Stage 4

Testing & Launch

By now technological development has largely ended and the new product is completed. It has been demonstrated to work in a trial environment.

Below is some information about possible funding and useful checklists things to propel you into the next stage.

Progress checklist

1 The product has been tested at a larger scale, preferably in the field, i.e. in a ‘real world context’ rather than in laboratory or artificial conditions.
2 I understand can describe implementation pathways for the product (who will be responsible for purchasing and implementing it) and the business model. I am finalising a plan for launch onto the market.
3 At this stage evidence can take several forms, with varying degrees of robustness. Minimally it is important to be able to describe the impact of the innovation in as much detail as possible.

At this stage evidence can take several forms, with varying degrees of robustness. Minimally it is important to be able to describe the impact of the innovation in as much detail as possible.

4 Various approaches to gathering evidence are possible; all carry a cost. The balance between time and effort spent on gathering evidence and launching and marketing will depend very much on the nature of the product and its customers. Risks associated with adoption (patient safety and financial risks for the adopting organisation), the number and range of stakeholders it impacts, and regulatory requirements will all influence the type of evidence needed.
5 Consider the conventional ‘hierarchy of evidence’ in medical research. In general, the greater the risk and higher the costs for purchasers, the more robust the evidence that is needed.

The hierarchy of evidence

1. High quality meta-analyses, systematic reviews of randomised control trials (RCTs), including cluster RCTs or RCTs with a low risk of bias

2. Well conducted meta-analyses, systematic reviews of RCTs, or RCTs with a low risk of bias

3. High quality systematic reviews of, or individual high quality non-randomised intervention studies (controlled non-randomised trial, controlled before-and-after, interrupted time series), comparative cohort and correlation studies with a very low risk of confounding, bias or chance

4. Well conducted, non-randomised intervention studies (controlled non-randomised trial, controlled before-and-after, interrupted time series), comparative cohort and correlation studies with a low risk of confounding, bias or chance

5. Non-analytical studies (e.g. case reports, case series) published in peer reviewed journals

6. Expert opinion, formal consensus

Potential sources of support and funding

These sources of support and funding are most relevant to your innovation from the answers given.

Wellcome Trust

The Wellcome Trust a an independent global charitable foundation dedicated to improving health. Iyts funding ranges from basic scientific research, including social science, to supporting proof-of-concept research and development for new healthcare products. Its innovation funding stream aims to help bridge the gap between fundamental research and commercial application by funding applied research and development projects to a stage where they are attractive to a follow-on funder, such as venture capital firms, industry and public-private partnerships. There are a number of funding schemes, including Health Innovation Challenge Fund and Pathfinder Pilots.

wellcome.ac.uk/index.htm
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South East Health Technologies Alliance (SEHTA)

"SEHTA is one of the largest healthcare technology networking organisations in the UK with 1,300 members. It offers three services: Consultancy Plus, Care Review and Cluster Development & EU Networks. SEHTA covers a range of health technology fields, including assisted living, diagnostics, and medtech and smartcare and digital companies, and assists with all stages of product / service development, from ideation to long-term business planning, from customer needs analysis to useablity trialling, and from competitor and political landscaping to partner and supply chain selection."

sehta.co.uk
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Knowledge Transfer Network Ltd

Knowledge Transfer Network Ltd (KTN Ltd) is funded by Innovate UK and is an interdisciplinary UK-wide network of knowledge intensive businesses and academics designed to stimulate innovation by promoting collaboration, best practice and knowledge sharing.There are 15 individual Knowledge Transfer Networks, including a Health Tech & Medicines KTN. KTN Ltd organises sector specific missions to different countries to help connect researchers and innovators in the UK with overseas opportunities. It can help UK organisations access overseas funding schemes and it works closely with Innovate UK on major international funding programmes,such as Horizon 2020.

Open the Knowledge Transfer Network
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NESTA

Nesta is an independent charity with a mission to help bring good ideas to life, Nesta is a leading innovation think tank, an investor in innovative ventures and an innovation lab testing out new approaches to supporting innovation. It has produced a useful innovation policy toolkit which describes the UK innovation ecosystem, available here: http://www.nesta.org.uk/innovation-policy-toolkit

Go to NESTA
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Intellectual Property Office

The Intellectual Property Office helps businesses understand how to manage IP. This includes IP online tools.

