Training Calendar 2014

Transcription

1 Training Calendar 2014 mtaa.org.au Medical technology for a healthier Australia

2 Contents About the Professional Development Program Course and Module Descriptions 1.0 Medical Technology Regulation and Clinical Activities Medical Technology Industry Code of Practice Working with Healthcare Professionals Healthcare Access Workforce Development Customer Acquisition, Retention and Development Commercialising and Manufacturing Medical Technology Presenter Profiles Career Pathways Learning Pathways Modules by Month Modules by Expressions of Interest Registration Information Frequently Asked Questions Medical Technology Association of Australia Limited Level 12, 54 Miller Street, North Sydney NSW 2060 PO Box 2016, North Sydney NSW 2059 P: (+612) F: (+612) E: pd@mtaa.org.au W: The Medical Technology Association of Australia (MTAA) is the national association representing companies in the medical technology industry. MTAA aims to ensure the benefits of modern, innovative and reliable medical technology are delivered to the community for a healthier Australia. Training Calendar 2014

3 About the Professional Development Program Ongoing professional development is essential for developing and maintaining a knowledgeable and sustainable medical technology workforce. Medical technology professionals require up to date knowledge, skills and understanding to deliver positive outcomes in an ever complex and changing healthcare environment. Participating in the MTAA professional development program fosters excellence and provides a wide range of learning opportunities to specifically address individual learning needs. Not sure where to start? Learning Pathways can help professionals identify current and future professional development trends in the medical technology industry. Further information about each training module is available from the Training Catalogue on the MTAA website. Blended learning approach MTAA offers training through a blended learning approach. This includes online and face-to-face training. Some modules are aligned to a unit of competency. In-house training In-house training is available for most MTAA face-to-face modules. These will be presented as a half day or full day session. Please visit Professional Development/Training on the MTAA website for more information. To arrange in-house training, please contact the Professional Development Manager. Enquiries Please refer all enquiries to the Professional Development Manager by P: (+612) or E: pd@mtaa.org.au Registration Registration for all MTAA training events must be made online using a credit card, unless otherwise stated. To register or express an interest in a module, please visit the MTAA website All module fees include 10% GST. Standard credit card fees and charges apply. All of it, great setup and easy to follow. Very informative. Medical technology for a healthier Australia 1

4 Course and Module Description MTAA offers seven training courses, each with a range of modules. Additional modules may become available during These will be promoted in the online Training Catalogue on the MTAA website. 1.0 Medical Technology Regulation and Clinical Activities The regulation of medical technology in Australia is similar, in principle, to that adopted in the European Union. However, there are differences. The Therapeutic Goods Administration (TGA) regulates the supply of therapeutic goods in Australia, including medical technology. Before a sponsor can supply items of medical technology in Australia, the TGA has to grant an approval and enter the product in the Australian Register of Therapeutic Goods (ARTG). The Regulation of Medical Technology and Clinical Activities course consists of a series of modules designed to assist employees working in the regulatory and/or clinical areas. 1.1 Introduction to the Regulation of Medical Technology in Australia 1.2 Advanced Review of the Regulation of Medical Technology in Australia 1.3 Quality Management Systems and Conformity Assessment Procedures 1.4 Developing Technical Documentation for Medical Technology 1.5 Understanding Clinical Evidence for Medical Technology 1.6 Introduction to Risk Management for Medical Technology 1.7 Working with Biohazards 1.8 Introduction to the Regulation and Design of Clinical Investigations for Medical Technology in Australia 1.9 Improving Clinical Investigations for Medical Technology 1.10 Regulatory and Quality Requirements for SMEs 1.11 Understanding Regulatory Affairs for Senior Managers 1.1 Introduction to the Regulation of Medical Technology in Australia An introduction to how medical technology is regulated in Australia. Understands the basics of legislative processes in Australia Develops a basic understanding of the Australian regulatory system for therapeutic goods Develops a basic understanding of the various acts and regulations used to regulate medical technology in Australia. Presenter: Cliff Spong, Slate Hill Consulting Half day 1.2 Advanced Review of the Regulation of Medical Technology in Australia A detailed review of how medical technology is regulated in Australia including the legislative framework for therapeutic products, regulatory model for medical devices, the operations of the TGA, how to make an application to supply a medical device and the relevant acts and regulations. Considers the many acts and regulations affecting the supply of medical technology in Australia. Presenter: Cliff Spong, Slate Hill Consulting Full day 1.3 Quality Management Systems (QMS) and Conformity Assessment Procedures Part 1: QMS for Medical Technology An introduction to the use of ISO 13485:2003 QMS and how it relates to the design, development, manufacture and supply of medical technology. Learns about the use and application of the ISO 13485:2003 QMS Understands how the system relates to design, development, testing, manufacture and supply Understands why a QMS does not have to be applied to the manufacture of Class I medical devices. Part 2: Conformity Assessment Procedures A description of the conformity assessment procedures which must be carried out by manufacturers of medical technology and how these are audited and certified by the TGA. Learns why conformity assessment procedures have to be used by all manufacturers of medical technology Understands conformity assessment procedures Gains insight into the auditing and certification processes used by the TGA. Presenters: Gary Burgess, TGA and Alan Edgecomb, Alan Edgecomb Consulting Full day 1.4 Developing Technical Documentation for Medical Technology An examination of the role technical documentation plays in the development of medical technology to demonstrate regulatory compliance. Understands the relationship between product development and the need for technical documentation Understands the regulatory requirements for technical documentation Appreciates differing requirements for technical documentation by different regulatory jurisdictions. Presenter: Cliff Spong, Slate Hill Consulting Full day Explores the Australian legislative framework for therapeutic products, in broad terms, and specifically, the regulatory requirements for medical technology Understands the roles and operation of the TGA Understands the basics for submitting an application to the TGA 2 Training Calendar 2014

