3. Evaluation of Device as per Design Specifications

Specifications

1) Full closure was achieved - this met specifications. 

2) Closure was comfortable (or at least not uncomfortable) - this is considered to meet specifications. 

3) The ease of use of the device does not meet specifications - it is difficult to take on and off and each application is not reproducible.

4) In terms of safety, the device does not meet specifications. While it is unlikely that damage will be caused during normal operation, it is unknown what harm will be caused during non-standard situations. For example - if the glasses fall off the user while being worn, there is potential for harm to the user (e.g. tissue damage). 

Key future work involves:

1) Development of easy on/off mechanism (interface between glasses and patch system, also a simplification of the patch system) that can result in reproducible application of the device, within <30-60s, while also including a safety mechanism in case the glasses happen to be suddenly pulled off. 

2) More reproducible and reliable fabrication processes and adhesive selection. 

3) A systematic study outlining displacement ranges and comfortable position ranges required for the actuator displacement and constraint positions. 

Obviously, integration of sensing and industrial design to include power and control in an ergonomic device are also required. 

Summary:

In summary, the current device is unsuitable for patient usage and much work is required before it becomes viable. However, proof of concept has been demonstrated for a promising closure method which could form the basis of a device superior to current treatment methods for temporary lagopthalmos arising from facial nerve paralysis.