Posts by: Caroline McGarry

Irish company Ostoform provides solutions for patients post-surgery with their medical device® Mouldable Seal with FLOWASSIST®which is now available for public and private patients in Ireland

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Health Innovation Hub Ireland worked with Ostoform on a product pilot which will change the lives of Irish patients post -surgery.

HIHI along with Kevin Kelleher, CEO of Ostoform, worked on a healthcare challenge. People who have had a surgically created stoma, particularly an ileostomy, are at risk of developing peristomal skin complications, with incidence rates of up to 63% reported in literature. Currently, treatments of peristomal skin complications are limited. Pastes are available, but they can often impede ostomy bags from sticking to the skin. Furthermore, the bags themselves can contribute to peristomal skin complications, by allowing waste to contact the peristomal skin, causing chemical irritation and standard seals are often broken down by stoma output, which then contacts your skin resulting in irritation and discomfort.

The Healthcare Solution is the Ostoform Class I medical device aims to prevent the development of peristomal skin complications. With all ileostomies, there is a risk of stoma output contacting the peristomal skin and causing irritation. Ostoform was designed to minimise this risk. The Ostoform Seal is a device designed to prevent the development of peristomal skin complications and ensures that stoma output flows away from the skin, keeping it safe, healthy and comfortable.

HIHI played a pivotal role in the development of this product pilot and designed and project managed two separate multisite clinical studies to assess the impact and efficacy of their FLOWASSIST novel ostomy device. The initial study included Tallaght University Hospital St James’s Hospital and University Hospital Galway, engaging two CRFs in Dublin and Galway.

The second study was conducted at Cork University Hospital, Mercy University Hospital Cork and University Hospital Galway. Patients with an ileostomy were screened from the stoma nurse’s outpatients list, those who met the inclusion criteria were invited to participate. There was no control group in this study as currently there is no accepted ‘standard care’ device for the management of peristomal skin complications so patients use a range of different devices. Ethics approval was obtained for both studies.

The outcome of the product pilot obtained its objectives. The purpose of this practical application study was to evaluate the effectiveness of the Ostoform® Mouldable Seal with FLOWASSIST® Protection in protecting the skin of people with an ileostomy, as well as to gather user feedback on the perception of the device. 60% of the participants remained at a very low DET score throughout the study, and 35% of participants demonstrated an improvement in DET score provides an indication that the novel barrier ring can be effective in protecting the skin. User feedback was positive with respect to comfort, device handling and the perception of the device’s ability to protect the skin. Furthermore, the majority of participants who already used a barrier ring, indicated that the FLOWASSIST device would result in a longer wear time.

In 2021, the clinical study with Ostoform and HIHI concluded and results were accepted for publication. An application for inclusion of this product on HSE Primary Care Reimbursement Scheme for public patients was submitted to the HSE and approved in September 2022. As a result, the Ostoform FLOWASSIST product is now available to Irish patients.

Kevin Kelleher Ostoform’s CEO spoke about the product pilot and HIHI’s involvement. “HIHI supported Ostoform by preparing and conducting two separate clinical studies, both of which demonstrated very encouraing results. Our FLOWASSIST technology demonstrated a statistically significant reduction in peristomal skin complications, along with additional user benefits. As a result, the product has been awarded premium reimbursement by the HSE. The HIHI played a central role in getting the Ostoform Seal to market in Ireland, and this will result in improved quality of life for ostomy patients across the country”.

Ms Noreen Lynch, Health Innovation Hub Ireland Clinical Liaison said: “As a nurse, I am always looking for new products that make it easier for patients to manage their recovery after surgery. We were delighted to support Ostoform to evaluate their FlowAssist seal with ileostomy patients and to see the real impact these products have on patients. The product is now available in Ireland to public and private patients and is already on the international market”.

Read the full case study here


Health Innovation Hub Ireland launches another successful FemTech case study with Nua Surgical

