“We have four major stakeholders in our business: the patient, the physician, the provider, and the payor and if we don’t understand all of those stakeholders and the value they play and the decisions they make, then we’re not doing our job,” explains Steve Eichmann, industrial design director for worldwide research and development at Ethicon Endo-Surgery (EES—ethiconendo.com). He admits, however, that this wasn’t the traditional way EES looked at product development, not until the company began development of its Harmonic FOCUS ultrasonic surgical device designed for use in delicate surgical procedures, including thyroidectomies (i.e., removing all or part of the thyroid gland). “We used to have what could best be described as an ‘over-the-wall’ approach to product development where we had a keeper of the knowledge and they championed the device development,” Eichmann explains.

When the product development team was tasked with developing the FOCUS, they looked at several different options for the device. First, the team considered following Harmonic’s trademark shaft-based design for the new device. While that would have seemed easy and cost-effective, the team questioned how effective this approach would be in the long run. Instead of taking the easy road, the team wanted to rethink the way they conducted their processes.

Settling Into the O.R.
“We wanted to involve the surgeons as our partners to help collaborate on the development,” Eichmann says, noting the FOCUS development team spent more than 48 hours observing approximately 40 procedures in various operating rooms (O.R.s) across the globe. To help better understand what was happening in the entire surgical procedure, the team set up three video cameras in the O.R.: one focused on the site of the surgery, another on the surgeon, and the third providing a view of the entire operating room. The images were then scrutinized down to the second with team members observing not just how the EES CS14 device—the predecessor to the one they were designing—was used during the actual procedure, but also how many times the surgeon had to switch out various instruments during different portions of the procedure.

“You have to understand every step of the procedure. You have to know when the surgeon has something in their hand, when they interact with tissue, and when they go to grab an instrument,” Eichmann says. Knowing exactly what’s happening at every second is critical to inventing a solution that can make the surgeon’s job easier, while also helping to reduce recovery time and thus cutting total costs to the payor. EES’s developers took the additional step of mapping out the entire procedure in graph form, illustrating which instruments were used at which times during the procedure and for how long. They even went so far to place heart monitors on the surgeons to measure stress levels at various points in the procedure.

“The surgeons can’t articulate these details in interviews—they don’t count the number of times they change tools in a procedure. But if my team doesn’t know that information, then we are not going to make the right decisions and provide the right solution,” Eichmann says.

Deciphering the Details
Using the three different vantage points of the procedure, product developers quickly realized that surgeons were using the CS14 for tasks it wasn’t originally designed for, including disection and manipulation of tissue. The team also noticed the shaft design of the CS14 didn’t allow surgeons to maintain proper posture, which caused unnecessary fatigue. Likewise, the device’s foot pedal-based activation caused additional problems, as the pedal would get jostled around and the surgeon would sometimes lose track of its location.

After studying terabytes of video data, the team began looking at solutions that did away with the shaft design altogether in lieu of something that was more intuitive. “We quickly realized that if you are doing open surgery and you have a shaft, you lose that one to one connection with the tissue, not to mention control and precision. As a design team watching these procedures we thought, this isn’t right,” Eichmann says. The team started looking at solutions that would act as an extension of the surgeon’s hands, allowing for better interaction with tissue, while also providing a more comfortable operating posture.

Devising a number of solutions using rudimentary models made from various pieces kept together with Velcro and magnets, the team narrowed their direction. Next, they produced low-fidelity prototypes of both shaft and scissor designs using 3D printing and presented them to surgeons. The decision to use low-fidelity models proved key in allowing for honest feedback, Eichmann says: “We used to send stuff off to the model shop and have it painted and pretty before we presented it, and it was hard for some people to make a negative comment about something that looked like we spent a lot of time on it. Low-fidelity models make it easier for people to provide criticism, which results in a better conversation.”

Initial research showed that surgeons overwhelmingly preferred the scissor design. While it might have been easy to just stop there and build off of the initial concepts, EES’s product developers wanted to make further advancements that would help the FOCUS become the preferred device worldwide. They started to look at device activation, and considered whether to do away with pedal activation in lieu of something that would be easier and more exact. Observational research indicated it would ideal for the device to feature hand activation, but issues arose. Early prototypes with hand activation revealed surgeons would have to apply too much pressure to the device, making it less stable during surgery. “When you are on a blood vessel, you don’t want to be moving that device around,” Eichmann notes. The team went back to the drawing board and developed switches that could be activated with less pressure with the added ability to provide multiple speeds.

Likewise, the team looked at how the surgical instrument would be handled during the procedure. While some different scissor designs were considered, team members wanted to adhere to their credo of intuitive operation, so they honed in on mimicking a tool that’s second nature to everyone in the operating room: a hemostat, the clamp used to stop bleeding during an operation. “Everyone is trained to handle a hemostat and when we used that as the basis for our design, we saw people grab the FOCUS in ways we never would have thought and that allowed us to have better insights every time,” Eichmann says, such as adding elastomeric material to the handles for improved grip. Another key development from the research related to the material and placement of the blade. The issue of the material was to reduce heat, so aluminum was used for the clamp. To improve visibility, the blade was moved to the top of the clamp instead; the previous device had the blade under the clamp.

And the new design is proving to be beneficial for the doctors and patients alike. EES recently completed a field review of the FOCUS in its early stage use and the results have surpassed expectations. Instrument exchanges in a typical thyroidectomy were on the order of 72 and now they’re down to approximately 25, thereby helping reduce procedure time. What’s more, they’ve determined that patient recuperation times are dropping significantly.

Expanding PDs Reach
Being that EES is part of the larger Johnson & Johnson family, it took little time for the parent to notice the effectiveness of EES’s development process; the FOCUS was one of the division’s most successful launches ever. Consequently, J&J has adopted some of the processes used to develop the FOCUS at its other divisions. “The ethnographic research is what we’re seeing the most interest in throughout the organization,” Eichmann says. For example, the company’s DePuy Orthopedics (www.depuy.com)
division, which develops devices used for hip, knee and trauma procedures, is following in EES’s product development footsteps.