ABOUT CLASS MEDICAL
In 2011, Dr. Niall Davis (co-founder) was a surgical trainee in urology under the tutelage of Mr Hugh Flood in University Hospital Limerick. He observed that urinary catheter balloon injuries were repeatedly occurring and continue to be under reported.
Frustratingly these injuries received little attention and there was no technical solution to the problem.
TransUrethral Catheter Safety Valve
"ONE DROP STOP"
Dr. Niall Davis with Dr. Rory Mooney and Professor Michael Walsh designed a safety system that minimises urethral trauma preventing inadvertent balloon inflation in the urethra. This collaborative process led to the development of the innovative TransUrethral Catheter Safety Valve (TUCSV).
This TUCSV gives clinicians and carers confidence that catheter balloon injuries (CBIs) can be avoided.
Providing a Safe Solution to a Worldwide Problem
Chief Technical Officer & Co-Founder
Dr Rory Mooney PhD, MSc, BE
Dr. Rory Mooney has held senior engineering roles with two large medical devices companies over the last 25 years at Lake Region Medical Ltd. (Integer Corp) and Stryker Innovations, EMEA commercialising new technologies. Dr. Mooney has also worked as an academic in Mechanical and Biomedical Engineering, in both the University of Limerick and Atlantic Technological University. Dr. Mooney was CEO of Class Medical, leading the company through the Seed round of investment. In 2019, Dr. Mooney handed this mantle to Mr. Kevin O’Shiel, to focus on the technical development of the TUCSV technology and company operations and scale-up.
Dr Mooney has successfully led the company in obtaining ISO13485 accreditation and the CE Mark for the TUCSV.
Clinical Advisor & Co-Founder
Mr Niall Davis MD, PhD
Mr. Niall Davis is a graduate of University College Dublin, Ireland and undertook basic surgical training with the Royal College of Surgeons Ireland (RCSI). He completed his Higher Surgical Training in urology in 2017 and completed his fellowship in minimally invasive urological surgery in Melbourne in 2019. He is a senior lecturer for the RCSI and works as a consultant urologist in Beaumont and Connolly Hospitals. Mr Davis teamed up with researchers Dr Rory Mooney and Professor Michael Walsh of the University of Limerick to help develop the transurethral catheter safety valve for preventing transurethral catheterisation injury. Mr Davis has also completed a PhD in tissue-engineering in the University of Limerick and has >100 publications in indexed medical journals. Mr Davis continues to work with his biomedical engineering colleagues in Ireland to develop and commercialise his research interests.
Chief Scientific Officer & Co-Founder
Prof Michael Walsh PhD, BE
Prof Walsh is an experienced biomedical engineer and an expert in the field of fluid mechanics. He is a founding member of the Centre for Applied Biomedical Engineering Research (CABER) Limerick, Ireland and responsible for raising over €5M in funding. Prof Walsh is an Associate Professor in the School of Engineering and a member of both the Bernal Institute and the Health Research Institute. He is well published in both medical and engineering fields (75 peer-reviewed journal papers). His current research team includes 8 PhD students and 2 post-doctoral students. He has supervised to completion 17 PhD students and 22 MSc students. He holds 2 granted patents as lead inventor, 8 further patent applications, 12 Invention Disclosures, a royalty bearing license of technology to indigenous Irish company and 2 technologies selected for EI Business Partner program.
CEO & Chief Financial Officer
Mr. O’Shiel has over 44 years experience in financial services. Last 20 of these were as Senior Vice President and Chief Financial Officer of Chubb Insurance company of Europe. Since retiring in 2012 he has served on the European insurance company’s board as a Non-Executive Director before stepping down in 2018 to focus on other projects. Mr. O’Shiel has also been active as an investor in a number of early stage start-up companies over the last ten years. Two of which have resulted is successful exits and 2 more recent ones that are now generating growing sales. He invests his time along with his funds.
Chief Medical Officer
Mr Hugh Flood
Mr. Hugh Flood is an academic Urologist since 1991 with a particular interest in Female and Reconstructive Urology. He was a Fellow with Professor Edward McGuire at the University of Michigan Medical Centre and has an MCh in Neuropharmaco/physiology. Previous appointments include Associate Professor of Urology at the University of Pittsburgh Medical Centre and Head of Urology at University Hospital Limerick. He was PI on an NIH RO1 grant (650k) while at UPMC. He has supervised a number of MCh/PhD medical theses at UL and UCC including an HRB grant-funded study (250k) at UL awarded to Dr. Niall Kelly. With almost 100 publications, Mr. Flood is a reviewer for a number of the major Urology journals and works as a Urology medicolegal claims expert for the State Claims Agency and the Medical Protection Society.
Senior Engineer & Marketing and Communications Campaign Manager
Ivan Cassidy’s roles in Class Medical focusing on the manufacture and the associated processes of the TUC Safety Valve, working closely with Ray McEvoy to bridge the Quality and Regulatory affairs with the manufacturing processes. Ivan has worked in Class Medical since 2017, in this time he has conducted design reviews, aided product development and testing, as well as undergone further training in ISO13485 and participated in NSAI audits. He has completed undergraduate studies in Limerick Institute of Technology, in Renewable and Electrical Energy Systems, as well as Galway-Mayo Institute of Technology earning a 1.1 Degree in Mechanical Engineering. He is currently pursuing a part time MSc in Biomedical Engineering evaluating the biological response of the human spine to external stimulus through computational modelling and analysis.
Sales Executive (Ireland)
Driven, dynamic and confident, Ms. Bannon has a passion for people, innovation and technology. Highly skilled in interpersonal communication with the ability to negotiate at all levels, Catriona has natural ability to network effectively which has helped develop contacts and help clinicians access new products to improve their practice.. With over twenty years’ experience in Medical Sales, Catriona has access to Key Opinion Leaders across most therapeutic areas, such as gynaecology, urology, oncology and endocrinology. Having Joined the team in 2019, Catriona is an extremely valued member of the sales team and works tirelessly to improve patient safety.
Quality & Regulatory Affairs
Ray McEvoy (B.Eng, M.Eng.Sc, M.Sc (Mgmt)) is responsible for Quality & Regulatory affairs as well as being QMS Mgmt Rep & PRRC within Class Medical. He has accumulated 40 years experience in design and manufacturing companies in the regulated industries such as Medical Devices, Pharma, Aerospace and Automotive. He has worked with Class Medical since 2017 and has implemented and developed the ISO 13485 Quality Management System, that has been certified by NSAI. He has guided medical device organisations from start-up through initial product launch to self-certification of Class 1 medical devices per MDD 93/42 and to FDA registration. As well as a strong regulatory background, he is also a certified Lean Enterprise Expert, 6-Sigma Greenbelt and has facilitated or participated in process improvement programs in the USA, Germany, France, UK, as well as Ireland.
Tim O’Connor (B.Eng., Manufacturing Engineering) has accumulated over 30 years experience in manufacturing companies, working as a Toolmaker/Manufacturing Engineer in regulated industries such as medical devices, automotive , mobile devices, consumer, electrical and industrial, with the last 10 years in medical devices. He has started working with Class Medical as a manufacturing Engineer in May 2021 and brings a wealth of knowledge to the team.
Office & Warehouse Administrator
Susan has 20 years experience in retail at various levels of seniority. She is now a motivated member of our team bringing a wealth of organisation experience and positivity, dealing with the day to day tasks, sales orders, accounts and warehousing.