Impact case study database

Following international award-winning research completed between 2003 and 2009 [R1 - R3, C6 - C6] trials with physically impaired patients (spinal cord injury, stroke and PDoC patients) began at the National Rehabilitation Hospital (NRH) of Ireland. PDoC patients are often incapable of reliable behavioural responses and thus behavioural based consciousness scales are insufficient to confirm awareness. We have collected substantial evidence (25 patients) that a subset of PDoC patients can modulate their brain activity to confirm consciousness and potentially enable interaction/communication without movement, thus impacting the patient, patient’s families and clinical teams. Associated impacts include:

I1: Establishing non-subjective evidence of awareness/consciousness in PDoC patients. For example, we used a BCI to assess awareness in a patient who had not communicated for 12 years, since suffering a brain injury as a teenager, and was considered to be in a minimally conscious state (MCS) . We provided non-subjective evidence of awareness and showed that the patient could modulate brain activity to interact with a computer in over twenty follow-up sessions between 2014 and 2018. The family reported immediate and long-lasting impact stating “[this] was a life-changing experience for our son… far better diagnosis of his condition… greater understanding of E’s capabilities… encouraged those working with E to redouble their efforts … reducing the amount of his medications [C4] ”. The research was top-10 nominated for the Annual BCI award 2015 [R6, C6]. Ethical approval for a national clinical trial with 17 hospitals across UK & Ireland has been granted (NCT03827187). Trials have been undertaken with twenty-five PDoC patients to date with additional reported immediate impacts as stated by clinical collaborators “… since 2014 the impact of the research has been deep and widespread, impacting patients, families, care teams, clinical interdisciplinary teams, awareness of spinal and brain injury, legal cases, international competitions and economically… from a clinical perspective the translational component of this research has been outstanding, enhancing and adding to real-time interdisciplinary team (IDT) therapeutic input, enhancing the clinical team-patient-family experience and incorporation of components of the BCI research in real-time patient care and augmenting IDT interventions.” [C7].

I2: Influencing the outcome of two medico-legal High Court cases. Research results with patient E and S have been presented in the High Court of Ireland (2015, 2020):- “the evidence that [Prof Coyle] gave to the High Court, in Dublin Ireland, in E’s case, against the Health Service Executive, Ireland, was instrumental in ensuring a successful outcome to the case which afforded E the financial ability to purchase the care regime [needed]…” (family, patient E) [R6, C4]; The High Court Judge’s report for patient E, [2015] IEHC 752, states the evidence by Damien Coyle “…was acknowledged … as substantially reflecting interaction with the plaintiff that was alternative to what was conducted [by others]” and “persuaded that some allowance should be made …in respect of Brain Computer Interface … annual sum of EUR3,750 (11-2015)… [and] EUR25,520 (11-2015) for provision of a Brain Computer Interface system…” [C4] . The family in the case of patient S stated “ Our legal team produced the report from Prof. Coyle and argued that this report clearly showed that S's brain function was coherent and stimulated when asked questions and that indeed she was aware of her surroundings and could make her preferred choices when given the option...this report had been a major contribution to getting the outcome we hoped to get... ” [R6, C5]. Solicitors in the case of patient S highlighting lasting impact in such cases stated that “…we have no doubt that [Prof Coye’s] services will be [the] cornerstone of the presentation of evidence in catastrophic injury cases…and … services will be required, used and approved by the Courts…” and the research report “…made a substantial financial difference to the level of damages we were in a position to claim and ultimately achieve for the client...” [C5]

I3: Enabling a spinal-cord injured (SCI) person to compete in Cybathlon. Between 2010 and 2011 EPSRC funded (EP/H012958/1) technology trials involving 11 people with spinal injury (3 reported in [R5]). Since 2016 one of the study participants competed with the Ulster team using our technology [R1 - R3] at the 1st Cybathlon (Zurich: ranking 6th), and subsequently in 2019 (Graz: ranking 3rd) and in 2020 (Global Format: ranking 6th). Enabling this person, who has had severe disability from SCI for over 20 years, to compete at an international level has impacted on the quality of life “…[the research] has had a major impact on my life and well-being…” [C8]. Cybathlon events have been attended by approximately 10,000 spectators, from “…over 100 countries…” and the organisers “…acknowledge the impact [Ulster] research and efforts have had on the establishment of the CYBATHLON initiative and raising awareness of disability globally...”  [C9]

