Hauke Schik, Director Quality & Regulatory Affairs, Philips
Hauke Schik, an Electrical Engineering graduate from University Karlsruhe, has held various quality & regulatory affairs positions in the medical devices industry, working more than 15 years for Hewlett-Packard and Philips Healthcare. His responsibilities included worldwide regulatory approvals for a wide range of products, post market surveillance and worldwide QMS compliance. Since 2010 he is Director Quality & Regulatory Affairs at the Philips Healthcare site in Boeblingen.ac
John Hicks, Material Science Specialist, Smith & Nephew
John Hicks gained an honours degree in Industrial Chemistry from Loughborough University of Technology. He has over 30 years experience in research and development in the healthcare industry especially in the area of woundcare. His experience includes material research and development, polymer synthesis, pilot scale polymer production and medical device design. John is currently a member of the research and technology team within the emerging business group investigating future business opportunities. Prior to that he has held the roles of Principle Scientist in the research group based in York, chemical development manager of a small polymer production plant and a development chemist focusing on adhesive systems. His major materials interests are polyurethane systems (foams & elastomers), silicones and acrylic adhesive systems.
Bill Quatier, Global Solutions Manager: Wireless Technologies, Welch Allyn
Bill Quatier has been working with Hospital IT and Biomed staff since the mid 1990s helping them design, implement, maintain, and troubleshoot wireless networks used for life-critical medical monitoring. Beginning as a technical support rep for Protocol Systems, and now serving as Welch Allyn’s global representative for 802.11 wireless networking, Bill oversees Welch Allyn’s wireless development roadmap, participating in every product and program with a wireless component. From hospitals no more than a dozen beds, all the way to 1700 bed hospitals and multi-site Healthcare Delivery Networks, and from once-a-day spot checks to once-a-second life critical data, Bill brings a global perspective to the challenges of implementing 802.11 wireless into medical devices and onto shared 802.11a/b/g/n networks.
Ian Scrimgeour, Consultant Product Design Engineer and Usability Specialist, Cambridge Design Partnership
Ian Scrimgeour has a strong background in consumer product design and engineering. Ian’s early career gave him the foundation on which his sound medical device design and usability engineering is based. After the transition into medical devices, he established and led the usability engineering programme at a global consumer medical devices company, where recent usability focused work led to a global design award. One of Ian’s core skills is product opportunity identification through meaningful and insightful front end user research. This work often involves establishing, budgeting, designing and executing usability studies in the medical industry. Ian excels at user-focused product concept generation, selection and robust development and is experienced in implementation and design delivery through to tooling and extended production support. Now working as a consultant at Cambridge Design Partnership, Ian helps clients from the medical device industry and beyond identify great usability opportunities and navigate the changing usability regulatory landscape.
Prof. Dr. Markus Veit, Managing Director, i.DRAS
Markus Veit obtained his PhD in Pharmacy. He has been adjunct professor at different Universities, today at the Department of Pharmaceutics in Gainesville, USA and Frankfurt, Germany. He is Managing Director of i.DRAS (International Drug Regulatory Affairs Services), of HWI ANALYTIK GmbH an analytical service provider and of ALPHATOPICS GmbH, providing training and consultancy. In the past 10 years he was involved in numerous projects concerning R&D of drug-device combination products and successful consultation in Europe resulting in CE marking. He is in particular an expert for all quality issues arising from need for such products to fulfill the requirements in place for pharmaceutical products and medical devices.
Philippe Auclair, Senior Director, Abbott Quality & Regulatory EMEA, Abbott Laboratories
Philippe Auclair is a Pharmacist PhD. Prior to being with Abbott, he worked for several International companies, such as The Zambon pharmaceutical group, Dow Corning, St Jude Medical, Guidant and Boston Scientific in various regulatory, quality and clinical positions. In his current capacity, Philippe is responsible for regulatory strategy and advocacy for Abbott Quality and Regulatory for Europe, Middle East and Africa. He is Chairman of the Post Market Surveillance Working Group and the Clinical Investigation Working Group of the European medical device manufacturers trade association EUCOMED and serves as Co-Chair of the European Advisory Committee of the Regulatory Affairs Professional Society (RAPS) He represents European Industry in various European Commission expert groups and served until the end of 2012 as secretary of the Global Harmonization Task Force Study group 2 dealing with adverse events reporting. In this capacity, he actively participated as trainer in programs organized by Regulatory Authorities in various geographies, such as Europe, Colombia, Brazil, China, India, United States. He participates on a regular basis on the faculty team of medical devices and pharmaceutical conferences, is a frequent contributor to journals and publications. Philippe received the “Global Leadership Award” from RAPS in 2010 and has been elected “RAPS Fellow” in 2012.
