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We are at the start of an industrial revolution in medical devices. The possibilities for medical devices to wirelessly connect, analyse and disseminate information as well as for controlling the device remotely are being realised. For example, there are already pacemakers that can be remotely monitored and programmed and blood glucose meters which stream data to a smart phone and the Internet. There are a myriad of wirelessly connected devices in development such as smart phone control nerve stimulation devices, devices which monitor adherence to a prescribed therapeutic regimen and devices with medical mobile apps.
The consumer health sector has led the way, with small wearable technologies that, collect data on activity rates, vital signs and provide the user with information on distance covered, calories burned and other information they may want. The data can be displayed on a mobile phone app and on a PC via the Internet.
The smart phone is a great enabler of this revolution, providing a handy tool with advanced and secure communication to vast sections of the population. However, in the medical device context smart phones are fraught with problems. There are numerous platforms and several operating systems. These tend to evolve much more rapidly than medical devices do. Verifying a mobile app across all of the evolving platforms and operating systems, to the satisfaction of regulatory agencies, presents a significant challenge.
Furthermore, a number of systems require development to:
This conference will start to explore this exciting new area of medical device technology.
Technical, marketing and commercial seniors:
9.30 Welcome and introduction
Dr Greg Berman
Key note presentation
9.40 Connectivity for pharmaceuticals and wider healthcare delivery
Dr David Jefferys
10.20 How strong security and looking after personal data should enable better healthcare
11.00 Discussion followed by refreshments
11.30 Combination drug delivery devices apps and cloud – everyone wins
12.10 Connectivity in clinical trials
12.50 Discussion followed by lunch
14.10 Multi-sensor remote data collection – critical success factors
14.50 Connectivity in drug delivery devices
15.30 Discussion followed by refreshments
16.00 Injectable drug delivery – What’s the benefit of connectivity?
16.40 Connectivity in drug delivery and Portal’s approach
17.20 Discussion followed by End of day one
17.30 – 18.30 Networking drinks reception for speakers and delegates
9.15 Review of day one
Dr Greg Berman
9.30 Regulatory requirements for connected medical devices
10.10 ‘How David beat Goliath’
10.50 Discussion followed by refreshments
11.30 Choose the right kind of smart: different smart features and options for different needs and strategies
12.10 The risk of big data
Tom Lawrie-Fussey and Louise Place
12.50 Discussion followed by lunch
14.10 Digital health system connectivity
14.50 Smart dispensing
15.30 Connecting low cost point of care tests using only a smartphone
Dr Neil Polwart
16.20 Chairman’s concluding remarks
16.30 Close of conference and refreshments
Dr David Jefferys is currently Senior Vice President with Eisai responsible for Global Regulatory, Government Relations, Public Affairs and Patient Safety (EMEA, Russia and Australasia). After qualifying in medicine he worked in clinical and academic medicine, before spending 20 years as a senior regulator for both medicines and medical devices. He was executive director of the UK Medicines Control Agency, CEO and Director of the MDA, joint CEO of MHRA. He was involved in the establishment of the European Medicines Agency, CPMP/CHMP member and MRFG and PER scheme chairman. For the last ten years he has worked in industry and chairs several key committees for ABPI, Efpia and IFPMA. He has lectured and published extensively in drug and device regulation and on benefit risk evaluation.
Gregory Berman is an Independent Consultant and Director of Cantab Innovations Ltd. Previously he was Head of the Medical Group at Kinneir Dufort, an award-winning research, innovation, design and product development company, with over 30 years’ experience helping companies discover, create, develop and realise tangible new products, brands and experiences. He helps clients in the life-science, medical and healthcare sectors to develop products in complex situations, optimise life-science R&D and exploit technology strategically. For example he:
Led the design and development of SmartJect™; an autoinjector which automatically retracts the needle and was launched by J&J in 2010 with an important next-generation drug.
Worked with Chrono Therapeutics, helping to develop their SmartStop™ based device, the world’s first programmable, wearable transdermal smoking cessation therapy.
Participated in a detailed design review of an autoinjector being developed by a leading pharmaceutical company for a new drug.
Undertook the Voice of Customer study for a leading biopharmaceutical company, as the starting point for developing high volume parenteral delivery devices for lifesaving immunotherapies.
Undertook a technology survey for a company interested in needle-free, transdermal, micro-needle, electroporation and iontophoresis drug delivery devices.
Markus Bauss has over 10 years’ experience in the area of pharmaceutical packaging in various leading roles such as global key account management, research & innovation and business development. Looking at upcoming new technologies such as smart phones, mobile apps and connectivity, he started his technology Start-Up company ConnectMeSmart GmbH in 2013.
