Redner

Francisco Almada Lobo is CEO at Critical Manufacturing. He holds an MBA and an Electrical Engineering Degree from University of Porto. Francisco has vast experience of implementing MES in complex manufacturing environments, especially in the semiconductor industry, where he worked for manufacturers such as Siemens, Infineon and Qimonda before co- founding Critical Manufacturing in 2009. He is a recognized industry 4.0 educator and evangelist, having spoken at more than 40 Industry 4.0 public events in the past two years.

Christophe Amiel is heading the design and operational implementation of international regulatory strategies as Senior Director within Voisin Consulting Life Sciences for digital health technologies and ground-breaking medical devices. Christophe holds a MSc in biomedical engineering and has developed an in-depth expertise in the MedTech domain over the last 20 years he has spent in various global technical, clinical and regulatory positions in SMEs and large medical device firms. Christophe is based at Voisin Consulting Life Sciences European headquarters in Paris, France.

Expert in deployment of lifecycle management system into Medical Device/Automotive vendors who seeking warranting successful Medical Device Development while maintaining Auditing and Regulatory Compliance through Process Automation Tools such as Orcanos ALM & QMS system.

It is no secret that Medical Device companies incur much costs and organizational stress relating to creating and maintaining their Technical File, DHF or ISO documentation or ASPICE compliancy, especially before first-time submission or external auditing by notified bodies.

Product quality through application development, database delivery management, and project manager in a wide variety of business applications. Particularly interested in software delivery processes and methodology such as Agile Scrum. Expert in the field of ALM application lifecycle management.

Specialties: Knowledge in the field of hardware, software, mechanical delivery and overall quality assurance. Knowledge in configuration management, testing, automation, development. Expert in building e-DHR system for small and medium business on an electronic platform.

Working with clients of tier 1 such as J&J, Medtronic, Siemens, Flex, Zimmer, CERN, aerospace, and defense as well government and other diverse industries.

LinkedIn Group manager of two important topics 21 CFR Part 11 and ALM. Acting as a personal trainer in Unistream organization developing next generation of junior entrepreneur during the high school period. Acting as Orcanos ALM/QMS/Manufacturing blog manager.

Laurence is an experienced business development and relationship management professional who combines over 25 years of commercial banking working with Chicago based middle market businesses with experience as the Chief Financial Officer for several middle market enterprises. Mr. Barr leverages this background as he works as part of the business development team at Kinsella Group. In this key role, he is responsible for seeking new business opportunities along with fostering ongoing relationships with established strategic partners, private equity firms and existing clients. He is also a primary contributor in the development of strategic initiatives that help increase knowledge and understanding, throughout the marketplace, of the services and benefits provided by Kinsella Group.

Mr. Barr has extensive experience in commercial banking in Chicago, having held key positions at well-known institutions, including MB Financial Bank, Fifth Third Bank and The Bank of Montreal, with responsibility for middle market corporate relationships defined as companies with revenue between $20 and $200 million. During this period in his career, he has had consistent success in managing teams, business development, lending, risk management analysis, deal structuring and due diligence to enhance decision making and ensure profitable results to identify and capitalize on opportunities to deliver optimal return.
Mr. Barr is active in organizations such as the Association for Corporate Growth (ACG), Turnaround Management Association (TMA) and Midwest Business Brokers & Intermediaries (MBBI). He is also active in his local community, where he serves as the President for the Deerfield based Coho Swim Club.

Antoine is the CEO and co-founder of Early Metrics, the pan-european rating agency for start-ups and innovative SMEs, analysing non-financial metrics. Antoine is a frequent commentator on economic and strategic topics related to innovation, such as start-up/corporate relations, start-up valuation and international growth. A keynote speaker at VivaTech, Ignite 2016 and Bernardins College, he was featured in the Financial Times, Business Insider, TF1, BFM TV, Les Echos.Antoine holds a MSc in Life Sciences from AgroParisTech, France’ leading Institute of Life Sciences. Currently living in the UK after many years in France, Italy and Spain, Antoine is a polyglot, and an avid rugby player.

Benno Bieri  has a wealth of professional experience as an electronics and software development engineer. His special field is technical consulting, engineering and management of challenging and budget-sensitive projects in medical technology, in equipment and special mechanical engineering as well as in the development of customer-specific software solutions in the packaging and logistics industry.

