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'You can only make social impact if it makes the world a better place'

Written by Brainport Eindhoven

Written by Brainport Eindhoven

Interview with Tom Sanders founder of the Early Warning Scan


Tell us about the Early Warning Scan for breast cancer?

My name is Tom Sanders and I am the creator of the Early Warning Scan. This system is a radically different approach to screening than the regular population screening for breast cancer. It is a painless and woman-friendly approach that suits every age group. Moreover, the technique is price-effective for large-scale population screening.

It works by detecting abnormalities by monitoring the movement of the breast. Because a tumour is always harder than the surrounding breast tissue, it exerts a pulling force internally. This causes a deformation on the outside of the breast.

We measure this with an advanced 3D scanner that accurately records the movements of the skin. Inside the scanner are 52 small cameras and 48 projectors. The latter project a fine pattern onto the breast and the cameras capture this pattern from different angles. From this, the computer compiles an accurate 3D image of the movement. An advanced AI system determines whether the movement is normal, or if there is any suspicious distortion.

Besides analysing movements, the measurement data are also used to analyse height differences in the skin. These height differences are mapped very precisely. If height differences are visible in one breast that are not present in the other, this is also an indication for further investigation. By checking annually, we can monitor the development of the breasts for life.

How did the idea come about? 

In early 2019, my wife was diagnosed with breast cancer. Something immediately struck me: she had already had five mammograms since she was 50. Nothing ever showed up on those. At 60, she discovered her breast cancer herself. At some point, she started getting small pain signals and she discovered a hardening in her breast. Her attending physician estimated that it had been there for at least five years. I was amazed; how could they have missed this? 

Mammography can do a lot, but overlooks some cancers. If you have an abnormal growth shape, for example. Breast cancer is not always a lump. It is also sometimes a branching structure growing in the mammary glands. Such a structure is invisible to mammography. Also, the technique is unsuitable for young women because the breast tissue contains too much glandular, muscular and connective tissue. Mammography is usable only when the structure of the breast changes during menopause.

“Mammography can do a lot, but overlooks some cancers.”

I specialise in 3D photography and the idea of the Early Warning Scan came to me one night. I thought there had to be a combination of techniques that could detect breast cancer in a different way. In my wife's case, the irregularity in the breast tissue was not immediately visible but could be felt. But with movement, you could see the abnormality. So I focused my approach on that: considering techniques that are used in material research from the industry. I didn't sleep much that night.

I presented my idea to my wife's surgeon and she was immediately enthusiastic. Surgeons are the best to know what is needed; they see women facing this disease. Young women are particularly badly affected. A young body has more life energy and the cell division rate is much higher. If something goes wrong there, it goes faster than in older patients.

Of course, breast cancer is less common in women under the age of 50 but as early as 25, you see an incipient rise in the number of cases. Between 40 and 50, the number increases alarmingly. That's exactly the group you miss with current screening because mammography doesn't work well then.

To continue with the development of the Early Warning Scan, a lot of money is needed. Therefore, after my wife recovered from her severe treatment, she set up the YvYa foundation. This foundation supports the development by applying for funding and acquiring donations and sponsorships. The YvYa also continuously seeks attention for the new technology needed. The efforts of the foundation -which, incidentally, consists only of women- ensured that we could build the first prototype in 2021.

That was also when we found out that commercialising a technique in the field of health, has many snags. You can't just say you want to do cancer research. In the Netherlands, there is a difference between healthcare and public health. Healthcare deals with clinical matters and insured care; if you are sick you go to the hospital or you take medicine. Public health is constitutionally the exclusive domain of the government. Breast cancer screening is therefore regulated and arranged by the government. As an entrepreneur, you need a special licence to deploy your technology and then only under government direction. 

To really make an impact on cancer, you need to look for improved screening and detection. At the same time, there are so many restrictions attached to that, that the pathway has many uncertainties as a result. That is why it is difficult to find investors who go along with this. They prefer to focus on mainstream healthcare where they can get returns within a manageable timeframe.

