Neural Implant podcast - the people behind Brain-Machine Interface revolutions

Nathan Copeland is a paraplegic neural implantee who has four Blackrock Utah electrode arrays implanted in his brain. He uses a robotic arm which has a wider functionality than a regular arm, and has even fist bumped the president with it. In this episode, he discusses his experiences being implanted and how using the implants has changed his life. Top three takeaways: When Nathan Copeland met President Obama and had a fist bump with him, he realized that the president was very interested in the science involved in his implants. He was able to connect personally with the president, and this reaffirmed the notion that the president is just a human being. There are many different types of robotic arms with slightly different structures and functionalities, and different people may prefer different varieties. Some people prefer ones that look more anatomical, while others may prefer ones with a wider functionality. Nathan Copeland initially had a fear of public speaking, but after giving presentations on his condition and the various robotic arms he used, he found that he was actually enjoying it more and more. In particular, he found it very fulfilling when people would tell him how inspired they were by his presentations, and this increased his enjoyment of public speaking. [0:00] Ladan introduces the episode and the guest, Nathan Copeland [3:20] Copeland describes the accident that led to C-5 quadriplegia and his time spent on a research registry to become a subject in the BCI study that gave him the implants [5:45] Copeland discusses the screening process he had to go through to become a part of this study and how he knew he wanted to be a part of it despite his mother's opposition to it [9:30] Copeland talks about the pain and discomfort he went through following the implantation of the electrode arrays [13:20] When Copeland went to meet President Obama, he was told that the president was "just a person". When Copeland did meet the president, it was obvious that he seemed very interested in the science behind the implants and was able to bond with Copeland as a person. [15:45] The training Copeland needed to use the robot limbs controlled by the implants was never something that he had to really work for [18:45] The robotic arm that Copeland uses is a non-anatomical arm, and he likes it because it can move in his workspace in ways a regular anatomical arm cannot [22:15] Different people may have different preferences in what they would want in a robotic arm – some would prefer a traditional anatomical arm, while others would want an arm with more functionality even if it looks unconventional [25:00] One of Copeland's biggest dreams that recently came true was to travel to Japan – he had wanted to visit Japan his whole life, and he knew that his condition would have made it very difficult [28:30] Copeland used to have anxiety when it came to public speaking, but after giving his presentation on the robotic arms he has used, it gets easier for him the more he presents it. A lot of people have been inspired by his presentations, and he now very much enjoys the experiences. [32:10] Copeland would like to see an improvement in the robotic arms used by the BCI systems [35:30] Copeland has a YouTube channel called BCI Can Do Better where he demonstrates the various activities he can do with his BCI system, such as playing Final Fantasy XIV Nathan Copeland's email address is [email protected]

Dr. Alie Caldwell, a.k.a. Alie Astrocyte, is a neuroscientist who is well-known for her YouTube channel Neuro Transmissions. In this episode, she discusses the YouTube channel, how it was created, what types of videos the channel produces, how the videos are made, and what she has gained out of it. Top three takeaways: In doing this channel, Alie Caldwell has had to overcome the challenge of maintaining a good work-life balance, since this channel is not her full-time career. In academia, you are taught to feel as though you don't know anything, which can make people feel hung up on inaccuracies; however, a lot of the time, you can explain something with simple terms and it will still be accurate. When building a YouTube channel, the most important thing is to realize what your goals are; you have to ask what you want to communicate, who you want to reach, and what is unique about your content. [0:00] Ladan introduces the episode and the guest, Alie Caldwell [1:30] Caldwell talks about her YouTube channel, the type of content she produces, and who her target audience is [4:30] Caldwell explains how a special event in her graduate program helped her get into making neuroscience videos [6:45] The biggest challenge when starting the channel was that since neither Caldwell nor her YouTube partner Micah does YouTube full-time, maintaining a good work-like balance while doing this "side project" became difficult at times [8:30] The channel tries to put out a video every two weeks, and every video takes roughly 20-30 hours to create and edit depending on the style and amount of animation [12:15] The content the channel puts out is high-level enough that Caldwell is confident enough in her research on the topic to be able to teach the topic without fear of inaccuracies [14:45] Caldwell recently finished her PhD and is currently employed by the Bigelow Memorial Science Communication Fellowship [17:45] Both Caldwell and her YouTube partner Micah are trying to figure out their next career steps; they are not intending to have YouTube be their full-time career [21:00] The most important thing is realizing what your goals are with your videos; what are you trying to get across, who are you trying to reach, and what is unique about your videos? [23:45] This YouTube channel was an opportunity to build a portfolio and stand out from other scientists with a distinct skill set [27:30] One main thing that Caldwell learned from the YouTube channel is public speaking and translating it into a video personality

We know you are facing challenging times in this current health crisis. The U.S. Small Business Administration is committed to help bring relief to small businesses and nonprofit organizations suffering because of the Coronavirus (COVID-19) pandemic. On March 27, 2020, President Trump signed into law the CARES Act, which provided additional assistance for small business owners and non-profits, including the opportunity to get up to a $10,000 Advance on an Economic Injury Disaster Loan (EIDL). This Advance may be available even if your EIDL application was declined or is still pending, and will be forgiven. If you wish to apply for the Advance on your EIDL, please visit www.SBA.gov/Disaster as soon as possible to fill out a new, streamlined application. In order to qualify for the Advance, you need to submit this new application even if you previously submitted an EIDL application. Applying for the Advance will not impact the status or slow your existing application. Also, we encourage you to subscribe to our email updates via www.SBA.gov/Updates and follow us on Twitter at @SBAgov for the latest news on available SBA resources and services. If you need additional assistance, you can find your local SBA office and resource partners at www.SBA.gov/LocalAssistance. If you have questions, you may also call 1-800-659-2955.

Daniel Powell is the CEO of Spark Biomedical, a medical device company based in Texas whose mission is to develop effective, wearable neurostimulation devices. In this episode, he discusses an auricular nerve stimulator to aid in the relief of opioid withdrawal both in adults and newborn infants. Top three takeaways: This auricular, transcutaneous nerve stimulator device works to alleviate opioid withdrawal by stimulating the necessary nerves to kickstart endogenous endorphin release in the brain. A major part of opioid addiction is avoiding withdrawals; opioids chemically replace endorphins and bind to opioid receptors, and the brain no longer produces endogenous endorphins, so that when the user no longer takes the drugs, they no longer have the necessary chemicals to deal with anxiety and pain. This is what makes opioid withdrawals unique and is why opioid addicts try so hard to avoid them. When starting a project, it is highly beneficial to have a diverse team of people with different skill sets that can contribute to every aspect of the project. [0:00] Powell explains his job – Spark Biomedical is currently developing an auricular, transcutaneous nerve stimulator designed to stimulate specific cranial nerve branches and is designed to relieve opioid withdrawal [3:45] There is some evidence to support the efficacy of acupuncture-based stimulation for treating opioid withdrawal in adults, which is the basis for the creation of the non-invasive auricular nerve stimulator [7:15] The ear pieces are easy to apply and disposable – since there are no needles, it is easy to replace the ear pieces as needed [9:15] When observing withdrawal symptoms in adults using this device, one can observe that the common symptoms – shaking, sweating, etc. – approach a normal level over a 60-minute window [10:45] So far, there have not been issues with the FDA, as Spark Biomedical has completed their pre-submission process, where they write down the questions to be answered by the FDA [13:30] This is Spark Biomedical's first main project; the company was formed specifically for this project at the end of 2018, and there was a good network of people to call on for both scientific and financial applications [16:45] When someone is addicted to opioids, they are not simply chasing euphoria, but are also trying to run away from withdrawals [20:45] During acute withdrawal, the stimulator helps to jump-start the brain to produce the endogenous endorphins necessary to occupy opioid receptors, which helps to alleviate withdrawal [23:45] A good dose of endogenous endorphins can alleviate withdrawal symptoms for a long time; one subject who used the stimulator device for an hour felt no withdrawal symptoms for six hours after removing the device [25:15] The project is currently in clinical trials for adults, and Spark Biomedical is currently partnered with MUSC to run the trials for infants; the hope is that the product is on market for adults in the second half of 2020 [28:15] A good piece of entrepreneurial advice is to have a diverse team with different educational backgrounds and skill sets to be able to contribute to every aspect of the project [31:30] A challenge when building the company is that it was built remotely, and does not convene in a single office [34:00] The company was built on people who were tired of corporate life, and pays based on results rather than hours

This outbreak of COVID-19 is a very difficult time for scientific research. A lot of experiments are being interrupted and put on pause, and conference travels are essentially not possible. In this episode, Ladan discusses what steps are being taken by government grant-funding agencies to assist researchers during this time. Top three takeaways: Grant-funding agencies such as the NIH and NSF are extending deadlines for grants and experiments, and late applications are being accepted without the need for pre-approval. NIH grant money can be used to cover fees incurred from interrupted travel, as well as changing any protocols as necessary. The safety and health of researchers and research participants alike is the number one priority during this time. [0:00] Ladan introduces the episode [1:30] The NIH and the NSF will extend the deadline for many grants and experiments during this time [3:45] Dr. Mike Lauer from the NIH explains the implications of this pandemic on scientific research and the way the NIH will be cooperating with researchers during this time [5:30] The NIH has put out a guide notice stating that late applications will not need pre-approval [8:00] Hotel and airline refund fees, as well as any other fees incurred due to interrupted travel, can be charged to NIH grants [9:45] There will be opportunities to apply for administrative supplements to cover costs incurred due to changing protocols and venues [11:00] This is a very difficult time, but also a time of compassion Info on how NIH is responding to the outbreak: https://www.nih.gov/health-information/coronavirus Message from Dr. Mike Lauer: https://www.youtube.com/watch?v=jLmBi5wvifk&feature=youtu.be Info on how NSF is responding to the outbreak: https://www.nsf.gov/news/special_reports/coronavirus/ Producer's log: I wrote these notes while in quarantine. Ladan locked me up in a tiny room and I don't know why. He said it was for my own good, and that he'll let me out "once the storm passes". I haven't been outside in over 2 weeks. I miss the world. I miss the laughter. I miss the sunshine. Someone please help me. Producer's log update: OK I'm just kidding, I'm not really locked in a little room. But I do miss socializing with people, I'm starting to get very lonely.