Mr. Block is an internationally recognized medical device expert consultant. Ken Block Consulting has been instrumental in solving complex regulatory compliance problems discovered through Notified Body audits and FDA inspections, as well as bringing dozens of new devices to market for clients worldwide. Areas of expertise include software and process validation, compliance gap analysis, audit/inspection preparation, training, Warning Letter resolution, 510(k) applications, and risk management. Clients range from startups to large multinational corporations. Due to the increased regulatory demands of the new Medical Device Regulation and ISO 13485:2016, Ken Block Consulting has recently opened an office in Europe.

Christophe is a passionate Sales Enablement and Transformation consultant. In Showpad, he helps marketers achieve more impact in the field and makes sales reps better engage with customers. He also supports sales leaders to identify and scale sales excellence in their teams.

Looking back at 8 years experience with leading corporates such as Procter&Gamble and Bain&Company, he guides enterprise customers to perfectly align structures, processes and sales enablement technology.

Christophe has a Belgian background, spends a big part of his time in the DACH-region and is very approachable in general.

Currently at Henkel, Andres is in charge of developing the Medical Device adhesives business in WE through direct customer interaction, partnerships and by enabling local sales organizations. He is also key account manager to major customers in WE.

He holds a  Master in Organic Chemistry from the University Institut Químic de Sarrià in Spain and an MBA at the WHU in Germany. Andrés joined Henkel in 2006 as a chemist, and has since then developed in different roles: product development, innovation, sales, and marketing, in Europe and Asia.

Hyun-Woo is a regulatory affairs manager at Carl Zeiss Meditec AG. Before joining Carl Zeiss Meditec AG in 2017, Hyun-Woo worked in the field of regulatory affairs at BIOTRONIK SE & Co.  KG from 2013 to 2016 and as project manager at the Goethe-Institut in Korea and Japan between 2010 and 2012. Hyun-Woo holds an M.A. degree in Japanese studies and cultural anthropology from Ruprecht-Karls-University Heidelberg and studied at Hitotsubashi University in Tokyo and Sungkyunkwan University in Seoul. Since 2014, he is a remote student of engineering economics.

Sebastian Clerkin, Ph.D., B.Sc., is the Founder of GMP Advisory Services Ltd. and has more than 10 years experience in laboratory, pharmaceutical and medical device manufacturing environments. He currently provides validation and regulatory expertise to the Medical Device Industry. He has direct experience across a broad range of medical device types and process technologies. He has a keen understanding of FDA regulatory requirements, and has a strong background in process development, design transfer and validation.
Sebastian has published articles in peer-reviewed journals on topics such as cleaning validation.
He has a PhD from the University of Bristol, which involved studying the toxicological and biological effects of prosthetic implants. He holds a B.Sc. in Biochemistry from University College Dublin, and is a member of AAMI and ASTM.

Over 20 years experience in the Medical Device and Combination Device industry, principally in the area of Engineering Management but more recently in the rollout of manufacturing execution systems.
A Broad knowledge of medical device products , the customers that use them, the regulatory guidelines that control them and the supply and manufacture of those products. Also experienced in dealing with supplier aspects of the medical device business.

Jay Crowley is the Vice President of Unique Device Identification Solutions and Services at USDM Life Sciences.

Prior to joining USDM in 2014, Jay was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health, where he developed and implemented FDA’s UDI System regulation.

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.

Valerio is currently managing the solution of transforming manufacturing environments to integrate new manufacturing technologies, data, computational power, connectivity, analytics and intelligence, human-machine interaction and advanced robotics, together with operational excellence approaches.
He is a professional with more than 20 years international experience. He started as consultant in the manufacturing industry, leading the implementation of improvement projects in several customers in Spain, Italy, France, Germany and Denmark.
He has consulted more than 60 companies along his career mainly in the Automotive, ASD, FMCG, Food & Beverage & Pharma industry. Main areas of expertise provided during these projects include Supply Chain Management, Design of Organization & Corporate Transformation (both in the design and implementation).

Before founding Activoris in 2015, 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.

Prior to join Voisin Consulting as Sr Director involved in Drugs, Devices and Combination Products regulatory strategy and international submissions, Marielle Fournier has been QA/RA Director as well as QP for a medical device & pharmaceutical company specialized in Ophthalmology. She was previously RA officer in an American development company specialized in hormonal medicinal products. Marielle has important knowledge in EU-US Quality & Vigilance regulations as well.

