MedPhab - pilot line

for photonic medical

devices.
www.medphab.eu
 Content

2-3 Introducing MedPhab

4-5 How to work with MedPhab?
6-7 Partners of MedPhab
8-9 Development phases
www.medphab.eu
10-11 Maturity levels (TRL and MRL)
12-13 ISO 13485
14-23 MedPhab technological offering
24-25 Investment offering
26-27 Model cases
28-31 Use cases
32 Contact details

Funded by:

MedPhab has received funding from the European Union’s Horizon 2020 research and innovation programme under
grant agreement No 871345. www.photonics21.org
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 Improved diagnostics, a higher level of support for chronic diseases as well as personalisation of treatments are
enlarging the demand for medical devices. Photonics technologies have become a key enabler in the realization of
modern medical devices with applications ranging from diagnostics to surgical tools and therapeutics. However, the
diversity of photonics technologies and applications alongside the complexity of the ecosystem have led to challenges
in the development and production of medical devices. Furthermore, strict regulations within the sector make the
introduction of new solutions a lengthy and costly process.

Addressing these challenges, MedPhab is Europe’s first Pilot Line dedicated to manufacturing, testing, validation,
and upscaling of new photonic technologies for medical diagnostics. MedPhab pilot production line will accelerate
the commercialisation of measurement, monitoring, and diagnostic devices and treatment instruments based on
photonics technologies. 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). Furthermore,
MedPhab operates within medical domain setting requirements, which considerable accelerates the regulatory
approval process.

Hospital Use
In a hospital environment, the solutions assist doctors with diagnosis and by giving them
real-time information of how the treatment is progressing, without the need to send patient
samples to a laboratory.

Introducing
MedPhab
Home Care Services
Introducing MedPhab Home Care Services The equipment for home diagnostics can
support non-invasive, continuous monitoring of patient’s condition, supporting healthy
living in a home environment. With remote diagnosis it is possible to increase value of care,
provide telehealth services, early diagnosis of disease, and support recovery after treatment.

Equipment for Molecular Diagnostics

Molecular diagnostics supports establishing a clinical picture or diagnosing an infection
based on a serum, saliva or urine sample.

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 Contact
Get in touch by contacting Get in touch by filling out the
us at [email protected] MedPhab intake form on our
webpage (www.medphab.eu)
Arrange a teleconference
Silicon photonics with or
our MedPhab Front Office Describe your technology needs
InP and basic information
representattives
Polymer photonics

Talk to Front Office

Personal communication with

Front Office on technology needs
(under NDA if required)

Meet your partners

How to work · Selection of most suitable

MedPhab partners
with MedPhab? · Definitionwithof project ambitions and goals
technical experts
(MedPhab 1-5 maturity approach*)

Project planning

Contract with suitable

MedPhab partner(s).

Project execution

Open calls will be launched in June 2021. Please check www.medphab.eu for further information
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 VTT. Provides companies an easy access to new business development and pilot manufacturing resources with a
key focus area in diagnostics.

Tyndall. Support the work of the relevant industrial end-use partners in the in-vivo diagnostic use-case and facilitate
the transfer from pre-commercial fabrication to commercial production and ensure the post-project sustainability plan.

Joanneum Research. Leads the in-vitro diagnostics technology, providing development and manufacturing of
microfluidic structures; manufacturing R2R UV NIL imprinting of structures on flexible foil substrates.

Imec. Implementation of manufacturing capability for IVD devices and for chip-level widely tuneable lasers for spectroscopic
sensing in wearables, surgery tools, electronic pills and implants.

CSEM. Design and prototyping of Micro- and Nano optics, flexible hybrid circuits, microfluidic chips, biosurface
functionalization; sensor integration and packaging.

Philips Innovation Services. Central integrator, providing access to an extensive infrastructure for microelectronics and
photonics assembly technologies and providing manufacturing capabilities in an ISO13485 certified setting.

Jabil. With deep engineering, manufacturing and supply chain expertise, Jabil offer system integration and technology
transfer to establish mature production solutions by providing the full suite of process and equipment development,
installation and validation within a ISO 13485 certified environment.

