Educational seminars on all aspects of product development for medical devices with electronics hardware and software
All webinars include 30 to 40 mins of presentation followed by 20 to 30 minutes of questions
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 presentation is a high-level overview of the product development process for active medical devices. We explain how active devices are different from inert MedTech, 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.