I advise industrial suppliers, component makers, converters and contract manufacturers
– in entering and scaling within the MedTech ecosystem

ISO ≠ Market Success

 

Medical technology is one of the most exciting—but also most demanding—markets for medical component suppliers, converters or contract manufacturers. Yet many companies underestimate what truly matters and where the real opportunities lie:

​​

• ISO 13485 or just 9001?

The distinction is often unclear—especially for components without direct patient contact. Many companies invest too early or in the wrong direction, without properly assessing market needs and a clear growth strategy.

• Regulatory readiness isn’t enough: 

ISO 13485 is not a ticket to the game—it’s merely part of the foundation. What really counts is whether a supplier can demonstrate true MedTech capability: commercially, organizationally, and in management execution.

• Cross-industry operations dilute positioning:

Many suppliers serve automotive, industrial or other sectors—treating MedTech as an add-on rather than a dedicated vertical. This slows down trust-building, visibility, and specialization. 

• The market is growing—but not for everyone 

MedTech, life sciences, and pharma offer solid growth and political resilience. At the same time, expectations around quality, documentation, and strategic partnerships are rising.

• Margins and long-term business potential are attractive:

Unlike in cyclical industries, MedTech enables long-term, high-margin series production—sometimes running for 10 years or more. But only if the supplier is seen as a credible and committed partner with clinical know-how.