A collection of free, on-site seminars covering the latest trends and developments in the Medical Device and Technology space.

Transcription

1 4-6 th April 2017, Messe Stuttgart A collection of free, on-site seminars covering the latest trends and developments in the Medical Device and Technology space. Our trend-led modules focus on a diverse range of topics ranging from regulatory updates, ehealth and Digital through to Miniaturisation. Why attend? The med tech industry moves fast, with new innovations, products and technology emerging every day. It s important to keep on top of regulatory issues, device advances, the latest healthcare and medical needs, issues and problems. Our free content sessions on-site will cover the issues that matter to you, addressing key challenges and opportunities in the market, helping you to stay ahead of the competition and grow your business. 5 reasons to add content to your schedule Save time on research by accessing the latest industry updates in one location - no need to attend additional conferences throughout the year! Hear from senior level speakers on the topics affecting your business Sessions cover various topics, addressing challenges and opportunities at each stage of the supply chain Hear from the most innovative young companies on the products and technologies of tomorrow in our Start-Up Forum All content is free to attend and open to anyone attending Medtec Europe

2 Speaker Highlights

3 Agenda at a Glance Hall 1 Start-Up Forum Time Day 1, 4 April Day 2, 5 April Day 3, 6 April 10:30-12:00 Start-up Academy Hear from our shortlisted start-ups on the latest innovations and learn more about opportunities for partnering and collaboration. Start-up Academy Hear from our shortlisted start-ups on the latest innovations and learn more about opportunities for partnering and collaboration. Start-up Academy Hear from our shortlisted start-ups on the latest innovations and learn more about opportunities for partnering and collaboration. 12:30-14:00 Where are they now? 2016 start-up academy finalists update 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. From Concept to Commercial Success You ve got an interesting concept, but how do you bring it to market? E-Health Innovation Forum 12:30-15:00 A group of the most innovative new companies working in ehealth will pitch to a board of key stakeholders in front of a live audience, followed by a Q&A session. 14:30-16:00 Market Access The European device market may still be the strongest globally, but expanding into other regions is very much a priority for many companies. This module will examine market opportunities in the US market, while examining uncertainty on both sides of the pond, prompted by Brexit and the new US administration. M&A, Investment & Financing What is the current market outlook for investment and mergers in Med tech? After a bumper year of acquisitions in 2016, what does the M&A market landscape look like for 2017? And with investment becoming harder to come by, what are Venture Capitalists looking for? This session offers an opportunity to understand where new innovations are coming from in the ehealth space, and what it will take to establish a route to market. Hall 1 Seminar Theatre Day 1, 4 April Day 2, 5 April Day 3, 6 April 10:30-12:00 mhealth & Digital mhealth presents an opportunity for making healthcare more personalised, accessible and convenient. Enabling patients to avoid hospital beds in favour of monitoring conditions remotely has the potential to reduce costs, strengthen healthcare systems and improve outcomes for more people across the globe. However, with new opportunities come new challenges around data privacy and security, interoperability and how these systems will be regulated. This module addresses both the opportunities and concerns posed by advances in this sector. Health Economics Reimbursement often comes top of the list of industry s biggest concerns, with many manufacturers now trying to think about reimbursement earlier in the product development process. What are payer s looking for? How can we improve clinical outcomes whilst simultaneously lowering costs? Regulatory Regulatory changes and updates are an ongoing industry concern; in these two modules dedicated to the latest regulatory updates, you will gain an overview and understanding of how to reach compliance.

