Please find details below regarding the latest SHIP challenge:
Neonatal Challenge – Near Patient Bilirubin Testing – this is expected to go live in September.
Women’s & Children’s Health Innovation Challenge: near-patient bilirubin testing to enable neonatal care at home
The open innovation challenge provides an opportunity for companies, working in partnership with regional test beds to develop disruptive innovative solutions that focus on the monitoring of jaundiced newborns at home. The aim of the competition is to develop solutions that deliver near-patient bilirubin testing to enable family centred care at home for babies who do not require to be in hospital.
Neonatal jaundice is an almost universal phenomenon, whilst generally benign, infants with significant jaundice are at risk of permanent neurological impairments if not treated. Phototherapy in hospital is the mainstay of treatment and is effective at preventing these complications. However, it leads to separation from family members at this unique time for bonding and places significant cost and capacity issues on hospital neonatal services.
Home phototherapy is a possible alternative and has been shown to be effective, person-centred and safe. The main challenge to delivering this treatment at home is timely and safe testing and monitoring of jaundice levels at home. Current processes, which involve blood sampling at home or hospital for laboratory testing, are person and time inefficient.
Innovative solutions are sought for near-patient bilirubin monitoring of newborns which are accurate, efficient, safe, accessible and equitable.
Solutions should comply with (or be working towards compliance) UKAS accredited point of care testing facility (POCT) (ISO15189:2022) method for analysis. Either the sample or the Result should return to NHS infrastructure for integration within the patient record.
These solutions should comply (or be working towards compliance) with NHS data protection guidance around storage of patient identifiable information and ideally interface with existing hospital results systems.
The solutions will have the potential to revolutionise care at home for both babies and healthcare services globally. The commercial potential across growing UK and global neonatal markets is 140 million births per year (£8billion market size).
Existing models of neonatal care
The care of babies in neonatal units and maternity hospitals ranges from extremely premature babies needing complex care, to the larger number of babies that could be cared for at home but remain in hospital, separated from their parents, as the care they require is currently only available within a hospital. Examples of this are treatment for jaundice, types of feeding and treatment to keep babies warm and monitor weight. This separation of otherwise well babies who could be at home has an enormous impact on families and bonding, in addition to reducing the availability of scarce cots within Neonatal units, beds within maternity hospitals and avoidable costs to the NHS. This challenge affects babies and parents in every maternity hospital, the scalability and hence impact of solutions will be significant.
Jaundice: a common neonatal problem
Jaundice is an almost universal phenomenon in the newborn, affecting 60% of term babies in the first week of life. In the UK in 2021 660,000 live births were registered. Jaundice is caused by raised levels of bilirubin (hyperbilirubinaemia), leading to yellow discoloration of the skin and sclera.
It is generally benign and transient, but if it is severe and untreated may lead to permanent behavioural and neurological impairments.
Phototherapy in hospital is the mainstay of treatment of jaundice, and is effective at preventing these complications. A typical course of phototherapy lasts 2-3 days. The impact of Separation from siblings, fathers and other family members at this unique time for bonding is substantial.
Approximately 6% of all admissions of term babies to UK neonatal units are for jaundice therapy. Our data suggest that many of these patients could be treated at home.
During a two-month monitoring period across NHS Greater Glasgow & Clyde Health Board in 2022, 77 babies required inpatient admission to a neonatal unit for phototherapy treatment for uncomplicated jaundice. The phototherapy course for these babies accounted for 178 additional maternal bed days (in the two month period) for mothers and babies who did not require any additional specialised in hospital care. Extrapolating this data, in NHS Greater Glasgow and Clyde alone it is equivalent to ~900 maternal bed days per annum and a cost approaching £1 million pounds
A survey of 29 parents and carers over the same two-month period found that 90% would have preferred phototherapy treatment at home.
To achieve these important potential benefits of home phototherapy, a first essential component of the care pathway is accurate, rapid jaundice testing in the home environment.
Developing home-based jaundice care
An effective and efficient home phototherapy service complements the strategic aims and objectives of NHS Scotland and aligns with the individualised patient-centred approach that underpins “The Best Start”, a 5-year plan for Maternity and Neonatal Services across NHS Scotland, prioritising family centred care and care at home.
NHS Greater Glasgow & Clyde’s five-year strategy, “The Pursuit of Healthcare Excellence,” is broken down into three key quality ambitions – effective care, person-centred care and safe care.
Home phototherapy is effective – phototherapy is a proven treatment for jaundice, and evidence shows that standard practice can be successfully adapted to the home environment. Home phototherapy is person-centred – respecting the importance of family bonding in the early newborn period and promoting shared decision-making. Home phototherapy is safe – the burden of avoidable harm does not increase significantly as long as parents and carers have appropriate access to advice and support.
Home phototherapy represents a significant addition to the spectrum of care currently delivered – reducing bed days while improving patient satisfaction. To quote one of our parents, “I truly believe that there should be funding made available for something like this!”