Ana González is currently Project Leader at EPIC (European Photonics Industry Consortium). Her expertise relies on the development of systems based on integrated photonic circuits, packaging and assembly, and the investigation of applications such as chemical/biological sensing and Datacom. In addition, she has been involved in technology transfer and business development processes. She received her Bachelor’s degree in Chemistry from the University Autonomous of Barcelona (UAB) and her PhD degree from the Catalan Institute of Nanoscience and Nanotechnology (ICN2).

Stephanie Grassmann established MedTechXperts GmbH and is the managing director. She obtained a Bachelor of Science in Mechanical Engineering from the UofS and a Master of Science in Biomedical Engineering from the UofC in Canada. Since 1990 working in start-ups to multi-national companies including 2 universities, Stephanie Grassmann has been actively involved in different roles as an international manager in RA and QM, a developer and a researcher in the medical area and technical industry. She has a detailed understanding of international market approval processes, obtained through various RA positions and through the examination and the compilation of medical device technical files (all risk classifications) in the areas of orthopedics, trauma, navigational surgery, wound healing, cardiology, and dental medicine. In addition, she has lead, developed, and was responsible for new or improvements to existing medtech products (implants, instruments, devices), according to the international, EU harmonised, regional, medical field and product specific standards and regulatory requirements. Working at the University of Calgary, at the Orthopedics Department of the Foothills Hospital in Calgary and at the Universität Bern and as well as being the author of clinical publications and clinical evaluations over 25 years, has lead to a wide breadth of clinical knowledge.

Prakash Gupta is a veteran Engineering Services leader and currently the Group Vice President and Chief Sales Officer of Product and Engineering Services (P&ES) business unit of Capgemini. In his role he manages worldwide Sales and Marketing and drives Capgemini’s P&ES Business.
With more than 2 decades of experience Prakash has a strong focus on Medical and Healthcare technology along with other Industry segments. Prakash has been instrumental in directing the P&ES Business Unit’s Strategy and has scaled the portfolio, Go-to-market, Account Management and tapping new geographies.
As an accomplished leader he has worked closely with several Fortune 500 companies and helped them achieve their business goals.
Prakash has done his Healthcare Executive MBA from University of California, Irvine and holds a bachelor of Engineering degree in Electronics and Telecommunication from Mumbai University.

Dr. Boris Handorn studied law at the Free University of Berlin and engineering economics at the Technical University of Berlin.
Dr. Boris Handorn specialises on product liability as well as regulatory issues in relation to medical devices. With regard to product liability, Boris has long-standing experience in advising in the life sciences sector. Besides product liability he advises comprehensively in medical device law, inter alia, with regard to outsourced processes including OEM-PLM relationships, supply chain and distribution contracts and implementation of MDR/IVDR. He further advises on digital health projects as well as R&D cooperations in the medical device industry.
Further activities:
• Visiting lecturer for medical device and pharmaceutical law at the Ludwig-Maximilians-University Munich
• Member of the scientific advisory board of the Research Centre for Medical Device Law at the University Augsburg
• Associated member of the legal committee of the BVMed (German Medical Technology Association)
• Member of the German Society for Biomedical Engineering (VDE-DGBMT) and collaboration in VDE-DKE publications

Terri has more than 20 years of experience in various legal and regulatory roles, with eight years focused on regulated content management in the medical device industry. Over the course of her career, Terri worked with leadership teams to form or influence change in regulatory and marketing business practices, most recently at CareFusion (now BD). A few years ago, she joined Veeva Systems to explore innovative ways of using technology and services to help life science companies successfully engage with their customers.

Dr.-Ing. Alexander Kaiser received the Dipl.-Ing. degree in electrical engineering from the University of Ulm in 2000. From 2000 to 2002 he was with the Centre for DNA-, Surface- and Microsystem Technologies, where he was working in the field of biomedical actuators and sensors based on diamond micro system technology. 2002 to 2005 he was performing research in the framework of a BMBF project, developing 3D integration technologies for silicon circuits, and the combination thereof with new materials, for which he obtained his PhD degree. Prior to joining Cicor in 2007, he was serving as a project manager for diamond-based electronics.
At Cicor Reinhardt Microtech GmbH 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. Alexander Kaiser holds a PhD from the University of Ulm, and has authored or co-authored several technical and scientific publications, book chapters, and patent applications.

