A webinar with GCMI and the Georgia Manufacturing Extension Partnership, June 25, 2024 at 10:30 a.m. EDST
When – at long last – it comes time to build your new medical device, be that for verification and validation testing, show and tell or educational examples, clinical trials or “full scale,” you will always wish you had followed the associated Golden Rule; Design for Manufacturability from Day One.
Design decisions with manufacturing at the right scale need to be made upfront, even if large-scale production seems far off. A device might serve its purpose perfectly as a 3D printed prototype, but producing it at scale for clinical use based on designs only appropriate for small batch production can become an expensive nightmare.
Via our colleagues at the Georgia Manufacturing Extension Partnership, “Join the Global Center for Medical Innovation (GCMI) and Georgia Manufacturing Extension Partnership (GaMEP) at Georgia Tech on June 25th to learn about the unique challenges that many face when entering the medical device space and the steps you can take to help avoid common pitfalls and achieve success [particularly as it relates to manufacturing].
“During this one-hour webinar we’ll cover:
- An overview of medical device regulatory requirements, including how the regulatory pathway varies for different medical device classifications.
- Common pitfalls and obstacles that designers or manufacturers encounter when taking their product to market.
- An overview of quality control requirements and how to achieve compliance with regulations such as ISO 13485 and FDA requirements.
- The importance of design for manufacturability, planning for changes in your supply chain, and including the right partners early in your process to help you scale your product efficiently and minimize setbacks.
Saylan Lukas, Interim Executive Director of the Global Center for Medical Innovation (GCMI), research faculty member of Georgia Institute of Technology and Dean Hettenbach, GaMEP Project Manager, Supply Chain and Manufacturing Technology, MedTech, Strategy and Leadership Development will lead the session.