MEDICAL TECHNOLOGY AND CONNECTED HEALTH LEADERSHIP PROGRAMME 2017/2018

Transcription

1 CONNECTED HEALTH LEADERSHIP PROGRAMME 2017/2018 Developed by industry leaders of today for the industry leaders of tomorrow The Internet of Medical Things Skillnet is funded by member companies and the Training Networks Programme, an initiative of Skillnets funded from the National Training Fund through the Department of Education and Skills.

2 About the Future Leaders programme The Medical Technology Leadership Programme (now incorporating Connected Health) was first developed by Irish Medtech Association members to enhance the capabilities of the sector s current and future leaders and to provide the industry in Ireland with value for money training at the highest level of quality. The Future Leaders programme, now in its twelfth year, is specifically aimed at middle to senior management in the medical technology industry and is fully accredited by ILM, a City & Guilds business. Many in or aspiring to leadership positions will often specialise in a specific function or area within their company. This programme has been developed to provide participants with a fundamental knowledge of all aspects of the medtech business from finance to strategy, clinical investigations to employment law, through a series of interactive full day workshops and practical demonstrations, facilitated by industry experts. Following a yearly review, and taking into account the changing health care ecosystem as well as the move to more connected solutions in the medtech industry, a new module has been added to shed light on the critical areas of cyber security, data protection and software and their impact on medical and connected technologies. Who should attend? Aimed at middle to senior management from all functions (scientists, quality & regulatory affairs professionals, engineers and technicians, product and product development managers, business development managers, marketing managers, investment and acquisition specialists, HR personnel etc). Accreditation The programme is fully accredited by ILM, part of the City & Guilds Group. Delivery 9 full day workshops delivered by Industry experts. October th October 17th October 18th October November th November 16th November 17th November, Personal Development Strategy Regulatory Affairs Fitzwilliam Hotel, Dublin & RCSI, Dublin Clinical Anatomy, Physiology and Cardiology (plus practical demonstration) Diagnostics and Clinical Trials Innovation Price Members: 2,150 per person January 2018, 15th January Finance (AM) Employment Law (PM) 16th January Sales & Marketing 17th January Software, Cyber Security and Data Protection Programme enquiries To book online please visit: For more information contact Jennifer McCormack by jennifer.mccormack@ibec.ie or telephone

3 Programme 16th October 2017 I Personal Development 09:30 11:30 Personality profiling / coaching Pre-course assessment with feedback given on the first day. There is an option of one to one meeting s with the course tutor to discuss results at a later date. Understanding yourself and others What are your particular strengths? Identify your management profile Who are those you relate best to and why? Identifying the challenges in your role 11:30 11:45 BREAK 11:45 13:00 Profiling in Practice What are your personal values? Identifying the important things in your life Thinking about how you live your life now 14:00 15:30 Leadership & Self Awareness Styles of leaders Your style Situational leadership Leadership in your organisation Best practice in leading organisations Video / discussion The role of power and influence in being a leader: Types of power Making decisions with confidence 15:45 17:00 Developing leadership strategies that work Drawing up a vision for your area Understanding the role of teams when leading others Your team profile 17th October 2017 I Strategy 09:30 11:00 Introduction Perspectives on strategy and what they mean today What kind of strategy do you have for your team? Putting Strategy into action Understanding what strategy is What does it mean for my team and me? What are the steps involved in drawing up a strategic plan for my area? 11:00 11:15 BREAK 11:15 13:00 Profiling in Practice Best practice examples of innovative strategies in a range of business contexts What is my style and approach and how does this affect my people? Bringing my team along Identify ways that will have a major impact on the way the team lives the strategy we put together Keeping motivation levels high throughout the process Practical tips in making the strategic plan work, delivering real results Focus on how to set strategy internally and how is strategy important to you and your department How to live it impact on the individual 15:45 17:00 How to influence strategy development at senior level e.g. CEO or most senior level in your site 18th October 2017 I Regulatory Affairs Course objectives and overview Background/Introduction to RA Overview of key players in the International regulatory world Basic introduction to EU regulations 11:00 11:15 BREAK EU regulations continued Overview of New EU Directive Classification CE Mark Conformity Assessment Quality Management systems standard: ISO Overview of impact of ISO 13485:2016 US FDA regulations and standards Classification Overview of Submission types Overview of regulatory system for other key markets: Canada, Australia and Japan Product Lifecycle and RA Risk management and Design Cycle Planning for Future Regulatory Changes Exam/questionnaire

