Educational seminars on all aspects of product development for medical devices with electronics hardware and software
All webinars are about 1 hour, in a radio interview style with the moderator asking questions throughout.
This presentation provides a high-level overview of the entire active MedTech development process. The audience for this event is primarily people new to MedTech. We summarise the key points from all the webinars delivered to date. Subjects include industrial design, electronics and software, regulatory requirements, obtaining grants and other sources of funding, quality systems, design controls, contracts, intellectual property, usability engineering, clinical trials and key standards. Delivered by the community coordinator and CEO of Genesys Medical Devices, Dr Tim Kannegieter.
8 March 2022 - Interoperability
This presentation by Rob Karp from Fluffy Spider Technologies looks at interoperability of medical devices within the wider healthcare system. Topics include the Single Digital Patient Record Project, Australian Digital Health Agency findings, the FHIR standard, data analytics, security, privacy and compliance, cloud connectivity and more. This presentation meets the needs of all levels, with introductory material for people new to interoperability and some deep technical dives to develop the more experienced.
9 Feb 2022 - Computer Software Assurance
This presentation by Ian Adams, Seer Medical explore best practices on computer software assurance, with lessons from the pharmaceutical industry. Key topics include: an impact and maturity model; the role of risk assessment; cost-effectiveness of validation; system development life cycle; and case mapping and test planning.
13 Oct 2021 - Hazards Analysis for Active Medical Devices
This is a follow-up to our earlier look at risk management and ISO 14971. However, in this webinar we take a more practical look at how to actually conduct a hazards analysis for active medical devices, showcasing the methods and tools for identifying, analysing and mitigating risks. We have included a worked example using a hypothetical respiratory ventilator. The topic is presented by Genesys CEO Geoff Sizer.
22 Sep 2021 - Growing the MedTech Industry
This webinar explores the MedTech Sector growth strategy of MTP Connect, the government-sponsored organisation responsible for driving growth in the industry. The presentation will cover the organisation's funding programs, key megatrends, focus areas and skill gaps. We then have an open discussion about what we can do to address pain points and areas of opportunity for the MedTech sector.
9 Sep 2021 - Working with the TGA
In this presentation, we cover processes for gaining regulatory approval from the Therapeutic Goods Administration (TGA). The risk-based approach to medical device regulation is explained, including evidence that needs to be provided. An overview of how software is regulated is included and will touch on artificial intelligence and cybersecurity. The webinar is presented by Dr Xin-Lin Goh, Director of the Devices Applications Section and Olivia Reeves Team Leader in the Devices Conformity Assessment Section.
25 Aug 2021 - MedTech Deals and Raising Capital
In this webinar, we have a conversation Kim Lyle of Electrogenics Laboratories (https://electrogenicslabs.com/) which is developing a medical device for measuring radiation dose in radiotherapy. The focus of the webinar is on the deals that need to be struck in commercializing technology, in particular on the capital-raising side of the commercialisation process. We look at the initial raising of seed capital, the commercial arrangements with early investments, structuring of the business and pitfalls to avoid.
11 Aug 2021 - Electromagnetic Compatibility for medical devices
In this presentation, we examine the radio frequency considerations in designing medical devices, including the all-important standards on electromagnetic compatibility (EMC), including IEC 60601-1-2. EMC in medical devices requires a rigorous analysis due to the safety considerations involved, which can arise from interference with other medical devices in health centres or even the susceptibility of your device to such interference. Any device that relies on Bluetooth, Wi-Fi, 4G or any other RF communication technology are the particular focus of EMC regulations. Testing may be required on a variety of RF or electrical characteristics including radiated emissions and immunity. Most issues can be avoided by sensible design considerations which we will outline in this presentation. This webinar will be presented by Geoff Sizer, CEO of Genesys Electronics Design
28 July 2021 - User interfaces for medical devices
The more user-friendly and impressive the user interface, the easier it is to market the product, but more importantly, it has to be safe. This webinar has two presenters - George Bou-Rizk from Genesys Electronics Design and James Brennan at Tiller Design. Industrial Design topics include the elements of a user interface (beyond graphic design), catering to the cognitive and physical abilities of varying users, adapting to the environment of use, the design process for user interfaces, human factors and usability engineering, and numerous tips for creating great user interface designs. Software engineering topics include the required medical device software life cycle set out in IEC 62304, dealing with Software of Unknown Provenance when using other devices as an interace, how to display the UI on screens connected to microcontrollers, working with Android and IoS.
