When the publisher of this magazine, Canon Communications llc, launched MEDTEC Ireland in September 2001, the United States—and indeed the world—was reeling from the events of 9/11. The show went on, however, and it has met or exceeded expectations each year since then. One reason for its ongoing success has been Ireland’s remarkable run as an economic dynamo and the Galway region’s strength as a medical manufacturing Mecca. Will this year be any different? The negativity is palpable, as Ireland feels the pinch of a global economy that is flirting with recession. But I suspect that this event will have the customary positive outcome.
Rampant economic growth since the mid-1990s made Ireland a poster child for the transformative powers of EU membership. But the economic expansion inevitably had to end. According to a report issued by the Economic Social Research Institute in June, the year 2008 will mark the country’s first fall in output since 1983. It was inevitable, according to John O’Dwyer, MD, European manager for medical devices, National Standards Authority of Ireland.
“What happened between 1996 and 2006 was not sustainable,” says O’Dwyer. “We were told that the “Celtic tiger” could not go on for five years, but it actually went on for 10!” The med-tech industry has less to fear than other sectors of the economy, adds O’Dwyer, who is a guest speaker at MEDTEC Ireland. “In the device area, we have not seen any economic depression or recession or whatever word you want to use,” he says. “The healthcare industry has not been compromised here in Ireland, as far as we can tell.”
In O’Dwyer’s estimation, Ireland’s general economic foundations are solid. As long as the government is vigilant and does not become complacent, things ultimately will work themselves out. And as far as the med-tech industry is concerned, the economic shakedown may be little more than a tremor.
With that said, here is what’s shaking at MEDTEC Ireland, which returns to the Radisson SAS hotel in Galway on 24–25 September.
New Directions for Device Directives
O’Dwyer, plus consultants Maria Donawa and Kevin Webb, and Norman Richardson, senior medical device specialist at TÜV Product Service, will be among the featured speakers at a session on Wednesday, 24 September, devoted largely to regulatory matters. These experts will, among other things, explain a number of revisions to the medical device directives that will soon be transposed into national legislation and examine their impact on device manufacturers.
Revising-directive 2007/47/EC introduces fundamental changes to the Active Implantable Medical Devices Directive (90/385/EEC; AIMDD) and Medical Devices Directive (93/42/EEC; MDD). For example, the revision places greater emphasis on clinical data and clinical evaluations, which must follow a defined and methodologically sound procedure. Those requirements along with postmarket clinical performance and classification matters will be discussed in detail at a session led by O’Dwyer, who is a member of the Clinical Evaluation Taskforce Committee for the EU Notified Body Experts group.
This session will also explore changing conformity assessment and vigilance requirements within the European marketplace. Donawa and her colleague Roger Gray will broaden the scope of the discussion as they address regulatory processes across the pond and how they mesh—or don’t—with EU regulations.
The daylong session is chaired by Maria Donawa, MD, and president of Donawa Consulting. She worked with US FDA for six years before moving to Europe in 1986 and founding a regulatory consultancy. She is a regular contributor to sister publication Medical Device Technology.
Running parallel to the regulatory-themed conference on the first day is a session devoted to R&D and design issues chaired by Sharon Higgins, director, Irish Medical Devices Association (IMDA).
Day Two: From Risk to Innovation
A perennial favourite among conference attendees, risk management is the focus of one of two daylong sessions scheduled for Thursday, 25 September. The other is dedicated to innovation.
Steven Walfish, president of Statistical Outsourcing Services, a consulting company that provides statistical analysis and training to a variety of industries, is scheduled to chair Strategies for Optimal Risk Management. The session will cover everything from identifying and correcting deficiencies early in the development process to the effective application of usability standards in medical device design. A host of experts including Gary Fahey, design control manager, Abbott Ireland; and Niall Murphy, a consultant with PanelSoft and author of Front Panel: Designing Software for Embedded User Interfaces, will tackle these and other topics.
The session on innovation will begin with a discussion led by consultant Michael Loftus on Ireland’s pursuit of a so-called knowledge economy. He promises to explore the changes that are taking place and to detail what Ireland’s med-tech sector needs to do to align itself with these emerging opportunities.
The innovation track will end with the intriguingly titled paper: Do You Need a Napkin? An Introduction to Innovation Leadership. Damian Costello, operations director, Systematic Innovation, argues that the confusion surrounding innovation stems from the tip of the innovation iceberg. What is below the surface represents the type of solid investment opportunity that global competitiveness demands. He should know—his consultancy has collaborated with such companies as Siemens, Proctor and Gamble, and Airbus.
Both sessions on day two of the conference will begin at 10:25 a.m. They will be preceded by a special presentation on environmental regulations for medical devices beginning at 9:20 a.m.