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New Technology

Chair: Dr Bruno Rosen

The New Technology Expert Group consider discovery, development, regulatory processes and vigilance processes across these areas. External therapeutic devices (eg mechanical ventilators), implantable devices, in vitro diagnostics (in particular we are interested in novel molecular diagnostics and companion diagnostics), wearable technologies and digital therapeutics (eg Apps to support behavioural interventions).

There is some overlap with eHealth, but we do not regard this as within our remit per se.

The group also considers the impact that innovation in these areas has on ‘traditional medicines’.

Meet some of our members

Dr Eddie Guzdar

Dr Rob Hastings

Dr Bob Holland

Prof Andrew Krentz

Prof David Neal

Dr Bruno Rosen

Some of the Group's Outputs

Consultation on the future regulation of medical devices in the United Kingdom: MHRA

Date: submitted November 2021

The New Technology expert group led the drafting of the response to the MHRA’s consultation on the future regulation of medical devices in the United Kingdom. This proposed possible changes to the regulatory framework for medical devices in the UK and was very large in scale with over 70 questions. The MHRA received over 891 responses by the time the consultation exercise concluded including from 263 healthcare professionals and 56 healthcare institutions.

Blog: A Mad Hatter’s Tea Party? (with apologies to Lewis Carroll)

Published: January 2022

A Mad Hatter’s Tea Party (with apologies to Lewis Carroll) (1)

After the large consultation response was submitted having been spearheded by the New Technology expert group, chair Bob Holland wrote a compelling blog which summarised the consultation and FPM’s response whilst offering insight into the broader regulatory landscape and the significance of the proposed changes. All with a reference to Lewis Carroll’s Alice in Wonderland!

Read Bob’s piece.

Call for evidence – Equity in medical devices: independent review

Date: Submitted October 2022

The Department for Health and Social Care recently conducted a call for evidence as a part of the independent review which will advise the government on the health impact of potential ethnic and other biases in medical devices and make recommendations for more equitable solutions. FPM’s New Technology expert group worked with staff and a nominated member of FPM’s EDI Forum to draft and submit a response, deploying the expertise of FPM’s members for the benefit of the public.

FPM Conversation: In Vitro Diagnostics – Companions or Not?

Date: July 2021

Conversation IVDs

This meeting discussed and debated the rapidly evolving IVDs landscape. The session included pre-session special guests from FPM’s New Technology expert group Bob Holland, Rob Hastings, Bruno Rosen and Tim Higenbottam who participated.

There is increasing adoption of biomarkers and diagnostics/companion-diagnostics in clinical trials and clinical practice, leading to an ever-rising collaboration within and between pharmaceutical companies and in vitro diagnostic medical device manufacturers.

It is important that pharmaceutical physicians and scientists, across a variety of different roles, have an understanding of how the IVD regulatory landscape is continuing to rapidly change and, critically, how Pharmaceutical Companies are adapting by developing new strategies to ensure effective collaborations in the IVDs arena.

This FPM Conversation aimed to enhance attendees’ awareness of the major elements of relevant IVD regulation(s) and provide expert perspective on important strategic and practical aspects of developing and implementing IVDs in support of patients.

Find out more about the conversation in this blog.

How to get involved

If you have any suggestions or would like to get involved with an FPM expert group, please let us know

Email fpm@fpm.org.uk