Munich, December 2021
The 13th edition of the Healthcare Innovation World Cup® was a great firework of innovation. +290 submissions from +60 nations worldwide submitted their smart health devices, medical wearables, digital biomarkers & electroceuticals that disrupt the health & care industry. Implandata Ophthalmic Products GmbH, the start-up from Germany, won the competition with EYEMATE – a remote glaucoma care system which can remain permanently in the patient’s eyes without impairing the patient’s vision or general well-being.
1. INTRODUCE YOURSELF! – HOW DID IT ALL START?
Some years back an automotive engineer from Fraunhofer Institute accidentally met a famous German eye doctor in a train travelling together. When starting talking the engineer explained that he is working on tire pressure sensors. The Professor, a glaucoma specialists responded: “This is interesting, it would be great to also have such a pressure sensor for my glaucoma patients in order to measure their eye pressure conveniently and more often, as elevated eye pressure is responsible for permanent loss of eyesight. Today we can measure it only in the doctor’s office, which in most cases is way to less to provide effective treatment.”
That was the start of a research project at Fraunhofer Institute together with the Professor’s eye clinic to develop a wireless implantable intraocular pressure sensor. Once a first demonstrator was realized, the Professor – knowing that I already established disruptive medical products – made me aware of this project. Neither Fraunhofer Institute nor the eye clinic had the interest, capabilities and resources to bring this technology to a commercial stage. After intensive discussions with glaucoma experts from all over the world, who all confirmed the unmet need of continuous monitoring of eye pressure, I acquired this technology and founded Implandata (the name Implandata is a combination of implant and data, as our implantable sensor is providing vital medical data) to get this technology from an early working prototype to a real product for commercial use.
It took us quite some while to mature the technology and the product design, to perform clinical validation and eventually to obtain regulatory approval for introduction of the EYEMATE product into the European market place. But with Covid-19 even further strengthening the case of digital health solution and remote disease management, the situation and long-term perspectives have never been so good for a product like ours.
2. WHAT ARE THE KEY MILESTONES YOU HAVE REACHED SO FAR?
Up to date, Implandata raised a total of €17m from various investors, including various eye doctors, to realize the product, to perform extensive clinical testing and to obtain CE marking, which allows us to introduce the product into the European market and many more countries in the world. We have also obtained FDA Breakthrough Device Designation, confirming the important medical need we are addressing and ensuring an expedited market approval process also in the US.
We are working with the leading glaucoma experts in the world and we have produced more than 20 peer reviewed publications in prestigious journals, presenting compelling safety, performance and efficacy data of our product. Our technology is rigorously protected by a rock-solid patents, extensive trade secrets and proprietary clinical use data. And we have a strong lead against competitors, which are at least 3-4 years behind us in the regard of availability of the product to the market.
3. WHAT WERE THE BIGGEST CHALLENGES YOU HAVE FACED?
Our biggest challenge was to resolve technology issues in order to ensure a long-term robust accurate telemetric intraocular pressure sensor, which at the same time is small enough to be minimal invasively placed within a patient’s eye and allows performing reliable measurement of the eye pressure. When we started, RFID components, analog-to-digital-converters, pressure sensors and integration of all these components on a monolithic application specific integrated circuit have been not such standard process as it is today. So we had to develop our own proprietary ASIC and to perform several time- and money-consuming redesigns, before we finally obtained a robust technology for long-term use.
On our way, we there were a lot of learnings. In retrospective I would have started with early pre-clinical and clinical validation before the final functional product is available, as this would have saved us significant time to show principal proof of concept in regard of medical usability and safety of the product. So my recommendation to upcoming start-ups would be to demonstrate usability and proof of concept as early as possible. Another advice would be, make sure to be well-funded. In developing first-of-its-kind technologies and products there is always the risk of delays and surprises and these are really hurting you, if your financial resources are too tight. And be realistic with your timelines and milestones. Investors sometimes tend to be too pushy in regard of timelines, but you are the expert knowing it better, therefore don’t give in when they are trying to be too aggressive. And make sure to have a good and transparent communication with your investors and shareholders, in good times and even more important also in bad times. Experienced investors know that there are always problems, mistakes and setbacks in such projects, but they want to understand them. If you have an honest communication with your shareholders, they trust and support you also in bad times.
4. WHAT IS COMING IN THE NEAR FUTURE?
We are very excited to get our first product launched with leading eye centers in Germany, Switzerland, Spain, UK, Benelux and Scandinavia in 2022 and thus make our products available to an increasing number of patients.
We are also thrilled to start our first FDA Investigational Device Exemption study, which is paving the path for regulatory approval of our product also in the USA.
And we are keen to advance our product portfolio to realize even less invasive next generation products, by which we can address an even larger glaucoma population and to make our products even more user friendly by integrating also big data and AI tools, further supporting medical decision making.
5. DESCRIBE YOUR EXPERIENCE IN THE INNOVATION WORLD CUP® AND STANDING AMONGST THE TOP15 WEARABLE AND EBV IOT HERO INNOVATORS 2021?
We applied with no specific expectations for the 13th Healthcare Innovation World Cup and have been already surprised and pleased to reach the Top12 of the competition. It is very challenging and sometimes really hard to develop a disruptive first-of-its-kind solution. Coming under the Top12 therefore was seen as an amazing appreciation of our efforts in the past. But winning the contest made the whole Implandata team and shareholders really proud, as this gives us strong visibility and wide attention, which is very helpful to master also the coming challenges with first product commercialization and also expanding into other markets. And on top, it opens up so many doors with potential technology partners, which can help us to realize our next generation technology solutions faster, more reliable and efficiently.
6. CAN YOU SHARE WITH US YOUR THREE TIPS FOR UP-COMING START-UPS?
1. Before you start, make sure that you understand the market that you intend to address from a business point of view, in regard of who are the users, what are their pains and what are their gains with your product, against which solutions are you competing and which business model needs to be applied to make revenues in this market.
2. Include users in our product definition and realization phase and define your value creating milestones thoroughly. Try to demonstrate proof of concept and product usability early on. It is better to identify misconceptions and mistakes earlier than later, that can save you a lot of time and money.
3. Make sure to be funded well and spend your money wisely. If your funding is too tight, you will be always in a fundraising mode and very vulnerable at delays and surprises, which you always will have. Being underfunded slows down your progress and you are losing time and money, which is tight anyhow.
THANK YOU FOR THE INTERESTING INSIGHTS AND WE SHALL KEEP WATCHING YOUR NEXT BIG STEPS!
Visit Implandata Ophthalmic Products GmbH and learn more about digital transformation of glaucoma care.
Join the 14th Healthcare Innovation World Cup. Submit your solution free of charge. The top selected finalists will be invited to present their solution live at MEDICA, the largest medical traid fair in the world.
Don´t miss your chance!
