We can customise this course to meet the requirements of your organisation.
our media partner
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, Independent Consultant, UK
Key note presentation
9.40 Impact of changing technologies on the healthcare market
Cecilia Bufton, Independent Business Adviser, UK
10.20 Connectivity for the pharmaceuticals and wider healthcare delivery
Dr David Jefferys, Senior Vice President Global Regulatory, Government Relations and European Product Safety, Eisai Europe Ltd, UK
11.20 The evolving perspective of pharma on devices and connectivity
Simon Wilson, Device Centre of Excellence, Pfizer, UK
11.50 What´s in it for me? – The value of new technology
Markus Bauss, Managing Director, SHL Connect, Sweden
14.00 Connected health study: new app for ageing research
Marie McCarthy, Director of Product Innovation at ICON, Ireland
14.40 Point of care blood-glucose monitoring
Representative from Roche Diagnostics
15.50 I’m connected – does that make me smart?
Phil Seeney, Managing Consultant in the Technology and Innovation Practice, PA Consulting Group, UK
16.30 Medical devices and patient engagement
Diarmuid Quinn, Director, 3rd Pillar Clinical, Ireland
17.15 End of day one
17.15 – 18.15 Networking drinks reception for speakers and delegates
9.15 Review of day one
Dr Greg Berman, Independent Consultant, UK
9.30 Three Stories from the front Line – scaling up in the UK
Francis White, VP Sales & Business Development, NHS Innovation Fellow, AliveCor Ltd, UK
10.10 Unconventional sensing for an unconventional world: connected technology to reveal how patients use new products
Jeremey Kooyman, Medical and Drug Delivery Device Design Engineer, The Cambridge Design Partnership, UK
11.30 Qualcomm Life: Powering internet of medical things, enabling intelligent care everywhere
Seamless care continuum from hospital to home and all points in between.
By combining Qualcomm Life’s wireless expertise and ecosystem of connected medical devices outside of the hospital with Capsule’s leadership for connecting medical devices, EMR’s and IT systems across the hospital enterprise, Qualcomm Life is creating one of the world’s largest open connected health ecosystems to deliver intelligent care everywhere enabling healthcare apps and connected devices globally
Thomas J Olesen, Commerical Director, Qualcomm Life, Europe, Germany
12.10 Case Study: 3M Intelligent Control Inhaler
Sam Van Alstyne, New Products Marketing Manager, 3M Drug Delivery
14.10 Smart inhalers – improving patient compliance and reducing healthcare costs
Dana Shears, Sales Director, The Americas, Presspart, USA
14.50 Tackling asthma control – expanding pre-cursor monitoring and revolutionising awareness
Jarad Dwarika, Co Founder A.D.A.M.M. – Intelligent Asthma Management™, Health Care Originals Inc., USA
15.30 A Manufacturer’s perspective on the new FDA post market guidance for cybersecurity
Jim Jacobson, Chief Product and Solution Security Officer, Siemens Healthineers, USA
16.20 Chairman’s concluding remarks
16.30 End of conference and tea
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 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.
Developed the business plan and identified partners for a quoted UK drug delivery company to develop a new drug formulation technology they had in-licensed
Has worked extensively with start-up drug delivery companies to help commercialise the technology.
He has also conducted a number of due diligence and technology assessments e.g.:
On behalf of Trinity Biotech Plc. (listed on NASDAQ) undertook the due diligence on Fiomi Diagnostics. Subsequently Trinity acquired Fiomi for $13.1m, strengthening its position in the growing $900m point-of-care cardiac biomarker diagnostics market.
For a UK plc evaluated a company developing a needless injector.
For a multinational assessed a small company developing an autoinjector
For a UK drug delivery plc evaluated a privately held US formulations group
An experts report for the offering memorandum for a French company producing therapeutic proteins.
