Fraunhofer Center for Assistive Information and Communication Solutions – AICOS27.4.2018
Members of the MDevNet Network, an initiative led by Fraunhofer Portugal AICOS that promotes knowledge transfer between stakeholders involved in the industry of technology-based medical devices, gathered at Porto Design Factory last week for a meeting of minds with parallel discussions focused on different themes.
During the MDevNet Network Membership Workshop, which took place in March, members identified three convergent themes, which were then assigned to three action groups. These groups assembled last week for work meetings to address and debate these challenges more comprehensively.
“Action Group 1” focused on the clarification of regulatory issues associated with medical devices and their impact on national entities involved in the process of medical device technology transfer and commercialization.
Major changes are on the horizon with the implementation of the European Medical Device Regulations and the General Data Protection Regulation, which is why these were at the forefront of discussion. Also among the issues discussed were the different national and international regulations, which differ widely in their level of strictness, and affect companies aiming for the global market. The general consensus though, especially for new entities to the market, was confusion as to what entities do what, and what for, in the certification process.
“Action Group 2” was tasked with the survey of obstacles and promotion of mechanisms of interaction between the national entities involved in the process of co-development and validation of medical devices. However, no regulatory agencies were present, which hampered the discussion as cooperation, members concluded, is key across the board. Not only between innovation agents and regulatory organizations, but with practitioners as well. Ideally, some argued, medical institutions could dedicate more time to disease prevention rather than mostly reacting, by allowing medical professionals to join research efforts.
As for “Action Group 3”, its members worked on promoting the effectiveness on the technology transfer processes in the MDevNet Network partners for the adequate transfer and commercialization of technology-based medical devices, based on their specific skills and competences (eg technical, scientific or legal). The vehicles for transferring medical device technology to the market were discussed, with Spin-Offs being recognized as the preferred method. The role of Licensing was discussed, which hangs more heavily on the ability of the researchers’ (or TTO’s) to not only communicate the value of the technology, but also to find a market fit, and in this way raising a different set of challenges.
While participants recognized several obstacles – such as lack of knowledge about regulations, processes and formalities, as well as a ‘language barrier’ that separates I&D, industry and regulation entities – members shared their awareness of new coming solutions such as specialized human resources and the introduction of these subjects at a university level.