Health Tech Enterprise

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Our expert team delivers training and entrepreneurship services that provide insights into the latest sector trends. We provide knowledge transfer to those developing new healthcare technologies and services, helping our clients understand the key steps and requirements for market access to aid strategic decision making.

Our bespoke, interactive training courses are available via webinars or in-person sessions and can include one to one mentoring support post-event. We cover a range of topics and offer workshops and events to develop entrepreneurial skills tailored to your needs.

We serve industry, academia, charities, not-for-profits, and healthcare institutions in the UK and internationally. Our specialist training modules can often be integrated into existing professional education, innovation or entrepreneurship programmes.

Our standard courses cover the full range of our expertise including:

1. Developing your MedTech IP & Commercialisation Strategies
2. Funding and Investment
3. Regulating Medical Devices
4. Human Factors and Useability Engineering
5. Essentials in Health Economics
6. Selling to the NHS

We can also deliver bespoke events tailored to your needs such as:

• Workshops & networking events for innovators to develop their skills and share learning
• Mentoring and coaching support for entrepreneurs
• Innovation Sprint events to develop solutions to known unmet clinical needs

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When piloting or implementing an innovative technology, important evidence and learning can be obtained that will help assess the potential value of that innovative technology to the NHS or other healthcare systems and can assist with facilitating adoption, securing further investment and scaling. We have extensive experience evaluating the implementation of new technologies into healthcare settings.

Evidence and Learning

The HealthTech EVALUATION methodology provides an independent analysis of the benefits of a new innovation within a real world setting and aims to facilitate adoption, secure further investment, scale and secure new customers.

We do this by helping you to identify the steps needed to set up and carry out an evaluation in order to gain evidence of the benefits your technology provides. We then work with you to evaluate the actual and perceived clinical, operational and economic benefits of your new product.

METHODICAL AND EVIDENCE-BASED APPROACH

For the evaluation to provide relevant and credible evidence, we use a staged approach. We work with you and your deployment site or commissioner to deliver the following:

• Defining potential benefits
• Agreeing metrics
• Collecting data
• Analyse results of implementation and impact

Using a “Logic Model” approach, we map out the anticipated potential benefits of the solution. This may include a review of the evidence to date, and that of competitor solutions. Consultation with key stakeholders will identify desired impact and expectations.

We investigate the metrics to be collected to assess the effectiveness of the implementation process and actual use of the technology. We agree systems and methods to capture the desired metrics and existing data before implementation is compared with that collected during and after implementation.

We review outcomes and analyse the perceived and actual, clinical and non-clinical, benefits. Where possible we capture quantitative data from existing clinical and operational systems. This can be complemented by time-and-motion studies, and qualitative feedback from clinicians.

From the evaluation we collect and review data that helps to highlight any lessons learned from the implementation process and can provide invaluable feedback as to the best way of implementing the new technology in further settings.

The HealthTech EVALUATION methodology provides you with an independent analysis of the product’s effectiveness in a real world setting.

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Successful Fund Raising

Is your business or research project investment-ready?

Securing funding to progress your business or research idea is one of the key cornerstones of any business plan. Whether it is grant funding or equity-based investment from angels and venture capitalists, Health Tech Enterprise has a highly successful track record in raising funding and investment within the Health Tech sector.

Advice for Start-ups, SMEs and Researchers

We provide a range of services to start-ups, SMEs and researchers seeking funding and investment opportunities to develop new medical technology related innovations. Our unique positioning within the Health Tech landscape helps us to leverage clinical, academic and investor networks to your benefit. These services include:

• Horizon scanning to find appropriate funding and investment opportunities bespoke to your needs
• A review and feedback service for draft grant funding applications
• Consortium building including finding appropriate clinical partners and technical/commercial advisors
• Business and project planning
• Refining investor pitch decks & developing your value proposition

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We have extensive experience helping clients understand the roadmap to regulatory approval in different markets. It is an essential part of any business plan for a new medical technology. Developing the right regulatory strategy enables you to get your products to market quickly by achieving compliance with UK, EU, US and other international standards.

Regulatory Roadmaps & Strategy Reports

We provide relevant, up to date and bespoke guidance and roadmaps on the latest regulatory requirements for medical devices, IVDs and digital health products. Our services include:

• Determining medical device classification and providing roadmaps on the process and guidance to gain regulatory approval. Roadmaps include both an overview of the medical device/IVD regulations which apply in different markets (Great Britain, Northern Ireland and the European Union, the USA) and summaries of the roles and responsibilities of Competent Authorities, Notified Bodies/UK Approved Bodies and other Economic Operators, including Manufacturers, Authorised Representatives (EU) and/or UK Responsible Person, as well as Importers and Distributors.
• Comprehensive strategy reports which give bespoke advice on medical device classification as well as the process and documentation required to achieve regulatory approval in the UK, EU & USA.
• Guidance on data protection and data security regulations, as well as clinical risk management and clinical safety standards for digital health products in the UK.

