model based on decisions from BM4 and BM5
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
Evaluate prototype in the competitive landscape based on pre-clinical studies (i.e. how does the prototype compare to gold standard. 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
- R&D6: Technical feasibility (pilot demonstration, materials biocompatibility/formulation)
- P&D1: Manufacturing/software-engineering
- P&D2: Testing protocols
Potential funding sources
UKRI, Wellcome Trust, Royal Academy of Engineering, Horizon Europe, condition specific charities, Rosetrees Trust, LifeArc, NIHR, Innovate UK, internal translational funding calls, companies
Deliverables
-
Safety testing certification for component parts
-
Functional prototype developed with indicative evidence of performance in a lab setting
-
Pre-clinical lab based and in-vivo (if required) testing done
-
QMS system in place and auditable records available for device component manufacture and device testing
-
Revised value proposition and target product profile
-
Finalised intended use statement
-
Initial regulatory risk assessment
-
Initial technical file
-
Potential service providers, suppliers and manufacturers 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 for use in pilot clinical investigations. This may be an iterative process that requires testing of multiple different prototypes before committing to the final design.
Obtain relevant certifications and ethical clearances for prototype device testing in clinical investigations. Perform feasibility / phase I clinical investigations (i.e. feasibility and safety testing in a (healthy) population).
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&D6: Technical feasibility (pilot demonstration, materials biocompatibility/formulation)
Refine the final prototype for use in a small scale, first in man, feasibility study on small patient groups for usability, safety testing and considerations of efficacy
No dependencies
R&D7: Adapting/extending to achieve health and care feasibility and efficacy
Adapt prototype based on clinical data from first in man study and key stakeholder feedback to ensure health and care feasibility (design input) i.e. after the HCE activities in this stage
- HCE2: Health and care feasibility
- HCE3: Health and care evaluation of safety and efficacy
R&D8: Adapting/extending to achieve health and care effectiveness
Adapt prototype based on clinical efficacy data and key stakeholder feedback to ensure health and care efficacy (design input) i.e. after the HCE activities in this stage
- 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 (detailing all processes required to create the device) to include with technical file and freezing the design of the refined product
- 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 service transformation model which will be required for final business case (i.e. how will current practice need to be changed / be changed by for your device to be used)
No dependencies
HEST5: Value proposition (e.g. expected benefit, cost savings, improving efficiency, improving patient satisfaction) / Target Product Profile
Update Value proposition based on HEST4/6 – what is the expected benefit of the device in terms of costs, patient care. This will be needed for funding applications and the technical file.
No dependencies
HEST6: Health economic analysis to address the value proposition claims (cost-benefit analysis)
Refine the 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.
R1: Research governance / Ethics
Gain ethical and research governance clearance for clinical studies
No dependencies
R3: Quality management system (ISO 13485 certification)
Obtain ISO13485 (QMS certification) certification or ensure using and working to ISO certified QMS system. Obtain any other ISO certifications. This may involve engagement with industry partners (e.g. manufacturers and test houses) to obtain ISO certification. Relevant ISO standard include (but are not limited to) ISO 10993 (biocompatibility testing), ISO 14155 (GCP – good clinical practice), IEC 60601 (electrical medical equipment) and ISO 14971 (risk management),ISO 20417 (information to be supplied by manufacturer), and ISO 20416 (post market surveillance.) ISO certifications will also need to be worked to for the type of sterilisation procedure your device will undergo
No dependencies
R4: Clinical investigation approval
Refine technical file based on pre-clinical data (e.g. design decisions, regulatory risk assessments (evidence working at ISO 14971 standards), test methods). For any clinical investigations that may affect the outcome of a patient, submit the technical file for MHRA approval for clinical investigations of final product (as you require exemption for use of a non-CE/UKCA marked device in humans to undertake the clinical investigation in HCE2/3) including CEP
- R&D6: Technical feasibility (pilot demonstration, materials biocompatibility/formulation)
R5: CE / UKCA marking
Initialise documentation for CE / UKCA marking application and start to collect clinical evidence on efficacy and safety for CE / UKCA marking and if affecting clinical outcomes. Run the study to accepted good clinical practice (GCP) 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
Work with industry partners (including service providers, suppliers, manufacturers and distributors - also considering start-up formation) to produce the final quality assured product
- 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
Work with industry partners (including service providers, suppliers, manufacturers and distributors - also considering start-up formation) to undertake quality assurance of final product
No dependencies
P&D3: Safety, compliance, interoperability and usability
Determine the safety, compliance, interoperability and usability of device of scaled up prototype from the in man studies in HCE3
No dependencies
P&D4: Quality control
Conduct Quality control of scaled up device to ensure meeting quality control specifications
- P&D5: Scale-up
P&D5: Scale-up
Scale up production to good manufacturing practice (GMP) standards for use of device in pilot clinical investigations
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
Refine plans for delivering the device to market -will it be a product or service
No dependencies
BM5: Spinout vs licence
Refine plans for delivering the device to market - set up spin out or licence out innovation. Define the academic exit strategy
No dependencies
BM6: Business plan / canvas
Refine business model based on decisions from BM4 and BM5
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.
