BioPhorum MedTech is a new Phorum which will address the unique challenges faced in combination product development and manufacture.

With a clear focus on regulatory compliance, drug-device co-development, device design, digital healthcare and supply chain, BioPhorum MedTech provides a platform for companies to share real-world challenges and experiences in a safe, open and collaborative setting.

Through conceiving and creating industry white papers and best practice guides, our members seek to create efficiencies, reduce risk and accelerate change. By engaging with industry stakeholders, we aim to influence the direction of the industry, ultimately leading to harmonized expectations and industry standards.

The Phorum’s program has been developed by BioPhorum members who came together to identify common problems and assess opportunities to reduce the risk and cost of combination product development and control, improve compliance, and to improve patient accessibility to these increasingly important products.

Two workstreams are currently addressing the following high priority topics:

  • Essential Performance Requirements (EPRs) for device specification setting – the objective for this workstream is to develop a standardized approach for the interpretation and application of EPRs during development and manufacture
  • EU MDR Article 117 implementation – the objective for this workstream is to develop an industry consensus approach for incorporating article 117 into device development processes.

In addition, the following activities are planned to start in Q4:

  • Post Launch Change workstream – this new workstream will focus on best practice approaches for managing variations in regional change requirements on post launch changes
  • Human Factors pathfinder – this new team will facilitate knowledge exchange and explore opportunities for best practice approaches across a range of topics including regulatory guidance implementation, study design & participant training
  • Digital pathfinder – this new team will investigate opportunities for collaboration in two topic areas initially;
  • Demonstrating the value of the digital solution
  • Managing the impact of different regulatory requirements on URS, DIR, design verification/ validation plans

Would you like to benefit from being part of BioPhorum MedTech? Would you like to learn about technology and regulatory solutions and take those ideas back to benefit your company? Would you like to share your experience in combination products with your industry peers?

For more information and to become a member of BioPhorum MedTech, please contact heather.tomlinson@biophorum.com

Learn how our Regulatory Interaction Team are already engaging with and collaborating with the regulators