New Partnership Goals: inXso and BrainStormCorner

Sponsors and Legal Representatives – Clinical Evaluation & Investigation under EU MDR 2017/745
The Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices – came into effect on 26 May 2021, better known as EU MDR – introduced a set of requirements for conducting clinical evaluation and clinical investigation of medical devices in chapter IV comprising Articles 61 to 80.

In recent years, the US Food and Drug Administration (FDA) has faced criticism regarding its review process, the need to keep up with the science today, and updating the regulatory framework accordingly. In response, the year 2023 has been the year that brings significant changes to the FDA regulatory framework, and several initiatives are waiting on the horizon.

Childhood abuse and assault can have a significant impact on a person’s mental wellbeing in adulthood. The trauma experienced in childhood can have lasting effects that can manifest in a variety of ways, including anxiety, depression, and post-traumatic stress disorder (PTSD).

A worrying trend observed across all regions and language groups is the global decline in the mental wellbeing of younger generations. The Mental Health Million data show that with each successively younger generation, there is a decline in mental wellbeing, as reflected in falling MHQ scores and a corresponding increase in the proportion of people who are distressed or struggling with significant mental health problems.

Even today, mental health issues are branded with a high level of stigma although it has a profound impact on the individual and society as a whole. Negative perceptions that stigmatize mental health issues may discourage and prevent individuals to seek help. This combined with poor access to mental health care services leads to significant public health issues, not to forget the economic costs to society, including healthcare costs, lost productivity, and reduced economic growth. To begin with, mental health is a public health issue affecting a person’s overall well-being, quality of life, and productivity and is of vital importance to both individuals and societies.

The Entrepreneurial Boost program – or Yrittäjyysbuusti in Finnish – is a program co-funded by the Pirkanmaa region Centre for Economic Development, Transport and the Environment, TE Services, and the Ministry of Economic Affairs and Employment of Finland. The program is a unique service model to support the entrepreneurial aspirations of early-stage entrepreneurs who are at the beginning of an entrepreneurial venture or business journey.

Expos, trade fairs, and shows are a way to build business networks and search for partners that open new potential markets. It brings a lot of positive exposure for companies and their innovations, builds customer interest, and opens doors for collaborative projects along the life science and medical technology value chain.

The EU Research and Innovation Programme 2021-2027 has gathered a lot of attention from the research communities around Europe this time around with their Cluster Health topics that are open for proposals. The published destinations aim to address acute and long-term problems in the healthcare ecosystem and the health and well-being of citizens from a societal point of view – without forgetting the lessons learned from the Covid-19 pandemic.

For 2021 inXso has created a webinar series outlining some specific features that are essential for global design of medical technology, and introduces some regulatory aspects in context of EU MDR and Swiss regulatory landscape, as well as some basic features from Chinese and Japanese regulations that everyone – or every company – considering these healthcare markets should now of.

Internationalization attempts usually fail due to a lack of thorough preparation and adherence to the chosen strategy.
When it comes to the medical industry – such as life sciences, healthcare technology, biomedical technology, and pharmaceuticals – an industry operating in a heavily regulated environment, any attempt to seek market growth through internationalization faces a multitude of specific considerations.