5 1.5 Understanding Clinical Evidence for Medical Technology An introduction to the use of clinical evidence to confirm that medical technology is safe and fit for purpose. Understands the different clinical trial needs for medical technology and medicines Understands the relationship between product development and the need for clinical evidence Understands the role clinical evidence plays as part of the regulatory requirements to supply medical technology. Presenter: Cliff Spong, Slate Hill Consulting Half day 1.6 Introduction to Risk Management for Medical Technology An introduction to how to manage potential risks associated with the development and manufacturing of medical technology. Understands the relationship between product development and the need to assess the risks of using the products Considers various methods of assessing risks and their consequences Understands the regulatory requirements for risk analysis. Appreciates differing requirements for managing the risks in operating a business Understands how specific risk management programs fit with broader risk management strategies Learns how to plan, implement and monitor effective risk management plans. 1.9 Improving Clinical Investigations for Medical Technology An interactive, problem-based learning workshop for participants to present specific issues confronted in relation to clinical investigations for medical technology. Problem-solves company based clinical investigations Learns strategies to improve clinical investigation development. Presenter(s): Professor Val Gebski, NHMRC CTC and Stefan Czyniewski and Suzanne M. Williams, Mobius Medical Half day 1.10 Regulatory and Quality Requirements for SMEs An introduction to the regulatory and quality requirements relevant to SMEs registering a new device. Understands the regulatory and quality requirements for achieving regulation of a medical device for the first time. Presenter: Cliff Spong, Slate Hill Consulting Half day 1.11 Understanding Regulatory Affairs for Senior Managers An overview of regulatory affair issues as they relate to senior managers. Recognises the regulatory framework. Up to 2 hours self-paced online Presenter: TBA Full day 1.7 Working with Biohazards An introduction to the risks associated when working with biohazardous materials. Understands personal risk and the role of WHS regulations when dealing with biological and chemical hazards Understands sterility assurance and the need for bioburden control. The session was informative and concise. Presenter: TBA Half day 1.8 Introduction to the Regulation and Design of Clinical Investigations for Medical Technology in Australia Explores the practical issues surrounding the design, organisation, conduct, data management and reporting for medical technology clinical investigations. Understands clinical investigation protocols Identifies and assesses clinical investigation sites Prepares and submits ethics committee submissions Initiates and commences enrolment in clinical investigation sites Monitors clinical investigations and reports adverse events Understands how to manage data, clinical investigation close-out activities and write reports. I liked the relevant real life examples. Presenters: Stefan Czyniewski and Suzanne M. Williams, Mobius Medical Full day Medical technology for a healthier Australia 3

6 2.0 Medical Technology Industry Code of Practice The Medical Technology Industry Code of Practice is a selfregulatory industry code and provides guidance on the medical technology industry s relationships with healthcare professionals and consumers. Industry has a long association of working with healthcare professionals. Under the Code there are specific obligations that need to be noted to ensure companies are compliant. This course reflects the latest edition of the Code of Practice. Three modules are available. 2.1 Introduction to the Code of Practice (online) 2.2 Complying with the Code of Practice 2.3 Advertising Therapeutic Goods in Australia 2.2 Complying with the Code of Practice An overview of aspects of the Medical Technology Industry Code of Practice including interactions with healthcare professionals, administration and compliance mechanisms. Understands the general principles of the Code Obtains a detailed understanding of the Code in relation to interactions with healthcare professionals Understands the Code s monitoring and complaints processes Considers the implications of non-compliance. Presenter: Alina Hughes, MTAA Full day 2.1 Introduction to the Code of Practice An orientation to the Medical Technology Industry Code of Practice. Develops a broad understanding of the Code Discusses the principles that underpin the Code. Up to 2 hours self-paced online 2.3 Advertising Therapeutic Goods in Australia An overview of current advertising requirements for medical technology companies. Understands the overall framework regulating the advertising of therapeutic goods Understands the requirements of the Therapeutic Goods Advertising Code in relation to advertising medical technology to consumers Understands the requirements of the Medical Technology Industry Code of Practice in relation to advertising medical technology to healthcare professionals. Presenter: Alina Hughes, MTAA Half day 4 Training Calendar 2014

