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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


Winners of the inaugural Clinical Innovation Awards aim at improving patient outcomes

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The inaugural Clinical Innovation Awards were hosted by Health Innovation Hub Ireland and Enterprise Ireland with the aim of supporting healthcare professionals to explore the commercial feasibility of their ideas.

Professor Seamus Morris scooped the overall award for his product, Mint, presented to him by HIHI’s Dr Steven Griffin. Three other winners and their inventions were also awarded prizes of €15,000 from Enterprise Ireland’s Commercialisation Feasibility Fund.

Read more on the awards and on how Mint aims to overhaul the treatment of neural compression in this article in Silicon Republic here

Find out how the ALADDIN Project aims to tackle the gap in knowledge around 3D printing technology…

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Additive manufacturing, also known as 3D printing, is a disruptive technology with promising potential in the health sector.

The technology has not yet been fully integrated in hospitals and the health care sector. There are different reasons for this. Some of the barriers are the lack of knowledge and skills on the use of the technology, as well as a complex value chain requiring the cooperation of stakeholders from different backgrounds. The ALADDIN project aims to tackle the gap in knowledge and help create a better cooperation among stakeholders, contributing to the integration of additive manufacturing in the health sector.

ALADDIN is an ERASMUS + project that brings together six European organisations developing an innovative training programme on additive manufacturing in hospitals, targeting not only health professional working in hospitals, such as Doctors, Surgeons, and Biotechnologists, but also Engineering Students with a future in the health sector.

Until September 2022, ALADDIN developed a training methodology, a teaching guide, training contents customised for each target group and an e-Learning platform. The contents were released in English, Spanish and French. Three multiplier events were organised: one on the 4th of June in Belgium, organised by HOPE; one on the 1st of September in Spain, organised by IDIVAL; and one on the 15th of September in Ireland, organised by HIHI.

Three pilot sessions were also organised through the summer period (June to September) in the three languages. Following the pilots, surveys were sent to the students and to the teachers to collect feedback on the course. A validation report was compiled in October 2022, describing the results of these surveys.

In September 2022, the Exploitation and Sustainability Report was updated. This plan sets the targets and procedures for ensuring the project’s results will be exploited after its end. It also specifies the guidelines for exploitation and transfer of the project results outside the original project consortium and project duration.

The contents of the course are now under preparation to be shared on the websites of each partner of the project.

Study seeks women to wear sensors to detect menopause symptoms

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Women could wear a sensor to detect menopause symptoms making it easier to discuss their condition with doctors, IdentifyHer, an Irish tech start-up, is hoping.

Read more on this story in the Irish Examiner

Learn more about the study:

Health Innovation Hub Ireland (HIHI) is supporting a new Irish Femtech start-up (IdentifyHer) in developing a wearable product that detects perimenopausal and menopausal symptoms. This study will assess the feasibility of using a (CE approved) wearable sensor to automatically detect vasomotor events in women.

What’s involved? Women who are experiencing vasomotor symptoms will be asked to wear the sensor for 3 days and record the time of an event on an app while at the same time the sensor will automatically detect and record any vasomotor events.

This data will be collected anonymously and will be used to further develop a wearable device to detect these symptoms in the future, making it easier for clinicians to diagnose perimenopause and provide the best treatment for each woman.

This study has been approved by the UCC Social Research Ethics Committee.

To register your interest in this study, please click here

For further information on this study contact

Participants will be asked attend a brief information session in the Health Innovation Hub, Western Gateway Building, UCC, where they will be provided with instructions and a wearable sensor (day 1). Participants will be asked wear the sensor for three days and record their hot flushes or night sweats on an app, returning the sensor to the Health Innovation Hub (day 4). Participants will also be invited to complete a questionnaire on day 4.

Learn more about femtech@Health Innovation Hub Ireland and join our network here



Learn how to join the Femtech @HIHIreland network and improve women’s health in Ireland in Irish Tech News!

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Irish Femtech industries are to benefit from the launch of new Femtech initiative at Health Innovation Hub Ireland. HIHI a government of Ireland initiative puts the spotlight on the development of Femtech in Ireland. Femtech is a relatively new area of development bringing together the essential players in femtech development including entrepreneurs industry, clinical experts, research and business expertise.

Read more here:


Read all about Femtech@HIHIreland in Silicon Republic!

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Femtech @ Health Innovation Hub Ireland wants to create an ecosystem of entrepreneurs and investors in the sector

A new initiative in Ireland aims to create a network of individuals in the femtech industry developing technologies that focus on women’s health.

Launched by the Health Innovation Hub Ireland (HIHI), the initiative aims to bring together essential players in the femtech industry, from entrepreneurs and clinical experts to business leaders, to stimulate and support growth in the sector.

HIHI is a Government-backed body based in University College Cork that supports businesses in Ireland innovating in health-related fields. In the past five years, it has supported more than 400 Irish health-tech companies.

Read more here: