The physicist of biomechanical engineering on drug delivery systems (DDS) Dr. Faraj Abdelnour works for AB Certification as "Directeur Marquage CE" since 2011. After four years in Research Development for pharmaceutical laboratories 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. Dr. Abdelnour participated actively in the transposition into French Law of the AIMD 90/385 and MDD 93/42 as well the French rules for matério-vigilance and the creation of the French Agency AFSSaPS. He provides assistance for managing compliance with assessment and certification procedures throughout Europe and the Middle-East, and helps clients direct their marketing efforts in the reimbursement environment in those markets, particularly in France and ME. His specialties are Medical Devices & In Vitro Diagnostic Devices, Vigilance and Post-market surveillance, Audits - Due Diligence, clinical study design, ISO – 13485, Quality Management, Quality Systems Development/Implementation, Regulatory Affairs, Regulatory Strategy Consulting, Regulatory requirements outside Western Europe, Strategic Reimbursement and Pricing, Health Technology Assessment and Submissions, Trouble shooting with authorities and Integrated development of cost-effective clinical studies.
MDM Conference & Conference
Christophe Amiel is heading the design and implementation of regulatory strategy as Senior Director within Voisin Consulting Life Sciences for medical devices (including in vitro diagnostics), e-health products, as well as combination products (drug-device association) including activities related to Clinical Trials Application and vigilance. Christophe has a broad technical expertise in clinical trial regulations and associated country-specific requirements, and has extensive experience in various trial phases, product types, indications and geographical areas. As a Project Manager, he supervises clinical programs design and implementation including the preparation of the core documents (protocol, Investigator’s Brochure, etc.), and study regulatory set-up and management from the clinical trial application (CTA) to the submission to both Competent Authorities and Ethics Committees. The management of large complex projects gives him the opportunity to actively interact with the different departments within the study sponsors, as well as with the regulatory teams of the Clinical Research Organizations involved. He also participates in strategic clinical decision meetings.
Dr. Faycal Benayad-Cherif is business manager (Vision & Software) at FOBA. He has more than 25 years of experience in the development and management of products. He has developed laser based imaging solutions and artificial vision technologies that offer unique ways to improve laser marking and engraving processes. Dr. Benayad-Cherif holds a PhD. In Engineering Design (biomedical) and a Master's degree in Electrical Engineering from Tufts University in Boston (USA). He is the author of several technical publications and holds several US and international patents on robotics, lasers and 3D imaging technology.
Speaking Session: Connected Devices: A clinicians view on the tangible benefits for patients
Dr. Sophie Chung is the CEO and Founder of Junomedical, a Berlin-based digital medical travel hub that is providing patients around the world access to affordable healthcare treatments. After earning her MD degree from the Medical University of Vienna in 2008, Sophie gained firsthand experience in treating patients as a doctor in Australia and serving as Director of Healthcare Strategy at Zocdoc in New York, a healthcare technology startup focused on doctor discovery and appointment booking. She was also a Strategy Consultant for McKinsey & Company’s Healthcare Practice where she worked with government, hospital, health insurance and pharmaceutical industry clients around the world. Sophie has completed and presented academic stem cell research in areas of Cardiology and Diabetes as well as given keynote presentations on academic research and consumerism in healthcare.
Moderator of Panel discussion: What are VCs looking for?
While still at school, in 1995 he started as an assistant of the management of a project development company in the construction industry. He was responsible for the Personal Assessment and Personal-/Organizational Development. He continued this job while doing his joint degrees in Psychology and Business Administration at the Justus-Liebig-University in Gießen. From 2005 on he gained first experiences in leading positions within the Personal and Change Management in this job. Martin Conrad is specialized in practical applications as well as scientifically in Business & Management Psycholoy with a focus on HR and market & opinion research topics, where he is still a lecturer at university.