Go to IPO
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Digital Health London

DigitalHealth London is a collaboration between MedCity and London’s three Academic Health Science Networks (AHSNs): Imperial College Health Partners, UCL Partners and the Health Innovation Network. It is supported by the Mayor of London and the Academic Health Science Centres (AHSCs). It aims to help London pioneer the development, commercialisation and adoption of digital health innovation to improve health outcomes. It helps to create and support networks to bring together London’s existing critical mass of digital health expertise, identify digital solutions to meet the needs of patients and clinicians, and build an evidence base of the health outcomes and economic benefits of digital health. DigitalHealth London also helps businesses by tackling issues such as procurement and commissioning.

Digital Health London
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The Medical Research Council (MRC)

The Medical Research Council (MRC) is a publicly funded government agency responsible for coordinating and funding medical research in the United Kingdom. The MRC focuses on high-impact research and has provided the financial support and scientific expertise behind a number of medical breakthroughs, including the development of penicillin and the discovery of the structure of DNA. The MRC's Biomedical Catalyst: Developmental Pathway Funding Scheme (DPFS) funds the pre-clinical development and early clinical testing of novel therapeutics, devices and diagnostics, including “repurposing” of existing therapies. DPFS is an ongoing scheme, with outline deadlines every 4 months. The next deadline is 4pm on 29 March 2017.

mrc.ac.uk/funding
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Devices for Dignity Health Technology Cooperative (D4D)

Devices for Dignity (D4D) Healthcare Technology Co-operative is funded by the National Institute for Health Research (NIHR) to drive forward innovative new products, processes and services to help people living with long term conditions. It aims to make a difference to the well-being of patients, the effectiveness of the NHS, and the wealth of the nation. Working with inventors, clinical and healthcare staff, industry, academics, charities, the public and patients, it addresses areas of unmet clinical and patient need in renal technologies, assistive and rehabilitative technologies, urinary continence management, and paediatric technologies.

devicesfordignity.org.uk
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Association of British Healthcare Industries (ABHI)

ABHI is the industry association for the medical technology sector in the UK. Its mission is to champion the benefits and use of safe and effective medical technologies to deliver high quality patient outcomes. ABHI engages with the NHS, government, regulators and other key stakeholders in the UK and abroad, in order to represent the industry. Its work focuses on UK market, economic growth, regulatory and ethics and compliance issues.

abhi.org.uk
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Association of the British Pharmaceutical Industry (ABPI)

The ABPI represents large, medium and small research-based biopharmaceutical companies in the UK. It is recognised by government as the industry body negotiating on behalf of the branded pharmaceutical industry for statutory consultation requirements including the pricing scheme for medicines in the UK.

abpi.org.uk
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British Healthcare Trade Association (BHTA)

The BHTA represents almost 500 companies making or selling healthcare and assistive technology products that help people live more independently.

bhta.net
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MedilinkUK

MedilinkUK is a national health technology business suppport service. It helps companies from concept to commercialisation and nurtures collaborations between academics, clinicians and industry. Medilink UK can provide bespoke market research for companies diversifying into the sector, or investing in research and development. Internationally platform, Medilink UK supports companies investing in the UK market as well as promoting the export of products and services to the US, Middle East and Asia.

medilinkuk.com
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British In Vitro Diagnostics Association (BIVDA)

BIVDA is the UK industry association for companies involved in the in vitro diagnostics industry. It represents both manufacturers and distributors. As well as providing a range of support services for its members, BIVDA aims to raisies awareness of the clinical and cost utility of diagnostics in the provision of effective healthcare.

bivda.co.uk
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Catapult

Catapults' have been set up by Innovate UK to drive future UK industry sectors by tackling the translational gap and bridge research and commercialisation, catalyse industry development, and focus on start-ups, incubators, and scaling-up SMEs. Amongst other fields, a 'Precision Medicine Catapult' has been established. Precision medicine combines accurate diagnosis with rules-based therapies and effective service delivery. The PMC is tackling the bottlenecks to product delivery, working with the precision medicine community and seeking to build a thriving industry.

