Smed Advisory

Services

Four areas. I keep pharma and medtech apart, because the buyer and the regulation differ, even when the work looks alike.

Each area lists concrete projects I have worked on and delivered.

Pharma

Commercial strategy and launch

When a launch has to be prepared across countries, a portfolio needs prioritising, or a new therapy area has to be assessed.

  • Global launch preparation. Launch framework, affiliate follow-up and challenge of brand plans in key markets.
  • Early commercial assessment. eNPV and sensitivity analyses, target product profiles and assessment of new therapy areas.
  • New business areas next to the core business, from commercial rationale to agreement in the leadership team.
  • Investment decisions. Cases, prioritisation and running portfolio committees.

Medtech

Devices and regulated software

When a device business has to grow, or when software needs CE marking or FDA clearance.

  • Growing a device business. Portfolio, new product launches and discontinuing old ones.
  • Software as a medical device. The route to CE marking and FDA clearance, quality management system and platform.
  • Connected devices. The commercial side of development, data collection and partner integrations.
  • Partnerships and acquisitions. Co-development, IP, minority investments and royalties tied to patient outcomes.

Transformation, digital and AI

Organisation, data and AI in operation

When an organisation has to change, and AI has to be put to work by the people who do the job.

  • Reorganisation. Operating model, roles and responsibilities, and implementing the new organisation.
  • AI in use. Use case selection, governance, EU AI Act classification and the adoption work that decides whether anything lands.
  • Data governance. Common definitions, data ownership and stewardship in the line.
  • Investments and processes. Prioritising digital investments, process ownership and moving workflows to a shared service centre.

I also take on work in other regulated sectors such as energy and finance, where the EU AI Act, NIS2 and GDPR apply. My cases are from life science.

Startups and scale-ups

Startups and scale-ups in pharma and medtech

When the commercial model does not scale, or the product has to enter a regulated market.

  • Commercial model, pricing and subscription structure.
  • Market access under MDR and selling to public healthcare.
  • Working with large pharma and medtech companies: how they buy, and what they require of a partner.
  • AI products built on agent-based workflows, from prototype to paying customers.

I have sat on both sides of that table. It is the biggest advantage I can give a startup.

Working together

Four ways to work together. We find the right one in the first conversation.

Defined project
A defined task with a deliverable, such as a launch plan or an AI governance model.Usually 4 to 12 weeks
Strategic sparring
Ongoing access for a leader or a leadership team.Monthly agreement
Interim management
A senior role through a transition, such as a reorganisation.Usually 3 to 9 months
Advisory board
A seat on the advisory board of a startup or scale-up.Ongoing