Since 2013, his focus as Consultant is devoted to multinational corporations (Healthcare, Lighting, Consumer Lifestyle, Biotech etc.) for example in the field of imaging, medical IT, intensive care, human genetics and cardiac interventions. At the same time he conducts projects for numerous middle-sized companies in the medical device industry. Additionally he is responsible for our market research consultancy projects like quantitative private practice or hospital surveys.
Speaking session: Medical device clinical trials – Just the necessary evil or a crucial competitive factor?
Jay Crowley is the Vice President of Unique Device Identification Solutions and Services at USDM Life Sciences. Jay was most recently Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for FDA’s UDI system. At USDM Life Sciences, Jay focuses exclusively on providing business process, technology and compliance solutions for the regulated life science industry. Jay held a variety of positions over his nearly 27 years at FDA, including work with design control regulations to reduce the chance of human errors with medical devices, patient safety and adverse event reporting. Jay also worked in the Office of the Commissioner of FDA, and the Office of Compliance at FDA.
Arnd Engeln has been the Scientific Director of the Do UX GmbH, Tübingen, an industrial supplier for user experience and user centered product development since 2012. From 2013 until today, he is a Professor for market and advertising research at Media University, Stuttgart. Focusing on user experience and user centered product and communication development. Prior to that, Arnd was a Senior Research Manager at Robert Bosch GmbH, Stuttgart where he was involved with the development and application of empirical methods for the research on consumer experience and product acceptance.
Speaking session: Usability and User Experience in medical device development
Before founding Activoris, Axel gained over 18 years of life science industry experience. He had roles with increasing responsibility in iv-Diagnostics, Lab Software, MedTech and Pharma. In his last position at Activaero GmbH, Axel was Managing Director, COO. In this role, Axel was responsible for production, logistics, alliance management, QM and IT. Axel established multiple licensing and collaboration partnerships with biotech and pharma. He carries extensive knowledge about sourcing, technology partnerships and contract management in the life science industry.
Before joining Activaero, Axel spent one year as a Sales & Marketing Manager at Intellitec GmbH. Axel started his professional career at Siemens HealthCare Diagnostics as a Software Project Manager withtin the European Marketing Organization. Axel holds a degree in business administration/marketing by the Fulda University of Applied Sciences.
Speaking session: Medical device clinical trials – Just the necessary evil or a crucial competitive factor?
Dr. Karsten Fischer joined BioMedPartners AG in October 2012 bringing experience of more than a decade in the healthcare and chemicals industry sector with a track record in investment banking, pharmaceuticals, management consulting, venture capital and academia.
Previously, Dr. Fischer has been working for WestLB in the healthcare and chemicals sector where he was heading the equity capital markets team realizing large primary market transactions and the strategic analysis working on debt, M&A, and equity transactions. He started his career with Deutsche Venture Capital, an affiliate of Deutsche Bank, investing into bio- and medical technology companies. He then consulted large cap pharmaceutical companies with McKinsey&Company on sales and marketing strategies before he went to Sanofi Aventis being responsible for Sales Force and Marketing Excellence.
He has a biochemistry and economics background and holds a PhD in infection biology (MPI Infection Biology and Colorado State University).
Panel discussion: What are VCs looking for?
John Gomez has been involved in high technology and cybersecurity since his days in primary school. He has worked for companies such as Microsoft, WebMD and most recently was the President and Chief Technology Officer of AllScripts; the third largest developer of electronic medical records and healthcare information technology in the world. In 2013 John founded Sensato, a cybersecurity firm specifically focused on healthcare technology and critical infrastructure. The company was recognized in 2015 and 2016 as one of the “Top 500 Most Innovative Cybersecurity Companies in the World.” In 2016 John founded the Medical Device Cybersecurity Task Force, which is a non-profit open-source group that is focused on developing cybersecurity frameworks for medical devices. John is a dynamic speaker who has a deep knowledge of cybersecurity from an attackers perspective. Although his core area of expertise is healthcare cybersecurity, he is also well known for his understanding of cyber-munitions, advanced attack methodologies and artificial intelligence.
