MedTech

Overview

BioPhorum MedTech focuses on addressing operational challenges associated with drug device combination product development.

Formed in 2021, the group brings together senior business leaders and subject matter experts across multiple disciplines including combination product and packaging development, device engineering, regulatory and quality to work on issues such as regulatory compliance, drug-device co-development, device design, digital healthcare and supply chain.

MedTech provides a safe space for companies to build their expertize through networking and sharing real-world experiences and case studies. Working together, we seek to identify, articulate and implement best practice approaches to reduce the risk and cost of drug device combination product development and control, improve compliance, and to improve patient accessibility to these increasingly important products. By working with external partners and industry stakeholders, we aim to influence the direction of the industry by creating harmonized expectations and industry standards.

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 program is developed by our members who work together to identify priority topics for collaboration. Four workstreams are currently addressing the following priorities:

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.
  • Post Launch Change Requirements – this workstream will focus on best practice approaches for managing variations in regional change requirements on post launch changes.
  • Human Factors –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 and participant training.

In addition, we have recently launched a pathfinder team to explore the emerging space of digital/ connected combination products. Initially the team will investigate two topic areas:

  • Demonstrating the value of the digital solution
  • Managing the impact of different regulatory requirements on URS, DIR, design verification/ validation plans
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BioPhorum MedTech

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

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