Recognized as a global center for education, arts and culture, administration, and industry, Dublin Ireland was a beautiful and fitting backdrop for the MedTech Forum 2023, where Europe’s medical technology community congregated to collaborate on the future of the industry in a city well-known for its long history of shaping the future.

MedTech Forum 2023 was hosted with the support of the Irish MedTech Association, and opened by an address by Simon Covey, Irish Minister for Enterprise, Trade and Employment on the importance of the key role Ireland and the European region plays in advancing patient care.

The conference was insightful, filled with key topics from In Vitro Diagnostic Medical Devices Regulation and Medical Devices Regulation (IVDR/MDR) to global convergence and modernization of device regulation to how digitization and data are influencing changes in regulation and market authorizations.  This thought-provoking forum broke all previous attendance records with +1000 attendees, including industry leaders, innovators, academia, policymakers, regulators, and consulting experts.

Digitization, new technology and regulatory landscape underpinned the plethora of topics discussed.  Sessions were abuzz with conversations about innovative technology, digitization, and how to properly regulate and implement them in safe and effective ways. The challenges and interpretation of transitioning to new CE marking regulations in the EU was a key trend over the course of the event. As a result, the session hosted by Lachman Consultants (Ireland) “510(k): Industry Landscape and Challenges” was to a fully engaged audience. The conversation chaired by Lachman Consultants CEO, Frances Zipp, focused on 510(k) processes and key considerations and trends from innovation to post market.  The panel included industry experts Padraig Maguire of S3 Connected Health, John O’Dea CEO, Palliare, and Deanna Anderson and Scott Deckebach both of Lachman Consultants, Inc.  A wide range of topics was covered from Market Authorisation Applications, cybersecurity requirements, Predetermined Change Control Plans and Data Governance.

Medtech is an industry that continues to be defined and shaped by the global revolution in digital technologies, the explosion of digital data and the increasing levels of device connectivity and by the complimentary and significant changes in the global regulatory landscape driven by key players including European Medicines Agency (EMA) and Food and Drug Administration (FDA).  As industry innovation leverages the explosion in new technologies and digitization, the future of the industry will be shaped by how we collectively address today’s pivotal topics including privacy, cyber-security, sustainability and data integrity and the use of technologies such as artificial intelligence, the internet-of-things and robotics.

Key challenges facing the industry include redefining how to maintain compliance and quality amidst an explosion in digital information, the adoption of new data technologies such as artificial intelligence and robotics, the expanding quantities of digital data and external partners in the supply chain, the increasing speed of new product introductions, the rapidly changing compliance and regulatory landscape, and expectations to shift to a culture of end-to-end risk-management including comprehensive programs to manage data privacy, cyber security and data integrity risk all “by design”.

The frenetic pace of technological change, explosion in data and fluidity of the regulatory landscape creates a challenging environment for companies to navigate successfully.  Manufacturer responsibilities, which span the lifecycle of the products from suppliers to post-market surveillance of product safety and performance, are burgeoning.  Manufacturers must proactively and continuously plan for, manage and adapt to new valuable opportunities and their potential risks.  Successful companies understand the big picture – not just innovating well with their product, but also innovating in ways to better maintain their responsibilities as end-to-end stewards across their product lifecycle.

Learn more about Lachman’s Medical Device Consulting Services.