Pharma and Biotech in Tyrol
Owing to the success of pharmaceutical companies in Tyrol, along with university and clinical research and the resultant biotechnology-oriented spin-offs, red (i.e. medical) biotechnology and pharmaceutical research and production have become core areas within the Standortagentur Tirol’s Cluster Life Sciences. The organisation aims to boost research and development in the fields of biotechnology and pharmaceuticals, enhance the Tyrolean research sector as a whole and strengthen other sectors complementing the strong medical technology sector. This is achieved through the targeted locating of new companies and business start-ups, optimum support for resident companies (small and medium-sized enterprises in particular), the overall expansion of the critical mass of companies in Tyrol, infrastructure development and intensive networking between research establishments, hospitals and industry.
>>Up-to-date Medical Technology & Health Care Branch Catalogue for the Tyrol and South Tyrol (2018 / Flipbook)
Medical technology initiative
When compared on a national level, Tyrol is a key location in the field of medical engineering. In order to further strengthen this position, the Standortagentur Tirol with its clusters actively supports cross-sector cooperation between cluster members, in particular in the areas of IT, mechatronics and material science (smart living, AAL – ambient assisted living, big data, data security, software as a medical product, industry 4.0 and biomaterials). The aim of this support is to afford the Tyrolean medical engineering sector a greater visible presence both in Austria and abroad, to strengthen regional networking, in particular between companies and research facilities, to extend qualification opportunities for manufacturers and suppliers and to further develop regional competences in the field of biomaterials and thus create a link to the life sciences community.
>>Up-to-date Medical Technology & Health Care Branch Catalogue for the Tyrol and South Tyrol (2018 / Flipbook)
Interconnected systems and smart production
What today affects the manufacturing industry above all will, in future, be an issue that transcends business sector boundaries. Industry 4.0 and its methods will also play a role in the fields of enterprise systems, smart city, smart energy solutions, mobility, tele-medicine, medical technology and digital construction, as well as in the tourism-related fields of snow-making technology and piste management. Therefore, the Standortagentur Tyrol clusters will be offering their members advice in these specific areas with regard to relevant financial subsidies and will examine and, if necessary, even establish, training and further education programmes. The clusters intend to expand and intensify both national and international collaboration and, if possible, collaborate on the creation of a virtual demonstration factory. The goal is to expand the reach of Tyrolean companies in industry, energy, transport and other sectors for devices connected to the Internet.
Medical Device Regulation (MDR)
The new Medical Device Regulation (MDR) from the EU has left no stone unturned in the medtech sector. Companies are facing huge challenges.
Only those who adapt their development and production efforts to the MDR as soon as possible will remain competitive.
In order to successfully introduce new products to the market, the first development steps must be documented seamlessly from the start and in accordance with the MDR provisions. If something was overlooked at the beginning, it can no longer be easily rectified at a later date. This means going back to the start in certain circumstances, losing all of the capital invested thus far in the product development.
Background
With the MDR, the EU is tightening its requirements for medical technology products, from bandages to pacemakers. The definition of a medical product has been expanded and more products are classified as risks. The technical documentation and clinical test requirements have also been intensified and expensive clinical trials are required for more products. Specially trained personnel must also be employed in the future to guarantee that the company complies with the MDR.
After a medical product has been placed on the market, compulsory reviews (so-called post-market surveillance) will see repeat and re-certification audits carried out every three to five years. Thus, manufacturers will still be held liable even after approval has been granted. Even employees at the so-called notified bodies must be prepared and trained in the MDR provisions. This will mean that more personnel will be required in the future as one person alone will no longer be able to cover and check the entire spectrum of medical products. Against this background and the associated, necessary investments, the ‘extinction’ of notified bodies has already begun. Currently (early 2017), there are still around 60 notified bodies across Europe, and medical technology companies will be queueing up for audits. This will lead to a delay in the market entry of products. The last remaining notified body in Austria, the Graz University of Technology, ceased their activities in October 2016.
A dramatic increase in requirements
The checks and documentation required in the MDR mean that the costs for the development and market entry of medical technology products will increase for companies. Even the unannounced inspections that are planned will create more costs for companies.
In many cases, the approval procedure will take longer. Market launches and innovations may be delayed and lead to a competitive disadvantage for European medical technology manufacturers. This is frightening investors away. If, in the future, manufacturers must disclose their supply chains and product details, then this disclosure of company knowledge, internal data and business relations may have a negative impact on the companies concerned. And: All MDR provisions shall apply retrospectively in the sense that even medical technology products that have been on the market for decades must go through the entire MDR procedure and must be MDR certified. A foreseeable consequence of this is that companies will calculate the yields from existing products exactly, and refrain from applying for the expensive MDR certification for lower yield products and simply remove these products from the European market.
If companies want to continue to be successful in the medical technology sector, then they must completely rethink and adapt their research, development and production processes. Tyrolean companies can count on the support of Cluster Life Sciences from Standortagentur Tirol.
Dates and deadlines
The new EU regulations for medical products & IVDs were published on 5th May 2017 in the Official Journal of the European Union, and came into force a few days later on 26th May 2017. From this point forward, the transitional provisions (Article 120 (MDR) and Article 110 (VDR)) applied. The regulation for medical devices is mandatory from 26th May 2020 after a three-year transition period. The transition period for the regulation of IVDs is five years, therefore this is mandatory from 26th May 2022. In order to carry out certifications under the new legislation, notified bodies can re-name themselves six months after the MDR comes into force at the earliest (so early December 2017).
You can read the Medical Devices Regulation and find more information here.
