Senior advisory for pharma, medtech and regulated industries
I help leaders and teams in pharma and medtech get the plans made, have the conversations and take the decisions, so execution can start. That is where it becomes real, and I stay until people actually work differently.
The hard part comes when the strategy has to run: roles that have to change, data that has to connect, software that has to be approved, and an organisation that has to want it. I have done that work for twenty years, in global pharma and medtech and in startups, and always inside MDR, FDA, the EU AI Act and GDPR.
Write to me at soren@smedadvisory.dk.
Three examples of what came out of the work.
Medtech
A new business area built from five to 200 people in six countries. A ten-year business plan approved by executive management. The quality management system and cloud platform built to carry the products.
Result.Products CE marked in class I and IIa and FDA cleared. In daily use by 100,000 patients in 2022.
Pharma
Built the launch framework. Prepared and followed up 20 to 30 affiliates, and challenged the brand plans in every major market: the US, China, Japan, EU5, Canada, Brazil and Latin America.
Result.Share taken from the market leader. The framework is still in use.
Transformation, digital and AI
Implemented two scientific search platforms. Chat-based use cases for data cleaning and data identification. A model for which data may be used with which models, and EU AI Act classification.
Result.More than 65% of the area uses the platforms in their daily work. AI training completed.
Email is the easiest way. I answer the same day.