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Medtech Masterclass – Making it Work: The Human-Centred Approach to Medtech Development
October 17, 2022 @ 8:30 am - 5:30 pm AEDT
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MASTERCLASS WORKSHOP HAS BEEN POSTPONED TO MONDAY 17 OCTOBER – To join our waitlist please email us at info@biomelbourne.org
MASTERCLASS PROGRAM COMPONENTS
This Masterclass Program has three parts:
- PART A | BioForum: (Previously delivered on Tuesday 30 August) | 7:30am – 9:30am | ACMI, Swinburne Studio, Federation Square, Melbourne
- PART B | Masterclass Workshop: Monday 17 October | 8:30am – 5:00pm | Cliftons Freshwater, level 18/2 Southbank Blvd, Southbank VIC 3006
- PART C | 30-minute Advisory Session: Individual meetings held across 18 and 21 October
ABOUT THIS MASTERCLASS PROGRAM
From the early research stage, right through to product development and commercialisation, the relationship between product usability, key stakeholders (users) and risk plays a vital role. Engaging end-users and identifying risk early in product development is fundamental to achieving success in market.
The Medical Technology sector is tightly regulated globally, with risk and safety considerations a central focal point for regulatory bodies. As such, the pathway to a market-ready medical device will be volatile without a clear understanding of the ecosystem, people and processes that exist around it, and the impact each of these may have.
This high-value Masterclass Program, sponsored by the State Government of Victoria, will guide medtech executives through two important interdependent strategies in the product development life cycle; user engagement and risk management & mitigation.
Our leading industry experts will examine how to access key stakeholders, derive evidence-based needs on a global scale, and tackle key risk categories to effectively prioritise and balance cost, quality and time-to-market – all while employing a user and patient-centric approach to product development.
Participants will gain invaluable knowledge, skills and tools to strategically engage stakeholders, manage and mitigate risk and ultimately, build great confidence in market adoption.
MASTERCLASS WORKSHOP | DATE TBC – AGENDA HIGHLIGHTS
- The symbiotic relationship between usability and risk
- Interactive workshop: Your feet in their shoes, your device in their hands
- Dissecting the user ecosystem
- Discussion and Brainstorm: Building evidence and validating assumptions
- Empathy: The secret weapon to building confidence in market adoption
- Case Study: An innovative approach to uncovering user needs
- Going Global: Getting your device across the regulated line
- Case study: Class II medical device for launch in US market
REGISTRATION FOR THIS MASTERCLASS PROGRAM INCLUDES:
- Three complimentary registrations for colleagues to attend the BioForum
- Attendance at the full-day Masterclass for one company representative
- One 30-minute advisory session (two company representatives may attend)
WHO SHOULD ATTEND?
- Early-stage medical technology executives developing products for the global market
- Medical technology professionals seeking to improve knowledge, skills and expertise
- Founders, CEOs, CSOs, CTOs, Commercial Heads, BD Managers, Product Developers, Product Designers, Engineers, Scientists and Researchers.
LEADING INDUSTRY EXPERTS
Sento Solutions (Sento) are a Usability Engineering (UE) and user experience consultancy. They are industry-leading experts, working with both local and global medtech start-ups and medical device manufacturers on over 20 medtech development projects.
Sento use a highly structured, proven process to create safe and easy-to-use experiences for medical device users and patients. They collaborate with multi-disciplinary teams in medtech start-ups, product development and medical device manufacturing groups. Find out more here.
REGISTRATION
BioMelbourne Network Members: $595; Non Members: $695
Unsure if your organisation is a member? Check our member directory.
This is a high value Masterclass Program. Heavily subsidised rates are made possible with sponsorship from the State Government of Victoria. The estimated value p/person is $3,500.
This Masterclass Series is sponsored by the State Government of Victoria.
CANCELLATION POLICY
A full refund can be issued up to 14 days prior to 17 October 2022. No refunds can be issued within 14 days of the program commencing.