In 2015 SHL Group and ConnectMeSmart partnered up in the Joint Venture SHL Connect to investigate the market for connectivity, emerging technologies and explore their potential application within each of SHL Group’s companies. SHLGroup is the world’s largest privately-owned designer, developer and manufacturer of advanced drug delivery devices such as auto injectors and pen injectors. In addition the company provides contract manufacturing and engineering services for the production of medtech and industrial products and final assembly, labeling and packaging services of drug delivery devices to the biotech and biopharma industries.
From 2004 to 2014 he has been working for Schreiner MediPharm, a leading supplier of advanced labeling solutions. Working in the U.S. and Europe, he contributed with innovative products, such as Needle-Trap, a label integrated needle stick prevention solution. He studied process engineering at the Technical University of Clausthal and started his career in environmental & recycling technology at RWE in Germany in 1997 prior to moving to the pharmaceutical area.
Phil Seeney is a Managing Consultant in the Technology and Innovation Practice within the PA Consulting Group. He holds a BSc (First Class Hons) in Mechanical Engineering from Aston University (1975) a DIC from Imperial College London and an M.Des from the Royal College of Art, London. Phil developed strong engineering skills in industry transitioning to product design and medical device development after studying at Imperial College and the RCA. He has over 40 years of product development experience covering fast moving consumer goods, consumer durable and healthcare sectors. For the last 25+ years, Phil has specialized in drug delivery and the development of medical devices. His experience extends beyond the development of products and he has conducted numerous technology identification and due diligence projects for blue chip pharmaceutical clients. Phil is no stranger to tackling the wider business issues and has assisted various clients in developing low cost manufacturing strategies and realizable cost reduction programs. Phil has a keen interest in the application of technology to improve patient benefits and outcomes and has written articles on the use of technology in connected drug delivery devices and in the future of inhalation.
Phil founded and chaired Management Forum’s leading annual conference on Nasal Drug Delivery in 1997, developing the two-day program of speakers for thirteen years to elevate it to Europe’s largest and premier conference in the nasal field. Phil has also chaired seminars on drug delivery and lectured on product design and development for manufacture. Phil’s primary areas of expertise are:
Dr. Patrick Anquetil is Portal Instrument’s Chief Executive Officer. He brings more than 18 years of experience in nanotechnology, including extensive knowledge in the areas of cleantech, material science, and instrumentation.
From 2009 to 2012, he was co-founder and director of strategic and process planning for SynapDx Corporation, where he had responsibility for development of the company’s business and operational plans as well as securing $9 million in Series A funding. He began his career as a science and nanotechnology equity research analyst at Susquehanna International Group, authoring and marketing nanotechnology industry and equity research reports to hedge funds and portfolio managers. He holds a doctorate in bio-instrumentation from MIT, an MBA from Harvard University, and a master’s degree from the ETH in Zurich and the University of Tokyo. His work has appeared in numerous peer-reviewed publications as well as mainstream media, including MIT Technology Review, Wired Magazine, PBS, and CNBC among others.
Tony is Senior Account Director with Chiltern International, previously he was Head of Medical Business Development residing in Kinneir Dufort’s newly-formed Medical Device Design Centre of Excellence in Cambridge UK. He has extensive experience of medical device development, having designed and developed drug delivery, diagnostic and surgical devices on behalf of a range of international clients. In 2008, he took on a strategic role to help make sense of market opportunities in the medical space before joining Kinneir Dufort in a purely commercial role in early 2012. He has a number of patents to his name in the drug delivery and consumables space.
Tom Lawrie-Fussey is a Chartered Mechanical Engineer with a Master’s degree from Cambridge University. After graduating he worked for a major UK automotive company, including a secondment to Germany, where he specialised in developing innovative real-time modelling techniques to enable vehicle electrical systems to be dynamically tested in the lab. He subsequently became a Consultant and then Business Development Manager and rapidly recruited a team of over 50 engineers specialising in providing system engineering capability across the UK, in the automotive and aerospace sectors.
In 2012 he made the move to Business Development in the connectivity space, creating the first of many Patents involving low-cost power-smart ubiquitous devices. Since then he’s led the commercialisation of this idea, in markets ranging from parcel tracking to sports impact measurement, culminating in a number of trials and licence agreements being signed.
He is now responsible for leading the business development of CDP’s capabilities in the electronics, software and communications space, spanning all major sectors.
Francis White, Senior Leader of AliveCor, heading up their International expansion. NHS Innovation Fellow, Champion of Patient Activation. A passionate advocate for individual health empowerment, he brings a fresh perspective to the healthcare industry and is an emerging thought leader on the exciting frontier of Digital Health. With a 25 year career in leading Medical Device Companies that serve many clinical areas, the move to AliveCor in January 2013 opened up an exciting new horizon. Enthusiastically driving successful adoption Direct to Consumer, B2B and through the more traditional channels of Primary Care and Hospitals.
