Photonics Solutions at Pilot Scale for Accelerated Medical Device Development

Project Information

MedPhab

Grant agreement ID: 871345

DOI

10.3030/871345

Project closed

EC signature date 6 December 2019

Start date 1 January 2020

End date 30 September 2024

Funded under

• INDUSTRIAL LEADERSHIP - Leadership in enabling and industrial technologies - Information and Communication Technologies (ICT)

Total cost

€ 17 381 960,99

EU contribution

€ 14 995 444,63

Coordinated by

TEKNOLOGIAN TUTKIMUSKESKUS VTT OY
Finland

Periodic Reporting for period 3 - MedPhab (Photonics Solutions at Pilot Scale for Accelerated Medical Device Development)

Reporting period: 2023-01-01 to 2024-09-30

Summary of the context and overall objectives of the project

Photonics technologies have become a key enabler in the realization of modern medical devices with applications ranging from diagnostics to surgical tools and therapeutics. The diversity of photonics technologies and applications alongside the complexity of the ecosystem have led to challenges in the uptake of the latest technologies. Furthermore, strict regulations within the sector make the introduction of new solutions a lengthy and costly process. Seamless operation between ISO13485 certified companies and RTOs makes MedPhab a single-entry point that can serve companies working at different technology readiness levels (TRLs). MedPhab supports the competitiveness of the customer companies by providing them with a one-stop-shop for accelerated design and development of photonics based medical diagnostics.
The main objectives of MedPhab are: 1)Set up a sustainable open access pilot line for accelerated product development 2) Mature technologies to TRL 6-7 through Use-Cases 3)Demonstrate MedPhab operational model through Demo-Cases

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

Objective 1
WP1: Single-entry point front office was established comprising operational structure to handle customer requests. Structured processes ensure seamless interaction between MedPhab research and industrial parties enabling accelerated product development across the full development chain.
WP2: Offering capabilities by the parties have been collected in the technology map. MedPhab partners were trained to use the technology map. The mapping improved the internal understanding of the service capabilities and structured communication with the external stakeholders.
WP3: Production kits were created to produce chained fabrication routes.
WP8: Non-profit association (NPA) model was established . Joint development of the offering was ensured by launching Chips-JU follow-up project, PhotonMed.
WP9: Communication and outreach activities have been performed to increase visibility. Initially, internal model-cases were used as a basis for the application-oriented marketing with demonstrators. Use-case demonstrators and inputs from the end-user companies were exploited in the communication. Open call projects with external companies supported substantially the marketing activities by brining external view for enhanced visibility and creditability.

Objective 2
WP3: Use-case demonstrator development was initiated by defining the specifications within WP3. Following phases including design, fabrication and validation were performed in technical WPs 4,5 and 6. Important part of the work was to define exploitation plans for the commercial uptake of the results.
WP4: In-vitro use-cases led by GenSpeed/Viennalab and Meep were demonstrated in WP4. GenSpeed/ViennaLab use-case focused on the nucleic acid analytics while in Meep use-case an immunoassay demonstrator based on Si-photonics was built and validated. (GenSpeed/Viennalab and Meep
WP5: Biopsy needle with spectroscopic functionalities were demonstrated in this case. This enables tissue and cell recognition continuously. (Stryker case)
WP6: Wearable device demonstrators for sleep apnea management and metabolism were integrated in this WP. These activities were led by Polar. Maculaser, as an end-user company, joined the project in 2023. As a joint effort between Maculaser and RTOs, a demonstrator for retinal treatment was built and validated.

Objective 3
WP1: Operational processes to handle customer requests were prepared and applied in the Demo-Cases.
WP7: Administrative procedures to handle cases have been prepared and implemented. In total 15 projects with the external companies were implemented. The applications covered in-vitro diagnostics, in-vivo diagnostics and phototherapy. The technology offering was broad comprising Si-photonics, microfluidics, fiber optics and packaging. According to the survey to the customers, the service quality was at high level with the average rating of 4.2 out of 5.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

1.Improve significantly the uptake of photonics technology by end-user industry, in particular SMEs, enabling a demonstrably more competitive European industry.
•Engage new business by providing low-barrier access to low-medium production volumes. MedPhab’s use-cases are developed towards new products and external companies have been contacted to establish joint R&D.
•Provide single entry point to access a complete service, covering all stages of the manufacturing process through front office.
•Simplify an access to advanced photonics technologies through modular approach. In WP3 “production kits” have been defined as a tool to make compatible fabrication chains.
•Lower risk of the decision for companies to enter the market with advanced photonics technologies enabled products to allow the businesses explore different manufacturing options.
•Demonstrate increased industrial leadership through introduction of 5 innovative products by MedPhab Use-Case partners.
•Strengthen European manufacturing capacity by empowering manufacturers with ISO13485 certificate.

2.Greatly accelerate the time to market
• Accelerate the manufacturing process through a holistic approach. This is addressed by the maturity map with technology and manufacture readiness levels to identify the expectations for the joint R&D.
• Pre-qualify for seamless regulatory approval process
MedPhab can provide seamless transition from non-regulated to regulated fabrication thanks to aligned quality standards and understanding on the regulations.
• Optimize customer handling processes
Streamlined customer handling processes have been developed allowing efficient communication with the customer and selection of right MedPhab service providers. All the partners have been trained to provide the same customer experience.

3.Create sustainable manufacturing capability in Europe
• MedPhab non-profit association (NPA) with an executive director was establish to manage the pilot line operations and to act as a front office.
Catalyze open-access ecosystem
• Catalyze open-access ecosystem
MedPhab non-profit association with open-access operational basis was established to manage the pilot line operations and to act as a front office. Relying on MedPhab pilot, Chips-JU pilot line project PhotonMed with 39 partners and 32M€ budget was initiated in September 2024. https://cordis.europa.eu/project/id/101139777
• Leverage regional/national investments
MedPhab, among other pilot lines, are strategically central initiatives for the parties and therefore exploitation and synergies with national investments.
• Form strategic alliances along RTO-industry value chains between MedPhab parties aligning fabrication processes with different maturity levels. Also, the open call rounds have led to over 40 enquiries with the likelihood to lead new long-term alliances. 15 projects with the external partners were implemented.
• Demonstrate ambitious but commercially viable sustainable business plan
The operation of MedPhab non-profit association lies on the sustainable business plan. NPA manages the operation of the pilot line while the renewal of technology offering and invitation of new members take place in ChipsJU-PhotonMed project.

MedPhab model case

MedPhab logo