Jeremy Magland and James Jun are researchers at the Flatiron Institute whose work involves spike sorting for analysis of large recorded neuronal data sets. In this episode, at the SfN 2019 Conference, they discuss the Flatiron Institute, spike sorting and the various algorithms involved in it, as well as an open-source algorithm the Flatiron Institute has developed for spike sorting and how it works. Top three takeaways: The Flatiron Institute, a division of the Simons Foundation, uses modern computing tools to advance scientific understanding, and they provide open-source code to aid labs in data analysis. Spike sorting algorithms take recorded extracellular data and use statistical methods to group it into clusters, from which it determines the number of neurons that are firing. The difference in clustering and sorting depends on the specific type of analysis the algorithm runs. MountainSort is an open-source spike sorting software that is distinct in that it doesn't require as many input parameters as other algorithms do. [0:40] Ladan introduces the episode and the guests, James Jun and Jeremy Magland, at SfN 2019; Jun gives his background and what he is studying [3:40] Jun explains how spike sorting uses extracellular recordings to receive signals from different neurons at once [4:55] Magland gives his background and what he is studying [8:05] There's a rainbow [9:10] Magland and Jun explain some advantages/benefits of the Flatiron Institute, a research division of the Simons Foundation; the institute creates open-source software to help labs with spike sorting [11:40] Jun discusses the Simons Foundation, how they started, how they created the Flatiron Institute, and the types of projects they fund [14:10] MountainSort is the open-source spike sorting algorithm developed by Flatiron which clusters spikes by using a statistical method to detect differences in spike densities and separate the neurons accordingly. This doesn't require adjustable parameters as input, unlike other software. [16:40] Jun discusses some differences in certain spike sorting algorithms and the type of analysis they use to sort spikes into different clusters and differentiate the neurons [19:55] Magland and Jun are looking forward to enhanced hardware and computing capabilities that improve the speed and accuracy of spike sorting

Dr. Pablo Celnik is a professor of physical medicine and rehabilitation at Johns Hopkins University School of Medicine. Buzz is a spinal cord injury patient who has recently received implants to help him regain sensory and motor control of his body. In this episode, they discuss the project directed by Dr. Celnik that involves the implantation of a bilateral set of implants that has been effective in helping Buzz regain sensory and motor control. Top three takeaways: Buzz's implants are unique due to the number of implants, and due to the fact that they are bilaterally implanted. The future of this project depends on factors such as funding and reapproval, and will likely involve observing how the addition of sensory information will help improve motor performance. It is important for spinal cord injury patients to understand that despite their injury, they can live a productive and happy life. [0:00] Ladan introduces the episode and the guests, Dr. Pablo Celnik and Buzz, a spinal cord injury patient, at SfN 2019; Buzz gives a background of his injury and condition [3:30] Dr. Celnik gives a background of his research, his department, and the project he is currently working on in neurorehabilitation [6:30] Buzz is special in that his implants are bilateral and more numerous; he has arrays in the dominant and non-dominant side, in both motor and somatosensory cortices [8:45] Buzz discusses his experience with learning to control his body using his implants [12:45] Dr. Celnik discusses his experience training Buzz with the new implants; they have started with one arm and have progressed to doing more complicated movements with both arms [16:15] Like any other research project, this project depends on every component's support, including funding and yearly reapproval. The future for this project includes evaluating how the addition of sensory information helps with motor performance. [18:50] Buzz has also been involved in patient advocacy, where he has mentored and guided other spinal cord injury patients in a peer mentoring program [22:00] Dr. Celnik mentions the significance of this type of work to help spinal cord injury patients restore their quality of life [25:00] Patients like Buzz illustrate how the field of neuroscience can be translated to a practical, significant application

Jennifer French and James Cavuoto are editors and publishers for Neurotech Reports, a news source whose mission is to provide up-to-date information about the field of neurotechnology that impacts research and venture capital. In this episode, they discuss some updates and recent events happening within the last month in the industry of neurotechnology. Top three takeaways: The 2020 North American Neuromodulation Society Annual Conference was a very informative and successful conference, and the Emerging Technologies Forum hosted by Neurotech News had great attendance and presentations Companies such as Medtronic are starting to capitalize on the use of glial cells in modulating pain networks Neurotech Reports will be hosting the Bioelectronic Medicine Forum which focuses on both the research and financial realms of bioelectronic medicine and neurotechnology [0:00] Ladan introduces the episode and the two guests, Jennifer French and James Cavuoto, who start by discussing the North American Neuromodulation Society Annual Conference in Las Vegas, NV [3:40] French and Cavuoto discuss how large the event was and that it will likely take place again given the excellent turnout [4:45] The role of glial cells in pain networks was a very significant discussion according to Cavuoto; Medtronic is capitalizing on this with a startup called Stimgenics that they have recently acquired [6:45] A recent publication of Neurotech Business Report has discussed some failures of certain neurotech companies [8:20] The 2020 Bioelectronic Medicine Forum hosted by Neurotech Reports will take place in New York City on April 7, 2020, and it hones in on the bioelectronic medicine aspect of neurotechnology [10:40] Neurotech Reports has released an updated version of two whitepapers, one of which describes funding opportunities for startups, and one discusses venture capital funding

Charles Lieber, a researcher in the field of chemistry and nanotechnology, has been arrested on charges of making false statements to the US government regarding his monetary ties to China. In this episode, JoJo Platt discusses his arrest, the events surrounding it, and what it could mean for the field and future international collaborations. Top three takeaways: Charles Lieber did not disclose his ties to China while receiving grant money from US government institutions The US Senate believes China's Thousand Talents Program, to which Lieber had a direct connection, was a means to divert US intellectual property We shouldn't cut all research ties to China, but we must be careful how we go about international collaborations; researchers must be open and transparent about all affiliations [0:00] Ladan introduces the episode and mentions the recent news regarding Charles Lieber [2:10] Platt hints at some future implications of Charles Lieber's arrest, and what it could mean for future collaborations, as well as a bit of the background on Charles Lieber and the events leading up to him getting arrested [5:30] Platt discusses the timeline of Lieber making arrangements with China to receive grant funding [8:20] Lieber had failed to disclose his relationships to China while receiving grant money from institutions such as the NIH and the US Department of Defense, which is illegal [11:00] Chinese Thousand Talents Program recognized by US Senate as a program intended to divert US intellectual property, part of Lieber's agreement with this program is that he must invite 1-3 international scientists to work as visiting scholars [14:45] Platt believes not all research ties to China should be cut, but we must be careful about how we do it; transparency about affiliations is key [17:45] Lab money and personal money are two distinct things; lab money is often spent without as much care as personal money [19:15] Risk of Lieber leaving the country is low, given that he surrendered his passport when he posted bail

In this episode, Ladan interviews Ritesh Kumar, a poster presenter at the SfN 2019 conference whose research involves restoring bladder functions. Ritesh is a researcher working under Dr. Robert Gaunt in the Rehab Neural Engineering Labs at the University of Pittsburgh. Top three takeaways: The device being investigated and tested is designed to conform to changes in volume in the bladder. The electrodes embedded in the device are aligned with specific functional regions of the bladder to generate optimum functionality. Isovolumetric evaluations of the bladder provide the basis for future material designs. [0:00] Ladan introduces the episode and Ritesh Kumar, the guest being interviewed; Ritesh gives some background on the research he is undertaking involving restoring bladder functions [3:45] The polymer used in the material being discussed is very stretchable to conform to volume changes of the bladder [5:20] The material is like a sock of electrodes, which is made of silicone that can conform to the shape of the bladder [7:00] Ritesh mentions he is interested more in science and design rather than patenting the technology [9:00] The studies the guest is conducting are at isovolumetric conditions, which are being done to make the basis for the design moving forward [10:30] Ritesh discusses future directions for his research Note: One additional name for acknowledgement is Maria Jantz

Dr. Bryan McLaughlin is the president of Micro-Leads, a medical device company working on implantable therapy for spinal cord stimulation. In this episode, he discusses his research and investigation into medical-grade technologies to treat spinal cord injury, as well as his collaboration with DARPA in this endeavor. Top three takeaways: The electrodes manufactured by Micro-Leads used for spinal cord stimulation target more fibers and have more electrode channels than other electrodes McLaughlin is investigating medical-grade electrode technology for spinal cord stimulation that uses flexible materials McLaughlin is collaborating with DARPA as part of their "bridging the gap" program for treatment of spinal cord injury [0:00] Ladan introduces the episode and the guest, Dr. Bryan McLaughlin, at SfN 2019 [1:15] Micro-Leads distinguishes itself from other spinal cord stimulation companies by offering electrodes that reach fibers that couldn't have been targeted previously, with more electrode channels [4:45] This technology specifically targets pain, which is a major unmet need [6:15] Dr. McLaughlin's research company has devised medical-grade electrode technology using soft, flexible materials that can be used to help patients with spinal cord injury. [8:50] Dr. McLaughlin discusses collaborating with DARPA to develop technologies for treating spinal cord injury

Brandon Prestwood, an amputee, is a participant in a research program which develops advanced prosthetics and implants to restore sensory function in amputees. In this episode, he discusses his experience as an amputee in this research program, as well as the implanted device he uses to restore the lost functionality of his forearm. Top three takeaways: Medical treatments for amputees can often involve excessive medications, many of which are opioid-based, which can be problematic as it can lead to addiction. Current technologies to restore limb functionality in amputees are very beneficial and promising, but there are still limitations to overcome and improvements to make. It is important for this technology to be available to all amputees, so that they may restore their limb functionality and improve their quality of life. [0:00] Ladan introduces the episode and the guest, Brandon Prestwood, on the second day of SfN 2019 [3:15] Prestwood gives a background on the accident that led to his injury and amputation [6:30] Prestwood discusses the medications he was made to take during the course of his medical treatment, and how he believes opioids are overprescribed [9:20] Prestwood discusses being a participant in a research program which develops implants to restore sensory function in amputees [12:15] Prestwood discusses the implanted myoelectric device he uses to restore the functionality of his forearm [15:00] Prestwood discusses the limitations of the device and what he can and cannot do with the device [18:40] Prestwood discusses the surgery whereby he received the device [22:15] It is important for every amputee to have the opportunity to restore their limb functionality. This type of technology has the capability to restore an amputee's quality of life and is incredibly beneficial to mankind.

Dr. Tim Marzullo is an engineer and co-founder of Backyard Brains, which seeks to develop technologies to make learning about neurophysiology easy and fun. In this episode, he discusses some such technologies at SfN Neuroscience 2019. Top three takeaways: Backyard Brains creates scientific technology that can be easily used by high school students to learn more about science (and win science fairs😊) Recent technologies have taught us that there is a whole molecular and electrical world within plants that has not been fully realized until recently Thanks to technology such as the Arduino microcontroller, one does not need specialized training in Matlab or LabVIEW to learn and investigate neurophysiology [0:00] Ladan introduces the episode and the guest, Tim Marzullo, at SfN Neuroscience 2019 [1:15] Dr. Marzullo gives a background on Backyard Brains and an example of an invention they are developing involving a Venus Flytrap [4:30] Dr. Marzullo discusses the learning curve of this technology and the level of difficulty involved in learning how to use it [7:15] The use of this technology by graduate and PhD students is discussed [10:30] There is a whole molecular and electrical world going on inside plants that had previously been thought of as static beings, and is only now beginning to be explored and appreciated [12:30] Someone at Backyard Brains had recently attached 9 electrodes to himself and played World of Warcraft, in order to test out muscle-electrode interfaces [14:00] Thanks to the easy-to-use Arduino microcontroller, it is getting easier to investigate neurophysiology

Dr. Allan McCay is a legal scholar working in Australia, and his work involves legal and ethical issues in the field of neurolaw. In this episode, he discusses the legal and jurisprudential issues behind brain-computer interfaces and how their advent and proliferation could affect how crimes are viewed in legal system. Top three takeaways: Brain-computer interfaces may change the way we will need to think about criminal justice and responsibility for crimes Higher courts will need to carefully consider how they respond to the issue of crimes committed by way of brain-computer interface as they will set a precedent for other courts The questions being raised in this dilemma are giving us a greater understanding of criminal law overall and its true purpose [0:00] Ladan introduces the episode and gives a background of Dr. Allan McCay [3:30] Dr. McCay explains criminal law in the brain-computer interface world [5:30] In criminal prosecution, it must be proven that the defendant had a "guilty mind" and intends to commit the crime, and committing a crime by way of brain-computer interface can muddy the waters in the prosecution [8:00] Dr. McCay gives a specific example of committing a crime by way of brain-computer interface and a "mental" criminal act [11:00] People cannot control mental acts and thoughts as well as bodily acts [13:30] Could a neural implants case create a precedent of no responsibility for crimes committed under a brain-computer interface? [18:15] Dr. McCay discusses how this issue will likely resolve in the future, and how the direction of the law on this issue will likely be set [20:45] The most likely outcome would consist of courts declaring that a mental act constitutes an actus reus, and this is something that lawyers may need to think about more [24:40] This whole dilemma and the questions being raised make us think what criminal law is really about, and allow for a greater understanding of criminal law [26:45] Ladan provides final thoughts on the discussion as well as details of a follow-up discussion with Dr. McCay