4 12:30 14:00 14:30-16:00 Industry 4.0 The Medical Device industry can no longer ignore Industry 4.0 if they wish to remain competitive in this era of digitalisation, interoperability and connectivity. How can this model be applied to your business and deliver real value and ROI? Connected Devices: Beyond Wearables Connected devices have come a long way in recent years; moving beyond the novelty of wearable technologies towards connected healthcare systems that offer tangible benefits for patients. This module attempts to see beyond the hype and to address the current state of play of this sector, what are real benefits these technologies can offer patients, and what are the concerns that need to be addressed Pharma Meets Medtec Once distinct entities, Pharma and Med tech are becoming increasingly aligned in their interests. No longer able to rely purely on the strength of their compounds, Pharma companies are increasingly looking to device manufacturers to explore how to add value to products in their portfolios. Innovation in Miniaturisation The industry is heavily focused on the evolution of device miniaturization. Minimally invasive, micro-surgeries are increasingly becoming an option for patients, enabling less time in hospital, quicker recovery and an overall improved patient experience. Manufacturers must focus on miniaturisation of devices whilst retaining safety, performance and reliability. Regulatory Regulatory changes and updates are an ongoing industry concern; in these two modules dedicated to the latest regulatory updates, you will gain an overview and understanding of how to reach compliance. Agenda Overview Day 1 Tuesday 4 th April Time Seminar Theatre Start-Up Forum 10: Start-Up Presentations 12:00 10:30-12:00 mhealth & Digital mhealth presents an opportunity for making healthcare more personalised, accessible and convenient. Enabling patients to avoid hospital beds in favour of monitoring conditions remotely has the potential to reduce costs, strengthen healthcare systems and improve outcomes for more people across the globe. However, with new opportunities come new challenges around data privacy and security, interoperability and how these systems will be regulated. This module addresses both the opportunities and concerns posed by advances in this sector. 10:30-11:00 The Mobile Device as a Medical Device: Latest Innovations in Technology and Security Standards David Kleidermacher, Chief Security Officer, Blackberry (confirmed) 11:00-11:30 Mobile apps and software to support drug device combination products - Outlining drug device combination products available which are supported by mobile apps - Exploring FDA and European regulatory requirements and perspectives for apps Hear from our shortlisted start-ups on the latest innovations and learn more about opportunities for partnering and collaboration.

5 12:30-14:00 - Reviewing challenges with app classification in different markets as devices or not - Clarifying the role of combination products in connected health, regulations in place and direction this is likely to develop in - Discussing mobile app & SW combination products development and evaluation hurdles Christophe Amiel, Partner, Voisin Consulting (confirmed) 11:30-12:00 Cybersecurity intelligence: The threats to healthcare you need to know about John Gomez, CEO, Sensato (confirmed) Industry 4.0 & IoT The Medical Device industry can no longer ignore Industry 4.0 if they wish to remain competitive in this era of digitalisation, interoperability and connectivity. How can this model be applied to your business and deliver real value and ROI? 12:30-13:00 Industry 4.0 for Smarter Manufacturing: The German Experience Representative, VDMA (pending confirmation) 13:00-13:30 10 key considerations when developing connected devices - Key areas to prioritise in the journey from idea to commercial device - Some of the pitfalls to avoid - Examples from case studies Representative, 42 Technology Limited (Confirmed) 13:30-14:00 How IoT Is Transforming The Way Medical Products Are Developed? Changing customer needs now warrant more frequent product updates due to technological advancements, and new functional requirements Agility is an opportunity for developers to reduce time to market and to ensure that their products fit customer needs The need to maintain compliance and product safety in a fast-paced Agile environment is a challenge Peter Haller, Senior Pre-sales Consultant, Intland Software (confirmed) Where are they now? 2016 start-up academy finalists update 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. Moderator: Jared Sebhatu, Program Director, Germany, German Accelerator Life Sciences (confirmed) CaveoMed Albertus M. Scheule, CEO

6 14:30-16:00 Connected Devices: Beyond Wearables Connected devices have come a long way in recent years; moving beyond the novelty of wearable technologies towards connected healthcare systems that offer tangible benefits for patients. This module attempts to see beyond the hype and to address the current state of play of this sector, what are real benefits these technologies can offer patients, and what are the concerns that need to be addressed? 14:30-15:00 Connected Devices Reality Check: Where are we now? - What are the clinical benefits that connected devices can offer patients? - Emerging consumer and professional healthcare trends driving interest in wearables - Innovative connected device solutions Representative, Philips (Invited) 15:00-15:30 The changing landscape of diabetes management - Moving from needles to patients managing and monitoring their condition through mobile devices - Data Management and security concerns - Artificial pancreas and other transformational technologies on the horizon Representative, Roche Diabetes Care (invited) 15:30-16:00 Presentation TBC Market Access The European device market may still be the strongest globally, but expanding into other regions is very much a priority for many companies. This module will examine market opportunities in the US market, while examining uncertainty on both sides of the pond, prompted by Brexit and the new US administration. 14:30-15:00 North American Market Access for Medical Devices Senior Representative, CSA Group 15:00-15:30 The Impact of Brexit on the Medical Device Industry 15:30-16:00 Presentation TBC

