How a Human-Centered Design Process Transformed the User Experience of Graft Preparation in the Operating Room

Abstract

In this case study, the human-centered design process used by the Industrial Design and Human Factors (IDHF) team at Johnson & Johnson MedTech in developing the SPEEDTRAP™ Graft Preparation System is overviewed. This article describes three broad efforts to “Understand” needs within knee soft tissue repair procedures and potential opportunities; “Explore” possible solutions through conceptual development, prototyping, and usability testing; and “Materialize” the refinement and delivery of the SPEEDTRAP™ Graft Preparation System. The key results for each broad effort are described.

Keywords

medical device usability human-centered design process Stanley Caplan User Centered Design Award

Learn how the Industrial Design and Human Factors (IDHF) team at Johnson & Johnson MedTech discovered unmet needs and subsequently delivered the 2020 Stanley Caplan User-Centered Design Award-winning SPEEDTRAP^™ Graft Preparation System. The SPEEDTRAP^™ Graft Preparation System has been shown to minimize graft preparation time by 77% (DePuy Synthes Mitek Sports Medicine, 2016) compared to traditional whipstitching techniques and may reduce overall operating room time, anesthesia, and tourniquet time.

Feature at a Glance

In this case study, the human-centered design process used by the Industrial Design and Human Factors (IDHF) team at Johnson & Johnson Medical Devices Companies in developing the SPEEDTRAP^™ Graft Preparation System is overviewed. This article describes three broad efforts to “Understand” needs within knee soft tissue repair procedures and potential opportunities; “Explore” possible solutions through conceptual development, prototyping, and usability testing; and “Materialize” the refinement and delivery of the SPEEDTRAP^™ Graft Preparation System. The key results for each broad effort are described.

Overview of Speedtrap^TM Graft Preparation System

Repair and reconstruction of damaged ligaments are some of the most frequently performed orthopaedic procedures in sports medicine today. Sports medicine surgeons repair damaged ligaments or tendons using replacement soft tissue grafts. Procedures are typically minimally invasive and are performed arthroscopically (using an arthroscopic camera that is inserted into the joint through a small incision).

Preparing the replacement graft can be a particularly time-consuming part of the surgical procedure. Inexperience or inattention can lead to inconsistencies in the quality of the prepared graft while suture needles introduce risk of injury to the user or potential damage to the graft. During the development of this product, an orthopaedic surgeon reflected that—in surgery—if they are waiting for the graft to be ready, 5 minutes can feel like an eternity, and they would push the assistant to hurry.

The SPEEDTRAP^TM Graft Preparation System (Figure 1) offers a simplified technique for preparing grafts. With its needleless design, it helps users apply uniform, consistent suture constructs to the graft faster and easier—significantly reducing graft preparation time compared to standard techniques (DePuy Synthes Mitek Sports Medicine, 2016).

Figure 1.

SPEEDTRAP^TM Graft Preparation System.

The system uses sutures to create a finger trap construct that compresses the graft rather than piercing it. This minimizes the risk of needlestick injuries to operating room (OR) staff and provides the strength needed to control the graft in clinical conditions. This high-strength suture construct comes pre-loaded on a sterile, single-use delivery device.

Users responsible for preparing the graft may include surgeons, physician assistants, scrub technicians, and nurses.

Background

As the IDHF team for Johnson & Johnson MedTech, we have been applying a holistic, human-centered design process (Figure 2) with a focus on usability since 1988. When engaged early and often throughout the product development process, we function as both a strategic business asset and key differentiator. We strive to elevate the quality of human-to-system interactions with expertise in physical, digital, sonic, and holistic system design for all users, including surgeons, care teams, and patients.

Figure 2.

The J&J MedTech IDHF human-centered design and human factors engineering process drives inclusion and participation from cross-functional partners to ensure consistently effective design and a strong usability approach.

As a multi-disciplinary global design team, we collaborate with cross-functional partners from opportunity assessment to launch, driving engagement and compliance through an understanding of behavioral science. Guided by a comprehensive toolkit of proven design and usability capabilities that are customized to business needs, we deliver best-in-class user experiences (Figure 3).

Figure 3.

Partnership with R&D and Marketing, from initial project scoping through launch, ensures alignment with stakeholders and shared business accountability. Market success is realized through the right combination of business viability, technical feasibility, and user experience desirability.

Our team integrates practices around a common understanding of user needs to improve decision-making as well as increase the effectiveness of programs. We engage relevant users throughout all steps of our process to ensure we deliver solutions that meet explicit and latent needs while prioritizing safety and mitigating risk.