JoJo Platt is the founder of Behind the Bench, a Neurotech News outlet, as well as a Platt & Associates where she consulted for places like Feinstein Institute for Medical Research. In this episode, she discusses how she developed her network and formed Behind the Bench, as well as recruiting in the field of bioelectronic medicine and what it takes to get hired. Top three takeaways: Platt's mission is to help promote and coalesce the field of bioelectronic medicine within the greater field of neurotechnology eventually led her to gain a large network, and to create Behind the Bench as a platform to publish research information and get to know researchers better Getting recruited for a desired job is mostly about your skill set and abilities, rather than how well known you are or how much you post on Twitter If you want a position in a lab, it is best to personally reach out to the P.I., but make sure that you are a match for the job based on your skill set [0:00] Ladan introduces the episode and the guest, JoJo Platt [0:30] Platt discusses her background and new project involving Behind the Bench [4:00] Platt discusses her role as a strategic development consultant at the Feinstein Institute for Medical Research as well as some of her achievements [6:30] Platt discusses recruiting neurotech consulting clients and learning important names in the field of bioelectronic medicine [9:00] Having a good set of skills is more important than writing a lot or being well-known in the field [10:30] If you want a research position, reach out to P.I. personally, but also make sure that you are truly a fit for the position based on your skills and experiences [13:00] Getting the right person and the right fit takes work, but it pays off in the end

This month's neurotech industry podcast features some highlights from the 2019 Neurotech Leaders Forum that took place November 4-5, 2019 In San Francisco. This is a two -day event focusing on the opportunities, trends and entrepreneur ventures in the industry. Here's what is featured: The Neurotech Reports roundtable was a lightning round session of topics with commentary and input from the editorial team. Topics included: How should the industry respond to negative press? How to ensure reimbursement for new neurotech devices? What are some lessons learned from the opioid crisis? Featuring the winners of the 2019 Gold Electrode awards. These are people and ventures that have made a significant contribution to the industry and those to watch in the future. The awards are given in 5 categories. Plus, this year the coveted Lifetime Achievement award was given to Elliott Krames.

Avery Bedows and Doug Clinton are part of Loup Ventures, a venture capital firm that invests in frontier technology. In this episode, which is the first of a quarterly series on neurotech news, they discuss recent events regarding investment in neurotech companies as well as growths and developments within the neurotech industry. Top three takeaways: Companies can sometimes look at the value of an investment not just in terms of revenue, but in terms of gaining a strong foothold in an upcoming area of development The Neuralink presentation gave more of a long-term view of future goals, in an attempt to increase their hiring and rein in excitement By 2020, there will be a lot more neurotech startups and overall more capital present within the industry, and lots of opportunities for investors [0:00] Ladan introduces the episode and his guests, Avery Bedows and Doug Clinton, who are with Loup Ventures [2:00] Facebook acquired CTRL-labs for $500 million, Avery discusses the significance of this [5:00] There is discussion over whether Facebook is more interested in brain-computer interfaces or VR [8:45] The value of the investment is explored and it is discussed whether Facebook acquired CTRL-labs more for monetary gain or as a way to truly enter the field of VR/AR [12:00] Thomas Reardon, a co-founder of CTRL-labs and inventor of Internet Explorer, knew that his product reached a lot of people, but wasn't part of a full-blown platform, so he needed to plug it into a company that provided the full-blown platform [15:10] Topic switches to Neuralink, Ladan and the guests discuss their thoughts on the Neuralink presentation where Elon Musk discusses the automation of electrode-thread implantation [18:20] Avery discusses what he found most interesting about the whole presentation and how he interprets it [21:50] Avery discusses some motivations for being in neuro that he has found in people [25:45] Doug mentions that the future of interface with which we communicate may be related to VR/AR, beyond that it may tie to direct interface with brain [27:40] Topic switches to Loup Ventures' investment in Rune Labs, Avery and Doug provide some background and opinions [31:30] Big picture for Rune Labs is seeing data platform for intracranial data from the brain, using data to enable other development of medical applications [33:30] There will likely be more capital in 2020 within this whole field, we will see info about young startups, lots of early stage neuro

Joe Bird is a lawyer specializing in patent litigation, and works for the firm Maynard Cooper & Gale. In this episode, he discusses the current lawsuit between Nevro and Boston Scientific for a high-frequency spinal cord stimulation device, he gives a general overview of patent law and how patents are enforced and litigated, and also discusses what this lawsuit means for the neurotech industry. Top three takeaways: Patent litigation is a very unique field of law, with a lot of special rules and proceedings, and can also be very expensive. Patent protection is very important, and can be a driving factor in the success of a company or industry. The Nevro vs Boston Scientific lawsuit has vast implications for the field of neurotechnology (particularly for spinal cord stimulation). Those in this industry should be aware that this could be a very costly part of entering the industry. Show notes: [0:00] Ladan introduces the episode and the guest, Joe Bird, a lawyer who specializes in patent litigation. [1:27] Bird mentions that he is a lawyer working for a firm in Birmingham and specializes in patent litigation, and discusses his previous experience working in law. [3:54] Bird discusses the emerging neurotech industry and how patent litigation in this industry is emerging. [5:37] Bird lays down the groundwork for understanding the lawsuit between Nevro and Boston Scientific [6:45] Bird gives an overview of how patents are administered and how patent litigation is carried out [8:00] Bird discusses high-frequency stimulation and how it makes the product unique [9:40] Bird discusses how Boston Scientific is challenging Nevro's patent and discusses the prior art involved. Prior art serves a very important purpose in patent claims. [12:00] Bird discusses patent claims, how they are made, what the rules are behind making them, and how they are unique [14:30] Bird discuss claim construction and how patents are enforced [15:45] Bird discusses the patent claim in the Nevro litigation and what it says [17:10] A problem found with the patent claim is: the phrase "an implantable signal generator configured to generate a signal" is ambiguous. [19:45] Another problem with the patent claim is: "to generate a non-paresthesia producing therapy signal" is a phrase that is an area of indefiniteness. Bird asks, "Can you patent something that doesn't create an effect?" [21:50] Two things important in the process of getting a patent claim issued are saying a product has a certain structure/composition, or function. Uses chainsaw as example [22:40] Bird states how the court did not like how Nevro's claim pertained to the claimed effect of the product, rather than an aspect of the product itself. [23:45] There are two kinds of patent claims: article of composition or structure of device (device claim), and method claims. Bird mentions how court found that wording of Nevro's patent claim was not indefinite for a method claim. [25:40] Strategy to enforce structure-based claim is different (and easier) than enforcing a method claim [28:00] Some patent clients conceal information about the process/products, some info does not go into patent. Bird says it is important to include all information possible in the patent. [30:13] How patents are distinguished, and how patents are checked to make sure there is no "patent overlap" [31:25] What does this Nevro vs Boston Scientific lawsuit mean for the neurotech industry? (specifically, for spinal cord stimulation) [32:00] Bird talks about how more successful products are more susceptible to patent litigation [33:00] This "war" is just beginning, and those in the spinal cord stimulation industry should be aware that litigation such as this could be a very costly part of entering the market [35:30] Bird is working on getting his yacht, and Ladan can visit him 😊 [36:00] Bird says "follow the money and you can tell where the controversies are going to be". He says the more revenue goes toward a product and patent, the more counsel they need. [39:00] The investment occurring in this industry would not occur without patent protection. Investors do not want to put money in a company unless the products can be protected. [40:35] Bird discusses non-practicing entities, which include research institutions, but also companies that simply acquire patents and instigate lawsuits [41:45] Be kind to your patent lawyer.

Top 3 takeaways Developments in the spinal cord stimulation market for pain heat up with regulatory approval of 2 new devices for the treatment of chronic pain. Medtronic faces competition as Axonics enters the market with their sacral nerve stimulation device for fecal incontinence. Two major announcement for the treatment of paralysis due to SCI; one from DARPA and the other from European start-up venture, GTX medical

This is the first episode of a new monthly series of the neurotech industry round-up. If you don't have time to scan the headlines every day, listen to this podcast to get a summary of the news over that last month. Joining Ladan is Jen French and Jim Cavuoto from Neurotech Reports to review what is drawing attention in the neurotechnology industry. Some of the headlines focused on regulatory approvals of devices in the areas of heart failure, sleep apnea, migraine, and Parkinson's disease, as well as the passing of the reign of NeuroPace from Frank Fischer to Michael Favet. We also highlighted the market of obesity and the variety of neurotechnology approaches for the treatment of this condition. 3 Takeaways: Several neurotech devices gain regulatory approval of the last month as the neurotech competition heats up. The research and commercialization of devices for the treatment of obesity explands with an array of approaches. Recent development from the company Humm who is marketing a non-invasive tACS device and research from the University of Houston in the area of PTSD.

David Pitino is a health technology researcher who started the Abilities Research Center in Mount Sinai. In this episode, he discusses innovation in the health tech industry, and how such technology and the industry overall can be improved. Top three takeaways: Communicating with your end user is critically important in solving challenges with medical technologies. One major improvement in most medical technologies is the increase in affordability of these technologies for patients. Improving the industry and technology is more important than monetary gain. [0:00] Ladan introduces the episode and David Pitino [0:45] Summary of opportunities and barriers in the technological and innovation space [3:30] It is important for developers to speak with the user of their technology [4:45] Pitino discusses his partnership with Not Impossible Labs and how they "solve absurdities", gives example of person who cannot afford eye-tracker technology [7:30] Impact is not measured in monetary value but in how industries are improved and how technology is made more affordable for patients

Paul Meadows is one of the founding members of IFESS and a veteran in the neurotech industry. He is currently the Chief Technology Officer at Imthera in the development of neurostimulation device for obstructive sleep apnea. The company was recently acquired by LivaNova. Previous Meadows was involved with neurotech development at Advanced Bionics as well as the Alfred E. Mann Foundation. Takeaways: 1. Current technology transfer developments are influenced by peer-reviewed published research. 2. Learn from the past so we don't repeat in the future, applies to neurotech applications. 3. We still have technology challenges in such areas as cybersecurity and battery technology as well as systemic in clinical technology adoption. [0:00] Ladan introduces the episode and joins the conversation with Paul Meadows and Jen French. [1:02] Paul Meadows describes his involvement and various positions with IFESS since the inception of the organization. [1:46] Discussion of his view of the evolution of IFESS over the years. [2:35] Meadows describes the importance of peer-reviewed publications and the need to review past research. [3:43] There are obstacles for technology adoption such as clinical physical therapist curriculum. [3:58] Meadow's outlook for exciting developments in the next 5 years in miniaturization, packaging and user-friendly interfaces. This is accompanied by identified risks such as cybersecurity. [5:52] Identifying that there is some basic science that is limiting technology advancements such as battery technology.