7 3.0 Working with Healthcare Professionals Medical technology industry personnel often work closely with healthcare professionals in healthcare facilities. This requires a range of skills, knowledge and understanding that responds to the work of healthcare professionals and their work environments. In addition, visitors to the perioperative environment require an understanding of the ACORN Standards for authorised admission. A range of modules reinforcing the skills required to work effectively with healthcare professionals are available. 3.1 Understanding Medical Terms (online) 3.2 Language of the Human Body (online) 3.3 Infection Prevention (online) 3.4 Healthcare Facility Protocols (online) 3.5 Introduction to Operating Theatre Protocols 3.6 Operating Theatre Protocols Update (online) 3.7 Professional Conduct (online) 3.8 Patient Privacy and Confidentiality (online) 3.9 Introduction to Anatomy and Physiology (online) 3.10 The Cardiovascular System (online) 3.11 The Digestive System (online) 3.12 The Endocrine System (online) 3.13 The Integumentary System (online) 3.14 The Lymphatic System (online) 3.15 The Muscular System (online) 3.16 The Nervous System (online) 3.17 The Reproductive System (online) 3.18 The Respiratory System (online) 3.19 The Skeletal System (online) 3.20 The Urinary System (online) Units of Competency The following modules are aligned to one or more competencies. Evidence of application of the learning may contribute to the completion of the competency. Successful completion of an assessment will result in a Statement of Attainment. For information on how to complete an assessment, please contact MTAA. Modules 3.1 Understanding Medical Terminology 3.2 Language of the Human Body 3.9 Introduction to Anatomy and Physiology 3.10 The Cardiovascular System 3.11 The Digestive System 3.12 The Endocrine System 3.13 The Integumentary System 3.14 The Lymphatic System 3.15 The Muscular System 3.16 The Nervous System 3.17 The Reproductive System 3.18 The Respiratory System 3.19 The Skeletal System 3.20 The Urinary System ACORN Unit of Competency BSBMED301A Use Advanced Medical Terminology HLTAP401A Confirm Physical Health Status Modules 3.5 Introduction to Operating Theatre Protocols and 3.6 Operating Theatre Protocols Update are approved by the Australian College of Operating Room Nurses (ACORN). 3.1 Understanding Medical Terms An introduction to where commonly used medical terms originate. Understands the origins of medical terms Recognises basic word structure Learns correct pronunciation. 3.2 Language of the Human Body An introduction to language associated with the different body systems. Recognises the main systems of the body Learns terms linked to different body systems. 3.3 Infection Prevention An insight into preventing infection within the healthcare setting. Learns about the types of infection Recognises a range of prevention strategies Understands standard precautions Learns about relevant policies and procedures. 3.4 Healthcare Facility Protocols An overview of healthcare facility (HCF) protocols that medical company representatives (MCRs) visiting HCFs to work with healthcare professionals (HCPs) should recognise, seek out and apply. Understands that HCFs follow a range of protocols, policies and procedures for clinical and operational activities Recognises that HCF protocols vary across sites Recognises the importance of identifying relevant protocols when entering a HCF for the first time Understands how to apply relevant protocols when working in the HCF Applies relevant company policies and procedures, and the Medical Technology Industry Code of Practice across HCFs. 3.5 Introduction to Operating Theatre Protocols An introduction to theoretical and practical training for MCRs new to the perioperative environment. Examines the ACORN Standards for Perioperative Nursing relevant to medical company representatives (MCRs) Understands the role of the MCR in the perioperative environment Examines patient privacy and confidentiality requirements Considers WH&S issues Understands the importance of managing accountable items including the Surgical Count and Time Out procedures Recognises and applies the principles of infection prevention. Presenters: State-based Nurse Educators Full day Medical technology for a healthier Australia 5

8 3.6 Operating Theatre Protocols Update A review of the ACORN Standards for Perioperative Nursing and an opportunity to investigate relevant industry issues. Understands the current ACORN Standards for Perioperative Nursing in relation to visitors to the perioperative environment Explores other relevant changes in policy Understands industry-based challenges of the perioperative environment Revises hand washing techniques The Cardiovascular System An introduction to the anatomy and physiology of the cardiovascular system. Understands the anatomy and physiology of the cardiovascular system Recognises common disorders of the cardiovascular system Recognises supportive medical technology. Up to 2 hours self-paced online 3.11 The Digestive System Please note, for modules 3.5 and 3.6 a photo identification card stating that the module has been approved by ACORN will be issued upon successful completion of the training. This card expires at the end of July 2014 for training completed before this date, or July 2016 for training completed from 1 August Professional Conduct An overview of the professional behaviour expected of medical company representatives (MCRs) when working with healthcare professionals (HCPs). This module examines how medico-legal issues and other factors impact on the professional conduct of MCRs. Acknowledges the professional behaviours HCPs expect of visiting MCRs Understands the ethical professional boundaries that apply when working with HCPs Appreciates the medico-legal implications when working with HCPs. 3.8 Patient Privacy and Confidentiality An overview of the importance of patient privacy and confidentiality for MCRs when entering the healthcare setting and/or working with healthcare professionals. Understands the broad concepts of patient privacy and confidentiality Lists the main pieces of legislation governing patient privacy and confidentiality Locates sources for further information about patient privacy and confidentiality in their state Describes basic obligations generally contained in patient privacy statements. 3.9 Introduction to Anatomy and Physiology An introduction to the anatomy and physiology of the human body. Understands the concepts of anatomy and physiology Learns about cell biology and the functions of life Learns of the different body systems. An introduction to the anatomy and physiology of the digestive system. Understands the anatomy and physiology of the digestive system Recognises common disorders of the digestive system Recognises supportive medical technology The Endocrine System An introduction to the anatomy and physiology of the endocrine system. Understands the anatomy and physiology of the endocrine system Recognises common disorders of the endocrine system Recognises supportive medical technology The Integumentary System An introduction to the anatomy and physiology of the integumentary system. Understands the anatomy and physiology of the integumentary system Recognises common disorders of the integumentary system Recognises supportive medical technology The Lymphatic System An introduction to the anatomy and physiology of the lymphatic system. Understands the anatomy and physiology of the lymphatic system Recognises common disorders of the lymphatic system Recognises supportive medical technology The Muscular System An introduction to the anatomy and physiology of the muscular system. Understands the anatomy and physiology of the muscular system Recognises common disorders of the muscular system Recognises supportive medical technology. 6 Training Calendar 2014