4 Programme 15th November 2017 I Clinical Anatomy, Physiology and Cardiology Fitzwilliam Hotel, Dublin & RCSI Dublin 09:30 11:00 Cardiovascular System 11:00 11:30 BREAK 11:30 13:00 Mechanisms of Disease and Applied Pathology 14:00 15:30 Bone, Cartilage and Orthopaedic Applications 15:30 16:00 BREAK 16:00 17:30 Practical Demonstration in RCSI Anatomy Lab 16th November 2017 I Diagnostics and Clinical Trials Fitzwilliam Hotel, Dublin & RCSI Dublin 09:30 11:00 Applications of diagnostic equipment & test in pathology 11:00 11:30 BREAK 11:30 13:00 Applied Physiology & Cardiology 14:00 15:30 Clinical trials 15:30 16:00 BREAK 16:00 17:30 Clinical trials management 17th November 2017 I Innovation Fitzwilliam Hotel, Dublin & RCSI Dublin 09:30 11:00 The Innovation Process: Introduction to Innovation Overview & Value of Innovation Innovation Makeover for Medtech 11:00 11:15 BREAK 11:15 12:15 The Innovation Process (continued) Innovation Process Flow & Output Medtech needs new services & Business models to Survive and grow Case Study s 12:15 13:00 The Patent Process: Guest Speaker Patent Overview Europe and US 14: Connective Health: Breakout Session on Connective Health 15:45 17:30 Idea to Commercialisation Output & Actions: Ideas to Commercialisation Output Actions Lab Notebooks CTM & Assignment Bond with Clinicians Start-up Vs Multinational Innovation output Summary Summary and exam 15th January 2018 (AM) I Finance HALF DAY 09:30 11:00 Basics of accounting What do you need to know? Source documents and what they do Building your confidence in the finance area 11:00 11:15 BREAK Gaining funding (sources, EI, VCs IDA) Action plan Recap and quiz 11:15 13:00 Finance for business decisions (choosing between products/materials etc) Budgeting Price setting, margins, cost of goods

5 Programme 15th January 2018 (PM) I Employment Law HALF DAY 14:00 15:15 Contracts of Employment Maximum working time, breaks and rest requirements Employment Equality 15:15 15:30 BREAK What is the cost of getting it wrong? Recent case law New developments in the legislation Recap and quiz 15:30 17:30 Discipline and Dismissals Principles of natural justice Adopting correct procedures 17th January 2018 I Sales and Marketing 09:00-10:40 Sales & marketing and your organisation s growth/success How important is sales & marketing to success? How to evaluate the contribution of sales & marketing to success Most common challenges 10:45 11:00 BREAK 11:00-13:00 Sales & marketing strategy Key dimensions of a sales & marketing strategy How to evaluate/assess your strategy Most common challenges faced in accelerating growth Key success factors - what can we learn from the best? Strengthening the link between sales & marketing and success 14:00-15:30 Best practice in the execution of sales & marketing What a best practice sales & marketing process looks like The strengths and deltas in sales & marketing execution Where does marketing end and sales begin? Is it an art or a science? How measurable or manageable should it be? Latest trends (marketing automation, sales enablement, etc.) The role of process, systems and technology The implications of buying trends (e.g. procurement) Your role in the sales & marketing process Talent & Resources The required level of resources/investment Recruiting talent - opportunities and challenges How to know if you have the right sales & marketing team? Interacting with sales & marketing Your role in building a winning sales & marketing team Recap Recap on key learnings and quiz 16th January 2018 I Software, Cyber Security and Data Protection HALF DAY 09:30 10:30 General Data Protection Regulation (GDPR) the impact on medtech 10:30 10:45 BREAK 10: Medical Device Software Growth and Challenges Medical Device Software development areas / standards Medical Device Software Lifecycle Processes Medical Device Cyber Security Medical IT Networks

