Category Archives: Neurotechnology

NeuroTechnology comes in several shapes and sizes, including some invisible options for maximum discreteness. The hearing health care provider will review your treatment options based on your specific hearing loss and hearing needs. Regardless of which treatment option is right for you, whether youre out to dinner with friends, hitting the beach, meeting with clients, or hiking, youll be able to hear what matters most with todays hearing loss technology.

Invisible Treatment Options: Once placed in your ear, its hassle-free so that you may even forget youre wearing the device! And thats the point. Hearing loss shouldnt hold you back, and neither should your hearing solution. Features in todays invisible technology options include:

Mini Receiver In The Ear Options: Groundbreaking NeuroTechnology is fast and precise enough to analyze and follow the dynamics of the entire auditory environment, and differentiate between speech and background noise. Advances in miniaturization of technology have led to the breakthrough of new NeuroTechnology proven to support brain function, including working memory, selective attention and processing speed (The Hearing Review: Dr. Desjardin, University of Texas, El Paso). These new devices have 3 features designed specifically to maintain the brains innate ability to hear in all different listening situations:

In addition, some options include Bluetooth and Internet compatible options that enable:

Continued here:

Learn About NeuroTechnology Treatment Options for Hearing ...

MUNICH--(BUSINESS WIRE)--NextMind, a fast-growing neurotechnology startup, announced today that its award-winning brain-computer interface is empowering real-time control in a concept vehicle presented this week in Munich at IAA Mobility Sept. 7-12. It is the worlds first automotive integration of a brain-sensing wearable, using NextMinds proprietary technology, which allows users to take control of the car just by using their thoughts.

NextMinds groundbreaking technology opens new possibilities for user interaction and engagement by instantly translating brain signals from the users visual cortex into computer commands, said Sid Kouider, NextMind founder and CEO. Brain-computer interfaces are going to impact every aspect of our lives and bring incredible benefits to improve our world. We are excited to be partnering with industry leaders like Mercedes-Benz to explore ways to turn these future possibilities into realities.

After months of co-development, visitors at the event can now experience using their mind to control the car's functions at its exhibit in Hall B3.

The driver links to the car using NextMind's non-invasive BCI upon entering. Once the user completes the short calibration process, the direct connection between the users thoughts and the car allows them to perform functions on the dashboard such as selecting entertainment channels and navigating a car in a virtual world.

While visitors to IAA Mobility can try out NextMind real-time controls for themselves, it will take more time before these technologies become widely integrated across consumer products. Until then, anyone can experience BCI technology at home using the NextMind Dev Kit.

About NextMind

NextMind lets your mind take control. A fast-growing tech startup, NextMind has developed a first-of-its-kind, brain-sensing wearable that delivers real-time device control using just a person's thoughts. NextMind's groundbreaking technology, based on proven scientific research conducted over the past 20 years, translates brain signals from the visual cortex into digital commands in real time, enabling easier interaction and control of cars, computers, AR/VR headsets or any digital device. For more information, visit next-mind.com and follow us on Twitter, YouTube, Facebook and LinkedIn.

In January 2020, NextMind captured the imagination of the tech community as a top newsmaker at CES 2020, winning two CES innovation awards, including the prestigious Best of Innovation in Virtual & Augmented Reality and as an Honoree in Wearable Technologies. Thousands of event attendees personally experienced NextMinds first-of-its-kind direct brain command technology. The remarkable NextMind brain-computer interface wearable was featured by ABC News, CNBC, VentureBeat, WIRED, etc.

In December 2020 NextMind started shipping its Development Kit as covered by TechCrunch, Engadget, CNET and hundreds of other news outlets. This $399 Dev Kit enables everyone to develop their own brain-enabled applications, but NextMind also offers an Enterprise version of the Dev Kit specifically for customers looking to integrate NextMind technology into existing products, or concepts. The Dev Kits have established NextMind as a leader enabling all developers to build the first generation of mind-controlled applications.

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NextMind brings Brain-Computer Interface wearable to IAA Mobility - Business Wire

KALAMAZOO, Mich., Sept. 7, 2021 /PRNewswire/ -- Stryker announced today that it has completed the acquisition of Gauss Surgical*. Headquartered in Menlo Park, CA, Gauss Surgical is a medical device company that has developed Triton, an artificial intelligence-enabled platform for real-time monitoring of blood loss during surgery. Triton has demonstrated improvements in maternal and surgical care through earlier recognition of hemorrhage leading to earlier intervention.

Up to 5 percent of mothers will experience a post-partum hemorrhage1, which is the leading cause of maternal death globally.2 Studies suggest that 70 percent of these are preventable.3 The Joint Commission revealed that prevention, early recognition and timely treatment of maternal hemorrhage had the highest impact on decreasing maternal complications.4

"Gauss Surgical's innovative Triton technology will help fill the void of quantifying blood loss to enable accuracy, early detection of hemorrhage and prevention of maternal morbidity," said Dylan Crotty, President of Stryker's Instruments division. "Our belief is that Triton technology will help improve the industry standards for quantifying blood loss in the labor and delivery department, furthering Stryker's commitment to improve safety and outcomes for our caregivers and their patients."

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About StrykerStryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better. The company offers innovative products and services in Orthopaedics, Medical and Surgical, and Neurotechnology and Spine that help improve patient and hospital outcomes.

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Stryker announces the acquisition of Gauss Surgical - DOTmed HealthCare Business News

This article was originally published here

J Alzheimers Dis. 2021 Sep 3. doi: 10.3233/JAD-215190. Online ahead of print.