9 3.16 The Nervous System An introduction to the anatomy and physiology of the nervous system. Understands the anatomy and physiology of the nervous system Recognises common disorders of the nervous system Recognises supportive medical technology The Skeletal System An introduction to the anatomy and physiology of the skeletal system. Understands the anatomy and physiology of the skeletal system Recognises common disorders of the skeletal system Recognises supportive medical technology The Reproductive System An introduction to the anatomy and physiology of the reproductive system. Understands the anatomy and physiology of the reproductive system Recognises common disorders of the reproductive system Recognises supportive medical technology The Urinary System An introduction to the anatomy and physiology of the urinary system. Understands the anatomy and physiology of the urinary system Recognises common disorders of the urinary system Recognises supportive medical technology The Respiratory System An introduction to the anatomy and physiology of the respiratory system. Understands the anatomy and physiology of the respiratory system Recognises common disorders of the respiratory system Recognises supportive medical technology. Medical technology for a healthier Australia 7

10 4.0 Healthcare Access The Australian medical technology industry includes Australian and overseas companies manufacturing and supplying medical devices, in vitro diagnostics and medical imaging equipment. The medical technology industry contributes significantly to the quality of public and private sector healthcare in Australia. Accessing healthcare in Australia can be convoluted and occurs in many forms. Some processes are interrelated, for example with Medicare, while others are stand-alone schemes. The Healthcare Access course consists of a series of modules to support employees working in this area. 4.1 Introduction to Reimbursement of Medical Devices in Australia (online) 4.2 Achieving a Successful Application for the Prostheses List 4.3 Understanding the MSAC Process 4.4 Preparing an MSAC Submission 4.5 Understanding the National Activity Based Funding Framework 4.6 Introducing the National Pricing Model Under Activity Based Funding 4.7 Understanding the National Classification Systems Under Activity Based Funding. 4.1 Introduction to Reimbursement of Medical Devices in Australia An overview of the healthcare environment and the linkages across reimbursement pathways. Develops a broad understanding of the healthcare sector and how funding works Understands basic elements of the Australian healthcare environment relevant to the reimbursement of medical devices including the significance of inclusion on the Australian Register of Therapeutic Goods (ARTG) Develop an awareness of the Medicare Benefits Schedule (MBS) and its significance and relationship to reimbursement pathways affecting medical devices (i.e. the Medical Services Advisory Committee (MSAC) process and its impact on the Prostheses List and other significant reimbursement pathways) Understands the basic operations of major medical device reimbursement schemes including the Prostheses List, the Pharmaceutical Benefits Scheme (PBS), the Repatriation Pharmaceutical Benefits Scheme (RPBS), the National Diabetes Services Scheme (NDSS), the Stoma Appliance Scheme (SAS), the Continence Aids Assistance Scheme (CAAS), and reimbursement of public and private hospitals in respect of privately insured patients by registered health insurance funds Understands the associated challenges. Up to 2 hours self-paced online 4.2 Achieving a Successful Application for the Prostheses List An overview of the Prostheses List process and instruction for preparing successful applications. Understands the Prostheses List process Understands and maps the application process Learns how to achieve the most appropriate listing. Presenters: David Ross, MTAA and Dr Sue O Malley, Medical Intelligence Full day 4.3 Understanding the MSAC Process An introduction to the importance of a successful Medical Services Advisory Committee (MSAC) application and resulting MBS numbers. Learning outcome Understands the new MSAC application process including the significance of all the stages of the process. Presenter: Dr Sue O Malley, Medical Intelligence Half day 4.4 Preparing an MSAC Submission An introduction to preparing an MSAC application and submission, including when one should be used in preference to another. Understands the data and evidence requirements Learns about the most critical aspects of preparing an MSAC application/submission. Presenter: Dr Sue O Malley, Medical Intelligence Half day 4.5 Understanding the National Activity Based Funding Framework An overview of Activity Based Funding (ABF) in Australia. Understands the fundamental principles of the ABF framework Learns about the role of the Independent Hospital Pricing Authority (IHPA) Gains an overview of the types of activity funded under the new pricing framework Understands the implications for the medical technology industry. 4.6 Introducing the National Pricing Model Under Activity Based Funding An introduction to clinical costing in the public hospital setting. Provides an overview of the ABF pricing model Understands the process for setting the National Efficient Price Learns about challenges hospitals are facing in collecting costing data. 4.7 Understanding the National Classification Systems Under Activity Based Funding An overview of the national classification systems that support Activity Based Funding (ABF). Learns about classification systems used under ABF Recognises the characteristics of classification systems used for ABF Gains an insight in the inpatient classification system, the AR-DRGs. 8 Training Calendar 2014

