MedTech Insights and Expertise

Medtec Europe 2017 Stuttgart

Medtec EUKinsella Group attended Medtec Europe April 4 -6 in Stuttgart Germany. We report some strong themes from show exhibitors and visitors around regulatory issues.

Key areas of interest or concern include:

  • Definition of Med Device vs Pharma vs Diagnostic. In Europe, this is an area that has been subject to a great deal of ambiguity with unclear and imprecise regulatory definitions. Many believe that most, but not all, of this ambiguity will be cleared up later this month in new EU regulations set to be passed in Brussels
  • Regulation of Medical Apps. A plethora of medical apps have been developed for smart devices. Many of these fit under statutory definitions that may require regulatory approval or oversight yet no process has been implemented to do so. This is especially problematic given cutbacks at notified bodies in the 30% range
  • Cyber security. Given the above issues with apps and the rollout of more internet connected medical devices, what standards of cyber security must be implemented for patient security and privacy?

There was also much discussion of the globalization of the industry, especially the globalization of the supply chain. This creates a much more demanding environment for suppliers to the large OEMs to compete.

There was a consensus that smaller companies would be less able to compete in this new and dynamic environment. The need to cover higher fixed costs associated with the macro trends could turn many small businesses unprofitable. All agreed that this is a global trend.

Robotics surgeries were discussed by some. It was noted that until robotics could produce results superior to those performed by surgeons, that robotics would stay in an assistive role.

Finally, there were continuing conversations about 3D printing. But as noted in our blog in previous posts, 3D seems to be a perennial favorite topic at shows. However, this year the number of companies exhibiting offering 3D appears to have declined. We are not sure if this represents a maturing technology or general less interest in it.

As a last comment, the Show has declined in size again while it sister show in Anaheim, California (MD&M West) grows in size. Some speculated that this is a result of the globalization of a U.S.-centric industry. Thus some exhibitors remained tentative in their support of the show.