I4: Creating a start-up company that employed 5 people, selling software, hardware and services in Rwanda, UK, Bangladesh. In 2013 an Invest Northern Ireland Proof of Concept project produced a prototype neurotechnology product, wearable electronics and suite of software applications. This led to two prestigious Royal Academy of Engineering fellowships for Professor Coyle (including an Enterprise Fellowship). In 2016, NeuroCONCISE Ltd was founded and seed-funded by Innovation Ulster and TechStart venture capital funds, to commercialise AI-enabled, wearable technology. NeuroCONCISE provides a suite of products (hardware and software) and services and has sold products (valued at GBP49,500) in 3 countries, has raised approximately GBP350,000 grant income (Innovate UK Project Nos. 103607, 104959), GBP210,000 equity investment, employed 5 FTE (83 person months) and has engaged multiple subcontractors across the UK [C10.1-3], won multiple awards including the IET Innovation Awards Best Start-up category 2018 and the inaugural IET & E&T Innovation of the Year Award 2018 where the new top award was chosen by the E&T editorial team, who said: "The judges felt that this project was part of something bigger, something genuinely important. It pulls on many interesting disciplines such as AI, electronics, software and big data, and interweaves them in a solution that promises real developments in the field. In terms of ‘engineering a better world’ this ticks all the boxes." [C6], [R1 - R6].

I5: Contributing to national reports that led to the formation of UK KTN Neurotechnology Innovation Network and UK Neurotechnology roadmap. On the basis of EPSRC (EP/H012958/1) funded research [R1 - R3] Prof Coyle was invited to contribute to a parliamentary report on assistive technologies [C1] and provide expert advice to Nuffield Council on Bioethics who reported on Novel Neurotechnologies in 2013 [C2]. Both reports have been cited in a proposal by KTN that led to the successful establishment of the Knowledge Transfer Network Neurotechnology Innovation network (March 2019) (where Professor Coyle is now an advisory board member) as acknowledged by KTN. “Your research, the neurotechnology research at the Intelligent Systems Research Centre and recently established Spatial Computing and Neurotechnology Innovation Hub along with your spinout company, NeuroCONCISE Ltd, has substantially impacted on [...] neurotechnology awareness in the UK, providing underpinning evidence that UK has a burgeoning and growing neurotechnology sector and driving the [KTN Neurotech] initiative… The impactful research you presented at a number of our workshops… [3 events] … has helped inform a much wider audience about the potential impact of neurotechnology, not only for the health sector, but also non-medical applications … Prof Damien Coyle helped design …a survey …with … response from across the neurotechnology community and has helped shape …a transformative roadmap for UK neurotechnology... and… also fed into the Regulatory Horizons Council’s recent study on regulatory reform around medical devices” [C3].

The NIFBM facility houses the only magnetoencephalography (MEG) laboratory on the island of Ireland (and, to our knowledge, the only one housed in a computer science research facility in the UK, perhaps the world). NIFBM has a focus on clinical research and applied clinical applications – positioning the facility uniquely to facilitate neuroimaging, brain dynamics analysis, interdisciplinary knowledge and expertise that inform life-changing operations and interventions. Impacts include:

I1: Presurgical evaluation of epilepsy patients using advanced Magnetic Source Imaging

Refractory epilepsy is characterized by frequent recurrent seizures that are resistant to medication. A systematic review and meta-analysis (2015) found that surgery offers patients with refractory epilepsy an improved quality of life and a better chance of becoming seizure-free. In January 2015 Consultant Neurologist/Neurophysiologist at Beaumont Hospital Dublin, Ireland,

and Clinical Lead of the National Epilepsy Programme in Ireland [C1], contacted the NIFBM facility to discuss the clinical application of MEG for pre-surgical evaluation of refractory epilepsy patients, particularly when there is an undetermined location of seizure-onset.

