The Challenge

When the Client came to us to develop the Instructions for Use (IFU) for their new implanted spinal cord stimulation system, the assignment looked straightforward: produce a clear, regulatory-compliant IFU ready for submission. But from the very start, we were writing blind.

Due to short timescales and supply limitations, we never had physical access to the device. No prototypes. No end-to-end demos. Just PDFs, technical drawings, and virtual Q&A sessions with engineers. That’s not ideal when you're expected to write instructions for how to implant, test, and troubleshoot a complex piece of medical technology.

To complicate things further, the device itself was a moving target. As our draft IFU took shape, the design team was simultaneously iterating on the product. Software configurations changed. Screens were updated. The surgical procedure for the implant evolved. Even the number of IFUs required changed. We weren’t just aiming at a moving target – we were writing for one.

What We Did

We built a flexible, modular content structure that could adapt as the product changed. Sections were written to be easily swappable and clearly versioned. We worked in tight loops with engineers, regulatory specialists, and product managers to keep language aligned with the latest tech specs—sometimes rewriting entire sections the day after approval.

To bridge the gap left by our lack of hands-on time, we:

• Insisted on visual walkthroughs (video and 3D CAD where possible).

• Created step-by-step flowcharts to test logic before writing narrative content.

• Ran simulated “paper walkthroughs” with technical reviewers, using the draft IFU as a script.

• Maintained a change log to track every design-related update and its ripple effect on the document.

What We Learned

• No access doesn’t mean no accuracy. With the right visual tools and expert collaboration, it’s possible to write usable, safe instructions without ever touching the device—though it’s not our preference.

• Design freeze is a myth. Especially in complex MedTech development, IFU writers must be ready to adapt up to the last minute. A modular writing system helped us stay nimble.

• When working quickly people move at different speeds. The rapid iteration of device and IFU design highlighted the times when the project team weren’t all keeping the same pace, with individuals sometimes getting left behind or momentarily being outside the loop.

• Illustrating something you’ve never seen take imagination. Not everyone imagines things the same way. Testing draft content with fresh eyes revealed ambiguity and inconsistencies we wouldn't have caught alone.

What We’d Do Differently

Next time, we’d push harder for early simulated interaction—whether that’s via 3D-printed mock-ups, interactive digital twins, or guided VR demonstrations. Anything to bring us closer to the real-world feel of the device.

We’d also formalize a “design-impact alert” system between product and documentation teams to avoid the tail-chasing that comes from finding out about changes too late in the game.

The Outcome

Despite the constraints, we delivered a clear, accurate, and compliant IFU on deadline—one that satisfied both regulatory reviewers and internal QA. The client now uses our framework as a blueprint for their next-generation product line documentation.