Narrative Salchow and Sayenko Dual interview episode: Christina Salchow-Hommen from Charité Universitätsmedizin in Berlin, Germany. Her presentation at RehabWeek2019 was titled "Characterization Of Optimal Electrode Configurations For Transcutaneous Spinal Cord Stimulation." The talk presented her findings from a small trial which included 5 participants living with spinal cord injuries. In the trial, they were trying to find the optimal placements and size of surface stimulation electrodes to elicit a response rectus femoris and the tibialis anterior muscles. The study found variability in electrode placement but some commonalities at the T11 level spinal circuit level. Let's catch up with her in our interview. Dimitry Sayenko from the Center for Neurogeneration at Houston Methodist Research Institute gave a talk about Neuromodulation of Spinal Networks to Recover Motor Function: Underlying Mechanisms and Clinical Translations." His talk discussed the differences in the epidural spinal stimulation clinical trials being conducted at the University of Louisville, UCLA and at EPFL in Geneva Switzerland. There were differences among the labs but he found the key is enabling versus inducing movement with stimulation and argued that the intense exercise regimes from some of these studies is not necessary. Let's listen in on his interview. Takeaways: Electrode placement, along with stimulation parameters plays an important part in the responses to transcutaneous spinal cord stimulation. [0:00] Ladan introduces the episode with an interview by Jen French of Neurotech Reports with Christina Salchow-Hommen at RehabWeek 2019. [1:10] Salchow-Hommen introduces herself and her affilitation with technology for people with impairments for restoration of mobility. [1:38} Discussion of the importance of electrode placement, adjustment of stimulation parameters between the 5 volunteers and patient reported preferences for transcutaneous spinal cord stimulation for people with paralysis. [3:35] Salchow-Hommen discusses the need to better monitor the brain during stimulation and better measurement tools to quantify reported feedback. [4:44] Ladan introduces the episode with an interview by Jen French of Neurotech Reports with Dimitry Sayenko at RehabWeek 2019. [5:17] Sayenko introduces himself and addresses his perspective of how the brain reacts to spinal cord stimulation for the restoration of motor response after paralysis due to SCI. Nearly 80% of spinal cord injuries result in some form of residual function. [6:41] Involvement of the brain with restoration of movement along with neuroplasticity for connections in the brain. [8:28] Coupling traditional therapy with spinal cord stimulation. He finds that the intense rehab is not necessary but the first few sessions are critical. Still the technology has an accumulative effect. [9:45} Discussion of the introduction of electrical stimulation following a spinal cord injury. When to introduce it in therapy. [10:50] Restoration of gait and the timing of stimulation. His lab found timing was not critical. [11:50] The introduction of machine learning into this therapy would be helpful. Sayenko expresses his excitement at RehabWeek.

Steven Plymale is the CEO of MyndTec. He joined the firm in late 2017 and has more than 25 years of experience in the medical device industry. Previously, he was CEO of Profound Medical, bringing the company from a small six-person team to going public in 2015 in an IPO that raised $60 million. Plymale was also with Xltek, now a division of Natus Medical, and Claron Technologies. Milos Popovic is the Director of the Toronto Rehabilitation Institute (KITE) and professor in the Institute of Biomaterials and Biomedical Engineering at the University of Toronto. He is also the co-founder and director of the MyndTec. Popovic's decade of research and randomized clinical trials with stroke and spinal cord injury populations led to the development of the MyndMove device. Takeaways: Multidisciplinary teams help to build a successful rehabilitation institute. Translation of rehabilitation technology is not easy but it can be fun. It is important to harness neuroplasticity in the body and the brain to achieve successful long-lasting outcomes in rehabilitation. [0:00] Steven Plymale and Milos Popovic introduced themselves to kick off the conversation with Jen French from Neurotech Reports and Ladan. [0:35] Milos Popovic describes how RehabWeek 2019 ended up being hosted in Toronto, the first time the event was held in North America, and the plan his team put together [1:32] Popovic describes his career journey from a nuclear engineer to director of an innovative rehabilitation research center and entrepreneur. [3:33] Discussion of the building of the rehabilitation institute in Toronto Health Network with a team of 90 people and the importance of working directly with patients. [4:58] Popovic describes the translation of technology from lab to the marketplace particularly in functional electrical stimulation and human clinical trials to a start-up company. [6:24] Steven Plymale describes how he was introduced to MyndTec and his initiation into a small, struggling start-up company. Hear how he was convinced that electrical stimulation is not voodoo science [7:50] Plymale and Popovic describe the MyndMove device.. Discussion ensues about the impact on upper extremity rehabilitation and the involvement of the brain, the melody of the neural activity, and how this therapy capitalizes on the neuroplasticity in the brain. [12:02] Plymale discusses the current stage of MyndMove in the project development spectrum including regulatory approvals, raising capital investment, and pricing model. [15:26] What is the target market for the MyndTec neural re-education device? Plymale also talks about their pursuit for clinical partners, their strategic focus and the economics of the medical device as an early stage venture. [18:06] Steven Plymale talks about his career journey in the medical device industry and how he enjoys start-up ventures. [19:25] Popovic concludes talking about what excites him at RehabWeek and the potential relationships building from this meeting.

Thierry Keller is a researcher in Tecnalia, a research institute in Spain. In this episode, he discusses some of the neuroprosthetic technologies for upper and lower extremity stimulation and recording that he is working to develop in his institute. Top three takeaways: Multiple stimulation channels, such as on the transcutaneous array, can provide better resolution of functions There needs to be open communication and sharing of knowledge between technology developers, clinicians, and end users in order to maximize the positive impact of an implanted device The point of research is not just to discover new things, but to be able to obtain conclusive results through repetition and testing [0:00] Ladan introduces the episode and Thierry Keller, who gives an overview of his background and research experience [3:30] When a product does not meet the needs of its end user, then it will fail. However, other needs, such as industry and stakeholder needs, must be taken into account. [5:20] Research is not just about finding, but to be able to repeat and obtain conclusive results. [8:00] Keller explains the transcutaneous array technology with multiple stimulation channels that Tecnalia is developing [11:50] It is possible to learn how a patient perceives stimulation using this device, such as whether there is a tingling or touch effect, by changing stimulation frequency [14:30] In addition to stimulation, the device also has the ability to record an electromyogram to allow the patient to command an upper extremity [17:30] Keller discusses an electrode similar to a MUX sense for lower extremity sensing and stimulation [20:30] Keller mentions that a similar type of electrode for upper extremities, with 32 channels that provide better resolution of functions, which can allow for wrist activation for lifting the hand and finger flexion [22:00] Keller discusses what IFESS is, its history and its missions [25:00] We need to spread knowledge about electrical stimulation to young researchers as well as therapists/clinicians and end users [28:00] Networking between technology developers and end users is very important

The Swiss Federal Institute of Technology in Zurich's Robert Reiner was one of the key figures to initiate the Cybathlon in 2016. The Cybathlon is a unique event in the development of every- day assistive devices in which people living with various disabilities compete while using the latest developments. There are six disciplines from advanced wheelchairs to FES cycling. Florian Haufe, a PhD candidate in Dr. Reiner's lab, fills us in a little more about this premiere event and what the expect in the 2020 competition. Takeaways: 1. Showcase of technology for people with disabilities in the spirit of competitive sport. 2. Competitive challenges center around tasks for people with physical impairments in every-day life and the use of assistive technology. [0:00] Ladan introduces the episode and joins the conversation with Florian Haufe and Jen French at RehabWeek 2019. [1:16] Haufe tells about how he became involved in the Cybathlon and what the event is about. [2:09} Discussion of the different competitive disciplines at the event and the tasks in the competition highlighted the exoskeleton discipline. [3:31] Haufe explains the scoring technique for the disciplines. [3:51] Haufe further describes the initial event that took place in Zurich in 2016 with competitors from academia and industry. There were 6 disciplines and over 5000 attendees. [5:40] What makes up the team is the pilot or end user/athlete along with a technical team that can range from students to licensed engineers to hobbyists. [7:10] Haufe describes the overall goal of the event. Giving people with impairments a platform for the use of assistive devices in the spirit of competition, allow technology developers to show what their latest inventions can do and increase public awareness are the goals of the event. [9:24} Here are the details about the 2020 event and how to get involved. Go to https://cybathlon.ethz.ch/cybathlon-2020.html

Vivian Mushahwar is a professor at the University of Alberta in the Department of Medicine, and she is in the division of Physical Medicine and Rehabilitation. She has a bachelor's degree in electrical engineering and a PhD in bioengineering, and has completed two postdoc positions in rehab medicine and neuroscience. In this episode, she discusses some of the technologies she is researching and developing with regards to nerve stimulation and walking/standing. Top three takeaways: Neural stimulation below levels of injury can greatly improve standing and walking performance in patients with spinal cord injury. A good understanding of neuroscience/neurophysiology combined with knowing how to stimulate to best treat spinal cord injury will lead to the best outcome for treatment. Collaboration between researchers and product users can lead to simpler products and solutions. [0:00] Ladan introduces the episode and the guest Vivian Mushahwar, who gives an overview of her background and research interests [3:30] Spinal cord spasticity consists of uncontrolled contractions which pose a problem for patient mobility. Plasticity can be induced in nerves through electrical stimulation, and this is used to treat spasticity. [6:30] Vivian's project involves putting fine implants in spinal cord, stimulate networks below level of injury, to help with standing and walking [9:15] Tissue is being deformed whenever it is stretched/strained, particularly muscle, and people shift posture/position constantly to prevent muscle deformation [11:30] The SmartyPants technology is designed to contract muscle periodically to prevent deformation which could lead to pressure ulcers [15:00] The SmartyPants technology has been stalled due to intellectual property disputes, and this is upsetting those who invested in the original technology [18:00] Deep vein thrombosis is a condition that could lead to deadly blood clots, and is caused by insufficient movement. Similar to SmartyPants, Vivian is working to develop a sock to prevent the formation of DVT [19:50] Simultaneous arm/leg cycling in exercise after spinal cord injury can double the improvement in walking [21:30] Engaging in communication and collaboration between different departments and the product users can lead to simpler solutions

Debbie Backus is with the Shepherd Center, a rehabilitation hospital located in Atlanta, and is also the president of ACRM, a multidisciplinary organization whose mission is to help improve the lives of people with disabilities, particularly brain and spinal cord injuries. In this episode, she discusses the current technologies used to help patients with movement disabilities, how far the technologies have come, the cost-effectiveness of such technologies, and how those technologies may continue to grow in the future. Top three takeaways: Organizations such as the Shepherd Center and ACRM serve to help and rehabilitate patients who have suffered injuries resulting in movement disabilities, and research technologies and novel interventions to restore mobility in these patients. Technologies such as FES and exoskeletons that are used by patients with movement disabilities are in their early stages, and are expensive to manufacture. If medical technologies can be shown to present a benefit to patients and their well-being, they may be further developed to improve cost-effectiveness, functionality, and ease of use. [0:00] Ladan introduces the episode and IFESS, the sponsor [0:28] Debbie Backus is introduced [0:44] Debbie talks about the mission of the Shepherd Center, and about the types of patients that the organization cares for [1:36] Debbie discusses ACRM, the services it offers, and how the organization started [2:52] Debbie talks about the technology involved in rehab medicine, and how it has grown over the years [4:11] Debbie talks about the way technology solves problems, and how when designing technologies to solve clinical problems, the problems are not always solved in the best way initially. [4:52] Debbie discusses certain challenges with technology, such as cost effectiveness. She discusses her own research into the effectiveness of FES cycles, and how certain components may be too expensive for patients to afford. [5:22] Debbie discusses how if it can be shown how such technology presents a clear benefit to patients, then perhaps more cost-effective options can be developed. [6:11] Exoskeletons designed for patient mobility are discussed, and they are likened to old-fashioned computers which would take up a whole room. It is discussed how as the technology improves, it will become more practical and economically feasible. [7:28] Debbie discusses FES bikes, and how once a patient is evaluated and is deemed fit to ride one, they should be able to go to a gym and use one [7:49] Real bikes are discussed for these patients, rather than stationary ones [9:38] Debbie discusses her impression with ACRM being involved with rehab week for the first time

Tom LeBlanc is the Marketing Manager at Bioness, a neuroprosthetics and neural rehabilitation technology company born out of the Alfred E. Mann Foundation. Let's listen in on his interview. He has several years of experience in marketing and communications within Bioness. Prior to joining them he was in the entertainment industry with the likes of Disney and Warner Bros. He holds an MBA from Pepperdine University. Let's listen to our conversation with him. Takeaway: Functional electrical stimulation can be used as a neuroprosthetic for everyday tasks or as a rehabilitation device to gain voluntary movement. [0:00] Ladan introduces the episode with an interview accompanied by Jen French of Neurotech Reports with Tom LeBlanc from Bioness on the exhibitor floor at RehabWeek 2019. [0:58] Tom introduces himself and his role in Bioness. [1:08] LeBlanc discusses the legacy Bioness device, the H200, for upper extremity functional electrical stimulation and the target populations. The device has various programs. [3:05] We move our discussion to the lower extremity device, the L300. LeBlanc describes the devices and the product extensions. It uses functional electrical stimulation with imbedded sensors and smart algorithms.