This article details how our IDHF team collaborated internally to create the SPEEDTRAP^TM Graft Preparation System—from front-end research and strategy to summative testing and validation. This user-focused approach not only resulted in an award-winning medical device, but also helped reinforce our internal human-centered design process.

Situation

Repair and reconstruction of damaged ligaments are some of the most frequently performed orthopaedic procedures in the U.S. These minimally invasive surgeries are typically performed arthroscopically with the surgeon using a camera to visualize the joint space and small working portals to manipulate tools. A patient’s damaged ligament is replaced by a soft tissue graft that is harvested from another part of the patient or from a donor.

In 2011, DePuy Synthes Mitek Sports Medicine, one of the orthopaedic companies of Johnson & Johnson MedTech, explored the potential to address unmet needs during the repair of knee soft tissue injuries.

About Graft Preparation

During anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL) repair, the patient’s damaged ligament is removed, and a soft tissue graft is prepared for insertion and fixation in the knee. This new graft is passed through bone tunnels in the tibia and femur and is anchored in place using screws or other implants and devices. Studies have shown that preparing grafts for use in ACL reconstruction and similar surgeries is an inefficient, time-consuming process (Hong et al., 2014).

Graft preparation usually occurs on a back table in the OR (Figure 4) using dedicated instruments. The surgeon or assistant uses sutures to apply whipstitches to the graft. These sutures are then used to pull the graft through the bone tunnel and properly tension the repair. The process may be completed by the surgeon (which extends procedure time), or it may be done in parallel by a physician assistant or scrub tech as the surgeon continues working.

Figure 4.

One example of soft tissue graft preparation in the OR from ethnographic research.

In some procedures, such as distal biceps repair, graft preparation must take place as a linear process since only the distal end of the patient's tendon is externalized from their body while the proximal end remains intact. Whether completed in parallel or in series, preparing the graft quickly and consistently is critical and can consume valuable OR time.

One case example in our ethnographic research (Figure 5) demonstrated that a significant amount of surgical time was devoted to graft preparation (in a parallel process for PCL repair). During this specific procedure, graft preparation took the assistant 17 minutes within a 43-minute procedure, or approximately 40% of their overall time in the procedure (DePuy Mitek Inc., 2012).

Figure 5.

In this example PCL repair procedure, approximately 40% of the assistant's time is spent on graft preparation. Whether performed in series or in parallel to the procedure, a significant amount of time is spent on graft preparation (DePuy Mitek Inc., 2012).

Understand

Discovering Latent Unmet Needs Through Ethnographic Research

As part of the Assess and Discover phases (#1 and #2 in Figure 2), we immersed ourselves in surgical environments to uncover the needs of sports medicine surgeons and their staff. Through ethnographic research, we observed an extensive number of cases with numerous users globally—43 knee soft tissue repair procedures with 25 surgeons in seven countries. Our goal was to gather insights through non-biased ethnographic observation and interviews with users. This enabled us to uncover a variety of previously unidentified and unanticipated opportunity areas. Soft tissue graft preparation was one of these areas replete with latent unmet needs.

Establishing a Strategic Direction

Following the ethnographic research study, we created a journaling tool (Figure 6) for a small team of surgeons to document their experiences during five graft preparation cases each. We also partnered internally to closely examine the many current graft preparation techniques (Figure 7). Our goal was to extract the performance characteristics behind why the techniques were selected and confirm that the identified opportunity warranted additional investigation. Three attributes emerged as most desirable: strength, speed, and integrity.

Figure 6.

During early research, sports medicine surgeons recorded their clinical experiences in journals.

Figure 7.

A variety of techniques traditionally used for graph preparation (Barber et al., 2019, p. 1164. Used with permission).

Traditional graft preparation solutions forced users to prioritize between these attributes. Manual graft preparation introduced risks and opportunities for error due to inconsistencies in technique, placement, and spacing—depending on clinician experience and time pressures. Most existing techniques relied on needle-tipped sutures that could cause needlestick injuries to the user and potential damage to the graft due to cheese-wiring (where sutures cut through weak tissue at the point of piercing).

Our goal was to create a solution that effectively delivered all three attributes for users at any skill level. Safety and efficacy were paramount.

Explore

Illuminating the Possibilities

Successfully translating the value proposition into an aspirational product vision required ideation fueled by research insights. During the Concept phase (#3 in Figure 2), these insights sparked a series of exploration sessions during which we brainstormed ideas for improving graft preparation. Our early concepts ranged in value and levels of innovation from incremental to disruptive. We asked users to evaluate numerous concept sketches and low-fidelity paperboard and 3D-printed prototypes, leveraging their feedback to categorize and down-select concepts. We continued collaborating cross-functionally to refine, prototype, and evaluate these ideas, with the goal of aligning on a leading direction.

