A Hundred Visions and Revisions:
How an effective prototyping strategy will save you time and money, and result in a safer, more effective product that people will actually want to use.
This lecture will cover:
· The difference between a prototype and a product
· Why make a prototype
· How prototyping fits into the medical device development process
· Prototype testing and evaluation (including bench testing, animal testing, clinical trials, and human factors evaluation)
· Regulatory considerations
· Examples/Case Studies
· Prototyping tools, techniques, and technologies
Joel Ironstone, President IPD Inc.
Joel Ironstone is a medical device development expert. He has brought several complex medical and healthcare products from concept to commercialization including over 25 successful FDA, Health Canada, and CE Applications. He is a prolific inventor in the fields of women’s health, minimally invasive surgery, pain management, and hospital products with dozens of issued and pending patents including multiple successful licences and technology acquisitions. He has held positons as CEO, Lead Engineer, VP Product Development, Direct of Operations, as well as VP Clinical and Regulatory Affairs for a variety of small and medium sized medical device companies
Joel is the president of IPD, a medical device consulting firm that helps its customers commercialize new health care products. They provide full support for development, regulatory affairs, and clinical trial design and execution. Joel also acts as a regional liaison for Starfish Medical, Canada's largest medical device design, development and contract manufacturing company. .
Veso Tijanic, M.Sc., COO, Thornhill Research Inc.
Veso has more than 25 years of experience in new product development in various engineering and management roles. In the last 15 years he has worked in the medical industry. His expertise is in conceptual development, mechanical design, manufacturing, project management and product development. For the last 10 years he has been with Thornhill Research Inc. where he is currently the COO and has led the mechanical group in developing medical devices including Life Support Systems, and Anesthesia Delivery systems.
Prior to that, Veso managed the engineering group at SciCan Inc. on developing medical washers, disinfectors and sterilisers, managed the product life cycle and supported the company’s new product idea creation, market research and marketing development. Veso is the inventor on several patents ranging from Transportation Displays, Medical Washers and Medical Devices.