Speaking Session: Cybersecurity intelligence: The threats to healthcare you need to know about
David Griffin joined 42 Technology in 2013, and since then has been involved in a range of projects from internet connected food factory sterilisation systems and utility monitoring solutions to fuel cell system optimisation, novel packaging development and remote datalogging devices for hostile environments. He started out with an undergraduate apprenticeship with Rolls Royce (Aero), then spent 10 years developing special purpose programmable machinery and robotics solutions for a wide range of industries, before moving into laboratory instrumentation for the drug development industry. His principal interests are in system design, control system development and fluid handling. He holds a degree in Engineering Science from Cambridge University and is an alumnus of the Cambridge ACDMM course.
Harald Grün has more than 20 years of experience in OEM projects for medical devices, diagnostic disposables, drug delivery systems and for micro systems. He holds a M. Eng. degree in plastics technology from the University of Applied Science in Darmstadt, a MBA for management and marketing from the University of Applied Science in Bern, Switzerland, and he has a degree as an Authorised Quality Management Person (QMB) from the Beuth University of Applied Science in Berlin. Since 2010 he works as a consultant and as an interim project manager for the medical device and pharma industry. In 2014 he has co-founded MDX Devices GmbH, concentrating on the development, industrialisation and production of micro injection moulded devices and components.
With a BSc in Business Information Technology and several years of experience working with enterprise software solutions, Peter has the expertise to understand and respond to complex customer needs. He has helped implement technology and adopt best practices at global companies working in a number of highly regulated industries (automotive, medical device manufacturing, embedded device development, etc). As Intland Software's Senior Pre-sales Consultant, he is looking forward to replicating the success of his talk at last year's Medtec Europe.
Keith Heaton has over 20 years of experience in medical product development including as an R&D Director for a global Medical Device manufacturer. He was named inventor on 120+ International patent families and he holds a Master’s Degree in Engineering Design Management and professional qualifications in International IP Law. Keith founded i2r Medical in 2009 to assist innovators transform their ideas into commercially viable medical devices.
Speaking session: Innovation to realisation in practice- Opportunities for SMEs
Stuart is CEO of HecoAnalytics Ltd that has developed and is marketing a web-based health economics platform, which for the first time gives companies of all sizes access to real-time, traceable data and economic models to support investment, development and marketing decisions. Stuart has been the founder, CEO and director of a number of public and private healthtech companies and has raised significant amounts of capital including having undergone an IPO. Previously, he has worked at Sphere Medical plc, Sagentia plc, Powderject plc and Pfizer Inc.
Alexander Kaiser received the Dipl.-Ing. degree in electrical engineering from the University of Ulm in 2000; and the PhD degree (Dr.-Ing.), for the work on developing 3D integration technologies for silicon circuits, and the combination thereof with new materials in 2007. Prior to joining Cicor Microelectronics in 2007, he was serving as a project manager for the development of diamond-based transistors.
At Cicor he started to work in the technology / development group, installing and optimizing new processes for the thin film manufacturing line. Now his main tasks within Cicor lie in providing solution architectures for customer projects and products, providing technical support to customers, and in developing new technologies for future applications.
He has authored or co-authored several technical and scientific publications, book chapters, and patent applications.
Dr. Lydia Kammler works for the DLR Project Management Agency (DLR PT) in Germany and is nominated by the European Commission as National Contact Point (NCP) for Health. In her function as NCP she serves as consultant for European Research Funding programs, currently Horizon 2020 (2014 -2020), and offers a free of charge assistance and guidance to the applicants. Before joining the DLR PT Mrs. Kammler studied Biology and holds a PhD in Physical Chemistry.
As Chief Security Officer for BlackBerry, David oversees product security strategy, directs the Center for High Assurance Computing Excellence (CHACE) research team, and manages security communications and technical analyst relations. David has 25 years of security strategy and product engineering experience. Prior to joining BlackBerry, David served as Chief Technology Officer at Green Hills Software, where he was responsible for technology strategy and R&D. He holds patents in the areas of software development tools, mobile security, and IoT technology. David is a frequent speaker at industry events, such as Mobile World, CES, and Embedded World conferences and is the author of the IoT security book, “Embedded Systems Security: Practical Methods for Safe and Secure Software and Systems Development.” David also leads a variety of security policy initiatives and received Diabetes Technology Society’s 2016 Leadership Award for pioneering work on medical device security standards.