6 Programme team John Lynam Managing Director, Thomas International John has been working as a Management Consultant/Trainer for the past 28 years for a range of companies in the public and private sector together with third level educational institutes. He is currently the Chairman of Thomas International Ireland which he acquired 18 years ago. This company runs a range of personality, aptitude and ability, emotional intelligence and job profiling tools again for a range of companies mainly in the corporate sector. They provide training in the administration, scoring and interpretation of the tools and work on a consultancy basis with certain clients. Deirdre Barrow Senior Regulatory Affairs Consultant, Independent RA Deirdre is the founder of Independent RA which provides remote regulatory services to medical device companies since Deirdre has 15+ years extensive industrial experience primarily focused in the Regulatory Affairs (RA) field. Her experience to date has ranged across the full set of Medical Device classification levels in all the major international markets. She has worked with many industry leaders and innovators, including Abbott Vascular, Medtronic and Biomedical Research and has extensive experience working in the United States including four years as a RA specialist with a CRO exclusively retained by the Division of AIDs (a sister body of the FDA). Deirdre holds a Masters Degree in Medical Technology Regulatory Affairs from Cranfield University (UK) and has qualified for both US and EU RAPS Certification. Prof Clive Lee PhD, MD, ScD (Dubl), FRCSI, FRCSEd, FAS, CEng, FIEI, HRHA, HonFTCD Clive Lee is the Professor of Anatomy in the Royal College of Surgeons in Ireland (RCSI) and the Royal Hibernian Academy (RHA) and Visiting Professor of Biomechanics in Trinity College Dublin (TCD). After qualifying in medicine and Internship, he was a Demonstrator and Locum Lecturer in Anatomy in TCD, obtaining his MSc in anatomy. He joined the Dublin Surgical Training Scheme and became a Fellow of both the Dublin and Edinburgh Royal Colleges of Surgeons in In the same year, he was appointed Lecturer in Anatomy in RCSI. After obtaining his PhD in bone biomechanics, he was a Fulbright Scholar at Harvard Medical School and was awarded his MD in He was appointed Chairman of Department in 2000 and Professor of Anatomy in RCSI in 2002, and in the RHA in He is a Chartered Engineer, past President of the Section of Bioengineering of the Royal Academy of Medicine in Ireland and past President of the European Society for Engineering and Medicine. In 2003, he was awarded the Fullbright Medal and, in 2010, the Samuel Haughton Silver Medal and his ScD for published work. In December 2013, he was elected the 61st President of the Anatomical Society. Dr Jacqueline Daly Division of Biology/Department of Anatomy RCSI Jacqueline Daly is a lecturer in the Division of Biology, Department of Anatomy in the RCSI. She lectures Human Biology, Molecular Medicine, and Pharmaceutical Biotechnology to Medical, Physiotherapy, and Pharmacy undergraduate students. She also lectures on postgraduate courses internal and external to the college. She is a graduate in Biochemistry (Hons) from Dublin Institute of Technology (DIT). Following her PhD she was a Wellcome Trust Post- Doctoral Fellow with TCD, investigating the role of inflammatory markers in a variety of conditions including: coeliac disease, hepatitis c, colon cancer and oesophageal cancer. She continued this research as a Dublin Molecular Medicine Centre (DMMC) Post Doctoral Fellow. Dr Daly s current biomedical research focuses on molecular diagnostics and therapeutics in bone disease, most specifically osteoporosis. Prof James O Neill MD BSC. FRCPI FESC, Connolly and Mater Hospital Dr James O Neill is a consultant cardiologist at Connolly and the Mater Hospitals, Dublin and a senior lecturer at the RCSI. He received his medical and science degrees from NUI Dublin, graduating in His training in Cardiology was in Dublin and at the Cleveland Clinic, Ohio, USA, where he was awarded a Fulbright Scholarship. His areas of expertise include cardiomyopathy, heart failure and cardiac imaging, in addition to general cardiology. He has published multiple papers in peer reviewed journals on these topics. He lectures to medical undergraduates and postgraduates. Dr. O Neill reviews papers for several journals.