To date, the NIFBM facility, underpinned by methods and knowledge presented in [R1-R3], has completed a presurgical evaluation for seven patients under the care of the Consultant Neurologist, 3 of whom are detailed in [C1, C3] “ …MEG* has a well-defined role in the identification of epileptiform dipole, deep to the sensitivity of surface EEG and immune to the characteristics of skull breach, highlighted well in [patient A’s] case…” and “…MEG* provided critical understanding of the location of the seizure onset zone within the large region of dysplasia. In addition motor evoked potentials, identified the primary motor regions, which were adjacent, but distinct from the seizure onset zone. In this case MEG served a critical role in operative planning, and [patient R] underwent a focal palliative resection, dissecting out the bulk of the peri-sylvian dysplasia, with particular attention to the epileptiform region as highlighted by MEG study and sparing similarly recognised Motor Regions within the MRI imaging abnormality. He is now employed, leading an active professional and social life, and has been free of seizure with associated alteration of awareness and generalised convulsion since 2016”. and “MEG study identified independent bi-hemispheric epileptiform foci… and provided accurate informative information with regard to the currently active source for seizures in [patient R’s]

case, and we hope to incorporate repeat study when future therapeutic options are available”.

All reports added clinical value, aiding in decision-making processes that led to improved outcomes for all patients.

* (in the letter meaning our MEG imaging and analysis)

I2: Change of practice for presurgical planning of epilepsy patients on the island of Ireland using clinical MEG

The Clinical Lead of the National Epilepsy Programme in the Republic of Ireland  [ C1] has made progress in joining forces with colleagues in Belfast to establish an all-island Epilepsy Surgical Programme for adults and paediatrics. This has been promoted and supported by a Consultant Radiologist, who has worked with the Clinical Lead of the National Epilepsy Programme and the NIFBM to establish a clinical programme via the NIFBM. The Consultant Radiologist was instrumental in promoting the use of NIFBM for epilepsy care in Ireland stating

[C2] “… Arising from the development of NIFBM and the successful presurgical evaluation of epilepsy patients going for life changing surgery for epilepsy treatment in 2018 we have made significant progress towards establishing clinically applied MEG services in Ireland – specifically the launching of an all-Ireland epilepsy programme, and the progression of MEG as diagnostic tool for traumatic brain injury (TBI)...”. Following the success of the impacts highlighted in [I1] it has been recommended by the Clinical Lead of the National Epilepsy Programme that clinical care for patients with refractory epilepsy will involve a presurgical evaluation using MEG, given the added clinical value MEG brings to the presurgical evaluation procedure “… repeated study and incorporation in our clinical decision process, will allow for the further development of MEG at NIFBM, and has the potential to lead patients with otherwise life limiting Epilepsy towards the prospect of seizure freedom...” The NIFBM facility, as the only MEG in Ireland and given the expertise available at the facility [R1-R3], will be engaged to undertake these evaluations when the facility is fully established for clinical care. Currently approximately 60,000 people across the Rep. of Ireland and Northern Ireland suffer from epilepsy. Refractory epilepsy (resistant to medication) can occur in 20% to 40% of cases, having a debilitating impact on the patient – loss of self-confidence, livelihood, adverse effects on education and relationships, increased risk of memory deficits (particularly long-term, which includes autobiographical memory), and increased risk of depression and anxiety disorders. Thus, the change in patient care stimulated by the impacts [I1] not only frees more patients from recurring and frequent seizures, but significantly improves patients’ quality of life and their clinical outcomes relating to these secondary impacts as evidenced on [C1, C2].

I3: Brain-computer Interface supported post-stroke neurorehabilitation

A novel BCI-driven hand exoskeleton supported rehab therapy has undergone phase-2 trials

[R5]. Pilot clinical trials on post-stroke participants have been conducted in two phases. The first phase involved ten healthy individuals and ten chronic stroke patients participating in a feasibility study followed by the participation of four chronic stroke patients in a longitudinal pilot trial in India during Aug-Sept 2016. In the 2nd phase during Apr-May 2017 at Ulster, five post-stroke patients undertook up to twelve sessions of rehab therapy and underwent weekly resting state MEG scanning to assess recovery related cortical changes [R6].