11 5.0 Workforce Development Workforce development is seen as critical to enable employees to meet the constant challenges of the medical technology industry, and to address the strategic goals of the company. A number of modules are available to address this learning need. The Workforce Development course currently consists of a series of modules designed to meet the challenges of industry. 5.1 Introduction to the Medical Technology Industry (online) 5.2 Introduction to Leadership and Management (online) 5.3 Management and Leadership Essentials (online) 5.4 Achieving Workplace Wellness (online) 5.5 Leading with Emotional Intelligence (online) 5.6 Administering Change (online) 5.7 Effective Time Management and Delegation (online) 5.8 Managing Challenging Conversations (online) 5.9 Managing Workplace Conflict (online) 5.10 Bullying and Harassment Awareness (online) 5.11 Planning Projects (online) 5.12 WHS Fundamentals (online) 5.13 Interpreting Medical Technology Industry Data (online) 5.14 Summarising Statistical Distributions for the Medical Technology Industry (online) 5.15 Media Skills 5.16 Customer Focus (online) 5.17 Conducting Literature Reviews (online) 5.18 Essential Presentation Skills (online) Units of Competency The following modules are aligned to one or more competencies. Evidence of application of the learning may contribute to the completion of the competency. Successful completion of an assessment will result in a Statement of Attainment. For information on how to complete an assessment, please contact MTAA. Modules 5.2 Introduction to Leadership and Management 5.3 Management and Leadership Essentials 5.4 Achieving Workplace Wellness 5.5 Leading with Emotional Intelligence 5.6 Administering Change 5.7 Effective Time Management and Delegation 5.8 Managing Challenging Conversations 5.9 Managing Workplace Conflict 5.10 Bullying and Harassment Awareness Unit of Competency BSBMGT605B Provide Leadership Across the Organisation 5.11 Planning Projects BSBHR502A Manage Human Resource Management Information Systems 5.12 WHS Fundamentals UEENEEE001B Apply OHS Practices in the Workplace 5.16 Customer Focus BSBCUS402A Address Customer Needs 5.1 Introduction to the Australian Medical Technology Industry An orientation for new employees, students, media or those with a general interest in the medical technology industry. Understands the breadth and diversity of the medical technology industry sector in Australia Understands the economic value of the sector for Australia Learns about the Medical Technology Association of Australia (MTAA). Up to one hour self-paced online 5.2 Introduction to Leadership and Management An introduction to the transition from technical expert to manager of a business unit. Provides an overview of the role of manager and leader Supports the transition to manager by highlighting the key responsibilities undertaken and the changes in working relationships. Up to one hour self-paced online 5.3 Management and Leadership Essentials An essentials checklist for those becoming a manager for the first time. Appreciates the management functions model Recognises the link between strategic planning and effective management. Up to one hour self-paced online 5.4 Achieving Workplace Wellness An overview of how to plan and implement a workplace wellness program. Learning outcome Understands the key activities involved in planning and implementing a workplace wellness program. Up to one hour self-paced online 5.5 Leading with Emotional Intelligence An insight into leading and managing using emotional intelligence (EI). Recognises EI at work Learns how to apply EI when leading and managing. 5.6 Administering Change Up to one hour self-paced online An introduction to key skills required for managing change in a business context. Learning outcome Recognises the key skills and strategies required to lead and manage change in the workplace. Up to one hour self-paced online Medical technology for a healthier Australia 9

12 5.7 Effective Time Management and Delegation An introduction to key strategies used to effectively manage work priorities and delegation. Learning outcome Learns methods for prioritising work activities and managing effective delegation. Up to one hour self-paced online 5.8 Managing Challenging Conversations An insight into preparing for and managing challenging conversations. Learning outcome Recognises strategies needed to prepare for and conduct challenging conversations. Up to one hour self-paced online 5.9 Managing Workplace Conflict An introduction to strategies for addressing and managing workplace conflict. Learning outcome Recognises practical strategies to address workplace conflict. Up to one hour self-paced online 5.10 Bullying and Harassment Awareness An overview of bullying and harassment in the workplace, and effective strategies for its prevention and management. Learns about bullying and harassment Recognises effective strategies for its prevention and management Planning Projects Up to one hour self-paced online An introduction to general project management principles and how to apply the skills to the project planning processes during the initiate and plan phase of the project life cycle. Explores general project management principles Learns how to apply these skills to the project planning processes during the initiate and plan phase of the project life cycle WHS Fundamentals An overview of work health and safety (WHS) fundamental principles for MCRs. Understands the fundamental principles of WHS Recognises government legislation that workers must comply with Understands his/her role and responsibilities with workplace safety, including when working off-site in a HCF Interpreting Medical Technology Industry Data An introduction to understanding statistics in order to interpret relevant data for the industry. Understands the purpose of statistics and sources of data Gains an overview of the types of statistical data Practices data analysis Summarising Statistical Distributions for the Medical Technology Industry An introduction to summarising statistical distributions relevant to the industry. Reads statistical data Summarises statistical distributions relevant to the industry Media Skills Up to 2 hours self-paced online An overview of how the media works and what journalists are looking for in response to an enquiry. Understands the news cycle and how the media works Appreciates the importance of monitoring the media Develops skills to create a media strategy and policy. Presenter: 5.16 Customer Focus Sue Driscoll, Health Communications Full day An introduction to how best to work directly with customers. Recognises the characteristics and practices of customer focused organisations Understands key strategies used to identify customer needs and expectations Understands the processes for responding to customer requirements Manages customer complaints Conducting Literature Reviews An insight into conducting literature reviews relevant to the medical technology industry. Learns about literature reviews Understands the process involved in conducting a literature review Recognises the range of tools available for literature reviews Understands how to organise material into the literature format Learns how to identify meaningful and relevant theory and research Understands how to cite the information gathered Essential Presentation Skills An introduction to strategies for preparing, planning and delivering an effective presentation. Understands the elements that make an effective presentation Practices the essential skills to plan, prepare and deliver a great presentation. 10 Training Calendar 2014

