CHEATA provides a unique offering; thanks to our partnerships and links we are able to offer a one stop shop for all medical technology adoption needs. Our service portfolio is not only unique and diverse but is also tailored to each of our client’s needs

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.

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 can assist in preparing the Value Proposition for a medical device. We review the product, place it in the relevant NHS pathway and confirm and define the proposed value proposition. In addition we can outline the health impact model with defined problem statements to be answered through economic modelling (see below).

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.

Building a strong economic case is one of the key pieces of evidence needed for any medical device and will form part of the Value Proposition. We can provide different types of economic modelling depending upon your requirements from simple cost analyses to more complex analyses such as cost consequence or cost utility analyses. CHEATA can assess the suitability of existing economic models and provide amendments where necessary or we can advise, design and populate new models e.g. decision tree or Markov models, from first principles.

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.

Widespread adoption across the NHS can be achieved through inclusion in relevant NICE guidelines and CHEATA has the expertise and experience to advise and support you with this process. We can advise on the suitability and risks of undertaking the application and can assist on all steps including submission of the initial Briefing Note, collation of clinical evidence relating to the device (Section B), and economic evidence (Section C), submission of the Sponsors Evidence Form and interaction and liaison with NICE throughout the process.

All medical devices need to comply with the new Medical Device Regulations (Medical Devices 2017/745 and In Vitro Diagnostics 2017/746) and carry a CE mark in order to be placed in the market in the UK and across the EU. CHEATA can provide advice and support for regulatory compliance where the level of support can depend on the existing expertise within the company and the amount of technical support required.

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. For clinical investigations of non-CE marked devices, we can review clinical protocols to ensure all requirements for the CE mark are included and we can liaise with the MHRA to obtain a letter of no objection. We have a clinical trials manager who has over 25 years’ experience in running trials at NUH who will ensure the trial runs as smoothly and efficiently as possible.

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.