Execution Clarity in Medtech Innovation: Audit-Ready by Design

Hamilton develops medical technology products under ISO 13485. In this interview, Program Manager Nicolai Rüedi explains how the company moved its innovation process away from document-driven thinking toward genuine process guidance, where regulatory requirements come in at the right moment instead of constraining ideas from the start. He shares how a single master system with clear navigation creates overview and cuts friction, and what it takes to turn that into real execution clarity on the ground.

Hamilton Headquarters in Switzerland

ISO 13485 sets the framework for how medical device companies, such as Hamilton, develop and document their products. It requires full traceability and ensures that every development step, from testing through verification and validation, is documented and reproducible.

Over the years, staying compliant had quietly shaped the way people thought about work. As Rüedi puts it: “Instead of seeing the flow, the documents were always front and center.” Processes were described on paper, but no one had a clear view of the process as a whole. The logic had become simple and limiting: complete the document, move to the next step.

Rather than tackling everything at once, Hamilton chose to start where the end-to-end impact would be greatest: the innovation process. Spanning multiple departments and involving more than 50 people, it had grown into a dense landscape of guidelines, work instructions, forms, checklists, milestones, and stage-gates, with around 250 documents on file with no clear way to see how they related to each other.

The goals behind the change were clear:

• The process needed to reflect how work actually happens, not exist as a parallel world alongside it.
• Regulatory compliance should not become a brake on innovation; requirements needed to come in at the right moment, leaving room for ideas to develop early on.
• The change had to deliver tangible value to the people using it: better overview, easier navigation, more transparency, and less friction in day-to-day execution.

Hamilton made a deliberate choice to avoid the obvious but often ineffective path of simply pouring the innovation process back into documents. If you are going to optimize, Rüedi reasoned, you cannot end up in the same logic you started from.

What followed was a mindset shift that had to be actively shaped. The guiding idea was both simple and demanding: completing your part does not mean you are done. It means you are contributing a building block to something larger.

The focus shifted from departments to the product itself and its level of maturity. The question was no longer “what do I hand over?” but rather: what maturity level are we trying to reach, and what does that require?

Regulatory requirements were not left out of that thinking. Quite the opposite. Hamilton integrated them deliberately, but at the right moment. As Rüedi frames it: “At what maturity stage do I need which regulatory requirements?” Early on, the idea should take center stage. There needs to be room to explore.

“The end-to-end process flow is what was new,” says Rüedi.

With the new process logic defined, Hamilton needed a system that could bring it to life in daily work, surfacing the right documentation at the right step without requiring people to go looking for it. The answer was visual process guidance in ADONIS: making the flow navigable without mapping every last detail, with step descriptions and links doing the heavy lifting.

ADONIS became the entry point for the entire innovation process. From each step, it is immediately clear which artifact applies and which document needs to be filled in.

“ADONIS works for us as a master system, a reliable source with clear guidance. I no longer have to search across five systems and tools to find the right information,” says Rüedi.

Versioning was another important piece. Documents have their own approval workflow, and ADONIS always points to the currently approved version. Tool sprawl was addressed just as directly. As Rüedi puts it: “You have to think of this as your master system, one you can trust, so you are not opening 20 tools like before.” Other systems are connected where it makes sense, but ADONIS is where work begins.

That is why Hamilton invested in navigation and user guidance, including cross-links and quick paths to supporting processes. The goal was always the same: less searching, less jumping between systems, faster execution.

To complement this, Hamilton built a knowledge transfer system. Methodologies, tool instructions, and practical guidance that would otherwise live only in people’s heads were documented in Confluence and linked directly from ADONIS.

Hint: Unlock seamless BPM collaboration with ADONIS Process Manager for Confluence.

Hamilton does not measure success with a single number. The real indicator is the disappearance of friction. Document sprawl is gone, and so is the constant jumping between systems.

What took its place was genuine process guidance. “I am now being guided, so I get to the outcome faster,” says Rüedi. Visual navigation serves as the entry point, with links at each step surfacing the right artifact in context. And when needed, people can zoom out and see how their piece fits into the whole.

In practice, the team sees it in the small things: fewer questions about which document applies, less time lost switching between systems. For teams wanting to put numbers to that, metrics like support request volume, search time, or time to independent execution work well and hold up in an audit context.

Transparency is another outcome, and not always a comfortable one. When roles and steps are visible in the process, there is nowhere to hide.

Onboarding has changed noticeably too. New employees get up to speed much faster because the big picture is visible from day one. Interfaces between teams are clear, even as the process itself stays complex.

And project leads have gained something they did not have before: the ability to catch problems early. With outputs and sequencing visible at each step, issues that would previously have surfaced late can now be corrected before they compound.

Hamilton is continuing to develop the logic while staying realistic about the pace. Many processes still live in documents, so the company is running a hybrid QMS for now: ADONIS as the entry point, with the core process on the landscape and direct links to the relevant documents. Prioritization is driven by value creation. Next in line are the supporting processes that feed into the innovation process, with procurement named as an early candidate.

There is also a developing idea to connect task status directly to process steps, making it visible at a glance where a task stands and when a step in the project is genuinely complete.

The lessons learned, distilled:

• Digitizing documents alone achieves little if the process flow is not right.
• Usability determines adoption. Without it, knowledge drifts back into people’s heads and shadow processes take over.
• Regulatory standards and innovation are not in conflict, as long as requirements are integrated into the process at the right level of maturity.