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:
Cecilia Bufton is an Independent Business Adviser with a passion for innovation in healthcare and a track record of delivering innovative, technology enabled products and services across multiple sectors & markets. A science graduate with an MBA, she has over 30 years’ experience working in the Pharmaceutical, Medical Device, IVD and Connected Health industries and has worked in a variety of roles including R&D, Regulatory Affairs, Strategic International Marketing, Sales & Business Development. She was also Director General of BIVDA, representing the IVD industry and acting as spokesman on regulatory, governmental, technological commercial and professional matters. This work involved influencing government and policy makers, working with regulators and standards bodies and supporting small and start-up companies to bring their ideas to market.
Thomas J Olesen
Thomas J. Olesen serves as Qualcomm Life’s Commercial Director, Europe, establishing 2Net as preferred platform for remote patient monitoring. He brings extensive global experience from the world of medical devices and in recent years specifically within mHealth and telemedicine. A native Dane, he contributed in making Denmark a leader in telemedicine working with the ministries of Science and Health. Due to his global background having lived and operated the majority of his life in major markets such as US, Brazil and today Germany, Thomas J. Olesen offers a global view on today’s challenges and opportunities in mHealth.
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.
Jim Jacobson is the Chief Product and Solution Security Officer for Siemens Healthcare. Since 2012, he has been responsible for the global security program for the medical devices and associated IT systems, solutions and services that Siemens Healthcare develops, sells, maintains and supports. He is also responsible for the internal processes that protect the privacy of patient data. As a recognized thought leader in medical device cybersecurity, he has been a speaker/panelist at both the FDA public workshop “Moving Forward: Collaborative Approaches to Medical Device Cybersecurity” in January 2016 and “National Health Sector Fly-in @ United States Senate” on cybersecurity in the healthcare critical infrastructure in June 2015. He participates in an advisory group to the FDA on cybersecurity vulnerability management. Jim often speaks on medical device cybersecurity and establishing an effective software security organization. He serves on the committee that developed the FDA-recognized consensus standard CLSI AUTO11-A “Information Technology Security of In Vitro Diagnostic Instruments and Software Systems.” He also sits on the Siemens Product and Solution Security Board responsible for governance and guidance for the security of the company’s products, solutions and services in all sectors including industrial, power, energy, renewables and mobility, in addition to healthcare. He leads the board’s work team responsible for the curriculum and training program in this area for Siemens employees worldwide. Prior to these roles, Jim has led medical device-related software development teams in ultrasound, laboratory diagnostics and informatics since 1990 at Siemens and other companies. Jim completed the bachelors program in physics at Oberlin College.
Simon WilsonSimon has spent almost 25 years developing a wide range of products since graduating from Southbank University in London with a degree in Engineering Product Design. Simon has worked in the development of consumer goods, hand held computers, mobile communications devices and mobile communications infra-structure products as well as a period of just under three years at a major London design consultancy before joining Pfizer’s Device Centre of Excellence, DCoE, in 2007.
Whilst working for Pfizer Simon has managed complex parenteral device development projects right through from initial concept development to clinical trials and the scale up beyond. Being well-known within DCoE as technology enthusiast and early adopter, Simon was tasked with managing one of the first connected device development projects that DCoE were asked to undertake it in 2014. Simon is now working on a number of ‘connected’ projects, helping other groups within Pfizer understand the complexities of developing products of this nature.
Dana 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. Dana received his B.S. Degree in Engineering from West Virginia University in 1981.
Presspart is a division of the Heitkamp & Thumann Group, a leading global partner for the supply of world class precision formed components in both metal and plastic. Founded 1978, the Group today comprises more than twenty medium-sized companies located in 10 different countries. Annual sales revenues for the group are over 350 million Euros from a global work force of just under 2000 employees. Presspart is the global leader in the supply of metal canisters and actuators for metered dose inhalers, operating from three manufacturing sites – Blackburn, UK, Marsberg, Germany and L’Arboc, Spain.
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, Director of Product Innovation, Information Technology, ICON plc, Ireland
Sam Van Alstyne
Sam Van Alstyne, New Products Marketing Manager, 3M Drug Delivery Systems.