Getting it right should be easy

The winning hack in the SwedenBIO Hack:

Small and medium-sized life science companies face many challenges on their development journey, where interaction with public authorities should not contribute to the challenges, but rather create opportunities.

Life science is a highly regulated industry. It is no longer only medicines that need to present strong evidence for their benefits, but also medical technologies and diagnostics are becoming more regulated. We see several upcoming EU directives and regulations and the trend is so clear that we can expect a further increase in the future.

At the same time, complexity is increasing through interdisciplinary advances. We talk about companion diagnostics, precision medicine, e-health and combinations of medicines – even from different developers. Here we need to make it easier for small and medium-sized enterprises, which do not have nearly the same resources as large companies. This may include resources in terms of staff, skills, budget and experience.

Developing products and services in life sciences is costly. In the early stages, money is limited for companies and delays and unpredictable or unnecessary costs hit already tight budgets and ambitious targets.

We want the success of Swedish life science to be seen as a co-creation. Where society’s needs and those who meet them see a common goal in working together, lowering thresholds and cutting lead times. The authorities that allow companies to test their products need to be more proactive and progressive to ensure that Sweden can count on continued revenues from the life science sector.

In its instructions to the Medical Products Agency (2020:57), the Government defines under §5 that “The Medical Products Agency shall, within the framework of its area of activity, promote innovation and life science by working for good access to and adequate use of new effective products.”

Therefore, we want to see that the authorities’ ability to assist and help small and medium-sized life science companies is done through co-creation, as the companies should be able to do the right thing and quickly test their products and services in order to move forward in their development. This is crucial for the development of strong new life science companies. Information exchanges, advice and a review of how to overcome threshold charges are some of the issues that need immediate attention.

Solution :

  1. Availability of targeted information for SMEs.
  2. Availability of advice on medical devices and eHealth products in a similar way as for medicines.
  3. The authority, together with SwedenBIO, should work to ensure that companies can be granted state funds to generate the necessary data for advice from the authority.

Björn Arvidsson, Head of Operations STUNS Life Science, Marie Gårdmark, CEO RegSmart and Arvid Söderhäll, CEO Empros Pharma.