SEHTA and eg Technology are delighted to be running a second series of Medical Devices Product Design & Development Webinars to enable you to continue to update your skillset and move your medical technologies and companies forward.
Each session will run for 45 mins max at 14:00 – 14:45 (BST)
These webinars will be run via WEBEX – details on application
Target audience for these webinars are: Medical Technology Entrepreneurs, Medical Device Software Developers, Technology Transfer Officers, Medical Technology University Researchers, IVD Developers, Business Owners, Executives, Product Owners, Regulatory Specialists within a company that need to understand the overall regulatory requirements for their medical devices to enable them to place a device on the market and to maintain access. All company sizes will find it useful.
Costs to attend:
£50 +VAT pp per webinar for SEHTA Members
£60 +VAT pp per webinar for Non-members
Not a member of SEHTA – it’s free to join – https://www.sehta.co.uk/Post/sehta-membership
Below is a list of all available webinars with dates – you can choose as many webinars as you wish to take part in.
| Webinar | Session Title | Date |
| 1 | New Product Development – First things First
Whether you are a first-time entrepreneur or part of a large medical company, starting a new product development programme can feel like a daunting task. So where should you start? What things do you need to consider at the outset to turn your idea into reality? Starting with an overview of the product development process, this webinar will move onto the most important, and often the most overlooked aspect of product development – understanding the user.
Topics to be covered include:
· The key things to consider from the outset of any development programme · The importance of putting the user first · How to obtain useful user insights · How to leverage those insights to make a better product
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Tuesday 10th November 2020 |
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Facilitator |
Danny Godfrey, Co-Founder, eg Technology
In 2002, Danny and Andrew founded eg technology ltd, a product design engineering company based in Cambridge UK. They have grown the company organically since then, and now employ over 30 engineering and commercial staff. Danny’s role is to provide corporate leadership, develop new business opportunities and oversee the technical and strategic direction of projects. He remains involved with the work that eg does, from the initial proposal writing, technical & creative input, design implementation, review processes and the early identification of development risks. Motivating staff and nurturing client relationships are important aspects of Danny’s day-to-day work – valuing and developing our team of bright, can-do people and ensuring clients are satisfied with what eg does have been the foundations of success for the company. Danny is also a member of the MedTech Accelerator Awards Committee. This organisation supports and finances projects for early-stage companies in the medical sector to create future spin-out companies that aim to bring new life-enhancing technologies to market.
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| Webinar | Session Title | Date |
| 2 | Defining User and Product Specifications During Product Development
This webinar will cover what User Requirement Specification (URS) and Product Requirement Specification (PRS) are, how they differ and how to define them during the product development process. The webinar will end with an interactive quiz.
Topics to be covered include:
· What is a URS and PRS and how do they differ? · What do the standards ask for? · Where do the URS and PRS sit in the product design and development process? · Writing the URS and PRS – best practices · Things to watch out for · Interactive quiz
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Tuesday 17th November 2020 |
| Facilitator | Kella Kapnisi, Project Manager, eg Technology
Kella works as part of the project management team. She is responsible for delivering projects from concept through to production, on time and within budget. Working closely with clients to ensure successful projects across a wide range of products, including medical devices, IVDs, lab equipment & consumer products.
Kella is also involved in strategic reviews of project operations, to ensure efficiency in our internal engineering design processes. She led the implementation of the requirement specification process at eg technology, which forms part of our Quality Management System and she delivered the resultant company-wide training sessions.
Kella has a background in polymer chemistry and a PhD in biomaterial engineering, under Prof Molly Stevens at Imperial College London, where she developed tissue engineered cardiac patches for treating heart attacks. Prior to joining eg technology, Kella was part of a start-up developing implantable heart assist pumps.
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| Webinar | Session Title | Date |
| 3 | Software Design for Medical Devices
This webinar will cover Software Design for Medical Devices, starting with a quick overview to medical device classification, international standards and the role of IEC 62304. This webinar is intended to look in more detail at some practical applications of the software development processes and what it actually means for the engineers
Topics to be covered include:
· Medical Device Classification & IEC 62304 – a quick refresher · What makes software development different? o Software Development o Software Testing o Software Updates · Structuring software development in practise o How to limit the scope of large software projects? o Where to draw a boundary around the software components? o How to maintain flexibility to update without major retesting/resubmission o Software decomposition of safety critical items · Software maintenance considerations o What are the regulators worried about? o When is a bug not a bug?
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Tuesday 24th November 2020 |
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Facilitator |
David Warwick, Director, eg Technology
David joined eg in 2009 and was appointed as a Director of the company in 2019. As a Director, he has an overall responsibility for bringing in new business to eg technology and works with the senior management team to constantly evaluate how the business operates to ensure that the company’s strategies support the future growth of eg.
David’s technical background is in Software Engineering and Electronic Design with over 15 years’ experience in developing medical and IVD device software. During his time at eg technology he has helped numerous clients with the compilation of their technical files and the CE marking and FDA approval of medical devices and IVDs as well as outsourcing final product manufacture. His experience with software development includes extensive experience working with IEC 62304 across all software safety classifications.
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For more information on each webinar and to register please click below