14 July 2021 - Commercialising MedTech
This webinar is about what innovators need to do to turn their ideas into products and services, creating a successful business in the process. We look at marketing fundamentals that aims to ensure that a product meets a market need. Topics include understanding the problem, how your solution addresses that, the importance of your customer and the market, competitor and substitute analysis, how you will make money, building your team to deliver and your exit point. The presenter is the CEO of Triple Innovation, Jeremey Pooley.
23 June 2021 - Insurance for everyone involved your MedTech product
After MedTech product design and development and trials are complete, there will still be some residual risks left that can't be avoided, which need to be insured against. In this presentation, Mieke Van Dam from Chubb insurance discusses the different kinds of insurance available to product developers, as well as manufacturers, distributors and designers. The standard insurance options relate to product liability, errors and omissions (financial injury), cybersecurity and clinical trials. Examples of insurance claims are discussed including a faulty hearing aid, software glitches and a cybersecurity breach caused by the product.
16 June 2021 - Verification and Validation
In this presentation, we delve into the critical processes of verification and validation in MedTech product design. We look at what is required by ISO 13485 and the key standards of IEC 60601-1 and IEC 62304. We then explore the actual processes required for V&V for the overall system, electronics, software, and manufacturing processes. We delve into the practical details of registers, logs and review processes. The presentation is delivered by Geoff Sizer, CEO of Genesys Electronics Design and CTO of Genesys Medical Devices.
26 May 2021 - Case Study: Opthalmic diagnostics by Cylite
In this webinar, we profile the development of Cylite's HP-OCT ophthalmic diagnostic technology - 2020 winner of the Sir William Hudson Award, Australia's highest engineering award. This device uses a 3D imaging technique to help patients with ocular conditions, using light waves to scan the surface of the eye while accounting for constant eye movement. It uses 1000 light beams and integrates the functions of numerous instruments into a single, automated platform. Presented by Dr Simon Poole (AO) from Cylite.
28 April 2021 - Startup Analysis: Neurode - treating ADHD
In this webinar, a panel of experts discuss the key success factors for MedTech start-ups, analysing the case of Neurode. The Neurode Wave is a wearable headset for improving cognitive performance for people with neurological conditions such as Attention-Deficit/Hyperactivity-Disorder (ADHD) where 30% of people with the condition are drug-resistant, leaving them with no accessible or effective treatment options. The case study was delivered by founders Nathalie and Damian.
14 April 2021 - Industrial Design Basics
A broad look at what Industrial Design is, and the design process, including understanding users and context, concept development, and the iterative proces of developing, refining and validating the design. Industrial design includes a focus on usability and human factors, as well as how visual and tactile communication can inform how users perceive and understand what a device does, and how it is used. This webinar is presented by Lincoln Black, a senior industrial designer at Tiller Design.
24 March 2021 - Designing Safe Products with IEC 60601-1
This webinar focuses on the standard governing the safety and essential performance of medical electrical devices - IEC 60601-1. Safety topics include electrical and mechanical hazards, usability, biocompatibility, labelling, documentation and the basic tenets of risk management. The webinar will explore the standard section by section, including its approach to compliance and how to test the device to prove compliance. This presentation is delivered by Geoff Sizer, CEO of Genesys Electronics Design.
10 March 2021 - Clinical Trials
This webinar is an introduction to all the processes of running a clinical trial required to gain evidence in support of a regulatory approval application. Topics include how to develop an investigational plan, gain the necessary approvals, recruit patients, collect data, and write reports. The different types of study designs will be explored along with the rules and guidelines that govern clinical trials. This presentation was delivered by Suzanne Williams, Co-founder and Principal of Mobius Medical.