A standard hand functional recovery measurement, the action-research arm test (ARAT), revealed that all the chronic stroke participants that underwent ten or more therapy sessions in the clinical trial achieved clinically important improvement in their hand function [R5, R6] and all reported transformative change in their quality of life because of the recovery of upper limb functional use and in improvement of overall mental health. A testimony from a patient as a video interview as well as a handwritten letter [C4] highlights multiple impacts this improvement in function has had e.g., “…more coordination of my hand picking things up… like a button… I can touch back of my head… hold my umbrella steady… tie my shoe laces… I feel more confident when I go out… to restaurant, using knife + fork... [looking forward] to upcoming wedding”, which were earlier not possible. A report from the occupational therapist details the improvement in patient outcomes following engagement with the technology developed at the NIFBM facility, “…having undergone the pilot trials the stroke participants have reported transformative change in their quality of life, particularly in the recovery of upper hand motor functions. This is clearly evident from the video interview I conducted with at least one of the patients” [C5, C6].

I1. Improved caller access to helplines: In our research [R1-R2], five cluster archetypes were identified, for example, high frequency callers making thousands of calls over time. Helpline Manager, Samaritans Ireland, said “ *The identified cluster archetypes and toolsets developed have become part of the lingua franca for Samaritans, used in analysing awareness campaigns and most recently, examining the impact of COVID-19 on the helpline. The research has now been replicated across the UK as well and the initial tools are being developed into a dashboard.*” [C1]

Policy Officer, Samaritans Ireland, said “ The data analytics approach by Ulster has provided us with solid quantifiable metrics of the impact of government policies and other events on public mental health through our helpline. We are now applying these metrics to serve operationally as real time mental health monitors of public levels of wellbeing.” [C1]

Since April 2020, research on caller archetypes and queuing was operationalised in a live dashboard service for the Samaritans, helping them better understand callers in real-time and improve service provision. In using queuing to manage high frequency callers and move their behaviour to that of regular callers, this freed up around 50% of the time previously taken to answer and speak with these callers, enabling Samaritans volunteers to answer significantly more calls. [C1]

I2. New assistance programmes for employees and vulnerable groups: Our collaborative research with Inspire Wellbeing [R3] co-developed a new digital mental health service called the Inspire Support Hub as part of our award-winning Knowledge Transfer Partnership. [C2, C3, C4, C5]

Inspire Chief Executive Officer said, “ *If we did not have the foresight, bolstered by the Ulster University team’s belief in the direction to take, then our company would now be playing catch up in digital employee access programs and student services.*” [C2]

In terms of impact, Inspire Director of Professional Services said, “Since June 2019, our Inspire Support Hub is used by over 350 clients across a range of sectors. This includes 560,000 employees in the workplace across Ireland, over 180,000 students in further and higher education across Ireland and over 60,000 clients in specialist occupational groups such as the emergency services and our local veteran community”. [C2]

An Inspire service user said, “ The Inspire Support Hub has really helped me get through the past few months. It is easy to use, with lots of information and I have been able to log in any time. I have been using the Hub to help me manage my drinking which has really worked during the lockdowns. I would have struggled without the help from Inspire.” [C2]

I3. NHS digital reminiscence app: Our work [R4-R6] which presents and assesses an app provided direct evidence to the NHS on the viability of apps for people with dementia, in terms of uptake, sustained engagement, and on the value of event logging to help understand anonymous app usage, leading to the Ulster-coordinated Apple and Google InspireD app development and rollout in 2020. [C6, C7, C8, C9]

Feedback from a person living with dementia said of the app, “ *I put everything to do with my life and the people I love inside a little piece of machinery that is wonderful. At the touch of a button, it can reflect everything that has happened to me in my past and the lovely people I’ve met.*” [C6]

‘The Songbirds’ play, commissioned by the InspireD team and based on the findings of the research, described as “ insightful and educational” by the Alzheimer’s Society, had audiences of approximately 2,000 across 14 showings. A person living with dementia described the play as “ just like watching myself. …. it gives a 100% perfect representation of a person with dementia, that is the truth”. [C6]

