CHEATA case studies

Background

Smartlife Inc Ltd are a Manchester-based company that specialise in smart garment technology.  They have developed innovative, patented textile sensors, electronics and firmware that are capable of detecting the body’s biophysical signals, and delivering actionable insight to users via mobile apps. In order to move their technology into the healthcare sector, they secured EU funding through the H2020 scheme (SME Instrument, Open Innovation call, Phase 1) to undertake a feasibility study to develop a garment that can measure and record an electrocardiogram (ECG) trace, to appropriate clinical standards. Currently this information is captured by a Holter monitor but it can be difficult to fit and to use for some patients over a 24 or 48 hour period and an alternative wearable garment would be a more convenient and suitable solution. The new product will be considered a medical device and will therefore need to comply will the EU Medical Device Regulations.

The CHEATA Solution

The client engaged with CHEATA to undertake the following work

• To undertake a review of the regulatory requirements of the garment and its manufacture
• To scope out the Value Proposition for the proposed technology including
• To conduct a clinical focus group with cardiology technicians to get feedback on the device and how it might be implemented in practice.

Outcome

CHEATA delivered several reports that contributed to the Phase 1 Delivery report as required by the EU.

• We produced a regulatory report on the device including identifying the potential class of the device, the EU standards it will need to show compliance against and the need for a quality management system to be implemented by Smartlife Inc.
• We also scoped out the Value Proposition and identified areas to be populated with further evidence on the clinical utility and the economic impact of implementing the device.
• Finally, we organised a clinical focus group with a number of cardiac physiologists (the people who currently fit Holter devices and analyse the data), where Smartlife demonstrated their device and gathered essential feedback, opinion and information. CHEATA produced a report summarising the questionnaire answers from the group as well as the dialogue during the session.

Background

The client is a leading medical device manufacturer specialising in wound care products. This is a very competitive sector and the company wished to interrogate publically available information sources to understand how similar devices were being evaluated using in vitro and non-clinical testing and what standards may apply to the products. 

The CHEATA Solution

CHEATA proposed a literature and evidence search as follows:

• To confirm and define the devices and product characteristics within the scope of the literature/evidence search
• Defined literature search of scientific literature databases PubMed, Medline and Cinahl
• Sift, review and appraise all relevant literature
• Search BSI website (BSOnLine) for relevant standards and confirm applicability
• Search product and company websites for publically available and published data not identified through the literature search
• Search FDA 510K database for relevant information

Outcome

• A list of standards was identified from BSOnLine and their applicability to the device list was confirmed. The standard references were noted and were considered to be the gold standard for product testing and development. The standards also helped to confirm the definitions of testing descriptions and categories.
• A literature search identified published peer-reviewed articles, conference abstracts and a significant amount of grey literature on product testing hosted on a variety of different websites/platforms.
• A search of publically available information on the internet identified more information from both competitor websites (promotional material), grey literature sources and conference websites.
• A report was prepared where the information was grouped by product characteristic
• All literatures sources were fully referenced and where possible contained the link to the open access article or the DOI number.
• All search strategies and processes were detailed enabling easier updates in the future

Client Feedback

“I thought the report was well done, the effort with stating methodology and the level of detail across a whole wealth of studies was perfect. Thank you for your help! “

Background

The East Midlands Academic Health Science Network (EMAHSN) is working with commissioners and acute NHS trusts to roll out the use of Silhouette® 3D cameras to assess diabetic foot ulcers. Initially they have been working in Southern Derbyshire with Entec Health, the UK distributor of Silhouette® (ARANZ Medical), to assess and treat diabetic foot ulcers in the community rather than at hospital.

The East Midlands Academic Health Science Network (EMAHSN) is working with commissioners and acute NHS trusts to roll out the use of Silhouette® 3D cameras to assess diabetic foot ulcers. Initially they have been working in Southern Derbyshire with Entec Health, the UK distributor of Silhouette® (ARANZ Medical), to assess and treat diabetic foot ulcers in the community rather than at hospital.This new approach means foot ulcer healing is monitored digitally and the information shared in real time with relevant healthcare professionals. It is anticipated that using Silhouette® will identify those ulcers that are not healing as expected and therefore need earlier intervention potentially reducing amputation rates. Switching the service from the hospital into the community is expected to improve both the staff and patient experience as well as deliver an economic benefit through reduction in outpatient follow up appointments.

