Meet the Experts
If you have ever considered hiring a consultant, you know that, contrary to the saying, talk is anything but cheap. That's one of the reasons why Meet the Experts has been overwhelmingly popular at the US conferences and expositions organized by Canon Communications LLC. The prospect of receiving complimentary one-on-one advice is undeniably appealing to device manufacturers who must confront a host of difficult issues on a daily basis. The other reason that attendees flock to these meetings is the calibre of the individuals dispensing advice--industry experts with a thorough understanding of everything from quality assurance to materials selection to regulatory matters. The recent MEDTEC conference and exposition, held in Amsterdam on 22-23 October, 1997, also hosted a Meet the Experts program, which included an impressive roster of industry luminaries, among them:
Gordon R. Higson, formerly director of scientific and technical services at the UK Dept. of Health, currently serves as consulting director of Quintiles Medical Technology Consultants (UK). His comprehensive handbook to the Medical Devices Directive, specifically written from the manufacturer's perspective, has become the standard reference work for medical OEMs. Mr. Higson also acted as chairman of sessions 103, 105, and 108, Understanding the Medical Devices Directive.
Norbert Anselmann is principal administrator within the division III.D.2 of the Directorate-General for Industrial Affairs of the European Commission. Mr. Anselmann joined the Commission in 1983 to coordinate efforts between the Commission and the standards bodies CEN and CENELEC. In 1989, he began preparing EC legislation on medical devices, and in 1992 was named to head the medical devices sector. He has authored several publications on technical harmonization and the removal of technical barriers. Mr. Anselmann joined the panel of session 108 to speak about implementation of the MDD and the effects of national variations.
Michael C. Baker is director general of EUCOMED, a confederation of trade associations representing the interests of European health-care manufacturers. Mr. Baker's involvement with trade association affairs began in 1980, when he cofounded the UK Sterilisation Packaging Materials Association (SPMA). He was instrumental in forming a European trade association in 1992 to represent the interests of medical packaging manufacturers. He served as the first chairman of the European Sterilisation Packaging Association (ESPA), and subsequently left his position as managing director of Wycombe Marsh Paper Mills Ltd. (UK) to serve as ESPA's secretary general. Mr. Baker led sessions 203, 205, and 208, which dealt with issues of sterilization for medical devices.
Zeger Vercouteren is director of commercial affairs for EUCOMED, an umbrella organization representing the interests of more than 2500 health-care manufacturers and distributors throughout the European Economic Area. Mr. Vercouteren has broad expertise in environmental, distribution, and trade affairs. Following EUCOMED's recent reorganization, he took over the legal and regulatory issues related to the MDD and similar areas of interest to the organization's constituency. Mr. Vercouteren served as chair of session 207, which covered the EU directive on packaging and packaging waste.
As director of Nobil Bio Ricerche (Italy), Marco Morra oversees the development of customized surface treatments for medical materials and devices. Prior to cofounding the organization, Mr. Morra worked in the surface-modification/surface-analysis lab of the Istituto G. Donegani, the corporate research center of Enichem (Italy). A member of the Society for Biomaterials and the American Chemical Society, he has received 15 patents, coauthored 50 papers, and written a seminal book on surfaces. Mr. Morra chaired session 206, Engineering and Analysis of Medical Device Surfaces.
John L. Webster is the convenor of CEN/TC 257 WG2: Labeling and Symbols. In his professional capacity, he serves as managing director of MDCI Ltd., a UK consultancy specializing in regulatory affairs, quality systems, and clinical trials for medical devices and diagnostics. Prior to joining MDCI, he was director of regulatory affairs in Europe for Meadox Medicals/Boston Scientific. He is a chartered chemist, a certified quality engineer, a member of the Royal Society of Chemistry, and a lead assessor for Lloyds Quality Management. He is also a member of the European Regional Operating Committee for the Regulatory Affairs Professionals Society. Mr. Webster acted as chair for session 301, QA Auditing and Process Control, and spoke as part of the panel of session 207, The Directive on Packaging and Packaging Waste.
Paul Chrostowski is currently director of risk-management programs for The Weinberg Group LLC (Belgium), a consulting firm with particular expertise in scientific and regulatory affairs. In his role as co-chair of session 304: Integrated Risk Analysis for Medical Devices, Mr. Chrostowski delivered a paper titled "Quantitative Integrated Risk Assessment for Medical Devices." Active in several professional societies, he has coauthored more than 65 publications and has addressed the President's Commission on Risk Assessment and Management in the US.
Alan Kent is chief executive of the Medical Devices Agency, a UK organization charged with regulating medical devices. Before entering public service, he worked in the private sector for many years, manufacturing medical devices in both the UK and US. As co-chair of session 304, Integrated Risk Analysis for Medical Devices, Mr. Kent spoke about risk assessment of medical devices.
The Weinberg Group LLC sponsored a special presentation (session 304) on risk assessment in medical devices. The Weinberg Group specializes in resolving issues that arise at the juncture of science, management, law, and regulation. By applying modern science and quantitative analysis, the company helps clients to improve product development, manage risk, and increase overall profits. Operating from Europe and the US, the firm comprises more than 100 full-time technical professionals supported by more than 250 internationally renowned experts in scientific and regulatory affairs. The Weinberg Group continues to work actively on behalf of the medical device industry to implement responsible and effective approaches to risk analysis and management.
