Dedicated medical pilot production line

At present, many infectious diseases like COVID-19 or HIV/AIDS do not have an adequate vaccine so patients rely on early, rapid diagnosis for effective treatment and survival.

Photonics, the technology based on light, provides healthcare professionals with advanced, highly targeted, minimally invasive diagnostics that detect body signals, symptoms and diseases early on. Developing medical devices, however, can take many years from concept to clinical trials.

While researchers and SMEs throughout the world work tirelessly to develop life-saving surgical tools, therapeutics and diagnostic devices, the work is carried out often in small and medium-sized companies, that often struggle to overcome such long and expensive processes. The team behind the pilot line aims to cut the costs involved in research and development of diagnostic devices.

So, to speed up the manufacturing of innovative photonics medical equipment, the European Commission has dedicated €15m to set up a unique, single-point entry medical ‘pilot production line’ under Horizon 2020, the Framework Programme for Research and Innovation.

Easy access

Called MedPhab, the initiative is the world’s first open-access medical pilot line that enables researchers, SMEs and businesses to turn their diagnostic and treatment devices that use photonics into industrially-relevant demonstrators.

The aim is to create easy access for European SMEs, researchers and businesses to a unified infrastructure dedicated to manufacturing, testing, validation and up-scaling of new photonics technologies that are used for medical diagnostics.

MedPhab coordinator Jussi Hiltunen said: “MedPhab is Europe’s first Pilot Line dedicated to manufacturing, testing and up-scaling of new photonics technologies for medical diagnostics enabling accelerated product launch with reduced R&D costs.

“We are giving researchers a way to develop research and development to market and to bridge the ‘valley of death’ - the impasse often associated with moving from prototyping to low-volume fabrication - while being cost-effective with faster delivery times.

“Our easy infrastructure provides the right experts for our clients to help them overcome integrating miniaturised photonic devices.

“When a project leaves MedPhab, their device will be at TRL 6 to 7, at a stage ready for pre-clinical trials, however, our clients can come to us at many different Technology Readiness Levels.”

Photonics

MedPhab focuses on photonics products to tackle one of the biggest societal challenges, the ‘instant diagnosis of major diseases’.

With its ability to reveal constituents and visualise incredibly small details in cells and tissues at a molecular level, photonics – the technology that uses and manipulates light – helps doctors and clinicians to understand diseases with greater specificity and sensitivity without being invasive.

Helping its clients to implement cutting-edge photonics technologies into their medical diagnostics products, MedPhab believes it will significantly improve health and patient care:

“There are exciting opportunities for research into the next generation of photonics-based medical diagnostic devices and MedPhab partners can help academic research groups by providing test devices that are required in pre-clinical studies,” said Hiltunen.

New devices from MedPhab technology will improve health and patient care and also generate revenue, job-growth and training opportunities for Europe. This will contribute to the European photonics sector in which 5,000 technology-intensive companies (many of them SMEs) directly employ over 300,000 people.

Use case validation programme

To ensure that the prototypes adhere to the highest medical standards, MedPhab selects companies that are validated with ISO13485 standardised manufacturing.

ISO13485 is the standard for a Quality Management System for the design and manufacture of Medical Devices, and MedPhab only selected these certified medical companies as part of our production line.

“Their participation ensures the seamless transition from pilot line production to up-scaled production without a need for changing service providers,” said Hiltunen.

Use-case companies have been selected for the validation of the pilot line services covering both in-vivo and in-vitro domains. 

Applications

The devices MedPhab focuses on are within three application areas: hospital use, home care devices and equipment for molecular diagnostics.

In the hospital setting, solutions assist doctors by giving them real-time information on how a treatment is progressing without the need to send patient samples to a lab.

The equipment for home diagnostics can be used for monitoring a patient’s recovery and for obtaining a broader picture than is currently possible.

Molecular diagnostics is about establishing a clinical perspective or diagnosing an infection based on a locally-tested serum, saliva or urine sample.

The pilot line also focuses on some specific technologies, including Fibre optics, Microfluidics, Surface functionalisation, Instrumentation, Optoelectronic integration, Custom medical patches, Miniaturisation for micromodules and wearables.

The pilot line is coordinated by Teknologian tutkimuskeskus VTT in Finland and includes 17 other partners from across Europe, including (Ireland) University College Cork - National University of Ireland, Cork, Stryker European Operations Limited, Radisens Diagnostics Limited; (Austria) Joanneum Research Forschungsgesellschaft, Jabil Circuit Austria Gmbh, Genspeed Biotech, Viennalab Diagnostics; (Belgium) Interuniversitair Micro-Electronica Centrum, Antelope; (Finland) Screentec, Polar Electro; (Switzerland) Csem Centre Suisse D'electronique Et De Microtechnique Sa - Recherche Et Developpement; (Netherlands) Philips Electronics Nederland, Stichting Het Nederlands Kanker Instituut-Antoni Van Leeuwenhoek Ziekenhuis; (France) III-V LAB, European Photonics Industry Consortium; (Czechia) Amires Sro.