Peter Halwachs, Managing Director of LISAvienna, welcomed the participants and expressed his delight that LISAvienna – in cooperation with the FH Campus Vienna and en.co.tec – had succeeded in bringing together so many experts in the field of medical device development for the business conference. Martin Mayer, technology expert at LISAvienna, introduced the programme.
Philipp Lindinger, AUSTROMED, reported on future prospects for medical devices and in-vitro diagnostics. He first reminded the participants that AUSTROMED, which represents the interests of Austrian medical device companies, currently has 115 members, which generate over €3 billion in annual sales with the help of around 9,000 employees. Lindinger identified lead trends in technologies tailored to the individual course of a disease (personalised medicine). These include 3D-printing with new materials (e.g. ceramics and metals), micro- and nano-technologies, prostheses that can help paraplegics walk again, and digitisation. In the field of in-vitro diagnostics, we can expect new rapid tests (antibiotic resistance, detection pathogens) and cost-effective screening processes (nosocomial infections). Electronic plasters for the continuous monitoring of bodily functions are also being developed. There is also great potential for innovations to improve patients’ quality of life in therapies with high side effects (e.g. scalp cooling to minimise hair loss during chemotherapy). Measuring implants that release active substances according to disease status are also already being tested.
Ana Pribakovic Borstnik, SIQ Ljubljana, focussed on the new MDR/IVDR and gave a detailed presentation of the most important differences to the current regulations. As a notified body for medical devices with its own laboratories, SIQ Ljubljana possesses considerable expertise on the subject, as the presentation clearly showed. With a view to future market entry, the new and much more extensive regulations should be considered when developing new medical devices. Even small and medium-sized companies will have to adjust their processes and documentation accordingly. As a result of the new regulations, more companies will have to cooperate with fewer notified bodies than in the past. The most important information about MDR has been summarised in Ana Pribakovic Borstnik’s presentation.
Martin Schmid, en.co.tec, focussed on ISO 13485:2016. By providing consulting services and seminars, en.co.tec contributes to ensuring that medical devices are developed and approved in accordance with legal requirements. In his presentation, Schmid pointed out that ISO 13485:2016 is not formally a harmonised standard and that compliance with this does not simultaneously entail compliance with ISO 9001:2015. In his opinion, it is currently advisable to meet the latter in parallel with industry-specific standards. With respect to ISO 13485:2016, Schmid stressed the extended scope and the clarifications for interpretation as well as the amended definitions and requirements. His set of slides summarises the most important points. In his concluding remarks, Schmid argued that the necessary changes should not be seen purely as an onerous duty but also as an opportunity to declutter the current QM systems, thereby making them more efficient.
Sabine Embacher-Aichhorn, Coordination Centre for Clinical Trials at the Medical University of Innsbruck, discussed the topic of clinical examinations and performance evaluation. She reminded the attendees that the GDPR will be valid throughout the EU as early as 25 May 2018 and that this will be the chief concern regarding clinical research. Embacher-Aichhorn summarised the key points of the GDPR and stressed that some points relevant for clinical research must first be specified in special laws in Austria. When it comes to MDR and IVDR, Austria still has some catching up to do; the amendment of the Medical Devices Act has not even begun yet. The presentation clearly summarises the central points of clinical trials as well as the performance evaluations of new medical devices. A comparison between the regulations in Austria and Germany is also included.
After some light refreshments, the participants had the opportunity to further their education in one of four workshops. For those who couldn't personally attend on 7 November, the presentation slides can be found here.
Workshop A: IVDR, Sven Hoffmann, TÜV Rheinland
Workshop B: New legal requirements for medical apps and software, Thomas Wilmer, University of Darmstadt
Workshop C: Early market access of health technologies, Ron de Graaff, Seijgraaf Consultancy, and Bob van der Kamp, IHC Switzerland
Workshop D: MDD versus MDR: Challenges for medical device manufacturers, Marco Rost, BSI Group
In addition to the lecture programme, the event also offered the opportunity to communicate with representatives of notified bodies and other organisations that can be helpful for the development and approval process. The following notified bodies were present with information stands:
- BSI - British Standards Institution
- mdc medical device certification GmbH
- SIQ - Slovenian Institute of Quality
- TÜV Rheinland
Many other organisations were invited to provide the participants with their expertise:
- OFI - Material applications and biocompatibility
- Alpscapes project & development GmbH - Reimbursement and health insurance companies
- CCT network Austria - Coordination centres for clinical trials
- RnB Medical Consulting GmbH - Medical software and clinical evaluation
- QM Jöbstl - FDA approval
- Leo Heilinger Management Consultancy - Marketing and sales of medical devices
- Medical University of Vienna - Centre for Biomedical Research
In addition, the participants were invited to the grand opening of the OP Innovation Centre with intensive care unit of the FH Campus Wien, including a tour. The Press release of the University of Applied Sciences summarizes this programme point.