ABSTRACT

Neurological disorders significantly impact the worlds economy due to their often chronic and life-threatening nature afflicting individuals which, in turn, creates a global disease burden. The Group of Twenty (G20) member nations, which represent the largest economies globally, should come together to formulate a plan on how to overcome this burden. The Neuroscience-20 (N20) initiative of the Society for Brain Mapping and Therapeutics (SBMT) is at the vanguard of this global collaboration to comprehensively raise awareness about brain, spine, and mental disorders worldwide. This paper aims to provide a comprehensive review of the various brain initiatives worldwide and highlight the need for cooperation and recommend ways to bring down costs associated with the discovery and treatment of neurological disorders. Our systematic search revealed that the cost of neurological and psychiatric disorders to the world economy by 2030 is roughly $16T. The cost to the economy of the United States is $1.5T annually and growing given the impact of COVID-19. We also discovered there is a shortfall of effective collaboration between nations and a lack of resources in developing countries. Current statistical analyses on the cost of neurological disorders to the world economy strongly suggest that there is a great need for investment in neurotechnology and innovation or fast-tracking therapeutics and diagnostics to curb these costs. During the current COVID-19 pandemic, SBMT, through this paper, intends to showcase the importance of worldwide collaborations to reduce the populations economic and health burden, specifically regarding neurological/brain, spine, and mental disorders.

PMID:34487051 | DOI:10.3233/JAD-215190

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Neuroscience20 (BRAIN20, SPINE20, and MENTAL20) Health Initiative: A Global Consortium Addressing the Human and Economic Burden of Brain, Spine, and...

The Facial Recognition Technology in the Financial Services Market examinations significant objective is to accumulate the most accommodating experiences for any business, which will then, at that point, help the association in settling on key choices. In the present serious world, each business has to think about the different disciplines of the business. This investigation ought to be refreshed consistently in light of the fact that it will help the association work in a powerful climate where it will fill in as a hotspot for all fundamental business decisions.

In light of different regions, the market has been sectioned into Latin America, North America, Eastern Europe, Western Europe, Japan, China, Asia Pacific, and the Middle East and Africa, Which also holds a large share of the market.

The worldwide customer decay brought about by the Covid episode is influencing makers in the IT industry, who are right now managing high inventories and anticipating that business should continue as normal to offset market revenue issues. In any case, the most recent COVID-19 pandemic has impacted world exchanging and trade, influencing these organizations. Regardless, this report contains the most cutting-edge detail on the COVID-19-related market unsettling influences.

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Top key players: NEC Corporation (NEC) (Japan), Aware, Inc. (Aware) (US), Ayonix Corporation (Ayonix) (Japan), Cognitec Systems GmbH (Cognitec Systems) (Germany), NVISO SA (nViso) (Switzerland), Animetrics (US), Neurotechnology (Lithuania), Daon (Ireland), Stereovision Imaging, Inc. (SVI) (US), Techno Brain (Dubai)

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The report includes six parts, dealing with:1.) Basic information;2.) The Asia Facial Recognition Technology in the Financial Services Market;3.) The North American Facial Recognition Technology in the Financial Services Market;4.) The European Facial Recognition Technology in the Financial Services Market;

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Global Facial Recognition Technology in the Financial Services Market Growing Technology Trends and Business Opportunities by 2028 NEC Corporation...

Two years ago, this blog wrote about the privacy implications of the exciting new field of brain-computer interfaces (BCIs). The approach discussed there involved implanting tiny threads directly into the brain. Such an invasive and medically risky procedure is unlikely to be adopted by the general public. But a new paper underlines the major advances in non-invasive BCIs, for example using electroencephalography BCIs (eBCIs) that measure electrical activity on the external surface of the scalp.

Most of the paper is devoted to a detailed review of over a dozen such eBCI headsets and their potential applications as mass market devices.. But the paper rightly concludes by considering the main ethical issues raised by these eBCI systems, which concern privacy and agency. It points out that neural information acquired using eBCIs could give important insights into how their users think, feel and behave. Neural data could be used to infer different aspects related to user intention, emotional response, and decision making, as well as conscious and unconscious interest. That, in its turn, means that eBCIs will be appealing tools for the large-scale collection of consumer biometric data for companies.

Its easy to imagine incentives being offered to users of eBCIs to allow their neural information to be shared with third parties, just as much personal data is shared as they move around the Internet. Indeed, one of the deeply troubling aspects of the routine and large-scale harvesting of highly personal data from people when they visit sites or use online services is that it normalizes this invasion of privacy. Once that happens, many people might think that since they have already given up so much about themselves, they may as well agree to upload their neural data too.

The other major ethical issue raised by the new generation of two-way eBCIs concerns agency. This refers to the subjective awareness of control over our own actions and, by extension, over events in the external world. Here, there is a subtle but serious problem thanks to the brains lack of proprioception, sometimes referred to as the sixth sense:

the human brain is unable to acknowledge the influence of an external device on itself, which could potentially compromise autonomy and self-agency. Because of this, users may be liable to mistakenly perceive ownership over behavioral outputs that are generated by the BCI, as well as incorrectly attribute causation to it. For instance, brain stimulation techniques have been shown to trigger changes in demeanor and character traits, which often leads to changes in personal identity.

