Abbott’s Rebecca Wilkins looks back at the Infinity DBS system’s development and offers advice to help device developers better understand unmet needs and meet them in innovative ways.
Abbott’s Infinity deep brain stimulation (DBS) implants and leads [Image courtesy of Abbott]
Months after St. Jude Medical won that initial indication for treating Parkinson’s disease and essential tremor — making it the first nonrechargable eight-channel DBS system, the first DBS system with directional leads and the first upgradable DBS platform for movement disorders — Abbott bought the company and its technology in 2017.
Since then, Abbott has added new features such as a smartphone app and won expanded indications to target all the major parts of the brain for treating movement disorders.
The device developer is now using the Infinity system to study DBS as a therapy for treatment-resistant depression, with an eye on potential applications for chronic pain and anxiety-driven disorders like obsessive-compulsive disorder. (Read more about that in our interview with Abbott Neuromodulation Global Clinical & Regulatory Divisional VP Jenn Wong.)
Abbott Neuromodulation R&D Divisional VP Rebecca Wilkins has been working with the Infinity system the entire time, joining St. Jude Medical in 2006 as an electrical engineer.
“I’ve always found the technology fascinating. We’re still learning about how the brain and the nervous system work, and being part of a cycle where you’re creating technology that’s advancing that understanding and then creates better technology is a dream job,” she said. “My mom has Parkinson’s and our products, so I have a personal motivation to continue to innovate and help people with motion disorders live full lives, and I think I have a uniquely empathetic view of what our patients go through.”
In a Medical Design & Outsourcing interview, Wilkins discussed the system’s development and the technical challenges of miniaturization, power optimization and industry firsts like the use of Bluetooth Low Energy for smartphone pairing.
“Infinity is a unique story of innovation, because … we were looking to solve a big problem with our motion disorder patients and our pain patients, which is that people hate charging the device,” she said. “It’s very burdensome and hard to do, and if you think about motion disorder patients, sometimes they have mobility issues. We wanted a recharge-free option that reduced that burden.”
Infinity DBS design and engineering
Abbott’s Infinity deep brain stimulation (DBS) neurostimulator is typically implanted in the patient’s chest, with leads running up the neck and into the brain. [Image courtesy of Abbott]
The implants needed custom chips and boards for miniaturization and manufacturability, including a tri-fold board that Wilkins described as “a flex circuit folded many different ways, kind of an accordion-looking thing.”
“It was a lot of fitting things in, simplifying, making sure we weren’t adding things that we didn’t need — because sometimes if you don’t stay focused, it can start to grow legs a little bit — and working closely with our manufacturing partners,” she said.
In another industry first, Abbott used Bluetooth Low Energy to connect to a patient’s smartphone to let them manage their therapy and let their doctor to remotely adjust the neuromodulation
“Motion disorder patients want discreetness,” Wilkins said. “They may already have some sensitivity around how they’re viewed because of their disease, so being able to adjust their therapy without pulling out something that’s clearly a medical device was top of mind for us.”
Infinity’s directional leads allow for focused stimulation to specific targets in the brain to maximize the therapeutic effects and minimize side effects on a patient’s speech or gait.
“There’s full rings on the ends, and then the middle rings are broken up into three segments so you can partition simulation and pick a number of combinations,” Wilkins said. “You ultimately have eight different contacts on that lead that you can create a field with.”
Power transfer for implantable devices requires optimization of three conflicting factors for performance, convenience and safety: charging range, time and heat.
“There’s things you can do with the energy transfer in terms of the frequency band you select. That might have some optimizations in power transfer, but then you have all these different radio requirements in different geographies you have to consider, especially if it’s a worldwide product,” she said. “You may want to have a large range, but maybe don’t want a huge coil outside the body, so you optimize the coil design with the range. And then usability, how long do you need to charge your device, things like that.”
“We make a lot of decisions around what do we do that’s custom versus what do we use an off-the-shelf product for and why, because you may get a much smaller custom chip, but if you don’t the mass to support that or you don’t have the volumes, there’s trade offs,” she continued. “It’s complicated. There’s no perfect answer. It’s always trade-offs. … Those can be tough decisions. As a leader, a lot of the time I spend is understanding the why behind the decision-making.”
The Abbott Liberta rechargeable neurostimulator (left) compared to Abbott Infinity neurostimulators [Image courtesy of Abbott]
With Medtronic winning the first FDA approval for adaptive DBS (aDBS) closed-loop neuromodulation to treat Parkinson’s, we asked whether Abbott is working on aDBS.
“We’re interested in understanding how to close the loop and what the right biomarker is, but we want to make sure that it’s solving clinical problems,” Wilkins said. “What we see right now is there’s a lot of interest in local field potential, so we’re watching that, but we want to understand does that bring better clinical benefits, because the cost is now you’re processing data at the implant level, which goes back to size and power consumption and battery life.”
“Go solve the biggest problems that haven’t been solved yet.”
Abbott Neuromodulation R&D Divisional VP Rebecca Wilkins [Photo courtesy of Abbott]
“I like to start meetings with,’What are we trying to do here? What’s the problem we’re trying to solve?’ And if I see a lot of confusion or I don’t see a cohesive statement, I know we need to step back and get a more organized about what we’re trying to do and reiterate the importance of the work,” she said. “Because when you’re in the trenches and you’re working on the minutia of something, you forget the big picture. I like to remind people why we’re here, why we’re doing what we’re doing. We could be anywhere. We’re here. There’s a reason why we’re here. Don’t forget that. It’s connection to our purpose.”
When considering the problem, she advised staying away from solutions early in the process, including offering potential solutions to users.
“Spend focused and disciplined time on a problem statement, understanding the problem, prioritizing the problems, and then getting out in the field and talking and viewing,” she said. “We have a lot of opportunities to map out a process flow and see things and then ask questions, but I encourage people not to ask questions that have integrated the solution in the question at first. … If you ask the wrong question, you get the wrong answer back and it can lead the team off. Asking really objective, neutral questions that take away biases is really important. ”
And remember that those patients aren’t always like you or your medtech colleagues.
“Think about how you’re asking questions to a really diverse candidate pool that represents your patient population,” she said. “They might not have the same technical capabilities, they might not have different things that we take for granted. Getting users in to walk through and live their lives so we can understand their lives through their eyes is super important.”
“Anytime we think about a solution, thinking about how we’re increasing access to care — what are we doing that’s making this more available to everyone — is hugely important for us,” she continued. ” … At Abbott, we’re really focused on solving these important patient needs. We love being industry first at things, and you’re going to keep seeing some really interesting innovation come out from us.”
