A new approach to medical device innovation
An EU-and industry-funded project has developed a new platform approach to the innovation chain for next-generation medical devices, giving a boost to European manufacturers, in particular SMEs. The project has established a facility that companies can use to manufacture and test prototype micro medical devices, ensuring European leadership in this vital technology-based sector.
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Europe is a world leader in medical device technology. However, this technology is undergoing a transition from traditional large, expensive machines towards small, disposable, minimally invasive diagnostic and therapeutic tools based on microelectronic and micromechanical technologies. To stay in the game, Europe needs to innovate more quickly.
The EU, participating states and industry/research-funded INFORMED project is tackling this challenge by setting up an integrated pilot production platform. Speed of innovation is the driving force behind the project, in particular giving a powerful boost to developing and commercialising cutting-edge microfabricated medical devices.
INFORMED offers microelectronic and micromechanical assembly facilities at Philips Innovation Services in Eindhoven, the Netherlands along with all the medical certification needed to pass into medical trials. Any company with a great idea but no in-house resources can draw on all the expertise of the platform on a normal commercial basis.
Europe has plenty of innovative small companies with great ideas for innovative microfabricated medical devices, says project coordinator Ronald Dekker, the principal scientist at Philips Research in the Netherlands. However, the sheer expense of developing these ideas into products means many ideas fall by the wayside and many companies are focused more on commercial survival than long-term success. Therefore, European industry needs new paradigms for the whole innovation chain based on microfabrication, from the idea for a new device, through research and development to pilot and full-scale microfabrication which is what INFORMED is about.
A platform for faster innovation
INFORMEDs 39 partners from 10 EU countries are testing this platform approach, and the benefits are already evident. Irish and Dutch partners have demonstrated a smart dressing with integrated sensors and electronics which monitors the acidity, humidity and temperature of chronic wounds to detect infection reducing the need for expensive regular inspections by medical professionals.
A smart ablation catheter for more successful treatment of heart arrhythmias is closer to market which could improve the survival rate of millions of people with atrial fibrillation. Spanish partners are testing a new nano-electronic platform for detecting bacterial infections and improving survival rates.
Organ-on-chip devices being developed through INFORMED will boost the number and diversity of new medicines available in coming years by speeding up drug development. The project has already resulted in the start-up company BIOND Solution also known as BI/OND to provide biologists with customisable organ-on-chip devices for a range of medical applications.
A vital part of the innovation chain
Compared to sectors such as mobile telephony or computing, the speed of innovation in medical devices is worryingly low, says Dekker. There are several reasons for this. The microelectronics used in biocompatible medical devices often use non-standard materials that few fabrication facilities have experience with; initial production volumes are small, meaning high production overheads even if the technology promises much; and test devices cannot be made in a simple university laboratory they need medical-quality certification of materials, processes and procedures, which are all very expensive.
Dekker sees INFORMEDs microfabrication production line as an integral part of a new platform approach to the medical device innovation chain. It fills a vital need between the conceptual phase and test-results phase of medical device development. By offering the substantial off-the-shelf experience of the microfabrication facility, innovative ideas wherever they come from can be realised and tested more effectively.
Our success depends on the complementary skills the project partners bring and their buy-in to the platform idea, says Dekker. There has been much excellent medical device research in Europe, but little of it sees the marketplace. We want to change this.
The idea for INFORMED was boosted by the successful cooperation on intelligent catheters in the earlier INCITE project. It will be taken forward, in particular in the recently approved POSITION II project that will be jointly funded under the umbrella of the Electronic Components and Systems for European Leadership Joint Undertaking (ECSEL JU).
The ECSEL JU, as a European Public-Private Partnership keeping Europe at the forefront of technology development in the ECS sector, is running an ambitious programme with a financial contribution from the EU, industry and research organisation and 29 participating European states, which is approaching EUR 5 billion for the period 2014-2020.
Moores Law successfully predicted the rapid technological advances in the semiconductor industry for decades, says Dekker. We want something similar for medical devices using a new platform-based ecology that brings a continuous and growing stream of innovative medical devices to markets and patients in Europe and worldwide.