The Innovation & Digital Eco-system lead in Health and Social Care, Department of Health in Northern Ireland said: “ Working collaboratively with Ulster University, the InspireD research and app is part of a wider digital transformation programme in health and social care which is being led by Digital Health & Care NI (DHCNI) with the support of DoH. Using a co-production approach DHCNI works across the health and social care organisations, governmental bodies, academic, industry partners and community & voluntary sector representing patients and carers to develop our digital eco-system. Our partnership with Ulster University on the InspireD App-research, development and roll-out is an example of this new programme of engagement. The overall aim is to embed clinically assured digital solutions that have been checked for data privacy and security into our clinical pathways.” [C7, C9]

I1 Internet-based product for managing the logging and dispensing of medication leading to 8 jobs, uptake by 150 users across 5 care homes and annual revenue of GBP1,200,000. [ R1, R2, R5]

[text removed for publication], a pharmacy automation business based in [text removed for publication], Northern Ireland (NI), has taken the findings from our research and created a new internet-based product for the management of their medication provision in care home settings. In 2016 the company wished to expand its operations into the domiciliary care market, but did not have the experience nor the technology expertise to do so [ C1]. Through its engagement with the PCRC, the research findings and workflow management through an internet care model from the MEDICATE Project [ R1] and mobile medication solution [ R2] were used to create the design of a new mobile internet-based solution for tracking and managing medication sachets within care home settings. Findings from the digitisation of workflow management in the medication process [ R1, R2] in addition to approaches to improve technology adoption [ R5] were incorporated into the solution. [text removed for publication] subsequently leveraged funding to realise the product and in 2019 launched its new product offering, [text removed for publication]. This is now being used in 5 care homes across NI to support approximately 150 users. Since engaging with PCRC, [text removed for publication] has grown its team from [text removed for publication] to [text removed for publication] (representing an increase in headcount of [text removed for publication]). The company has since entered a new market of medication management in care homes and has increased its annual revenue from [text removed for publication] in 2016 to [text removed for publication] in 2020 [ C2]. Improvements have been found from both patient and healthcare professional perspectives as evidenced in documented testimonials [ C7]. The manager of Inspire Supported Living Care Home said that in using the automated processes of [text removed for publication] “ it is a simplistic system” which has “ drastically reduced our timeframe” for managing medication within the care home [ C7]. Families using the solution have advocated that it assists with managing complex medication regimes and that “ there is absolutely no confusion as to what that medication is”. Users of the solution who previously had been challenged with the complexity of their medication regime have reported that “ it has given me peace of mind” [ C7].

I2 Online training platform for carers of people with dementia with 80 individual licences and 13 group sales in 6 EU countries. [ R3]

Through involvement in the EU STAR Project and evaluation of the findings from the randomised control trial conducted by the consortium [ R3], PCRC joined with members of the consortium to develop a multi-lingual online training portal, the ‘STAR Training Portal’. Since 2015, the portal ( www.stratraining.eu) has generated 13 group sales and 80 individual licences in 6 EU countries UK, Netherlands, Romania, Italy, Malta and Sweden. The ambition was to deliver a low cost and affordable solution to support carers of people with dementia (25 Euros per user). Profits are split between partners within the original STAR consortium on a pro-rata basis aligned with the original Project funding and in accordance with a Joint Ownership and Collaboration Agreement [C3].

I3 Establishment of new policy guidelines for 45,000 Social Care Council staff in Northern Ireland and impacting the life and health sciences sector in Northern Ireland. [ R2, R4, R6]

Through extensive research on caring solutions and technology driven care models the PCRC has engaged with a number of agencies and initiatives to deliver impact across a broad range of care based training, policy development and advisory initiatives that have informed roadmaps for delivering connected health products and services for caregivers including:-

• Northern Ireland Social Care Council (2018-2019)

• Connected Health Summer School (CHSS) (2016-2019)

• International Federation of Ageing

• MATRIX Life and Health Sciences NI

• The Health Innovation Research Alliance Northern Ireland (HIRANI)

The PCRC has worked with the Northern Ireland Social Care Council (2018-2019) to assist it in understanding and developing its digital capability for its 45,000 registered staff who deliver social work and social care services in Northern Ireland [ C5]. The development of the council’s digital skills for social care strategy has been based on the collection and analysis of staff feedback undertaken by PCRC [ R4][ C6]. This has resulted in an increase of 50% in users engaging with the council’s online learning zone for the promotion of technology within the workplace [ C5].

