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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 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.

See more here:

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.

Link:

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