In other words, the brains paradoxical lack of awareness about itself as a physical organ, and its inability to distinguish different kinds of external inputs, could make it easier to implant thoughts and desires using BCIs without the subject being aware of that fact.

The evident seriousness of these challenges has prompted ethicists and researchers to explore ways to combat the use of BCIs to undermine privacy and agency. An increasingly popular suggestion is to update the Universal Declaration of Human Rights for the age of neurotechnology. Recently, one group of scientists and lawyers suggested enshrining and protecting five basic neuro-rights:

(1) the right to identity, or the ability to control both ones physical and mental integrity; (2) the right to agency, or the freedom of thought and free will to choose ones own actions; (3) the right to mental privacy, or the ability to keep thoughts protected against disclosure; (4) the right to fair access to mental augmentation, or the ability to ensure that the benefits of improvements to sensory and mental capacity through neurotechnology are distributed justly in the population; and (5) the right to protection from algorithmic bias, or the ability to ensure that technologies do not insert prejudices.

Back in 2019, when Privacy News Online first looked at this area, such proposals were purely theoretical, and seemed unlikely to form part of a legal framework with any real-world impact. But things have moved on since then. For example, Spain aims to bring in a Charter of Digital Rights, whose aim is to preserve offline rights in the online world. Section XXIV concerns digital rights in the use of neurotechnologies. Remarkably, new mental privacy laws in Chile are even further along. As an article on the Rest of the World site explains, a constitutional bill awaiting approval by Chiles Chamber of Deputies, and a bill explicitly about neuro-protection, will establish rights to free will, mental privacy, equal access to cognitive enhancement technologies, and protection against algorithmic bias essentially those listed above. The Rest of the World article points out the radically new approach taken by the Chilean neuro-protection bill:

Rather than describing it in broad-brush terms, it proposes to treat neural data as a special kind of information that is intimately related to who we are and that partly defines our identity. The bill therefore states that neural data must be legally considered as organic tissue.

By treating neuro-data as an organ, the law prohibits Chileans from being compelled to give up brain data and, crucially, its collection will require explicit opt-in authorization. Another implication of this legal analogy is that brain data cannot be sold; it can only be donated for altruistic purposes. The buying and selling of brain data is prohibited, regardless of consent.

It is noteworthy how fast the world of neuro-rights is progressing. It is also striking that the country in the vanguard of addressing the novel and profound ethical questions that BCIs raise is Chile. This is a sure sign that protecting mental privacy will not just be a problem for a few rich Western nations, but for the entire world. Other countries need to learn from the Chilean moves, and start working on their own legislation enshrining key neuro-rights.

Featured image by Baburov.

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Chile is Passing a Neuro-Rights Law to Protect Mental Privacy. It's Time for Other Nations to Do the Same. PIA VPN Blog - Privacy News Online

Breakthroughs in neuroscience and artificial intelligence are bound to change the way we interact with people and the world around us, though many remain unaware of this emerging field of technology.

Brain-machine interfacing is a direct means of communication between a human brain and a machine. Communication is achieved through devices like electroencephalograph machines (EEGs) and implants which monitor neural signals by a head-worn device or more invasively by a device inserted into or onto the brain itself.

Although this may sound straight out of a sci-fi movie, brain-machine interface (BMI) technology has already arrived and is being tested in humans and animals.

While BMI tech is still in its early days, conversations about what constitutes an ethical cognitive-augmentation of humans are worth starting now. It may not be long before this technology is commercially available and widely adopted.

Many different approaches to BMI are being taken by corporations and research institutes. Some have their sights set on the medical treatments made possible by this technology. Others are focused on the long term consumer applications for these tools.

We can expect BMIs such Neuralink, Elon Musks latest technological venture, to return certain motor functions to impaired individuals. Using a neural implant, called the Link, the activity of specific neurons can be detected and decoded to better understand what different areas of the brain do.

The initial goal of our technology will be to help people with paralysis to regain independence through the control of computers and mobile devices.

Neuralink, launched in 2016, aspires to help people with spinal cord injuries by giving them the ability to control computers and other digital tools with their minds. Users would initially learn to control a virtual mouse, but could eventually control multiple virtual devices, like keyboards or game controllers.

While Neuralink is focused on developing tools to give people the ability to communicate more easily by text and speech, new possibilities are appearing quickly in this field of research.

In movement-related areas of the brain, neurons represent intended movements. There are neurons in the brain that can carry information about everything we see, feel, touch, or think, Neuralink explains on their website.

As users think about moving their arms or hands, we would decode those intentions, which would be sent over Bluetooth to the users computer.

Earlier this year, Neuralink released a video of a macaque monkey named Pager, playing simple computer games, receiving doses of banana milkshake as a performance reward. Initially trained to use a joystick to move a cursor to a highlighted area of a digital grid, Neuralink was able to decode the intent behind Pagers neural activity to give him control of the cursor using only his mind once the joystick was unplugged.

The experiment was taken one step further when Neuralink demonstrated Pagers ability to play a classic game of Pong purely by thought.

On the other end of the spectrum for BMI applications, is widely adopted consumer usage. Although we cannot expect implants like Neuralink to become publicly available any time soon, non-invasive BMIs are being used to augment tools you likely already use, like headphones.

Neurable, a tech start-up, aims to develop neurotechnology for everyday life. Enten is a pair of smart headphones that uses EEG to detect the difference between high-attention and low-attention brain states, without having to put a chip in your brain.

Enten headphones are paired with your phone to offer you helpful suggestions throughout the day that optimize personal productivity.