Thomas Dzierozynski, Senior Partner, Avarent
Thomas Dzierozynski has been involved in the pharmaceutical, medical device, biologics and biotechnology industries for over twenty years. He has led numerous, technically-oriented projects focusing on engineering design, commissioning and qualification, verification and validation, process improvement, regulatory market clearance, increased assurance of product safety and efficacy, risk management and implementation of corrective actions to address/avert enforcement actions. Prior to working for Avarent, Mr Dzierozynski was Vice President of Validation Services for Quintiles Consulting, and worked at Baxter Healthcare Corporation in diverse quality, engineering and management positions.
Pat Baird, Product Design Owner, Baxter Healthcare
Pat Baird is a Product Design Owner at Baxter Healthcare. In his 12 years at Baxter, he has worked as a software developer, functional manager, and program manager before moving to his current position in the Systems Engineering group. Drawing on nearly 20 years’ experience in product development, he has published and presented over 20 papers on topics ranging from software development to change management to stakeholder management to risk management. He is one of the founders of the Infusion Systems Safety Council, and is chairman of multiple industry initiatives including: the Infusion Systems Standardized Terminology Committee, the Listening Systems Committee (improving adverse event reporting), and the Assurance Case Technical Information Report Working Group. He is also the co-chairman of the AAMI Infusion Pump Standards committee, a US representative to the IEC standards committee, a member of both the AdvaMed Infusion Pump and Clinical Trials Working Groups. He was recently honoured by AAMI as a recipient of their 2011 Standards Developer award for his work with the Safety Council. Pat holds a BS in computer science and an MBA, and is completing a master’s degree in Healthcare Quality and Patient Safety at Northwestern University in Chicago.
Kenneth L. Block, FDA Regulatory Expert, Ken Block Consulting
Ken Block, RAC, is an FDA regulatory expert helping companies bring their medical devices to the U.S. market. He has extensive 510(k) experience in a wide variety of medical specialties, and is an invited FDA speaker on three continents. In the role of Vice President (Regulatory/Quality) for a new mobile medical app company, Mr Block recently determined the proper FDA regulatory strategy, established FDA compliance, and was key to quickly launching the product in coordination with multiple corporate partners including AT&T.
Ed Rozynski, International Senior Advisor, Medical Device Manufacturing Association
Ed Rozynski is representing the Medical Device Manufacturers Association (MDMA) which, based in Washington, D.C., provides educational and advocacy assistance to more than 280 innovative and entrepreneurial medical technology companies. Mr. Rozynski is able to appear at MedTec Europe with the support of Halt Medical which, based in northern California, uses advanced radiofrequency (RF) based technology to provide minimally-invasive treatment of uterine fibroids. Halt Medical’s FDA cleared and CE-marked Acessa System utilizes a low risk, laparoscopic procedure that is highly successful at treating all of the patient’s existing fibroids, thus, reducing the level of symptom recurrence, including bleeding, pressure and pain.
During his many journeys, Ed enjoys introducing medical device executives to health and hospital leaders in key markets, such as China, India, Brazil, Japan, Europe and U.S. Ed has served as a former U.S. trade negotiator and, also, is an expert on international health care systems. Ed likes to use his knowledge and experience to help medical device companies, especially start-ups with their global pre-market strategy, including how to navigate regulatory, payment and purchaser systems in key global markets. Mr. Rozynski also periodically contributes to U.S government advisory councils at a Presidential and Cabinet-level on ways to improve U.S. manufacturing competitiveness. Immediately prior to working with MDMA as a senior advisor, Ed launched Stryker's Corp.'s global government affairs program and worked on U.S. health reform legislation. He has appeared before the U.S. Senate and House testifying in favor of pediatric device legislation. In addition to various other industry positions, Ed's served in the Office of the U.S. Trade Representative and negotiated U.S. investment treaties with foreign governments which have been approved by the U.S. Senate. Ed earned B.S. and M.A. degrees in Economics from The University of North Carolina at Greensboro. UNCG's Business School awarded Ed Rozynski their Distinguished Alumni Award in 2010.