Catapult
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Health Technology Assessment (HTA) programme

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Efficacy and Mechanism Evaluation (EME) programme

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MedCity

MedCity supports entrepreneurs, SMEs, major industry and investors involved in the life sciences and med tech sectors working in London and the South East by: • Providing a single front door and concierge service for industry and investors looking for partners, infrastructure and expertise • Facilitating and supporting collaboration across all parts of the sector to turn innovations into commercial products and services • Fostering an environment that supports and encourages entrepreneurialism • Raising awareness globally of the region’s rich life sciences ecosystem It provides useful advice on accessing the market here: http://www.medcityhq.com/access-the-market/

MedCity
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National Institute for Health and Care Excellence (NICE)

The role of NICE is to improve outcomes for people using the NHS and other public health and social care services. NICE evaluates new technologies using health technology assessment (HTA) techniques, producing evidence-based guidance for purchasers in the NHS. NICE Scientific Advice provides advice to technology developers on the generation of relevant evidence for an HTA or discussions with commissioners/payers. NICE Scientific Advice also provides 'light advice' exclusively for small and medium enterprises developing pharmaceuticals, medical devices or diagnostics to help them understand the process of a NICE evaluation and ensure trial designs produce evidence relevant to a future evaluation.

nice.org.uk
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Imperial Innovations

Imperial Innovations is a technology commercialisation company, combining the activities of technology transfer, intellectual property licensing and protection, company incubation and investment. It is focused on the commercialisation of the most promising opportunities from a broad range of technology sectors, with particular expertise in therapeutics, medtech, engineering & materials and ICT. Imperial Innovations has a technology pipeline agreement with Imperial College London until 2020, under the terms of which it has exclusive commercialisation rights and continues to act as the College’s technology transfer office. It also acts as the technology transfer office for selected NHS Trusts linked to Imperial College London, including Imperial College Healthcare NHS Trust and London North West Healthcare NHS Trust. It runs an incubator in London that is the initial home for many of its technology spin-outs. Following a fundraising in January 2011, Imperial Innovations broadened its market beyond Imperial College by making investments in opportunities arising from intellectual property developed at, or associated with, the University of Cambridge, the University of Oxford and University College London.

imperial Innovations
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Wellcome Trust Translation Fund

The aim of Translation Awards is to develop innovative and ground breaking new technologies in the biomedical area. Projects must have already demonstrated proof of principle, supported by experimental data. Applications should bridge the funding gap in commercialisation of new technologies in the biomedical area and must plan to take the product, technology or intervention to a stage at which it is sufficiently developed to be attractive to another party. To encourage more applications in underserved and challenging areas, the fund will have strategic highlight areas. However, projects covering any aspect of technology development from a range of disciplines - including physical, computational and life sciences - will be considered at any time. Projects must address an unmet need in healthcare or in applied medical research, offer a potential new solution, and have a realistic expectation that the innovation will be developed further by the market.

Wellcome Trust Translation Fund
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Academic Health Science Networks

Academic Health Science Networks (AHSNs) aim to improve patient and population health outcomes by translating research into practice, and developing and implementing integrated healthcare services. They will support knowledge exchange networks to build alliances across internal and external networks and actively share best practice, and provide for rapid evaluation and early adoption of new innovations. A core objectives is to speed up adoption into practice by supporting the identification and faster spread of research and innovation at pace and scale. They are also concerned with wealth creation through co-development, testing, evaluation and early adoption and spread of new products and services

england.nhs.uk/ourwork/part-rel/ahsn/
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Department of Health Rapid Review Panel

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NHS Innovation Challenge Prizes

The NHS Innovation Challenge Prizes exist to encourage, recognise and reward these frontline ideas, and support innovators in getting them embedded across the NHS. The programme includes tailored training and mentoring for innovators than cash funding.

NHS Innovation Challenge Prizes
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Identify your strengths and weaknesses

Complete these useful quick checks on innovation risk and potential for adoption

Evidence needs and ease of adoption

Try to position yourself in the graphic below by asking yourself: What will organisations gain and what they will lose by buying your innovation.

Opportunistic sells A ‘smash hit’ Sure failures! Long hauls Edit your position

Assessment of project delivery risks

These questions will help you think about the likelihood of successfully bringing your project to the market. Please look at these categories and consider where your project sits on the sliding scale from 1 to 5 (1 = low)

Edit your innovation risk

Your level progress

It is important to identify where your innovation sits in relation to the typical stages of development. Sometimes these are called ‘technology readiness levels’ (TRL). These stages are a systematic way of identifying the maturity of a particular technology. There are variations, but broadly innovation stages are divided into the categories shown.

The "innovation stages" section goes into more detail about each stage

View the innovation stages
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Stage 0 Preliminary research
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Stage 1 Basic technology research
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Stage 2 Feasibility & development
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Stage 3 Demonstration
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Stage 4 Testing & Launch
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Stage 5 Adoption & Spread
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