Speaking session: The Mobile Device as a Medical Device: Latest Innovations in Technology and Security Standards
Bernd Krämer has collected more than 20 years of hands-on experience in in vitro diagnostics (IVD). He covered a broad range of areas, including Marketing, Product Management, Regulatory Affairs, R&D and IT in a German IVD company. Bernd contributed to building up the company from the early beginnings as a biotech startup all the way to a globally operating provider of system solutions for the medical laboratory diagnostics and market leader in infectious serology. As senior director IVD at anteris medical GmbH he is today focusing on IVD medical devices and their strategic positioning, development, and registration on behalf of customers worldwide.
Dirk Kreder is a Ph.D. from the life sciences by training and holds an International Executive MBA. He worked more than 15 years for biotech and global pharma companies in the US, Switzerland, and Germany before starting several companies in the Munich area. His main enterprise anteris medical GmbH was founded in July 2014. It is mainly focused on strategic positioning, development, and registration of combination products, such as prefilled syringes, inhalers, and autoinjectors, on behalf of pharmaceutical and biotech customers worldwide. Anteris provides the “glue” between the medical device and the pharmaceutical development activities on the backdrop of numerous successful registrations of biosimilars, complex generics, and other combination products by anteris’ associates.
Unmesh has 10 years of healthcare industry expertise, comprising of strategy consulting, primarily with global pharmaceutical companies. His particular expertise lies in Market opportunity assessment, portfolio, brand, growth and go-to-market strategy. His industry expertise lies among life sciences engagements across various therapeutic areas, leveraging relationships with key opinion leaders in sectors such as Global Pharmaceutical & Biologics Contract Outsourcing, API manufacturing in India & China, European Oncology & Diabetes market prognosis & Pharma sales force effectiveness.
Vincent Legay holds a Ph.D. in microbiology and cellular biology, and an MBA. Along with his expertise in Medical Device Life-Cycle, Vincent has more than 10 years of experience in the areas of microbiology, biocompatibility, risk management for medical devices. During his career, he has held a number of positions including laboratory supervision/management, GLP Study Director, Technical Specialist covering in vitro/in vivo evaluation of medical devices, Sales Manager for Europe, and now acts as one of NAMSA C&C consultants in EU supporting manufacturers in the pre-clinical and clinical strategic and regulatory pathways.
Albertus graduated in Medicine at University of Ulm and received his MBA at University of Applied Sciences Neu-Ulm. He possesses 17 years of academic career – MH Hannover, University Hospital Tübingen as a Cardiac and Vascular Surgeon and Professor of Surgery at the Medical Faculty University Tübingen. He has significant experience in managing the processes of moving from idea, to prototype to product and in consulting Start-Up Companies.
Alexander Seifalian, Professor of Nanotechnology and Regenerative Medicine has worked at Royal Free Hospital and University College London over 25 years, published over 647 peer-reviewed research papers, and 14 UK and International patents. He is currently director of NanoRegMed Ltd, working in commercialisation of his research. During his career he has led and managed many large projects with multidisciplinary teams with very successful outcomes in terms of commercialisation and translation to patients. He was awarded the top prize in the field for the development of nanomaterials and technologies for cardiovascular implants in 2007 by Medical Future Innovation, and in 2009 received a Business Innovation Award from UK Trade & Investment (UKTI). European Life Science Awards. Winner of most innovative new product 2012 “Synthetic Trachea”. Hamburg, Germany, 29 may 2012. He also was awarded Nanosmat Prize in August 2013 in. In 2016 in Brussels he received the Heals distinguish research award in recognition for his outstanding work in regenerative medicine from Heals Healthy Life Extension Society. He developed world first synthetic trachea, lacrimal drainage conduit, and vascular bypass graft using nanocomposite materials and bioactive molecules and stem cells technology.