Users may be prompted to take breaks at certain points in the day when low-attention brain activity is detected, or instead might have notifications automatically muted during peak cognitive performance. Playlist recommendations are even algorithmically curated for your individual enhancement.

At Neurable, were translating brain activity into simple actionable insights you can use in your everyday life. After all, your brain knows you best.

There is a lot of middle ground to be covered in innovation between Neuralinks medically focused implant and Neurables consumer-focused headphones. But as BIM technology improves, we can anticipate the development of tools that strike a healthy balance between restorative function and cognitive augmentation.

It is worth noting that Neuralink has expressed plans to offer its tools to healthy patients in the future.

Access to emerging technology always brings about a new set of ethical questions, especially when personal data is involved, let alone neural information depicting human intention.

We expect that as our devices continue to scale, and as we learn to communicate with more areas of the brain, we will discover new, non-medical applications for our BMIs. Neuralinks long-term vision is to create BMIs that are sufficiently safe and powerful that healthy individuals would want to have them.

Dr. Amedeo DAngiulli from Carleton Universitys Cognitive and Emotion Research (NICER) Lab says, this technology will become state of the art, and the kind of standard. For medical applications, we will be in this situation where we will have the technology, and people will clearly benefit from it. I dont think theres anyone that can actually doubt that

On the other end, we will also have the issue that when we get to augmenting, there will be the usual fuzzy gray area where we dont know if the application of that technology is necessary.

Currently, the conversation surrounding invasive and non-invasive approaches to brain-machine interfacing is concerned with how close to the brain a data-reading device is. DAngiulli says we should be more concerned with how invasive or protective corporations are about our neural data, as they gain access to it in the coming decades.

I see the invasive versus non-invasive distinction as very blurred and very artificial because in any case where you have individual data interfacing with a third-party machine, the repercussions can also be dire.

We dont want a situation where these technologies are launched and then for private interests, there are caveats that cannot be fixed, he says.

As BMIs become more mature, we ought to develop stronger measures for the protection of user data. Eventually, the primary application of these tools will shift from medical to augmentative, and many more ethical standards and protocols will become necessary.

I dont think that the major applications will be rehabilitation or medical. I think the major applications will be individual; everybody will have a personal AI exactly as we have a personal computer Maybe we wont type on the computer anymore, but the computer will be part of us, DAngiulli says.

The future will look very weird and different from now.

As innovation in neuroscience and artificial intelligence continues to bring humans closer to the nature of their own minds, now is the time to consider how much meddling is ethically permissible.

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Explainer: Brain-machine interfacing could change the way we interact with the world and with ourselves - capitalcurrent.ca

NEW YORK, Aug. 13, 2021 /PRNewswire/ -- The orthobiologics market research report has been added to Technavio's catalog. The market is anticipated to witness healthy growth at a CAGR of 7.01%.Advanced Medical Solutions Group Plc (UK), Akcome Medical Holdings Co. Ltd. (China), Anika Therapeutics Inc. (US), Arthrex Inc. (US), Bioventus LLC (US), Globus Medical Inc. (US), Johnson and Johnson Inc. (US), Medtronic Plc (Ireland), Nuvasive Inc. (US), and Stryker Corp. (US)are some of the dominant players likely to contribute to the significant growth in the market.

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The orthobiologics market is driven by the increase in focus to reduce orthopedic surgeries and the increasing prevalence of orthopedic disorders coupled with an aging population. However, high costs and inadequate reimbursements for orthobiologics products and procedures can hamper the growth of the market during the next few years.

Read the 120-page report with TOC on "Orthobiologics Market Analysis Report by Product (Bone graft substitutes, Viscosupplementation, and Stem cells) and Geography (North America, Europe, Asia, and ROW) Forecasts,2021-2025":

https://www.technavio.com/report/report/orthobiologics-market-industry-analysis

Top Five Orthobiologics Companies:

Arthrex Inc.

The company is involved in new product development and medical education in orthopedics.The company offers orthobiologics such as ACP double-syringe system, Angel system, BioPatella OATS Instrument Set, and others.

Bioventus LLC

The company operates in key geographic segments including the US and International. The company offers orthobiologics such as EXOGEN Ultrasound Bone Healing System, StimRouter PNS neuromodulation system, and others.

Medtronic Plc

The company offer healthcare products and services while operating in key business segments including Cardiac and Vascular Group, Minimally Invasive Therapies Group, Restorative Therapies Group, and Diabetes Group.The company offers orthobiologics such as Infuse Bone Graft, Grafton DBF, Grafton demineralized bone matrix, and others.

Nuvasive Inc.

The company generates revenue from a single operating segment which includes the development of spinal hardware and surgical support products.The company offers orthobiologics such as Osteocel, Attrax, and Propel DBM.

Stryker Corp.

The company operates in the key business segments including Orthopaedics, MedSurg, Neurotechnology & Spine.The company offers orthobiologics such as AlloWrap DS, Demineralized Bone Matrix, ProChondrix CR, and others.

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Orthobiologics Market Product Outlook (Revenue, USD bn, 2020-2025)

Orthobiologics Market Geography Outlook (Revenue, USD bn, 2020-2025)

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Orthobiologics Market to Grow by $ 2.02 bn at 7.01% CAGR during5 | Evolving Opportunities with Dominant Players including Medtronic Plc and Nuvasive...

