Glen Burnie, Maryland – CSSi LifeSciences, a trusted partner from discovery to commercialization for drugs and medical devices, announces the establishment and launch of its fully integrated Medical Device CRO. CSSi LifeSciences Medical Device CRO aims to positively impact the timeline of regulatory clearance and increase profitability for medical device companies, in order to successfully launch its innovative research discoveries and product concepts into the market.
CSSi LifeSciences supports small and large companies in avoiding the "large CRO shuffle" by providing highly specialized regulatory and clinical expertise in medical devices, while also offering unparalleled and cost-efficient services from start to finish. The company's goal is to accelerate product development by providing insight-driven guidance that saves time and cost.
"The pathway to commercialization for a new medical device can be ambiguous and complex due to ever-changing regulations and requirements. To help companies overcome this barrier, we developed our unique Medical Device CRO," said Jim Sergi, president and partner, CSSi LifeSciences. "We take pride in being an industry leader, as well as creating a new breed of CRO, one that focuses specifically on the medical device industry. We believe taking this approach in today's new world of healthcare is intelligent, critically honest, and backed by a history of verifiable results, including over two hundred and fifty successful 510(k) applications."
In an effort to meet the growing demands of the medical device market, CSSi LifeSciences's team of medical device experts serve as a liaison for device manufacturers from inception to commercialization, leveraging deep subject matter expertise and regulatory experiences to effectively move new products to market with speed, accuracy, and the quality necessary to ensure safety, compliance, and health authority approval.
"Collectively, our medical device team has over 100 years of development and commercialization experience, coupled with global regulatory knowledge that goes beyond published guidance documents and initiatives," said Sergi. "Our team possesses the necessary skills and resources to make our clients' medical device efforts an end-user success."
CSSi LifeSciences supports all phases of medical device development, from design engineering and testing to clinical studies and reimbursement. The company offers a broad suite of comprehensive and scalable services, including regulatory filings to US and foreign Notified Bodies; clinical study planning, monitoring, and reporting; FDA and EMA Agent for Foreign Registration; medical device testing and Design History Files; Quality Management Systems (21 CFR 820 and ISO 13485); health authority interactions; and, regulatory and scientific communication.
About CSSi LifeSciences
CSSi LifeSciences provides fully integrated, specialized regulatory and clinical services to support the entire product lifecycle, from discovery to commercialization, for pharmaceutical and medical device companies. With global expertise, CSSi LifeSciences has been a key partner in the development of more than 500 drugs, biologics, medical devices, and in-vitro diagnostics. The company's headquarters is located in Baltimore, Maryland, with additional offices in San Francisco, California; London, United Kingdom; and Hyderabad, India.
Source: CSSi LifeSciences
Autumn leaves cover graves at Arlington National Cemetery in Washington D.C.
Cleveland, Ohio – To commemorate those who sacrificed their lives in protecting this nation, and to honor all who serve in the military or have served, GIE Media's offices are closed Friday, Nov. 11, in observance of Veteran's Day.
Montreal, Quebec – Some potentially good news for aging Baby Boomers: researchers believe that they have developed a hip replacement that will last longer and create fewer problems for the people who receive them than those currently in use. The secret? An implant that "tricks" the host bone into remaining alive by mimicking the varying porosity of real bones.
Interestingly, the key factor that distinguishes the new implant is that it’s less rather than more solid than those in current use, while still being just as strong.
Tricking bones into staying alive
Damiano Pasini, the man behind the design of the new hip replacement, points at the pyramid-like shapes visible on its surface. The implant is known as a femoral stem and connects the living femur with the artificial hip joint. "What we've done throughout the femoral stem is to replicate the gradations of density found in a real femur by using hollowed-out tetrahedra," he explains. "Despite the fact that there are spaces within the tetrahedra, these forms are incredibly strong and rigid so they're a very efficient way of carrying a load. Just think of the lattice-work in the legs of the Tour Eiffel."
Pasini teaches mechanical engineering at McGill University and first started working on the concept for the implant more than 6 years ago. He smiles ruefully as he pulls earlier versions of the implant down from the shelves in his office to show how far he has come since then. He elaborates:
"So because the implant loosely mimics the cellular structure of the porous part of the surrounding femur, it can "trick" the living bone into keeping on working and staying alive. This means that our implant avoids many of the problems associated with those in current use."
Indeed, the main problem with most implants is that because they are solid, or only porous on the surface, they are much harder and more rigid than natural bone. As a result, the implants absorb much of the stress along with the weight-bearing role that is normally borne by the living femur. Without sufficient stress to stimulate cell formation, the bone material in the living femur then becomes reabsorbed by the body and the bone itself begins to deteriorate and become less dense. This is one of the reasons that many implants become painful and need to be replaced after a time. It also explains why people often have difficulty if they have to have the same hip replaced a second time, because there simply isn't enough normal, healthy bone to hold the implant in place.
It is a problem that orthopedic surgeons are seeing more and more frequently.
Implants not so easy the second-time around
Dr. Michael Tanzer from the Jo Miller Orthopaedic Research Laboratory at McGill has been collaborating with Damiano Pasini for several years. "Because people engage in various sports where they may be injured more than they did in the past, we see younger people needing hip replacements more frequently," Tanzer says. "And because people are also living longer, they often need to have the same hip replaced a second time. Unfortunately, I've seen many cases where people simply don't have enough living bone for that to work easily. We are optimistic that this implant will reduce these kinds of problems."