Simon is the co-founder and COO of Bluedrop Medical - a connected health startup developing an IoT foot-scanner which utilises computer vision and AI to remotely monitor and prevent diabetic foot ulcers.  Simon previously worked at Medtronic in R&D, developing implantable devices and was a member of the TAVI BioInnovate team. Simon holds a Masters in Biomedical Engineering and a Bachelors in Mechanical Engineering, both from UCD. 

Andrew Koubatis is Director of Medtech at Altran Switzerland . He studied Mechanical Engineering at McGill University and has an MBA in Management of Technology from École Polytechnique Fédérale de Lausanne. With more than 30 years of experience, he has worked on the development and integration of a broad range of technologies within the aerospace, life science, energy, industrial and consumer products industries. He is currently specializing in Medical Devices and innovation projects. In addition to his expertise with medical devices, he has worked with major pharmaceutical companies in the development of new combination products

Dr. Klaus Kruttwig obtained his doctoral degree in the field of cell biology and MRI imaging from the RWTH Aachen University. As a postdoctoral researcher at the University of California Davis and San Francisco, USA he worked in the area of biomedical engineering and cell biology, especially investigating tumor development in genetically modified mice using hyperpolarized MRI technology.

Since November 2016 Klaus is Head of the Biointeraction team at the INM - Leibniz Institute for New Materials, Saarbrücken, Germany. He works in the program division of Functional Microstructure in the department of Interface Materials. His research focus is the development of novel materials and functionalization strategies for cell culture surfaces, wound dressings and cellular scaffold materials. Klaus’ major personal interest is the investigation of scientific basics enabling novel product development in cooperation with industrial partners and clinicians.

Experience
- Since April 2017 Sales Manager at GlencaTec AG
- Before: 11 years of experience in contract manufacturing business for medical device at Cendres+Métaux Medical Division
Functions: Project Manager --> Product Manager --> Key Account Manager
Education
- Executive Master of Business Administration in International Management
- Dipl. Ingenieur FH Mikrotechnik
- Dipl. Maschinenzeichner in Feinwerktechnik

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. In a previous role at IMS Health Consulting Group, Unmesh led a resource optimization engagement with a leading generic pharma company involving market sizing, structuring, customer coverage, frequency and channel optimization. At Novartis, he provided high complexity sales force and marketing analytics, enabling strategic decision making for internal customers and at UfM Health System, contributed to statistical analysis for leading nursing publications. Unmesh holds a MSE (Biomedical Engineering) University of Michigan-Ann Arbor, MI, USA.

Giedrė joined Euromonitor in 2013, and is mostly in charge of developing and commissioning of Euromonitor’s analytical content related to healthcare, medical instruments and drug sectors from the industry and manufacturing perspective. She is responsible for building datasets, and wiring annual overviews about medical device and pharmaceutical industries, as well as preparing opinion pieces, podcasts, video-casts, webinars and etc., in addition to consulting company’s clients on major industry developments.

Bernd Maisenhölder joined Iftest in 2016 as Director Marketing. In his role, he serves the company in both strategic as well as operational marketing. An important part of his assignment is to identify and develop new, emerging applications and customer segments particularly in the medtech field. Prior to working at Iftest, he had global responsibility for the Consumables Business at Tecan, Switzerland, driving innovation and product development as well as commercialization for Life Science Research, Diagnostics and Applied market segments.
Bernd graduated from the University of Konstanz, Germany, in 1993 with a masters degree in Physics. He then joined the Paul-Scherrer Institute Zurich, the former RCA research lab in Europe, to do a PhD in Integrated Optics for biosensing applications together with Ciba-Geigy and Balzers. From 1997 to 2004, he worked at Balzers in the field of optical biochips for protein and gene arrays in close collaboration with Novartis, Basel.

Alan has worked at the cutting edge of the application of Lean Innovation to Life Science Regulatory Affairs, Quality and Product Development functions for the past decade. He has helped some of the most successful Pharmaceutical and Medical Device companies to solve complex problems through process innovation, meaningful engagement and partnership.  Alan is a Biochemist by training, is a co-founder of Avellana Innovation and lives in Galway, Ireland.