Katharina Mattes studied business engineering at the Karlsruhe Institute of Technology (Germany) and at the Ecole Nationale Polytechnique in Grenoble (France). From February 2010 till October 2016 she worked as a scientific researcher and project manager at the Fraunhofer Institute of Systems and Innovation Research ISI focusing on innovation management, the development of service based business models. Moreover, she worked on innovation networks, knowledge and technology transfer platforms in the field of energy and resource efficiency. Doctoral degree in management at the Freie Universität Berlin in May 2016. Since November 2016 head of the coordination office of »Allianz Industrie 4.0 Baden-Württemberg«. The Allianz Industrie 4.0 Baden-Württemberg is a network founded and sponsored by the state of Baden-Württemberg in 2015 aiming to pool technological expertise in production as well as IT and communications to promote Industrie 4.0. The main mission is to provide support for small and medium-sized industrial companies in their shift towards Industrie 4.0. More than 50 partners – companies, Chambers of Industry and Commerce, cluster organizations, unions and applied science institutes – are involved. Together with these network partners, the Allianz strives to make Baden-Württemberg one of the world’s leading regions for Industrie 4.0 technologies. The coordination office is located at the VDMA (Mechanical Engineering Industry Association).
Nicholas Mockett is a corporate financier and has served the global plastics and packaging industries exclusively for over twenty years. His experience includes leveraged buy-outs (including MBOs/MBIs), mergers, acquisitions and disposals, public company takeovers and public to privates, refinancings and restructurings. He has worked on dozens of deals, around the globe, worth billions of Euros. Throughout the sector, he has been active in pharmaceuticals, healthcare, and medical devices as well as applications for personal care, food, and chemicals. Nick is a Freeman of the Worshipful Company of Horners and a member of the Editorial Board of Plastics in Packaging.
Dr. Aristotelis Nastos is Partner at Creathor Venture focusing on life sciences and healthtech investments. Previously he has held several positions within the German life science industry focusing on venture financing, most recently at the NRW BANK in Dusseldorf as the head of the Healthcare Team. He currently holds a number of board positions and has been instrumental in a number of important financing and M&A transactions such as the sale of Direvo AG to Bayer.
Aristotelis also worked at Peppermint Financial Partners in Berlin concentrating on investments in life sciences and nanotechnologies. With a Masters of Science in Biology from the Ruhr-University of Bochum and subsequent Research Fellowship at the Dept. for Cell Biology at the University of Essen (PhD) and a Post Doc at the Randal Institute of the King's College in London (UK) as an International Fellow of The Wellcome Trust he has developed a deep scientific understanding in the field of Life Sciences.
Panel discussion: What are VCs looking for?
Bhoopathi is the author of the international bestselling book, The Race for Work. He has over 16 years of experience in business and technology management, and has spent the last several years evangelising about the integration of Operational Real-Time technologies with IT technologies. He has conceptualised and delivered technology solutions powered by advanced analytics to multiple industries. Bhoopathi is an active speaker, author and blogger on Business and Emerging Technologies. He has spoken on ‘the impact of Data and AI on society in general and industry in specific’ at several international and regional forums.
Panel discussion: What are VCs looking for?
Thor Rollins is a certified microbiologist and specializes in the selection and conduct of in vitro and in vivo biocompatibility tests. He actively speaks on biocompatibility related topics through Nelson Labs external seminars, webinars and tradeshows. He presented on biocompatibility at the American College of Toxicology annual meeting in 2013 and has many published articles on biocompatibility topics. He is a participating member on all Association for Advancement of Medical Instrumentation (AAMI) TC 194 and 10993 ISO committees and plays an active role along with the FDA and regulatory committees developing standards, discussing biocompatibility methods and voting on changes to those standards. As one of a select group of experts in the industry, Thor’s participation on the committees offers him insight on industry changes and helps prepare clients for changes in testing.
