Medical Device Development - it takes a village, persistence and creativity

Dr. Suzanne O’Rourke is the founder and managing director of Triskele Consulting Limited, which provides design & development, quality systems/compliance and regulatory support to predominantly start-up medical device companies. With niche expertise in active devices, active implantable devices, implantable and invasive devices combined with specialist knowledge of the related sterilization requirements, Triskele Consulting develops and delivers the strategy to bring new products to market.  Suzanne, a Mechanical Engineer, has more than twenty-five years of cross functional industry experience in research and development, process and new product engineering, quality systems development/compliance, post market and regulatory, spanning tiny organisations (1 – 3 people) to multinationals.  With over ten years working in start-ups, Suzanne has experienced the start to finish cycle of idea conception, through design and development verification and validation, to shipping first-in-human devices and ultimately market approved/cleared devices to first customers. 

Ireland is one of Europe’s largest MedTech hotspots.  It is recognized as a centre of excellence, which is reflected in fourteen of the top fifteen MedTech companies maintaining a presence here.  It is the second largest employer of MedTech professionals in Europe, per capita.  Much of the mainstream success of the sector is as manufacturer and global supplier of medical devices.  Of the 400 (plus) MedTech companies in Ireland, the majority are small-to-medium sized (SME) enterprises, with a growing number focusing on novel medical device development.  Ireland’s richness in innovation is fortunate to be supported by opportunities for strategic R&D investment, including sources like Enterprise Ireland, the university-based innovation hubs and the hugely successful BioInnovate program. 

Growing in its reputation for device innovation, Ireland’s start-up community are the cutting edge of healthcare technology, identifying new medical solutions to previous unmet clinical needs, to treat patient problems were previously no known or only limited solutions existed.  New medical solutions may be technically novel and/or new intended use/indications for use or both.

The journey from a great idea to achieving market access is one of peaks and troughs; many start-ups fail because they don’t understand the nature of industry and what is required to sell that first product.  Time, energy and funding is often wasted because the regulatory requirements, use of a comprehensive and sequential risk-based design and development methodology and the necessity to document and record in a compliant manner are ignored.  This presentation will focus on the practicalities of developing a novel medical device to address unmet clinical needs from the technical, quality and regulatory perspective … before the investment runs out.

Medical and technical skills are typically considered the highest priority in start-up MedTech device development but, behind every medical device is a team – including multidisciplinary clinicians, engineers, scientists and many other contributors.  It takes a village.