3DTech’s task in the RESTORE project is to develop its Brinter® 3D bioprinting platform towards more accurate and efficient bioprinting of nanoenabled cartilage microtissues for repairing of chondral lesions. In this scope, 3DTech has just started the printability tests of the nanocellulose/alginate bioink produced by the RESTORE partner, University of Gothenburg. Although the optimization of the final composition of the bioink is still under development, the first bioprinting experiments with Brinter® platform using a mechanically driven endless piston based print head, Visco Tool, were quite promising. Simple test patterns (grid, S-line, and tube) were printed using a needle with an inner diameter of 250 µm, and the printed line width and post-printing dimensional stability were evaluated.
After printing, the structures were crosslinked with CaCl2 and rinsed with PBS. The printed test patterns reproduced the original CAD models quite accurately and maintained their shapes during the overnight incubation test. The estimated line width was approximately 350–400 µm when printing with a speed of 3 mm/s.
During the upcoming months, the Visco Tool’s ability to maintain post-printing cell viability will be evaluated by printing chondrocytes embedded in the nanocellulose/alginate ink.
The European MedTech sector has around 27.000 Med-Tech companies, 95% of
which are SMEs. These companies need to demonstrate not only safety and
performance over the entire life cycle of a product, but also, tangible
benefits for the patients and the healthcare system. The new Medical Device
Regulation (MDR) increases as well the requirements related to the reliability
in relation to its intended clinical use placing a heavy burden on medical
device innovation in Europe.
Being the MD’s sector a highly innovative one, with an average lifecycle
per product of 18-24 months, this scenario represents several challenges,
especially for high-tech SMEs.
SMEs are particularly affected by MDR’s extensive documentation and
report obligations and new clinical testing requirements. With the increased
demands and their associated complexity, a significant number of SMEs in the
MedTech field are now economically and resource wise at risk, which threatens
value chains and thus has the potential to affect the sustainability of the
entire European medical device sector. There is potential for a massive loss of
innovation, jobs, economic strength and product diversity.
CIDETEC is participating in 2 European Project that aim to minimize the impact
of the MDR to SMEs, while maintaining a high level of safety for the patients
and robustness for the processes.
These 2 projects are “Open Innovation Test Beds” meaning a network of
services that covers a part or the total of the development value chain, and
help companies to arrive to market at an accelerated pace.
TBMED is a 4-year-long project coordinated by CIDETEC Nanomedicina that
has received funding from the European Union’s Horizon 2020 research and
innovation programme. Its aim is to increase the access of high-risk medical
devices to patients, by helping SMEs to minimize the market approval and
reimbursement process time, optimizing the process of transforming a prototype
(TRL4) into a valuable innovative MD (TRL7).
TBMED will establish an Open Innovation Test Bed (OITB) consisting of a connected network of labs providing a single entry point to services along the whole value chain, from preclinical development to clinical testing, based on Quality-by-Design (QbD).
The objectives of the service platform are:
Increase the quality and reduce the risk of MDs and facilitate subsequent clinical
Build the arguments to demonstrate real benefits (value / final
outcomes) of the new devices to increase their success in entering the market
Reduce cost and variability of the manufacturing process and the speed
of product release to the market by carrying out statistically DoE for process
In order to develop the platform, 3 use cases in different TRL stages are
Keratoprosthesis: a biocompatible and flexible synthetic cornea (TRL 3)
Glycobone: an injectable ready-to-use hydrogel tailored for oral bone defect reconstruction to be developed for 2 different indications (TRL 4/6)
Hyperthermia treatment for colorectal cancer, based on magnetic nanoparticles and alternating magnetic field (TRL 3/4 )
The OITB will be developed during the course of the project and will
become a commercially available platform after the project is finished
providing services in areas such as technology development, business support
A consortium consisting of 5 Research groups (CIDETEC, University of Zaragoza, INSERM, CURAM, FRAUNHOFER), 5 SMEs (ANTARES, SILAB, CYBERNANO, nB, EURICE), 1 industry (AJL) and 2 clinical research organizations (BIOEF, ECRIN), all of them with significant track record in knowledge creation and innovation in their respective domains, guarantee the successful implementation of this project and the creation of the OITB as a separate legal entity afterwards.
MDOT is a 5 years
collaborative project in the framework of DT-NMBP-02-2018 Open Innovation Test
Beds for Safety Testing of Medical Technologies for Health (IA). The goal of
MDOT is to implement a platform as a meta-network to preserve Med Tech
innovation and economic strength, reduce animal testing, and support MDR´s new
level of patient safety.