Jeanette Benaddi, Chief Executive Officer, Medvance
Janette Benaddi is the CEO of Medvance™. The company provides clinical research and regulatory consulting services to the medical device and in-vitro diagnostic industries. Janette has over 20 years experience of managing pre and post market clinical studies in both devices and pharmaceuticals. Prior to founding Medvance 14 years ago, Janette worked in Paris for a medical device consultancy group as Project Director in Clinical/Regulatory Affairs. Janette has also worked with several multinational organizations in various clinical, regulatory and marketing roles. She has extensive experience of conducting clinical studies with medical device products. Janette is a registered nurse, has a BSc in Management studies, a Diploma in Company Direction, a Diploma in Management studies, holds a teaching certificate and is a Chartered Scientist. She is Chairman of the Knowledge Transfer Network Clinical Studies Special Interest Group. Janette has published several articles and sits on a number of committees involved in the regulation and standardization of medical device studies.
Jasmin Nuhic, Senior Manager, Manufacturing Engineering, Medtronic
Jasmin Nuhic is a professional with a proven record of leading teams that deliver results with full scope, below budget and ahead of schedule through process optimization, business growth and talent development. He has over 12 years of experience in FDA regulated industry with vast experience in operations, quality management systems, manufacturing, concurrent engineering, program management and information systems. Jasmin has a positive and verifiable track record in continuous improvement and cost saving initiatives through use of lean sigma and six sigma methodologies.
Dr. Siegfried Schmitt, Principal Consultant, Parexel International
Siegfried Schmitt joined PAREXEL Consulting in 2007. He provides consulting services to the medical device and pharmaceutical industry on all aspects of regulatory compliance, particularly the design and implementation of Quality Management Systems and Competitive Compliance. He is the PAREXEL practice lead for Quality by Design. Dr Schmitt’s areas of expertise include all aspects of quality and compliance for systems, processes, facilities and operations for drug substances and drug products, particularly for sterile cytostatic or cytotoxic biotech products. He has previously held positions in industry as Senior Production Chemist with Roche and global Quality Director with GE Healthcare and as Validation Manager with Raytheon and Senior Lead Consultant with ABB. Dr Schmitt is an active member of various industry associations, including DIA, PDA and ISPE, conference presenter and organiser of international events. He is also an accomplished author and editor, having won the coveted ‘distinguished PDA author / editor award’ in 2008 and again in 2012 for his book “Quality by Design - Putting Theory into Practice”. Dr Schmitt is a Chemist by background and holds Chartered Chemist and Chartered Scientist status.
Shayesteh Fürst-Ladani, Managing Director, SFL Regulatory Affairs and Scientific Communication
Shayesteh Fürst-Ladani studied microbiology and did a MBA. Mrs Fürst-Ladani is Managing Director of SFL regulatory affairs & scientific communication Ltd, a consulting company with affiliations in Switzerland and UK providing with her team comprehensive regulatory, legal, public affairs and communication support to life science companies. Mrs Fürst-Ladani has specialized in the healthcare industry regulatory affairs for many years in leading life science companies like Roche and Baxter. She is a frequently invited speaker at conferences and organized and chaired many international conferences on Combination Products. Shayesteh is Chairwoman of the Combination Product Topic Group at EuropaBio the European bio trade associations and SIAC Chair for drug&device&IVD.
Dr. Anna Norlin Weissenrieder, Senior R&D Manager, St. Jude Medical Systems
Anna Norlin Weissenrieder has a MSc in Chemical Engineering and a PhD in Material Science and Engineering (Corrosion Science) from the Royal Institute of Technology in Stockholm, Sweden. She has over 10 years experience from various R&D positions in the medical device industry with focus on material/device development, assessment, productification and characterization. She is currently employed at St. Jude Medical Systems AB, Uppsala, Sweden, as an R&D Manager and is responsible for a group with focus in novel material/component/device research, material processing development, and device assessment and characterization. The group is also responsible in providing expertise and support to various functions, such as product development projects, production, regularoy and quality. She has previously worked at the SJM Cardiovascular Division at St. Paul USA and at the Cardiac Rhythm Management Division in Stockholm, Sweden.
