Zimmer Biomet (ZB) is a major player in the medical device industry with a focus on robotic-assisted technology. The company has a global presence and is well-established in markets such as the United States, the European Union, Japan, Canada, the UK, Australia, and New Zealand.
ZB specializes in designing, developing, and manufacturing orthopaedic products that are used for joint replacements. This includes everything from the patient’s implants to the robots that assist in the operating room, as well as the software that powers these robots.
UX Case study
Designing a surgical hip planner
This case study explores the development of an X-ray-based surgical planner for pre-operative assessment and planning of hip replacement procedures. Recognizing the evolving needs of modern surgical practice, subsequent development efforts focused on expanding the capabilities of the platform to encompass three-dimensional (3D) planning. See ONE Planner Hip 3D.
Problem
Why this project?
ONE Planner Hip is a pre-surgical planning software designed for use with the ROSA Robot system by Zimmer Biomet. It allows surgeons to accurately template hip replacement surgeries. The software provides a detailed 2D X-ray visualization of the patient’s hip anatomy and a precise fit of the planned implants. In essence, ONE Planner Hip offers surgeons the same level of precision as a measuring tape provides a carpenter.
Desired outcome
Our goal was to develop a user-friendly, low-complexity surgical planner that generates outputs directly applicable in the operating room. A significant benefit of this approach is reduced inventory costs. By predicting the necessary implants beforehand, hospitals can minimize the number of sterilized implants on hand, leading to potential cost savings for patients.
Service’s design
How does it work?
ONE Planner Hip occupies the ‘middle ground’ (indicated by blue arrows in the diagram) in our surgical planning offerings. It is designed for situations where only X-ray images are available. This approach is particularly relevant in markets like the United States, where high insurance costs and limited access to CT scanners are common.
From a service design perspective, Zimmer Biomet offers three solutions for patient data management. The thicker (blue) arrows in the diagram above highlight the specific area of focus for this case study.
Audience
For whom are we building this?
ONE Planner Hip is a surgical planning tool designed for use by orthopedic surgeons specializing in total hip arthroplasty. While compatible with various implant systems, ONE Planner Hip is specifically designed for use with Zimmer Biomet implants.
Roles and responsibilities
Team’s setup
The business case and priorities were developed by our product owner and management board. Our team was responsible for determining the approach and timeline for achieving those priorities. The tasks related to user experience were divided among the UX designer (me). A product owner (Ivo Flipse) was present to guide us in each phase and help set the next targets. The team was composed of several developers.
My responsibilities
The definition of each responsibility can be found below in the Step by step description.
Among them include: Competitor benchmarking, Design ideation, Wireframing, Generating a testable prototype, User testing, User results analysis and documentation.
Scope and constraints
Limitations
The medical field presents unique challenges for user testing. The high cost of engaging healthcare professionals for product evaluation necessitates careful planning and budget allocation. Unlike typical consumer products, A/B testing in the field is often impractical and potentially risky due to the potential impact on patient health and safety.
The stringent regulatory environment of the medical industry significantly impacts the development process. Iterative development, common in other sectors, is often constrained by rigorous auditing procedures, extensive risk assessments for every change, and comprehensive documentation requirements. The possibility of unannounced audits and the potential for substantial fines from regulatory agencies necessitates meticulous adherence to these guidelines.
Consequently, user testing within the medical domain is typically limited to a few scheduled events per year. These events often involve intensive testing sessions, where surgeons may participate in multiple evaluations conducted by different teams within a single day.
Scope of tests
Duration
We ran 4 in-person tests (labs), and 1 online test. They were carried out along the 2 years of development of the application.
Audience
The tests or labs were composed exclusively of orthopaedic surgeons and professors at medical universities. There were on average 12 participants.
Location
Tests were carried online through one-on-one interviews as well as user surveys.
Process
Step by step description
1. Scope mapping
Initially, there was a lack of clarity regarding the scope and requirements of a hip templating planner. Diverse perspectives from stakeholders within Zimmer Biomet resulted in a confusing array of conflicting ideas. Through collaboration with the Product Owner and key stakeholders, a defined set of requirements was successfully established.
2. Competitor benchmarking
Competitor analysis was conducted through research on platforms like VuMedi and other professional clinician resources. We meticulously examined the workflow of each competitor, analyzing their individual steps and comparing these observations with the user feedback we had gathered.a
3. Initial mockups
The Product Owner and I, as the UX designer, engaged in a highly iterative design process. Daily sessions focused on generating and refining design concepts, which were then presented to the development team for feedback and discussion. Over several months, we collaboratively finalized the overall design vision, incorporating input from the development team and key stakeholders. Our approach emphasized capturing the core essence of the application concept while intentionally avoiding premature definition of every minute detail.
3.1. Scoping
The team adhered to Agile principles, specifically the Scrum framework, as outlined in their project charter. Following the completion and user testing of the initial mockups, the team transitioned to iterative development. The initial mockups phase served to establish the core application concepts and gather initial user feedback.