Bimal Lakhani is the Vice President of Product Development at HealthTech Connex and NeuroCatch, a recent startup targeting the analytics of brain disorder diagnosis and improvements. He is also Associate Professor at the University of British Columbia in Vancouver, Canada. He holds a PhD in Rehabilitation Science. This conversation talks about the company, science behind it and where it is going in the future. Takeaways: We currently do not have a quick mechanism to check out brain health. Clinical interfaces need to intuitive and easy to use for the clinician. How is your brain today? Can we bring people to check their brain health like they check their smartphone? [0:00] Jen French from Neurotech Reports kicks off the introductions on the RehabWeek exhibit floor. [0:33] Bimal Lakhani describes the new venture of NeuroCatch to meet the need to get a comprehensive matrix of the brain in the clinical setting, in otherwords the "vital signs" of the brain. [2:33] Lakhani talks about the NeuroCatch platform technology as a neurodiagnostic tool and their strategy for hardware industry partnerships. [3:33] Description of the target areas for NeuroCatch and the gap in clinical need and the focus of their current research including concussion and other brain injuries. [5:04] How is your brain doing today? Lakhani also describes the device and what it does. [7:08] The walk-through of the software tool interface for an EEG evaluation and the keep it simple approach. [11:19] The NeuroCatch device is approved for clinical use in Canada. Lakhani describes the other markets on their radar. [11:53] Discussion of data collection and cybersecurity along with their relationship with clinical partners. [1:26] What is the target market for the MyndTec neural re-education device? Plymale also talks about their pursuit for clinical partners, their strategic focus and the economics of the medical device as an early stage venture. [12:36] Description of HeuroCanada partnership and clinical adoption in rehabilitation setting. He also talks about the parent company, HealthTech Connex, and their relationship with Helius Medical. [14:25] Lakhani discusses the next steps for NeuroCatch and their future focus for people to be conscious of their brain health.

Ursula Costa is the Head of Clinical Affairs at Hocoma AG, an established neural rehabilitation company based in Zurich, Switzerland. She is a licensed physical therapist who has recovered herself from a spinal cord injury as a young girl and then nurtured her passion for neurorehabilitation. She holds a PhD from Universitat Autonoma de Barcelona in Physical Therapy and has held a professorship at the same university. Takeaway: Rehabilitation technology is a tool to help the patient gain maximum potential not a tool to do the motion passively. Technology coupled with rehabilitation aids in the achievement of neuroplasticity and physical recovery. [0:00] Jen French of Neurotech Reports introduces Ursula Costa from Hocoma at RehabWeek 2019. [0:37] Hocoma AG was the initiator of the RehabWeek concept. Costa explains what the event means to them and connecting with clinicians. [1:27] Through the lens of a physical therapist, Costa talks about her personal story of recovery from a spinal cord tumor and how that motivated her to study physical therapy. [2:37] The line of Hocoma products focus on neural rehabilitation. They have introduced robotics into the field as well. Costa walks us through some of the technology and the challenge of clinical adoption. [3:45] Costa discusses the principle of neuroplasticity and intensity in rehabilitation and how technology can help assist in the rehabilitation process. [4:51] Costa talks about the excitement for the future of rehabilitation and the mindset change about efficiencies of technology and personalization of rehabilitation.

RehabWeek Exclusive interview the Kim Skinner Kim Skinner is the Director of Physical Therapy at Helius Medical Technologies where she is instrumental in the introduction of the PoNS rehabilitation program. Prior to this she was the Physical Therapy Director and Researcher at the University of Wisconsin, Madison working with sensory processing and neurological disorders. She holds a PhD in Physical Therapy and Health Sciences and maintains her license in physical therapy. We met up with Kim at RehabWeek and had a conversation about the company, the rehabilitation science of the PoNS device and where it is going in the future. Takeaways: Harnessing neuroplasticity in rehabilitation stimulation must be paired with an activity. Clinical interfaces need to intuitive and easy to use for the clinician. How is your brain today? Can we bring people to check their brain health like they check their smartphone? [0:00] Introduction and Jen French from Neurotech Reports kicks off the conversation RehabWeek exhibit floor at Helius Medical. [0:25] Kim Skinner introduces herself and Helius Medical and new PoNS device. She worked in the initial research for the device. [1:12] Description of the PoNS device components, how it works and the target indications and clinical application of mild to moderate brain injury with chronic balance deficits. They designed a 14-week rehabilitation program harnessing neuroplasticity. [4:10] Further discussion about application of the technology to other indications that have balance issues. Their initial focus is on the brain injury population, but more research needs to be done on how this can benefit other populations. [5:18] Discussion of the design of their clinical trials and some of the challenges associated with that both in the clinical and at home. They have a training template that can be individualized for each patient. [6:39] Skinner further describes the training protocols and when to stimulation to maximize outcomes couples with balance training and movement exercises to prime the brain. [8:26] The stimulating device goes onto the tongue rather than skin. How does that feel or taste? She also talks about the stimulation pattern and parameters as well as [9:53] Discussion of the 143 electrode array design and how they mapped the tongue to figure out the stimulating rate. [12:19] The visual substitution device was the predecessor of this device and how it evolved out of the University of Wisconsin, Madison. [13:16] Skinner talks about where the PoNS device is currently available with a prescription and how they are working on availability in the US, Europe and Australia. It is currently approved in Canada through the HeuroCanada clinics.

In this episode, Ladan recaps his experience at the Toronto rehabweek and discusses what he did and who he spoke with. Top three takeaways: Rehabweek brought together various fields such as engineering and rehabilitation science, as well as clinicians The aim of the event was to bring together different disciplines working toward the same goal and to find similar key points between them One can learn a lot from talking to people from different fields and gaining a better understanding of the progress occurring with neural implants [0:00] Ladan opens the episode discussing the experience at rehabweek [2:00] Ladan's guest Jen describes what the conference was about and who it was targeted for, as well as some people that were interviewed [4:30] Ladan discusses the benefits of running his podcast and getting the opportunity to interview big names in the field of neural implants

Doctor Henry Greely is a professor of law at Stanford University. His primary focus surrounds discussing the ethics of biological innovation and their implications to society. He is the president and founder of the International Neuroethics Society. In this episode, he delves into the complications associated with developing ethics in the similarly developing fields of biotechnology. Top Three Takeaways: There are gaps in the ethical standards surrounding new biomedical advancements. Researchers should treat patients in their best interest once they are implanted with biomedical devices. Is there a moral difference between implantable devices and external smartphones? Show Notes: [0:00] Ladan introduces the episode and Doctor Henry Greely who will be speaking about Neuroethics. [1:50] Greely explains how he is a law professor and delves into the different areas of law he has worked in. [3:00] Greely also explains the different subjects associated with the ethical arguments in biomedical advancements. [5:30] There are gaps in the ethical standards surrounding new biomedical advancements; Greely specifically mentions the recent experiment of keeping a sheep brain alive. [6:15] Greely looks at the social, legal and ethical consequences of new advancements in technologies emerging in the next twenty to thirty years. [8:30] Stem cell research has followed ethical guidelines created in 2005 that are not forced by law; they give a piece of mind to institutions and researchers. [11:00] It is much harder to make differences in subjects that are highly politicized. [12:00] Greely looks at bioethics as a way to do research in safe and acceptable ways; he then goes into detail of ostracization cases where people went against ethics. [15:00] Greely and his colleagues seek ethical guidelines for patients who finish their clinical trials and continue with life afterward. [16:30] Researchers should treat patients in their best interest once they are implanted with biomedical devices. [19:30] A grant would be useful to draft a set of guidelines when it comes to biomedical advancements. [21:30] Greely makes it clear that enhancement occurs in our world all the time through activities such as teaching. [23:00] The letterbox region activates when someone learns to read and sees the writing. [24:30] The internet serves as a major human enhancement; Greely poses the question between the moral difference between internal and external human enhancements. [28:30] Neural implant enhancements are not a very big concern for ethics right now because they require electrodes to be placed in the brain. [31:30] The smartphone has been adopted extremely quickly considering they are only eleven years old. [33:30] Greely does not see a moral difference between implantable devices and external smartphones. [36:30] Social etiquettes emerge according to the masses with new technology; these social reactions are hard to predict. [38:30] Wearable technology may be helpful, but it opens up a problem with data security.

Doctor Takashi Kozai, or Doctor TK Kozai, is currently an assistant professor at the Swanson School of Engineering at the University of Pittsburgh. He currently works in his own laboratory and researches in-vivo calcium brain imaging. He also has a background in research concerning carbon electrode development. He has been offered to work with the Neuralink Team associated with Elon Musk, but turned down the offer to focus on the innovational aspects of neural implant development. Top Three Takeaways: In-vivo brain imaging seeks to map the generation of brain signals and realize how humans detect these signals. Though Kozai expresses his amazement at the work of Elon Musk's team, he shares that he declined the offer to work with Neuralink because it did not necessarily focus on his interests. Innovation in any field lasts forever and influences the development of future technology. Show Notes: [0:00] Ladan introduces his guest TK Kozai that he met at the Neural Engineering Conference in San Francisco that he recently attended; he works with in-vivo calcium imaging and turned down Elon Musk's offer to work on the Neuralink team. [1:45] Kozai describes his interests as understanding the materials and designs of neural implants, as well as the biological degeneration and regeneration around the interfaces. [2:20] In-vivo brain imaging seeks to map the generation of brain signals and realize how humans detect these signals. [3:05] Kozai reaffirms the importance of glial cells and other molecules that support the functioning of neurons. [4:15] Modulating the stiffness and designs of electrodes often has many unintentional effects. [5:25] Kozai's research has shown that higher frequency stimulation leads to decreased antidromic activation over time. [7:10] Kozai confirms that there have been struggles in the path of his research development that had to be dealt with in order for progression. [7:30] His team has been excited to use two-photon microscopy to study how degeneration tissue reaction nucleosis evolves over time. [7:45] Challenges include head-capping and packaging of the neural interface. [9:30] Kozai shares how his advisor initially had doubts concerning his research in carbon electrodes. [10:30] Kozai explains how he set the research for his paper into motion from an idea. [12:00] Though Kozai expresses his amazement at the work of Elon Musk's team, he shares that he declined the offer to work with Neuralink because it did not necessarily focus on his interests. [14:00] Academia explores the innovation and progression in neural bioelectronic development that is often exciting. [15:00] Kozai's lab is now focusing on how to treat different types of neural degeneration with engineering. [16:40] Technological health developments can be developed from studying how injuries affect people genetically prone to certain neurodegenerative diseases. [18:30] Kozai explains how is high-school biology teacher influenced his interest in biology. [21:30] He hopes that technology in brain-machine interfaces will build-off and develop from his work.