13 6.0 Customer Acquisition, Retention and Development Businesses within the Australian medical technology industry constantly need to find strategic ways to acquire, develop and retain customers. This course explores different ways to create the most out of business opportunities and relationships. The Customer Acquisition, Retention and Development course consists of a series of modules designed to support employees responsible for this important strategic area. 6.1 Achieving High Impact Sales 6.2 Achieving a Winning Mindset 6.3 Gathering Sales Knowledge 6.4 Planning for Success 6.5 Developing High Trust Relationships 6.6 Discovering What They Really Want 6.7 Delivering Value 6.8 Repeating Business 6.1 Achieving High Impact Sales What worked in the past doesn t work today. Gain an insight into high impact selling, and the three pillars for selling in the medtech market. Learn about high impact medical sales Understand the five fundamental sales principles Discover why customers want to buy from their provider of choice. Up to 2 hours self-paced online 6.2 Achieving a Winning Mindset An introduction to being sales ready. It is more than just having the capability to sell, it is the winning mindset and the will to sell. Learn about the characteristics of the top salespeople Develop clarity around the choices and attitudes available. Up to 2 hours self-paced online 6.3 Gathering Sales Knowledge An insight into sales capability and its two components, knowledge and skill. Medical sales demands sales knowledge fluency; product knowledge is not enough. Know more to sell more Learn about commercial teaching Understand how to create customer needs profiles Understand the differences in knowledge levels. 6.5 Developing High Trust Relationships An overview of how to know the customers better than they know themselves. Understand own thinking preference, and the preferences of customers Identify the elements of rapport, including matching and mirroring Understand how to establish trust as the cornerstone to strong business relationships. Up to 2 hours self-paced online 6.6 Discovering What They Really Want Before the solution there is a need to discover. An insight into questioning technique as the make or break element. Learn about Whole Brain questioning skills Identify the differences between open and closed questions Lean how to create questions that explore the customer s needs rather than simple information gathering. 6.7 Delivering Value Up to 2 hours self-paced online An overview of how to give customers what they actually want. Clearly differentiate between feature and benefits Learn about creating value propositions that appeal to different customers. 6.8 Repeating Business Up to 2 hours self-paced online An insight into how to confirm the sale, and supporting future sales that is key to prosperity in the closed medical market. Understand how to ask for the business and maintain the relationship Identify the next step for progressing the sales process Develop skills for retaining long term customers Discover the Sales Relationship Formula. Up to 2 hours self-paced online Up to 2 hours self-paced online 6.4 Planning for Success An insight into getting to know the key decision makers, their buying process and setting effective goals. Learn to plan for strategy and plan for the call. Clearly identify key customers, and plan a sales strategy to suit Create SMART goals and pre-call plans. Up to 2 hours self-paced online Medical technology for a healthier Australia 11

14 7.0 Commercialising and Manufacturing Medical Technology This course aims to help innovators and companies develop effective relationships with organisations that are key to their success. While regulation and healthcare access are the focus of many companies, there are other relationships that need to work effectively in order to develop a sustainable business. Working With Series 7.1 Working with Researchers and Clinicians 7.2 Working with Market Researchers 7.3 Working with Product Developers 7.4 Working with Technology Commercialisation Companies 7.5 Working with Clinical Investigations 7.6 Working with Venture Capitalists 7.7 Working with Contract Manufacturers Overseas 7.8 Working with Distributors 7.9 Working with Business Risks 7.1 Working with Researchers and Clinicians An insight into working with researchers and clinicians in order to develop innovations that meet market needs. Understands the importance of using clinicians during the development of medical technology innovations Understands the role that research organisations can play in developing medical technology innovations Learns how to work effectively with research organisations. Presenter: Professor Tony Penna, NSW Office of Health and Medical Research Up to 1 hour online webinar 7.2 Working with Market Researchers An introduction to the steps innovators should consider to build the business case for their innovation. Understands how to determine the market potential for a product or service Understands the hurdles that need to be overcome Develops a realistic pathway and timeframe to market. Presenter: Matt Godden, Australian Healthcare Solutions Up to 1 hour online webinar 7.3 Working with Product Developers An overview of the role of product developers in the development of medical technology. Learns how to work effectively with a product developer Develops insight in how to prepare a design brief. Presenters: Richard Sokolov and Willem Mees van der Bijl, ide Group Up to 1 hour online webinar 7.4 Working with Technology Commercialisation Companies An outline of the steps involved, and how to effectively work with, a technology commercialisation company. Understands the steps involved in turning an idea into a manufactured product Develops insight into costs associated in commercialising a product Develops insight into quality and regulatory standards and documentation requirements. Presenter: Don Watton, Ellex-Precise Up to 1 hour online webinar 7.5 Working with Clinical Investigations An outline of the issues to consider when undertaking a successful clinical investigation. Learns how to design a clinical investigation, including budgets and patient recruitment Learns about protocol development Learns how to manage a clinical investigation (to CRO or not) Understands the logistics of undertaking an investigation. Presenter: Matt Godden, Australian Healthcare Solutions Up to 1 hour online webinar 7.6 Working with Venture Capitalists An insight into working effectively with venture capitalists. Develops insight into the preparation required prior to meeting with a venture capitalist company Understands what sort of funding is available Understand responsibilities once venture capitalist funding has been acquired. Presenter: TBA Up to 1 hour online webinar 7.7 Working with Contract Manufacturers Overseas An insight into how to find a manufacturer off-shore, and strategies to ensure that quality of output is consistent, and integrity of Intellectual Property is maintained. Understands the issues involved in manufacturing off-shore Examines options for seeking assistance in identifying appropriate off-shore manufactures Learns about available services to assist with the legal and regulatory issues associated with off-shore manufacturing. Presenter: Brian le Mon, GBOS Up to 1 hour online webinar 7.8 Working with Distributors An overview of the importance of selecting the right distributor and maintaining the relationship. Understands the process for selecting the right distributor Understands what to do to achieve a successful distributor relationship. Presenter: Brent van den Berg, Device Technologies Up to 1 hour online webinar 7.9 Working with Business Risks An investigation into strategies that companies can adopt to minimise or manage risk. Understands what sorts of risk is associated with doing business Understands how to evaluate risk and what strategies can be adopted to alleviate risk. Presenter: TBA Up to 1 hour online webinar 12 Training Calendar 2014

