Navigating EU medical device regulation, with Koios Medical

In our latest blog, I’m joined by Chad McClennan, president and CEO (that’s Chief Executive Owl) of Koios Medical, a US start-up founded in 2012 that uses AI to help detect and interpret ultrasound images.

Koios DS (Decision Support) Breast is the only FDA-cleared cancer diagnosis software using AI on breast ultrasound images, and earlier this year also achieved Conformité Européene (CE) Mark approval for use in Europe. Koios soon hope to extend their software to other use cases, including thyroid, lung, prostate, and even skin cancer.

At Hardian Health, we’ve been working hard with Koios Medical to help Chad and the team navigate the minefield that is EU medical device regulation, and gain a footing here in Europe. It was to our great pleasure that Koios DS Breast was issued the CE Mark in March of this year, and we look forward to the seeing the exciting developments the team at Koios have in the pipeline.Chad and I got together to reflect on Koios Medical’s journey with Hardian Health to-date, the challenges involved in scaling digital health solutions across continents, and the importance of tackling medical regulations early.

It was a chance encounter at the Radiological Society of North America (RSNA) conference in late 2018 when Chad and I first crossed paths. Koios Medical had recently secured 510(k) clearance from the US-FDA for the Koios DS Breast tool, and was looking to expand into other markets, to tackle the very real problem of breast cancer elsewhere in the world. In the US alone, 350 breast cancer cases per day evade early detection due to misdiagnosis, whilst conversely, up to 80% of the lesions that are biopsied return as benign*. For Chad, his appetite for growth and definition of success wasn’t measured by impressive funding rounds or high-profile board appointments. On the contrary, Chad and the team at Koios Medical were passionate about addressing this significant clinical challenge by partnering with subject matter experts, such as Hardian Health, who knew how to get the job done.

Don’t go it alone

With a background in consultancy, Chad is all too aware of the importance of outside help and deep expertise, which has underpinned the partnership between Koios Medical and Hardian Health. Though it may be tempting to attempt to tackle medical regulations in-house, this exercise in expediency may prove expensive in the long run. Indeed, Chad warns, the costs due to delays and stumbling blocks in the regulatory process may far exceed the cost of enlisting an outside agency to help avoid those stumbling blocks in the first place! Moreover, digital health companies often view their product through the eyes of end-users, whose focus and priorities are vastly different from that of the regulators, and therefore companies may be well-served to seek the input of experts with their ears close to the ground.  On this point, I couldn’t agree more.  My team at Hardian Health and I caution clients against kicking the regulatory football into the long grass, as not meeting regulatory standards is often a significant bottleneck hindering start-ups from going to market. Focussing on regulations at an early stage also allows the internal processes, structures, and knowledge-base to bed-in, such that jumping through the regulatory hoops with each version or iteration of a product becomes evermore straightforward.

Koios DS (Decision Support) Breast is the only FDA-cleared cancer diagnosis software using AI on breast ultrasound images

Different health infrastructures = different challenges

Although Koios Medical’s experience in securing 510(k) clearance in the US certainly helped them traverse some of the layers of complexity here in Europe, the fact remains that converting from an FDA clearance to obtaining a CE Mark is far from a simple form-filling exercise. Chad describes bringing Koios DS Breast to Europe as almost a completely different paradigm, pointing again to the value of local expertise. At Hardian Health, we help clients navigate the quagmire that is bringing a product to market, providing world-class expertise on scientific validity, regulations, health economics, and procurement. Some of the challenges in scaling a product across geographies are a function of differences in health system infrastructure; the ‘fee-for-service’ system across the Atlantic, for example, meant that radiologists were pushing for financial incentives to drive adoption, which is less relevant in the context of the NHS. Others were more technical. The Koios DS Breast tool uses the BI-RADS categorisation for breast lesions developed by the American College of Radiology (ACR), whilst nations elsewhere in Europe use their own risk stratification tools. Both Chad and I are all too aware of the importance of following local guidelines and enlisting the help of local physicians, to ensure products such as Koios DS Breast can safely and effectively be used in a manner that is context-specific. To this point, Hardian Health is clinician-led – unlike other regulatory consultancies – allowing consultant (attending) level expertise to be obtained at short notice.

Changing perceptions 

Clinicians have long been apprehensive about the use of AI in healthcare, citing concerns over their accuracy and perceived encroachment into patient care. Chad is quick to point out that tools such as Koios DS Breast are complementary technologies, designed to supplement and not substitute clinical expertise. Changing perceptions towards AI and driving adoption must be achieved by building a substantial body of evidence and data demonstrating the potential for AI to greatly improve patient care. Chad envisions a future in which AI-based decision-support tools become routinely integrated within clinical care, the norm rather than the exception. After all, he adds, second opinions are common in medicine, so why not strive for the equivalent of three hundred second opinions all reviewing an ultrasound image, with levels of agreement more than is humanly possible?

Hardian Health is clinical digital consultancy focussed on leveraging technology into healthcare markets through clinical strategy, scientific validation, regulation, health economics and intellectual property.