Doctor Alejandra Gonzalez is a postdoctoral researcher at the University of Texas-Dallas that works in the fields of neurotechnology. She currently focuses on how she can develop graphing fibers that have better electrochemical properties for implantable devices. Top Three Takeaways: Her team is creating graphing fibers without good electrochemical properties and good mechanical properties to use as electrical interfaces in peripheral nerves. Conventional electrodes have charge capacities that range from 0.05-0.2 mC per centimeter squared, and conventional graphing fibers have one of 300 mC per centimeter squared. She mentions how it sometimes is difficult to combine the fields of neurology and engineering. Show Notes: [00:00] Ladan introduces the episode from a recent neural engineering conference he attended in March of 2019. [1:15] Alejandra Gonzalez introduces herself from University of Texas-Dallas as a postdoctoral fellow. The poster covers the fabrication of high performance of graphing electrodes for the use of interfaces. [1:45] Her team is creating graphing fibers without good electrochemical properties and good mechanical properties to use as electrical interfaces in peripheral nerves. [2:10] Conventional electrodes have charge capacities that range from 0.05-0.2 mC per centimeter squared, and conventional graphing fibers have one of 300 mC per centimeter squared. [2:35] Metallic coatings have been added to the fibers to improve their charge capacities to 940 mC per centimeter squared. [3:00] The design of Gonzalez's fibers reduce impedance and improve electrical flow. [3:25] The fibers can be in thinner than 20 micrometers in diameter. [4:00] Gonzalez pictures this technology being used as cuffs around peripheral nerves. [4:30] She mentions how it sometimes is difficult to combine the fields of neurology and engineering.

Ian Baumgart is a Biomedical Engineering Master's student at the University of Wisconsin-Madison. He currently conducts research in Doctor Kip Ludwig's Neural Engineering Laboratory. Baumgart's current project focuses on the Injectrode, which is an injectable pre-polymer that can act as a conductor throughout the body along with nerves. Top Three Takeaways: The Injectrode is basically liquid pre-polymer with conductive particles that are completely injectable. The benefits of this procedure involve the fact that it is minimally invasive—it can be injected into deep structures relatively easily. The injectrode is softer and conforms better than a wire. Baumgart's team hopes to develop insulation for the injectrode; he would also like to increase the shelf-life of the injectrode and characterize its composition. Show Notes: [0:00] Ladan introduces the NER Conference he attended in March of 2019 and explains how he conducted interviews at the poster sessions. [1:15] Ian Baumgart introduces himself from the University of Wisconsin-Madison working in Doctor Kip Ludwig's Neural Engineering Laboratory. [1:30] Baumgart introduces the Injectrode which is basically liquid pre-polymer with conductive particles that is completely injectable. [2:15] His team eventually hopes to further develop the surgical aspect of the procedure to better administer the Injetctrode. [2:30] Baumgart goes into the details concerning the setup of the experiment and the similarities observed throughout testing. [3:40] The benefits of this procedure involve the fact that it is minimally invasive—it can be injected into deep structures relatively easily. The injectrode is softer and conforms better than a wire. [4:45] The physical properties have yet to be characterized in the Injectrode. [5:25] Baumgart's team hopes to develop insulation for the injectrode; he would also like to increase the shelf-life of the injectrode and characterize its composition. [6:00] His paper is currently in the Bio Archive and will be published soon; its name is A Truly Injectable Neural Stimulation Electrode Made from an In-Body Curing Polymer/Metal Composite.

Doctor Cary Kuliasha is a postdoctoral research associate working with Doctor Jack Judy's research laboratory at the University of Florida. His team focuses on the potential effects the body's environment could have on biomedical devices over time through accelerated aging. Kuliasha's work currently focuses on how Anisotropic Conductive Adhesive technology could be applied to bioelectronics since it is currently used in computer technology. Top Three Takeaways: The point of the project is to mimic a chronic inflammatory environment with oxygen species that could potentially affect an implantable device. The Anisotropic Conductive Adhesive and the silicon packaging experienced failure relatively quickly in the aging environment. There is a correlation between the RA environment and how the body affects bioelectronic devices; the strength of the correlation is unknown. Show Notes: [00:00] Ladan introduces the episode from a recent neural engineering conference he attended in March of 2019. [1:10] Doctor Cary Kuliasha introduces himself from the University of Florida where he works with Doctor Jack Judy; he presents his poster as "In-Vitro Accelerated Aging Assessment of Anisotropic Conductive Adhesive and Implantable Packaging for Bioelectronic Interfaces". [1:50] His project mimics the physiological environment for a bioelectronic device in the body over time. [2:30] The point of the project is to mimic a chronic inflammatory environment with oxygen species that could potentially affect an implantable device. [3:20] The poster focuses on the backend packaging that implantable devices need; Kuliasha explains how this topic is often neglected. [3:55] The poster focuses on the connector technology that the backend packaging needs to connect to the neural interface of implantable devices. [4:30] Kuliasha goes into detail concerning the new Microflex technology that uses a golden ribbon. [5:15] Anisotropic Conductive Adhesive technology commonly used in connecting different kinds of computers together is now being studied in the body for biomedical devices. [6:15] The Anisotropic Conductive Adhesive technology was encapsulated in silicon and then put into an environment similar to the body at 77 degrees Celsius to see how it changed over time. [6:45] The Anisotropic Conductive Adhesive and the silicon packaging experienced failure relatively quickly in the aging environment. [7:45] Kuliasha explains how failure leads to improvement in the field of engineering. [8:30] There is a correlation between the RA environment and how the body affects bioelectronic devices; the strength of the correlation is unknown. [9:00] A ten degree Celsius increase in temperature in the RA environment doubles the time of aging. [9:45] Kuliasha plans to test other manufacturers and possibly other connectors that do not involve Anisotropic Conductive Adhesive.

Andrew Trask is currently a student at Oxford University and Author of Grokking Deep Learning performing his Ph.D. concerning anonymizing data. He discusses the facts concerning deep and machine learning and their possible benefits to society. Trask also discusses privacy securing techniques that would further benefit the field. Finally, Trask discusses his connection with Open Mind, which is a company that uses machine and deep learning to overcome the barriers in adoption. Top Three Takeaways: Machine Learning is a set of algorithms that allows for a system to learn while deep learning is a subset of Machine Learning techniques that are inspired by the human brain. Research in Deep Learning and Machine Learning to bring down sample complexity; more data is always better but cannot always be managed. Different types of privacy securing techniques are used to further propel the fields of Machine and Deep Learning. Show Notes: [0:00] Ladan introduces Andrew Trask who will discuss deep learning. He currently is performing his Ph.D. at University of Oxford concerning anonymizing data. [1:10] Ladan mentions how Trask wrote his book Grokking Deep Learning. The book seeks to teach the fundamentals of deep learning; the term "grokking" comes from the idea of an innate understanding. [2:25] The book fills the void for an intuitive guide in the subject of deep learning. [3:20] Trask was not a Ph.D. student when he started writing the book; he found an implementation of the deep neural networking and removed as much unnecessary information as possible. [5:55] Machine Learning is a set of algorithms that allows for a system to learn while deep learning is a subset of Machine Learning techniques that are inspired by the human brain. [6:30] The Deep Learning's parametric algorithm would construct a hierarchical view of the world by recognizing lines and edges; the second part of the algorithm would take this information to form shapes, textures, and shadows. [8:20] Machine Learning includes Deep Learning and other learning techniques as subsets. [10:00] Trask disagrees with those who claim that all forms of Machine Learning and Deep Learning as artificial intelligence; Machine and Deep Learning focus on finding patterns. [11:50] Sample complexity relates to how many data points an algorithm needs to learn a pattern. [12:40] Research in Deep Learning and Machine Learning to bring down sample complexity; more data is always better but cannot always be managed. [14:00] There is much more unlabelled data in any field than labeled data; large amounts of labeled data is preferable. [16:00] Hospitals are not willing to share useful information for the development of algorithms in safe ways. [16:30] Research in this field concerns sharing private and intelligent information in a secure way. [17:40] An example of useful Deep Learning would be to find trends associated with aging in the brain that could lead to the reversal of its effects. [19:00] Federated learning is a new tool that replaces approaching different data providers with sending statistical models into someone's organization that only reveals the results needed. [21:30] Differential Privacy is a set of formal proofs to prove that statistic leaving an organization has no private data. [22:40] Patterns that are not unique to someone should not be considered private information. [24:00] For example, brain cells firing in response to certain information that is generalizable would not be considered personal information. [25:15] Secure Multiparty Computation refers to how the statistical model that is used for Machine Learning is put at risk. [27:50] AI models and data sets are just large collections of numbers. [28:30] To learn more, study a deep learning framework; fast.ai is a very helpful website for this. [29:00] Open Mind serves as an open-source community that utilizes privacy securing technologies to lower the barriers of adoption.

Cory Inman is a postdoctoral fellow at Emory University School of Medicine who studies the effect deep brain stimulation has on the emotional experience of humans. He seeks to treat depression in patients and potentially improve their memories through the effects of deep brain stimulation. In this episode, he explains how his team studies deep brain stimulation and navigates the ethics associated with the rising technology. Top Three Takeaways: The exact areas of brain stimulation determine if the patient experiences a change in emotion. Rat and other animal models lead to inferencing in order to see the results of deep brain stimulation. The ethics of deep brain stimulation and research must always be realized in order to prevent the technology from being abused. [0:00] Ladan introduces Cory Inman and explains how he studies deep brain stimulation and its effects on the emotional aspect of someone's personality. He also invites listeners to the 2019 Bioelectronic Medicine Forum in New York. To register, follow the hyperlink or call (415) 546-1259. If you mention the Neural Implant Podcast Channel, you will receive a free ebook written by Jennifer French and published by Neurotech Press. [2:30] Inman explains how he has tried to enhance memory through deep brain stimulations. [3:15] His team studied how stimulating the amygdala could affect depression. [4:30] Patients who are having their brains monitored by implantable electrodes monitoring for seizures are asked if they would like to participate in research on deep brain stimulation and emotion. [6:20] Inman goes into detail about the conversations occurring surrounding the ethics of deep brain stimulation. [8:00] It is explained how Inman's research institution sees 30-45 patients a year which is much more than other ones focusing on deep brain stimulation. [8:45] The stimulations in the brain are very localized; very specific nuclei in the amygdala can be stimulated. [10:00] Neurologists agree that certain areas of the brain are not normal in epileptic patients; these areas of the brain could be removed if they are redundant in other parts of the brain. [12:00] Out of sixty patients, only about two patients experienced emotional changes with amygdala stimulation. [13:30] The exact areas of brain stimulation determine if the patient experiences a change in emotion. [14:00] Most of the human cognition occurs unconsciously; different areas and amounts of stimulation to the neural circuit could lead to awareness of emotional differences. [15:15] Inman explains that staying aware of the ethics of deep brain stimulation poses the largest challenge to his team. Another challenge involves the lack of knowledge in the area. [17:00] The amperage and frequency can be altered in stimulation; another challenge involves a large number of variables that can be altered with deep brain stimulation. [19:30] Animal models provide more flexibility to modify parameters that can be later applied to humans. [20:15] Stimulation of the amygdala is dose-dependent—increased and stronger stimulation leads to more of a response. [21:00] Rat and other animal models lead to inferencing in order to see the results of deep brain stimulation. [22:00] Implications of this research involves helping people suffering from disabilities and diseases. [23:50] Inman shares how one can easily lose a sense of self when suffering from memory loss. [25:00] Inman hopes to use deep brain stimulation to help people remember the memories that create a sense of self. [26:00] Inman expresses his concern for the use of deep brain stimulation to control the emotions of other people; he says that it is our job to make sure the dark side of this technology never emerges. [27:30] Ladan explains how this technology is very controlled and would be hard to take advantage of. [29:00] With unlimited funding, Inman would gather all of the world experts in various neural technologies to create an augmented reality for patients that would help improve memories. [30:40] Inman wants to test the real-life memories of people outside of controlled experimental settings. [32:00] The NeuroPace RNS is placed in epilepsy patients that get seizures from multiple areas of the brain at one time. [33:15] The device monitors areas of the brain known for causing seizures and stops them via stimulation. [35:30] Inman wants to create a virtual reality that could help test people's memories and help increase their retention. [37:00] Inman expresses his gratitude for the Neural Implant Podcast Channel because it creates an outlet for developments in neural technologies. [40:00] Ladan describes his interest in how deep brain stimulation could affect people's emotional states.