4. Testing initial mockups
Early in the design process, we conducted online user interviews to gather feedback on initial mockups. Each session began with a brief introductory presentation followed by an interactive exploration of a clickable wireframe prototype created in Figma. We minimized guidance to encourage user-driven exploration and facilitated open discussion by actively prompting users to ask questions and share their thoughts freely.
5. Developing the happy path
After establishing the core user flow (the ‘happy path’), we proceeded to develop alternative scenarios that deviated from this primary path. The happy path encompassed the essential user goals, such as accurately placing and modifying shell and stem components on the X-ray image.
The user flow architecture in ONE Planner Hip is visualized using a combination of coloured arrows. Purple arrows depict the ‘Quick Route,’ a streamlined planning pathway typically completed within 3 minutes per case. In contrast, black arrows represent the ‘Detailed Route,’ which allows for more comprehensive planning and generally requires more than 3 minutes to complete.
6. Producing component library & refining concept
This phase involved the initiation of coding for ONE Planner Hip. Recognizing the need for further refinement, we concurrently continued design iterations and user testing for key aspects of the concept. This stage also saw the development of refined micro-interactions and the formalization of a standardized component library. Concurrently, we commenced real-world user testing of ONE Planner Hip within clinical settings.
Level 1 tokens that make the components of the ONE Planner Hip library
Level 2 components made out of tokens for the ONE Planner Hip library.
7. High fidelity screens
At this stage, I designed high-fidelity prototypes for user testing. To minimize distractions and ensure accurate user feedback, it was crucial to present prototypes that closely resembled the final product’s visual appearance. This approach aimed to avoid potential biases that might arise from design imperfections or the limitations of wireframe abstractions.
This compact module houses all controls for manipulating the shell outline. It appears automatically upon surgeon selection.
This intuitive editor empowers surgeons to precisely adjust the stem position within the femur.
Cut out simulation of how the implant would affect the difference between the two legs.
This in-app training section provides surgeons with quick access to information and step-by-step guidance on common tasks within the application.
Main Menu: Provides access to tutorials, the product’s medical label, and case finalization options.
The Medical Label Screen provides access to the product’s regulatory information for both surgeons and auditors.
This screen enables surgeons to perform contralateral planning, a valuable tool when the anatomy of one side is significantly compromised.
If the DICOM data includes X-rays of the patient in either a sitting or standing position, an additional screen becomes available to the surgeon for evaluating pelvic tilt.
Surgeons can customize the visualization of pelvic tilt. The interface provides controls for adjusting contrast, brightness, and color inversion for both standing and sitting patient positions.
This screen becomes accessible to the surgeon following the completion of necessary modifications. It serves as confirmation that the patient data has been successfully processed for use in the operating room.
8. User research
Over the two-year product development cycle, we conducted three large-scale laboratory studies and two online interviews. In each session, surgeons were tasked with specific objectives and subsequently asked to complete a questionnaire. This data collection method allowed us to:
- Quantify our design hypotheses: Assess the validity of our design assumptions based on surgeon feedback.
- Prioritize development efforts: Determine the most critical development areas based on surgeon needs and identified challenges.
9. Documentation for regulatory bodies
All changes implemented in ONE Planner Hip were meticulously documented following a rigorous Design Control Procedure. This comprehensive procedure encompassed:
- Acceptance Criteria: Clearly defined success metrics for each change.
- Patient Risk Analysis: A thorough evaluation of potential patient risks associated with the change.
- Impact Analysis: A detailed assessment of the change’s impact on product documentation, including specific modifications to relevant sections and the user interface.
- Verification Evidence: Visual documentation of the implemented changes for clear traceability.
Furthermore, all changes were meticulously documented within the corresponding user stories.
A robust Quality Management System (QMS) was established, outlining detailed procedures for all aspects of product development and ensuring adherence to rigorous quality standards by the entire team.
As a designer, I played a crucial role in the development of key regulatory documents, including the Design History File (DHF) and the Information for Use (IFU).
Furthermore, as part of the scribe team during regulatory audits, I was responsible for:
- Documenting Failure Mode and Effects Analyses (FMEAs).
- Maintaining and improving Corrective and Preventive Actions (CAPAs).
Conclussion
Results
Post-market surveillance has consistently yielded positive user feedback, with a recurring theme being the interface’s streamlined nature. Users frequently commend the intuitive design, emphasizing its effectiveness in achieving intended outcomes with minimal complexity.
We are confident that ONE Planner Hip represents an optimized solution for pre-operative hip replacement planning. In contrast to many competitive tools on the market, which often feature an overabundance of features leading to a cluttered and confusing user experience, ONE Planner Hip prioritizes a streamlined and intuitive design. This focused approach has garnered praise for its simplicity and ease of use, resulting in a significantly lower learning curve for surgeons.
critical gap in the current ONE Planner Hip offering is the absence of a 3D planning solution. Given the increasing utilization of 3D data from CT scans in the Zimmer Biomet ROSA Hip robot system, a dedicated 3D planning tool is essential to meet the evolving needs of surgeons for accurate and comprehensive pre-operative planning in the three-dimensional space. See ONE Planner Hip 3D.
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I live and work in the Randstad area of the Netherlands (Amsterdam, Rotterdam, Utrecht, The Hague, Leiden, Delft, Harlem, etc).
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