The PCRC has raised awareness of the use of technology for reminding purposes, to support persons with dementia and in general healthcare provision in a number of settings [ R2, R6]. Through the Connected Health Summer School (CHSS), which annually presents the research results from the REMIND consortium, the PCRC has co-organised and delivered the event over the last 4 years (2016-2019) to technologists, clinicians and industry practitioners [ C4]. In a post event assessment to determine the benefits of the CHSS, all respondents stated that the summer school would have an impact on their future careers; and, that improvements in knowledge across technical, health and business domains were achieved [ C4]. One industry participant stated the “ summer school has been an amazing experience. Both from a personal and from a professional development perspective. The direct contact with the problem owners offers a clear and full perspective of their needs and wishes. It also allows for direct, well-nuanced feedback of any solution direction that is being considered. The offer of both technical and health care oriented sessions show the full breadth of the potential solutions, allowing participants to look beyond their own discipline. Professionally, I have benefited greatly in my development. Hoping to contribute to the medical technology field, I am now organizing a boot camp in the Medical Device Regulation (MDR) for the second year in a row. In this boot camp, we bring medical technology companies, start-ups and students together to test specific use cases for compliance with the MDR.”

Based on a general appreciation for the expertise acquired by the PCRC from research in the area of technology-based solutions for care provision, Prof Nugent was invited to join a panel of technology experts by the International Federation of Ageing to produce the ‘Reablement and Older People’ guidelines for the design and implementation of technology driven care models [ C8].

Prof Nugent was also invited to join the MATRIX Northern Ireland Science Industry Panel, a business led expert panel, formed primarily to advise government, industry and academia on the commercial exploitation of R&D and science and technology in Northern Ireland. The Chair of the MATRIX Panel stated that Prof Nugent was appointed to the panel “based on his research and academic track record and that he was a valuable member of the panel and that his research helped to inform the content of the report and shaped the recommendations” [ C9].

The expert panel published the MATRIX Life and Health Sciences NI ‘Capability Assessment and Foresight Report’ in 2015. MATRIX commissions research, analysis and studies to build an evidence base for future science and R&D policies in Northern Ireland. One of its objectives is to ‘identify, agree and oversee a programme of market led science and technology Foresight studies’. The report outlined recommendations to government highlighting the need (amongst others) for the further training of healthcare professionals and in terms of clear leadership and co-ordination the report highlighted “the importance of building a committed, visible leadership and co-ordination capability for the sector. A facility whereby decision makers within industry, academia and government meet to make decisions for Northern Ireland would dramatically progress this issue” [C9] . Following recommendations from the report in 2019 Invest Northern Ireland have funded the establishment of The Health Innovation Research Alliance Northern Ireland (HIRANI) an alliance of universities, health organisations and other industry bodies, established to drive and support ambitious growth in Northern Ireland’s Life & Health Sciences sector. The Chair of the MATRIX Panel stated “The recommendations from the Matrix report absolutely led to the establishment of HIRANI as a vehicle to coordinate and lead the life and health sciences sector in NI. Moreover, the recommendations also formed the basis of Invest NI’s life science sector strategy informing areas of sectoral strength and approaches that might support business growth and expansion in the sector”. Research by the Fraser of Allander Institute in 2020 revealed that the life science sector in Northern Ireland is thriving, supporting 18,000 full-time jobs throughout Northern Ireland.

