A healthcare company sought HFE support in the development of an HF plan for a drug/device combination product and its accompanying IFU.​
Provide documentation and develop HF plan for combination device​
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IFU
Iteratively design medical device IFU
A pharmaceutical company needed to evaluate the effectiveness of their instructions for use for a new product.
Improve usability of home monitoring system for patients with implanted pacemakers and defibrillators
A medical device manufacturer asked us to evaluate the usability of a home monitoring device for individuals with pacemakers and defibrillators and explore ways to improve the product according to...
Ensure safety and usability of an autoinjector
A pharmaceutical manufacturer required a validation study to determine if an autoinjector and its related materials were safe and effective.
Assess usability of large volume autoinjector platform concept
A pharmaceutical manufacturer was interested in collecting data to inform the development of a large-volume autoinjector and its accompanying IFU and labeling.
Assess feasibility of multi-fixed dose device for the treatment of Type 2 diabetes
A pharmaceutical manufacturer was interested in obtaining empirical data and user feedback regarding the usability of a medication delivery system, including the devices, labeling, and IFU.
Provide documentation and develop HF plan for combination device​
A healthcare company sought HFE support in the development of an HF plan for a drug/device combination product and its accompanying IFU.​
Iteratively design medical device IFU
A pharmaceutical company needed to evaluate the effectiveness of their instructions for use for a new product.
Improve usability of home monitoring system for patients with implanted pacemakers and defibrillators
A medical device manufacturer asked us to evaluate the usability of a home monitoring device for individuals with pacemakers and defibrillators and explore ways to improve the product according to user needs and preferences.
Ensure safety and usability of an autoinjector
A pharmaceutical manufacturer required a validation study to determine if an autoinjector and its related materials were safe and effective.
Assess usability of large volume autoinjector platform concept
A pharmaceutical manufacturer was interested in collecting data to inform the development of a large-volume autoinjector and its accompanying IFU and labeling.
Assess feasibility of multi-fixed dose device for the treatment of Type 2 diabetes
A pharmaceutical manufacturer was interested in obtaining empirical data and user feedback regarding the usability of a medication delivery system, including the devices, labeling, and IFU.