Regulation and innovation are not opponents in healthcare

woman in hospital bed

Written by Dr Tom Oakley, CEO, Feedback Medical

As a Radiologist I have always been acutely aware of the importance of medical imaging to patient care. Almost every patient coming into hospital will have a medical imaging study of one sort or another, an X-ray, an ultrasound or a CT scan. Imaging now underpins almost all clinical decision making processes and it makes sense, as ultimately we want to see what is going on inside a patient without having to cut them open – which I think we can all agree is a good thing.

Traditionally imaging has been used by Radiologists to assist frontline clinicians but increasingly frontline clinicians are using imaging directly, as part of their daily work. This is especially true in the emergency and surgical settings where imaging is used to quickly see what is going on and to plan a procedure. Frontline clinicians aren’t Radiologists, they have different needs from their medical imaging and more often than not they aren’t sat at a desktop terminal when they want to access it. Instead these frontline clinicians want to be able to access imaging flexibly, on the go and on their own devices.

Getting imaging into the hands of a senior clinical decision maker not only saves time but it also improves patient care because better decisions are made faster. Surely then, enabling clinicians to see imaging on their own devices and outside of the hospital setting is a good thing for patients? Of course, there is no point giving clinicians access to imaging if the imaging is not of sufficient quality for them to be able to make informed decisions, if the quality isn’t good enough it will hinder the diagnostic process and could put patients at risk.

This is where regulation comes in. The Medical Device Directive outlines the standards that medical devices must conform to and it is very clear, any product that displays digital patient images for the purpose of diagnosis is considered to be a medical device. It is fundamental that manufacturers produce and maintain products of sufficient quality that they can consistently deliver the standard of performance that is required by the end user. This has never been more true than in the space of medical imaging devices.

There is a common misconception that just because something is digital, that it is not a medical device. This is incorrect. There is also a view that digital products should be allowed to move quickly to market, often bypassing ‘unnecessary’ regulation which is often viewed as putting barriers in the way of innovation. This is dangerous. 

Ultimately the driver of all innovation in healthcare should be to improve patient care and the daily working lives of the caregivers. Sadly putting unregulated technology into the hands of clinicians puts both groups at risk. If a product should be a medical device but isn’t appropriately certified, then the clinician that uses it takes on liability for any harm that arises from that use of the product. It’s not the company that produces the product but the clinician that uses it and their employing Trust that are liable.

Bleepa is the medical device that my company, Feedback Medical, delivers to enable clinicians to collaborate on cases and review medical imaging flexibly on the go using any internet connected device. It is the only UK communication platform to combine instant messaging with clinical quality medical imaging to be appropriately certified as a medical device. There are a number of communication tools available that claim to share medical imaging but none are appropriately regulated and they are putting Trusts, clinicians and most importantly patients at risk. 

Digital innovation is transformative, fundamentally necessary and happening at an incredible rate but it must be done safely, especially where the stakes are so high, such as in healthcare. I am here to champion responsible, regulated innovation and to ensure that we set the standard for the digital innovation that we want to see and that our clinicians want to use. Regulation and innovation are not opponents, they can co-exist. We took Bleepa from a concept to fully certified medical device in less than a year. We are proof that you can still innovate at pace whilst complying with safety and quality standards.

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