After successfully performing various tests on their implant, the researchers are so convinced that their femoral stem will work that they have already filed patents on it. They believe that because their current design is fully compatible with existing surgical technology for hip replacements it should be easier for the FDA to approve and surgeons to adopt.
Fits existing implant technology
In the meantime, Burnett Johnston, who started working with Pasini on developing the implants when he was a Masters student has now enrolled at McGill's medical school.
His goal? To be the first person to actually implant one of these replacement hips once he qualifies as a surgeon and the new femoral stems have been fully tested, adjusted and accepted – something that Pasini estimates may happen in about three-to-five years' time.
Source: McGill University
Cleveland, Ohio, and Chicago, Illinois – Scientists at the University of Chicago and Case Western Reserve University have found a way to produce realistic sensations of touch in two human amputees by directly stimulating the nervous system.
The study, published Oct. 26, 2016, in Science Translational Medicine (STM), confirms earlier research on how the nervous system encodes the intensity, or magnitude, of sensations. It is the second of two groundbreaking publications this month by University of Chicago neuroscientist Sliman Bensmaia, PhD, using neuroprosthetic devices to recreate the sense of touch for amputee or quadriplegic patients with a "biomimetic" approach that approximates the natural, intact nervous system.
On Oct. 13, 2016, in a separate publication from STM, Bensmaia and a team led by Robert Gaunt, PhD, from the University of Pittsburgh, announced that for the first time, a paralyzed human patient was able to experience the sense of touch through a robotic arm that he controls with his brain. In that study, researchers interfaced directly with the patient's brain, through an electrode array implanted in the areas of the brain responsible for hand movements and for touch, which allowed the man to both move the robotic arm and feel objects through it.
The new study takes a similar approach in amputees, working with two male subjects who each lost an arm after traumatic injuries. In this case, both subjects were implanted with neural interfaces, devices embedded with electrodes that were attached to the median, ulnar and radial nerves of the arm. Those are the same nerves that would carry signals from the hand were it still intact.
"If you want to create a dexterous hand for use in an amputee or a quadriplegic patient, you need to not only be able to move it, but have sensory feedback from it," said Bensmaia, who is an associate professor of organismal biology and anatomy at the University of Chicago. "To do this, we first need to look at how the intact hand and the intact nervous system encodes this information, and then, to the extent that we can, try to mimic that in a neuroprosthesis."
Recreating different sensations of intensity
The latest research is a joint effort by Bensmaia and Dustin Tyler, PhD, the Kent H. Smith Professor of Biomedical Engineering at Case Western Reserve University, who works with a large team trying to make bionic hands clinically viable. Tyler's team, led by doctoral student Emily Graczyk, systematically tested the subjects' ability to distinguish the magnitude of the sensations evoked when their nerves were stimulated through the interface. They varied aspects of the signals, such as frequency and intensity of each electrical pulse. The goal was to understand if there was a systematic way to manipulate the sensory magnitude.
Earlier research from Bensmaia's lab predicted how the nervous system discerns intensity of touch, for example, how hard an object is pressing against the skin. That work suggested that the number of times certain nerve fibers fire in response to a given stimulus, known as the population spike rate, determines the perceived intensity of a given stimulus.
Results from the new study verify this hypothesis: A single feature of electrical stimulation – dubbed the activation charge rate – was found to determine the strength of the sensation. By changing the activation charge rate, the team could change sensory magnitude in a highly predictable way. The team then showed that the activation charge rate was also closely related to the evoked population spike rate.
Building neuroprosthetics that approximate the natural nervous system
While the new study furthers the development of neural interfaces for neuroprosthetics, artificial touch will only be as good as the devices providing input. In a separate paper published earlier this year in IEEE Transactions on Haptics, Bensmaia and his team tested the sensory abilities of a robotic fingertip equipped with touch sensors.
Using the same behavioral techniques that are used to test human sensory abilities, Bensmaia's team, led by Benoit Delhaye and Erik Schluter, tested the finger's ability to distinguish different touch locations, different pressure levels, the direction and speed of surfaces moving across it and the identity of textures scanned across it. The robotic finger (with the help of machine learning algorithms) proved to be almost as good as a human at most of these sensory tasks. By combining such high-quality input with the algorithms and data Bensmaia and Tyler produced in the other study, researchers can begin building neuroprosthetics that approximate natural sensations of touch.
Without realistic, natural-feeling sensations, neuroprosthetics will never come close to achieving the dexterity of our native hands. To illustrate the importance of touch, Bensmaia referred to a piano. Playing the piano requires a delicate touch, and an accomplished pianist knows how softly or forcefully to strike the keys based on sensory signals from the fingertips. Without these signals, the sounds the piano would make would not be very musical.
"The idea is that if we can reproduce those signals exactly, the amputee won't have to think about it, he can just interact with objects naturally and automatically. Results from this study constitute a first step towards conveying finely graded information about contact pressure," Bensmaia said.
This article has been republished from materials provided by University of Chicago Medical Center. Note: material may have been edited for length and content. For further information, please contact the cited source.
Research paper: Dustin J. Tyler et al. The Neural Basis of Perceived Intensity in Natural and Artificial Touch. Science Translational Medicine, 2016; DOI: 10.1126/scitranslmed.aaf5187
Source: Case Western Reserve University & University of Chicago