H2020 Phase 1 Feasibility Study Client: Smartlife Inc Ltd
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.
Information Gathering- Client Confidential
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! “
Regulatory Review - Platelet Solutions Ltd
Background
Platelet Solutions Ltd is a spin-out company of the University of Nottingham formed in 2011, and is the outcome of many years of research and experience in the Thrombosis and Haemostasis Group. The company focuses on the provision of products and services for platelet function testing. Platelet function testing is required for diagnosis of abnormal bleeding and to monitor platelet function in those who are at-risk of vascular events such as heart attack or stroke.
Previously, platelet function analysis had to be performed immediately after taking the blood sample but Platelet Solutions patented method allows samples to be processed using simple disposable kits and be posted for expert analysis.
They have been developing a new platelet processing kit that required CE mark certification ready for market launch.
The CHEATA Solution
Platelet Solutions Ltd engaged with CHEATA to undertake the following work:
- To perform a gap analysis on the data already compiled for the Technical File against the applicable Essential Requirements of the IVD Medical Devices Directive
- To deliver a list of recommended actions to achieve regulatory compliance with the IVD Directive
- To outline the impact of the proposed changes to the IVD Regulations on the current regulatory position
Outcome
A comprehensive list of actions that enabled Platelet Solutions to understand and implement the necessary steps required in order to achieve regulatory compliance for their new product.
Platelet Solutions have now successfully achieved CE mark approval for their platelet processing kits.
Engagement with NICE MedTech Evaluation Programme: Coloplast UK
Background
Coloplast develops products and services to make life easier for people with deeply personal and private chronic conditions. One of their products, Peristeen®, a transanal irrigation system, was launched in 2003, and has since accumulated a body of evidence (both published and unpublished) from clinicians and healthcare workers. A review of this data suggested that Peristeen could be suitable for review by the NICE Medical Technology Evaluation Programme (MTEP) for inclusion into medical technologies guidance.
The CHEATA Solution
Coloplast engaged with CHEATA to undertake the following work in close collaboration with their product team:
- To review their product evidence and data pack
- To confirm and define the proposed Value Proposition including:
- Identification of the specific patient segment
- How the product would fit into the current patient care pathway.
- To undertake an economic impact assessment on the health economic model within the defined patient segment and care pathway
- Advise on the commercial benefits and risks in making a submission to NICE
- Preparation and submission of the Briefing Notification to NICE
- Preparation and submission of the Sponsor’s Submission of Evidence form to NICE
- Responding to NICE and External Assessment Centre (EAC) comments and correspondence
- Support and attendance at NICE Committee meetings including registration as a product stakeholder
- Ongoing support until the conclusion of the NICE process
Outcome
The submission of the Briefing Notification to the NICE Medical Technology Evaluation Programme was successful and the product progressed into the MTEP pathway for review by an External Assessment Centre before review by the Medical Technologies Advisory Committee (MTAC).
The outcome of the MTAC review was a positive recommendation and NICE have now published MTG36: Peristeen transanal irrigation system for managing bowel dysfunction.
The Committee’s top line recommendation was:
“The case for adopting Peristeen for transanal irrigation in people with bowel dysfunction is supported by the evidence. Peristeen can reduce the severity of constipation and incontinence, improve quality of life and promote dignity and independence.”
Feedback from Coloplast
Bruno Gallo Santa Cruz, International Medical Specialist (Bowel Management): Your guidance, support and expert advice has been outstanding.
Coloplast press release – https://www.coloplast.co.uk/about-us/news/2018/#section=NICE-publishes-Peristeen%c2%ae-guidance-to-treat-constipation-and-faecal-incontinence---_431292
Story on the Nursing Times – https://www.nursingtimes.net/news/policies-and-guidance/nice-backs-irrigation-device-for-constipation-and-incontinence/7023411.article
Economic Impact Assessment Client: EMAHSN, with Entec (Aranz Medical)
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
Regulatory Support Client: Surepulse Medical Ltd
Background
The University of Nottingham and Tioga Ltd secured Innovate UK grant funding to assemble a joint clinical, design and engineering project team to integrate the an optical sensor into a single use newborn hat and to undertake clinical studies on newborn babies. The hat will enable clinicians to resuscitate ‘hands-free’, reduce delays and errors, and so improve resuscitation outcomes, giving newborn babies the best start to life.
CHEATA are an integral part of the project team and have provided regulatory advice and support as the device progresses towards CE mark readiness and MHRA submission for a clinical trial. From this collaboration, a company, SurePulse Medical Ltd has been established to further develop, test and commercialise the Surepulse device. For more information visit www.surepulsemedical.co.uk.
The CHEATA Solution
The client engaged with CHEATA to undertake the following work
- To provide advice on the regulatory requirements for the Surepulse device including assessment of progressive iterations of the device and of the technical file for CE mark submission
- To engage with the MHRA to secure approval for a non-CE marked device to be used in a clinical trial
- To review the clinical trial protocol to ensure all endpoints required for the CE mark submission are included
- To attend a Notified Body audit for CE mark submission
Outcome
The project team has secured approval from the MHRA to conduct the clinical trial with a non-CE marked device. Once the trial has been completed CHEATA will continue to work with the project team to complete and assess the technical file and to advise on the submission to a Notified Body for CE mark approval.
To find out more about Surepulse Medical Ltd, please visit their website - click here
HTA and Engagement with NICE: Client not disclosed
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.
Clinical Evaluation Testing and Report Client: Alert-it
Background
Alert-it are a leading medical device manufacturer specializing in home-use devices. The company needed specific support to ensure on-going regulatory compliance with the UK CA and CE mark processes through independent simulation-based clinical testing and preparation of Clinical Evaluation Report.
The CHEATA Solution
CHEATA proposed a full support package to deliver the testing and complete the Report as follows:
- Define a testing schedule to meet the claims made in the regulatory dossier
- Independent testing of devices in Trent Simulation and Clinical Skills Centre against defined test schedule using appropriate simulation manikins
- To prepare a Clinical Evaluation Report for regulatory compliance purposes (in accordance with MEDDEV2.7/1 rev 4, GHTF SG5/N2R8:2007 and Medical Device Regulation (EU) 2017/745 MDR 745/2017: Article 61 and Part A of Annex XIV) including:
- Confirm and define the devices and product characteristics within the scope of the literature/evidence search
- Confirm and review the manufacturer held data from the Simulation Testing for inclusion in the Report
- Structured literature search for additional evidence of scientific databases including PubMed, Medline, Embase/Emcare and Cinahl
- Run searches and document the output in a PRISMA diagram
- Sift, review and appraise all relevant literature
- In conjunction with the company, discuss the state of the art and the accepted risk/benefit profiles and other summaries for the C
- Produce Clinical Evaluation Report in accordance with MEDDEV2.7/1 rev 4, GHTF SG5/N2R8:2007 and Medical Device Regulation (EU) 2017/745 MDR 745/2017: Article 61 and Part A of Annex XIV
Outcomes
- Simulation Testing Schedule and Testing Report
- Clinical Evaluation Report document
- Excel database of literature search outputs, sift and appraisal
- On-going support for subsequent literature search updates
- No non-conformance issues relating to the CER after UK AB/NB audit
Information Gathering Client: NHS Supply Chain
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