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Nua Surgical founders Padraig and Marie Therese Maher and Barry McCann
NUA Surgical is a Galway based, start-up company dedicated to innovating in women’s health. The company, which is a spin-out from the University of Galway and BioInnovate Ireland, was founded in 2019 by Barry McCann (CEO), Marie-Therese Maher (COO) and Padraig Maher (CTO). They have developed the patented SteriCISIONTM C-section retractor, which aims to improve access and visualisation during caesarean surgery and provide multiple benefits to clinicians, patients and healthcare systems.
The Enterprise Ireland backed high potential start-up has been recognised nationally and internationally with multiple awards for its innovative approach to improving maternal health outcomes. These include overall winner of IntertradeIreland Seedcorn Competition (2020), EIT Health Headstart winner (2020), Parkview Health Global Maternal Health Innovation winner (2021), and overall winner at the National Start-Up Awards (2022).
NUA Surgical’s SteriCISIONTM retractor has been designed alongside obstetricians to answer their unmet needs when performing a caesarean delivery. It will provide superior access to the uterus, enabling hands free management of the surgical incision space and therefore reducing the opportunity for bacteria transfer into the wound. The self-retaining retractor will be provided as a sterile, single use disposable device which is also important to reduce the risk of infection.
Its ergonomic design enables easy, safe and fast retraction, mimicking the natural hand movements of the obstetrician and the soft-touch adjustable paddles cater for their visualization needs on each patient’s anatomy. Ultimately, SteriCISIONTM will provide suitable access and visualization for clinicians to safely deliver the baby, identify any bleeds and repair the uterus in a time-sensitive surgery.
Speaking on completion of the case study Barry McCann CEO of Nua Surgical spoke about working with HIHI.
The insights are invaluable! We are grateful for the support of the HIHI team and are excited to be involved with their FemTech programme moving forward.”

Health Innovation Hub Ireland announces another successful case study with Gasgon Medical

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Gasgon Medical has developed a novel closed-system air trap, the AirVault. As a single-use device, AirVault is designed to provide a safe, easy and effective technology to prevent the impact of Air-in-Line, a common disruptor of infusion therapy, which will result in improved safety for patients and healthcare staff. Gasgon has just frozen its design so that it can focus on a multi-centre study designed to capture clinical evidence and contribute towards CE mark and FDA accreditation. Gasgon Medical approached HIHI to get feedback on its AirVault medical device from clinical experts to ensure it will meet the needs of healthcare professionals and their patients.

Through its clinical network, HIHI identified suitable clinicians to attend five focus groups in three different hospitals in Cork and Dublin. HIHI facilitated the focus groups, advised on the key questions which were addressed by over 35 experts in nurse practice development, nursing management, infection control,
oncology, pharmacy, quality risk management and biomedical engineering.

The company received valuable feedback and suggestions, which assisted them in the final design of the AirVault. The clinical feedback also highlighted other use-cases for this technology which HIHI is currently helping the company to explore.

Read the full case study here:

Health Innovation Hub Ireland (HIHI) announces the launch of a pilot study in collaboration with Whyze Health Ltd at Blackrock Health Galway Clinic

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Health Innovation Hub Ireland (HIHI) announces the launch of a pilot study in collaboration with Whyze Health Ltd at Blackrock Health Galway Clinic

A new platform aims to deliver more informed prostate cancer treatment plans

As part of Health Innovation Hub Ireland (HIHI) Pilot Call 2022, HIHI is delighted to collaborate with WHYZE Health Ltd. and Blackrock Health Galway Clinic in a pilot study of WHYZE Health’s platform.

What is the platform and what does it hope to achieve? Through the WHYZE Health Platform, patient-reported outcomes and health data can aid the delivery of informed prostate cancer treatment plans, providing physicians with the necessary information to select the best treatment options for their patients. By analyzing these data systematically and in real-time, the portal allows for real-world outcome feedback to be provided to patients and their care teams for the first time. This, in turn, streamlines the care provided by physicians, reduces diagnostic timelines, and improves patient outcomes. The study aims to demonstrate the real-world evidence (RWE) power of patient-reported outcomes to improve health outcomes and quality of care.

Dr Tanya Mulcahy, Director of Health Innovation Hub Ireland welcomed the launch of the pilot. “HIHI is thrilled to work with WHYZE Health and Blackrock Health Galway Clinic to showcase the efficacy and value of the WHYZE Health Platform in a live environment. By giving patients more control over their care and streamlining treatment options for physicians, the WHYZE Health Platform has the potential to improve health outcomes and advance the transition to patient-centred healthcare”.

The platform tracks the patient’s progress and collects relevant RWE throughout the entire health cycle of the patient’s treatment plan, including follow-ups. This easy-to-use tool empowers patients to take control of their care, considering individual risk factors and desired outcomes for each patient. The benefits are that providers can share healthcare data with patients and allow online scheduling of upcoming appointments. Additionally, the platform drives a patient-centred transition to healthcare by bringing health and research opportunities directly to healthcare providers and patients, advancing global awareness of clinical trials, and enabling better health outcomes. Integration of digital technologies into hospital services is key to the connection and communication with patients and will be the future of healthcare.

