Arthroscopy Pump

  • 10k Pump

    10k Pump

  • 24k Pump

    24k Pump

  • 87k Pump

    87k Pump

  • CrystalView Pump

    CrystalView Pump

Services Provided

  • Program / Project Management

  • Risk Management

  • Systems Engineering

  • Mechanical Engineering

  • Electrical Engineering

  • Software Engineering

  • Software Quality

  • Electrical Product Safety

  • Regulatory / Quality

Client Background:

Similar to a previous project for an Arthroscopy Console, this client returned to Concise Engineering to partner on another product refresh.

Client’s Request(s):

While doing the work necessary to refresh the look and feel of the product, management also asked for an analysis of product complaints and failures, to improve customers’ satisfaction.

Project Actions:

The project consisted of two phases:

  1. Root Cause Analysis (products & processes)

    • Identified key concerns; revealed operational elements impacting complaints

    • Proposed, tested, and implemented corrective design & process changes

  2. New Product Development/Refresh

  • Updates to the electronics board and software

  • Changes to associated disposable and accessory products

  • Support and expertise to comply with IEC 62304 and support a 510(k) application

  • Incorporated improvements requested by Sales and Marketing based on user feedback

Outcome:

After the completion of the project and product launch, our client updated us on a few key metrics:

  • Successful 510k completion

  • Statistically significant improvements to overall complaint rates

Furthermore, the client reported that our results were cost and time-effective, estimating a 1/3 time-and-cost savings over hiring a new team in-house

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Hydrosurgery