ZimmerBiomet (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 orthopedic 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.

Problem

Desired outcome

Our original goal was to create a superior product that would outperform anything currently available on the market.

We had the opportunity to learn from our competitors’ mistakes and carefully examine their products.

We quickly realized that to succeed, we needed to streamline our workflow, allowing surgeons to template a surgery in under 10 minutes.

Service’s design

How does it work?

One of the key advantages that ONE Planner Hip 3D has over its predecessor is the ability to template a surgery in 3D. However, this new service requires CT scan data instead of X-rays. CT scans can capture the X, Y, and Z dimensions of an object to maximize accuracy. To use OPH3D, hospitals must be equipped with CT scanners. Therefore, OPH2D still has a place in the market since not all countries, insurance plans, country healthcare policies or even healthcare facilities have access to the necessary tools required for OPH3D.

Within ZimmerBiomet, we offer three solutions that a patient and their data go through from a service design point of view.

Audience

For whom are we building this?

The ONE Planner Hip 3D is designed for orthopedic hip surgeons who specialize in total hip replacement surgeries. This group can be further divided into three subgroups:

• Enthusiasts: They are generally professors in universities or leading speakers in the field. They understand that new technologies come with new issues. And that includes re-training on a process that they’ve done for more than a decade.
• Producers: These surgeons typically work in public hospitals in the US. They prioritize speed and cost efficiency over everything else.
• Traditionalists: These surgeons are not so keen on new technologies. They prefer new tools that adhere to the medical framework and produce results that meet their medical expectations.

It’s important to note that there are significant differences between countries in terms of surgical practices, which can be attributed to the medical industry’s impact on the economy. For instance, a Japanese surgeon working in a public hospital may prioritize precision over speed, while an American surgeon working in a public hospital may prioritize cost efficiency. This is largely due to differences in healthcare costs across countries.

Roles and responsibilities

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

One of the distinguishing features of the medical field is the high cost of summoning professionals to test a product. Therefore, it is natural that user testing would run into thousands of dollars to conduct. In addition, unlike regular commercial products, one cannot simply A/B test a feature by putting it out in the field, as this could potentially risk a patient’s health or even life.

The nature of the medical industry means that iterative development cannot be applied in the same way as in other commercial fields. Auditor rounds are common, risk assessments are carried out on every single change, no matter how minimal it may be, and everything has to be documented thoroughly. A surprise audit can happen at any moment, and one does not want to be the reason for a multimillion-dollar fine by a regulatory agency.

For this reason, user tests are limited to a few occasions per year. These tests are rather long, and the user (usually a surgeon) is subjected to multiple tests from multiple teams in a single day.

Scope of tests

Process

Step by step description

Cloud of use cases in the process of being arranged. See in PDF

2. Competitor benchmarking

As always, it is necessary to explore if there are similar solutions available in the market. Unfortunately, obtaining access to competitor products was particularly difficult this time. Unlike other industries, the competing products in this field are kept behind physical devices in hospitals. It was not feasible to go to hospitals just to try out the tools used by other surgeons. Moreover, surgeons are often restricted by legal obligations from disclosing how their products work to the public.

Fortunately, various tutorials and marketing videos were available on platforms like VuMedi where surgeons and sales representatives provided explanations about how their products work. This abundance of information helped me to create a visual catalog of user experiences and develop ideas for refining the competitor’s products. These ideas were later incorporated into our product, providing us with a competitive edge over anything that is currently available on the market.

Competitor benchmark: User flow of Mako 4.0 Total Hip Replacement by Stryker

Competitor benchmark: User flow of ONE Planner Hip 2D by ZimmerBiomet

Competitor benchmark: User flow of Formus Labs

Complete competitor benchmark. See in PDF

3.1. Scoping

The team followed the Agile principles of software development and conducted the activity in accordance with the Scrum rules established in their charter. Once the grand design stage was completed and tested with users, the team began iterative development. The grand design aimed to cover the fundamental concepts of the application and allowed users to provide feedback.

4. Testing grand design

We tested our grand design early on via online interviews due to Covid-19 restrictions. Users were presented with an introductory presentation, followed by a clickable wireframe made in Figma. We gave minimal guidance and encouraged users to ask questions and share their thoughts on the prototype.

The two core screens that were designed the earliest in the grand design

5. Developing the happy path

The entirety of the happy path was designed. We decided to have a phase of grand design to secure the surgeon’s acceptance of the concept and minimize risks. Once the concept of the happy path was designed we began developing the other branches that deviate from the happy path.

Architecture of the happy path in OPH3D. The purple arrows represent the quick route (less than 5 minutes to perform per case). The black arrows represent the detailed route (10 or more minutes to perform per case).

6. Producing Hi-fidelity screens & refining concept

In this stage, we started coding to create OPH3D. However, some parts of the concept needed more refinement, design, and user testing. We also created micro-interactions and formalized a style guide. At this point, we began testing OPH3D with users in real-world environments in Montreal (2023), Detroit (2023), and Phoenix (2004).

Review screen: It is the first screen the user faces. The user is meant to examine the plan and decide how much he/she wants to modify.

Quick change: The user can change quickly the components of the implant system and check the effects in Leg length difference and Range of Motion.

8. Cadaver labs, Personal interviews & User tests

As mentioned earlier, there were a total of 4 large-scale tests and one set of personal interviews online.

Analysis of results from the 1st questionnaire. See in PDF

8.2. Phoenix Lab (2022): Cadaver Lab

In November, the surgeons collaborated with several teams from ROSA Hip to conduct a series of experiments and trial surgeries on cadavers. The primary objective was to test the Shell editor. Additionally, they wanted to reassess their priorities and make sure they were developing the right product.

Shell editor micro-interactions: Slice of the acetabulum and different visualizations of the pelvic bone.

ROM micro-interactions: The user is able to conduct 4 distinct ROM selected from the Validation of the concept in 2021

8.4. Detroit Lab (2023): Stem editor

The lab in Detroit had a specific focus on developing the Stem editor. Additionally, there was a small-scale review of the Shell editor. During this time, initial insights were gained regarding the neck cut, which will be further tested in the Phoenix (2024) lab.

8.5. Phoenix Lab (2023): Neck cut

During this lab, we made further adjustments to the Stem editor, Shell editor, and Review screen, with a focus on confirming our theories on working with the Neck cut of the Stem editor.

During the lab, we developed a feature for surgeons who desire Pelvic Tilt. However, this feature received less attention.

9. Documentation for regulatory bodies

Each change made to OPH3D was carefully documented through a Design Control Procedure. This procedure included Acceptance Criteria, a Risk Analysis for the patient, an Impact Analysis that specifically described which sections of the product documentation were modified, and a Verification evidence section to visualize the alterations. The changes were directly documented in the user story. The Product owner and the Developer Engineers were in control of these documents.

Conclussion

Results

Learnings

Appendix

Appendix; the extra bits

How is a CT Scan processed?

Our team has extensive expertise in CT scanning, which has enabled us to develop innovative products for hip preservation. One of our notable products is Move Forward, which offers an alternative to hip replacement surgery. Maurice Veerkamp leads this segment of our team. All of our scan engineers utilize a proprietary tool that we created in-house called Arbiter, which is not yet available for commercial use. However, we are working towards developing it as a stand-alone software that can process CT scans of any type.

New user flow (so far) for ArbiterONE. See in PDF