I have spent more than two decades in MedTech, working in Quality and Regulatory, executive leadership and transformation roles, from venture-backed startups and private equity-backed businesses to family-owned companies and multinational organisations.

Over time, I became less interested in whether a process existed and more interested in why it worked in one organisation and created friction in another.

If a CAPA remains open for six months, we can ask why it has not been closed. But I also want to know why nobody reacted earlier. Who had the information. Who owned the decision. Where escalation should have happened. The same applies at organisational level. What looks like Regulatory complexity may have started with an unclear responsibility somewhere else. What looks like a process problem may be a process compensating for an organisational problem it was never designed to solve.

As companies grow, responsibilities become distributed, decisions move across functions, and structures that once worked well start to behave differently. They are still documented. They may even still be compliant. They just no longer reflect how the organisation actually works.

Not every execution problem is structural. Sometimes a process is simply badly written. Sometimes somebody made the wrong decision. But when the same friction keeps returning in different places, I become interested in what sits underneath it.

Because at that point, fixing the visible problem may not fix the problem at all.