InnoScot Health regulatory specialist believes new regulatory pathway’s support for innovators could be ‘huge step forward’

Fresh support for innovators from a new regulatory pathway that is set to be launched later this year could be a ‘huge step forward,’ according to a specialist. 

The Medicines and Healthcare products Regulatory Agency (MHRA) is preparing to unveil the Innovative Devices Access Pathway (IDAP), a framework for innovators and manufacturers intended to generate the evidence needed to achieve regulatory approval for their technologies and solutions. 

IDAP will be operated by MHRA, the National Institute for Health and Care Excellence (NICE), Health Technology Wales (HTW) and Scottish Health Technology Group (SHTG). 

Elaine Gemmell, Head of Regulatory Affairs at InnoScot Health, said: “These plans for the provision of a multi-partner support service for developers represent an exciting development. 

“Of course, any initiative that takes uncertainty out of the route to making products widely available, provides targeted scientific advice that brings new products to patients sooner, and ultimately fosters innovation that can transform health outcomes, is to be welcomed. 

“It’s encouraging then that IDAP already appears to be a well-structured, unified approach to achieving those aims. 

“Successfully supporting innovators in their regulatory ambitions and health technology assessment decisions, enhancing engagement, and opening up patient access – previously difficult to achieve – really would be a huge step forward.” 

MHRA said that, once IDAP is up and running, partners will use lessons learned from a pilot to develop the pathway, in turn helping to establish the UK as “a centre for medical innovation.” 

The agency plans to create “an end-to-end visible framework” that will “demonstrate how the UK regulator, health technology assessment and the healthcare system are working together to deliver safe, effective, and earlier innovative medical products to patients.” 

Elaine continued: “At a time when innovation is needed to meet healthcare challenges, IDAP’s introduction could be a very important step in accelerating and adopting new technologies and solutions. 

“Certainly, targeted scientific advice has been available previously for pharma and is a very useful tool if successfully integrated into this new regulatory pathway, while inclusion of the devolved administrations would be great to see.” 

InnoScot Health continues to closely monitor developments in medical device regulation, ensuring awareness and compliance with legal responsibilities, and supporting the design and development of products under an accredited regulatory framework. 

As a formal partner of NHS Scotland, InnoScot Health believes it has a unique role to play in encouraging and developing new ideas from its staff. 

Expert advice and support is available from the team via the website or online consultation. Visit www.innoscot.com