I1 – ECG algorithm for computing biomarkers  This impact directly follows from [R1]. The algorithm has now been fully adopted since our

final 2015 publication and is being used to compute ECG biomarkers in drug trials [C1]. The algorithm is being used to compute features such as the J-T peak and the QRS-T angle which

are regarded as important for predicting mortality/morbidity and adverse side-effects in drug trials. According to the FDA, Ulster’s algorithm is being used to predict “the risk of drug-induced abnormal heart rhythms”.  To date, the FDA has used Ulster’s algorithm [text removed for publication] to detect adverse cardiac side-effects ensuring patient safety and drug quality. While FDA regulatory constraints place an embargo upon the surrounding specific drug trials, we are able to clearly demonstrate that Ulster’s research has impacted upon the practice of a large regulatory organization (FDA) which has adopted Ulster’s algorithm for routine use.

I2 – Medical training This impact directly followed [R2] and [R3]. Having developed a simulator that allows users to see the effects of ECG recording errors, it was shown to be a useful educational tool [C3], and was hence integrated into a medical textbook (12th edition Marriott's Practical Electrocardiography, first established in 1954) and [text removed for publication] [C2] resulting in gross revenue of [text removed for publication] (2014 to 2019). Also, one educator created an online video using the simulator receiving approximately 7,828 views since August 2018 [C4].

I3 – Validated medical devices This impact directly follows [R2-R5]. Ulster’s work in [R5] with HeartSine involved validating the user performance of a novel defibrillator inbuilt with automated audio-visual feedback. From

this work, HeartSine went on to gain regulatory approval for a first-of-kind medical device (AED)

that uses advanced feedback technology to guide users to perform CPR. This device is now available on the market, and has been approved [text removed for publication]. According to HeartSine, sales of these devices have [text removed for publication] since the study involving Ulster. Feedback from a paramedic who recently used the device to save a life said that: “I have been a Paramedic for 30 years.… I recommend this AED daily to anyone that asks” [C7].  Ulster’s research in [R2] and [R3] on the effects of ECG electrode misplacement errors on ECG signals was highlighted by the U.S. Department of Health [C5] and identified by a medical company (eNNOVEA Medical) [C6]. Ulster collaborated with eNNOVEA Medical and helped demonstrate that its device (CardioQuick Patch) reduces electrode placement errors [R4] as well as improving ECG reproducibility (since patients often require multiple recordings). The solution (CardioQuick Patch) is available on the market: Quote from [text removed for publication] at eNNOVEA Medical: “it was this time last year that we kicked off the … CardioQuick Patch®:

… study. Since its presentation as a poster at ISCE and publication in the Journal of

Electrocardiology we have engaged over 15 new hospitals including prestigious institutions such as UPMC and University Hospitals Cleveland Medical Centre as well as private industry such as Eli Lilly Pharmaceuticals. In addition, we have entered into negotiations with a major ECG instrument manufacturer to have us OEM the CardioQuick Patch for sale by their field force. Much of this would not have happened so rapidly if it were not for the research, manuscript development and presentation you and the university were part of. In the 30 years of device development and new product launches, I can say that working with you… was the most fruitful and delightful experience I have had. ….”

I4 – Informing standards This directly follows [R1] and [R6]. Ulster’s ECG algorithm as adopted by the FDA has informed a draft standard and associated technical reports in 2018 [C1], namely IEC 80601-2-86 (medical electrical equipment). The FDA has included a description of Ulster’s algorithm in these documents [C1]. Ulster’s work on [ R6] regarding automation bias of ECG algorithms has been

cited and used to inform the working IEEE standard (P7003) on algorithmic bias in 2018 [C8].

Our work on ECG data structures informed the development of PDF-ECG [C9, C10] in collaboration with companies such as AMPS, Phillips Medical, Mortara Instrument and GE Healthcare. PDF-ECG is a novel electronic solution that preserves the raw data as well as presenting an image of the ECG. PDF-ECG was used as a proof of concept at Fondazione

Poliambulanza Hospital (Brescia, Italy).

I1 Establishment of a free to use, national, IoT communications platform (LPWAN) accessed by >130 companies.

In 2018 Ulster established a free-to-use, national, IoT communications platform (LPWAN-NI). LPWAN-NI offers a low-power, wireless, wide-area, network for development of IoT solutions

[R2].