Screentec Oy. Develop advanced, high-integration level manufacturing and packaging methods for photonic
personalized health monitoring modules by creating disruptive process combinations.

III-V Lab. The epitaxy of III-V multilayers and quantum wells on InP wafers by MOVPE/GSMBE growth and the fabrication
Partners of of transfer-print ready semiconductor optical amplifier gain-chips for the development of heterogeneously integrated III-V/
Si widely tuneable lasers. III-V/Si photonic design.
MedPhab Stryker. Is validating the pilot line services and development of a biophotonics tissue recognition (TR) medical device
and technology platform for surgical guidance in-vivo.

Polar. Design, manufacturing and validation of non-invasive sensors for measuring biomedical signals using optical
and galvanic measurement methods.

Radisens. Will develop cost-effective integrated photonics modules for a point-of-care blood monitoring platform.

Antelope. Uptake of the pilot line by industry engaged in in-vitro diagnostics.

GENSPEED Biotech. Design/simulation/verification of integrated micro-optical detection schemes and disposable

microfluidics test-chip for fluorescence-based detection.

ViennaLab Diagnostics GmbH. (VL) contribute competence in developing and producing in-vitro diagnostic tests that
comply with ISO standards as well as European (CE) and global IVD regulations.

The Netherlands Cancer Institute. (NKI), offers clinical feedback on user cases, defining clinical needs and
requirements, testing possible prototypes when applicable and feasible.

European Photonics Industry Consortium. (EPIC) is contributing to dissemination activities and the business
development by promoting activities, planning, creating and hosting events and sharing market insights.

AMIRES. Is a consulting and management company for research, development and innovation projects, facilitating the
access of European research to high-tech SMEs and improve exploitation of innovative ideas.

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 Costs and duration of the projects will vary according to the stage of development and maturity of the technology, the
requirements and expectation for the content and regulatory aspects. In MedPhab, a 1-5 maturity chart is designed to
articulate the pilot line’s position in a typical medical device development process flow. The MedPhab 1-5 maturity chart
is an indication of a typical product development process flow as well as regulatory and cost aspects that need to be
considered when maturing technology in the medical domain.

Plan jointly the route towards the product launch!

Development
phases

MedPhab is strongly positioned in the stages of product development which focus on advancing manufacturing and
integration level. Basic research as well as high-volume manufacturing is not in the scope of MedPhab. In each maturity
level varying regulatory guidelines will be applied.

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 Technology Readiness Level (TRL) – is a measurement method for estimating the maturity of technologies. TRLs are
based on a scale from 1 to 9 where TRL1 corresponds to “Basic principles observed” and TRL9 to “Actual system proven
in operational environment”. MedPhab will bridge the gap between R&D (TRL4-5) and pre-commercial production.
Additionally, MedPhab is taking care to carefully map the integration capabilities, thus also addressing the manufacturing
readiness level.

Manufacturing Readiness Level (MRL) - is an indication of the maturity of a product or technology to be produced. The
MRL scales from Basic manufacturing identified as (MRL 1) to Full rate production demonstrated with lean production
practices in place (MRL 10).

With help of these definitions for TRL and MRL, at MedPhab we are able to describe the relation and interdependency
of technology and manufacturing maturity as outlined in the chart below. The numbering from 1 to 5 in the chart refers
to the maturity levels of projects enabled through MedPhab and helps to identify a project’s position in the development
lifecycle.

Innovation Maturity - Product vs. Process

9 5
Product 4
8 Development, Launch
High risk route
and Sustaining

Technology Readiness Level

7 Engineering
Maturity levels 6 Advanced Development
3

(TRL and MRL) 5 2

4
Exploratory
3
1
2 Safe route

1
1 2 3 4 5 6 7 8 9 10

Manufacturing Readiness Level

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 When putting in place a medical device, design, development project, or manufacturing
line, three elements need to come together. ISO13485 is a standard that represents
the requirements for a Quality Management System (QMS) for the design and manufacture of
medical devices. SMEs lacking a sufficient QMS system need to outsource the manufacturing
or invest in a QMS and manufacturing infrastructure. MedPhab puts in place and offers
systems, procedures and protocols suitable for SME’s to guide them through this very
difficult part of their device development.
Partners of ISO 13485 MedPhab operates in medical domain setting requirements to meet regulations
MedPhab and offers seamless operation between ISO13485 certified companies and RTOs.
Production of a small to medium quantity of devices is done by MedPhab ISO13485
certified companies and RTOs, ensuring seamless transition from pilot line production
to up-scaled production without the need for re-design.