From drug delivery technology to brain-computer interfaces, revolutionary medical devices transform peoples lives in incredible ways. Today, the demand for new devices is greater than ever, thanks to the accelerated pace of medical technology innovation. Getting past the concept phase for many groundbreaking ideas requires risk management; however, inefficiency and inconsistency often impede forward momentum.

Taking a medical device from concept to reality is a lengthy and intensive process that requires rigorous research and testing and extensive trial and error. On average, it takes approximately 3-7 years to bring a medical device to the advanced formal design phase An increasing number of concepts are meeting their demise in the medical device valley of death, which is when a lack of funding prevents progress beyond early advance development and transition into the more costly formal design, verification and manufacturing phases necessary for regulatory submission, review and approval. Failure to properly evaluate and retire risk at each stage of the development process is a key reason this occurs.

The pitfalls of the valley of death are causing investors to shy away from medical technology projects, which is hampering the development of lifesaving innovations. Implementing and applying a clearly defined process for identifying and reducing potential risks throughout a project saves time and money and prevents potentially life-changing medical devices from getting stalled in the valley of death.

Effective Risk Identification and Retirement

Big opportunities often come hand in hand with big risks and that is especially true of medical devices, which directly impact peoples health and safety. The process of bringing them to market is inherently fraught with risks from technical engineering and financial risks to regulatory and market risks, and more. But finding ways to address, mitigate and manage issues and challenges along the way is a worthwhile endeavor that enables medical device makers to bring game-changing innovation to life.

A recent Greenlight Guru survey found that 33% of medical device professionals think risk management adds value but is not a strategic asset. Even more troubling is that 12% of respondents said risk management is viewed as a "checkbox" activity at their organization and only meets minimum requirements. The reality is that risk management should underpin every aspect of medical device development as the financial and safety implications are profound.

There are three ways to retire risk throughout the medical device development process. You can determine that a risk is minimal enough to safely proceed as it will be easily resolved at another stage. Alternatively, you can identify and implement mitigation activities that will eliminate the risk or reduce it to acceptable levels. You can also conclude that a risk is dire enough to stop a project from moving forward. Making go and no-go decisions at every stage of a medical device development project reduces uncertainties and drives momentum. A structured and repeatable framework for risk retirement decision making enables you to continuously and consistently identify risks and determine how to proceed.

The Biggest Risk Retirement Mistakes

Retiring risk is a complex process that requires a thoughtful, balanced and holistic approach. Designers often dont think broadly enough about what could go wrong, which is why its crucial to have an experienced risk analysis team make overarching assessments that factor in engineering, materials science, software development, cybersecurity, human factors and manufacturing. Another common mistake is not retiring enough risk during advance development, which can keep a concept from exiting the formal design and verification phase.

On the other end of the spectrum are companies that try to anticipate and resolve every potential risk too early on, which stymies progress and prevents concepts from entering the formal design phase. Careful assessment throughout a project can determine which risks are acceptable to carry forward and address later. An objective perspective and the ability to compromise are vital to effective risk retirement as adjustments will inevitably need to be made to the original idea. As alterations are made to address a given risk, its imperative to consider how other aspects of the device will be impacted by the changes, whether those impacts are acceptable, and if not, what modifications will be necessary.

A medical devices risk profile evolves with emerging information such as test results from prototypes, new regulatory requirements, new discoveries and changing market conditions. Its imperative to continually monitor and learn from insights and data. An established process for re-evaluating risk throughout the development cycle can help ensure all relevant factors are considered.

How a Risk Retirement Framework Can Help

Using a defined and comprehensive framework to guide the process can help prevent risk retirement mistakes from delaying and derailing medical device development. For example, my company, Battelle, has developed a constantly evolving and updated framework for risk analysis and retirement that is specifically designed to help medical device companies evaluate all potential risks not just technical issues at every stage, from start to finish.

We begin with a key performance indicator (KPI) chart for the medical device, which identifies the various risks, defines the level of danger and determines how risks will be addressed in the current stage of development. The adjustment of how a risk is mitigated at various stages is important. For example, if one is developing a new drug delivery device that must be accurate to within a fraction of a microliter, this would likely be a key performance indicator. In the final stretch of the project, this KPI will be demonstrated through the verification testing of actual devices but in the concept stage, it could be sufficiently retired with the thorough analytical model that demonstrates the concepts likelihood of providing sufficient accuracy. When risks are identified and deemed addressable at a later phase in order to keep a project moving forward, they are flagged for focused concept and engineering studies to identify solutions and mitigations before they can go on to the next stage.

Whether its connected drug delivery devices that improve patient safety or neurotechnology that empowers paralyzed patients to regain conscious control of their fingers, hand and wrist, breakthrough medical innovations make peoples lives better in impactful ways. Thats why its essential to prioritize risk management and retirement and employ a consistent framework that fosters the successful development of safe and effective medical device products.

Learn more about Battelles Risk Retirement Framework.

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How savvy risk retirement can keep medical devices from perishing in the "valley of death" - FierceBiotech

Picture this: Its June 11, 2046and a young designer, Vance, wakes up and puts on an earpiece called Eva. The device, a brain-computer interface (BCI) of the future, decodes neural signals in his brain. Using only his thoughts, he asks the device to report his daily notificationsand 13 new thought messages appear on his phone.

Later, at work, a barrage of notifications are announced through the earpiece until he asks all except phone calls and messages to be silenced until 11:30 a.m. Using his mind to operate an imagined desktop application called Neural Sculptor, he designs a three-dimensional animated figure, mentally narrating the creation of the eyes, ears, hair, mouth and beard.