Laurent Foetisch, Managing Director, Supply Chain Operations SA
Laurent Foetisch is a Swiss citizen based in Bussigny near Geneva in Switzerland. He holds a Diploma from the Lausanne Business School in 1980. Laurent worked for the International Committee of the Red Cross (ICRC) in Pakistan, Ethiopia and Mozambique as an Administrator, as Global Supply Chain Vice President at Serono and Merck Serono from 1990 until 2011 and from 2007 till 2010 he integrated the Merck KGaA Pharma Ethical Supply Chain and the Serono Biotech Supply Chain to create the Merck Serono global value chain organization. Since 2011, Mr Foetisch is the founder and Managing Director of Supply Chain Operations SA. He provids supply chain support to Healthcare companies with a team of 4 senior experts cumulating more than 85 years of experience. He is also the founder and partner of Cold Chain Consultants Switzerland, teaching Supply Chain Management within the hospitality process at EHL Lausanne. Laurent is also a member of the Marken Advisory Board.
Dr. Francesco Tessarola, Biophysics & Biosignals Laboratory, Department of Physics & BIOtech-Indepartmental Center on Biomedical Technologies, University of Trento
Francesco Tessarolo graduated in Physics at Trento University, Italy, in 2002. He got his Master in Biomaterials in 2005 and his PhD in Materials Engineering in 2006 from Trento University. From 2006 to 2009 he was a research fellow with the Biophysics and Biosignal laboratory in the Physics department. He is currently a senior researcher with the Interdepartmental centre of Biomedical Technologies of the Trento University and a collaborator of the Provincial Heath Agency of Trento in the management of the research activity at the Section of electron microscopy of the department of Medicine Laboratory. He is also a contract professor at the University of Verona, Italy, teaching on Electrical and electronic measurements and on Electron microscopy methods. His main research interests are on biocompatibility of medical materials, characterization of critical medical devices pre and post-use, sterilization induced modification on biomedical polymers, hard tissue and soft tissue integration of biomaterials in humans, microorganisms interaction with medical surfaces. He presented more than 90 communications at national and international congress’s and scientific symposiums and authored more than 20 papers dealing with material-tissue interaction, implants failure analysis and processing modifications of critical medical devices.
Dr. Boris Lux, Head of Quality Assurance and Regulatory Affairs, Jenavalve
Boris has more than 22 years he has experience in Quality Assurance for medical device development and manufacturing. Comprising the entire product life cycle he has implemented and optimized quality management systems and related procedures required for EU, US and other markets. He received a Diploma and Ph.D. in Physics from the Technical University Dresden (IPA). Thesis: “Picture Quality Parameter for Microfich Technics” and leads the development of an optical and tactile measuring computer aided system (MMC).For Dräger Medical AG, biolitec AG and Angiomed GmbH a C.R.BARD subsidiary, he held leading positions in risk, change/improvement and corrective management for medical devices and equipment, like anesthesia workstations, diode lasers (PDT), fibre probes, stents (Chromaxx) and ePTFE covered stents (Fluency, Flair). Always embedded in a complex, international company environment he has exercised a wide spectrum of quality tools in team, knowledge, data, and document management. Since Apr 2009 he is responsible for Quality Assurance and Regulatory Affairs at JenaValve Technology GmbH during all development steps of bioprosthesis heart valves for Transcatheter Aortic Valve Replacement aplications. Over the last 4 years he assured e.g. the compliance in quality requirements during development and lead the CE mark approval process of The JenaValve and all activities for other market approvals. For commercial products he is responsible for all quality processes, like process quality control and improvement, manufacturing documentation, supplier qualification and control, implantation feedback and medical reporting.