7 Day 2 Wednesday 5th April Time Seminar Theatre Start-Up Forum 10:30-12: Start-Up Presentations 10:30-12:00 Health Economics Reimbursement often comes top of the list of industry s biggest concerns, with many manufacturers now trying to think about reimbursement earlier in the product development process. What are payer s looking for? How can we improve clinical outcomes whilst simultaneously lowering costs? 10:30-11:00 Reimbursement: the Payer s Wishlist - What are Payers looking for in a device? - Hear the Payer s Perspective on how to develop products for reimbursement Representative, Health Insurance Organisation 11:00-11:30 The Cost Effectiveness Plan How to Incorporate Health Economics into your Product Design? Stuart Hendry, CEO, Heco Anaytics (confirmed) 11:30-12:00 Presentation TBC Hear from our shortlisted start-ups on the latest innovations and learn more about opportunities for partnering and collaboration. 12:30-14:00 Pharma Meets Medtec Once distinct entities, Pharma and Med tech are becoming increasingly aligned in their interests. No longer able to rely purely on the strength of their compounds, Pharma companies are increasingly looking to device manufacturers to explore how to add value to products in their portfolios. 12:30-13:00 The Rise of Drug Device Combination Products: How Pharma and Medtec are realigning their interests 13:00-13:30 Regenerative Medicine: Partnering for Therapeutic Success 13:30-14:00 Combination/borderline products: the rapid evolution from exotic border-crossers to pharma blockbuster products As primary containers for liquid drugs evolve into sophisticated delivery systems, the pharma products making use of them become a new breed of regulatory entities The US and EU markets follow largely the same concept and regulatory requirements US FDA has outlined specific additional requirements for combination products Scrutiny of the device part of regulatory submissions increasing significantly From Concept to Commercial Success You ve got an interesting concept, but how do you bring it to market? 12:30-13:00 Medical device clinical trials Just the necessary evil or a crucial competitive factor? Axel Fischer, CEO & Founder, Activoris Medizintechnik GmbH (confirmed) Martin Conrad: Consultant & Head of Market Research at HiTec Consult (confirmed) 13:00-13:30: Innovation to realisation in practice- Opportunities for SMEs Keith Heaton, Managing Director, i2r Medical Ltd (Confirmed) 13:30-14:00 Presentation title TBC Senior Representative, Quasar