Back at home, with Evas voice as a guide, he cooks ratatouille and makes plans with a friend. Before signing off for the evening, he reads part of a book and silently asks Eva to save inspirational passages. She tells him, Based on your serotonin levels, the most impactful quote was, You cant wait for inspiration, you have to go after it with a club.

This scenario is pure fantasy, of course a speculative YouTube video about the future of BCIs created by the product design studio Card79. But Afshin Mehin, design director at the company, which has worked on everything from the industrial design of implantable brain-computer interfaces for Elon Musks Neuralink to futuristic wearable tech for companies like Lululemon, said its a future thats starting to come into focus.

I think the implications are super broad and expansive at this point because we have a lot of imagination about what BCIs could do, Mehin said. And I think this is a fun time to imagine whats possible.

If Mehins predictions come true, as the uses of brain-computer interfacesprogressfrom highly regulated clinical and experimental research trials for people with neuromuscular conditions such as spinal cord injuries, amyotrophic lateral sclerosis (ALS), cerebral palsy and brain stem stroke to public health and consumer applications, UX and UI designers will play an important role in imagining their potential uses and ethical implications.

And indeed, the results of recent research demonstrations are impressive. Last month, a team at the University of California, San Francisco (UCSF), led by neurosurgeon Edward Chang, used a high-density electrode array to decode words from brain activity. As reported in a study published in the New England Journal of Medicine, the trials first participant was a 36-year-old man who experienced a stroke that left him unable to form intelligible words. With an electrode array surgically implanted in his sensorimotor cortex, an area of the brain involved in tactileperception and the planning and execution of physical movement, the man was able to form words on a computer screen at a rate of roughly 15 words per minute.

I think the implications are super broad and expansive at this point because we have a lot of imagination about what BCIs could do.

While BCIs take many forms and target different brain regions, the subdural implant Changs team used maps groups of neurons linked to muscle movements in the vocal tract. The researchers asked the participant, dubbed Bravo-1, to imagine saying 50 common words, each almost 10,000 times, according to a report in MIT Technology Review.

By training a deep learning model to detect and classify words by neural signals, the researchers could correctly identify Bravo-1s words with 47 percent accuracy. When they fed his sentences through a natural language model that predicts the probability of word sequences from their syntax and usage think auto-correct and auto-complete the accuracy rate jumped to 75 percent.

Still, for as much promise as BCIs hold for enhancing communication in people with severe paralysis, there are plenty of kinks to be worked out.

In the UCSF study, the systems performance is restricted to a highly limited vocabulary range, nowhere near the more than 170, 000 words in the English language. Plus, it took 22 hours of brain recordings in 48 sessions to produce.

I dont want to downplay it by calling it a baby step, Dean Krusienski, a professor of biomedical engineering at Virginia Commonwealth University who has spent decades studying BCIs, said. Its a very major advance, but theres still a long way to go to achieve more natural verbal communication.

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For Facebook, which helped fund the project led by Chang, the study apparently failed to provide compelling evidence to move forward with a separate but related project:anAR/VR headset that would let users send text messages by thought dictation. In a blog post where the company expressed its goal in funding the research to determine whether a silent interface capable of typing 100 words per minute is possible, and if so, what neural signals are required itannounced it wasdiscontinuing prototype development of the headset in favor of a wrist-based product with a more conceivable path to market.

The bigger setback for Facebook, though, may be that an optical headset of the type the company envisioned for consumer use is far different than a prosthetic surgically inserted inside the brain.

Its still like listening to the stadium a block away, Cynthia Chestek, an associateprofessor who researches brain-machine interfaces at the University of Michigan, said of the former. You can tell somethings happening, but you wouldnt attempt to overhear a conversation.

When neurons fire, she explained, they create a puff of voltage. The closer a device is to the neurons, the better the data. Yet, the signal falls off [in a ratio of] one over the distance, which is a super, super steep fall off, Chestek said. The reason you can record anything at all from outside of the head is because lots of things are happening at the same time.

So what can you measure externally?

For example, from outside the scalp you can determine what side of the brain a seizure is on or tell what sleep cycle somebody is in, Chestek said.

These deductions can be instructive, but theyre a far cry from deciphering signals from individual neurons to help people type telepathically at 100 words per minute.

Its still like listening to the stadium a block away. You can tell somethings happening, but you wouldnt attempt to overhear a conversation.

On the other hand, brain implants are unlikely to take hold as a consumer option in the near future due to U.S. Food and Drug Administration (FDA) regulations and the surgical risks involved. Invasive procedures like electrocorticography, as reported in theMcGill Daily, usually involve the implantation of electrodes epidurally (under the skin), subdurally (under the scalp) or intracortically (recording within the cerebral cortex). These risks, the report notes, include infections, hemorrhage, tissue damage, personality changes and immune reactions that diminish the devices effectiveness.

Still, for neuroscientists developing BCIs and testing their potential to restore communication and mobility in people who have lost bodily movement due to paralysis or neurodegenerative disease, the field is full of promise.

A lot of really exciting stuff is happening, Chestek said. People are finding ways of recording or stimulating thousands of individual neurons. People are also figuring out how to create electrodes that are smaller than neurons so they can go into the nerves and not do damage. So everybodys excited.

As an illustration of whats possible, Krusienski pointed me to a 2012 video of Jan Scheuermann, a woman with quadriplegia, who used her mind, assisted by an implanted BCI, to control a robotic arm to raise a chocolate bar to her mouth and take a bite.