17 December 2021 - Connected Medical Devices
Most medical devices today have a connection to the cloud, either for storing data or accessing advanced analytic processing capabilities. In this presentation, we walk through all the IoT technologies required to get your device online including RF communication options; powering your device; displays and user interface; local/cloud data storage; mobile apps; and other key electronic components such as the microprocessor, antennae, and connectors. Delivered by the CEO of Genesys Electronics Design, Geoff Sizer.
2 December 2020 - What smaller MedTech companies learn from Cochlear
As Cochlear has grown from a startup to the leading MedTech company it is today, it has learned many lessons that have been embedded in its systems and process. In this presentation, the Head of R&D Processes and Services at Cochlear Peter O'Neill outlines the best practices in relation to up-front planning, the importance of partnerships over supply agreements as well as the management of requirements, risk and change.
25 November 2020 - TearView Case Study: Beyond 700
After discovering that they could see the tear film in real-time using infrared technology, and securing IP, two scientists set up a company to design and manufacture a device called TearView with associated software. The tear film is a thin moist layer spread over the front of the eye by blinking. When problems occur, it can lead to a debilitating condition called Dry Eye, with eye redness, sensitivity to light, diminished vision and constant, and pain. This webinar takes you on a tour from ideation to product launch.
4 November 2020 - Industrial Design and Translational Research
The complex medical device projects typically found in translational research often require the interaction of several technologies, subject matter experts, research disciplines and commercial imperatives. Design can play a crucial role in helping coordinate these efforts, delivering a device that is always concerned with patient outcomes and benefits, going well beyond a traditional ‘program management’ role. Robert Tiller, CEO of Tiller Design, discusses better ways of working, with examples from projects the company is working on.
21 October 2020 - Risk Management for Active MedTech
The application of risk management to medical devices is addressed by the pivotal standard ISO 14971. Risk management primarily involves identification of hazards and mitigating risk.
While some hazards are known, others require analysis and may overlap several domains of expertise, from medical risks to usability. Safety by design, the use of information, labelling, warnings and training resources are key protective measures. The topic is presented by Genesys CEO Geoff Sizer and supported by Sue Lynch from MedTech Pathways.
9 Sept 2020 - FemTech: Active MedTech for Women's Health
The NSW Active MedTech Community supported Women's Health Week 2020 with an exploration of FemTech. FemTech is an approach to MedTech development that puts the perspective of women first to ensure the technology meets their needs. An overview is presented by the Sydney Ambassador of the FemTech Collective and FemTech consultant Megan Capriccio. Megan is supported by two leaders in the FemTech industry, Sarah McDonald, CEO of Baymatob and Dr Michelle Perugini, CEO of Life Whisperer.
2 Sept 2020 - Packaging and sterilisation for Active Medical Devices
Most active medical devices need to be delivered in appropriate packaging and many need to be sterilised for use in a variety of healthcare contexts. Of particular interest for Active MedTech is the need to ensure that sensitive electronics are not damaged in the sterilisation process. We look closely at the requirements of the ISO 11607 standard on Sterile Barrier Packaging. This webinar is presented by Sabre Medical CEO Doug Watson.
2 Sept 2020 - Usability engineering for MedTech devices
Usability is a key factor in the design of products that humans need to interact with correctly to achieve the essential performance expected of the device. Usability includes ergodynamics of the physical nature of the device, how information is displayed and identifying potential usability hazards. In this presentation, we will explain the role of usability and discuss the application of IEC-62366-1, including human factors use specification, hazard related-use scenarios and critical tasks, as well as formative and summative evaluations. Presented by Sue Lynch of MedTech Pathways
In this presentation, we take a close look at the pivotal standard IEC 62304 and how this influences the development of software of Active MedTech devices. This standard specifies the requirements for firmware and software in medical devices at every stage of the product's life cycle. Topics include requirements analysis, architectural design, software unit implementation and verification etc. The webinar is presented by Geoff Sizer is the CEO of Genesys Electronics Design, a ISO 13485 certified contract designer of medical devices.
1 Jul 2020 - Manufacturing Active Medical Devices
This presentation explains the process of manufacturing medical devices with a focus on optimising your design for manufacturability. Topics discussed include the importance of a clear Bill of Materials, what information is required in a manufacturing design transfer package, accounting for testing process in your estimates, optional extras and tips for saving costs. The webinar is presented by Circuitwise Electronics Manufacturing general manager Serena Ross.