The goal of MDOT is to
establish a ‘one-stop-shop’ platform that enables MedTech SMEs to:
1) better know the regulatory
requirements for safety assessment of their medical devices
2) establish a database of detailed testing data of commonly used materials and
3) gain access to advanced testing and fabrication methods
4) perform evaluations of commonly used parts together, and
5) safely and transparently exchange testing data using state-of-the-art
technology to decrease cost while increasing quality and safety of medical
Operability of MDOT will be
demonstrated using three demonstrators:
1) A test bed for the unmet
medical need of aerosol delivery through inhalers specifically designed and
adopted for infants, term and preterm neonates to allow tests under
standardised conditions, which does not yet exist.
2) A test bed for the long term accelerated testing of polymeric active
medical devices inaccessible with current technologies due to the temperature
sensitivity of polymers that will be also transformed into prediction software
3) A test bed for increasing the safety and lifetime of total joint
arthroplasty that involves state of the art testing protocols on wear
measurement and computational modelling.
The MDOT platform design and development, profits greatly from the specialised expertise present within the MDOT consortium. Together, the partners cover the value chain from basic and applied research and testing (ITEM, CIDETEC Nanomedicine, University of Bayreuth, University of Linz, University of Leeds, University of Southampton), to MedTech industry (DEMCON, ACMIT, MATHYS), regulatory affairs experts (MT-Consult, Nanoconsult), and clinical application (University of Poznan, Hannover Medical School).
– Developer of one of the demonstrators: Hydrophilic coating to control wear of the prosthesis. – Head of the Orthopaedic Node inside the testing bed: Communication and MDR.
Askel’s deep tech solution, COPLA®, focuses on early
intervention and prevention of joint surface degradation. COPLA®, is a medical
device already in use for the benefit of veterinary patients. The next step is
to move forward to treat human patients. To reach this milestone, the company
has announced a share issue on the crowdfunding platform Invesdor (www.invesdor.com/askel). The crowdfunding is
open until the end of January 2020.
used as a platform in RESTORE project to create 2nd generation COPLA®
by building nanoenabled 3D matrix for efficient cartilage repair. By joining
Askel’s crowdfunding campaign you can also be part of Askel’s story.
In the frame of the EU project RESTORE, Reykjavik University is developing 1ST European database of chondral lesions morphometric and associated 3D models. Thanks to its partnership with the University Hospital Landspitali, the scan acquisition of patient’s knee started in March 2019. It will be soon available for public consultation through a web application. This Continue reading
Contradictory evidences of sport activity on knee cartilage health and disease
Soccer players and athletes in high-impact sports including volley are frequently affected by knee injuries. Injuries to the anterior cruciate ligament and menisci are frequently observed in soccer players and may increase the risk of developing an articular cartilage lesion. In high-level athletes, the Continue reading
RESTORE’s 1st intermediate meeting was held the 14th and 15th of October 2019 in San Sebastián, Spain. The consortium partners discussed the work progress and together identified opportunities and challenges to reach their objective: effective solution for articular cartilage repair. RESTORE’s 2nd intermediate meeting is scheduled to take place from March 26 to March 27 Continue reading
The Horizon 2020 project REFINE – Regulatory Science Framework for Nano(bio)material-based Medical Products and Devices (http://refine-nanomed.com/) has newly published a white paper on Anticipation of regulatory needs for nanotechnology-enabled health products, which is of high interest for everybody involved in the development and translation of nano-enabled medical products and devices. Today, nanotechnology-enabled health products are Continue reading
RESTORE member Stina Simonsson gave a talk at the ICRS (International Cartilage Regeneration & Joint Perservation Society) world 2019 meeting in Vancouver in Canada with the collective aim of advancing the understanding of joint injury, injury prevention, repair, degeneration, reconstruction and rehabilitation, so as to prolong joint health, maintain patient function, mobility and quality Continue reading
3DTech Oy, a Finnish SME partner in RESTORE, has developed and brought to the global market a unique modular 3D bioprinting platform, Brinter™ (www.brinter.com).
Although 3D bioprinting of human body parts still sounds like science fiction, it may well become a reality in the near future. Already, bioprinters, like Brinter™, can be used in a variety of applications, such as a versatile tool for biomaterial development, as well as in basic research in tissue engineering and regenerative medicine conducted at universities and research institutes. Furthermore, our mission during RESTORE project is to improve the performance of the 3D bioprinting process by testing and integrating new print heads into our Brinter™ bioprinting Continue reading
Askel Healthcare Ltd, a SME partner in
RESTORE project, has a cartilage repair device, called COPLA® Scaffold, in Animal Healthcare market (www.askelhealthcare.com). While
COPLA® Scaffold is helping companion animals, Askel
is moving towards human use Continue reading
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