Boyd Biomedical, Inc.

© 2026 Boyd Biomedical, Inc.

Case Studies

SILS™ Hand Instruments

Articulating laparoscopic instruments that move as an extension of the surgeon’s hand, built to advance single incision surgery.

About the Work

Covidien, now part of Medtronic, was advancing single incision laparoscopic surgery with the SILS™ Procedure. Conventional rigid laparoscopic tools couldn’t deliver the access, maneuverability, or ergonomics the procedure required, so Covidien came to Design by Boyd for a new class of instrument. We developed articulating concepts that tie tip movement to handle movement, so the instrument acts as an extension of the surgeon’s hand. We then took the instruments through design and development and verification and validation, and helped Covidien secure 510(k) clearance. Backed by two utility patents, the SILS™ Hand Instruments drove wider adoption of the procedure, and the platform continues under Medtronic.

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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

Design Transfer

Device Master Record

Our Work

Concept Generation & Development

The team at Design by Boyd collaborated with Covidien's legal team to generate new technical concepts for articulating laparoscopic instruments, working carefully within the competitive landscape to develop a defensible and innovative approach. The defining insight: tying articulation directly to handle movement, so the instrument tip functions as a natural extension of the surgeon's hand.

Invention disclosures from this work led to a series of utility patents (US 8,801,752 B2; US 9,883,880 B2) protecting Covidien's intellectual property. Benchtop prototypes were designed, fabricated, and tested in vitro to evaluate and refine the concepts before moving into Design & Development.

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Our Work

Design & Development

With refined concepts in place, the team at Design by Boyd developed the full SILS™ Hand Instrument design—compiling requirements from Covidien's clinical experts in the SILS field and translating them into detailed technical specifications. Industrial design studies conducted in close collaboration with Covidien's design team produced an ergonomic handle engineered for optimal surgical control.

Injection-molded plastic and metal components were used to build "looks-like" and "works-like" prototypes for benchtop evaluation of device functionality and clinical effectiveness, with animal testing protocols developed in close partnership with the Covidien team. A complete Design History File was maintained within Covidien's quality management system throughout the program, alongside detailed design specifications, a risk management file, and collaborative development of a pilot manufacturing line with Covidien's manufacturing team.

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Our Work

Verification & Validation

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

The team assisted Covidien's regulatory team in preparing their 510(k) submission (K091869), which was approved and cleared the SILS™ Hand Instruments for commercial sale.

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Our Work

Outcomes

Covidien successfully commercialized the SILS™ Hand Instruments and drove widespread adoption of the SILS™ Procedure—establishing a new standard in minimally invasive surgery and reinforcing Covidien's position as a global leader in the field. The company has since become part of Medtronic, carrying the legacy of the SILS™ platform forward.

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Intellectual Property Protection

Close collaboration with Covidien's legal team during concept development yielded multiple invention disclosures and a series of utility patents—securing the intellectual property that gave Covidien a defensible position in an emerging and competitive surgical category.

Development of the SILS™ Procedure

The SILS™ Hand Instruments solved the clinical barriers standing between single incision laparoscopic surgery and widespread adoption—delivering the articulation, maneuverability, and ergonomics that surgeons needed to make the procedure viable at scale.

Successful Product Launch

From concept through 510(k) clearance, The team at Design by Boyd delivered a fully developed instrument platform with complete design documentation, validated processes, and regulatory approval—giving Covidien the foundation to launch a new surgical category with confidence.

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