Dr Steven Griffin, Manager, Health Innovation Hub Ireland, University of Galway explained the value of HIHI pilots to the healthcare system and to patients in Ireland. “These pilots highlight the benefits of novel solutions to patients, healthcare staff, and the healthcare system. In turn, successful pilots demonstrating value should be must-haves for modern patient-centred healthcare systems.”


Photo caption – From left to right: Prof. Frank Sullivan, CMO WHYZE Health and Director Radiation Oncology, Prostate Cancer Institute (NUIG) Blackrock Health, Galway Clinic; Phil Blackwell, Chief Technology Officer, WHYZE Health; Dr. Tanya Mulcahy, Director, Health Innovation Hub Ireland; Frances Abeton CEO, WHYZE Health; Evelyn Smyth, Interim CEO, Galway Clinic; Abby Langtry, Chief Patient Officer, WHYZE Health; Alyson Banks, Patient Safety Executive, Galway Clinic (Photo: Business Wire)


Dr Tanya Mulcahy talks to 96FM news about the HaPPE apron

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Listen back to Dr. Tanya Mulcahy’s interview with Mairead Twohig on 96FM News.

A compostable PPE apron has been developed by two Cork entrepreneurs to tackle the single use plastic increase due to PPE usage during Covid.

According to the WHO, during the pandemic, plastic production more than doubled.

Dr Mary O’Riordan and Lisa O’Riordan created the HaPPE Apron which is CE approved and has been piloted at the South Infirmary in Cork.

The product was a winner of the Health Innovation Hub Ireland Open Call 2022.

Speaking to Cork’s 96FM & C103 News, Director of the Hub, Dr Tanya Mulcahy says pilots in other hospitals are planned.

Dr Mary O’Riordan says the product takes five weeks to degrade while the standard LDPE apron takes about 50 years.

Our news reporter Mairead Twohig has more


Irish start-up HaPPE Earth develops sustainable PPE for healthcare

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Irish start-up HaPPE Earth develops sustainable PPE for healthcare

New PPE apron has been trialled in Cork hospital

An Irish start-up has developed a more sustainable alternative to traditional personal protective equipment (PPE) in a bid to help cut carbon emissions from healthcare.

The “green” PPE apron from HaPPE Earth is made from a proprietary resin that is composed of compostable bioplastics. It matches the safety parameters of current, medical Low-Density Polyethylene (LDPE) single-use aprons, is CE approved and suitable for use in healthcare.

It also produces lower levels of carbon emissions in its manufacture. Overall, the apron has a carbon footprint 75 per cent lower than a standard PPE apron, with no waste in the manufacturing process and using sustainable energy sources for production. Because it is compostable, it places less burden on the non-clinical waste services of hospitals.

Developed by Irish entrepreneurs Dr Mary O’ Riordan and Lisa O’Riordan, the HaPPE Apron is being piloted at South Infirmary Victoria University Hospital (SIVUH) in Cork, and a second trial is due to begin at Tallaght University Hospital in Dublin.

“To see our compostable apron being used by frontline staff in the South Infirmary Victoria University Hospital and to get such support from the HIHI team was invaluable to us. It is through collaboration like this that we bring practical solutions to our health system,” the co-founders said. “We want to make an impact on sustainability within healthcare – the HIHI programme is extremely well organised and supportive, we were delighted to be part of it”.

The product was one of 11 winners of the Health Innovation Hub Ireland (HIHI) Open Call 2022, leading to the pilot assessment in Cork. Some 7,000 HaPPE Aprons were tested for wearability, acceptability, sustainability and durability, across the elective orthopaedic ward, the orthopaedic rehab ward and across the hospital catering and kitchen services.

“Worldwide, the healthcare sector is responsible for as much as 4.6 per cent of total greenhouse gas emissions. If Ireland is to make an impact, we need to look at innovative products that reduce carbon emissions while maintaining safety,” said Dr Tanya Mulcahy, director of Health Innovation Hub Ireland. “The HaPPE apron is safe, equivalent to current PPE and is addressing sustainability – it’s also Irish. I am delighted that HIHI and SIVUH have demonstrated that this is a viable option for Irish and global healthcare.”

Irish start-up HaPPE Earth has created a sustainable alternative to PPE- to reduce healthcare carbon emissions

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Read the Irish Examiner article on how Cork entrepeneurs developed a compostable PPE apron to reduce plastic waste

Cork entrepreneurs develop compostable PPE apron to reduce plastic usage

Lisa O’Riordan, Co-founder HaPPE Earth, Johnny Brackett HCA, Niamh Allen, HIHI Clinical Liaison and HSE Clinical Nurse Manager, Dr Mary O’Riordan, Co-founder HaPPE Earth, Lily Matthews, Clinical Nurse Manager 1 Picture: Jim McCarthy

Two Cork entrepreneurs have developed a compostable PPE apron which disintegrates in just five weeks compared to traditional PPE gear which takes up to 50 years to degrade.

