One year ago, a group of stakeholders from several BioPhorum members came together to define a program of work for BioPhorum’s newest collaboration, MedTech. Since then, MedTech has welcomed nine members and more than 40 leading subject matter experts (SMEs) to work together to address operational challenges associated with combination product development and commercialization.
In that time, the SMEs have shared insight and experience, and benchmarked current industry practices with the aim of developing consensus approaches to the application of Essential Performance Requirements (EPRs) for devices and the implementation of EU Medical Devices Regulation Article 117.
“Combination products are a rapidly growing sector within the pharmaceutical space as the industry looks to find new and convenient ways to improve the user experience when delivering our therapies. In this evolving environment, BioPhorum Medtech has allowed us to directly collaborate with our peers across the industry to jointly discuss and implement best practices with the ultimate goal of enabling industry to advance better products to our patients,” said Bryan Bobo, Manager, Combination Products, Regeneron.
With both workstreams well on their way to delivering their objectives, the next phase of the phorum’s development begins.
The MedTech Leadership team has evaluated new topics for inclusion in the MedTech program and we are delighted to announce that the following activities will begin in Q4:
- Post Launch Change Requirements Workstream – this team will investigate how variations in regional regulatory requirements impact on the management of post launch changes.
- Human Factors Pathfinder – this team will explore opportunities for knowledge and best practice sharing across a range of topics related to human factor studies.
- Digital Pathfinder – this team will explore opportunities for knowledge exchange and benchmarking focusing initially on two topics
- Demonstrating the effectiveness/ value of the digital solution
- Managing the impact of different regulatory requirements on URS, DIR, design verification/ validation plans
With a clear focus on regulatory compliance, drug-device co-development, device design, digital healthcare and supply chain, BioPhorum MedTech provides a platform for licence holders and suppliers to share real-world challenges in a safe, open, and collaborative setting.
Sriman Banerjee, Head of Packaging Development & CDE, Takeda explained, “BioPhorum MedTech addresses the combination product space which includes drug product and devices. The workstreams allow peer companies to align and discover solutions to challenges facing the sector including human factor studies, digital approaches as well as to build best practices through creating papers on subjects like EU MDR.”
By working with our members to develop industry consensus views and robust solutions to operational challenges, we aim to help the industry meet its goal to provide these important products to patients worldwide.
If you are responsible for combination product development, device design, human factors engineering, quality and regulatory please contact email@example.com.