3 June 2020 - Getting contracts right for Active MedTech projects
Good contracts are critical to ensure the smooth running of MedTech projects and to protect against the issues that might arise. This presentation looks at the range of agreements that are required starting with non-disclosure agreements and supplier agreements, through to those required with investors and shareholders. Central to the role of all of these agreements is intellectual property. The presentation is delivered by Lis Boyce from Dentons. Lis is also involved with a number of MedTech groups at AusBiotech.
20 May 2020 - Design controls for MedTech product development
At the heart of designing a medical device is the need to carefully manage the design process so that the final product meets the original needs and intended use. Design Control refers to the use of procedures and plans to control and record the development of a medical device. Design controls are often perceived as an annoying overhead. However, properly applied they lay the foundation for a smooth pathway to compliance and certification, as the CEO of Genesys Electronics Design explains in this presentation.
Venture capitalists are expert at understanding what innovations are worth investing in. Their insights as to what is likely to make a product successful should be compelling reading for any MedTech entrepreneur. In this presentation, Callum Bir explains the various pathways to market, from incubators to scale-up. The range of investment vehicles are explored including the timing from seed to IPO. Key topics underpining the negotiation process, such as valuation, are discussed.
19 Apr 2020 - A conversation on industrial design for MedTech
From biocompatibility of materials through to branding your MedTech innovation, industrial designer play a critical role in the success of MedTech product development. Human-centred design informs the industrial design process, starting with deep insight as to how people will interact with the device and developing the core usability and mechanical concepts underpinning how the device will work. In this webinar we talk to John-Paul Daneel, Business Development Manager at Design and Industry.
In this session of the NSW Active MedTech Community we collaborated with Venture Cafe Sydney to brainstorm what it would take to rapidly develop an Automatic Ventilator from scratch, in Australia. The discussion worked with real requirements for ventilators that have been published by governments at the height of the Covid-19 pandemic. A plausible design was presented and a panel of experts were invited to make comment, along with the audience.
18 Mar 2020 - Setting up your ISO 13485 quality system
Every manufacturer of active medical devices must have a quality system in place. This webinar outlines the processes and best practices in getting your system ready for audit.
The most important standard in MedTech is the ISO 13485 standard on quality management systems for medical devices. This standard sets out the requirements for regulatory purposes. The founder of Ora Innovations, Kevin Badin, will outline what companies need to do to successfully establish their quality systems for medical devices.
18 Mar 2020 - Software and electronics - overview
Software and electronics is what makes a medical device "active". This presentation breaks down the hardware development process for electronics as well as the corresponding firmware and software development process. An overview is given of the IEC 60601-1 standard for medical electrical equipment and the IEC 62304 standard for medical device software. The webinar is presented by Genesys CEO Geoff Sizer. Geoff has over thirty years of experience designing electronic devices.
19 Feb 2020 - Obtaining grants to support your MedTech journey
Grants feature strongly in the development of almost every active MedTech project. In this webinar, the full range of grants available in Australia is outlined. The webinar is delivered by the CEO of Pattens Group, Bruce Patten. His company has assisted individuals and companies apply for grants. Previously, Bruce was Group Finance Controller for bionic ear company, Cochlear Limited, which provided him with extensive experience in securing a range of government grants and the formulation of strategies to substantially assist company growth.
12 Jan 2020 - Regulatory requirements for Active Medical Devices
This 40-minute presentation explores the compliance and certification requirements for creating and marketing active medical devices. The two main regulatory regimes around the world are examined. The critical role of the technical file and how it applies to different regulatory processes is explained. The role of harmonized standards and quality systems in the regulatory compliance process is also explored. The webinar is presented by a senior consultant at Brandwood CKC, a leading regulatory consultant for medical devices.
This was our original high-level overview of the product development process for active medical devices. Compare it to the presentation at the top of this page to see how much we have learned as a community.We explain the range of service providers needed to bring your product to life and the complex web of quality systems, regulatory processes and product certification. This webinar is aimed at people considering developing a medical device and service providers wanting to understand the big picture outside of their field.