DTRAX

User Research / Mechanical Engineering / Industrial Design

DTRAX providence medical industrial design and engineering medical device design by speck
The Client

Providence Medical Technology is a medical device company focused on innovative solutions within the cervical spinal surgical industry. They have pioneered a proprietary approach to cervical fusion and developed surgical instrumentation and implants that offer unique solutions for cervical spinal conditions.

"High-Risk Cervical Fusion Patients Deserve More." -Providence MT

The Product

DTRAX is a novel implant for neck and arm pain. It provides indirect decompression of nerve roots and stabilizes the treated motion segment. The implant is inserted using the DTRAX facet system via the DTRAX Delivery Tool. The DTRAX implant provides distraction of the facet joint to increase neural foraminal volume for nerve root decompression.

The Challenge

Speck Design was charged with designing and engineering a minimally invasive surgical tool and implant screw for surgical procedures for nerve root decompression. The deployment tool's exact size and physical characteristics were undecided, but a smaller tool would be needed to satisfy the request for a minimal incision at the operation site (<10mm). Since the deployment device needed to be hammered in place for deployment, an ergonomically and mechanically attentive design was required to avoid transferring stress to the handle.  

The DTRAX implant screw would need to be preloaded onto the delivery tool for deployment. The size and head shape of the screw were also undecided and would need to be resolved by the Speak team of engineers. 

Regulatory challenges and requirements were:

  • An implant designed to be classified as a Facet Screw (FDA Product Code MRW) 7.3.1 
  • An implantable device designed to be released as an unclassified 510(k) device. 
  • A tool delivery to be classified as Class I

The process

The concepts for the tooltips were developed and prototyped first. After that, the industrial design of the delivery system was cycled and included sketches and foam models. The prototype concept tool designs were then adapted to function with the ergonomics and aesthetics of the handles. Due to the number of conceptual variables, the entire process needed to be incredibly iterative. 

Our team depended heavily on feedback from users at surgeon training labs but also on in-person observations while we watched doctors use the device in lab settings. These research methods and processes were critical elements in helping increase the implant's reliability of deployment while reducing its size. Based on feedback, best surgical practices, and the deployment requirements, Speck redesigned the entire system into an innovative device in which the screwdriver and implant holder were combined into a single tool.

Hammer plates on the handles were used so that the force of the impact would be transmitted directly to the instrument tip rather than through the handle. Additional research and development were conducted to address manufacturability concerns, material choice, and the specific mechanical testing of the implant.

the outcome

The DTRAX facet system is a first-of-its-kind minimally invasive medical device for cervical spinal decompression. Some of the advantages of the DTRAX system are minimal trauma/blood loss, minimal scarring, and shorter recovery periods. These benefits mean lower complication rates and lower costs passed on to patients. The new system represents a safe and effective alternative to open surgery for neck and/or arm pain patients and better patient care for neurosurgeons and orthopaedists. In addition, a 60-patient prospective study evaluating DTRAX has demonstrated its safety and efficacy comparable to cervical fusion and total disc replacement. The system adheres to the regulatory requirements laid out by Providence and is improving the quality of life for high-risk cervical fusion patients with conditions such as diabetes and osteoporosis.

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Product Description

Providence Medical Technology is a medical device company focused on innovative solutions within the cervical spinal surgical industry. They have pioneered a proprietary approach to cervical fusion and developed surgical instrumentation and implants that offer unique solutions for cervical spinal conditions.

"High-Risk Cervical Fusion Patients Deserve More." -Providence MT

Project Overview

DTRAX is a novel implant for neck and arm pain. It provides indirect decompression of nerve roots and stabilizes the treated motion segment. The implant is inserted using the DTRAX facet system via the DTRAX Delivery Tool. The DTRAX implant provides distraction of the facet joint to increase neural foraminal volume for nerve root decompression.

Project Approach

Speck Design was charged with designing and engineering a minimally invasive surgical tool and implant screw for surgical procedures for nerve root decompression. The deployment tool's exact size and physical characteristics were undecided, but a smaller tool would be needed to satisfy the request for a minimal incision at the operation site (<10mm). Since the deployment device needed to be hammered in place for deployment, an ergonomically and mechanically attentive design was required to avoid transferring stress to the handle.  

The DTRAX implant screw would need to be preloaded onto the delivery tool for deployment. The size and head shape of the screw were also undecided and would need to be resolved by the Speak team of engineers. 

Regulatory challenges and requirements were:

  • An implant designed to be classified as a Facet Screw (FDA Product Code MRW) 7.3.1 
  • An implantable device designed to be released as an unclassified 510(k) device. 
  • A tool delivery to be classified as Class I

Providence Medical Technology is a medical device company focused on innovative solutions within the cervical spinal surgical industry. They have pioneered a proprietary approach to cervical fusion and developed surgical instrumentation and implants that offer unique solutions for cervical spinal conditions.

"High-Risk Cervical Fusion Patients Deserve More." -Providence MT

DTRAX is a novel implant for neck and arm pain. It provides indirect decompression of nerve roots and stabilizes the treated motion segment. The implant is inserted using the DTRAX facet system via the DTRAX Delivery Tool. The DTRAX implant provides distraction of the facet joint to increase neural foraminal volume for nerve root decompression.

Speck Design was charged with designing and engineering a minimally invasive surgical tool and implant screw for surgical procedures for nerve root decompression. The deployment tool's exact size and physical characteristics were undecided, but a smaller tool would be needed to satisfy the request for a minimal incision at the operation site (<10mm). Since the deployment device needed to be hammered in place for deployment, an ergonomically and mechanically attentive design was required to avoid transferring stress to the handle.  

The DTRAX implant screw would need to be preloaded onto the delivery tool for deployment. The size and head shape of the screw were also undecided and would need to be resolved by the Speak team of engineers. 

Regulatory challenges and requirements were:

  • An implant designed to be classified as a Facet Screw (FDA Product Code MRW) 7.3.1 
  • An implantable device designed to be released as an unclassified 510(k) device. 
  • A tool delivery to be classified as Class I

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