What can we learn from… a progressive Notified Body?

Medtech governance in Europe is highly decentralised, with product certifications also being "outsourced" to private entities (i.e. Notified Bodies). This would be complicated enough if classic Notified Bodies didn't also bring their own enormous challenges to the table: lack of availability, lack of new tech competence, lack of transparency and communication.. Companies feel they have no control over their destiny.

So what's Scarlet doing differently as a Notified Body:
1️⃣ Focus on one subject matter (digital devices only) to ensure top and uptodate competence
2️⃣ Fit the conformity assessment process around the applicant and their timelines
3️⃣ Engage transparently and pragmatically about expectations in pre-sub Structured Dialogues
4️⃣ Scale resources flexibly with externals

and, my favourite,

5️⃣ Train their trusted consultants in an independent manner in order to increase the chance of high quality submissions and enable more effective reviews.

Which other NBs do this? None that I'm aware. But please share if you know any good practices you've experienced.

Therefore, I'm particularly enthusiastic to have been part of this special training session last Friday! Not only with a like-minded NB, but among a group of 18 like-minded regulatory experts ❤️

New times and new tech need a new approach - a mantra of Edge Compliance. I hope other and new NBs will take example.

Note: I'm not affiliated but believe the initiative deserves genuine praise and broadcasting.

Thank you Dan Levy and Sandy Wright at Scarlet - also for the photo credit. Stellar job!

At Women’s Health Week Europe

An absolutely incredible time at Women's Health Week at the Barbican! The opportunity and momentum for femtech re undeniable.

It's no philanthropic initiative, it's a business sector with real problems be solved and real money to be made. Women, i.e. 51% of the population, control more than 80% of household health decisions, yet suffer ill-health for 19% more time than men - mostly during their working years.
Closing the gap could generate >$1trillion annual global GDP by 2040. It's no charity, it's business sense.

The innovation that is happening in this space fills us with awe, anticipation and gratitude. Will post more about some of the founders and products that we learnt about.

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!