Streamlining the deployment of personalized cutting guides for total ankle replacement

Enhatch partnered with 3D Systems to provide its advanced preoperative planning solution to a leading US-based medical device company. 3D System’s client was a leading provider of innovative joint replacement solutions. The client was offering a cutting-edge total ankle replacement device. This solution was created by a team of engineers and global surgeon leaders looking to provide a device that mimics the patient's ankle shape and supports natural movement.

As a part of this solution, the tibia and talar cutting guides were offered as patient-specific solutions. These guides were custom-made using CT scans based on the patient’s unique anatomy. 3D Systems was handling the 3D printing of these guides. These special cutting guides were critical as they ensured that the implant was placed according to the preoperative plan during surgery. There was a need for a seamless preoperative planning solution where all stakeholders could quickly and efficiently collaborate to design these guides. Also, there were multiple workflows for different product lines. So, the ability to easily build custom workflows was also a key requirement of the preoperative planning solution.

3D systems used Enhatch's preoperative planning software to manage their client's patient-specific product offering easily. Enhatch's portal:

  • Easily facilitated the design, sizing, and creation of these guides.
  • Provided a single, compliant, and contained environment for all key stakeholders to collaborate.
  • Enabled the creation of multiple workflows for different product lines.
  • Could define customized role requirements, responsibilities, and access.
  • Easily tracked progress and approvals on each case.
  • Managed case logistics and purchase orders in one place.
  • Provided access to a survey for valuable feedback on the process.
The patient-specific cutting guides were launched successfully. Over 650 surgeries have been completed successfully to date.

About the Customer

3D Systems is one of the leading providers of additive manufacturing solutions worldwide. They have manufactured 2M+ medical devices and have delivered 150K+ patient-specific cases and devices. They have a track record of success in helping medical device manufacturers and healthcare providers accelerate innovation and transform healthcare. 

3D System's client was a leading medical device company in the United States. They have been in business for over three decades and have a successful track record of developing and launching innovative products

" Enhatch makes it so easy for us to upload patient scans, assign teams and surgeons to cases and get approvals. No installations, no integrations so we can get started immediately. Our surgeons, reps and engineers love that they can use their laptops or tablets to review cases and leadership gets to monitor all progress using the dashboard."

Taylor Broaddus, Case Management Supervisor
3D Systems

Client Challenge

3D Systems was looking for a preoperative planning solution for their client that could achieve all of the below objectives:

Unified solution with controlled access for all key stakeholders 

Patient-specific solutions demand collaboration among various stakeholders (surgeons, engineers, hospital administrators, sales reps, etc). 3D Systems sought a user-friendly and unified solution for: 

  • Seamless collaboration.
  • Easily facilitating the design, sizing, and creation of patient-specific guides.
  • Ensuring that all data, designs, etc, related to the patient-specific process are contained in one location.
Ability to easily create custom workflows  

3D Systems required a planning solution that could help them efficiently:

  • Create custom workflows quickly based on specific products and preoperative planning processes.
  • Enable custom role-based access to different work steps.
Visibility to status, approvals and progress on cases

3D System's client sought complete visibility and transparency into every process step. They wanted to be able to track all cases, approvals and progress.

Efficient data transfer with faster identification of data issues on 3D scans

3D Systems and their client sought to expedite the data transfer process and detect data issues sooner. This required a solution allowing efficient data transfer with immediate data protocol verification capability on upload.

Improve the efficiency of the preoperative planning process

Overall, 3D System’s client wanted to improve the efficiency of the entire preoperative planning process to get products into the surgeon's hands faster.

The Enhatch Solution

Requirements gathering

As a first step, we talked to 3D Systems and their client to understand their requirements in detail.

AI-driven preoperative planning solution demo

We demonstrated our cutting-edge preoperative planning solution that:

  • Offers a secure digital environment to facilitate preoperative planning.
  • Enables easy visualization of medical imaging data.
  • Allows for efficient data transfer with data protocol verification upon upload.
  • Customizes workflows as per client's need.
  • Has 21 CFR part 11 compliant approval of assets (reports, 3D proposals, etc.).
  • Creates custom role-based access to different workflow steps.
  • Leverages AI to increase efficiency.
Identified opportunities for increased efficiency 

Enhatch identified several opportunities for increasing efficiency in the preoperative planning process. 

Swiftly implemented and trained key stakeholders

The Enhatch team swiftly implemented the preoperative planning solution on time. The team ensured seamless integration, and conducted comprehensive training for all key stakeholders.

The Impact

With Enhatch’s solution, 3D System’s client was able to:

Launch the patient-specific cutting guides seamlessly

The Enhatch portal helped facilitate these guides' design, sizing, and creation by efficiently managing the entire end-to-end process. The tibia and talar cutting guides were launched successfully.

Easily create custom workflows with role-based access 

With Enhatch's portal, 3D Systems and its client could easily:

  • Create custom, step-by-step workflows for each product line.
  • Provide role-based access for each workflow step.
Effortlessly manage preoperative planning with multiple stakeholders

Enhatch's preoperative planning solution increased transparency for all stakeholders. All aspects of preoperative planning were accessible in one place. With Enhatch's portal:

  • The surgeon or sales rep can initiate a new case and provide all relevant details (for example, surgery date, patient info, case info, etc.).
  • The clinical team can view data and understand if the medical imaging data is acceptable for preoperative planning.
  • Relevant reports can be viewed, reviewed, and approved easily.
  • There was full transparency w.r.t shipping and tracking of PSI devices.
  • They could easily manage purchase orders and case logistics - all in one place.
  • They could provide access to a survey that provided valuable feedback on the PSI process.
Enhatch portal streamlines workflows for better preoperative planning collaboration.

Enhance communication during preoperative planning

Enhatch's portal facilitated better communication during the preoperative planning process. Some examples of this include:

  • Portal prompting surgeons w.r.t time slot availability for preoperative planning.
  • Automated alerts for stakeholders (e.g., surgeons) when reports are ready for review.
Increase efficiency through AI-driven preoperative planning

With Enhatch's AI-driven preoperative planning solution, there were several opportunities for driving efficiency. This could reduce the lead time for delivering patient-specific solutions to customers. Some examples of this are:

  • Swiftly identifies any data issues after scan upload.      
  • Ability to rapidly present 3D models.
  • Accelerates segmentation with semi-automatic detection of bony landmarks and implant placement.
Ensure access control with 21 CFR Part 11 compliant portal

With Enhatch's portal, 3D System's client could:

  • Easily ensure authorization and access control.
  • Approve digital signatures.
  • Set role-based permissions and access.
Improve logistics and shipment process

The entire process, from purchase order creation to shipment tracking, was streamlined by easily integrating with the client's ERP.

Enhatch, we are on a mission to make surgeries faster, safer and smarter. Our customers include medical device companies, distributors, and point-of-care facilities.