A new way to navigate the regulatory maze of medical technology

How do you prefer to face a challenge? Fly solo or work with a team of like-minded experts?

The MedTech Phorum is a new collaboration for professionals in medical technology companies. It will allow members to discuss their challenges and the industry responses needed to deliver technical innovation in a highly regulated environment.

If you want to ensure your company has a voice in shaping industry practices and standards, then join your peers at one of our two launch events:

  • North American launch – 30 October 2019 – Westin O’Hare Hotel, Chicago
  • European launch – 5 November 2019 – Steinberger Airport Hotel, Frankfurt, Germany

 The agenda for these events can be downloaded here and you can register for either one here.

 

The events will focus on the evolving regulatory landscape and aim to attract leaders in Quality and Regulatory Affairs. Delegates will be able to hear insights from BioPhorum’s medical technology industry survey and can help shape the future work program of the Phorum through a wholly collaborative approach.

An industry voice

The MedTech Phorum is a global collaboration. It will have a single voice to promote an agreed industry position, which is important when regulators often hear different opinions from different sources.

It will help members develop and implement harmonized processes that comply with the key regulatory requirements in the major markets of the US, Europe and Asia.

The Phorum has already started its collaboration and has written a positioning paper on why this is a critical time for the industry to start working together. It has also created a private LinkedIn BioPhorum MedTech Group where members can discuss shared challenges and proposed solutions.

You can also learn how BioPhorum’s Regulatory Interaction Team is already engaging with regulators. The team consists of around 40 representatives from 30 biopharmaceutical manufacturers and supply partners and provides a platform for dialogue with agencies before a product’s implementation.

Industry challenges

Medical technology is a global business that brings huge benefits to patients. But it also has some serious challenges. These include a divergent regulatory and standards landscape with different requirements depending on the product and the host country, and pending changes to regulations, particularly in Europe.

Medical technology is also developing rapidly, particularly in digital healthcare and ‘smart’ devices. It attracts the largest number of applications to the European Patent Office of any technical field – more than pharmaceuticals and biotechnology combined. This pace of change significantly outstrips the rate at which regulatory guidance is amended.

The market is also enormously diverse with products ranging from a simple toothbrush to an MRI scanner. This means that different companies can have different levels of technological maturity.

Faced with these challenges, can the medical technology industry afford not to collaborate?

For more information on the MedTech Phorum and how your company can get involved, please email tara@biophorum.com or richardsn@biophorum.com, or contact the team via medtech@biophorum.com or https://www.biophorum.com/phorum/medtech/overview/

Contact address

BioPhorum
The Gridiron Building
One Pancras Square
London
N1C 4AG

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