Jim Cavuoto runs Neurotech Reports where he seeks to educate the industry and public concerning neurotechnology and neuroprosthetics. Cavuoto studied at Case Western University as a biomedical engineering student and began writing about neurotechnology as an undergraduate student. His organization serves as an information source for four fields of neurotechnology: neuromodulation, neuroprosthetics, neurosensing, and neurorehabilitation; a yearly growth report and weekly newsletter is provided by Neurotech Reports. His website can be found at www.neurotechreports.com. Top Three Takeaways: Neurotech Reports seeks to educate the field of neurotechnology to inspire innovation. Several very promising early stages of biotechnology are emerging, such as retinal implants. Neuromodulation for psychiatric needs have not been met and require more funding. Show Notes: [0:00] Ladan introduces his guest Jim Cavuoto from Neurotech Reports; he also invites listeners to the 2019 Bioelectronic Medicine Forum in New York. To register, follow the hyperlink or call (415) 546-1259. If you mention the Neural Implant Podcast Channel, you will receive a free ebook written by Jennifer French and published by Neurotech Press. [1:50] Cavuoto introduces himself as running Neurotech Reports with Jennifer French (listen to her episode here) as partners; he describes the purpose of the organization as educating the neurotechnological field. [5:10] They hope to leave people better about technological trends, government regulations, and reimbursement trends. [6:20] Cavuoto describes his background from Case Western University where he wrote articles about technology in his undergraduate career. [9:10] Cavuoto describes how Warren Grill brought him back to the biomedical engineering field after time away. [10:45] He describes the difficulty associated with starting a company in September of 2001. [13:45] Cavuoto describes several moments of excitement in the field that motivated development. [15:45] The possibilities of treatment to spinal cord injuries are revealed and discussed. [18:15] Several early stages of biotechnology offer promise to the future. [19:15] Cavuoto predicts that the development of biotechnology will mirror Moore's law in technological advances. [20:45] Awareness and funding are still needed to drive biomedical engineering. [22:45] Cavuoto explains how the amount of development in neurotechnology that cures disease and provides insight on brain activity. [23:20] Bionic Pioneers is a true account that highlights the challenges and triumphs of 10 people who participated in trials of neurotechnology.

Jennifer French of Neurotech Reports received a spinal cord injury in 1998 and became the first woman to receive the Stand and Transfer neural implant system. A silver medalist in sailing at the 2012 Paralympic Games, she sits down to discuss her experiences with her implantable device and how it has affected her life. During this discussion, she mentions her struggles and successes with her device along with her concerns and hopes for the technology. If you like this episode then come to the Bioelectronic Medicine Forum in New York on April 4th. To register, follow the hyperlink or call (415) 546-1259. If you mention the Neural Implant Podcast Channel, you will receive a free ebook written by Jennifer French and published by Neurotech Press. Top Three Takeaways: Body sensors in neural implants have unknown lifespans; their potential failure induces a sense of stress. The implantation of electrodes involves invasive surgery and long recovery time; the development of more reliable electrodes and less invasive procedures is necessary. There is a large risk concerning cybersecurity and tapping into wireless devices, such as pacemakers. Show Notes: [0:00] Ladan introduces Jennifer French from Neurotech Report; he also invites listeners to the 2019 Bioelectronic Medicine Forum in New York. To register, follow the hyperlink or call (415) 546-1259. If you mention the Neural Implant Podcast Channel, you will receive a free ebook written by Jennifer French and published by Neurotech Press. [3:00] It is mentioned how sensor failure associated with closed-loop diabetes treatment induces stress. [4:20] Different kinds of sensors in the body have unknown lifespans; they may or may not last very long. [5:40] The developers for the original pacemaker created in the 1960s and 1970s by Medtronic relied on guessed parameters. [8:00] Describing muscle stimulation, it is noted that muscles do not act in isolation; once one muscle is stimulated, another will act differently. [9:25] Machinomite IST uses two channels to allow someone to stand and adds ankle movement as well. [11:10] Network Neural Prosthesis (NNP) looks to build a network into the body in order to create modules and provide other functions. [12:30] Jen French describes the controls of her neural prosthetic implant. [14:55] The controls use buttons to activate muscles; there is usually a three-second delay for ramp-up. [17:10] French describes the first implant she had in 1999 that included eight electrode channels. [18:40] Many factors can lead to the failure of electrodes. [20:10] French has gone through four major surgeries for her electrodes. [22:10] When one gets electrodes put in, two major aspects are needed: the electrodes must be effective and they cannot shift. [23:40] Doing research on higher mammals and moving towards minimally invasive procedures will improve the field of electrodes. [25:10] Cuff electrodes use less power and allow for more flexibility. [27:10] Black boxes for the electrodes often overheat. [29:40] There is a large risk concerning cybersecurity and tapping into wireless devices, such as pacemakers. [32:40] Society is getting to the point where it will soon be able to monitor implantable devices on mobile phones. [37:10] French does not know her expectations concerning her implants because she is still participating in a clinical trial. [40:10] Coming up with systemic ways of funding is necessary to ensure no patients are forgotten in clinical trials. [42:10] Patients in failed clinical trials should be granted new opportunities. [43:00] French constantly must stimulate her muscles via several techniques to prevent atrophy. [45:10] French explains how the stimulation has affected her autonomic system. [48:10] Autonomic systems are very much affected by spinal cord injuries. [50:40] Aiming for easier targets in neural implant function may allow for more easily acquired secondary functions.

***Apologies! The wrong episode audio was incorrectly uploaded previously*** Dr. Francisco Delgado, or Frank, has worked as a postdoctoral researcher at the University Florida under Dr. Kevin Otto's laboratory for a little over two years. As he plans to move on and pursue his career with the Food and Drug Administration, he reflects back on what he received as working in the Otto lab. Not only does he offer advice to future postdoctoral researchers, he also points out how they can receive the most from their experience as well. Top Three Takeaways: Postdoctoral careers are necessary to become an academic but less necessary to work in industry. Candidates should try out possible postdoctoral laboratories before making a commitment to ensure it is what they want to do. Mistakes are not failures but ways to view gaps of knowledge to improve upon. [0:00] Frank explains how he feels odd on his last day and explains how everything is ending and coming together. [2:00] Frank describes how he is going to the Food and Drug Administration with two offers: one from the Center for Tobacco Products and one from the Center for Devices and Radiological Health. [3:45] Frank and his girlfriend agreed to move on and find new positions as soon as a clear endpoint arrived in their work. [5:30] Frank explains how working as a postdoc, he had to put his papers and publications on hold in order to work with DARPA; he was also able to help many people get their projects started. [7:15] A postdoc career often takes one in may unexpected directions. [9:00] Frank recommends for postdoc students to volunteer in whatever lab they may choose to work in for a week to ensure it is a good option for them. [11:30] Frank shares how sometimes he feels postdocs are not helpful because they are irrelevant to many industries; one needs to do a postdoc if they wants to become an academic. [12:40] Frank's postdoc gave him more confidence in what he could do than his PhD program. [14:00] Frank describes the pressures of possibly making mistakes in someone else's laboratory. [15:30] Frank had to apply his past experiences from his graduate career to be able to learn new tasks quickly. [18:00] Franks shares his viewpoint that people need to be willing to make mistakes in order for progression. [20:00] Frank strikes down the notion that mistakes are equivalent to failure. [21:30] Scholarly papers should move towards publishing the mistakes along with the positive results.

Thomas Hughes, JD works as the senior principal advisor for The Regulatory and Clinical Research Institute based in Minneapolis, Minnesota. His organization works to assist medical device companies pass regulatory steps to sell their product and find paths for reimbursements necessary to fund the medical devices. He stresses that one of the most critical steps in developing a device involves focusing on the reimbursement process. Top Three Takeaways: Medical device companies must consider the reimbursement process when passing their devices through the regulatory process. Reimbursement is a three legged stool: coding pathway, the payment attached, and coverage are all necessary. The Regulatory and Clinical Research Institute works with a variety of companies—not just startups. Show Notes: [00:30] Ladan introduces his guest Thomas Hughes as a medical device consultant who has travelled through many parts of the world—check out Travel Wisdom Podcast to learn more about his travels. [1:20] Hughes explains his role as senior principal advisor at a clinical research organization called The Regulatory and Clinical Research Institute (RCRI). [2:40] Hughes describes how he helps organizations get through the regulatory period for their medical devices. [3:10] Hughes spoke at the forum to explain to medical device companies about how to not only get their devices through regulations, but also acquire reimbursement for them. [3:45] Startup medical device companies must prove to purchasers that their products should be purchased. [4:30] Hughes aids companies in understanding how to implement health economics into their products. [6:00] The design features are critical for a product because it must work well and be disruptive—the medical device must be proven valuable. [7:15] Medical device companies must research and cater to the financial aspects of their products. [8:30] Reimbursement is a three legged stool: coding pathway, the payment attached, and coverage are involved. [10:45] The target groups and codes certain medical technologies must be researched for depends on the type of device. [13:00] Multiple codes for reimbursement may exist for a medical device. [13:45] The first step for reimbursement it to look for existing codes; if this does not work, the company may need to take steps in order to create a new code. [15:00] RCRI does not work with just startups; they work with several large companies still seeking help. [16:20] Hughes has worked with many startups recently because investors seek to know the landscapes for new medical technologies. [18:00] Companies may have a great design for their product, but they must think how they will pay for it. [19:30] Check out Tom Hughes article from October of 2018 in Medical Outsourcing Magazine.

