How the First Disposable Surgical Ratchet Was Made

In this Q&A, a developer of surgical instruments explains how a novel device for use in orthopedic procedures was conceived and developed.

Brian Buntz

Reusable ratchets for surgical orthopedic procedures can cost more than $1000 per unit--not to mention the high costs of cleaning and maintaining them.

With hospitals and clinics across the country looking for ways to cut costs, the surgical device firm ECA Medical Instruments (Thousand Oaks, CA) has debuted the first disposable surgical ratchet--a bidirectional device that is designed to cut surgical costs by more than $1000 per surgery. The device can be used to secure screws, fasteners, and connectors used for spine, trauma, and extremity implant procedures.  

In the following Q&A, the company's executive vice president Jim Schultz explains how his company came up with a device that could translate to such extensive surgical cost savings. He also sheds light on the device's proprietary internal drive mechanism that can be used to drives crews, fasteners and connectors for a range or orthopedic spine implant procedures.

Qmed: Where did you get the idea for this product?   

Jim Schultz: Market demand. A current pain in the market is the cost and handling of reusable ratchets. They are expensive to buy, expensive to maintain, and clean. On top of that, you have the costs of inventory and logistics.

The ambulatory surgical center market is keen to embrace surgical instruments that provide best possible outcomes at best value. Single-procedure instruments and procedural kits are way of the future.

Qmed: What are the main advantages of a disposable ratchet?

Schultz: A disposable ratchet is a general purpose instrument for medical implants that supports the move to lower upfront and life cycle cost solutions. The device achieves both the desired clinical value and economic value.  The ratchet was also developed specifically for our new lumbar fixation kit, which has been FDA cleared with Intelligent Implant Systems (IIS) in Charlotte, NC. That ratchet is identical to one we just launched and it will be used in surgeries starting in September this year.
 

Qmed: How does that device help save more than $1000 in surgical costs?  

Schultz: The savings is per instrument per year. It is derived from a specific ROI calculator we developed for our major OEM customers to outline the cost savings that can be achieved by them as the implant maker by converting from reusable devices to single-procedure (disposable) devices. The cost savings are derived from: reduced life cycle costs for packaging, handling, cleaning (including cleaning agents, chemicals and water, electricity), instrument calibrating, spares, reprocessing, sterilization, inventory management, and labor.   
 

Qmed: What sets the device apart from other disposable devices?

Schultz: The instrument uses unique internal ratcheting technology that allows for lower cost and robust actuation.

Delivering a cost effective bidirectional ratcheting capability in any easy to use, robust package and adding the requirement for cannulation (a small hole of about 0.05 in. that runs the full length of the instrument to accept K-wires, trocars, needles, screw driver shafts, etc.) was not a simple task.

The internal drive mechanism and design is ECA Medical Instruments proprietary. The challenge is how do you develop a cost effective, easy to use, and robust ratcheting instrument used to secure a variety of implant screws, fasteners and connectors for a orthopedic and spine implant in a human surgery? It must work without fail and be ergonomic and easy to use (intuitive) and do the intended job. Yet it must be sterile-packed, low cost, and function perfectly for each implant procedure and be highly versatile for use on a wide range of ortho and spine implant procedures--used for both fixation and extraction.

Keeping the instrument structurally sound through a wide range of stress and load conditions and maintaining a design for manufacturability mindset poses many design and production considerations. ECA conducted a wide range of DFMEA and PFMEA studies to gain the optimum solution. We also use FEA simulation software for product development.
 

Qmed: What technologies enabled the development of this device?

Schultz: It took design know-how to efficiently and effectively merry stainless steel with engineered polymers in a robust, low cost instrument.  Design for manufacturability (DFM) is also key to developing and fielding a low cost, high value instrument.

It helped that ECA Medical Instruments has more than 36 years of experience as developing disposable precision torque-limiting, fixed driver, and related surgical instruments and procedural kits. 

Brian Buntz is the editor-in-chief of MPMN and Qmed. Follow him on Twitter at @brian_buntz.

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