7 Programme team Dr Helena Kelly BSC(PHARM), MPSI, PHD, Consultant Cardilogist, Lecturer in Pharmaceuticals, RCSI Helena Kelly graduated with a BSc (Pharm) from Trinity College, Dublin (TCD) and subsequently carried out PhD research in the area of hydrogels and sustained drug delivery in TCD. After completing her PhD she worked in the pharma and biopharma industry for 8 years. In 2008 she was appointed Lecturer in Pharmaceutics in the School of Pharmacy, RCSI. From January 2012 to March 2014 she was seconded as Project Manager for the establishment of the Irish Institute of Pharmacy (IIoP) and in 2014 was made Senior Lecturer. Dr. Kelly is a Principal Investigator in the Tissue Engineering Research Group (TERG) and is also Deputy Co-ordinator of the FP7 funded AMCARE (Advanced Materials for Cardiac Regeneration) Consortium [ Derek Young CEO i360 Medical Derek is Founder, CEO and key promoter of i360medical, a Healthcare Solutions and Medical Device Innovation Company that provides its services to Global Hospital Systems, the medical device industry and clinical communities. He is a named inventor of 30+ patents with commercial success globally. Derek successfully co-founded a number of medical device start-ups before spinning into the RCSI where he established a Healthcare Innovation Hub to develop the ideas of other clinicians and inventors. i360medical, which is a direct spinout of the Healthcare Innovation Hub, is tapping into the growing expertise in Ireland and internationally to help generate and commercialise new world-class healthcare technology solutions. Over the last 12 years Derek has also spearheaded and completed at least 12 Medical Device Exits with key International Healthcare MNCs. With a background in Mechanical Engineering, Surgical Innovation and Business Development, Derek also holds a number of board positions on medical device companies and medical research groups at both a national and international level. Tony Shore Director Invisio Tony s international management experience encompasses Ireland, the UK and a number of MiddleEastern countries; in each case he was responsible for large teams of people in both multi unit and multi cultural environments. Prior to forming Invisio, Tony held a Senior Group Management role with one of Ireland s largest and most dynamic private companies. During this time, he was extensively involved in the successful re-development of a number of businesses, two of which achieved the prestigious quality ISO 9000 award. Tony has a wealth of practical hands on management experience in both small and large organisations. He has designed and delivered programmes for UCD s Michael Smurfit Business School, the Central Bank, the University of Limerick anddit Hothouse and presents regularly for Hothouse, an incubation centre for many emerging companies. Bríd Deering HR Compliance Trainer/Consultant, PeopleSkills Ltd Bríd Deering is the founder of PeopleSkills Ltd, a HR Compliance training company, and an associate trainer with Ibec. Before setting up PeopleSkills Ltd in 2006, Bríd worked as the HR Manager Ireland for Wyeth Pharmaceuticals and as an Industrial Relations Executive for Ibec. During her time with Ibec Bríd advised employers on all areas of HR, employment law and industrial relations and represented companies at the Employment Appeals Tribunal and the Labour Relations Commission. Bríd holds a Masters in Occ. Psych. & HRM; a Post Graduate Diploma in Employment Law and Certificates in Training & Development, Stress Management, Mediation, Conflict Resolution and Nutrition. Ray Collis B.comm, MBS, Director of Growth Pitstop Ray Collis has published 6 books on the topic of business performance over the past decade. These books document 10-years programme of working on business performance with more than 400 teams and 3000 managers in some of the world s best companies across 47 markets and 12 industries, including: BT, KBC, ARUP, IBM. 3M. Microsoft, Pfizer, Asavie and Sage. Ray is recognised world-wide as leader in the field of how big organisations buy (ES Research USA 2012) and is one of the few who have delivered at IBM University. Ray delivers on a range of Irish University programmes including: Diploma in International Business Development, IMI; Breakthrough Sales Performance, IMI; DIT/EI International Selling Programme.

8 INTERNET OF MEDICAL THINGS SKILLNET Ibec, 84/86 Lower Baggot Street, Dublin 2 PHONE (0) jennifer.mccormack@ibec.ie IRISH MEDTECH ASSOCIATION 84/86 Lower Baggot Street Dublin 2 PHONE (0) FAX (0) info@irishmedtechassoc.ie Irish Medtech Association is a business sector within Ibec