In partnership with our Medical Regulatory Associates, we are also able to provide:

• Dedicated regulatory services to achieve for compliance with UK and EU MDR/IVDR, FDA and global regulatory requirements.
• Development of Quality Management Systems to meet European, US and International standards (ISO 9001 / ISO 13485 / FDA Quality System Regulation).

Human Factors

The application of Human Factors, or Usability Engineering processes, into the development of medical devices, leads to safer and more intuitive products, as well as facilitating the regulatory approvals process, so accelerating the adoption and spread of innovative medical technologies. HTE is able to guide you through this process and conduct the required testing and assessments

HTE can help with the iterative process where design concepts, prototypes, and final products are assessed and reviewed by the intended users, which can include clinical or operational staff, as well as patients and carers.

Health Tech Enterprise is an independent provider of Human Factors services, conducted under IEC 62366-1:2015/AMD 1:2020. Typical services include:

• Working with Health Tech companies to help plan and implement usability studies, identifying device user profiles, use environments, possible use errors, as well as identifying and assessing realistic use scenarios and clinical tasks.
• Designing and Conducting Formative Evaluations. Formative Evaluations reduce risks in the design and development phase, as well as provide an opportunity to review preferred design concepts, layouts and formats. These studies, conducted with the intended users (clinicians and/or patients), examine use errors in identified tasks, review risks and safety implications, as well as assess the innovation’s overall ease of use.
• Designing and Conducting Summative Testing. Usability testing of final products and product documentation (e.g. user manuals & IFUs) which is required when compiling technical files for final regulatory approval prior to product launch.

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Carbon Impact Assessments

Understanding that climate change affects social and environmental determinants of health, the NHS aims to become the world’s first net-zero national health service, and pledges to achieve a net zero of the carbon emissions they can influence, by 2045.

To support future development and new technology adoption, the NHS will soon require all applicants to its national funding programmes to consider and articulate the environmental impact of the products for which they are seeking support. The NHS will also work to substitute for low-carbon alternatives where they are available and before the end of the decade, the NHS will no longer purchase from suppliers that do not meet, or exceed, its commitment to net zero (i). NICE have also pledged to develop a framework to incorporate environmental sustainability information within their guidance.

We are supporting the NHS Net Zero Plus ambition by providing clients with a service that will quantify and effectively communicate the carbon impact of their MedTech innovations.

Service Offerings:

HTE can provide carbon footprint evaluation services either stand-alone or as a part of the Health Technology Assessment Support and Evidence Appraisal. The services include:

Quantitative comparison of reduced greenhouse gas emissions and waste between the intervention and comparator, arising from more effective logistics, and reductions in patient travels and unnecessary treatments. Quantitative evidence of carbon footprint reductions is increasingly required to secure NHS-issued funding and grants.

Qualitative analysis of potential greenhouse gas emissions savings from the intervention by using the most up-to-date Greener NHS guidelines. It is particularly useful in developing the value proposition of the technology to the key stakeholders.

Advice on data collection during clinical trials and statistical post hoc primary data analysis relating to the environmental impact of the technology. The real-world data evidence is crucial to developing a strong case for the technology’s impact on the NHS’s carbon footprint.

The analyses provide a robust evidence base for the environmental impact that supports the value proposition of the innovation. The evaluations can also give insight into what steps should be done to maximise the positive environmental impact of the innovation.

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Service Offerings

Having the right arguments for demonstrating health and cost impact of your innovation is essential for success. Our team includes professionally qualified and experienced health economists who can provide comprehensive health economic assessments and evaluations to support your innovation. Health Tech Enterprise provides a range of offerings to ensure you have the right kind of evidence to convince decision makers and provide health economic evaluations and, tailor-made to your requirements at each stage of technology development.

Evidence Synthesis & Literature Reviews

Reviewing the existing body of published work is a key part in planning for your market access strategy and a crucial cornerstone of evidence-based medicine. Full Health Technology Assessments (HTAs) by NICE require a systematic literature review to be part of the submission.

• Systematic Literature Reviews (SLR)
  Considered the gold-standard of reviews, which critically evaluates and interprets all the available study evidence relevant to a particular question. Systematic Literature Reviews form the comprehensive evidence base needed for Health Technology Assessment and are expected by regulators and publishers.
• Pragmatic Literature Review
  Adapts the conventional systematic review process to take into consideration limited time and resources available. It uses a streamlined methodology to accelerate the review process and focuses on finding the right evidence to address urgent issues or to inform data parameters for an early-stage health economic model.
• Meta Analysis & Network Meta Analysis
  Meta analysis uses statistical approaches to combine the results from a collection of studies to answer a specific question. A network meta-analysis is a pairwise meta-analysis to allow comparison of more than two interventions by using direct and indirect evidence. Depending on the quality of the studies available, a meta-analysis can reduce costs by avoiding unnecessary clinical trials.
• Scoping Reviews
  Used to explore the breadth and extent of all the published evidence available, identify key concepts and research gaps in the research to inform objective setting for future research. Rather than extracting and analysing results, this review maps the landscape of available data.