Gerald (Ger) Manley is a medical device professional with 20 years’ industry experience. Ger founded G&C Creations ltd in 2004 and to complement the consultancy division of the business, added contract technical services in 2009. G&C Creations is based out of Ireland and provides consultancy services across Europe and North America.
16 of the 20 years’ experience are in the medical device field working for a host of different companies with considerable market share in the diagnostics, instruments, consumables, packaging and orthopedics sector. Ger has extensive experience in New product introduction, technical transfers, product launches, process improvement, Lean, end to end supply chain and outsourced manufacturing. He has worked and consulted in all aspect of the medical device field and provides extensive consultancy on validation, design controls and all aspects of Quality systems.
National Cert. Electronics Engineering- Tralee Institute of technology Ireland.
National Diploma Mechanical and Electronic engineering - Tralee Institute of technology Ireland.
Bachelor of Engineering Hons Mechanical / Production Engineering - University of Limerick Ireland.

Lorcan Mannion has built his career on adapting Lean to deliver successful global programs in R&D, RA, QC & QA functions in the world’s leading Life Science companies. With his Avellana colleagues, he shares a passion to re-focus Lean on empowering product and process innovators, in the space between design-thinking and launch, to highlight the important, reduce uncertainty and confidently deliver on the promise of the design hypothesis.

Lecturer at a Management Academy, Member of panel of experts “Renewable Energies” - to present
Member of several Chambers of Commerce and networks - to present
Principal Management Consultant “European Material Cycle Coordinating Body “ (MCCB) - to present
Serial entrepreneur, holder of several copyrights, multiple marathon finisher - to present
Management Consultant with a basis of numerous successfully completed projects
Professional experience as Member of the Board of Directors and Supervisory Board
Study of Business Administration at “University of Bristol”
Study of Automotive Engineering, Light Construction, at “University of Applied Science Ulm”
German Army - Training and activity as a „Permanent Aircraft Member / Flying Staff “

Michael McMullan has a BEng Mechanical & Manufacturing Engineering from Queen’s University Belfast and a Business Masters from Ulster University. Michael has been the Sales Manager for the Electroforce group within TA Instruments in Europe for over 5 years and has a wealth of experience with Medical Technology, Devices and Implant Testing. Based in Ireland, Michael has an excellent understanding of the key drivers within MedTech and healthcare as whole.

Nicholas Mockett is a corporate financier and has served the global packaging related industries exclusively for twenty-five 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.

Katja Müller is employed as Scientific Associate at the biological testing laboratory of senetics. She started her PhD at the senetics healtcare group GmbH & Co.KG after she had worked as scientific associate at the Leibniz Institute on Aging in Jena. In the senetics Biolabs she is mainly responsible for development and performance of biological tests of medical devices. She completed her Master´s degree in Biochemistry at the Friedrich Schiller University of Jena. 

Ash focuses on investing across the UK in early and growth-stage companies with Mercia Technologies PLC, an publically-listed investment house with over £350m under management in third-party funds. He serves as a non-executive director to portfolio companies applying a broad range of technologies to solve problems in human and animal health.

Martin studierte Betriebswirtschaft an der Wirtschaftsuniversität Wien und verfügt über umfassende Erfahrung im Innovationsbereich. Er hatte Schlüsselpositionen bei Roland Berger Strategy Consultants and Mayr-Melnhof Karton inne und war Projektleiter einer Vielzahl von Innovationsprojekten. Martin verfügt über umfassende Branchenkompetenz in den Bereichen Maschinenbau, Energiewirtschaft, Bauwesen, Informationstechnologie und Medizintechnik.

Dr. Prinz studied Biology at the University of Münster and received a doctor’s degree in Molecular Microbiology at the University of Utrecht in the Netherlands. After a postdoctoral fellow position at the University of Freiburg he joined in 2002 Proteome Sciences R & D GmbH & Co. KG in Frankfurt/Main as a project leader and quality manager and has been involved in different topics in biopharmaceutical research. Since 2013 he is engaged at the VDE Association for Electrical, Electronic & Information Technologies concentrating on technology scouting and regulatory requirements in the field of medical devices.

Benno Bieri blickt auf eine reiche Berufserfahrung als Elektronik- und Software-Entwicklungs-Ingenieur zurück. Sein Spezialgebiet ist technische Beratung, Engineering und Leitung ebenso herausfordernder wie budgetsensitiver Projekte in der Medizintechnik, im Geräte- und Spezial-Maschinenbau sowie in der Entwicklung kundenspezifischer Software-Lösungen in der Verpackungs- und Logistik-Branche.

