“The AHSNs have provided invaluable support in facilitating the early evaluation of imPulse™, and instigating a clinical trial which is being currently run in Exeter. They continue to provide contacts and guidance in the positioning, promotion and marketing of imPulse™.  The product development would have struggled without this support.”
George Ostaszewski, IC Design Manager, Plessey
Overview

Plessey is a Plymouth and Swindon based SME operating in the field of compound semiconductors. The company has developed a low cost, easy to use, lead-one ECG device known as imPulse™, to assist primary and secondary care staff in the automatic identification of atrial fibrillation (AF).

imPulse™ is a portable, handheld device that detects ECG signal by the placement of the thumbs on the sensors embedded in the unit, allowing a lead-one rhythm trace to be taken with no need for any skin preparation.

Five years ago, Plessey approached the West of England AHSN for market access advice to help build an internal business case for the development of imPulse™. At this stage an early prototype had been developed but technical feasibility was still being assessed.

The West of England AHSN supported Plessey on a successful application and implementation of the 2013 SBRI Healthcare cardiovascular call. This support led to Plessey receiving £1,097,158 in funding, helping the product to go from prototype to production in less than 12 months.

Since then, the West of England AHSN, along with the South West AHSN, have assisted Plessey with evaluation and clinical trial opportunities, and also supported early adoption and spread of imPulse™.

“Having performed an initial test of imPulse lead-one ECG device, it is clear that this device is able to provide and record a usable single lead ECG similar to lead 1 of a 12-lead ECG…this device could be effectively used in the screening for abnormal heart rhythms, particularly atrial fibrillation”
Consultant cardiologist, Devon

How is the AHSN involved?

The West of England AHSN has been working in partnership with Plessey since 2013 in the form of advice, introductions, funding opportunities and submission reviews.

In addition to supporting Plessey’s successful SBRI Healthcare application in 2013, the AHSN has provided introductions and access to local NHS organisations and teams. The West of England AHSN provided support for the regional evaluation of imPulse™ in collaboration with the Bristol Heart Institute. To support regional adoption of imPulse™, a focus group was conducted with 50 GPs to evaluate their needs and explore drivers or barriers to adoption.

The West of England AHSN has also contributed towards national adoption of imPulse™, providing advice to Plessey to support their listing on G-cloud, leading to the availability of imPulse™ on the Innovation and Technology Tariff (ITT).

The South West AHSN are also working with Plessey to conduct clinical trials and evaluation, appraising the use of imPulse™ to detect AF.

“Colleagues in primary and secondary care have welcomed imPulse’s potential to improve the patient experience and give reassurance in rapidly capturing quality ECG signals. The interactions between Plessey staff and frontline healthcare practitioners have benefitted all parties as practitioners help to shape novel products that work in real healthcare settings.”
Dr Elizabeth Dymond, Deputy Director of Innovation & Growth, West of England AHSN

Impacts / outcomes of AHSN involvement to date

Financial impact:

Support received from the West of England AHSN helped the imPulse™ team to build an internal business case for the development and commercialisation of the product, helping to secure internal funding and confidence from senior leadership to support the development of the product.

Commercialisation of imPulse™ has supported the following jobs and investment:

  • Supported four jobs in the development team at Plessey
  • imPulse™ device is manufactured in the UK, supporting jobs and regional growth in Pencoed, Wales
  • Plessey have partnered with consultants based in the UK to support the business development and marketing of imPulse™

SBRI Healthcare funding received: £1,097,158.

Clinical impact:

Clinical trials and evaluation are ongoing to provide evidence to demonstrate impact on patient outcomes, health economics and resource utilisation. Ongoing trials and evaluations include:

  • Clinical trial in Exeter to evaluate the sensitivity and specificity of the imPulse™ device for the detection of AF.
  • NICE Diagnostics Assessment Programme: Lead-I electrocardiogram (ECG) devices for detecting atrial fibrillation

Awards & recognition:

  • Won at the National Technology Awards 2017 in the “Healthcare Technology of the Year” category
  • Shortlisted at the Elektra Awards 2016 in the “Excellence in Product Design for Medical” category
  • “Highly Commended” recognition at the 2016 Institution of Engineering and Technology (IET) Awards.
Plans / timescales for further work
  • Clinical trial setup in Exeter with support from South West AHSN. Trial will evaluate the sensitivity and specificity of the imPulse™ device for the detection of atrial fibrillation (AF).
  • The trial started in July 2018, targeting N=200 people.
  • NICE diagnostics assessment ongoing.
  • Developing relationships and opportunities to trial imPulse™ within NHS organisations, private healthcare organisations and internationally.
  • Strengthening relationships across the AHSN Network.
  • Additional product developing ongoing, looking for market access advice and guidance.
Opportunities to get involved
  • Clinical trial setup in Exeter with support from South West AHSN. Trial will evaluate the sensitivity and specificity of the imPulse™ device for the detection of atrial fibrillation (AF).
  • The trial started in July 2018, targeting N=200 people.
  • NICE diagnostics assessment ongoing.
  • Developing relationships and opportunities to trial imPulse™ within NHS organisations, private healthcare organisations and internationally.
  • Strengthening relationships across the AHSN Network.
  • Additional product developing ongoing, looking for market access advice and guidance.
Opportunities to get involved

Plessey are looking to demonstrate the effectiveness of imPulse™ to support the adoption and spread of the product and would like to hear from anyone interested in:

  • Conducting a clinical trial and/or evaluation in additional patient pathways, eg diabetes management, COPD management etc.
  • Conducting health economic evaluation such as cost effectiveness analysis and budget impact analysis on various patient pathways
  • Discussing pathways to adoption in local NHS organisations
  • Providing market access advice and guidance to support additional product development.
Start and end dates

September 2013 – ongoing.

Contacts

Rosie Brown, West of England AHSN
E: [email protected]

George Ostaszewski, IC Design Manager, Plessey
E: [email protected]
T: 01752 693017

imPulse™: portable ECG monitor