Joylux: vSCULPT

...

Revolutionary, home-use device for the treatment of pelvic floor disorders.

Video: vSCULPT product story

The Challenge

Deliver a fully working prototype in 16 weeks that rejuvenates the tissue and muscles of the pelvic floor.

The Solution

A global first, combining LED light therapy, gentle heat and sonic vibration in a personal product with an easy to use interface.

health-canada-approved-315

Health Canada approved medical device

iso-13485-health-canada-approved-315

ISO Medical Device Certification.

01

Tough Design Challenges

A form factor with heat generation from high energy LEDs, requiring custom designed power management circuitry, in a user-friendly design.
02

Rapid turnaround

Deliver a fully fuctional prototype in record time to help Joylux conduct clinical trials.
03

Electronics Integration

Design a custom electronics board to meet power and regulatory device requirements.
04

Complex Manufacturing

Work through complexities of sealing multiple materials while maintaining strict quality controls.
A

Design

Joylux came to Design 1st with a vSCULPT concept image that met the user criteria for this market. Joylux embarked on this complex medical product with another design company who fell behind schedule. They met with Design 1st who assessed feasibility, applied clever engineering and production-oriented expertise to get Joylux back on track. The challenge was how to integrate the LEDs, heat and vibration technology into the ergonomic constraints of the industrial design targets. The solution had to be manufacturable and meet strict regulatory guidelines. Time to market was critical.

To solve this challenge, the design, electronics and manufacturing risks were identified upfront. The first step after architecture planning was to build low-cost demo models to test first in the lab and then with users. The demo units would follow the production design architecture but needed to be lower cost in order to produce dozens of units for trials. The custom designed prototype would be 90% re-usable in the production design.

"We quickly identified risks and opportunities to facilitate low-cost trial units"
"Tissue effects were optimized for a 10-minute therapy cycle"
B

Engineering

Building out the chosen design concept into 3D CAD was very challenging. The outer shell had to be comfortable, optically clear and waterproof plus it had to withstand the high energy LED heat generated without degrading. The internal components use high amounts of energy from a portable battery. This device uses light at a specialized frequency which needs to work inside the device without the outer shell getting hot.

The LED light therapy control circuitry was devised using two spectrums of light for the therapeutic effects and an aluminum frame/inner body was employed as a heat capacitor. This allowed for testing of multiple combinations of power output and patterns to test tissue penetration effects. Once the right combination was chosen, prototype units were built to test the effects and assess the user experience.

C

Testing

Once the form factor and electronics of the device were locked in, the Design 1st team set out to build multiple prototypes to test variables and remove production risk. The challenge was ensuring all ISO and regulatory requirements were followed during prototyping to expedite regulatory approval of the device.

The first round of engineering testing used gel and a water bath to replicate human tissue and to monitor heat and power outputs of the prototypes. The next evolution was creating and prototyping fully functional units. The Joylux team carried out user trials and showcased the solution to investors to bring the product to full production.

"Build multiple prototypes to optimize design variables"
injection modeling tool for vsculpt
"Use silicone overmolding to seal electronics and allow light transfer without loss"
D

Manufacturing

The complexity of the vSCULPT device shape led to several manufacturing challenges when it came to sealing the product from water entry. A mixture of over-molded clear silicone skin and a manual assembly procedure was employed. This would double seal the electronic circuits within the plastic and metal housing assembly, for very high reliability.

Working with the tool and molding suppliers, Design 1st was able to fine tune the manufacturing process and achieve a perfect seal on each vSCULPT product.

“Design 1st understands getting high quality products to the market quickly, while maintaining the user WOW factor. The Joylux team required an experienced, creative design-engineering team to guide us through development and set up of our manufacturing. The Design 1st team was first class, they helped transform our technology and marketing goals into a world class product to help women.”
- Colette Courtion, CEO & Founder Joylux.

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