5 Key Points to consider in Design Transfer of Medtech
Design Transfer is often viewed as a one-time event. However, it should be an integral and ongoing part of the product development process, and should begin as early as possible.
Communication between collaborators (“The Team”) is crucial to turning innovative ideas into commercial medical devices.The Team must identify and maintain procedures and checkpoints that ensure the design requirements successfully translate into production processes and specifications.
This includes designing and specifying final test procedures and performance required for acceptance. Through early collaboration, seamless transfer to manufacturing is possible; increasing production efficiency, improving yield, decreasing re-work and shortening time-to-market.
During this informative presentation, Doug Browne, Director of Mechanical Engineering and Design Transfer at Sunrise Labs, and Ted Trask, Director of Corporate Quality Assurance/Regulatory Affairs at Cirtronics will share tips from their decades of real-world experience. They will discuss critical moments in the development journey where collaboration and communication lead to successful transfer of new medical products to full scale manufacturing.
Discussion topics include:
- Building successful relationships throughout the product design process
- Identifying and mitigating risks early
- DFx optimization including manufacturing, testability, serviceability and sustainability
- Creating a supply chain strategy based on BOM, scalability, and fluctuations
- The power of focusing on your strengths and working with trusted partners
Speakers Include
- Doug Browne, Director of Mechanical Engineering & Design Transfer, Sunrise Labs
- Ted Trask, Director of Corporate Quality Assurance/Regulatory Affairs, Cirtronics
Greenlight Guru is a modern quality management software platform built exclusively for the unique needs of the medical device industry. Their platform is currently being used by innovative medical device companies in over 600 cities and 50 countries on 6 continents to bring new products to market faster while simplifying regulatory compliance and reducing risk. Device makers across the globe are replacing their outdated paper-based and general-purpose legacy quality systems with Greenlight Guru. Being the only modern, industry-specific, cloud-based eQMS, Greenlight Guru is easier to implement, easier to use, and simply fits medical device processes better allowing companies to innovate faster and be more efficient. To learn more about how they can help your device company or demo their software, please visit www.greenlight.guru.
Sunrise Labs brings their “best-in-class” medical device design and engineering expertise for all stages of product development. Employing optimized ISO-13485:2016 certified work processes,Sunrise develops life-changing medical and wellness devices such as complex electro-mechanical, connected health, and life science instrumentation. Their clients’ success demonstrates the Sunrise team’s strength in software, electronics, systems, mechanical, optical engineering, fluidics, and user centered design.
Located in Bedford NH, Sunrise employs over 90 in-house dedicated employees in a high-performance culture based on engineering excellence, mutual respect, and integrity. Eric Soederberg, President of Sunrise Labs, attributes the growth and success of the company to the caliber and commitment of the Sunrise team. To learn more, please visit their website: www.sunriselabs.com