15 Presenter Profiles Presenter: Gary Burgess Organisation: Therapeutic Goods Administration (TGA) Module: 1.3 Quality Management Systems and Conformity Assessment Procedures Gary Burgess is a qualified biomedical engineer, who has spent several years in the private sector developing electronic equipment and medical devices, before moving to Canberra to join the TGA as a medical device assessor. Gary has six years experience at the TGA dealing with conformity assessments of medical device manufacturers. He has attended QMS audits of manufacturers as a technical specialist, and has represented the Australian regulator on Study Group 1 of the Global Harmonization Task Force (GHTF), which is concerned with pre-market evaluation of medical devices, including conformity assessment. Gary is currently the Director of the Conformity Assessment section in the Office of Devices Authorisation (ODA) at the TGA. Presenter: Margaret Butler (Sydney) Organisation: State-based Nurse Educator Qualifications: RN, OR Nursing Certificate, BN, MAEd, in Workplace Training & Assessment. Module: 3.5 Introduction to Operating Theatre Protocols Margaret is a Perioperative Nurse Educator in the operating suite of St Vincent s Hospital, Sydney. In this role she coordinates tertiary affiliated postgraduate perioperative nursing education programs and professional development and specialty workshops. Margaret is also active in promoting perioperative nursing to undergraduates at various universities including a perioperative elective for nurses at ACU National North Sydney Campus. Margaret is an active member of the NSW Operating Theatre Association. Presenter: Stefan Czyniewski Organisation: Mobius Medical Qualifications: Bachelor of Medical Science, University of Sydney Modules: 1.8 Introduction to the Regulation and Design of Clinical Investigations for Medical Technology in Australia 1.9 Improving Clinical Investigations for Medical Technology Graduating with a bachelor degree in Medical Science from the University of Sydney in 2000, Stefan worked as a research assistant for an orthopaedic surgeon, primarily on hip and knee resurfacing prosthesis and autologous chondrocyte implanting in post market research. In 2003, Stefan joined the clinical research team at Fornier Pharma (now Solvay Pharmaceuticals) and was based at the Clinical Trial Centre at the NHMRC. Stefan worked as a clinical research associate and data manager on the FIELD study, a multi-centre, international, phase III study. His role at the clinical trials centre included project management for Australian and New Zealand clinical sites, coordinator of a cardiovascular sub-study and assisting with laboratory data processing. Affairs Manager at Ventracor and continued this posting until Stefan is a founding member of Mobius Medical and brings with him a sound knowledge of clinical trial project management, electronic data capture systems and data management in both medical device and pharmaceutical trials. Presenter: Sue Driscoll Organisation: Health Communications Module: 5.15 Media Skills Sue Driscoll is the Chief Executive Officer of Health Communications, an associate of Victorian Hospitals Industrial Association. Health Communications specialises in providing public relations and marketing support to all areas of the Australian healthcare sector. Sue is an experienced practitioner who worked in major metropolitan Melbourne hospitals and Victorian health agencies for around 20 years. During this time she coordinated hospital and network responses to major crises that face a Victorian public hospital. Sue has taught strategic communication planning and community relations to Masters students as well as writing and editing courses at undergraduate and postgraduate levels. In addition she has provided industry training for health and PR managers on communication planning, issues and crisis management, and of course media management. An ex-journalist, she is a former President of the Public Relations Institute of Australia (Victoria) and has been a regular commentator on public relations and communications on ABC Radio. Presenter: Alan Edgecomb Organisation: Alan Edgecomb Consulting Qualifications: Bachelor of Photography, Griffith University; Certificate in Business, Southbank Institute of TAFE; National Diploma in Electrical Engineering, Witwatersrand College for Advanced Technical Education, Johannesburg, South Africa Module: 1.3 Quality Management Systems and Conformity Assessment Procedures Alan Edgecomb has more than 35 years experience in the medical device industry. Alan has worked for Siemens Medical Systems and Philips Medical in South Africa and for General Electric Medical Systems (now called GE Healthcare) in Australia. Alan was the Quality and Regulatory Affairs Manager for the South East Asia region of General Electric Medical Systems, the Quality and Service Manager for an Australian start-up company, ImpediMed Limited, and currently is the Quality and Regulatory Affairs Manager for Abacus ALS in Brisbane. Alan also provides consulting services to various medical device companies in Brisbane. Alan has been involved with ISO 9001 and ISO quality management systems for the last 17 years having implemented and managed QMS at various sites in Australia as well as AS/NZS 4801 Health and Safety management systems. Alan has been running QMS training courses for the past 10 years. In 2006, Stefan joined Ventracor as a Senior Clinical Research Associate. Stefan was placed in charge of the clinical dossier for CE Marking of the VentrAssist, a left ventricular assist device, achieving CE Mark in December In 2007 Stefan was promoted to Clinical Medical technology for a healthier Australia 13