8 Pharma development processes are now challenged to comply with concepts from the medical device world: requirements engineering, usability engineering, risk management, design control The need for efficient approaches to compliance Dr. Dirk Kreder, MBA, Founder and CEO, Anteris Medical (confirmed) 14:30-16:00 Innovation in Miniaturisation The industry is heavily focused on the evolution of device miniaturization. Minimally invasive, micro-surgeries are increasingly becoming an option for patients, enabling less time in hospital, quicker recovery and an overall improved patient experience. Manufacturers must focus on miniaturisation of devices whilst retaining safety, performance and reliability. 14:30-15:00 CerMet based encapsulation and feedthrough technology enables new designs and unprecedented potential for miniaturization for sensors and active medical implants -High end therapy requires highly integrated and miniaturized active medical implants (retina- and cochlea implants, neurointerfaces, miniaturized medical sensors) - Encapsulation and feedthrough technology did (over the past decades) not keep up with the developments of electronics and software and is becoming more and more a bottleneck for therapy developments - A new biocompatible material technology is presented that will enable: a significantly increased number of communication ports 3D-Design and integrated functionality Unprecedented potential for miniaturization Jens Troetzel, Vice President Advanced Technologies, Heraeus Medical Components (Confirmed) 15:00-15:30 Emerging trends and challenges in robotic surgery Representative, Zimmer Biomet (invited) 15:30-16:00 Presentation TBC M&A, Investment & Financing What is the current market outlook for investment and mergers in Med tech? After a bumper year of acquisitions in 2016, what does the M&A market landscape look like for 2017? And with investment becoming harder to come by, what are Venture Capitalists looking for? 14:30-15:00 Drivers of M&A and Investment in the sector - An Overview of recent M&A and private equity investment in recent years. -What are the key drivers behind this activity? - Industry structure, supply chain and economic fundamentals. - Deal activity, sector performance, and valuation trends. -Outlook for 2017 and beyond Nicholas Mockett, Partner, Moorgate Capital (Confirmed) 15:00-16:00 Panel discussion: What are VCs looking for? - Overview of 2017 market trends for financing and investment - Will Venture Capital continues its trend towards fewer deals, how will this affect the market? - What are VCs looking for to invest in start-ups and innovative enterprises? Panellists: Dr Aristotelis Nastos, Partner, Creathor Venture (confirmed) Dr. Joachim Rautter, Managing Director, Peppermint VenturePartners GmbH (confirmed) Dr Karsten Fischer, Partner, Biomed Invest (confirmed) Wolfgang Kintzel (Head of Life Science Investments with NRW.BANK (invited) Dr Lukas Günther, Partner, Alstin Capital (invited) Day 3 Thursday 6th April Time Seminar Theatre Start-Up Forum

9 10:30-12:00 12:30-14:00 Regulatory Regulatory changes and updates are an ongoing industry concern; in these two modules dedicated to the latest regulatory updates, you will gain an overview and understanding of how to reach compliance. 10:30-11:00 New EU Regulations on MDR Fiona Maini, Director Risk Advisory, Deloitte (Confirmed) 11:00-11:30 Overview of IVDR Regulations Bernd Krämer, Senior Director IVD, Anteris Medical (Pending confirmation) 11:30-12:00 Consequences of the new MEDDEV 2.7/1 Rev 4 on clinical evaluation for legal manufacturers in the EU - Key elements of the new MEDDEV 2.7/1 Rev 4 - Consequences for medical devices manufacturers - Application of the new MEDDEV 2.7/1 Rev 4 by notified bodies Fabien Roy, Senior Associate, Hogan Lovells (confirmed) Regulatory Regulatory changes and updates are an ongoing industry concern; in these two modules dedicated to the latest regulatory updates, you will gain an overview and understanding of how to reach compliance. 12:30-13:00 Usability and User Experience in medical device development - Norms for usability in the development of medical devices: ISO DIN EN Avoiding risk, reducing costs and accelerating time to market through implementing a user-centric design process -How to apply these principles to your own design & development process Arnd Engeln, Do UX GmbH (confirmed) 13:00-13:30 Recent updates and changes to the most recent ISO standard on biocompatibility We will cover the new changes to the ISO series of standards including , -17, and -18. We will highlight the impactful information for the recent FDA guidance on biocompatibility and the effect it has on your devices. What is on the horizon? Description on what biocompatibility will look like in the future. Thor Rollins, Biocompatibility Specialist, Nelson Laboratories (confirmed) 13:30-14:00 13:30-14:00 UDI Marking for Medical Devices: Challenges and Solutions 2017 Start-Up Presentations 10:30-12:00 Hear from our shortlisted start-ups on the latest innovations and learn more about opportunities for partnering and collaboration. ehealth Hub The ehealth Hub is a cross-border, newly EU-funded initiative. It will provide business oriented services tailored to the needs of European ehealth SMEs and relevant stakeholders (investors, demand side stakeholders, commercial distributors, legal and regulatory firms and experts) In this module, a group of the most innovative new companies working in ehealth will pitch to a board of key stakeholders in front of a live audience, followed by a Q&A session. This session offers an opportunity to understand where new innovations are coming from in the ehealth space, and what it will take to establish a route to market.

10 -The UDI marking content and physical limitations - Material marking UDI challenges, metals, plastics... -The mark quality and traceability requirements. - How UDI marking reduces liability while increasing yields. Faycal Benayad-Cherif, Business Manager, Software and Vision, FOBA (confirmed)