Please Note: This BioForum is a stand-alone event, as well as being Part A of the Masterclass Program. Registered Masterclass participants are not required to register separately to attend.
Medtech success hinges not only on the safety, efficacy and usability of a product, but on the team’s ability to effectively carry a product across the regulatory line.
Through all stages of product development, the snakes and ladders of team curation can be a challenging game. Understanding the why, when, who and how of team curation is crucial for a successful journey to market.
Join leading industry expert Stephen Leahey, Exa PD to dissect the key considerations for building a medtech dream team; outsourcing and engaging experts for product development; and matters of strategic alignment: the QMS question, partnerships and free IP.
Presenting virtually from Minneapolis, US product designer Tom KraMer, Kablooe Design will explore effective team curation for US market access and practical insights for working with the FDA.
Sharing the journey of Analytica Ltd, Chelsea Cornelius will share her insights and lessons learnt on building a team for global success.
WHO SHOULD ATTEND:
Healthtech executives: Founders, CXOs, Commercial Leads, BD Managers, Product Developers, Designers, Engineers, Scientists and Researchers.
Professionals seeking to improve knowledge and expertise.
Date: Tuesday 30 August 2022 Time (AEST): 7:20am: Registration, tea & coffee (in person only)
7:30am – 8:00am: Stand-up networking breakfast (in person only)
8:00am – 9:00am: Presentations
9:00am – 9:30am: Panel and Q&A Venue: ACMI, Swinburne Studio, Federation Square, Melbourne VIC 3000 Live Stream: via Zoom Webinar. A link to join the event will be shared prior to the event.
Online Registration BioMelbourne Network Members: $20
BioMelbourne Network Non Members: $40 In person registration: BioMelbourne Network Members: $75
BioMelbourne Network Non Members: $150
In person registration Full refund given up to 7 days prior to the event
No refunds within 7 days of the event
Online Registration Full refund given up to 3 days prior to the event
No refunds within 3 days of the event
Stephen Leahey, Engineering Manager & Director, Exa Product Development
Operating as the Director and Engineering Manager at Exa Product Development, Stephen brings a wealth of experience earned through 20 years in manufacturing, consulting, and product development. Stephen's early career focused on developing skills as an Electronics Engineer working to develop and manufacture telecommunications devices.
Over a period of 9 years, Stephen managed the manufacture of several product lines, both onshore in Australia, and in mainland China.
Stephen also spent time contributing to ACMA standards working groups for the Australian National Broadband Network.
As Engineering Manager & Director, Stephen has guided the Exa PD team to become trusted, long-term development partners to a diverse range of clients.
Stephen's extensive engineering capability includes: Digital signal processing & Simulation systems; Communications protocols; Analogue and digital devices; Battery-powered devices; Regulatory compliance.
Prior to founding Exa PD, Stephen spent a period of 5 years working within a product development and consulting environment. There, he led the electronics engineering team to develop several high-profile systems including: Utility devices; Medical devices; IoT devices; Power electronics for manufacturing industries.
These experiences allowed Stephen to better understand the commercial drivers of product development, refine a system engineering approach to development, and develop strategies that drive and support successful engagement between businesses and consultancies alike.
Tom KraMer, President & CEO, Kablooe Design (US)
Tom KraMer is the managing principal and a product design engineer at Kablooé Design, a Minneapolis MN based product design and innovation company.
For over 30 years Mr. KraMer has been involved in research and development for many types of products including medical devices, and after of 18 years of product design and development work in the field, he spearheaded the formation of the D3 (Design Driven Development®) process, which Kablooé uses to help direct its customers through the development process in an innovative way. Tom has led Kablooé Design innovation projects for Medtronic, St. Jude Medical, Boston Scientific, and Kodak health imaging, as well as product design and development projects for small start-up companies. Kablooé has in turn helped develop atrial fibrillation therapies, coronary intervention devices, drug delivery devices, prostate surgery devices, and many other unique and innovative medical devices, but has also developed many non medical devices including toys, guitars, the Stowboard®, lipstick containers and farming tractors.
Tom has been providing these product design and development services for product companies since 1990. He began to push Kablooe’s portfolio deeper into medical device design in 2000, and medical devices now represent over 70% of Kablooe’s project work. Tom has personally done hands-on design work, prototyping, innovation development, research, testing, and engineering-for-manufacturing for his clients. He has over 30 years of experience designing products for manufacturing and has a personal passion for user-centric devices. He leads the charge for user-centered design, innovation, research, human factors and ergonomics at Kablooé design and has personally directed usability research, focus groups, ethnographies, and human surgeries at the University of MN and hospitals in Minneapolis, Detroit, Pittsburgh and others.
Mr. KraMer holds an Executive Certificate in the Master of Product Development at Northwestern University and a bachelor’s degree in Industrial Design at MCAD. He also holds a certificate from Stanford University for the Cardiovascular System in Health and Disease, and spends much of his professional time teaching and lecturing about the human centered D3® development process and innovation training at worldwide trade conferences, for training organizations, and for corporate teams and universities nationwide.
Chelsea Cornelius, Chief Operating Officer, Analytica Ltd
Combining Arts (Cultural Studies) and Engineering (Mechanical) at Swinburne University seemed like an unusual double degree to most, but Chelsea saw the advantage of gaining a better understanding of the human condition – the history, motivation, psychology – in order to provide innovative and relevant engineering solutions. Following this double degree, Chelsea specialised in Biomedical Engineering by completing her Masters at Melbourne University, fuelled by her experience working in a physiotherapy clinic and seeing the need for technological advances in health.
She has quickly worked her way from Junior Engineer through Project Manager to Product Development Manager and now Chief Operating Officer in 11 years in her company, Analytica Ltd, demonstrating her drive for progress and efficiency. She has a passion for women’s health and developed a novel device to treat urinary incontinence, which affects 1 in 3 women word-wide. Participating in all parts of the life cycle of the unique system, called the PeriCoach – from feasibility, prototyping and design, to quality assurance, regulatory affairs and customer engagement and service – she has been able to gain invaluable experience in all aspects of product development and supply, and has realised the potential for exponential growth in technology for women’s health.
By consulting extensively with both women’s health specialists and sufferers throughout every phase in the design and development of the PeriCoach, Chelsea ensured that the result was a comfortable, user friendly and technologically advanced system that was a real-world solution to those desperate sufferers. Her commitment to improving the lives of many has resulted in a safe, effective and powerful tool. She continues to consult with experts and regularly seeks feedback from users in order to provide continuous improvement of the system so that it is meeting and exceeding expectations at every stage. Having been on-market in the US, UK/Ireland and Australian/New Zealand, clinical trial and real-world data results been incredible and demonstrate that this breakthrough device truly is changing people’s lives.
While she is passionate about her work, Chelsea strives to maintain a work-life balance by enjoying other activities such as travel, waterskiing, dirt bike riding and racing speedway.
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.