R&D1:

Develop generic methods and technology

BM1:

Understand IP management and contract-related research disclosure agreements

R&D1:

Develop applied methods and technology based on available health & care data, following good laboratory practice (GLP) principles with accurate and detailed record keeping

R&D2:

Perform scientific literature review on applied methods and technology development based on available health & care data

HEST1:

Identify potential areas of health & care application

R1:

Understand Ethical/HRA approvals & research governance requirements (including contracts and sponsorship) for obtaining existing healthcare data

BM1:

Consider IP protection (e.g. patenting); record funding and contracts for IP ownership

R&D2:

Record device requirements, prior knowledge and evidence of a valid clinical association to inform device specification

R&D3:

Create software specification and design for development of prototype (consider whether coding language is suitable for end use)

R&D4:

Understand and consider human factors that influence the development of the solution

R&D5:

Understand and consider aspects of responsible innovation that influence the development of the solution (including health equity assessment and strategies for bias mitigation)

HEST1:

Understand current and foreseeable specific health & care need

HEST2:

Understand current and foreseeable clinical guidance relevant to the health & care need being addressed

HEST3:

Understand current and foreseeable clinical workflows relevant to the health & care need being addressed

HEST4:

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

HEST5:

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

HEST6:

Conduct health economics “desk research” (literature review) and conceptualise a preliminary health economic model to inform concept development; consider current and upcoming competing solutions

R1:

Arrange Ethical/HRA approvals for suitable healthcare development data (including sponsorship)

R2:

Formalise intended use (based on HEST2/3); understand both Software as Medical Device (SaMD) regulations and risk classification to inform concept development

R3:

Understand requirements around quality management systems (e.g. version control) and the recording of design decisions, data and activities

BM1:

Consider additional IP protection based on developed concept and freedom to operate; record funding and contracts for IP ownership

BM2:

Identify the market (i.e. who is going to buy it); understand market size to determine if there is a viable market

BM3:

Understand of market share including analysis of competitors

HCE1:

Collect patient and end user feedback of concept

R&D3:

Collate representative healthcare data; develop an initial prototype (according to good machine learning practice (GMLP) for medical device development if applicable)

R&D4:

Address human factors when developing the prototype

R&D5:

Address aspects of responsible innovation when developing the prototype

R&D6:

Test the prototype in the lab to evidence technical feasibility; compare prototype performance to existing solutions

HEST4:

Refine how the product will be embedded into the clinical service

HEST5:

Refine the value proposition and target product profile

HEST6:

Refine the conceptualised health economic model and identify data to collect

R2:

Define the intended use of the SaMD and its target population; identify the correct SaMD according categorisation of the solution and understanding implications

R3:

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)

R4:

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)

R5:

Understand the requirements for regulatory assessment (e.g. UKCA, CE, FDA), for example, with regards to software development standards and clinical investigation standards

P&D1:

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

BM2:

Finalise market size analysis to determine if there is a viable market

BM3:

Finalise market share opportunity (including analysis of competitors)

BM4:

Develop a commercial strategy for delivering the device to market (will it be a product or service?)

BM5:

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

BM6:

Draft an outline business model (consider creating a business canvas)

HCE1:

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&D4:

Refine the prototype addressing human factors and usability

R&D5:

Refine the prototype addressing aspects of responsible innovation when developing the prototype (including health equity requirements and cyber security requirements)

R&D6:

Refine the prototype addressing findings of lab pilot studies

R&D7:

Refine the prototype based on health & care feasibility data and key stakeholder feedback (e.g. patients, end user)

R&D8:

Refine the prototype based on health & care efficacy data and key stakeholder feedback (e.g. patients, end user)

R&D9:

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

HEST4:

Refine how the product will be embedded into the clinical workflow / health and care pathway

HEST5:

Refine the value proposition and target product profile

HEST6:

Refine the conceptualised health economic model and health economics data collection

R1:

Arrange Ethical approvals for pilot studies in health & care setting

R3:

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

R4:

Refine the technical file (e.g. design decisions, regulatory risk assessments, test methods) for clinical investigation approval

R5:

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)

P&D1:

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)

P&D2:

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

P&D3:

Assess Safety, compliance, interoperability, cyber security (ISO/IEC 27001) and usability of the product; review Digital Technology Assessment Criteria (DTAC) requirements

P&D4:

Conduct quality control of refined product to assess whether it meets the specifications and requirements

BM4:

Review commercial strategy for delivering the device to market (considering refinements of the product/service)

BM5:

Review commercial strategy for delivering the device to market (considering refinements of the product/service) as well as the academic exit strategy

BM6:

Refine the business model

HCE1:

Perform health & care risk assessment

HCE2:

Conduct investigation of the product to generate evidence of health & care feasibility

HCE3:

Conduct investigation of the product to generate evidence of health & care efficacy and safety (based on risk classification)

HEST4:

Refine how the product will be embedded into the health & care pathway by integrating collected evidence

HEST5:

Refine the value proposition and target product profile by integrating collected evidence

HEST6:

Develop the health economic model/case based on the preliminary modelling and collected evidence

R4:

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)

R5:

Prepare application for regulatory assessment (e.g. UKCA, CE, FDA)

BM4:

Review commercial strategy for delivering the device to market (considering refinements of the product/service)

BM5:

Review commercial strategy for delivering the device to market (considering refinements of the product/service) as well as the academic exit strategy

BM6:

Refine the business model

BM7:

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

HCE4:

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

HCE5:

Initialise plans for post-market surveillance and clinical follow-up

HEST4:

Finalise how the product will be embedded into the health & care pathway by integrating collected evidence

HEST5:

Finalise the value proposition and target product profile

HEST6:

Finalise full health economic analysis

HEST7:

Refine end-user business model / procurement case for the product (including needs assessment, cost-benefit analysis, implementation and adoption strategies)

HEST8:

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

R5:

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)

P&D5:

Plan scale-up of production (including support and maintenance)

P&D6:

Get Digital Technology Assessment Criteria (DTAC) accreditation (if appropriate)

BM6:

Finalise the full business model

BM7:

Confirm commercial viability of the product; seek company or venture capitalist funding

BM8:

Refine a sales and marketing strategy based on business model

HCE5:

Refine and finalise plan for post-market surveillance and clinical follow-up

HEST7:

Monitor end-user business model / procurement case for the product; ongoing health economic analysis

HEST8:

Obtain NICE Health Technology Evaluation recommendation (if appropriate)

R6:

Collate post-market clinical evidence on safety and performance; update clinical evaluation report regularly and maintain quality management system

P&D5:

Implement scale-up to meet market demand

P&D6:

Launch and distribute product (including strategies for communication and training processes to increase acceptability by end users)

BM8:

Implement the sales and marketing strategy (including customer outreach activities and advertising)

HCE5:

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