It is frustrating that millions are spent on cancer drug research but not on early detection.  Through the commitment of the YvYa Foundation, we were able to start laboratory tests. That is why we have now been able to apply for a grant of 300,000 euros to conduct the first clinical trial. By the end of 2023, we will hear whether that will go ahead. Many non-profit partner organisations are now contributing to the development, but a lot of money is still needed. In addition to the requested grant, another 200,000 euros are needed to complete that first clinical trial properly.

It is frustrating that millions are spent on cancer drug research but not on early detection.


Where are you now with development? 

Right now, we are expanding the functionality with hyperspectrum imaging. Whereas before we mainly looked at the shape, we are now able to include colour as well. Various breast cancer symptoms are accompanied by discolouration, which we also want to be able to detect. We want to be ready by the end of this year.

In December 2023 we will hear whether our grant application for the clinical trial will be approved. If that funding goes through, we will start in April 2024. The research will take two years. Then we will have a proof-of-concept in a real-life situation. That is a very important milestone because it will give us the first scientific proof of the efficiency of our technique.

What do you need to take the next step with the company? 

As with any medtech startup, funding is an issue. Scientific research requires a lot of money and the return on investment is far into the future. With our innovation, we are not an economically attractive project. It is forbidden by law to create shareholder value with breast cancer screening. Therefore, the Early Warning Scan cannot be financed in a normal way, despite the potentially huge social impact this technology has. 

The first thing investors look at is whether the idea is economically interesting, i.e. whether it can make money. Brainport also has an economic angle. Organisations are quick to say 'we want to make impact'.  But no one dares to say out loud that social impact and return are contradictory. The return counts, and the impact is nice. If you want to make impact in healthcare, your starting point should be fewer sick people. That is contradictory to profitability thinking, because sick people are precisely what make good money. This is not the case with our innovation.  Research subsidies could be more flexible, simple, transparent and quicker.  Moreover, laws and regulations are very complex and our government is pushing for market forces. There should be new financing structures that support projects like ours; where the (health) profits go to society, but the costs lie with the entrepreneur.

Where do you want to be in five years? 

Then we will be working on a large-scale clinical trial to further scientifically substantiate efficacy. Think of a test involving many thousands of women. After all, a proof-of-concept is not yet proof that your system also works well for large groups. With the results of this test, we can complete the CE certification process. This is followed by the process of obtaining the mandatory licence to use the Early Warning Scan for population screening. Several independent researchers and regulators must test whether the results are sufficient to expose all Dutch women to our technique. Once we all pass that, the government will look into it. That is what the RIVM and the Health Council are doing. They will investigate the public health benefits of using our technique and whether the costs are justified. Only if they advise positively will the minister grant a licence.

How can the Brainport ecosystem help you achieve the goals? 

We benefit a lot from publicity. The ecosystem of the Brainport region helps us a lot. Lots of people and companies wanting to help get the Early Warning Scan onto the market. Just not structurally. 

One solution for funding could be the Social Impact Bond. This is a financing instrument where private money is used to solve social issues. This construction is hardly used yet and is perfect to support initiatives with social impact but no return. In fact, it is a three-party agreement between entrepreneur, investor and government. Thanks to the investor, the innovation becomes possible. But because the profits go to society, the government pays back the investor's investment with pre-agreed returns upon proven results. The advantage of this construction is that the government guarantees a return on proven results, making investors more likely to make an investment. If all goes well, the investor gets his money back with a return. If things go wrong, the investor only misses out on his return. This construction can change things at a fundamental level. The Brainport region should actually have a professional club of people working to bring initiatives with high social impact, but without traditional returns, to fruition.

Precisely a flourishing region like Brainport can contribute to innovations that have an enormous impact on people's well-being. And it fits very well with what the government wants: a government that collaborates with knowledge institutions, industry and end users.


What question do you have for other pioneers within Medtech? 

Healthcare mainly attracts commercial parties. We want to do something with cancer screening so we fall under public health, which is not a free market. Most companies don't understand what we are up against. I would like to challenge my fellow pioneers to consider what they can do with themes within public health. This might make them look at public health with a different perspective. Within public health, other parties are involved. An advisory body with contacts at the government, the Health Council and the RIVM could coach fellow pioneers. It's a closed world and you need people who know their way around at policy level.

Economic return is nice for a few. You only make social impact when the world benefits.


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