Jared is the visionary that has led commercialization of HCO’s patented technology, seeing the vast potential for a wearable that monitors respiratory performance at clinically accurate levels. He is passionate about HCO’s technology, and the remarkable difference it can make in the lives of those who have respiratory illnesses and their caregivers. Throughout his career, he has held leadership roles in manufacturing; operations management; engineering and design management and technical sales management.
Marie McCarthy is a Director of Product Innovation at ICON, and as part of a multidisciplinary innovation team, has specific responsibility for developing solutions in the direct to patient paradigm, including the operationalization of wearable devices. She has coordinated projects to collect data generated from wearable devices into a range of systems (e.g. EDC) and analytics platforms (e.g. Intel and ICONIK)
Marie acts in an advisory capacity for a number of sponsors on the relevant clinical endpoints and considerations to be deployed when embarking on the incorporation of wearable technology into clinical trials. As part of the ICON CNS innovation group she provides insight into outcomes addressed by wearable technology.
Prior to ICON, Marie worked at Philips Respironics, with responsibility for strategic European marketing decisions including the development and implementation of the international sales & marketing strategy for Actigraphy in both clinical and pharmaceutical market segments. She delivered the Actigraphy component of a number of educational programs including the Manchester Sleep Medicine Course, the Edinburgh Sleep Medicine Course, and workshops at the British Sleep Society (BSS) and European Society of Sleep Technicians (ESST). Marie was responsible for the support and training of researchers, clinicians and trial sites in the appropriate use of Actigraphy, and has a network of connections with leading clinicians and researchers throughout Europe.
Prior to this, Marie was the Global Marketing Manager at Trinity Biotech and was responsible for global marketing activities associated with a portfolio of point-of-care products, including rapid HIV test. Marie has developed and maintained relationships with key opinion leaders, who have decision making roles, and determine global HIV policy in organizations such as the WHO, CDC, UNFPA, UNICEF. In addition, Marie developed specific training programs, and initiated the development of interactive online training sites for B2B clients as well as end-users.
Marie has held a number of part-time lecturing roles, with responsibility for the Marketing Modules for FETAC level 6 accredited courses at the Institute of Commercial Management, the design and delivery of an international marketing course at Export Edge, and was an Associate Tutor at the Open University, supporting social marketing students with a virtual learning experience (VLE). Marie has presented at a number of industry conferences on wearable technology, including the DIA Clinical Forum and the PRISME Forum, and holds a BSc and MSc from University College Dublin, and an MBA from the Open University.
Arnaud is currently business development associate at BIOCORP, in charge of finding partnerships and license opportunities for BIOCORP’s range of connected devices. Previously, he worked for a healthcare consulting firm with a strong focus on connected health strategies for pharma and insurance companies. Other past experiences in the pharmaceutical industry (Sanofi) and the insurance industry (AXA). Graduated from HEC Paris, a major European business school. For 20 years, BIOCORP has been designing, developing and manufacturing medical devices for the pharmaceutical industry, enhancing drug reconstitution, safety, packaging and delivery.
Neil is the Head of Connected Health and Director of Front-End Innovation for Medicom Innovation Partner, a Phillips-Medisize Company, based in Cambridge UK. Neil consults for BioPharma clients, innovating and executing strategies to enhance stakeholder engagement through connected devices and service design. He has over 22 years’ commercial experience covering medical devices, telemetry, digital imaging, clinical decision support, secure mobile working, patient engagement and health analytics for businesses including Philips Healthcare, Microsoft, Elsevier Health Sciences, Hospira, Map of Medicine and ZOLL. Prior to Neil’s commercial career he trained at Leicester University Hospitals in Operating Department Practice and was Faculty for numerous Advanced Life Support programs having qualified in the UK and United States.
International business pharmaceutical consultant.Proficeint business development specialist, inventor & founder of three enterprises. Advocate of new disruptive technology.Keen to work with ambitous organisations who are looking to create expodential value,growth.
Caroline Rivett is Head of Cyber Security, Healtcare Practice, KPMG, UK.
Mette Luxhoj is Regulatory Affairs Manager, Global RA, RA/AQ Department, Radiometer Medial ApS, Denmark.
Dr Neil Polwart, Founder, Novarum DX and BBI Group Head of Mobile, UK. With a PhD in Chemistry, Dr Polwart has over a decade of experience in mHealth within the diagnostic industry, delivering connected health and enabling true point of care technology.
Louise has over 10 years’ experience in Medical devices and IVD Companies, having originally trained as a Pharmaceutical Scientist. She specialises in Device Technical management for Combination Product submissions and CE Marking for Medical Device and EMA Medicinal Product Submissions. She has participated in successful audits against ISO 13485 and 21 CFR Part 820, as well as the Human Tissues Authority, and has completed Regulatory Affairs Certificates in Pharmaceuticals and Medical Devices from the Regulatory Affairs Professionals Society.