One small nibble for a woman. One giant bite for BCIs, Scheuermann said.

And after that breakthrough and similar demonstrations at universities across the country, the field has continued to advance with roughly 30 people implanted to date. Just last year, Chestek and her colleagues trained electrode-implanted monkeys to telepathically operate distinct digits of their hands a potential pathway to use BCIs to animate individuated finger movements in people with artificial hands.

Developments such as these are encouraging to Mehin. As part of San Francisco Design Week, he premiered Card79s Day in the Mind video as part of a panel discussion about the future UX of BCIs. Speaking to me by phone after the event, he said one possibility is that a BCI could serve as a home assistant that lives in the brain, giving people the capacity to do things they already do like order food or compose a memo faster and with a greater degree of privacy.

The other obvious superpower is that youre able to access data that you dont, literally, have to hold inside your head. And I think thats the one people get excited about, he said. Assuming the bandwidth is high enough, its easy to start to imagine querieslike, Whats the capital of Angola? What was our revenue last quarter? Things you can easily get back in a qualitativeway.

Mehin admits these scenarios are somewhat far off, especially if they are to be achieved non-invasively, as Facebook had imagined. But advances in machine learning applications with narrow intelligence could accelerate development. The scenario presented in the Day in the Mind video, for example when Vance mentally constructs a cartoon head was inspired by an existing Figma plug-in, GPT-3, that can create layout templates for scrollable windows, buttons and profile pictures by making inferences about a users intentions from common patterns associated with their text commands.

Assuming the bandwidth is high enough, its easy to start to imagine queries, like, Whats the capital of Angola? What was our revenue last quarter? Things you can easily get back in a qualitativeway.

Machine learning will start to pick up on your specific neural fingerprint and then be able to accommodate it, Mehin said. Its got to get faster, deciphering the nuances of how a version of a word sounds in your brain versus someone elses.

The first consumer products will likely be much less sophisticated, something resembling the flagship product of the Montreal-based company eno: noise-canceling headphones designed to improve concentration by using electroencephalography (EEGs) to track electrical brain activity. In 2016, Card79 worked on the desktop UX of the companys website, and from 2016 to 2018, they collaborated with a London-based company, Kokoon, on the design of headphones purported to enable better sleep.

The products work in much the same way: data from EEGs is fed into algorithms that infer usersmental states and generate complementary soundscapes either to sustain focus, in enos case, or to help people sleep more restfully, as Kokoon maintains its product can do.

But Chestek and Krusienski remain skeptical of the capabilities of such devices.

EEGs may be fun for video games, but even for that, it may or may not work, Chestek said. You have to do something like use the Force. Train hard enough, right? Its not nothing, but youre never going to use [EEGs] to drive a car, she said.

Yet even if the data these devices generate is relatively crude, it could present an immediate, low-risk opportunity for software companies to pursue BCI development. That UX is even part of the conversation surrounding BCIs suggests they are moving closer to reality.

Like any user experience, Mehin said, Youre going to try and create value up front and say, Okay, right out of the gate, we can get you to, say, press that cursor without having to move your armor mentally turn on a light something that gets [people] to understand how the system works and appreciate its value, even if it might not be that powerful.

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Meanwhile, the design of BCIs continues to improve. Early brain implants,such as the Utah intracortical electrodearray built by Salt Lake City-based Blackrock Neurotech, Chestek told me, were limited in the strength of the neural signals they could detect. The 20 mm-wide, razor-thin chips contained about 100 metal electrode filaments sprouting from a silicon base. BrainGate, a multi-institutional U.S. research collaborative, used them in the first clinical tests of BCIs in people withparalysis andneurodegenerative diseases.

While the Utah arraycontinues to perform well, Chestek said, newer implants being developed by software companies like Neuralink contain thousands of electrodes, meaning they can sample from larger collections of the brains roughly 85 billion neurons.

Each neuron individually doesnt tell us much, Krusienski explained. We need to know whats happening in groups of neurons and interconnected networks of neurons to really decode high-level function in the brain.

The performance has gone up, Chestek said.[Even with] the original 100-channel sensor, we are much better at interpreting the signals. If somebody ever hands us 1,000 channels like Neuralink is trying to do, its going to get better by leaps and bounds.

Shrinking the size of implants is another promising area of experimental research, which could make electrocorticography surgery less invasive by minimizing the risk of damage to vascular tissue.

Each neuron individually doesnt tell us much. We need to know whats happening in groups of neurons and interconnected networks of neurons to really decode high-level function in the brain.

Theres a movement within neurotech of building smaller and smaller electric devices, Matt Angle, CEO of Paradromics, an Austin-based neurotech company, said. The brain is a network of blood vessels, almost like a loosely woven blanket. If the device is small enough under 50 micronsor about the size of a cross-section of a human hair, he told me it can be inserted in the gaps between these blood vessels with less risk of damage to surrounding brain tissue.

Moreover, recent findings in medical journals, such as those reviewed in a paper Krusienski and his colleagues published in Frontiers of Human Neuroscience, have shown the potential of inserting electrodes into deeper brain structures through stereotactic guidance in essence, inserting electrodes through a small hole drilled in the skull. This technique appears to yield less trauma and better outcomes than electrocorticogramimplants, and also has the potential to reach new brain regions.