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 MedPhab pilot line develops a technology map allowing a systematic matching between technology needs (customer)
and the pilot line offering (modularized competences of MedPhab partners). Typical combinations of (sub-) technologies
are combined in production kits to allow accelerated and more efficient development in previously tested and
proven process flows between MedPhab partners.

Non- Photonic
Photonic components peripherals Integration Post-processing

Integrated circuits Electronics Fiber/waveguide Over moulding

coupling
Silicon photonics Printed circuit boards Rigid
Active component/
InP Ics waveguide aligment Flexible
Polymer photonics Roll-to-roll printed Grating couplers Stretchable
electronics
Micro-optics Flex-to-Rigid/F2R Hermetic sealing
Opto assembly
Polymer Opto-mechanics Photonic module
Free-space lens encapsulation
Glass aligment
Injection moulding Mirror/grating assebly
Opto-fluidic interface
Fiber optics Metal tooling Coupler lenses, prisms
2D and 3D printing Microfluidric interfacing
Standard
Component assembly In-vitro cartridge
Customized
MedPhab Facet handling
Microfluidics assembly
Rigid board Consumer packaging
Injection moulding
technological Optical components Thermoplastics
Flexible foil
Stretchable foil Thin film deposition
offering Standard
UV-curable
Module assembly
LSR high volume Roll-to-roll vacuum
Active components Adhesives Sheet/wafer vacuum
Surface acivation
Roll-to-roll liquid phase
Standard sources MEMS Array spotting Sheet/wafer liquid
Detectors Bio-reagent dispense phase
Si-processing
Organic electronic Surface modification
Sin-processing

Diagnostic devices consist of numerous photonic and non-photonic components that need to be integrated for the
required overall functionality. For example, a typical spectroscopic unit requires combination of fiber optics, electronics
and their hermetic sealing for an integrated system. In in-vitro diagnostics, low-cost fabrication of disposable microfluidic
cartridges is key to commercially successful products.

MedPhab uses an approach to simplify the development of these diverse systems by using modular technology
blocks covering 1) Photonic components, 2) Non-photonic peripherals, 3) Integration and 4) Post-processing
steps. This modular concept enables a structured approach to highly fragmented heterogeneous technologies.
For fabrication cases, the fabrication chain is designed by choosing the relevant blocks. Depending on the customer’s
needs, either customized or standardized fabrication processes with ISO13485 certificate can be applied.
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 Photonic
Components

MedPhab offers a wide portfolio of photonics technologies: fiber optics, micro-optics, integrated circuits and Fibre optic sensing probes can be used for clinical applications, such as tissue identification for diagnostics and
active components. surgical guidance. The optical fibres can be integrated into a standalone probe or integrated into surgical tools. The
probes design can include a single optical fibre or multiple optical fibres in an optimum probe geometry for a given
Photonic integrated circuit technologies within MedPhab offering include silicon photonics as well as III-V materials with application. MedPhab offers design and build of fiber optic including fiber splicing, tapering, cleaving, polishing,
wafers of different sizes and thickness. Variation of processing techniques allows fast prototyping and verifying design, laser processing and connectorizing.
wafer level manufacturing, advanced packaging options and hybrid integration of III-V materials on silicon.
All-printed electrocorticography arrays (MEA) can be fabricated by inkjet printing of ultra-pure platinum or gold ink
Micro-optics manufacturing technologies are heavily explored in MedPhab. Master tooling and upscaling using UV formulations (bio-compatible) electrodes and screen printing of polyimide as a passivation layer.
and R2R nano imprint lithography replication processes enable the manufacture of micro/nanostructures on polymer,
glass and silicon-based material. Also available are commercial applications such as: replicated micro-lenses with
micrometric inter-lens gap on bare die or on wafer chunk with gap-independent specification, as well as the transfer
of grating/lens master structures into glass or silicon.