Ultimately, based on the desired attributes, a pre-loaded, deployable suture construct was chosen for further development (Figure 8). With thorough prototype evaluation and feedback from users, we were confident that this concept could provide the unique combination of benefits important to clinicians, including efficiency in deployment, reproducibility, atraumatic graft preparation, and reduced slippage—all while delivering strength comparable to other techniques.

Figure 8.

Selection of a promising direction based on its strong value proposition.

While the concept and value proposition resonated with users, it was critical that our product be cost effective and viable to compete with the low cost of using sutures alone. We refined the suture construct and deployment method to ensure the final product delivered on its value proposition without exceeding the financial constraints of purchasers.

Developing a Leading Direction

We further optimized the design through additional prototyping, testing, and iteration during the Develop phase (#4 in Figure 2). By applying our human factors expertise in applied behavioral science and understanding of ergonomic principles—such as hand size, pinch strength, grip, holding posture, tendon size—we strove to develop a more robust product and an optimal user experience.

We engaged users through multiple rounds of formative testing of low-fidelity to mid-fidelity prototypes. With each evaluation, our prototypes increased in quality and fidelity. Further refinement led to a rigid molded delivery device that offered increased control and consistency.

Materialize

Optimizing the System

User testing and input drove specific design features and improvements (Figure 9) during the Refine phase (#5 in Figure 2). For instance, grip texture indicated where to hold the device while providing friction for gloves that are often wet during surgery. An opening at one end of the device and pinching features at the other end were used as references for correctly loading the graft. The hinged design also intuitively led users to “squeeze and pinch” to secure the graft. When clamped, a window at the top of the delivery system allowed the user to view and confirm proper positioning of the graft and deployment of sutures. Size-specific deployment devices helped users distinguish between short and long length suture constructs. Additionally, multiple suture colors and patterns were provided to enable clinicians to organize graft bundles during use.

Figure 9.

Multiple rounds of testing and user input guided final device refinements and features.

Through testing, we uncovered an opportunity to bring additional clarity to in-person and remote training through a downloadable Quick Start Guide. This single-page guide (https://bit.ly/3xL2iGY) clearly communicated steps for use to support in-service training of surgical staff.

Additionally, we identified an opportunity to enhance the user experience. Sterile sutures require a desiccant to preserve structural integrity and performance characteristics before use. The desiccant is typically represented by a common medical packaging paper called Monadnock Suture Stock. Using biocompatible inks, we printed an instructional illustration of the device and directional loading of the graft onto the desiccant (Figure 10). Placing the information on the desiccant helped ensure that the most critical piece of information would be transferred into the sterile field to be viewed immediately before use.

Figure 10.

Instructional illustration of loading a graft into the device included in sterile packaging.

Confident in our leading solution, we worked closely with internal and external partners to resolve technical and production aspects and ensure the design intent was maintained in the final product. This included mechanical and technical verification, product specification and control drawings, and high-fidelity prototypes.

Final formative testing (Figure 11) was conducted with representative users in a lab setting to obtain objective evidence that the device could be deployed without use errors that lead to hazardous situations. Additionally, the testing confirmed all ease-of-use requirements were met by the design. The team also tracked time on task and device feature satisfaction ratings to ensure the product would deliver on its commercial value proposition.

Figure 11.

Final formative evaluation in a lab setting.

Implementing and Delivering

During the Deliver phase (#6 in Figure 2), we conducted summative usability testing and design validation (Figure 12) using production-equivalent devices in simulated OR environments with practicing surgeons and assistants to determine if SPEEDTRAP^™ Graft Preparation System had met the objectives in strength, speed, and integrity. This testing demonstrated that representative users can safely and effectively use the SPEEDTRAP^™ Graft Preparation System, and that the system fully met user need requirements and enabled faster preparation of soft tissue grafts (DePuy Mitek Inc (2016)). Testing also showed the system maximized the versatility of the graft preparation technique across procedure types, provided secure attachment to the graft, and did not alter the size of the graft when applied.

Figure 12.

Summative usability evaluation.

