Boyd Biomedical, Inc.

© 2026 Boyd Biomedical, Inc.

Glacial® Skin

About the Work

When Blossom Innovations formed R2 Technologies to commercialize Glacial® Skin—a novel precision cooling technology developed in partnership with Mass General Brigham—they needed a development partner who could take the concept from early-stage ideation all the way through regulatory clearance. The technology was genuinely new. The development path would require invention, iteration, and rigorous clinical and regulatory discipline.

The team at Design by Boyd partnered with R2 Technologies across every phase of development—from concept generation through 510(k) clearance—building the intellectual property, design history, and validated device that launched Glacial® Skin as the 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

The team at Design by Boyd collaborated with the R2 Technologies team to develop technical concepts for how the system could generate controlled, precision cooling. Several invention disclosures emerged from this work, ultimately yielding 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 and established a defensible market position.

Benchtop prototypes were designed, fabricated, and tested to evaluate concepts in vitro. Results from that testing informed concept refinement and provided the foundation for the Design & Development phase.

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Our Work

Design & Development

With refined concepts in hand, the team at Design by Boyd developed a full device design—compiling requirements from clinical input and independent research, then translating them into detailed technical specifications. Industrial design studies shaped an ergonomic handpiece built around anticipated clinical usage.

"Looks-like" and "works-like" prototypes were built and used in animal studies to evaluate functionality and clinical effectiveness, with the Design by Boyd team working closely alongside R2 Technologies to develop testing protocols. Throughout the program, the team created and maintained a complete Design History File, detailed design specifications, all manufacturing documentation, and a risk management file—while also developing the firmware and user interface integral to the system.

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Our Work

Verification & Validation

With the design finalized, the team at Design by Boyd translated technical specifications into verification and validation testing protocols and supported all testing activities—including testing for regulatory compliance with relevant electrical safety and usability standards.

The team assisted R2 Technologies' regulatory team in compiling their 510(k) submission (K161480), which was subsequently approved and cleared Glacial® Skin for commercial sale.

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Our Work

Outcomes

R2 Technologies successfully commercialized Glacial® Skin and established the technology as the global leader in CryoAesthetics®. A foundation of protected intellectual property, a rigorously documented design history, and a cleared regulatory submission gave R2 Technologies everything needed to launch with confidence and compete at the highest level.

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Intellectual Property Protection

Collaborative concept development yielded multiple invention disclosures and a series of utility patents protecting R2 Technologies' core innovations—establishing a defensible IP position before the product ever reached market.

Successful Product Launch

Design by Boyd guided Glacial® Skin from early concept through 510(k) clearance, delivering a fully developed device with complete design documentation, validated manufacturing processes, and regulatory approval—giving R2 Technologies the foundation for a confident commercial launch.

Global Market Leadership

Built on a decade and a half of research and a development process designed to match its ambition, Glacial® Skin became the global leader in CryoAesthetics®—a market position made possible by the precision, rigor, and clinical credibility built into every phase of the program.

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Your innovation Just Might change the world. But is your design up to the task? We help you turn Just Might into Just Mighty.