Health Technology Assessments

HTA Support & Evidence Appraisal

• HTA submission
  As well as preparing the HTA submission document, we can integrate systematic literature reviews, evidence synthesis and economic modelling into your HTA submission for approval by the regulatory agency
• Critical Appraisal of HTA submissions & research results
  We can perform critical appraisals of your HTA submissions and  your research results to identify areas of uncertainty, potential risks of bias and confounding and provide recommendations on how to address these.
• Review of Reviews
  Reviews and critically appraises the quality of existing systematic literature reviews in a specific field to assess risks of bias, differences in methodologies and the impact this may have had on the findings.

Budget Impact & Cost-effectiveness Analysis

Health Economics & Decision Modelling

To gain market access to the NHS it is essential to quantify properties, effects, costs and impacts of the new health technology. As well as clinical evidence, these need to present the economic evidence and the incremental health benefit which can be achieved in relation to costs as part of a Health Economic Assessment.

HTE can provide a range of Assessments, appropriate to each stage of technology development

• Budget Impact Analysis
  Often used at an early -stage investigation to determine the impact of a technology on a specific budget (e.g. NHS, Health insurance plan). This type of analysis is concerned with assessing the affordability of the technology from the perspective of a designated budget holder.
• Cost-effectiveness Analysis
  A full model assesses the relative cost-effectiveness of the new technology as compared to current care. A CEA provides impact evidence required by NHS and PSS budget holders and is an essential component of a Health Technology Assessment (HTA) application. This type of analysis  models both current and new care pathways for the addressable market population and often includes a systematic literature review to identify data for parameter inputs. The analysis compares the cost in monetary units with outcomes using a generic measure of utility-weighted health outcome (e.g. QALYs) as per the NICE reference case.
• Cost Consequences Analysis
  Alternative to a cost-effectiveness analysis when measures of effect have not yet been quantified. A less prescriptive form of cost-effectiveness analysis, this is often used to strengthen funding applications. The analysis models both current and new care pathways for the addressable market population, comparing costs against discrete categories of outcomes which do not require utility weighting (e.g. presented as monetary savings, health outcomes in natural units or condition-specific outcomes).  Outcomes tend to be presented in a non-aggregated form.
• Visual customer communication tools
  Design of user-friendly visual representations of the outputs from Health Economic Evaluations to communicate the value of your innovation to potential customers and budget holders.
• Environmental Impact Assessment
  To support future development and new technology adoption, the NHS will soon require all applicants to consider and articulate the environmental impact of their products. HTE provide clients with a service that will quantify and effectively communicate the environmental impact of their MedTech innovations.

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Click here to book a free 30-minute consultation, and let’s work together to find the perfect solution for your needs.

Understanding how your technology is trialed, used and purchased in the target clinical environment is crucial for a successful value proposition. We help you understand the relevant clinical pathway and connect you with key experts and clinicians, acting as an independent advisor on your product’s suitability and commercial viability.

Even the most compelling medical innovations can fail if they don’t consider the practical, logistical and financial constraints within any given healthcare setting. Beneficiaries (patients), users (clinicians) and payers (healthcare organisations) often have different and sometimes conflicting requirements.

We map out the current care pathway and identify all key stakeholders in the process. On your behalf, we work with healthcare providers in the UK and internationally, including our NHS Partner Trusts and extensive network of clinicians. This helps us gain insights into care pathways and conduct primary research on your product’s clinical and operational benefits. We also assess its impact on patients, and their caregivers.

Finally, we pinpoint where in the care pathway your product can improve efficiency, patient outcomes and costs.

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A rigorous IP & Commercialisation strategy will maximise your innovation’s commercial potential.

We have extensive experience helping clients gain a greater understanding of their intellectual property (IP) position and developing a plan to protect their assets. We also advise on how to translate an idea into a viable product or service and appropriate commercialisation strategies to bring products to market for health technologies in the UK and international markets.

Our services include:

Intellectual Property (IP)

Evaluating and advising you, based on the specific attributes of your technology, on what and how to protect your technology to safeguard your potential future revenue streams and maximise the value of your innovation.

Patentability and freedom to operate searches to explore potential areas of prior art which might affect the likelihood of securing IP protection and assessing the patent landscape for any technology that might keep you from using your invention freely.

Patent landscaping to help you have an understanding of the existing patent landscape for a particular technology within a specific country, region or globally. An IP landscape will provide you with crucial information as to whether competition exists and can be used to identify strengths and weaknesses of a patent or innovation strategy.

Commercialisation Plans

Devising a commercialisation plan and advising you on the key steps required along the innovation development pathway to bring a new technology to market.

Undertaking commercialisation options analyses by reviewing and exploring the opportunities and challenges of the principal routes to market.

Developing investor/funder pitch decks and business plans to support your commercialisation strategy.

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