Our core service packages range from Proof of concept right through to developing the right evidence base for a medical device or technology. Why not use our expertise to support your team in creating a product that is not only regulation compliant but truly fit for purpose.
The following are just some of the services we offer; please contact us directly to discuss your specific needs and to see how our experience and expertise can help you:
- Concept development
- Key opinion leader review
- Design support & prototyping
- Engineering / scientific / healthcare consultancy
- Regulatory compliance
- Risk management
- Product technical Dossiers
- CE marking readiness review
- Clinical Trials / Ethics Management / Investigation / post-market efficacy research
- Health Technology Assessment (Economic and Impact Assessment)
- NICE adoption submission
We can provide research support, access to key opinion leaders, support you with understanding and meeting regulatory requirements, apply our expertise in helping you develop a market ready product that is not only standards compliant but is truly fit for use in Health & Social Care. When you are ready for commercialisation we can support development of an evidence base; providing health technology assessment and designing and supporting Clinical Trials.
Widespread adoption across the NHS can be enhanced through inclusion in relevant NICE Medical Technology guidance (MTG) and CHEATA has the expertise and experience to advise and support you with this process. We can advise on the suitability of undertaking the application including a brief review of your evidence base and can support you on your NICE journey. The process for notifying NICE now starts with the new NHS Innovation Service.
The process for notifying NICE has now switched from the Health Tech Connect portal (which was run by NICE), over to the Innovation Service run by NHS England. The new Innovation Service webpage can be found through this link. We are in the process of learning how this new system works but we can still advise on the NICE pathways and more information will follow once we understand the new process in more detail.
Client 1 - Global LE that made a successful submission to NICE, click here
Client 2 –An International company that decided to delay application to NICE click here
Regulatory Compliance Support
All medical devices need to comply with the appropriate legislation which has been reviewed now that the UK has left the EU. In the UK, the UK CA mark requires adherence to the UK Medical Devices Regulations 2002 (covered by MDD 93/42/EEC; AIMD 90/385/EEC; IVDD 98/79/EEC). Across the EU, medical devices need to carry a CE mark in order to be placed in the market as set out in the new Medical Device Regulations (Medical Devices 2017/745 and In Vitro Diagnostics 2017/746).
CHEATA can provide advice and specific support for compilation of the clinical evaluation report where the level of support can depend on the existing expertise within the company and the amount of support required.
This can involve a relatively small amount of advice and high level support from CHEATA e.g. classification review, strategic advice, Our staff have completed training in undertaking a Clinical Evaluation Report and can undertake the planning, literature searches and appraisal, and prepare the CER and associated documents. We can also support with some of the documentation associated with the IVD Performance Evaluation. We can also advise you to ensure that your clinical investigation or performance study includes the right end points to meet your UKCA/CE mark requirements. Do get in touch to discuss your specific requirements and how we can help support you achieve regulatory compliance
Health Economic Assessment
Building a strong economic case is one of the key pieces of evidence needed for any medical device and may form part of the Value Proposition or be a stand-alone piece of work. We offer bespoke economic analysis appropriate to your stage of development and target market. Within a Value Proposition, at an early stage of development, we offer a Health Economics Scoping Exercise. As you progress towards and beyond regulatory approval we can develop a full Health Economic Analysis to support adoption.
A Health Economics Scoping Exercise involves a review of the literature and publicly available sources to identify any economic evaluations or costings relevant to the current pathway or devices similar to the technology in development. From this review and any other evidence provided by the developers (such as bench or animal studies), a potential structure for a decision analytic model may be suggested. The Scoping Exercise would highlight important evidence sources and identify the parameters of importance for health economic analysis (particularly outcome measures and resource use) which could be included in future studies. As part of the Scoping Exercise, we would identify which costs and health outcomes are likely to be impacted by the introduction of the new technology. We will suggest when and where incremental costs would be incurred and potential cost savings realised. This can inform the design and follow-up period required in future studies.
A full Health Economic Analysis would typically build on the Health Economics Scoping Exercise and involve the development of an early economic model. This may take the form of a decision tree or Markov model or a combination of both. The analysis may take a cost minimisation, cost-effectiveness, cost-utility or cost benefit approach, as appropriate to the decision problem. Developing an early model (or multiple models for plausible scenarios) provides an opportunity to explore the potential for the technology to be cost effective and cost saving. It will also identify which parameters are the most influential for health economic analysis and provide guidance, through headroom and threshold analysis of the levels of effectiveness and price of technology which will maximise the potential for cost-effectiveness or cost savings. As well as building a model from first principles, CHEATA can assess the suitability of existing economic models and provide amendments where necessary. As part of a full Health Economic Assessment we will consider when and where costs are impacted. This is essential as decision-makers will want to understand if and when additional costs are to be incurred as well as anticipate the timescale over which cost savings are likely to be realised.
We have advised many clients on the potential economic impact of their device in a particular patient pathway. Our input can range from an "easy-to-digest" summary suitable for presenting to ICBs or including in the Value Proposition for investors, through to more complex modelling suitable for NICE submissions.
