Crans-Montana, a compliance perspective

Regulation is often seen as pain in the neck… until it isn't. A national tragedy takes place in Switzerland on NYE, and we ask ourselves why didn’t this underground bar have compliant emergency exits? Why wasn’t it inspected in more than 5 years? How could a combustible soundproofing material be permitted and line the whole ceiling? How could staff pull off such a deadly stunt (regularly!) with zero awareness about fire risk? Why the heck were the victims-to-be filming instead of fleeing??

And in particular, how could ALL these hazards manifest simultaneously??

I am horrified by the incident in Crans-Montana (news article). It should never have been. It lights up the painful memory of the Grenfell tower fire in 2017, which had shocked me deeply as I was living in London back then.

We all assume and expect to be protected by regulation. We all assume and expect compliant and responsible behaviour of others. The reality is that if things go south, we are on our own to face the consequences. We all have a responsibility to do our bit, whether it’s fire safety or health.

Being alert to risks, and raising the awareness of others too. Informing yourself and doing your best at least, not ignoring. Holding others accountable by asking questions or reporting unsafe practices. Raising your voice to policy-makers if something isn't enough.

I hope my work does a bit on all these things, within the realm of healthtech, of course, not fire regulation.

As a result, Switzerland now banned the use of pyrotechnics in indoor spaces and is investigating not only the bar owners but the municipality, that did not inspect the bar ONCE in 5 years. The sale of any flammable soundproofing materials is also under scrutiny.

Could this bring into 2026 a bigger wave of respect for regulation and compliance? Am I hopelessly wishful?

Today in Switzerland is a national day of mourning for the 40 victims, mostly teenagers. It breaks my heart to think of what’s left of the 116 injured.

I pray for them and for something like this to not be allowed to happen again - by regulators, by business owners, by fellow citizens, by luck (that's a factor too..🍀), by us all doing our little responsible part in society.

(Image rights: https://www.bbc.com/news/articles/c9dvyyjyj18o)

At Swiss Medtech 2025

Swiss Medtech events never disappoint!
Key learnings from attending yesterdays session in sunny Bern (inside a stunning casino!):

1️⃣ US tariffs and lower FDA capacity are discouraging EU/CH startups from going US-first, but there are clever best-practices to work around them.

2️⃣ EU's gap between numbers in MDR applications and certifications is widening in unsustainable ways due to a poor EU-wide governance model for medtech, and how this needs fixing ASAP.

3️⃣ Switzerland is working out creative legal basis to be an attractive alternative (e.g. to fast-track FDA medical devices and to modernise its regulatory framework faster than the EU can)

4️⃣ Emerging markets (e.g. Saudi Arabia) get devices to market 6 months faster than traditional markets, meaning their patients get better outcomes, HCPs get better education, and the healthcare system innovates exponentially faster.

Grateful to Bernhard Bichsel and Sandra Item from ISS AG, Integrated Scientific Services, Daniel Delfosse, Eva von Mühlenen, LL.M., from Sidley Austin LLP, Glenda C. Marsh from Johnson & Johnson MedTech for putting together such an inspiring and informative afternoon!