Exploring the Adoption of Implantable Brain Stimulation into Standard of Care for Central Nervous System Disorders Proceedings of a Workshop (2024) / Chapter Skim
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2 Crossing the Chasm: Lessons Learned Across Medical Technologies
2 Crossing the Chasm: Lessons Learned Across Medical Technologies
Pages 7-20
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From page 7... ...
(Mann Woods) • Responsive neurostimulation has faced challenges in adoption due to relative complexity of programming and high patient burden compared to devices with similar outcomes -- emphasizing the advantages of collecting long term seizure data could be key to encouraging more widespread adoption.
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From page 8... ...
To illustrate this process, he showed an adoption curve and indicated where different technologies fell on that curve. Deep brain stimulation is still in the realm of pilot research, being carried out by early adopters and visionaries but not adopted in mainstream clinical practice in the way that cardiac pacemakers and cochlear implants have been.
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From page 9... ...
Those who are interested in wider adoption of implantable brain stimulation can look to cardiac implants as a model, he said. The theory of heart pacing was first sketched out in 1889, but it was not until 1958 that the first wearable external pacemaker appeared, and 1960 for the first implantable pacemaker -- a latency period of about 70 years from theory to practical devices (Aquilina, 2006)
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From page 10... ...
LESSONS LEARNED ACROSS THERAPEUTIC AREAS Strategies for increasing the adoption of implantable brain stimulation therapies could be developed by leveraging insights gained from the adoption of other novel therapeutic approaches. To this end, a panel of four speakers discussed lessons learned from the use of different technologies for various disorders that might be applied to implantable brain stimulation: FDA-approved neuromodulation therapies,1 cochlear and retinal implants, responsive neurostimulation for epilepsy, and DBS for OCD.
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From page 11... ...
Importantly, Pinto emphasized that patient perspectives must be considered as well. CDRH is looking for ways to accelerate the realization of its vision, Pinto said, and he listed three programs intended to help with that: collaborative communities,2 the Breakthrough Devices Program,3 and the Total Product Life Cycle Advisory Program, or TAP.4 2 To learn more about the collaborative communities program, see https://www.fda.gov/ about-fda/cdrh-strategic-priorities-and-updates/collaborative-communities-addressing-healthcare-challenges-together (accessed November 26, 2023)
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From page 12... ...
Overall, he concluded, the FDA is dedicating effort and resources to hear from many different perspectives to inform its programming and strategic planning. Cochlear Implants and Retinal Implants Carla Mann Woods, the chief executive officer of Mann Healthcare, and a member of the board of counselors at USC Viterbi School of Engineering, spoke about the adoption of cochlear implants and retinal implants to gain insight and lessons that might apply to the adoption of implantable brain stimulation.
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From page 13... ...
population is on Medicare, and while the FDA approved cochlear implants for adults with moderate hearing loss in 2002, it was not until 2022 that Medicare allowed payment for cochlear implants for those patients. That was a huge number of people who would have been suitable candidates, Mann Woods said, which means that Medicare's refusal to pay for them had a huge impact.
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From page 14... ...
Only 200,000 Americans have received cochlear implants since 1985, compared with many millions who could have benefited and Mann Woods continued, even today, just 50 percent of candidate children receive an implant, and less than 5 percent of candidate adults do (Nassiri et al., 2022)
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From page 15... ...
The treatment is indicated for patients who continue to have seizures originating from up to two foci in the brain despite adequate trials of at least two seizure medications, she said. Placing the RNS device requires knowledge of the seizure onset zone, which typically involves sophisticated neuroimaging techniques.
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From page 16... ...
"Judging a device based on the number of seizures is short-sighted," she said. "We know that long-term EEG can inform better surgical plans, elucidate cycles, and inform medication response, yet we give more weight to patient complexity and cost and patient burden." Given the growing value of EEG data recording devices outside of clinical settings, she said, "why not start with existing [RNS]
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From page 17... ...
Multiple access and workforce issues affect OCD care, even conventional care, he said. "You can't find an OCD expert psychiatrist." Even in large medical centers, the best places to offer OCD treatment, clinicians do not have adequate time or resources.
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From page 18... ...
"I think we can do better than we do now," he said. DISCUSSION Funding Opportunities for Deep Brain Stimulation Procedures Litt opened the discussion session by offering a question about funding to the panel: "If we are successful and there's increased uptake for these devices, how are we going to pay for it?
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From page 19... ...
Litt concluded that including participants in the conversations about implantable brain stimulation will also be important and this sentiment was reflected in the workshop's ensuing discussions with individuals with lived and living experience. PREPUBLICATION COPY -- Uncorrected Proofs
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From page 20... ...
PREPUBLICATION COPY -- Uncorrected Proofs
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