Unmet Need – Renal clinic at home

Briefing for applicants

The Academic Health Science Network for the North East and North Cumbria (AHSN NENC) are delighted to announce a new Unmet Needs Challenge, connecting innovators from healthcare with our Innovation Pathway Partners to explore collaborations that improve health outcomes for our regional population.

We want to seek, and facilitate swift progress on, cross-sector collaborative projects that benefit our patient population by improving health outcomes and efficiencies as well as accelerating the adoption of evidence-based innovation.

The AHSN NENC is seeking partners to help develop a device which will be able to, safely and accurately, test patients’ bloods for serum Potassium and Creatinine within a home-based setting. The innovation must also support integration into the care pathway so that patients receive the right care at the right time.

Applications are welcomed from companies of all sizes, individuals, NHS teams and charities who are interested in forming collaborations to develop the device to address these issues.

Background

Development of a hand-held device to enable patients to safely and accurately self-test their own kidney function at home represents an important unmet clinical need both for patients and the NHS.  Development of a device to meet this need would have huge benefits for both patients and the NHS as it would also align with the NHS Long Term Plan (2019), which sets out how the NHS will move towards a new service model in which patients get more options, better support, and properly joined-up care at the right time, and in optimal care settings. The Plan also refers to clinic workload pressures encountered by GP practices and hospital outpatient departments, which together currently provide around 400 million face-to-face appointments each year. Over the next five years, the Plan proposes that development and utilisation of healthcare technologies, together with redesigned hospital support, will enable up to a third of outpatient appointments to be avoided, saving patients 30 million trips to hospital and saving the NHS over £1 billion a year in new expenditure averted.  Central to delivering the NHS Long Term Plan, is a wide-ranging and funded programme to upgrade technology and digitally enabled care across the NHS, to enable patients and their carers to better manage their own health and any conditions they may have.

A device to enable patients to self-test their own kidney function at home would align well with the NHS Long Term Plan, because patients are often required to attend Primary and Secondary Healthcare Services for routine monitoring of kidney function blood and urine tests, when they are well and do not otherwise need to see a Healthcare Professional. Common examples include monitoring of kidney function when heart failure drugs are started or titrated, monitoring of kidney function following kidney transplantation, or earlier monitoring of recovering from acute kidney injury at home, instead of remaining in hospital.  Although such tests are clinically justified and required, having to attend clinics for these tests is not always necessary.  Such unnecessary clinic visits or hospital stays could be avoided if such patients could use hand-held devices to self-test their own kidney function at home, in a similar fashion to patients with diabetes self-testing their own blood glucose levels from finger-prick capillary blood samples.

In addition to mitigating the negative impact of unnecessary clinic visits upon patients and the NHS, patient self-testing of their kidney function at home will promote “patient self-care”, which is associated with significant positive implications for patients, and which is also promoted by NHS England, who state: “Evidence tells us that supporting patients to be actively involved in their own care, treatment and support can improve outcomes and experience for patients, and potentially yield efficiency savings for the system through more personalised commissioning and supporting people to stay well and manage their own conditions better.” (https://www.england.nhs.uk/ourwork/patient-participation/).

The Renal Clinic at Home is envisaged in three parts:

  1. Hand-held device with disposables used (where appropriate) by the patient to measure capillary Potassium and Creatinine.
  2. Assessment of urine dip results (urinalysis) using the DIP.IO urinalysis device. This is already CE approved for patient self-use and is in use in the NHS, for use by kidney patients. The use of this requires a wireless enabled mobile phone.
  3. The ability to communicate via the cloud from a wireless mobile phone, tablet or lap/desktop to a central point (clinic). This is to receive advice from the central point, with instructions about what the patient should do as a result of the test results received (change medication etc). This type of interaction is already widely in use in the NHS using software provided by Inhealthcare or via HealthCall.

 

The Unmet Need identified here is the measurement of renal function: specifically of serum Potassium and Creatinine, using a hand-held device capable of use by patients themselves, or their carers in the patient’s home.

The potential market for this type of device within the UK is the 85 renal clinics across the UK which would look after about 2400 renal transplants per year (UK Renal Registry), about 61000 patients who are being treated for kidney failure from various causes (UK Renal Registry), and Acute Kidney Injury patients (with 532000 episodes reported to the Renal Registry over the 18 months between April 2016 and September 2017). There is also a potential market within patients suffering from heart failure (figures available on request). However, at the moment we have identified this as an Unmet Need within the Renal Specialty for the Renal Clinic at Home.

One of the main benefits from this Challenge would be helping to solve an Unmet Need within the NHS in an area which would have a great benefit to the patient population and the NHS. There is also a big market for these devices, not only in Renal patients, but also within many other specialties, such as heart failure patients, to assist with self-monitoring of renal functions.

The Challenge will be looking for a company who would either have a device which would be suitable for this with some modifications, or which would be able to be adapted into this setting.  We would alternatively be willing to work alongside the company to codevelop a product which would be able to be used within this setting, and guide them through the regulatory process with assistance from AHSN partners.

The AHSN NENC has a proven track record of working with NHS Foundation Trusts in North East England to support patient self-care, and they have supported development and delivery of a service that enables patients to self-test their anticoagulation treatment at home, for example (http://www.nhshealthcall.co.uk/north-east/).  We are currently supporting a pilot study to evaluate safety and feasibility of self-testing of kidney function at home, and informed by this work, we are seeking to collaborate with partners to develop a cost-effective, user friendly hand-held device to enable kidney self-testing to be utilised in everyday clinical practice across a wide range of clinical settings.

The Unmet Need

Self-testing of renal function: specifically of serum potassium and creatinine, using a hand-held device capable of use by patients themselves, or their carers in the patient’s home.

Application timeline

Application submission deadline: 1 March 2019

Shortlisted applicants will be notified on 15 March 2019 and invited to present to a panel of industry experts on the afternoon of 25 March 2019.

 

Submit your application