Boston Scientific’s Transbronchial Needle Case Study

Enhancing Usability, Reducing Costs, and Streamlining Procedures

Problem

Lung biopsy aspiration procedures were complex and inefficient. It required a multi-person team—a surgeon, nurse, and technician—to operate a two-handed device prone to detachment, kinking, and sample loss. With operating rooms charging by the minute, the inefficiency resulted in significant additional costs, potentially in the hundreds of dollars per procedure.

The process was cumbersome and involved multiple steps: the technician unwrapped the device, handed it to the surgeon, who used fluoroscopy to identify the nodule. The technician or nurse would then insert and deploy the needle based on the surgeon's command, with one person deploying it and another applying vacuum to collect tissue samples, which were then processed by the technician. Not only was this scenario challenging to navigate for all, but it often resulted in sample loss.

Solution

To address these challenges, we developed a single-handed aspiration system featuring a syringe-based vacuum mechanism. This innovation enabled physicians to control both needle deployment and aspiration independently, reducing staffing needs and operational costs.

The device’s intuitive design includes a thumb-slide mechanism for needle deployment and a pinky-operated vacuum, allowing for precise, one-handed control. This streamlined approach enhanced procedural efficiency, improved physician control, and contributed to better patient outcomes.

Outcome

The Transbronchial Needle was designed, tested, and brought to market in under one year. It delivered enhanced performance and clinical outcomes, reduced operating room time, and eliminated the need for an additional technician during procedures. In addition, this device is capable of utilizing any syringe size, which allows the user to select size based on user grip strength. Its continued use in clinical settings today is a testament to its long-term success and sustained adoption.

Services Provided To Create Boston Scientific’s Transbronchial Needle

Research

  • Engaged with Boston Scientific team members to document concerns on the existing manufacturing line.

  • Analyzed failure modes in the current procedure.

Usability

  • Reviewed videos and procedural documentation to observe how the product was used.

  • Identified issues such as sample loss due to improper vacuuming and inconsistent needle deployment. These issues were corrected by redesigning/retolerancing the needle and sheath to create a positive stop at the end of the sheath, thus consistently positioning the extension of the needle tip to be Deployed.Consistently.To be.10mm.Plus or minus?.25mm.

Workflow Optimization

  • Mapped out the full procedure, identifying failure points and streamlining the workflow to reduce operational complexity.

Animal Studies

  • Participated in reviewing animal study videos conducted by Boston Scientific to ensure product performance.

Program Management

  • Based on experience and simple math, we were capable of estimating part cost at the onset of the project allowing for proper budgetary planning.

  • Developed a detailed summary of the project, including milestones, product cost targets, pre-engineering tooling costs, and estimated testing costs.

  • Engaged with partner vendors early to ensure realistic, real-world cost projections.

Project Management

  • Managed the project timeline from start to finish, assigning roles and responsibilities of both internal (Boston Scientific) and external (HaA) resources.

Regulatory Compliance

  • Qualified and trained under Boston Scientific’s Quality Management System (QMS), enabling seamless integration into their team for documentation and work instructions.

Industrial Design

  • Sketched initial concepts and built CAD models.

  • Down-selected designs based on human factors, environmental needs, and product workflow

  • Developed graphics, color material finish and branding 

  • Final designs balanced form, fit, and function.

Engineering

  • Collaborated with personnel on the manufacturing floor to address tolerancing issues, including part size, needle length, and wire/tubing dimensions.

  • Selected the optimal mechanism to maintain a compact form factor while ensuring functionality.

CAD Development

  • After finalizing the product specification and form, created 3D CAD models to initiate the manufacturing process.

Prototyping

  • Produced fully functional, sterilizable test units using native materials for animal studies.

  • Worked with an injection molding partner to expedite first article inspections and minimize risk during production.

Manufacturing Support

  • Identified tooling and injection molding manufacturers.

  • Provided tooling codes and part quantities to support testing and validation requirements.