Cousins Dr Mary O’Riordan and Lisa O’Riordan developed the compostable apron in response to a doubling of the amount of plastic pollution generated during the Covid-19 pandemic.

The apron, which is suitable for use in healthcare settings, was developed under their start-up HaPPE Earth and has been piloted at Cork’s South Infirmary Victoria University Hospital.

Dr O’Riordan has worked in clinical medical practice for 18 years, the last eight of those involved with Public Health Medicine, specialising in Emergency Response for Highly Emerging, Infectious Threats.

“As a result of Covid, it became very important to me and my co-founders that we take immediate steps to tackle the single-use plastic increase due to PPE usage, and so HaPPE Earth was born,” she said.

Compared to the standard LDPE apron, which is used across healthcare and takes about 50 years to degrade, the HaPPE apron degrades in just five weeks while offering the same level of protection to healthcare professionals and patients.

The apron reduces the carbon footprint of a standard apron by more than 75% through the use of local transport and manufacturing. Made of compostable resin, it also ensures no waste in the manufacturing process while the manufacturing plant itself uses sustainable energy for production.

It was one of 11 winners of the Health Innovation Hub Ireland (HIHI) Open Call 2022 and as a result, the HIHI conducted a pilot assessment of the apron in the South Infirmary Victoria University Hospital in Cork.


The HaPPE Aprons were tested for wearability, acceptability, sustainability and durability across two wards as well as the hospital catering and kitchen services. The co-founders of HaPPE Earth said it was “invaluable” to see the apron used by staff in a hospital.

“It is through collaboration like this that we bring practical solutions to our health system. We want to make an impact on sustainability within healthcare — the HIHI programme is extremely well organised and supportive, we were delighted to be part of it,” they said.

HIHI Director Dr Tanya Mulcahy said it is important to look at innovative products that reduce carbon emissions while maintaining safety to make an impact. She said the apron has been proven to be safe and equivalent to current PPE and hopes to see it used across the entire healthcare system.

Read about HaPPe Earth’s sustainable alternative to PPE featured in today’s Irish Examiner




Read Silicon Republic’s article on All-island project aims to improve procurement of Irish medtech SMEs

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Health Innovation Hub Ireland national director Dr Tanya Mulcahy. Image: Daragh Mc Sweeney/Provision

The All-Island Medtech SMEs project plans to improve medtech adoption in secondary care across Ireland’s healthcare systems.

A new cross-border partnership aims to push past the procurement barriers impacting medtech SMEs and public healthcare systems.

The All-Island Medtech SMEs (AIMS) is bringing together various stakeholders such as businesses and academics.

The project’s overall goals are to develop a framework to support procurement and improve medtech adoption in secondary care across the Republic and Northern Ireland.

The project is being delivered by Health Innovation Hub Ireland (HIHI) and the Health Innovation Research Alliance in Northern Ireland (HIRANI).

HIHI national director Dr Tanya Mulcahy said smaller businesses are often “precluded from the procurement process”.

“AIMS will look at how we can address barriers such as these so that indigenous medtech can scale and grow and our health systems can choose from a wider pool of innovation,” Mulcahy said.

MedTech Innovator is a nonprofit global competition for medical and digital health tech companies. Last May, MedTech Innovator CEO Paul Grand told that he saw Ireland as one of the strongest performing countries in the innovator every year. Ireland had the highest representation of any country in the 2022 innovator.

“The Irish medtech ecosystem, particularly in Galway and Dublin, is amazing,” Grand said. Many MedTech Innovator companies that made it to the finals over the years have been from Ireland.”

HIRANI programme manager Dr Siobhán McGrath said the AIMS project is ambitious because the members can see ways to ensure Irish medtech SMEs “thrive in the indigenous market”.

“Through creating a network of health stakeholders North and South, capturing common challenges, sharing knowledge in relation to all-island supply chains and procurement channels, we can deliver this,” McGrath said.

AIMS is funded by InterTradeIreland’s Synergy initiative, which aims to boost cross-border collaboration among SMEs and other groups such as universities, third sector organisations and government agencies.

Last year, the Synergy initiative supported a series of cross-border networking events, with the goal of boosting collaboration between tech start-ups in the Republic and Northern Ireland.