NEWS

January 2020
Public announcement: a key EU partnership in the field of AIMDs development.

Soft Encapsulation Enabling Next Generation of Miniaturized Implants: the SEALANT project.

While Active Implantable Medical Devices (AIMDs) enabled huge societal achievements since decades, new technologies are required to enlarge the therapeutic window. That is especially the ambition of the SELANT project, started in October 2020, enabling a next generation of medical implants

The SEALANT consortium benefits from the proven expertise and years of experience in design, development and production of components and technologies used for active medical devices:  OSYPKA AG (DE, medical devices manufacturing), Comelec SA (CH, encapsulation solutions and OEM), University of Freiburg, Department of Microsystems Engineering (IMTEK, DE, research in MEMS-based optogenetic implants) and NMI Natural and Medical Sciences Institute (DE, research institute active in miniaturized implant encapsulation and advanced testing).

The SEALANT project is supported through the Eurostars Program following promising evaluation from expert’s comity (ranked 14 out of 378 eligible projects). Independent project reviewer says: “The SEALANT application presents skillfully a project to demonstrate the usability of high technology coatings to replace traditional implantable medical encapsulations. Several attempts addressed that challenge but never achieved to date. Attaining that goal will offer this medical field with larger solutions to treat unaddressed pathologies with minimally invasive and affordable systems”.

In this project we aim at making soft encapsulation technologies safely applicable for AIMDs, to overcome the conventionally used bulky cans made of metal or glass for specific applications. The technology’s performance is investigated on different types of implants: from adapting existing products up to breakthrough micro-optical implants for optogenetics. A platform concept applicable to various AIMDs will enable design rule extraction and establish the respective encapsulation evaluation.

Starting point of the project is a recently developed multilayer coating technology with advanced barrier properties, based on Parylene-inorganic multilayer stacks (Comelec SA). While conventional Parylene is an essential process in medical device industry, the potential of these multilayer coatings has not been widely explored for its use in AIMD. With SEALANT, this brand-new coating type gives rise to new encapsulation methods that can be applied to a broader range of products. This therefore enables the development of completely new implantable products.

Dr. Thorsten Goettsche, CTO at OSYPKA AG, explains why his company is pleased to be involved in the project: “Our customers have an urgent need for faster development times and more flexible solutions for new innovative active implants, both technically and in terms of development. The market sees great potential in alternative housing or encapsulation solutions.”

“The Parylene/Inorganic multilayer coatings technology that was developed at Comelec in a unique hybrid equipment platform presents outstanding material performances. With SEALANT, we aim to demonstrate how to use it as highly reliable encapsulation material that will give rise to a completely new paradigm in the field of AIMD design”, said Dr. Florian Bourgeois, Head of Research at Comelec SA.

“The next generation of optical cochlear implants (oCI) based on the method of optogenetics faces specific challenges in view of their long-term stable encapsulation. In particular size constraints and the request for mechanical flexibility due to the oCI implantation into the spiral-shaped cochlea can only be achieved using a multilayer coating technology as targeted in this ambitious project”, explains Dr. Patrick Ruther, head of the Neural Implant Group at IMTEK.

The team is excited to pave the way for future AIMDs in a three-year cooperation.

+ download Press release (PDF)

Event at Comelec SA – 10 and 11 March 2020

together with IVAM, Comelec SA organizes (International Microtechnology Business Network) the first Focus Group meeting taking place in Switzerland.

Representatives from different institutions and companies active in the field of medical implants will be present on March 10th and 11th.
In this particularly demanding field, we will be able to discuss these advanced technologies and present some solutions.

If you are interested to join us, please register and find detailed information on:

https://www.ivam.de

EN9100 certification

COMELEC SA EUROPEAN LEADER IN PARYLENE TREATMENT IS PROUD TO ANNOUNCE ITS CERTIFICATION IN 9100: 2018. FOR ITS SERVICES OF SURFACE TREATMENT AND EQUIPMENT MANUFACTURING.

La Chaux de Fonds, June 2019.

The company announces the achievement of EN 9100: 2018 (Equivalent to AS9100: D and JIS 9100: 2016) certification for its surface treatment service activities as well as the design and manufacture of equipment related to Parylene technology. This certification integrate a quality approach turned resolutely towards excellence in order to better support the technological evolution of the aeronautical, space and defense markets. It also demonstrates the mastery of its special processes as well as a rigor in the means of control. Comelec is already listed in the OASIS (On Line Aerospace Suppliers Information Systems) database, which increases its visibility internationally. Finally, this certification rewards the work done by the entire COMELEC SA team and reinforces the know-how and professionalism that has been providing to you for 40 years.

The Parylene C is a food contact approved substance

We are glad to inform you that the Parylene C is a food contact approved substance and is registered through the FCN nr 001777 at the US Food and Drug Administration. This certification will enable you to consider this coating for pieces intended to use in direct or indirect contact with food stuff. The notification was effective on 17th August 2017 and now displayed in the authorized list at the fda website www.fda.gov. Our team is available to answer to all your questions. Please don’t hesitate to contact us by phone to the +41329240004 or by our contact form.

FREE STANDING PARYLENE MEMBRANES ARE NOW AVAILABLE !

Parylene films open new applications when used as a free standing membrane while keeping its outstanding properties.

Parylene is a polymer material which is biocompatible, hydrophobic, and resistant to the vast majority of organic solvents, strong acids and bases. It is elaborated without solvent from an original process known as Vapor Polymerization Deposition. Due to its strong penetration ability (ideal for complex 3D shapes) and its excellent barrier properties, Parylene coatings have been extensively used as an encapsulation material in various industries (electronic, medical, sensors, MEMS, etc). More recently, the use of free standing Parylene films opens new possibilities to further make use of these exceptional properties.

With an increasing demand for implantable devices, the medical industry presents a huge potential to make use of free standing Parylene. Indeed, Parylene films become more and more essential to the manufacturing of smart flexible devices (implantable electrodes, smart patches, etc…) able to adapt to movements of the human body. In this context, Comelec promoted this technology in the frame of the European project “Informed”. Combined with other materials and structuring technologies, applications are infinite.

The use of Parylene free standing films as membranes with tunable properties also represents an important source of applications, for example in the fields of gas detection or fluid filtration.

Comelec has developed a manufacturing process to produce these films in large quantities and with high thickness uniformity. The main commercial Parylene grades are already available as free standing films with thicknesses in the range 5 – 50 µm (others on request).

Depending on the customer, the Parylene films may be provided free standing or on silicon wafers (up to 200mm) for further post-processing (easily removable from silicon substrate by delamination or resist dissolving).