-       Biomedical Engineer

-       1994 – 1997     Head of Certification Body - mdc medical device certification

-       1997 – today    General Manager - mdc medical device certification GmbH

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.

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.

Andrew Rut is CEO and co-founder of MyMeds&Me a provider of Reportum, a dynamic solution for the digital intake of adverse events from all sources globally. Reportum is a leading SaaS product that is now in use by 5 of the top 30 Pharma companies and its footprint is growing rapidly. Andrew has deep expertise in Pharmacovigilance as well as the emerging challenges of data privacy participating in numerous conferences and benchmarking initiatives. He trained as an Endocrinologist at University College London and Baylor College of Medicine, Houston. He has held senior roles spanning Drug Discovery and Development within GSK working across 3 continents: USA, Europe and Asia-Pacific. He was previously Head of Safety at GSK and EU QPPV where he drove significant innovation and streamlining into the organisation.

Prior to joining Mercia, Ash was the clinical technology director at Babylon Health where he helped to build a multi-award winning medical technology platform which secured Europe's largest ever Series A investment in digital health ($25.0million). He is also an anaesthetics and critical care doctor, having trained at the Imperial School of Anaesthesia. Ash holds an MA in Medical Sciences and a BMBCh Medical Degree from the University of Oxford, and he is a member of both the Royal College of Anaesthetists and the CFA Institute, UK.

Patrice Slupowski is Vice-President Digital Innovation running the open-innovation corporate product marketing team of Orange, in charge of several projects around APIs, Internet of Things, mobile applications & mobile OS, personal data aggregation, privacy or emerging technologies (AI, VR, …).
Patrice Slupowski is a marketing expert in IoT, social networks, connected TV, wellness & personal data and mobile multimedia services. He founded a start-up called Waptoo in 1999, one of the first companies to believe in the opportunities around mobile data, creating WAP and mobile services and proposing some automated mobile testing software, for companies and telcos, which has been acquired by Lagardere Group.
Patrice has been involved in digital space from the very first minute, and is permanently connected from 1990. Patrice is a graduate in Information Science and Technology from Paris-Dauphine University.

Daniel is the Marketing Manager for Healthcare solutions in Europe at Renesas Electronics, a world-leading semiconductor company headquartered in Tokyo, Japan. His focus areas for the business development in Europe are connected health applications, interoperability and security. He has an engineering degree in applied computer science and an MBA.

Christian Söhner is FOBA’s Global Vertical Manager Medical and responsible for the
development of customer relations in the field of laser marking on medical products. After
his business degree at the University of Technology Dresden, he gained 15 years of
profound experience in the medical industry, while working for Abbott, BrainLAB, Stryker
und Dentsply and others. Christian Söhner is networking with official agencies and notified
bodies (ministries, BVMED, EPRD, GS1, HIBC, TÜV, BSI und DQS etc.) and is an expert
for the regulatory compliance and the technical implementation of UDI-marking on medical
instruments and implants.

Born in 1970, Ole Stein has been Sales Manager at MedNet GmbH since October 2016. He is responsible for the sales activities and strategic development of Medical Components and Sets within MedNet. In addition he is in charge of representing MedNet’s partner quasar on the European market.
Since 1998 Ole Stein has held various management positions within the Masterflex Group, most recently as General Manager for the European business, including the General Management of the brands Novoplast Schlauchtechnik GmbH and Fleima-Plastics GmbH, starting in January 2014.
Ole Stein has earned a diploma in plastics engineering at the University of applied Sciences Osnabrück.

Raphael Sznitman is an Assistant Professor in the ARTORG Center for Biomedical Engineering Research at the University of Bern (Switzerland). He received degrees in Computer Science from the University of British Columbia (Canada) and Johns Hopkins University (USA). His research focuses on developing new image analysis, machine learning and AI methods for healthcare applications and translating these to practice. 

Jana Viehbeck is working as Scientific Associate at senetics healthcare group GmbH & Co. KG since October 2017. Her tasks are mainly customer-specific product development as well as the testing and validation of customized products in the technical field. Jana received her Master's degree in Biomedical Engineering from the technical university of Applied Sciences Regensburg. 