Mike Reinikainen, Managing Director, Abnovo
Mika Reinikainen is the Managing Director and founder of the medical device consulting company, Abnovo Ltd (www.abnovo.eu). He previously headed Quintiles Consulting Europe. Mika provides advice on regulatory strategy, crisis management, enforcement of compliance and interpretation of European and national requirements, as well as determination of borderlines between legal regimes. He also provides authorised representative services and litigation support as well as running workshops (e.g. on post-market surveillance). He has more than 30 years of experience managing European medical regulatory affairs in industry (Pfizer Hospital Product Group of companies), as healthcare legal counsel (Hogan & Hartson) and as a regulatory consultant (Medical Technology Consultants Europe, BRI and Quintiles). He has also been involved directly in the development of the Medical Devices Directives (as Consultant to the European Commission and through trade associations) and of technical standards (former Chairman of CEN TC 257). He is currently a member of the European Commission’s Medical Device Expert Group and of the Commission’s Working Groups on Borderlines and Classification, Software Qualification and Classification and New & Emerging Technologies. He is a founder and Chairman of the European Association of Authorised Representatives (EAAR). He holds a Master’s degree in law from the University of Nice (France) and a Master’s degree in Business Administration from Wharton (University of Pennsylvania, USA).
Michael Ginap has over 20 years of experience in Supply Chain Management in the process industry as well as in automotive and logistics services, and has held several operational and strategic management positions across Planning, Sourcing, Manufacturing, Logistics and Customer Service, both in local as well as in Regional and Global functions. His expertise includes initiatives such as customer service excellence, supply chain process re-engineering, logistics integration in the course of M&A’s, sales & operations planning, logistics services, process quality assessments, and inventory management. The list of companies he worked for include JohnsonDiversey, Unilever, Robert Bosch, Panalpina, and Kühne & Nagel. Michael has a strong drive for customer service and business process improvement. He is experienced in building and leading cross-functional and multi-cultural teams. He aims at pulling supply chain improvements from the customer end – balancing service, cost, and inventory, while developing people. Michael earned a master’s degree (Diplom-Kaufmann) in Business Administration at Mannheim and Frankfurt/Main Universities in Germany. He became a member of the Supply Chain Council (SCC) in 2000, and since served on the Europe Chapter Leadership Team, now as its Treasurer and until recently as its Chairman and also as Vice-Chair of the Global Board of Directors. Michael is a SCC certified SCOR® Instructor and a frequent speaker at supply chain conferences internationally. Michael is founder of Avineo, offering diagnostics, training and coaching as well as expert counselling in the field of Supply Chain Management and Customer Service Excellence to companies from various industries.
Maral Haar, Usability Engineer, Draeger
Maral Haar graduated in Psychology at the Technical University Darmstadt, Germany in 2004. She worked as a freelance usability consultant in different domains such as entertainment, consumer electronics and web. She specialized in usability for video games, until she joined Draeger in 2005. Since then she is a researcher and usability engineer in the software group at the research division, which supports both Dräger Medical and Dräger Safety. Her main interests are the users, their needs, goals and requirements. This results in an interest in methods to gain knowledge about users, to make this knowledge available for a whole development team during the whole development process and to use this knowledge for design creation and decisions. At Draeger she educates and trains colleagues in usability methods and generates awareness for usability issues. She also teaches usability methods at FH Bern, Switzerland and talks occasionally at public events. She published various scientific papers in the area of usability and filed some patents.
Faraj Abdelnour, President, ACIDIM
Faraj F Abdelnour, PhD is a physicist and has a PhD in biomedical engineering on drug delivery systems (DDS). After four years in Research Development for industries dealing with sterile endo-vascular devices, he was in charge of French homologation and vigilance for surgical devices and Drug Delivery System, and relations with test laboratories at the French Ministry of Health. Faraj participated actively in the transposition into French Law of the AIMD 90/385 and MDD 93/42 as well as the French rules for matério-vigilance. Faraj provides assistance for managing compliance with assessment and certification procedures throughout Europe and the Middle-East, and advises in the reimbursement environment and market access dealing with healthcare products in Europe mainly in France and Middle Eastern countries.