In a separate study, side-by-side comparisons demonstrated SPEEDTRAP^™ Graft Preparation System outperformed several of the most popular traditional graft preparation methods (Barber et al., 2019) (Figure 13) with significantly reduced graft preparation time and standardized consistency (DePuy Synthes Mitek Sports Medicine, 2016). According to Barber et al. (2019), the SPEEDTRAP^TM Graft Preparation System demonstrated the best overall performance. It was among the fastest to prepare the graft (45 seconds vs. 4–6 minutes with Krackow stitches). It had the least amount of displacement in the first 100 cycles, and the highest strength (mean: 437N). It did not cause tendon damage during load-to-failure testing.

Figure 13.

The SPEEDTRAP^™ Graft Preparation System outperformed several of the most popular traditional graft preparation methods including the baseball stitch.

One sports medicine surgeon commented, “The speed was faster than you can imagine. It took virtually no time at all. [It] had a nice solid fixation with no compromise.”

Results

Delivering Key Wins Through a Human-Centered Process

The foundation of this project was rooted in ethnographic research in the area of knee soft tissue repair. This research objectively revealed the previously unknown opportunity of graft preparation.

Through a deep analysis of needs and behaviors, both communicated and observed during user engagement and testing, a unique solution that optimized functionality and reduced the risk of errors was commercialized.

From initial market and opportunity assessment to final device delivery, this initiative took less than 5 years. Ultimately, SPEEDTRAP^™ Graft Preparation System provided a differentiated solution that complemented a series of product launches, bolstering the organization’s knee platform portfolio while driving new growth and revenue.

This project further demonstrated the value of IDHF’s human-centered research, design, and usability engineering processes and showcased the value of multi-disciplinary partnerships within Johnson & Johnson MedTech resulting in a solution that was feasible, viable, and desirable.

This strategic and tactical approach to understanding human behavior, identifying opportunities, and providing meaningfully differentiated solutions could be applied to product development efforts both within and outside orthopaedics and the medical device field.

For an animation of the SPEEDTRAP^TM Graft Preparation System in use go to https://www.youtube.com/watch?v=KCLK4FdNf04.

Footnotes

Jacob A. Marks is a Principal Designer for Johnson & Johnson MedTech where he focuses on leading teams in developing innovative, intuitive, and engaging experiences for the future of MedTech. An accomplished problem solver, Jacob believes that a strategic approach to contextualizing the opportunity is critical to providing delightful experiences for all users. He holds a BS in Industrial Design from Wentworth Institute of Technology and has been delivering best-in-class human-centered physical and digital solutions for almost 20 years across medical, consumer, and consumer healthcare fields. Jacob has brought more than 70 products successfully to market for clients ranging from startups to Fortune 500 companies. He holds more than 30 utility and design patents and 10 prestigious industry design awards and recognitions.

Kevin Zylka is a Senior Industrial Designer for Johnson & Johnson Medical MedTech, focused on developing meaningfully differentiated products through a user-centered approach to design. He is experienced in delivering solutions throughout the medical device development process, from opportunity identification to product launch. He has led industrial design and human factors efforts for multiple successful projects across sports medicine, total joint replacement, and general surgery. He graduated with honors from the University of Cincinnati’s College of DAAP with a BS in Industrial Design and is named on seven medical device patents.

Emilie Copeland D’Agostino is an independent writer who helps teams succeed by crafting messages that matter. She specializes in marketing, UI copy, design writing, corporate communications, and case studies for high-performing organizations in medical, healthcare, pharmaceuticals, law enforcement, and product innovation industries. Emilie refined her skills as a copywriter for a national publishing company where she wrote award-winning campaigns, executive speeches, and annual reports. She excelled as a project manager for a software firm, helping Fortune 50 companies deliver proposals that led to remarkable business growth. She earned her bachelor’s degrees in Professional Writing and Communications from Purdue University.

The authors would also like to recognize Mark Shainwald, Georgette King, Meghan Murray, Daniel Dufour, and Scott Woodruff for their contributions to the human-centered design and usability process of the SPEEDTRAP™ Graft Preparation System.

Please refer to the SPEEDTRAP™ Graft Preparation System instructions for use for a complete list of indications, contraindications, warnings and precautions.

References

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(2019). A biomechanical comparison of six suture configurations for soft tissue–based graft traction and fixation. Arthroscopy: The Journal of Arthroscopic & Related Surgery, 35(4), 1163–1169. https://doi.org/10.1016/j.arthro.2018.10.140

DePuy Mitek Inc (2012) ACL/PCL ethnography research report: challenges and opportunities Report No. 32. DePuy Mitek Inc.

DePuy Mitek Inc (2016). Summative usability testing: Data sheet. Usability/design validation report Report No. 8. DePuy Mitek Inc.

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