16 Presenter: Professor Val Gebski Organisation: NHMRC Clinical Trials Centre Module: 1.9 Improving Clinical Investigations for Medical Technology Val Gebski heads the biostatistics team at the NHMRC Clinical Trials Centre, which he joined in He has extensive knowledge of clinical trial methodology, conduct and analysis and is the Group Statistician for a number of national collaborative clinical trials groups in oncology. He also has extensive experience in designing and conducting meta-analyses as well as the involvement in developing terms of reference for Independent Data Safety and Monitoring Committees (IDSMC), participating (including chairing) in international IDSMC s and preparing reports for these bodies. Val is an honorary Fellow of the Royal Australian and New Zealand College of Radiologists and is involved in curriculum development and teaching in the Masters of Public Health, Clinical Epidemiology and Medicine, as well as being a co-director of the Masters of Clinical Trials (Research) being run from the Clinical Trials Centre at the University of Sydney. Presenter: Lee Glanzmann Organisation: BSI Group Qualifications: Bachelor of Engineering (Electrical)/Bachelor of Science (Applied Physics) Module: 1.6 Introduction to Risk Management for Medical Technology Lee Glanzmann is the Australian Medical Devices Business Manager for BSI Australia & New Zealand and a technical expert in the Active Implantable Medical Devices (AIMD) team in the BSI UK notified body. Graduating with a double degree in electrical engineering and physics from the University of Technology, Sydney, Lee has worked in the medical device industry for over 10 years in Australia and overseas. In 2002, Lee joined LVAD manufacturer, Ventracor in the Software and Electronics Engineering department, which led him on a journey of developing electronics hardware and software from the first human implant through to CE Marking. After a short stint in the telecommunications industry, in 2009 Lee moved to London, UK to join the BSI notified body as a technical expert. He moved back to Australia taking on board responsibilities of design dossier reviews for CE marking, ISO13485 auditing, business development and medical devices training. He also delivers BSI s ISO13485, lead and internal auditor training and ISO training courses in Australia and New Zealand. Presenter: Matt Godden Organisation: Australian Healthcare Solutions Qualifications: Bachelor of Health Sciences, Bachelor of Education; MBA, Mt.Eliza Business School (Melbourne, Australia) Modules: 7.2 Working with Market Researchers 7.5 Working with Clinical Investigations Matt Godden (Australian Healthcare Solutions Managing Director) has over 20 years experience in clinical and corporate healthcare. Matt has performed sales, sales management, marketing, strategic market development (Asia Pacific) and general management roles in the medical device industry having spent almost 10 years at Medtronic Inc. and also being involved in St. Jude Medical Inc. s start up organisation in Australasia. Matt s most recent corporate role was as Director / General Manager of Medtronic Australasia s Cardiovascular business. Presenter: Alina Hughes Organisation: MTAA Qualifications: Bachelor of Arts and Bachelor of Laws, University of NSW; Master of Laws, University of Sydney Modules: 2.2 Complying with the Code of Practice 2.3 Advertising of Therapeutic Goods in Australia Alina Hughes joined MTAA in 2010 and is the Code of Practice Manager. Alina has worked in the field of corruption prevention, ethics and compliance since After graduating from the University of New South Wales with a Bachelor of Arts and Bachelor of Laws, Alina initially worked as a solicitor for Minter Ellison Lawyers in Sydney. From , Alina worked in corruption prevention at the NSW Independent Commission Against Corruption and RailCorp. Alina has provided advice and training on ethics and compliance issues to a wide range of audiences. She has presented at the Australian Public Sector Anti-Corruption Conference and ARCS Congress. In 2012, she facilitated a discussion panel on industry codes at the MTAA s MedTech Conference. In 2013, she was a trainer at the APEC Train-the-Trainer Workshop for Voluntary Codes of Business Ethics in the Medical Device Sector in Kuala Lumpur. Presenter: Michelle Love (Brisbane) Organisation: State-based Nurse Educator Qualifications: Bachelor of Nursing, Australian Catholic University; Graduate Certificate in Nursing (Perioperative), Australian Catholic University; Certificate IV in Workplace Training & Assessment. Module: 3.5 Introduction to Operating Theatre Protocols Michelle Love has worked as a registered nurse in operating theatres for over 15 years. Her qualifications include Bachelor of Nursing, Graduate Certificate in Nursing (Perioperative) and Certificate IV in Workplace Training & Assessment. Michelle has worked at the Royal Brisbane & Women s, Holy Spirit Northside and The Prince Charles Hospitals. She has experience in elective and emergency surgery, particularly focusing in the speciality areas of urology, vascular and burns. She has worked in a variety of roles including registered nurse, clinical nurse, clinical pathways project manager and nurse educator. Currently she is the Perioperative and Procedural Areas Nurse Educator at The Prince Charles Hospital, Chermside. Her role includes the education of staff in the operating theatre, recovery, sterilising department, endoscopy unit and cardiac investigations unit, as well as corporate education for all hospital staff. Michelle was a co-author of a chapter for an Australian perioperative nursing textbook called Perioperative nursing: an introductory text, which was published in Presenter: Willem Mees van der Bijl Organisation: ide Group Qualifications: Master of Science (MSc) in Industrial Design Engineering (Cum Laude), University of Technology Delft, The Netherlands. Module: 6.3 Working With Product Developers Willem has extensive professional experience in product development of medical devices as well as industrial and consumer goods. His experience extends into new business development where he has used his skill and passion in design, development and implementation to create and to launch new products and start ups. 14 Training Calendar 2014