Fabien Roy, Associate, Hogan Lovells International LLP
Fabien Roy's practice focuses on European Union (EU) and national regulatory matters involving pharmaceutical, and medical device laws and guidelines. He has developed close contact with relevant government authorities in these sectors. Fabien is a keen writer and regularly publishes articles concerning developments in the medical device and pharmaceutical sectors. He is also a regular speaker at dedicated conferences. Fabien focuses particularly on the different stages of the medical device CE marking process. He advises on a wide variety of topics which include the following: determination of the appropriate classification of individual products; clinical investigation procedure (e.g. authorisation from the EU Member States competent authorities, opinion from Ethics Committee, amendment to the Protocol, informed consent, serious adverse event qualification and notification, handling of personal data); drafting of clinical investigation and clinical trial agreements, distribution agreements and contract manufacturing agreements; clinical evaluation; conformity assessment procedure; review of Instruction For Use, products' labelling and promotional material including websites; post-marketing surveillance activities including the notification of adverse event, product recall or product withdrawal; reimbursement. Fabien also advises on questions regarding marketing authorisation procedures, variation procedures, and clinical trials, promotional and marketing activities in the pharmaceutical sector. Fabien joined Hogan Lovells International in 2007 (at that time Hogan & Hartson LLP). He was called to the Brussels Bar in early 2011.
Michael Maier, Senior Partner, Medidee
Michael Maier is founder and Senior Partner of Medidee Services SA, a Swiss based consulting group specializing in worldwide Medical Devices Regulatory Affairs and Compliance programs since over 10 years. Besides this commitment, Michael serves the World Medical Device Organization for developing the Educational Program and serves on boards of Start-up companies in the medical device field. Prior to his current commitments, Michael managed the Swiss Office of the Medical Notified Body (CE0344) of DEKRA Certification B.V. (former KEMA Quality B.V.)
He earned a MBA in 2004 and an Engineer degree in Medical Engineering in 1996.
Michael is member of SGSV (Schweizer Gesellschaft für Sterilgutversorgung) and in standardization committees of the SNV (Schweizerische Normen Vereinigung). He gives trainings on regulatory affairs and quality management for the medical device industry at WMDO and ARIAQ.
Michael Maier is a regular speaker and trainer for medical devices, quality management and regulatory affairs related topics on international events.
Dr. Saleh S. Al-Tayyar, Chair, Asian Harmonization Working Party (AHWP)
Dr. Saleh Al-Tayyar is the Vice Executive President for Medical Devices Sector at the Saudi Food & Drug Authority. He is an energetic, motivated senior executive with academic, managerial, strategic, and extensive experience and proven success in development and leadership skills. He is an Assistant Professor in the Department of Biomedical Technology Department, College of Applied Sciences, at King Saud University, and a foot Biomechanics Consultant at the university Diabetes Center at King Saud University Diabetes Center. He has a Ph.D. in Biomedical Engineering from Mississippi State University, U.S.A. Dr. Al-Tayyar has over twenty five years of experience in health care institutions; He chaired many organizations and committees, among which is the Asian Harmonization Working Party (AHWP).
Siddharth Saha, Research Director, Healthcare, Frost & Sullivan
Siddharth Saha has over 13 years of health services planning, and operational and commercial leadership for the syndicated research business within the healthcare practice in Europe. Particular expertise in Mentoring and managing the European research analysis team for healthcare and life sciences, managing the process of identifying, researching and analyzing the key market challenges, issues and opportunities in healthcare and Client engagement role managing functions from value proposition demonstration to closure and from design to fulfillment; project steering role for custom consulting assignments.
John Merritt, Director, ComCast
John P. Merritt is President and founder of Merritt, Myers, Inc., a consultancy based in Shanghai, dedicated to the medical device and pharmaceutical industries also serves as International Business Director the Shanghi Institute for Minimally Invasive Therapy at University of Shanghi for Science and Technology. Mr. Merritt is one of the few individuals in the world with extensive international experience working for leading medical device manufacturers including C.R. Bard, Covidien (Davis & Geck and Professional Medical Products); as well as leading medical packaging material suppliers, including Amcor, Oliver-Tolas; and packaging machinery fabricators, including Tiromat and Rapidpak. In addition Mr. Merritt is a visiting professor at Wuhan University and currently sits on the editorial review board for Chinese Medical Device Manufacturing.
Mr. Merritt holds an MSME, specializing in Manufacturing Engineering from Columbia University (USA) and an MBA, specializing in International Business from the University of Rhode Island (USA) and is a PhD candidate at Nyenrode Universiteit (The Netherlands). Over the years he has made industry presentations in Asia, Europe, and North America, and he has published numerous articles in Asia, Europe and North America.
