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 have been mobilized to focus on 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 to these topics, the team identified others which represent opportunities for further workstream activity during 2021, subject to members’ interests:
- Best practice in human factor studies
- Best practice in design and development of simple, co-packaged combination products
- Best practice approach for post launch changes
- Demonstrating the value of the digital solution
- Digital healthcare and Software as Medical Device (SaMD) classification
- Shipping validation requirements for BLA submissions (device performance)
The Phorum will also evaluate a number of pathfinder topics during early 2021.