Periodic Reporting for period 2 - MedPhab (Photonics Solutions at Pilot Scale for Accelerated Medical Device Development)
Periodo di rendicontazione: 2021-07-01 al 2022-12-31
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.
Addressing these challenges, MedPhab, Europe’s first Pilot Line dedicated to manufacturing, testing, validation, and upscaling of new photonic technologies for medical diagnostics. 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. MedPhab accelerates innovation cycle and technology maturity at the same time, improving the position of Europe in photonics and has opened the access to advanced photonics technologies to companies of any size.
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
Addressing these challenges, MedPhab, Europe’s first Pilot Line dedicated to manufacturing, testing, validation, and upscaling of new photonic technologies for medical diagnostics. 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. MedPhab accelerates innovation cycle and technology maturity at the same time, improving the position of Europe in photonics and has opened the access to advanced photonics technologies to companies of any size.
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
Objective 1
WP1: Single-entry point front office (FO) has been 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. The provide unified customer experience by all the partners, quality management and way-of-working training sessions were organized for the partners.
WP2: Offering capabilities by the parties have been collected in the technology map. MedPhab partners were trained to use the technology map.
WP3: Production kits have been created to produce chained fabrication routes. This WP was completed at M18.
WP8: Assessment of different models for sustainable operations have been created. Non-profit association model was chosen and legal structure was established and approved by the supplier parties.
WP9: Communication and outreach activities have been performed to increase visibility. The emphasis was to provide solution-based market material by showing demonstrator examples.
Objective 2
WP3: Specifications prepared in the previous period were transferred to designs. Demonstrator were fabricated and validation was initiated.
Design and fabrication of:
the in-vitro cases (GenSpeed/Viennalab and Meep-WP4
medical device for hospital environment (Stryker case) -WP5
wearable monitoring device (Polar case)-WP6
Objective 3
WP1: Operational processes to handle customer requests have been prepared and applied in the Demo-Cases.
WP7: Administrative procedures to handle cases have been prepared and implemented. First 6 projects with the external companies were initiated.
WP8: To engage particularly with potential pilot line users MedPhab was actively participating in number of relevant events. MedPhab project website medphab.eu has been updated and commercial website medphab.com was developed to provide information to the public about MedPhab its and advantages. MedPhab dissemination materials and social media have been prepared for promoting the aims, services and results of the project; events in which MedPhab participates; open calls and pilot line offer.
WP1: Single-entry point front office (FO) has been 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. The provide unified customer experience by all the partners, quality management and way-of-working training sessions were organized for the partners.
WP2: Offering capabilities by the parties have been collected in the technology map. MedPhab partners were trained to use the technology map.
WP3: Production kits have been created to produce chained fabrication routes. This WP was completed at M18.
WP8: Assessment of different models for sustainable operations have been created. Non-profit association model was chosen and legal structure was established and approved by the supplier parties.
WP9: Communication and outreach activities have been performed to increase visibility. The emphasis was to provide solution-based market material by showing demonstrator examples.
Objective 2
WP3: Specifications prepared in the previous period were transferred to designs. Demonstrator were fabricated and validation was initiated.
Design and fabrication of:
the in-vitro cases (GenSpeed/Viennalab and Meep-WP4
medical device for hospital environment (Stryker case) -WP5
wearable monitoring device (Polar case)-WP6
Objective 3
WP1: Operational processes to handle customer requests have been prepared and applied in the Demo-Cases.
WP7: Administrative procedures to handle cases have been prepared and implemented. First 6 projects with the external companies were initiated.
WP8: To engage particularly with potential pilot line users MedPhab was actively participating in number of relevant events. MedPhab project website medphab.eu has been updated and commercial website medphab.com was developed to provide information to the public about MedPhab its and advantages. MedPhab dissemination materials and social media have been prepared for promoting the aims, services and results of the project; events in which MedPhab participates; open calls and pilot line offer.
1. Improve significantly the uptake of photonics technology by end-user industry, in particular SMEs, enabling a demonstrably more competitive European industry
• Accelerate technology maturity from TRL 5 to TRL 7 through 5 Use-Cases, whose demonstrators have been built for the validation.
• 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. Currently temporary front office structure is running that is led by PINS and VTT covering both low and high TRL requests. The operations are transferred to non-profit association.
• 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. The risk of the companies is lowered by providing plan for the production route from low TRL (proof-of-concept) to high TRL development meeting ISO13485 regulations.
• Demonstrate increased industrial leadership through introduction of 5 innovative products by MedPhab Use-Case partners
• Strengthen European manufacturing capacity by empowering 3 leading manufacturers with ISO13485 certificate providing capabilities for various photonics and related technologies.
2. Greatly accelerate the time to market
• Accelerate the manufacturing process (including design and post-processing) through a holistic approach. This is firstly addressed by the maturity map with technology and manufacture readiness levels to identify the expectations for the joint R&D. This interaction is handled by the front office. Once confirmed, the needed technologies and right parties are selected, and fabrication plans are created using production kits.
• 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. To improve the level of understanding on the regulatory topics, two trainings have been organized for MedPhab parties.
• Optimize customer handling processes
Streamlined customer handling processes have been developed in WP1 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
• Catalyze open-access ecosystem
The Community Management Platform (CMP) has been taken into use including the technology offering by MedPhab parties. It can be expanded this to create open-access ecosystem comprising members outside current members.
• 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 30 enquiries with the likelihood to lead new long-term alliances.
• Demonstrate ambitious but commercially viable sustainable business plan
Sustainability planning towards non-profit association model has been part of the WP1 (FO operations) and WP8 business model planning.
• Accelerate technology maturity from TRL 5 to TRL 7 through 5 Use-Cases, whose demonstrators have been built for the validation.
• 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. Currently temporary front office structure is running that is led by PINS and VTT covering both low and high TRL requests. The operations are transferred to non-profit association.
• 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. The risk of the companies is lowered by providing plan for the production route from low TRL (proof-of-concept) to high TRL development meeting ISO13485 regulations.
• Demonstrate increased industrial leadership through introduction of 5 innovative products by MedPhab Use-Case partners
• Strengthen European manufacturing capacity by empowering 3 leading manufacturers with ISO13485 certificate providing capabilities for various photonics and related technologies.
2. Greatly accelerate the time to market
• Accelerate the manufacturing process (including design and post-processing) through a holistic approach. This is firstly addressed by the maturity map with technology and manufacture readiness levels to identify the expectations for the joint R&D. This interaction is handled by the front office. Once confirmed, the needed technologies and right parties are selected, and fabrication plans are created using production kits.
• 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. To improve the level of understanding on the regulatory topics, two trainings have been organized for MedPhab parties.
• Optimize customer handling processes
Streamlined customer handling processes have been developed in WP1 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
• Catalyze open-access ecosystem
The Community Management Platform (CMP) has been taken into use including the technology offering by MedPhab parties. It can be expanded this to create open-access ecosystem comprising members outside current members.
• 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 30 enquiries with the likelihood to lead new long-term alliances.
• Demonstrate ambitious but commercially viable sustainable business plan
Sustainability planning towards non-profit association model has been part of the WP1 (FO operations) and WP8 business model planning.