As the pre-filled syringe market increasingly takes on digital health components it is important to think about the human factors validation strategies that companies should consider. A post-conference workshop following the Pre-Filled Syringes West Coast 2019 event will aim to provide an overview on this.
Pre-filled syringe
The Pre-filled Syringes West Coast conference is taking place from June 3rd to June 4th 2019 in Hyatt Regency Mission Bay, San Diego, USA. The post-conference workshop will be taking place following this on June 5th for half a day.
Natalie Abts, senior program manager, Usability Services will lead the workshop which aims to generate discussion around challenges, lessons learned, and future directions for human factors considerations regarding similar products. Additionally, the workshop will aim to hear regulatory and industry perspectives on study design for pre-filled syringes, understand current FDA thinking on human factors submissions and discuss considerations for products incorporating digital health.
Rita Lin, human factors reviewer, Centre for Radiological Health and Devices, FDA will hope to discuss and cover the following topics:
- FDA human factors guidance applying human factors and usability engineering to medical devices
- Review Xcertia mHealth app guidelines and discuss relevance to pre-filled syringe industry
- Discuss current directions and challenges with pre-filled syringes from regulatory and industry perspectives
To demonstrate the concepts under discussion and help participants work through a study plan, a case study of a pre-filled syringe with connection to a mobile app will also be utilised throughout the course.