Features

How a MedTech SME is using IP to drive change in treatment delivery

09 October 2020

4iP interviews Alexandre Tsoukalis CEO, Managing Director and co-founder, Micrel Medical Devices

Micrel is an innovative MedTech SME, headquartered in Athens, Greece. It develops smart drug delivery systems for hospitals and home care for treating specific illnesses such as Parkinson’s disease and cancer and for managing pain control and intravenous nutrition. Micrel broke into the international marketplace by developing solutions that are more user friendly than competitors’, enabling patients to follow their treatment at home with doctors monitoring and refining treatment over the Internet. 4iP Council spoke to Alexandre Tsoukalis Micrel’s CEO, Managing Director and co-founder, about the company’s evolution.

Alexandre Tsoukalis CEO, Managing Director and co-founder, Micrel Medical Devices

What motivated you to found Micrel in 1980?

The pumps for the blood disorder, thalassemia, available in Greece in the ‘80s had a lot of service issues and customers were complaining about their quality. We designed and produced a syringe pump for treating the illness, based on delivering infusions of the drug Desferal, that proved to be extremely reliable. Customers were delighted with our offering which was also smaller and lighter than competitor systems. Its rechargeable battery gave mobility and with it freedom to home users, many of whom were children.

What were your biggest challenges in the start-up phase?

The small size of our internal market was a limitation. Europe was closed to SMEs due to country per country product registration approvals. In France, we applied for homologation (judicial authority to trade) 16 times then we abandoned: the process usually requires just one application. In Germany, a big registration company for the GS certification mark told us our design was not a problem but trusting a Greek company was. As a consequence, we turned our attention to laboratory equipment and designed a spectrophotometer from scratch for 125 new Greek health centres tender which we won. This enabled us to finance our Rythmic™ pump project. There were no venture capitalists in Greece at that time and the banks did not lend money easily.

How would you describe your standing to date as a MedTech innovator?

Micropumps and actual Rythmic™ pumps use fairly standard technology in their basic design so we put considerable effort into innovating for user friendliness and reliability. Our customers are chronic patients who use the pump every day and they appreciate small impactful changes. This is why we do not focus on cost but on being the best in the market. MicrelCare™ was the first telemedicine patent application worldwide in 2001 using cellular networks. It has received thousands of citations since then and when it was introduced in 2006 it substantially increased the competitiveness of Rythmic™ pumps.

Since 2011, we have been filing more patent applications for innovations. Some of these are already available in our pumps such as a therapy feedback functionality which works via questions answered on the pump. This allows the pump to deliver a VAS score, which is a subjective measure for acute and chronic pain. Other innovations include statistical based alarms - a first in industry (two patent families) and downstream pressure monitoring that enables the system to detect implanted catheter obstructions before a surgery is mandatory (one patent family).



What challenges do you face as an SME competing against large established corporates and how do you overcome them?

Big multinationals have a larger marketing and sales network advantage, but when we persuaded a customer to take a trial, statistically, we win because most of our innovations cannot be explained in a brochure or website; you have to use our product to understand the difference. Everybody says on paper that they have good infusion but when you test our pump for a week you can appreciate what better infusion and its management really means.

Some of your devices use cellular connectivity modules and home care systems reliant on internet communications. Has the evolution and use of telecoms infrastructure hindered the applicability of your innovations and what impact will 5G have on their future workability and adoption?

MicrelCare™ currently uses 3-4G and as soon as modules on 5G are available we can adapt the communication. At present, MicrelCare is not sold as a life support system but rather as a therapy assistant. This is because of network reliability: we can’t be certain that messages will actually be transferred in due time. 5G with zero latency and assured communications can allow MicrelCare™ to be used for life support and enable new features to be added such as remote programming. However, this also adds to regulatory documentation and complexity.



Much of Micrel’s innovation extends beyond infusion pumps. For example, you have a patent in RFID and barcode labelling designed to help prevent drug administration errors. Where do such ideas originate?

I read two patent applications from a big competitor and did not like the solutions they gave but I understood the problem. Our driver for the future is our belief that drugs and pumps must be designed each for the other, as a drug-device combination. We have four patent families all registered with the EPO and the US patent office, and aimed at protecting our completely feasible and easy to implement solutions. These cover all possible implementations and give us exclusivity on what we intend to do: our solution is 100% safe from medication errors, offering infusions with the highest possible ease of use. These fillings allow us to stop competitors.