Doctor Frederic Gilbert works at the University of Tasmania in Australia and studies neuroethics. A major theme is how Deep Brain Stimulation affects personality disorders. In a very limited amount of research, studies have indicated that some patients have experienced strong personality changes inclining them to depression, addiction and sometimes even suicide. Gilbert paints the importance of medical ethics when making medical innovations in order to protect patients. He argues that medical ethics must involve informing patients and their families of all risks associated with treatment. Top Three Takeaways: Deep Brain Stimulation may cause personality disorders to occur in some patients. Medical Ethics is important to prevent any unnecessary harm to a patient. Though neuroethics may seem to threaten sciences, they actually aid the progression of helpful innovation. Show Notes: [0:00] Frederic Gilbert introduces himself and begins to discuss the effects of Deep Brain Stimulation (DBS). [2:00] Gilbert ensures that DBS is safe and effective even though some patients experience personality side-effects. [4:00] In respect to Parkinson's Disease, DBS is better than nothing because the positive effects outway the risks. [6:00] Gilbert explains how an exaggeration on ethics must take place to prevent patient harm. [9:00] Gilbert points out how no studies studying how DBS affects personality disorders held a control group. [11:30] It is described how 400,000 patients use DBS for a broad range of treatments. [13:30] Neuroethics is described as the ethics of neuroscience that puts patient safety first. [16:00] Neuroethics may be seen as a threat to science even though it actually helps ensure safe progression. [19:30] Gilbert describes how he works with a group at the University of Tasmania that develops electromaterials; his group works at developing artificial intelligence that predicts epilepsy. [22:00] Gilbert makes clear how the ethics of neurotechnology must involve informing patients and families of all effects and risks.

Robert Gaunt is in the field of biomedical engineering from the University of Pittsburgh's Department of Physical Medicine and Rehabilitation focusing on sensory neuroprosthetics. His research aims to assist patients who suffer from afflictions that range from amputations to bladder control. He recognizes the challenges the development of neuroprosthetics faces and urges that more funding and research be put into solving these dilemmas. Gaunt makes clear the importance of group collaboration in the field of neuroprosthetics in order to ensure the progression of the field. Top Three Takeaways: The goal of his work is to make usable sensory prosthetics for people that need them in a reasonable time period. There are a number of technical issue in neuroprosthetics; delivering commercial quality systems that pass regulations needs funding. Patients often dedicate the most to any clinical trial by offering most of their time. Show Notes: [0:00] Gaunt describes the panel from the conference meant to describe patient perspectives on clinical trials. [2:00] Gaunt makes clear that the patients have dedicated very much of their time to the trials. [2:50] Gaunt introduces himself formerly and describes how he is from the University of Pittsburgh. [4:10] Gaunt describes his work with the Biomedical Engineering Department at the University of Alberta on brain/bladder control. [6:00] Gaunt describes how the bladder control is a highly sensory function. [7:50] It is explained how fully implantable wireless system would be a very strong stride for neurotechnology. [9:40] Usable prosthetic arms can benefit people in doing everyday tasks. [11:00] Gaunt explains how there are a number of technical challenges in the neuroprosthetic field—delivering commercial quality systems that pass regulations needs funding. [12:00] Gaunt goes into detail on projects for amputees and control for their prosthetics. [14:00] Anyone interested in the field of neuroprosthetics should love it and find a problem they wish to solve. [17:40] People wishing to start a business in this field must have a good business plan and funding. [19:00] Gaunt points out how collaboration and team science is very important for innovation.

Roberta Goode started Goode Compliance International to assist companies in the industry of biomedical engineering facing the scrutiny of regulations instilled by organizations like the Food and Drug Administration. Goode explains the purpose of her company and the path she took to ensure its success through years of experience and learning. She later began Altrec LLC as a second career to assist clients to break down the complexities associated with starting a company and promoting a service or product. Top Three Take Aways: 1. Goode Compliance International moves in and works with companies needing assistance for their products passing regulation by taking a personal approach of collaboration. 2. Goode ensures that innovational products often need to be created regardless of experience; service based ventures often require much more experience. 3. Ensure a valid and strong plan is present when starting a company with the necessary investors, patents, and team; do not confuse action with traction. Show Notes: [0:00] Ladan introduces Roberta Goode as the founder of Goode Compliance International which serves as a consulting firm that assists medical devices pass regulation. [2:00] Goode explains how innovation and ideas must be born immediately concerning products. [3:00] Consulting businesses and providing services requires experience. [4:10] Goode explains how Goode Compliance International helps medical devices receive the approval of the Food and Drug Administration. [7:00] Goode's organization sends consultants to help companies to alter and improve their products. [8:30] Goode shares how her business model received success because her team would move in and create a plan of collaboration. [11:00] Goode's team would be deployed for months for 9-18 months. [12:00] Many underlying issues often become revealed when assisting a company. [15:00] When hiring her employees, Goode would hire the top three or four performers in her classes through interviews spanning weeks. [16:00] Goode mentions how important it is for her employees to pay attention to detail. [18:00] Experts in the field of consulting with Goode Compliance International would be assigned as mentors to the graduates. [20:00] Goode really enjoyed the field of biomedical engineering but found no life/work balance. [22:30] Goode decided to start her own organization and enjoyed having a connection helping others. [25:00] Goode began her venture by attaining several important jobs to gain experience before starting her own company. [27:30] She ensured she returned something to the companies she learned from. [29:30] Altrec LLC was started to assist clients to break down the complexities associated with starting a company and promoting a service or product. [32:30] Goode ensured she had time for her own life through the flexibility of her second endeavor. [34:00] Goode Compliance International fulfilled every contract and ensured the future for its employees in order to wind down the company by December 2017. [36:30] Goode did not sell her company because she did not want to sell her reputation or name. [39:00] Goode did not have the time to trust the investors to use her name. [41:30] Investors, patents, and a strong team provide the route necessary in starting a company and making a product available. [44:00] It is important to have a five year plan and an exit plan when starting a company. [45:30] Just because one is doing many actions does not ensure they are making progress in their company.

Founded by Martin Bak in 1983, Microprobes for Life Science seeks to provide a unique electrode model that uses Parylene-C as an insulator. This company aims to sell customizable products to neuroscientists studying electrophysiology. All products are handmade, tested for precision and quality, and made by request of the customer. The company has experienced steady growth at 6-8% since its conception and uses its handmade approach as its business model. Top Three Takeaways: Microprobes for Life Science creates customizable neurotechnology focusing on electrodes. All products are handmade by highly trained technicians and experience extreme testing. The company has experienced steady growth at 6-8% and seeks to enter the clinical market. Show Notes: [0:00] Martin Bak introduces himself as the founder of Microprobes for Life Science. [3:50] Nicolas Alba introduces himself as the Chief Operating Officer of Microprobes for Life Science. [5:00] It is explained how the company uses traditional hand-manufacturing techniques to make customizable products. [8:00] It is described how the products must be precise and flawless—most technicians have been trained for more than ten years. [10:00] All products must go through extreme testing; the products envelop the forefront of new techniques. [15:00] Microprobes for Life Science uses the skills of technicians to take the long route and make products that emulate quality. [17:00] Their business approach takes advantage of hand-making products and training technicians. [18:30] The company focuses on electrodes to be able to support the neuroprosthetic community the best way possible. [20:00] Microprobes for Life Science has experienced 6-8% steady growth since conception. [22:00] The company seeks to enter the clinical market which may be more stable. [23:00] The field has an excellent opportunity for entrepreneurship and has many interesting people that will help humanity.

As the Chief Executive Officer of Nia Therapeutics, Dan Rizzuto and his team are currently developing a neurological implant that increases the memory of patients suffering from Alzheimer's diseases and traumatic brain injury. By using deep brain stimulation (DBS) to increase high frequency functions and decrease low frequency functions in areas important to memory, such as the frontal lobe, Nia Therapeutics has successfully improved memory capability by 18%. Though this is only the beginning for a new neurotechnology, Rizzuto and his team provide hope for patients suffering from debilitating diseases to be able to fully function again and experience healthy aging. Nia Therapeutics is currently recruiting hardware engineers. The listing for this profession is available at: https://www.linkedin.com/jobs/view/principal-electrical-engineer-at-nia-therapeutics-993933469/ Important Research Concerning Topic: Burke et al. (2014) Human intracranial high-frequency activity maps episodic memory formation in space and time. Neuroimage, 85: 834–843. This paper from our group identifies the intracranial biomarkers of human memory. High-frequency activity in specific brain regions during the encoding of new memories predicts whether subjects will remember the information at a later time. Ezzyat et al (2017) Direct Brain Stimulation Modulates Encoding States and Memory Performance in Humans. Current Biology 27(9):1251-1258. This paper illustrates how direct brain stimulation can be used to modulate memory performance. In 36 patients with implanted electrodes we demonstrated both positive and negative effects on recall performance, depending on the timing of stimulation relative to the patient's ongoing brain activity. Ezzyat et al (2018) Closed-loop stimulation of temporal cortex rescues functional networks and improves memory. Nature Communications, 9(1):365.This recent paper from our team shows how precisely timed and targeted brain stimulation was used to reliably improve word recall performance in 25 patients with implanted electrodes. Top Three Takeaways: 1. Biomarkers for high memory capability include increased high-frequency activity and decreased low-frequency activity in certain areas of the brain. 2. An 18% increase in memory compounds over time greatly increasing the capabilities of a person. 3. No major side-effects have been noted as of now; the potential for memory improvement still continues to grow for those suffering from traumatic brain injury. Show Notes [0:00] Nia Therapeutics seeks to improve memory for patients suffering from traumatic brain injury through an implant. [2:00] The company developed in January of 2018 as part of the Restoring Active Memory Project funded by DARPA. [4:00] There are clear biomarkers that indicate good or bad memory. [7:00] With the known biomarkers, the brain can be stimulated into a mode of good memory. [8:45] The biomarkers of good memory encoding in the brain mirror the biomarkers of good retrieval. [10:15] This technology is specifically meant for those suffering from traumatic brain injury and neurodegenerative diseases. [12:30] There was a documented 18% increase in memory from the implantable device; this would move 25% of memory-impaired individuals from disabled to nondisabled. [14:30] Memory increase compounds over time. [16:00] There are still surgical risks associated with this treatment. [19:30] No major side-effects have been documented. [22:00] Rizzuto recently closed Nia's first financing of over one million dollars. [24:00] The funding will be enough to design a platform; extensive testing through the FDA is still necessary. [28:00] Patients are the unsung heroes of the clinical trials. [30:00] Many of the patients who volunteered suffered from epilepsy which is an effect of traumatic brain injury. [32:00] Some patients experienced 30-40% memory improvement; the idea of this technology is to restore memory.

Jack Judy is the director of Nanoscience Institute for Medical and Engineering Technologies at the University of Florida He serves to bridge the divide between engineering, medicine, and the sciences through the work he does with neurotechnologies and neural implants. He has focused on peripheral nerve interfaces and how stimulating these could help amputees in the Wounded Warrior Project. He has worked with DARPA for several years where he has revolutionized biotechnology and biomedicine to confront issues many in the field were ignoring. Top Three Takeaways: 1. Biomedicine and biotechnology provide an avenue for innovation in the future of neural implants that could provide alternative forms of treatment for certain treatments. 2. Many issue concerning neural implants are not being discussed openly which thwarts improvement in much for the field. 3. The field of biotechnologies and biomedicine has potential but very strong challenges that include funding, research, and over excitement without delivery. Show Notes [0:00] Jack Judy Introduces himself [2:50] Ladan asks about the approaches Judy and his colleagues are taking in building physical objects that will work with neural tissue. [6:30] Judy explains how higher channel counts in neural implants could compromise good electrical connection. [11:30] Judy explains how he got involved in the field of neurotechnology through DARPA. [16:00] Judy explains the problems he perceives in neurotechnology. [22:30] Judy explains how he worked with DARPA to serve the nation and assist the defense. [26:00] Judy explains how DARPA chose to shed a light on the reliability issues neurotechnology has. [29:05] The hype cycle concerning MEMS technology is discussed; the relationship between the hype cycle of neural implants is also explained. [37:00] Judy acknowledges the excitement in the field of biomedicine, but he advocates for research and funding. [43:00] Judy explains how the field does face obstacles but the strong engineering school and strong medical school in close proximity at the University of Florida provides a good environment for progression.