HCE2: Health and care feasibility
Perform Feasibility and safety in early-stage clinical investigation (phase 1 – on healthy patients) / first-in-man studies / clinical investigation
- R4: Clinical investigation approval
HCE3: Health and care evaluation of safety and efficacy
Undertake Pilot in man study to determine validation of device efficacy done as part of feasibility and safety testing in HCE2
- R4: Clinical investigation approval
Potential funding sources
UKRI, Wellcome Trust, Royal Academy of Engineering, Horizon Europe, condition specific charities, Rosetrees Trust, LifeArc, NIHR, Accelerated Access Collaborative (AAC; incl SBRI Healthcare), Innovate UK, internal translational funding calls, companies, venture capitalists
Deliverables
-
Final product (frozen development/design)
-
Revised value proposition and target product profile
-
Conceptual health economic model with preliminary data
-
Gain ethical clearance for clinical studies
-
ISO certification
-
Submission of technical file and obtain MHRA approval for clinical investigation
-
Refine GMP manufacturing and release of batch for clinical testing
-
Feasibility confirmed in small scale clinical investigation
-
Revised strategy for delivering the innovation to market (including academic exit strategy)
-
Revised outline business model
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]
Feasibility and safety testing of prototype device in patient population (i.e. pivotal study) to 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 preparation for service transformation model which will be required for final business case (i.e. how will current practice need to be changed / be changed by for your device to be used)
No dependencies
HEST5: Value proposition (e.g. expected benefit, cost savings, improving efficiency, improving patient satisfaction) / Target Product Profile
Update value proposition – what is the expected benefit of the device in terms of costs, patient care. This will be needed for funding applications and the technical file.
No dependencies
HEST6: Health economic analysis to address the value proposition claims (cost-benefit analysis)
Re-engage with health economist for full cost benefit analysis after clinical investigations in HCE3/4
- HCE3: Health and care evaluation of safety and efficacy
- 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.
R1: Research governance / Ethics
Gain any additional ethical and research governance clearance for clinical studies required for larger clinical investigations
No dependencies
R4: Clinical investigation approval
Seek approval for subsequent larger clinical investigations and include refined technical file based on clinical data and any design changes (e.g. design decisions, regulatory risk assessments, test methods). For any clinical investigations that may affect the outcome of a patient, submit the updated technical file for approval with the relevant regulatory Authority (e.g. MHRA in the UK) for clinical investigations of final product (as you require exemption for use of a non-CE/UKCA marked device in humans to undertake the clinical investigations).
No dependencies
R5: CE / UKCA marking
Refine Regulatory Compliance (e.g. CE/UKCA/FDA/Other marking) technical documentation (which includes risk assessment) based on early phase clinical data
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&D3: Safety, compliance, interoperability and usability
Determine the safety, compliance, interoperability and usability of device of scaled up prototype from the in man studies in HCE3
- P&D5: Scale-up
P&D4: Quality control
Confirm specifications for larger scale manufacture ahead of larger clinical investigations
- P&D5: Scale-up
P&D5: Scale-up
Scale up production for use of device in larger scale clinical investigations
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
Refine plans for delivering the device to market -will it be a product or service
No dependencies
BM5: Spinout vs licence
Refine plans for delivering the device to market - set up spin out or licence out innovation. Define the academic exit strategy
No dependencies
BM6: Business plan / canvas
Refine business model based on decisions from BM4 and BM5 to apply for funding
No dependencies
BM7: Investment required and RoI
Assess commercial viability to confirm manufacturing, distribution and marketing of the device is financially sustainable (including return on investment study)
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.