Angle is one of the people keenly interested the technologys development. His company is developing an ultra-thin, wireless BCI implant featuring four, 400-electrode modules for clinical use in patients with severe paralysis. The device, scheduled for completion by the end of the year, will be tested on sheep in early 2022, he told me, with the hope of securing FDA approval for testing in humans thereafter. In the meantime, the company unveiled what its calling the largest ever electrical recording of cortical activity, from over 30,000 electrode channels in sheep cortex.

If high-bandwidth, bi-directional devices like the ones being developed by Neuralink and Paradromics become commercially accessible, Angle said, they could provide new avenues to treat medical conditions that purely biological approaches cannot yet address. In effect, these BCIs become modems for the brain, connecting cortical structures to computers that circumvent traditional signal pathways to trigger sensory and motor responses.

Were really, really far from being able to regrow a retina or reattach an eye to the brain, Angle said. But were at a point now where we can put visual data into the visual cortex [to recreate image sensation]. Were really far away from being able to repair a spinal cord and allow a person whos quadriplegic to walk. But what we can do, right now, is put devices in the motor cortex of a patient whos paralyzed and allow them to use the signals in their motor cortex to control a mouse on a screen, to type, even, we think, to produce speech.

A Los Angeles company called Second Sight might offer a glimpse of what lies ahead. It gained approval by the FDA for the treatment of the degenerative eye disease retinitis pigmentosa with a retinal implant called Argus II. The 60-electrode device, Angle said, is being used to reconstruct a low-pixel visual display for people who experience decreased vision in low light or have limited peripheral vision. The device has been implanted in more than 350 people, according to the companys website.

All this raises some important ethical questions. Assuming BCIs can be installed safely, who will have access to these devices? Could having neural superpowers divide society into different classes? And crucially, how will users privacy be protected once their brains become quasi-data streams?

Ario Jafarzadeh, head of player experience design at Roblox,speaking to me after a panel discussion on BCIs at San Francisco Design Week where he was a guest, said that while touching on many topics, the conversation centered on the role UX designers could have in shaping BCI development.

What resonated with me, if [brain-computer interfaces] are inevitable,and we know about Black Mirror scenarios at least three episodes of the show involved BCIs it behooves the design community to get ahead of it and have this be a force of good in the world and not a dystopia, he said.

If commercial BCIs take hold, Mehin sees UX designers becoming de facto ethicists who sit between the interests of product marketing teams who wish to collect user data and consumers who wish to keep their thoughts to themselves.

What resonated with me, if [brain-computer interfaces] are inevitable ...it behooves the design community to get ahead of it and have this be a force of good in the world and not a dystopia.

In much the same way regulations in the European Union governing cookies under the General Data Protection Regulation and ePrivacy Directive required designers to surface messages letting users know how their data was being tracked, government mandates will likely dictate theprotections designers are required to build into their systems.

High visibility displays of a BCIs on or off status are one way designers might begin to build consumer trust. The speculative BCI operating system in the Day in the Mind video, for instance,would require the user to swipe up on an auxiliary phone screen display to connect to the earpiece through an encrypted neural connection. Giving the system access to onesthoughts, in other words, would necessitate a high degree of intentionality.

It shouldnt be like Chrome for your brain, Mehin said. There should be this entire level of protection thats giving you the sense that things are actually not that easy to access.

Easily accessible permissions settings could offer another layer of protection.

In the video, theres a point where the main character says, Eva, turn off all notifications until 11:30 am. And that level of control has to be built into the experience so someone, as soon as they feel overwhelmed, can either shut off the device or tune it down, Mehin said.

But to have a real impact, BCIs will need to be psychologically safe for users who dont change the default settings at all.

In the book Nudge: Improving Decisions About Health, Wealth, and Happiness, authors Richard Thaler and Cass Sunstein suggest default settings often dictate what people want. Facebook Portal, a video calling device that keepsthe microphone and camera turned off by default, acknowledges users desire for privacy, and BCIs, presumably, could be similarly gated toprevent involuntary oversharing. But consenting to show your face on camera or share your views verbally is obviously much different than letting a device mine your thoughts.

Whats more, the impact on those who dont wish to use BCIs would need to be considered. Just imagine how it might work in the context of online datingif one person has a BCI and the other doesnt.

How would you initially meet someone? Mehin asked. How would you flirt with them? At what point would you invite them into your thoughts? What would dating look like if youre not having a good date? Would you just kind of start chatting with friends in your head?

And thats only the tip of the iceberg.

Elon Musk is talking about other things like psychotherapies orpsychiatric disorders, Krusienski said. Pretty much, any neurological disorder, hes claiming theres a possibility to do this with [Neuralinks] technologyor brain-computer interface technology, in general.

If theoretically feasible, thats a long way off. Before broaching the ethical dilemmas inherent in using BCIs to manage social interactions or lay the foundation for mind-altering psychiatric treatments, Mehinbelieves UX and UI designers may be implored to address a more fundamental question: Whose needs do BCIs best serve?

To that question, Anglehas a clear answer.

Especially with respect to implants, I think we should be thinking about what we can deliver to people with severe disabilities. And, I think, people in theUI/UX domaincould have a huge impact, moving into assistive communication, Angle said. We want to build things that are seamless, or natural, for patients to use. And thats a skill set you dont necessarily find in the person whos doing the signal processing or the person who did their Ph.D. in the motor cortex. Its a skill set of people that dont normally think about neurotechnology, but should.

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Brain Implants Will Arrive Sooner Than You Think. What Does That Mean, Exactly? - Built In