Challenges of current jaundice testing in newborns
However, for jaundiced babies both in hospital and at home the challenging aspect of their patient journey is testing and monitoring of jaundice or ‘bilirubin’ levels. At present a blood test is required (approximately 0.25mls blood), which is then transported to the laboratory and then analysed, Figure 1. There are several problems with this current system – it can take several hours, samples can get lost, samples can be mislabelled and samples can be haemolysed meaning there is no result and the blood test has to be repeated which is distressing to families and delays clinical treatment decisions. The current system also depends on several staff members – the individual taking the sample, personnel involved in transporting the sample, the laboratory staff and then the individual who is responsible for looking out for the result and deciding if any treatment is required then communicating this treatment plan. The current system is not efficient or patient centred, with errors and challenges identified at each point of the process map and we are looking for innovative ways to improve and streamline this system.
Figure 1: Existing pathway for jaundice testing in newborn infants
The project team hosted a stakeholder event in March 2023 which was attended by members of the multidisciplinary team caring for jaundiced babies and have held several meetings with other Health Boards across Scotland. They unanimously agreed that innovative solutions for near-patient or point of care patient bilirubin monitoring would be most welcome and an aspect of care that has the opportunity to improve the efficiency of patient care and has scalability to every maternity service in the UK.
Progressing near-patient testing of bilirubin in the home environment for babies requiring treatment for jaundice, would also address existing care inequalities and impact on sustainability and the environment by reducing parent and staff travel. Sustainability and reducing inequalities are key strategic priorities of NHS Scotland.
We would like to focus this challenge on an area that has potential solutions already in development, so we are interested to know if the market has solutions that address testing and recording for jaundice at home and/or out with the hospital setting. Potential solutions would require to demonstrate an effective user friendly testing system, validation of the sample volume, quality and analytical performance, and comply (or be working towards compliance) with UKAS accredited point of care testing facility (POCT) (ISO15189:2022) method for analysis and enable an interface with the NHS infrastructure for integration within the patient record to fulfil clinical governance requirements.
Long term vision
The goal of innovation and service redesign is to deliver family centred care at home for babies who do not require to be in hospital.
Developing care at home is a current priority across all UK NHS services and within the maternity landscape offers an enormous opportunity to reduce unnecessary maternal bed and cot occupancy. It will undoubtedly improve patient flow through neonatal and maternity services.
In NHS Scotland with the move to centralisation of Perinatal care for the sickest mothers and babies, developing processes to minimise unnecessary maternal bed and cot occupancy supports this model. Ensuring the smallest and sickest patients can be treated in the right centre at the right time.
Near-patient bilirubin testing to enable neonatal care at home would:
Achieve substantial cost efficiencies to the NHS by minimising unnecessary maternity and cot day’s usage.
Improve maternal and family bonding in the newborn period by keeping families together, appreciating the positive long term impact this has on maternal and infant mental health.
Impact positively on breast feeding rates with all the benefits for long term health and wellbeing this realises.
Reduce waiting times for decisions on treatment of jaundice in the new born, impacting on the potential complications of untreated high bilirubin levels.
Improve the patient journey and family experience of those experiencing neonatal jaundice.
Reduce health inequalities by widening this care pathway to families in more diverse geographical areas, a key ambition of NHS Scotland.
Reduce staff and family travel impacting positively on sustainability and the environment.
Support the long-term vision that neonatal care at home is embedded into normal clinical practice. Technology, patient monitoring systems and pathways with integration with the NHS patient record will all be in daily clinical use to realise this ambition. Patient satisfaction will increase, staff satisfaction will increase and efficiency of in patient resources will be optimised ensuring fiscal efficiencies to the NHS.
Validate near-patient testing technologies with transferable potential to other adult and paediatric disease settings.
Such initiatives must work with local, regional and national NHS Boards, Regional Test beds, Primary Care groups where appropriate to provide solutions which are readily tested, evaluated and reported in 12-18 month timescales to affect wider national strategies and NHS adoption.
The challenge will provide an opportunity for companies, working individually, collectively and/or in partnership with academia/strategic partners to bring to the attention of NHS Scotland, innovative solutions that are either commercially available and requiring some service development and/or feedback/further evaluation in order to enhance their scope for adoption and spread.
Organisations can apply for a share of £210,000, inclusive of VAT over a 2 phase competition. Phase 1 is allocated £60,000 for up to 4 projects. Phase 2 is allocated £150,000 for up to 2 contracts. Project costs should include all costs associated with any subcontractors or innovation hub resource requirements and include VAT.
This is a Small Business Research Initiative (SBRI) competition funded by the Scottish Health Industry Partnership (SHIP), part of the Chief Scientists Office, Scottish Government. Successful applicants receive 100% funding and access to advice from the NHS Scotland innovation hubs.
To lead a project, you can:
be any type of organisation of any size
work in conjunction with one of the NHS Scotland Innovation test beds to deliver R&D services
work alone or with other organisations as subcontractors
Contracts will be awarded to a single legal entity only.