Micrel Medical Devices today is an ambulatory pump specialist. So called ‘bedside’ or ‘large volumetric pumps’ are produced by huge pharmaceutical and device companies not leaving any space for us to enter the market. With automatic drug identification (without human intervention) and a completely different innovative pump design (two patent families registered in Europe and the US), we believe we can not only enter but prevail in this market that strives for innovation. A nurse in the US said “Wow… that’s incredible” and the biggest key opinion leader in our field said, “this is the dream of every nurse”.



What have you learned about IP and its strategic use?

IP, even with marginal innovation, is needed to enter into a market that is already crowded by patents. To ensure your on-going business and leverage a disruptive innovation that has sound market acceptance, you need to survey the market at an early stage, plan your business strategy, and patent block competition from all possible alternatives and improvements to reserve as much space as possible for your business growth.

How do you manage the use of ‘other people’s innovations within your products?

Sometimes you need a product based on standard technologies, as most companies do, or you may need to use a recent development by a competitor. In this case, you have to improve it, find an inventive step or an equivalent alternative and secure a patent on this improvement or alternative. This is the way technology evolves.

How important is IP strategy to the evolution of your business?

Some companies start with a disruption. Others, as we did, start with an urgent need that must be addressed as soon as possible. We were better in small things, and gradually as we gained more exposure to the market and customer needs, we started patenting several aspects of the product that ranged from peripheral to the basic infusion mechanism. When we needed a huge disruption for the LVP pump, we changed it all, even the infusion mechanism, to make it smaller, easier to load, more accurate and completely pulseless and linear. Two patents, both granted in Europe and the US, contain more than seven improvements of a rotary peristaltic mechanism that is two centuries old. This combined with medication safety is our strategy to make a giant innovation step. Our target market will not be able to argue that changing thousands of pumps is too costly because a huge IP and feature advantage will bend their resistance. All this is still in the development phase, the market currently only sees the tip of the Micrel iceberg which is the actual products.

How relevant is the IP system to MedTech and why should MedTech companies be attuned to IP policy decisions?

MedTech is a dense domain in IP that makes our life difficult. When we started patenting on barcode labelling I realised that it is not possible to find and read all the existing patents because a single company alone can have more that 200 of them. When we overtook the competition’s patents by developing substantial improvements we did not need to read all the existing patents because we had changed the field of application. Our patents on safety and labelling are getting granted so it looks like our strategy is starting to pay off.

Will COVID 19 have positive consequences for medical innovation? For example, has red tape been reduced or system change accelerated as a consequence of fighting the virus?

There has been impact on respiratory and infusion devices and pharmaceutical developments, but I do not see roads to heaven. Maybe in coming years healthcare budgets will increase and the trend of remote working for standard businesses could create a space for larger telemedicine use.

Let’s future gaze, where will we see the biggest leaps in term of MedTech innovation over the next decade?

There is large space in lower market size business areas, which are not the focus for big investments. These areas are behind in their technological achievements and so can improve largely as we saw in infusion where innovation was low. Imaging and surgery are already far ahead, new materials could lead to changes in medical consumables and in devices. 5G will impact remote surgery and telemedicine and there will be a need for equipment for forthcoming genome based personalised medicine.

What is your advice for other inventors and SMEs?

Perseverance and belief that SMEs can achieve change and innovation even better than large corporations. This is a game where so many hours of thinking are spent for thousands of possibilities matching unmet needs with technological possibilities and then models to see if a concept can survive in a given environment or it can change the environment to prevail. A patent can change a product’s DNA and generate a new product that potentially will replace older products on the market in the same way as Darwin discovered for life: market selection instead of natural selection.

Such concept discovery and survival emulation and how it fits to the practice is an awfully expensive exercise when done by large corporations. True innovation can cost 10 times more than a ‘me too’ solution but an owner does not pay himself… The trick that I learned the hard way is that this can only happen when the company starts to be self-sustainable and does not need 100% of the owner’s time, or before a start-up starts to have survival problems. Employees can add to and contribute to finishing an idea but strategic thinking is hard to get . So, my advice to navigators is please take time to think! It takes so much time and effort to see a solution that is so obvious and is in front of your nose.

You have to persuade yourself that if you do not do it, nobody else will. This will give you the right attitude against humanity which is waiting for change.

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The views expressed in this feature are those of the interviewee and may not reflect the views of 4iP Council or its members. The purpose of this feature area is to reflect thinking on the topic of intellectual property and enable open discussion.