Drug device combination products are an increasingly important part of drug life-cycle management. Allied Market Research estimates that the sector will be worth $139bn by 2025, with growth driven by a rise in chronic diseases and increased focus on home-based healthcare. This is an innovative sector with increasingly complex devices being used to deliver drugs – yet there are no harmonized international standards to guide development. Organizations must therefore interpret the specific combination product regulations in each country.

The lack of a standard approach results in complex regulatory documentation requirements and increased cost and time to get products to market.

Yet, with these challenges come many opportunities, which is why we are excited to announce the launch of BioPhorum MedTech, which will primarily focus on combination product development and manufacturing.

Would you like to be involved? Would you like to share your experience in combination products with others? Would you like to learn about technology and regulatory solutions and take those ideas back to your company?

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

“Collaborative activities through BioPhorum MedTech will enable us to develop a robust product design framework and accelerate clinical developments of combination products, which will contribute to patient-friendly products with fewer development risks and smoother regulatory filings,” said Noriyuki Kobayashi, Senior Scientist – Formulation Development, Bioprocess R&D Labs at Kyowa Kirin Co., Ltd.

BioPhorum MedTech benefits

BioPhorum MedTech offers companies the opportunity to learn and develop collaboratively. It is a platform to build relationships with peers who can share their worldwide and industry-wide perspectives. It is also a channel to engage and influence industry stakeholders through collaboration. This will lead to harmonized expectations, guidance documents and, ultimately, global industry standards.

By creating industry consensus and robust solutions, companies will see improved regulatory compliance, simplified device control strategies, better alignment of the device-drug development processes and a greater realization of the value of connected devices.

Exciting work program

The Phorum’s scope will be driven by member company interests. It will initially focus on biological drug delivery systems such as pre-filled syringes, pen injectors and autoinjectors. However, there is also the potential to look at other drug delivery technologies, such as ambulatory on-body infusion pumps, drug-eluting stents and inhalation technologies.

A stakeholder team of eight BioPhorum members has identified 27 individual problem statements, representing a pipeline of opportunities to reduce the risk and cost of combination product development and control, and improve compliance – ultimately improving patient access to these increasingly important products.

Two topics have been prioritized for immediate workstream activity:

• Essential Performance Requirements (EPRs) for device specification setting – to develop a standardized approach for the interpretation and application of EPRs during development and manufacture

• EU Medical Devices Regulation Article 117 implementation – to develop an industry consensus approach for incorporating Article 117 into device development processes.

Also, the following topics present opportunities for workstream activity during 2021 (subject to member interests):

• Best practice in human-factor studies
• Demonstrating the value of the digital solution
• Best practice in the design and development of simple, co-packaged combination products
• Digital healthcare and the ‘software as a medical device’ classification
• A best practice approach for post-launch changes
• Shipping validation requirements for biologics license application submissions.

In a constantly evolving technological and regulatory landscape, and with an exciting work program, BioPhorum MedTech gives you an excellent opportunity to influence the future of medical technology.

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