Mr. Shlomi Rom joined Quasar in 2013, following ten years with PCB Technologies. Mr. Rom has brought with him an in-depth knowledge and understanding of the business, in terms of both Operations and Sales and Marketing. Mr. Rom served as Overseas Sales and Marketing Manager and Production and Planning Manager at PCB Technologies. Prior to PCB, Mr. Rom was a business consultant for companies in a wide range of industries. He holds an Industrial Engineering degree from the Braude Institute and an MBA from the University of Haifa in Israel.
Fabien focuses particularly on guiding clients through the regulatory and technical regulatory requirements applicable to the CE marking of medical devices. He assists clients in addressing a range of complex issues during clinical investigation procedures (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), conformity assessment and registration procedures (e.g. preparation and review of Technical Files, preparation and review of responses to the competent authorities' and Notified Bodies' requests) and post-market activities (e.g. adverse event reporting, Field Safety Corrective Actions and promotional and advertising of medical devices). Fabien is also a qualified lead auditor for ISO 13485 quality management systems. He consequently has a deep understanding of the range of quality issues encountered by medical device Clients. Fabien also assists Life Sciences Clients in the preparation, drafting and review of numerous agreements including clinical study agreements, sponsor's representative agreements, registry agreements, CRO agreements, European Authorised Representative Agreements and distribution agreements.
Moderator of 'Where are they now?' 2016 start-up academy finalists update session
We revisit the 2016 Start-Up finalists to see how far they’ve come in a year – learn more about their burgeoning innovations and steps to commercialisation.
Speaking session: eMDI - Creating Patient Value Through Increased Adherence
Mr. Dana Shears has over 25 years’ experience within the Pharmaceutical Drug Delivery industry. He has spent the past 11 years with H&T Presspart, part of the Heitkamp and Thumann Group, currently as the Sales and Business Development Director for the Americas region. He is also responsible for commercial activities for the eMDI platform technology. Prior to joining Presspart, Mr. Shears held business development and marketing positions with Bespak, Allied Signal, Honeywell, AAI Pharma and Nypro Healthcare. Mr. Shears received his B.S. Degree in Engineering from West Virginia University in 1981.
Daniel Shoukier is a worldwide-recognized expert for medical devices and drug combination products. He is the managing director of the Bellingswood Group, a consulting company for global market access and registration of medical devices and drug combination products. He is also a lead auditor and medical expert for notified bodies.
Jens Trötzschel is Vice President of Advanced Technologies at Heraeus Medical Components, one of the world’s leading providers to deliver state-of-the-art solutions for the medical device industry. In his current position, Mr. Trötzschel is responsible for identification and development of new technologies and applications to enable medical device manufacturers to produce advanced devices for improved therapies and patient outcomes. Since joining Heraeus Medical Components in 1997, he has held a variety of senior-level positions in R&D, operations and product management, with specialized expertise leading innovative custom material, technology and product development programs. In 2015 his team received two Global Heraeus Awards for “Best Innovation” and for “Best Customer Value” for the CerMet technology, a pioneering new ceramic platinum composite which allows miniaturization of medical devices. This breakthrough will enable new treatments in the area of neuro-stimulation, especially in the brain. A prolific inventor, he developed more than 40 patent families with over 100 national patents and patent applications. Mr. Trötzschel studied Physics at Friedrich Schiller University Jena and completed his Master Study of Material Science and Material Technology at Technical University Bergakademie Freiberg.
Paul is Chief Executive Officer for Diasolve & Origin Sciences. He has recently held senior positions with Lumora, Enigma Diagnostics and Roche Diagnostics Paul was a founding member of the NICE Diagnostics Advisory Committee, and a member of BIVDA’s board. He has a degree in pharmacology and an MBA from London Business School. Diasolve was founded to help bring innovative, cost effective diagnostic related products to market. With a small but highly experienced team, Diasolve has won Innovate UK awards to develop HYPEREM™, the FFR infusion micro catheter, and access the opportunity for a more precise approach to fractional flow reserve (FFR) measurement in the cardiac cath lab.