Read more about how we helped the Health Innovation East Midlands (formerly East Midlands AHSN) funded project, Silhouette, evidence the cost savings for their novel 3D camera in assessing diabetic foot ulcers in a community setting.
The integration of Human Factors in the design, development, implementation and evaluation of Healthcare Technologies is a vital part of ensuring that devices and systems fit the needs of their users and stakeholders and that they are developed with consideration for the specific environments and contexts in which they will be used. Early consideration of human factors in device design can have a big impact on medical device development and is key to understanding the capability of the users and how they interact with the technology.
It also ensures that you design in good use and practice and design out poor practice and potential for errors. Together this can accelerate the opportunity for improved performance, efficiency and experience of healthcare staff and patients.
CHEATA can provide the Human Factors expertise to support your device development including User Requirements Capture (Focus Groups), full task analysis, usability testing, workload analysis (cognitive and physical), error and reliability testing and user experience.
Identification of potential clinical opportunities or patient populations
Some medical devices are designed with a very specific purpose in mind whereas others can be used in a variety of different settings, ways and patient populations. CHEATA can identify clinical areas or patient populations where your medical device could potentially be used. Evidence from literature searches can be supported by face to face discussions with clinicians, nurses and healthcare workers to understand current practices and the potential for the use of the medical device in specific healthcare settings. Our in-house health economist can also add insight about which clinical areas or populations may offer the most potential value.
We are currently working with 2 medical device companies to identify the best patient population to be the focus of future clinical studies. This has involved searching for data from of a variety of sources including standard literature sources such as PubMed and EMBASE, freely available online resources such as those found on the NICE website and NHS or even NUH information sources. The output delivers an evidence-based "long list" of potential populations which the client can then review and discuss which they would like to investigate further. We then consult with relevant groups and clinicians based at NUH to gather their input into the use of the device in a particular patient pathway as well as offering the company the opportunity to meet with the clinicians to discuss the willingness to scope out any potential clinical investigations that may be deemed appropriate.
Value Proposition: Product Overview and Scoping
A well-constructed Value Proposition that tells potential purchasers and investors why they should choose your device is crucial to the progress of any medical device. CHEATA provide a service whereby we can review the medical device and the relevant NHS pathway(s) and define the proposed value proposition. We can also help to outline the health impact model with defined problem statements to be answered through economic modelling.
The output of this service is a report that enables the company to see where their product meets the NHS need and enables decisions to be made on product development, market potential and adoption strategies. The report would typically include:
- Device overview and problem statement
- Value proposition statement
- Patient and system benefits
- Patient pathways and NHS workflows
- NHS adoption barriers and enablers
- Potential reimbursement routes or strategies
- Health economic assessment
- Recommendations on future evidence gathering and/or clinical trial outcomes
Read more about how we helped SmartLife with their outline Value Proposition.
Medical Device Training for NHS Implementation
Once a medical device has been commissioned into an NHS Trust, training support for both staff and clinical engineers would be considered best practice. We can advise on a range of training support including devising lessons plans to support on-site training as well as support for on-going device verification and maintenance.
Implementation of the new Medical Device Regulations has resulted in more devices requiring a clinical investigation prior to CE mark submission. CHEATA can support clinical trials, investigations or performance studies either through our own clinical trials manager or we can collaborate with specialist clinical trial experts at Nottingham and Derby NHS Trusts.
We work closely with the Research and Innovation Department (R&I) at NUH who facilitate the organisation, hosting and running of clinical investigations and trials within NUH at the clinical research facility (CRF). We can also collaborate with Derby Clinical Trials Support Unit (Derby CTSU) which provides a variety of bespoke services that can be tailored to the specific needs of a project, where an investigator has the option to choose all the services offered or any single/multiple of their CTU services, e.g., study design, trial management, statistical analysis, randomisation, data management, all the way to the publication of the trial or investigation. More information is available at https://www.uhdb.nhs.uk/derby-ctu
For clinical investigations of non-CE/UKCA marked devices, we can review clinical protocols to ensure all requirements for the CE or UKCA mark are included and we can liaise with the MHRA to obtain a letter of no objection. Clinical trials represent a significant financial investment outlay for a product and we can assist in estimating the costs associated with running a trial at NUH using the NIHR commercial costing tool. This could be used for internal budgeting purposes or could be included in any grant submissions that would cover the cost the clinical study.RE
Clinical Focus Group
Input and opinions of end users should be the basis of new product design. Whether your device is at prototype phase or is still in the initial stages of development, CHEATA can help with User Needs Elicitation through arranging Clinical Focus Groups. These groups provide valuable feedback and information to companies about the potential role of their product in the NHS including most appropriate use, deviations from current care pathways, potential changes to the product, benefits or obstacles to its use in practice and how it compares to current devices.
We can also work with our Human Factors expert to ensure that the Focus Group is asking the right questions, capturing the feedback in the most appropriate way and ensure that the session delivers a useable output.
Read more about how we helped SmartLife with their Clinical Focus Group
CHEATA are happy to work with you or your grant submission writers to include relevant CHEATA services into the proposal. We have experience of a range of funding stream including NIHR i4i, EPSRC, H2020 and Innovate UK.