HCE3: Health and care evaluation of safety and efficacy
Perform larger scale clinical investigation (phase 2) in relevant patient
- R4: Clinical investigation approval
HCE4: Health and care validation of safety and efficacy, effectiveness
Undertake larger scale clinical investigation (phase3/ pivotal) in relevant patient group to confirm patient effectiveness
- R4: Clinical investigation approval
HCE5: Real world evidence post-launch
Initialise plans for post-market evaluation to include in technical plan
No dependencies
Potential funding sources
UKRI, Wellcome Trust, Royal Academy of Engineering, Horizon Europe, condition specific charities, LifeArc, NIHR, Accelerated Access Collaborative (AAC; incl. SBRI Healthcare), Innovate UK, internal translational funding calls, companies, venture capitalists
Deliverables
-
Device fully tested and validated in patients
-
Revised value proposition and target product profile based on collected evidence
-
Early health economic model
-
Revised technical file (including revised regulatory risk assessment)
-
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]
Service transformation modelling and health economics modelling to prove benefit of device and development of business plan to attract funding for adoption into market.
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 Service transformation model
No dependencies
HEST5: Value proposition (e.g. expected benefit, cost savings, improving efficiency, improving patient satisfaction) / Target Product Profile
Finalise Value proposition – what is the expected benefit of the device in terms of costs, patient care. This will be needed for funding applications and the technical file. Include information from HEST4/6.
- 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 health economics modelling
No dependencies
HEST7: End-user business model / Procurement case
Refine end user business model
No dependencies
HEST8: NICE Health Technology Evaluation
Submit to NICE if required
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 Regulatory Assessment (e.g. CE/UKCA/FDA/Other) based clinical data and submit technical file to notified body (determined by MHRA) in order to obtain conformity mark (CE marking / UKCA) 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
Determine how to increase manufacturing output to meet demand following quality assurance processes to ensure compliance with product specifications and safety p for productisation and distribution. If changes to the manufacturing process are required then new regulatory approvals maybe required.
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
Refine and finalise plans for delivering the device to market - will it be a product or service
No dependencies
BM5: Spinout vs licence
Refine and finalise plans for delivering the device to market - set up spin out or licence out innovation. Determine the academic exit strategy.
No dependencies
BM6: Business plan / canvas
Refine and finalise business model based on decisions from BM4 and BM5
No dependencies
BM7: Investment required and RoI
Implement business plan (i.e. approach funders)
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
Prepare a clinical evaluation report (CER) summarising the clinical outcomes of the clinical investigations for inclusion in technical file to notified body
No dependencies
HCE5: Real world evidence post-launch
Refine and Finalise plans for post-market evaluation to include in technical plan
No dependencies
Potential funding sources
UKRI, Wellcome Trust, Royal Academy of Engineering, Horizon Europe, condition specific charities, LifeArc, NIHR, Accelerated Access Collaborative (AAC; incl. SBRI Healthcare), Innovate UK, internal translational funding calls, companies, venture capitalists
Deliverables
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Finalised value proposition and target product profile
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Full health economic analysis
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Finalised technical file including Revised regulatory risk assessment
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Regulatory Approval (e.g. CE/UKCA/FDA/Other)
-
Full business model
-
Product ready for deployment
-
Sales and marketing plan
-
Post-market surveillance and clinical follow up 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]
Commercialisation and marketing of innovation. Collecting real world evidence which may inform product improvement and 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
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
Ensure CE/UKCA approval and device registered with MHRA or appropriate approval body
No dependencies
R6: Post-market surveillance (PMS) and post-market clinical follow up (PMCF)
Collate post-market clinical evidence; update clinical evaluation report annually and maintain quality management system
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&D5: Scale-up
Increase manufacturing output to meet demand and if this requires a change in manufacturing processes then gain new regulatory approval.
- P&D6: Production and distribution
P&D6: Production and distribution
Productisation and distribution (i.e. launch the product)
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.
BM7: Investment required and RoI
Approach funders, investment capitalists for funds to upscale manufacturing process
No dependencies
BM8: Marketing and promotion
Refine sales and marketing strategy
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
Post-market surveillance and clinical follow-up of the product to collect data on long-term effectiveness, potential adverse effects, and usage of the device
No dependencies
Potential funding sources
NIHR, Accelerated Access Collaborative (AAC; incl. SBRI Healthcare), Innovate UK, companies, venture capitalists.
Deliverables
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End-user business model / procurement case
-
Initial release version of the product has been manufactured and deployed
-
Updated clinical evaluation report with post-market surveillance data