Patrick von Meiss obtained a degree in micro-technical engineering from the Ecole Polytechnique Fédérale de Lausanne (Federal Institute of Technology of Lausanne) in 1988. He then completed his studies with an MBA in 1992.

With more than 30 years of experience in machine tools and the medical equipment industry, Mr von Meiss gained critical knowledge in various segments such as dental, orthopedics, drug delivery and active implants. His various positions as Head of departments counting from 5 to 100 collaborators allowed him to get acquainted with all stages and processes from R&D, to manufacturing and customer advice.

His deep knowledge of all technologies, processes and challenges related to the manufacturing of innovative miniaturized implants is another string to his bow that he is looking forward to share during his presentation at Medtech Europe 2018.

Charles is a financial management professional with extensive experience leading medium- and small-sized businesses in environments demanding change or growth. He has broad and deep relationships across med tech contract manufacturing, precision manufacturing and with OEMs. He has lead two cross border med tech transactions between the US and Europe in recent years and was instrumental in building the world’s largest orthopedic contract manufacturer through acquisition.
Mr. Weikel has broad experience in global manufacturing and medical devices, especially in Europe and Asia. As President and owner of a leading niche U.S. equipment manufacturer in the 1990’s, he tripled sales to Asia while establishing joint manufacturing and assembly operations with local partners and governments.
He also has expertise is in strategic development issues that increase shareholder value, including acquisitions, divestitures, new-product development, corporate refocusing and entry into new markets. He has managed numerous corporate restructurings with creditors, including banks and vendors.
With seven years’ experience in the financial services sector, at GE Capital and Bank of America, Mr. Weikel provided investment and commercial-banking services to Fortune 500 and middle-market customers.
Mr. Weikel earned a Master of Business Administration in Finance, with honors, from the University of Chicago, and a Bachelor of Science in Physics from the U.S. Naval Academy. Upon graduation from the Academy, he was commissioned an officer, entered the U.S. Navy Nuclear Training Program and subsequently served as a Nuclear Officer aboard the USS Nimitz and the USS Mississippi in the Mediterranean and Caribbean areas.

After studying mechanical engineering at the University of Stuttgart, Thomas Weisener did his doctorate at the Fraunhofer IPA. Today he is CEO of HNP Mikrosysteme GmbH. The company deals with technical solutions for industrial microfluidics. In addition to micro annular gear pumps, dosing systems are developed and offered for the life science, chemical and mechanical engineering industries. A main focus in the company's R & D area are applications in analytical instrumentation.

Hans Christian Wenner is an educated electronics technician and additionally studied electrical engineering, principal subject electromechanical constructions, at the Technical University of Darmstadt, graduating as Dipl.-Ing.
After various positions in the industry and at a Notified Body, he drives his own business since 1998 (Ingenieurbüro Wenner).
Main topics are: assisting the industry during regulatory processes by supporting the preparation of the technical documentation in accordance with the Medical Device Directive, moderation and documentation of risk management, implementation of development processes (software as well as hardware-centric) as well as training.
He is also a long-time active member of the international standardization groups IEC TC 62 / SC 62A / JWG 3 (Medical Device Software) and ISO/TC 215 - IEC/SC 62A JWG7 (Safe, effective and secure health software and health IT systems, including those incorporating medical devices) and - among others - the national bodies DKE UK 811.3 (safety of medical equipment / systems / equipment in the networked application) and DKE / GAK 811.0.4 Coordination Revision ISO 14971/24971.
He is author of various publications.

Martin is Global Director for Active Medical Implants for TÜV SÜD Product Service GmbH, since 2016. He started with TÜV SÜD as Product Specialist & Lead Auditor in 2014. Martin has held previous roles in Regulatory Affairs for BIOTRONIK SE & Co. KG, as well as a role in Sales for BrainLAB Sales GmbH. Martin has a degree in Biomedical Engineering from the University of Applied Sciences Hamburg and studied Information Technologies at Høgskolen I Agder, Norway.

Matthias Wufka is working for Zühlke Engineering as a Business Solution Manager. In this role he is responsible for a project portfolio in the sector MedTech, Pharma and Lab Equipement in southern Germany. He started his career in a company for intensive care equipment. He supported and guided many medical device projects in different roles (Developer, Quality Manager, Project Manager). In addition to the development of medical products he was one of the lead contributors for the new Zühlke medical development process. One of his specific interests is the incorporation of modern agile methods into medical development processes.