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© 2026 Boyd Biomedical, Inc.
SILS™ Hand Instruments
About the Work
When Covidien set out to bring single incision laparoscopic surgery to widespread clinical adoption, they faced a fundamental instrument challenge: conventional rigid laparoscopic tools couldn't deliver the access, maneuverability, or ergonomics the SILS™ Procedure demanded. Solving it required rethinking how a surgical instrument moves—and protecting the innovations that made it possible.
The team at Design by Boyd partnered with Covidien to develop the SILS™ Hand Instruments from concept through 510(k) clearance—generating the intellectual property, developing an articulating instrument platform, and building the design history and regulatory documentation needed to bring a new surgical category to market.
Concept Generation
Concept GenerationConcept Evaluation
Concept Development
Concept Refinement & SelectionDesign & Development
Development PlanningRequirements & Specification Definition
Device Design
Device Manufacturing
Risk Management
Documentation
Verification & Validation
Verification & Validation PlanningProtocol Generation
Testing & Test Management
Report Generation
Manufacturing Transfer
Device Master RecordConcept 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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%20-%20SILS%20Hand%20Instruments/Case%20Studies%20-%20SILS%20Hand%20Instruments%20-%20Graphic%201%20(800%20x%20800).png?width=400&height=400&name=Case%20Studies%20-%20SILS%20Hand%20Instruments%20-%20Graphic%201%20(800%20x%20800).png "Case Studies - SILS Hand Instruments - Graphic 1 (800 x 800)")
%20-%20SILS%20Hand%20Instruments/Case%20Studies%20-%20SILS%20Hand%20Instruments%20-%20Graphic%202%20(1920%20x%201080).png?width=400&height=225&name=Case%20Studies%20-%20SILS%20Hand%20Instruments%20-%20Graphic%202%20(1920%20x%201080).png "Case Studies - SILS Hand Instruments - Graphic 2 (1920 x 1080)")
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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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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%20-%20SILS%20Hand%20Instruments/Case%20Studies%20-%20SILS%20Hand%20Instruments%20-%20Product%201%20(800%20x%20800).png?width=400&height=400&name=Case%20Studies%20-%20SILS%20Hand%20Instruments%20-%20Product%201%20(800%20x%20800).png "Case Studies - SILS Hand Instruments - Product 1 (800 x 800)")
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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