Case studies

Pumps & delivery devices

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Risk assessment for surgical equipment

A medical manufacturer had US-approved surgical equipment, but its current design was not working for some international markets.

Challenge

International markets required the system to be smaller and more compact, but still maintain the necessary functionality. With the new changes, the manufacturer wanted to conduct testing in the US to get FDA approval, which would facilitate approval in international markets.

Approach

We tested the redesigned device with a surgical team trained on the current system.

This included in-person testing in an outpatient clinic, in the surgical team’s environment. We evaluated system setup, tool programming, and use during a simulated surgery.

Outcome

We evaluated and updated their Risk Assessment (uFMEA), aligning with previously submitted documents, while identifying new risks and user paths for the redesigned equipment.

Acceptability of new drug formulation and device

A pharmaceutical manufacturer was simultaneously developing a liquid formulation for a drug (currently only available as a pill), as well as a new delivery device to administer this liquid formulation.

Challenge

The manufacturer wanted to evaluate the usability and acceptability of the new formulation and prototype device and gather insights for further development.

 

Approach

We conducted one-on-one in-depth interviews with participants currently taking the pill form of the medication. Participants were asked to complete a simulated-use scenario using the prototype device. We obtained feedback on ease of use, physical attributes, need for instructions, and overall acceptability of the device. We also captured participant data around the new liquid formulation, including appearance, taste, and color.

Outcome

While the device was relatively easy to use, feedback about the acceptability and usefulness of the device for daily use was largely negative. Participants nearly unanimously cited the size of the device as a major deterrent (especially as it related to portability, storage, disposal, etc.) and were also hesitant about the potential taste of the medication. Due to these issues, it was not recommended that development of the device be pursued for this medication unless substantial changes were made. 

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