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Summary
This Neuromodulation Consultant & Biomedical Engineering Expert is passionate about finding solutions for unmet medical needs through innovative science and engineering. With a PhD in Biomedical Engineering from Case Western Reserve University, he is an expert in neural stimulation and neuromodulation. Dr. Poletto has worked as a scientist, engineer, and a clinician at organizations like Medtronic, the National Institutes of Health (NIH), Case Western Reserve University, and Baylor College of Medicine and offers clients access to deep expertise at the intersections of science, engineering and medicine. This Neuromodulation Consultant & Biomedical Engineering Expert leverages his extensive knowledge and background in neuromodulation to help companies conduct research and develop products that lead to solutions for real world problems. His extensive scientific and clinical work history uniquely positions him to understand client goals and how to achieve them. His ability to foresee and mitigate issues his clients may not have anticipated helps him set his clients up for success. His many scientific publications have been cited well over 2500 times and he holds several patents in the field of medical devices and neural control.
This Neuromodulation Consultant & Biomedical Engineering Expert is an expert in the design of neural stimulation leads and electrodes for stimulation in the brain, spinal cord, and periphery. He leverages computational modeling to optimize designs and has served important roles as an expert in electrical safety. He holds patents in lead design and selective stimulation techniques, as well as therapy optimizations that have been referred to as in the top ten most important innovations in the field of neuromodulation.
Highlights
- Neuromodulation
- Study design
- Lead design
- Selective stimulation
- Electronics design
- Mechanical design
- Computational modeling
- Neurophysiology
- Electrical stimulation safety
- Prototype fabrication
- In Vivo and In Vitro testing
- Regulatory approval
- IP strategy
- Technical communication
- Biomedical engineering
- Mechanisms of action
Relevant Accomplishments
- Transcutaneous Neural Stimulators
- Designed and built prototype commercial system for treating foot drop.
- Designed and built high voltage research stimulator for use with small electrodes.
- Investigated mechanism of action for commercial system to assist swallowing.
- Designed, patented, and built vibrotactile system to aid swallowing – currently in commercialization.
- Investigated psychophysics for optimized electrotactile communication.
- Authored chapter on Tactile Stimulation for the Encyclopedia of Medical Devices.
- Created and experimentally verified novel waveforms for improved comfort and localization of fingertip electrotactile stimulation.
- Implanted Neural Stimulators
- Helped design upper extremity neuroprosthesis system.
- Helped design and test patented FES system to aid swallowing. Assisted in technology transfer to commercial manufacturer.
- Served as chief electrical safety scientist for world’s largest medical device company, performing rapid failure and risk analyses for numerous implanted systems.
- Designed and experimentally verified novel electrode for gastric stimulation to treat obesity.
- Designed and patented novel electrode array and stimulating waveform to allow focused current steering to remote target tissues such as in spinal cord stimulation.
- Performed and presented an extensive electrical safety analysis of DBS that led to Health Canada reversing its decision to deny a requested increase in the allowed current density for DBS. Without this decision, there would be no DBS in Canada. Cited as one of the single most important advances in DBS in decades.
- Designed and patented method for using light and optogenetics to treat epilepsy.
- Served as scientific lead for a cross functional team to develop novel implanted system for treating chronic migraine. Dealt with all aspects of developing a new implantable system from conception to commercial release.
- Founding member of a neuro-cardiology team at Medtronic. Team designed and tested the first catheter-delivered vagal nerve stimulator.
- Designed and filed IP for several novel lead types, surgical tools for lead implantation and removal, and lead anchors. Leads were for peripheral nerve, dorsal root ganglia, periurethral, and spinal cord stimulation.
- Experimentally identified best design specifications and implantation techniques for a novel stimulator to be implanted in the head, dramatically reducing the risk of adverse events for stimulating sites on the head.
- Independently designed and built an experimental implantable neuroprosthetic system for leading manufacturer to use in developing a novel therapy. Solely responsible for product development from concept to final product validation and delivery.
- All of the above involved design verification and/or validation in a medical device setting.
- Neurophysiology
- Published author on a wide range of neurophysiological topics, including electrical stimulation of nerves, tactile stimulation, neural control of speech and non-speech sound production, neural processing of speech and non-speech sounds, and neural control of swallowing.
- Proposed and experimentally verified hypothesized mechanism of action for novel headache therapy (occipital nerve stimulation, ONS).
- Conducted many pre-clinical, clinical, and human-subject research studies on a wide variety of topics related to neural processing of sensory data, neural control of movement, functional electrical stimulation, and neuromodulation.
- Computational Modeling
- Built a computational model of human cardiac Purkinje fibers, the first of its type.
- Used Numeric optimization to help the Fish and Wildlife Service set appropriate harvest limits on clams and other sea creatures.
- Created a computational model of various human sensory fibers, used the model to make predictions, and verified the predictions experimentally, solving two longstanding challenges for fingertip electrotactile stimulation that were previously thought unsolvable.
- Created a computational model of gastric stimulation and used this model to explain why a large clinical trial had failed. The model was also used to suggest a novel electrode design that was verified experimentally to provide better results.
- Created a computational model to investigate high frequency stimulation of human sensory nerves. The model was extremely ‘stiff’ and novel methods were needed to solve the differential equations. Two companies have been founded on the insights garnered from this model.
- Created computational models to help optimize several therapies, including those for abnormal swallowing, migraine headache, cardiac failure, epilepsy, spinal cord stimulation for pain, periurethral stimulation for incontinence, and postsurgical peripheral nerve pain.
- Identified an error in the most popular neuronal modeling software that altered the results of several published papers from other authors.
Intellectual Property
- Inventor or co-inventor for dozens of filed patent applications, with at least seventeen being granted thus far.
- Served on multiple boards for intellectual property and innovation strategy.
Cross functional Communication
- Cultivated and managed relationships with top experts and key opinion leaders in multiple countries across multiple disciplines.
- Served on multiple cross functional teams for technology and product development, risk analysis, reimbursement strategy, clinical research, innovation management, and marketing.
- Negotiated solutions to product safety concerns with regulatory agencies, obtaining product marketing approvals for diverse therapies in multiple countries.
- Served as thought leader for device and therapy innovation, creating an extensive intellectual property portfolio.
- Served as lab Safety Officer, member of the Institutional Safety Committee, and Controlled Substance Custodian at the NINDS/NIH.
- Sole engineer for large, interdisciplinary team investigating normal and abnormal neural control of the larynx. Responsible for innovative technical development of research designs, analytical methods, instrumentation, including custom hardware and software, and staff training.
Study Design
- Conducted scientific reviews and managed projects to assure legal and ethical compliance, scientific merit, and timely completion.
- Wrote protocols for internal and contract research to improve responder rate, improve patient selection, and explore mechanism of action for a novel headache therapy.
- Served as lead scientist for multiple industry sponsored and academic study programs, mostly related to early stage therapy development and optimization.
- Designed and conducted human and animal subject research studies using a broad range of technologies including: functional and anatomical magnetic resonance imaging (fMRI, MRI), magnetoencephalography (MEG), electroencelphalography (EEG), functional electrical stimulation (FES), electromyography (EMG), neural stimulation, electroneurography, video motion analysis, 3-D articulography, and videoradiography.
Roles
- Independent Consultant
- Lead Scientist
- Chief Technical Officer
- Contract Researcher
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