AI takes healthcare by storm

The whitepaper entitled ‘Smart Code, Safe Care: Navigating AI Acceleration in Regulated Medical Devices’ supports businesses launching or wishing to maintain software or AI-powered devices in key markets such as the UK, US and EU.

Ruaidhrí Primrose, director at Firefinch | Supplied

Whether it’s university spinouts with an innovative algorithm that could improve the lives of patients directly, or established corporates integrating a new AI component into an existing physical device, there are a variety of key considerations to ensure that each solution can enter and remain in its target market whilst maintaining regulatory adherence.

IMed Group and Firefinch have combined their expertise to help businesses of all sizes understand the ever changing technical and regulatory environment. Navigating international regulatory variations is a key component of project success, whilst each regulator prioritises patient safety in their region, guidance and documentation requirements may not be consistent.

As the compliance map keeps evolving, digital medical device manufacturers must adapt by integrating new skills and processes into their team. This environment places unprecedented demand on organisations developing digital medical devices.

Teams must develop or acquire new cross-disciplinary skills that bridge software engineering, product development, clinical risk management, cybersecurity, data science, and regulatory compliance. They must integrate ethical data management systems, implement robust AI governance, navigate ISO requirements, validate systems that behave probabilistically, and adapt to shifting regulatory norms across different geographies.

This newly developed white paper delves into how different digital components relate to a medical device’s functionality and classification. IMed’s regulatory experts also offer an overview of how the UK, the US and Europe regulate Software as a Medical Device (SaMD) and AI-powered medical technology, highlighting consistencies and differences.

Jonathan Ripley, managing director at IMed Group | Supplied

Jonathan Ripley, managing director at IMed Group, said: “We’re continuing to provide our insights to the market in the form of expert commentary and guidance as we understand that lack of clarity is one of the key obstacles SaMD and AI device businesses face today.

“We’re delighted to have been able to combine the knowledge of life sciences software development teams at Firefinch Software with that of our regulatory specialist to support both established businesses and startups navigate this exciting new phase.”

Ruaidhrí Primrose, director at Firefinch, commented: “The digital medical device market is quite literally learning on the job. We're seeing an increase in partnerships between internal medical device developers and external teams who are equipped to navigate the nuanced regulatory landscape concerning the use of AI and its medical device applications.

“Teams like ours are the link that can translate innovative scientific workflows into sophisticated, functional software. Our feedback suggests these blended teams often provide clients with the confidence their project adheres to regulatory requirements and avoids costly rework whilst crucially protecting patient safety and privacy at all times.”

You can read the white paper here: Smart Code, Safe Care: Navigating AI Acceleration in Regulated Medical Devices