LPWAN-NI consists of over 60 gateways covering the geography of Northern Ireland including hard to reach border regions. LPWAN-NI has been accessed by over 130 companies and

approximately 17M messages have been sent via the network since its establishment in 2018

[C1]. This has been independently verified by Digital Catapult [C1]. Ulster was awarded

GBP185,000 in funding to support local start-ups with the aim of producing new products leveraging the network [C1]. 19 new business ventures have been created, and large public service providers such as [text removed for publication] are using the network to monitor essential equipment [C2]. One exemplar of companies benefiting from the network is [text removed for publication] [C2]. [text removed for publication] now employs 3 members of staff (headcount 3, 2.5 FTE) and has been established to drive novel solutions to market based on LPWAN technology and University expertise [C2].

I2 Development of open software infrastructure to underpin the collection of sensor data

for self-management solutions in Northern Ireland and Italy.

Collection of qualitative and quantitative healthcare data lends itself to a wide range of applications including psychology, sports, health and wellbeing. Researchers at Ulster have produced an open, scalable, and flexible software architecture for the collection and sharing of such data [R1-R2]. Variations of this architecture have been adopted by the SMEs [text removed for publication] and [text removed for publication]. Since 2016, [text removed for publication] has been using the data aggregator, which collects data from health devices, mobile apps and self-reporting, as a self-management platform for various Chronic conditions [text removed for publication]. It has confirmed that the integration of Ulster research into its product portfolio has led to the following impact [C3]:

• Development of a new self-management app for long term chronic conditions.

• Used the aggregator to secure contracts of over EUR130,000 (10-2020).

• Established collaborations with more than 15 international partners.

The software architecture has additionally been utilised by [text removed for publication], to collect data from sensor technology in a care home and prison environment. The solution was the subject of two Invention disclosures within Ulster [C4]. The solution was subsequently licensed for evaluation by [text removed for publication] on 23/08/2017 [C5]. Since licensing this technology, [text removed for publication] has diversified its company from security, establishing a health division [text removed for publication].

I3 Creation of a self-management product, incorporating behaviour change strategies, for an SME in Northern Ireland, currently being sold in 22 countries.

Ulster’s research into the design, development and evaluation of self-management technologies, specifically processing for sensor data for behavioural insights [R3-R4] and the development of health apps [R5-R6], has directly led to the creation of new products for SME [text removed for publication]

Following the underpinning research [R3-R6], knowledge was transferred to the company through a KTP project. The impact of this research partnership has been acknowledged by the Senior Knowledge Transfer Adviser from KTN [C8]. The partnership was also rated as “Outstanding” by a panel of independent reviewers as part of the KTN assessment [C9]: “This project has embedded a very significant new capability into the business, which has allowed the company to capture clinically important data (KTN, Knowledge partnership adviser)” [C8].

[text removed for publication] consists of a connected sensor that quantifies movement and a mobile app that contains elements of goal setting and gamification to encourage participation

in physical activity.Both measurement and gamification were investigated within the fundamentalresearch [R4] and taken forward through the KTP. This is the first software enhanced product to be offered by [text removed for publication] [C6]. The first product in this range, [text removed for publication], was launched in December 2019 and is currently being marketed in 22 countries, including the UK, Europe, Middle East, and new markets in Australia. [text removed for publication] have been delivered with 25 demo units produced and sales of approximately [text removed for publication]. In [text removed for publication] 2020 [text removed for publication] was acquired by [text removed for publication]. The innovation, as demonstrated by product lines such as the [text removed for publication], has been critical in attracting such an acquisition. [text removed for publication] have been impressed by the innovative approach to research and development at [text removed for publication] and are keen to grow the [text removed for publication] of their business with [text removed for publication] in Northern Ireland” [C6].

It is estimated that over 100 children have already positively benefited from using the product. A case study with a child using the device, his parents and care team has highlighted the impact this technology has on children’s quality of life. Physios have reported improvements in standing time  from 20 to 48 seconds in 8 weeks. Classroom assistants have reported that [text removed for publication] is now able to stand up much straighter and needs less help in and out of his wheelchair than before” [C7].