The clusters help their members increase their innovation skills and so be one step ahead of the competition.
You want to make new contacts and find partners, increase your knowledge and learn from the best, develop innovations and secure your market advantage, enter new markets and be seen? Standortagentur Tirol's cluster services provide you with the appropriate instruments to do all this.
Standortagentur Tirol's cluster services focus on networking between businesses and science to enable as much knowledge and technology transfer between the two as possible. The clusters aim to generate innovation with new products and services, strengthen the cluster members' business and R&D competence and to extend the knowledge and value chains in Tyrol to national cross-industry economic areas.
Cluster Life Sciences from Standortagentur Tirol offers special services to support Tyrolean companies in the implementation of the MDR:
- Basic check for medical products
What: Approval consultations in the early phases of product development. (Is your product a medical product? How should it be classified? Which regulations must be observed? How can these be implemented optimally?). The MedTec Check is a special offer and follows the guidelines of MDR 2017/745 respectively MDD guidelines 90/385/EWG and 93/42/EWG.
Who: Cluster Life Sciences Tirol in cooperation with the PMG European Testing Centre for Medical Devices at the Graz University of Technology and eHealth+Care Consulting, Hall i.T., among others.
How: In order for us to give you the best advice, we ask that you provide us with a brief description of your (planned) product including a definition of the intended use (incl. Medical applications), and name a contact person within your company.
When: On-going according to your needs.
Cost: For cluster members of Standortagentur Tirol:
Package 1 ‘Classification report’ EUR 540,-
Package 2 ‘Classification report & regulations research’ EUR 770,-
Package 3 ‘Classification report & regulations research & individual consulting’ EUR 990,-
Cost for non-cluster members + 35 % (all costs are excl. 20 % VAT).
- On-site quality improvement group
What: Information workshop on the new features and changes in the MDR, on-site at cluster member’s company premises.
Who: Cluster Life Sciences Tirol in cooperation with selected MDR experts.
When: Two or three times per year. Find information on the next on-site quality improvement groups here.
Cost: Free for cluster members of Standortagentur Tirol. EUR 70,- (excl. 20 % VAT) for non-cluster members.
- Special support
What: Support in the targeted search of an appropriate notified body as well as companies that can help you solve specific challenges surrounding the MDR.
Who: Cluster Life Sciences Tirol.
When: On-going according to your needs.
Cost: Free for all Tyrolean companies.
- Consultations with medtech experts
What: Exclusive one-hour consultation with industry experts where you can ask your questions regarding development and approval, quality management, sales and marketing, clinical studies, refining your business plan, subsidies (Land Tirol, Federal Government, EU), and patent law.
Who: Cluster Life Sciences Tirol in cooperation with select experts.
When: Once or twice a year. Ask for more information on the next medtech consultation sessions here.
Cost: Free for cluster members of Standortagentur Tirol. EUR 100,- (excl. 20 % VAT) for non-cluster members.
Download the Clusters Life Sciences Tirol brochure on the MDR and special services here.
Download the dossier from the Austrian Society for Biomedical Engineering (ÖGBMT), supported by 23 organisations, here (only in german language available).
For this purpose, you as a cluster member can simply choose cluster services you need according to the modular principle.
find out more
The Advisory Board of the Life Sciences Cluster Tyrol:
The strategy for coordinating cooperation, development and expansion projects carried out by the Life Sciences Cluster Tyrol is regularly discussed with the cluster's advisory board. It is made up of practitioners and researchers from various fields in the network.
Univ.-Prof. Dr. Ing. Daniel Baumgarten
UMIT Tirol - Die Tiroler Privatuniversität
Head of the Institute for Electrical Engineering and for Biomedical Engineering
Priv. Doz. Dr. med. univ. Theresa Hautz-Neunteufel
organLife, Medizinische Universität Innsbruck
Transplant immunologist
Mag. Thomas Hugl
Atlanto e.U.
Life Sciences Consulting
Markus Hütter, MBA
MED-EL Elektromedizinische Geräte GmbH
Manager, Business Development Robot-assisted Surgery
Dr. Thomas Pellizzari
akedis Innovations GmbH
CEO
Ass. FH-Prof. Dr. Dipl.-Ing. Daniel Sieber
MCI - Medizin-, Gesundheits- und Sporttechnologie
Head of department and study programs in medical, halth and sports technologies
Dr. Gertraud Unterrainer
afreeze GmbH
CEO
Prof. Dr. Klaus Weinberger
Health Hub Tirol GmbH
CEO
Link your Business - Clusters mean networking and networking means links.
Cluster brochure Life Sciences Tyrol
Facts and figures on the Life Sciences Cluster Tyrol (German + English / 2013)
Business directory Medical Technology & Health Care
Compact overview of the diverse Life Sciences industry in Tyrol and South Tyrol (flipbook DE+EN / 2018)
Compact overview of the diverse Life Sciences industry in Tyrol and South Tyrol (pdf DE+EN / 2018)
Tyrolean pioneers in business and science at a glance.
The competence atlas shows all of the cluster members on a map of Tyrol with a detailed description of each business activity, specific competences and specialisations as well as the cluster they belong to. Cluster members not only gain additional visibility, but also an effective tool to find suitable cooperation partners.
Only cluster members can be added to the competence atlas, but anyone who wants to get an overview of the Tyrolean innovation landscape can use the competence atlas.
You can either find cluster members directly on the map of Tyrol or in the search mask on the bottom right. To see more information, simply click on a cluster member's entry in the list or in the map.
Please notice, translation may not be available for all registered companies.
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