Dr. Kurt Moyer, Director of Research, NSF Pharmalytica
Dr. Moyer is currently the Director of Research at NSF Pharmalytica. Prior to joining NSF Pharmalytica, Dr. Moyer served as a Senior Research Investigator for Sanofi Aventis and a Research Scientist for the DuPont Pharmaceutical Company. Dr. Moyer holds a Ph.D. in Biochemistry from Villanova University and a BS in Biochemistry from Millersville State University.
Dr Manfred Kohler, European Commission
Dr. Xiang Zhang, Principal Consultant, Medical Materials and Devices, Ceram
Dominique Devos, Clinical and Training Advisor, European Medical Association (formerly Director Clinical Affairs Europe, Covidien)
Alexander Behring, Manager Customer Quality, Johnson & Johnson
Sanjay Banerjee, MD, Zimmer India
Raj Long, Global Head of Regulatory, GE Healthcare
Igor Veljanovski, Quality Engineer Analyst, Beckton Dickinson
Manfred Maeder, Global Head TRD QA, Novartis Pharma AG
James Pink, Partner, NSF – DBA
Steven A. Colantuoni, Director of Corporate Marketing, Offshore Group
Chris Ferris, Head of Electronics & Software, Team Consulting
Hans-Heiner Junker, Division Manager Certification Medical Technology, TÜV SÜD
Timothy Cline, Chief Marketing Officer, Valtronic
Sunita Ahir, Regulatory Affairs Manager, DTarget
A patch that measures EKG, EEG and EMG and communicates wirelessly with a smart phone could help make home healthcare more comfortable. The device, called Bio-patch, also measures body temperature. When bio-patch is placed on the chest, it measures EKG. Placing the device on the skull measures EEG, and attaching the device to the underarm [...]
Peter Blair Henry, dean of the NYU Stern School of Business, recently published a book titled, Turnaround: Third World Lessons for First World Growth, that got a fair amount of media attention. His thesis is that emerging economies are applying economic policies nurtured in the developed economies and prospering in the process. Meanwhile, western economies [...]
Google made several health-related announcements at the Google I/O conference this week in San Francisco, but the most interesting development related to medical technology happened a few days earlier. Computer programmer Lance Nanek announced on his blog that he and a team of programmers had developed a Google Glass hack for physicians. The open source [...]
The use of animal experiments is the elephant in the room in medical research. Among the many questions asked on the floor of a medical trade show, one is usually whispered: “Do you do animal research?” But people avoid the conversation not only because it’s an uncomfortable topic. Researchers conducting animal experiments at companies and [...]
The timing could not have been better for MEDTEC Japan 2013. Just one month before the show, which was held on 24 and 25 April 2013, Japan’s Prime Minister Shinzo Abe vowed that he would aggressively promote the medical device industry, which he characterised as one of the few sectors that can shore up the [...]
A device that monitors air quality in operating rooms in real time was named the winner of the first Innovation Awards at MEDTEC France in Lyon. Developed by STS Industrie (Besançon, France) in collaboration with the University Hospital of Besançon (Hospitalier Régional et Universitaire de Besançon; CHRU) and its associated clinical research centre, the Screenair [...]
Last month, we reported on progress in setting the foundations of a harmonised unique device identification (UDI) system. US FDA seems to be on track to present its final draft of a UDI system to the International Medical Device Regulators Forum (IMDRF) in November 2013, and a consensus has formed on the value of a [...]
The medical device industry maintains a good reputation among patient groups, a global survey by PatientView has found. Despite a few high-profile scandals last year, such as the Pip implant and hip implant controversies, 40% of respondents said the industry’s reputation improved in 2012, according to a press release from PatientView (pdf). 68% of the [...]
Haughton Design (Stafford, UK) has teamed up with the University Hospital of North Staffordshire and two other businesses to found the Medical Devices Alliance, an initiative designed to accelerate medical device development for customer companies. University Hospital staff and patients will benefit by being able to offer input on the look, feel and function of [...]
Prostate cancer accounts for approximately 10% of all cancer-related deaths. Percutaneous radiotherapy is an external treatment that subjects cancer cells to ionising radiation over a specified period of time, and does not have any major side effects. Using CAT scans, 3-D radiation areas can be generated to minimise damage to proximal healthy tissue. Nevertheless, healthy [...]