SEM image of a field of transfer-print-ready semiconductor optical amplifiers

Replicated microlenses with micrometric inter-lens gap on bare Silicon die Courtesy of CSEM
fabricated on an InP platform Courtesy of III-V Lab

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 Non-photonics
Peripherals

Roll-to-roll printing and digital printing of ultrapure gold allows production of multilayer circuitries and multilayer medical Microfluidics manufacturing services include production of microfluidic structures based on polymer or liquid silicon
electrodes and other printed electronics components/parts. Flex-to-Rigid platform enables the integration of highly rubber materials, thermoplastics and others. Production techniques include micro-milling, adhesive bonding,
miniaturized electronics functionalities. laser welding, injection molding, R2R UV Nano Imprint Lithography. Laser lamination and adhesive die bonding
with various materials are also offered.
Opto-mechanical components production techniques include FDM and SLA 2D and 3D printing, 3D printing in
steel as well as flex-to-rigid printing enabling processes from rapid prototyping of low resolution parts to production For MEMS development and production, MedPhab exploit 2D and 3D printing, Chemical Mechanical Planarization
of high resolution and complex parts with integrated structures. (CMP), Dry etching and Lithography, furnace processing (oxidation, annealing, curing, etc.). Additionally, plasma
enhanced chemical vapor deposition (PECVD) and Sputtering are available for thin films and extreme fine thin
layer deposition.

Printed and hybrid integrated electronics on a digital patch for patient monitoring Courtesy of VTT MEMS-based microfluidic device Courtesy of Philips

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 Integration

Fiber-waveguide coupling, optical and other component assembly alongside surface activation comprise MedPhab’s Various component assembly techniques are available depending on the application. Glue Dispensing, STM
multiple integration capabilities. or R2R line assembly and pick and place technology enable assembly on Flexible and Stretchable foil or rigid
boards. Other techniques include wire bonding between an integrated circuit (IC) and its packaging; anisotropic
MedPhab offers coupler lenses, prisms and Grating couplers. By means of active alignment, optical components conductive film (ACF) for the electrical and mechanical connections; thermocompression bonding and soldering
such as fibers, lenses, beamsplitters, etc can be aligned in 6 degrees of freedom, down to sub-micrometer precision. with a metal filler.
Pick and place technology offers a superb placement accuracy while fulfilling other requirements.
Surface activation technologies include bio-reagent dispense, array spotting at the micro-, nano- or pico-liter
scale, vapour phase deposition of surface chemistry as well as surface activation of foil substrates or thin-film
deposition.

Transfer printed active components on photonic integrated circuit Courtesy of IMEC Industrial SMT assembly line Courtesy of Philips

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 Post-processing

Postprocessing MedPhab capabilities include overmolding, hermetic sealing, opto-fluidic interface and thin film Highly-reliable hermetic, ceramic micro-packages can be performed with bio-compatible / bio-stable materials.
deposition. Butterfly packaging or golden can be used, also allowing very low CTO and high thermal conductivities. Alternatively,
soldering or other custom packaging solutions can be developed.
Rigid or stretchable overmolding can be done, using processes such as adhesive roll lamination, injection overmoulding
or with LSR (liquid silicon rubber). Cold and heat lamination capability of flexible foils in sheet and R2R processes MedPhab offers design, automation and production of electronics on stretchable / conformal substrates using
are also available. printed electronics processes.

Roll-to-roll (R2R) liquid phase deposition allows production of nano-scale thin films, micro-optical or functional
nanostructures as well as microfluidic chips.

Hermetically sealed VCSEL package for a cochlear implant to stimulate hearing Courtesy of CSEM Assembled in-vitro cartridge for inflammation detection Courtesy of VTT

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 MedPhab offers a service to help companies developing Photonics-based
medical devices move forward to the Pilot Production Phase. MedPhab
Investment
connects these users with investors interested in photonics and provides
coaching material, which increases the chance of raising capital.
offering

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 Diagnostic devices consist of numerous photonic and non-photonic components that need to be combined for the
required functionality. Modular blocks with preliminary division enable a structured approach to highly fragmented
heterogeneous technologies used in component manufacture and device integration. For each case, the fabrication
chain is designed by choosing the relevant blocks. Model-Cases are chosen to create libraries for four segments:
photonics component manufacture, non-photonic peripheral manufacture, device integration and post-processing.

