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A J&J MedTech leader offers advice for device innovation, including an unusual method in the OR

May 12, 2025 By Jim Hammerand

Johnson & Johnson MedTech’s Sandeep Makkar discusses customer empathy and determining user needs for device design and development.

A photo of Johnson & Johnson MedTech Worldwide President of Endomechanical & Energy Sandeep Makkar.

Johnson & Johnson MedTech Worldwide President of Endomechanical & Energy Sandeep Makkar [Photo courtesy of J&J]

It’s not easy for medical device designers and engineers to get into an operating room to observe procedures in search of better solutions. And when you get the opportunity ask a device user about their pain points, they might not even know what they really need.

Deep insights for device design and development come from customer empathy, Johnson & Johnson MedTech  Worldwide President of Endomechanical & Energy Sandeep Makkar said in a Medical Design & Outsourcing interview. He offered advice for other device developers, including a unique way his team identified an innovation opportunity out of complete silence.

“Most device manufacturers look at a point of care, almost like a transaction within a procedure: an anesthesia machine looking at a point of time, or an energy device looking for a sealing or a transection moment, etc.,” he said. “The successful companies or the successful technologies are those that zoom out and look at the workflow. My guidance would be to have empathy for the surgical teams — not just the surgeon but the surgical teams and the surrounding ecosystem — and looking at the patient more as end-to-end care.”

“You have standard questionnaires, you have usability, then concept and use,” he later continued. “So you have a certain concept — first paper concepts, and then prototypes — then you have them use it … and as the prototypes evolve, you have them give feedback. That’s one element. But that’s after the solution has been identified. One step before, when you’re just trying to think through what solutions would you put in play, sometimes your end user doesn’t know what to ask for. And in this case, sometimes it’s just being in the operating rooms and observing workflows — and there are formal methods to capture that.”

A photo of Johnson & Johnson MedTech's Harmonic Focus ultrasonic shears

Johnson & Johnson MedTech’s Harmonic Focus ultrasonic shears [Photo courtesy of J&J MedTech]

When developing the Harmonic Focus ultrasonic shears for thyroidectomies, his team put heart rate monitors on surgeons, monitored the audio in their operating rooms and measured the exchange of instruments during the procedures.

“The surgeon may not be able to articulate sometimes, but when we were observing, the devices got near the recurrent laryngeal nerve and the room would go quiet,” he said. “Instruments are being exchanged, the room goes quiet, heart rate goes up. That’s when you know.”

That tension and silence in the room indicated an energy device could add value by minimizing the number of instruments being exchanged and by reducing the risk of injury to that nerve.

“That’s exactly what that device did,” Makkar said. “We created a device that reduced the number of instruments exchanged and reduced the risk for electrical energy transmitting into the nerves, and that device has been very successful for us even decades later now.”

If they had asked what the need was, they might have thought the need was for a better dissector to transect the tissue — and they would have missed the opportunity.

“It’s really reading the workflow of the room, which is why I’m a big believer,” he continued. “… We studied the workflow — [the] entire team’s workflow, then you zoom in to the job to be done so you can create a technology that simplifies the operating room experience end-to-end while delivering on its primary mandate, whether it’s a tissue effect that you desire or a hemostasis solution, or whatever that need is.”

“How are you improving workflows through your device? Are you making it simple to use, simple to access, simple to use, simple to dispose? Is your device connected to the other components of the workflow seamlessly? … Our technologies must reduce the cognitive burden for our end user, helping them make better decisions intraoperatively or post-op follow-ups or plan their surgeries better, improve ease of use, learning curves, effectiveness and safety, all of that.”

“It’s common sense, but as you get into the design process, sometimes technology takes over,” he continued. “That’s why we keep talking about: Make your technology more human, care more adaptable, and people more connected with your technologies.”

More from Makkar: What J&J MedTech’s new Dualto says about the OR of the future

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