The CHEATA Solution

The client engaged with CHEATA to undertake the following work:

• To develop an economic impact model to help inform a Business Case for Silhouette® to be included in a Diabetes Foot Service Digital Solution Model
• Work with the project team to collate the information needed
• To model the economic impact of using Silhouette® including:
• Switching care from the hospital into a community setting
• Cost of technology deployment, inpatient cost of treating a foot ulcer, cost of treating a foot ulcer in the community (including approximate numbers of community visits)
• Savings from reduced referrals coupled with a better referral process
• To update the economic model after one year of deployment to understand the accuracy of the model
• Attend steering group meetings to update the project team on progress and developments and to help influence commissioning processes

Outcome

CHEATA worked closely with the wider project team to gather the relevant information required to create and populate the health economic impact model. Once the model was completed, this was incorporated into a report for inclusion in the Value Proposition

Next Steps

The health economic impact model (and the Value Proposition) will be updated with data gathered in the first year of implementation to understand the accuracy of the initial projections and assumptions and to demonstrate the cost-savings achieved.

To find out more about the Silhouette project, click here

To find out more about the Silhouette camera system, please visit the Entec Health website

Background

The client­ is a leading company who designs, develops and manufactures aerosol drug delivery and associated lung health devices. They sought CHEATAs advice and knowledge to help contribute to the Value Proposition of one of their CE marked products that is currently on the market and to advise on engagement with the NICE MTEP committee for potential inclusion into their guidelines.

The CHEATA Solution

The client worked with CHEATA to undertake the following:

• To review their product, evidence and data pack
• To confirm and define the proposed Value Proposition including:
• Design a questionnaire and undertake an informal survey of key healthcare workers in the respiratory area to gather feedback on the use of the device in different patient populations
• How the product would fit into the current patient care pathways and competitor analysis
• To review the economic impact and to define the problem statements to be answered by the subsequent economic modelling within the defined patient segment and care pathway
• Advise on the commercial benefits and risks in making a submission to NICE.

Outcome

The deliverable report, which included a gap analysis on the current evidence and a cost benefit analysis, made a significant contribution to the Value Proposition for the medical device under review. A range of options regarding further steps and recommendations were detailed in the report. The client decided to defer submission to NICE until the results of additional studies were available for review.

Background

The Clinical and Product Assurance (CaPA) team of NHS Supply Chain are key to ensuring that all the products NHS Supply Chain supply are safe and reflect the needs and preferences of our NHS partners. The CaPA Framework ensures that NHS Supply Chain procurement is underpinned by evidence and expert input from a wide range of stakeholders, from patients and users to national clinical expert bodies. NHS Supply Chain and CaPA have a need for specific Intelligence Gathering services to provide this information to ensure the best products are in the Catalogue.

The CHEATA Solution

CHEATA proposed a full support package to undertake the required Intelligence Gathering activities:

• Searching and appraising of relevant published literature in scientific databases such as PubMed, Medline and Cinahl
• Identification of relevant Guidance data from National Institute for Health and Care Excellence (NICE) or other professional bodies eg the Royal Colleges or national and international working groups
• Safety notices and device alerts from the UK (Medicines and Healthcare products Regulatory Agency), USA (Food and Drug Administration) and Australia (Therapeutic Goods Administration)
• Identification of relevant standards (UK/EU)
• Information regarding device classification
• Searches of clinical trials databases
• Identification of new or innovative products that could be included in the catalogue

Outcome

• Framework for requesting and reporting Intelligence Gathering information
• Two part report: Part 1 contains the information which can be lifted directly into the CaPA reports and Part 2 provides more detail if required
• Informs procurement teams on the information needed to be provided by manufacturers to ensure the right products are listed