Model Case for Molecular Diagnostics

Disposable plasmonic-fluidic sensors
Pilot production of integrated microfluidic structures
for highly sensitive molecular diagnostics

MedPhab will enable small and medium scale manufacturing of nanostructured substrates together with surface
metallization processes and will establish processes for their integration in microfluidic structures. This will help to
address the need for signal enhancing substrates required for highly sensitive molecular diagnostics.

Model Model Case for Hospital Use &

cases Home Care Services
Wearable PIC temperature sensor
PIC-based sensors and miniaturized packaging
for temperature modulation sensing

MedPhab manufacturing and design capabilities in the field of PIC-based sensors and miniaturized packaging will be
used to support the proof of concepts device to sense a temperature modulation with an integrated interferometer in a
miniaturized package.

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 Use cases

Use Case for Hospitals Use Case for Personalized Diagnostics

Biopsy needle with integrated sensor for tissue recognition Wearable device with integrated photonic components
Optical techniques such as absorption spectroscopy can be used to recognise different tissue states. This recognition Medical wearable devices allow continuous, real-time information about physiological parameters via non-invasive
capability has the potential to compliment other medical imaging/detection modalities and deliver enhanced guidance measurements. Visible light LED and IR-laser systems can be used to monitor physiological parameters and changes
during minimally invasive surgical procedures. Photonic miniaturisation, packaging and manufacture is key to related to cardiovascular symptoms and chemical composition of tissues, also enabling cardiovascular, respiratory and
enabling the translation of these technologies to the hospital. Stryker, Tyndall National Institute, Philips and NKI many other diseases to be addressed.
have come together to work on integrating photonics-based sensors with surgical instruments. The group will focus
on biopsy of metastatic tumour in the liver and will demonstrate how application of these techniques could improve Mechanical (substrate materials, connection flex to cable, flex to flex etc.), electronical (circuit design, thermal
biopsy procedures and benefit both patient and clinician. behaviours, conductive traces, adhesion etc.), and optical (integrated LEDs, tuneable laser sources, photodiodes,
micro-optics and lens window etc.) components will be integrated into an opto-mechanical sensor module. The
photonic LED/laser modules and their hybrid integration on a carrier platform will be further assembled on a
flexible wearable band.
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 Point of care IVD reader
A miniaturized point-of-care reader will be created by the joint effort of Radisens
Diagnostics, CSEM, VTT and Jabil. This optical-based reader will contain LED
illumination sources (400-800nm), detectors, an infra-red thermometer, micro-optical
elements, an incubation system, driver and control electronics, a servo-motor and
a user-friendly cartridge handling system. These reader front-end modules will be
integrated with the system electronics and a touchscreen user interface. The point-of-care
IVD reader, combined with a microfluidics cartridge consumable, will be used to initially
measure ferritin (iron stores) in a relevant environment and in future, other
immunoturbidimetric or clinical chemistry tests.

Photonics based IVD consumable

Use Cases Die-level biofunctionalization processes represent one of the challenges for scaling
photonics-based IVD solutions. This issue will be addressed through development of
for in-vitro a wafer-level process. Within this project, a wafer level scale process will be developed
and tested using a blood based inflammation marker detector.

diagnostic

Genetic Analysis
IVDR compliant in vitro diagnostic system comprised of a multicolour fluorescence
reader and disposable low-cost cartridge will be developed for the detection of genetic
disorders, e.g. lactose intolerance. The development will include an IVD module for a
multi-colour fluorescence readout and foil-based IVD chips with polarization filters, light
guiding structures and biofunctionalization.

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 MedPhab
Photonic Medical Devices

Contact details

[email protected]

www.linkedIn.com/company/medphab

www.twitter.com/medphab

www.medphab.eu

Funded by:

MedPhab has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement
No 871345. www.photonics21.org
32 1