Table 1

Design evolution based on user evaluations

	Round I Prototype A (PU 32)	Round II Prototype B (PU51-53)	Round III Prototype C (PU56)	Round IV Prototype D (PU55)
Key characteristics	PU pouch Two fixed rings	Inner ring replaced by foam band Tampon tube applicator	Foam band reduced to foam dots Foam cap used for packaging, insertion aid, and device stability Different lubricants evaluated	Foam cap replaced by dissolving band (DB) Different lubricants evaluated
Evaluation sites	All sites	Seattle	All sites	All sites
Devices evaluated	40	19	130	98
User feedback	Insertion: Easy for many, but troublesome for some. Stability: Very good at all sites. Comfort: Mixed results. If device fits well it ‘disappears’ after insertion. Inner and outer rings cause pressure/pain for some. Fit: Fixed inner ring creates a ‘sized’ device. Sizing is problematic. ‘Device was easy and disappeared when inserted, but would prefer more flexible and elastic inner ring.’ (Mexico 101-July, 2001) ‘Device is stable, but uncomfortable.’ (Mexico-205, February 2002)	Insertion: Easier than double-ring device, but difficult and inconsistent deployment from tampon tube. Tampon applicator not widely accepted. Stability: Ok if foam band opens up and contacts vaginal wall. Comfort: Discomfort for both partners from foam band. Doesn’t ‘get out of the way.’ Fit: Difficult to get snug fit, device feels loose. ‘Felt pressure from ball of foam, disturbing.’ (Seattle-039, December 2001) ‘Applicator opening too wide, rough, jabbing.’ (Seattle-040, November 2001)	Insertion: Better than double-ring, but still difficult/awkward for some. Stability: Much better, but varied with different lubricants. Comfort: Better for both partners, but foam cap ‘awkward’ and ‘bulky’ for some (especially Mexico). Removal: No problems. ‘Foam shapes much better than foam band—not so impeding, but enough grab to keep pouch from coming out.’ (Seattle-043, February 2002) ‘More comfortable than double-ring prototypes; external ring much better.’ (Mexico-205, May 2002) ‘My penis did not hit against the foam cap…this gives very good feeling…smooth as silk or velvet.’ (Thailand-313, November 2002)	Insertion: Much easier. More consistent pouch deployment than from foam cap. Stability: Good. Comfort: Better than previous. Removal: Easy. Sensation and satisfaction: Good. Dissolving material OK, but some concerns, especially South Africa and Mexico. Couples who evaluated both foam cap and DB prototypes in all sites preferred DB. ‘…the edge of the DB needs to be softer.’ (Seattle-043, April 2003) ‘The material is the best feature because of its softness.’ (South Africa-01, June 2003) ‘I reached orgasm well, very close to natural. I have a good feeling.’ Thailand-104, January 2003)
Design recommendations	Make device ‘softer,’ more friendly. Find different feature for internal stability—need ‘one-size device’ to fit broad size range of women. Develop a different insertion aid—not the inner ring. Define outer ring diameter, profile, and flexibility.	Continue to refine internal stability feature to provide secure fit—but ‘get out of the way.’ Develop different insertion aid and packaging scheme to improve aesthetics and handling. Continue to investigate sizing—need one-size device.	Handling/insertion still awkward. Refine package to be smaller, with more integrated features. Continue to refine foam dots (shape, no, placement, and material) for acceptability, aesthetics, and stability. Device still being evaluated in two sizes. Need to establish a one-size device that fits many.	DB edge is too ‘sharp.’ Refine DB to improve aesthetic appeal. Address safety of dissolving material in user instruction and counselling.

PU, polyurethane.