Carla Zampaglione, Director, Usability Engineer, Croissant Connoisseur, Sento Solutions
Carla’s background and skillset is unique to the broader medtech industry. A former mechanical engineer with international product development experience and knack for speaking ‘human’, she founded Sento Solutions; a usability engineering and user experience (UX) consultancy for medical device product development.
Carla has grown Sento to be the only company in Australia to exclusively offer usability engineering and UX for medical devices. Sento has become the industry-leader with its expertise, leading-edge knowledge and a portfolio with more than twenty successful medical device developments. The company has never wavered from its core values and purpose; to make people’s lives easier.
In addition to setting the vision and direction for Sento, Carla oversees all Sento’s client relationships, network collaborations and expert panellist and mentoring programs. Carla’s strength is in her intimate knowledge of relevant global usability standards and regulations, including IEC62366, FDA guidance to applying usability engineering and ISO14971. Sento uses its understanding and interpretation of these regulations to guide clients through a proven, customised and compliant process to develop safe and effective medical devices.
Carla is also a sessional lecturer at Swinburne University in the School of Engineering. She also sits on the advisory committee for the Centre for Design & Innovation (CDI) at Swinburne.
Carla has a passion in mentoring young STEM students and graduates. Carla also enjoys teaching spin classes at her local gym and baking croissants, learned while in France, where she qualified as a Pastry Chef.
Carla has grown Sento to be the only company in Australia to exclusively offer usability engineering and UX for medical devices. Sento has become the industry-leader with its expertise, leading-edge knowledge and a portfolio with more than twenty successful medical device developments. The company has never wavered from its core values and purpose; to make people’s lives easier.
In addition to setting the vision and direction for Sento, Carla oversees all Sento’s client relationships, network collaborations and expert panellist and mentoring programs. Carla’s strength is in her intimate knowledge of relevant global usability standards and regulations, including IEC62366, FDA guidance to applying usability engineering and ISO14971. Sento uses its understanding and interpretation of these regulations to guide clients through a proven, customised and compliant process to develop safe and effective medical devices.
Carla is also a sessional lecturer at Swinburne University in the School of Engineering. She also sits on the advisory committee for the Centre for Design & Innovation (CDI) at Swinburne.
Carla has a passion in mentoring young STEM students and graduates. Carla also enjoys teaching spin classes at her local gym and baking croissants, learned while in France, where she qualified as a Pastry Chef.
Rachel Enright, Project Manager, Mechanical Engineer, Empowerment Enthusiast, Sento Solutions
Rachel’s background is in mechanical engineering and medical device development. She has creative flair which brings a unique perspective to the work at Sento. Rachel makes significant contribution to end products by advocating for the end user and patient at every step and demonstrating deep empathy for all stakeholders. Rachel also ensures that all projects meet their development and commercial objectives!
To deliver to Sento clients, Rachel draws on her experience as a carer for people with disabilities for 7 years, as well as her knowledge of assistive devices and mobility design. Her background both in Germany and Australia bring together excellence and practicality in her engineering.
Rachel’s unique gift in 'human' to 'engineer' translation promotes Sento’s core services, making her an integral member of Sento’s growing team.
When Rachel is not making people's lives easier at Sento, Rachel loves throwing herself into projects that empower people including youth leadership camps and women’s groups. She's also a dedicated, proud mum to her 2 young kids and a very active dog Sam.
To deliver to Sento clients, Rachel draws on her experience as a carer for people with disabilities for 7 years, as well as her knowledge of assistive devices and mobility design. Her background both in Germany and Australia bring together excellence and practicality in her engineering.
Rachel’s unique gift in 'human' to 'engineer' translation promotes Sento’s core services, making her an integral member of Sento’s growing team.
When Rachel is not making people's lives easier at Sento, Rachel loves throwing herself into projects that empower people including youth leadership camps and women’s groups. She's also a dedicated, proud mum to her 2 young kids and a very active dog Sam.
