Case Study

Glacial® Skin

About the Work

Blossom Innovations, a leading technology development company in clinical dermatology, formed R2 Technologies to commercialize Glacial® Skin in partnership with Mass General Brigham. Glacial® Skin is a novel technology that utilizes precision cooling to affect the skin.  Blossom Innovations turned to the team at Design by Boyd to develop the system from concept generation through regulatory approval. The product, Glacial® Skin, is now a global leader in CryoAesthetics®.

Concept Generation

Concept Generation
Concept Evaluation

Concept Development

Concept Refinement & Selection

Design & Development

Development Planning
Requirements & Specification Definition
Device Design
Device Manufacturing
Risk Management
Documentation

Verification & Validation

Verification & Validation Planning
Protocol Generation
Testing & Test Management
Report Generation

Manufacturing Transfer

Device Master Record
Our Work

Concept Generation & Development

We collaborated with the team at R2 Technologies to develop technical concepts for how the system could generate controlled cooling. Several invention disclosures were generated from this work, which led to a series of utility patents (US 9,855,166, US 9,974,684, US 11,197,776, US 11,590,022) that protected R2 Technologies' intellectual property. We designed, fabricated, and tested benchtop prototypes to evaluate these concepts in vitro. We then used the results from this testing to refine the concepts and begin the Design & Development phase.

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Our Work

Design & Development

Based on the refined device concepts, the team developed a design for the new system. We compiled design requirements based on input from doctors and independent research, and then these requirements were translated into technical specifications. We conducted industrial design studies to develop an ergonomic handpiece based on anticipated usage. The team built "looks-like" and "works-like" prototypes, which were used in animal studies to evaluate the device's functionality and clinical effectiveness. We worked closely with the team at R2 Technologies to develop their animal testing protocols. We created and maintained a Design History File (DHF), which documented the development process and the final design. We developed detailed design specifications, all manufacturing documentation, and we created and maintained a risk management file, which helped feed additional design specifications. As part of the system, we also developed firmware and a user interface for the device. 

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Our Work

Verification & Validation

During the Verification & Validation phase, our team translated the technical specifications into verification and validation testing protocols. We supported all of the testing, including testing to show regulatory compliance with the relevant standards for electrical safety and usability. As part of our work, we assisted the regulatory team at R2 Technologies in compiling their 510(k) submission (K161480), which was subsequently approved and cleared the device for commercial sale.

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Our Work

Outcomes

R2 Technologies successfully commercialized their novel new technology, Glacial® Skin, and have become the global leader in CryoAesthetics® using precision cooling to affect the skin. 

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Intellectual Property Protection

Successful Product Launch

Global Market Leadership

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