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IFU design for surgery

Challenge

ProFibrix, a MedTech start-up, needed clear Instructions for Use (IFU) for their surgical device. They challenged Team Consulting to work on an accessible IFU design, so the instructions could be easily read by surgeons.

Approach

Team was the lead development partner for the surgical device, meaning we were able to progress the IFU design in parallel with the device’s industrial design. We combined industrial design and rigorous human factors processes to develop an IFU that ensured safe and effective use during surgery.

Outcome

ProFibrix received regulatory approval for their surgical hemostat delivery device in both the US and Europe.

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hand-holding-surgical-spray-device

Designing instructions for surgeons

ProFibrix came to Team to help them develop a surgical hemostat device to deliver a sticky powder that prevents bleeds during surgery. As part of this development, we worked on a bespoke IFU design to ensure it was clear how to use the device safely and effectively during surgery.

hand-holding-surgical-spray-device

Our intention was to approach the design process holistically, utilising key touchpoints in the IFU, packaging and device industrial design to influence user behavior. Designing these elements together allowed us to ensure they worked harmoniously to provide a smooth user experience.

Paul Greenhalgh, User Experience and Innovation Director, Team Consulting
gloved-hands-holding-a-surgical-device-over-an-ifu-1

Identifying use errors

We carried out extensive human factors research to observe and understand where user error could occur and mitigated this through a combination of instructional material and improvements to the hemostat device’s user interface.

“During the human factors studies, we observed that some users were twisting the detachable nozzles the wrong way, so we adjusted the illustrations in the IFU to be drawn from the user’s point of view, making the required action clearer.”
Diane Aston-James, Human Factors Operations Director, Team Consulting

gloved-hands-holding-a-surgical-device-over-an-ifu-1

Parallel industrial and information design

As Team developed the IFU design and device industrial design in parallel, we were able to make parts of the device clearly identifiable in the instructions, color coding key interaction points such as the actuation button and nozzle. This also allowed us to optimise and describe the set-up procedure, ensuring safety critical functions were understood, such as operating pressure and orientation constraints due to the gravity fed nature of the technology. The illustrations were designed to be realistic, but not photorealistic, focusing attention on key details. A minimal color palette was also used to increase the visibility of warnings and critical use steps.

Having the freedom to alter the physical design alongside the IFU was a key factor in improving its usability. We could make physical design changes that made key features much easier to understand when reading the instructions.

Paul Greenhalgh, User Experience and Innovation Director, Team Consulting

Working in a sterile field

As the device was primarily designed for use during open or laparoscopic surgery, it needed to remain within a sterile surgical field, while the non-sterile packaging and IFU had to remain outside. This meant we needed to make sure the instructions could be read and understood from a distance. We tackled this obstacle by printing our instructions onto a large format instructional ‘poster’.

Surgical-IFU

Information design

Our instructions were designed, prototyped and tested in a highly iterative manner, to ensure the information design was as intuitive and practical as possible. One strategy we used was to show the system components before the first use step, to help familiarize the user with the device before operating.

Surgical-device-IFU

Information 'chunking'

Another applied technique was ‘chunking’, where use steps were divided across clearly defined panels, using paper folds to differentiate each section. This helped to separate each step and make the instructions easier to follow.

Close-up-of-surgical-device-IFU

Information hierarchy

The IFU design also followed a hierarchy of information to highlight the most important pieces of information in each section, making the key content more memorable. We used varying font size, font color and contrasting backgrounds to implement this hierarchy and emphasize crucial details.

Outcome

This user-centered IFU design was completed by Team Consulting as part of a full device development service, resulting in a ground-breaking surgical device for our client. ProFibrix has since been fully acquired for $240M.

The IFU design has since been highlighted in the book Information Design Unbound, written by information design experts Sheila Pontis of Massachusetts Institute of Technology (MIT) and Michael Babwahsingh of Sense Information Design LLC.

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