Every Breath You Take

Efficient oxygen consumption is critical to all life. Cosmed USA Inc. is a research grade laboratory instrument manufacturer focused on devices for cardio-pulmonary testing, metabolic and body composition testing used for research and diagnostic purposes; measuring oxygen utilization by the human body. This runs the full gamut from the clinical level to Olympic athletes to patients on ventilators in ICUs.

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Claudio Bellini, Executive VP Business Development, says that COSMED is recognized for innovation of instruments and the extreme accuracy of its O2 and CO2 analyzers, as well as several patents on proprietary technologies for metabolic and body composition measurement.

 “We are in the research market, so both the clinical and sports diagnostic applications are fairly equal. We have two different business divisions, one focused on sports with applications for sports science and teaching as well as professional sport performance. The other division focuses on medical and clinical supplying out instruments to physicians, hospitals, clinics with the specialty areas of cardiology and pulmonology,” Bellini says.

In the field of measuring oxygen consumption, COSMED offers a wearable device that can be used in both a sports and clinical arena called the K4b2. The K4b2 has become the bestselling equipment for in-the-field measurement of oxygen consumption among universities, sport science and research centers. A second device for measurement of body composition is the Bod-Pod, which is an air displacement technique for fat and fat-free mass analysis with lung volumes measurement.

Bellini says that they offer several configurations of each of these systems. “The latest include wearable versions that we expect to launch at the beginning of the year, which will incorporate several new technologies: inclinometer, gyroscope and accelerometers, that can be used in the field for sports or in physical therapy for those recovering from injury or stroke to monitor motor recovery levels.”

The biggest challenge with these types of devices is the time to market. It takes a lot of time to research, develop and test, plus added time for medical use product experimentation, validation and proof of instrument accuracy for the regulatory agencies. To meet its challenge, Cosmed operates using multiple R&D teams with small, focused and dedicated groups.

             “We believe compatibility drives usage. This is why we use focus groups. We can stay centered on our specific technology and yet remain open and relevant to our users,” Bellini concludes.      

            Talk To Me

            When it comes to interoperability, all medical devices need to communicate for accurate data tracking and storage. However, different devices, manufacturers and the age of those in use simultaneously, affect smooth communication. While most large medical facilities have been addressing this need for years, it has been a challenge.“There is no commonality. They were dependent on the manufacturer having a device that would send data seamlessly,” says Dave Dyell, founder and CEO of iSirona. “Our DeviceConX software installed on a server is a simple solution that normalizes data so it is consistent across the platforms. It can authenticate data prior to delivering it to the EMR.”

           

           This was not an easy challenge to address. There are many different devices that need to be integrated in a total medical data communication system. Some are extremely old. Some are new and ready to send data. The bulk are somewhere in-between. “The latest are ready for Wi-Fi and others are not, but ways to achieve transmission are possible. Some are not even compatible for any type of data transfer integration – you can’t even plug into them,” Dyell says. “There was obviously a need for a communication bridge--something that could enable integration regardless of how old or new the product was. That’s exactly what we do. We sit in-between and we make it possible for everything to talk to each other in a seamless way. Different manufacturers use different communication protocols that they design just for their devices. Nothing is universal in the medical device world.”

“We know how to talk to all devices, even those that are inoperable for data transmission on modern networks. We can normalize and standardize them. We have a very refined implementation process. This is very ‘dirty’ IT. If you would try to hand our technology to someone and say, here’s the manual figure it out, it would not work. There are just too many moving parts; too much variability. So we decided at the onset that we were going to establish a series of best practices, come up with an implementation methodology that would see a customer through all of it and then of course, implement the technology, turn it online, test it and get it into use.”

Once done, then iSirona creates a roadmap for the client so they can see all the data available to them and decide what they actually need, because much may be redundant. “Sometimes software updates or new add-ons are available from vendors. But until we go through each device, the customer has no way of making an informed decision. We find out what they need-- what data they need, and we work out the best solution that fits their needs,” Dyell says.

A Turn of the Head

Surgical procedures involving the spine have typically been fusion technology. However, the benefits of non-fusion surgery are clear: maintenance of motion, faster healing and reducing the deterioration rate of the areas adjacent to the initial surgery. A new non-fusion option is the recently FDA approved cervical disc replacement technology from LDR Spine.

             “The Mobi-C® Cervical Disc is our number one product outside of the United States and the focus of our non-fusion efforts; however we actually have two exclusive technology platforms. One is Mobi, which is the basis of Mobi-C and also Mobidisc, our lumbar disc replacement device that is available in markets outside of the United States. The other platform technology is our VertiBRIDGE®  plating technology which is applied to a family of interbody cages for use in both the lumbar and cervical spine fusion procedures,” Joe Ross, EVP of Global Marketing, says.

He explains why disc replacement is a critical step forward in spinal treatment. “If you fuse a segment of the spine, or multiple segments of the spine, you are transferring motion and forces to the remaining unfused levels which must take up the motion that has been lost by fusion surgery. We believe that a Mobi-C procedure can be a better way to alleviate a patient’s pain and treat their symptoms, while maintaining more natural spinal motion and simultaneously reducing stresses that might cause degeneration at the adjacent levels of the cervical spine. We feel that this is particularly important in level two spinal surgery where more than one segment of the spine is fused, as multilevel fusions may cause more aggressive adjacent segment degeneration which could result in future surgeries.”

Mobi-C acts like a normal human cervical disc, providing motion in flexion, extension, lateral bending and rotation. Mobi-C has a mobile-bearing core made from ultra-high molecular weight polyethylene (UHMWPE) core that rests on the inferior endplate of the device and can provide limited translation both front to back and side to side, accommodating the instantaneous axis of rotation (IAR) of the spine segment.

This mobile core design is the key difference when compared to the ball and socket type design of other disc replacement products. “We believe that it allows for a more natural motion. Secondly, no keels or screws are used to fix Mobi-C to the vertebral bodies above and below the device. In this way it is very bone sparing. Finally, because of the geometry of the device and the short and long-term fixation features, Mobi-C provides a simplified surgical technique for implantation as compared to other cervical disc replacement devices.

 “Mobi-C is the only cervical disc replacement device that is FDA approved for use in both one-level and two-level procedures. We are currently supporting surgeon-led training labs on the proper use of the device and we are very happy with the early interest in and acceptance of Mobi-C by the spine medical community,” Ross concludes.

            Deadly Bug

            Fighting HAIs (Hospital Acquired Infections) is an ongoing challenge, and something that Sciessent is very proactive about. Jeff Trogolo, PhD, CTO says that they have developed a delivery mechanism whereby ionic silver or other antimicrobial is released to the surface of whatever material their powder is mixed into; solid catheter tubing or a coating put onto a medical device, textile or carbon filter. “The silver is delivered in a very gradual way so the antimicrobial action lasts a long time.”

                “Whenever a device is in contact with bodily fluids and blood, where there are abundant nutrients for bacterial growth and proteins that can bind the silver, you need to have enough silver to make sure the antimicrobial action continues working, but not so much at any one time that the silver is used up too quickly,” Trogolo says.

            “Most silver coating strategies deliver silver based on dissolution; little oxide particles or silver metal particles are put over a metal coating where dissolution  will happen as it happens. There is no way to control it. You can’t change the way something dissolves in a given chemistry,” he explains. “What’s unique about our Agion® technology is that it’s an ion exchange process. For that silver to come out there needs to be another ion that comes in and takes its place. Typically in a blood contact application, that’s going to be sodium or potassium that is present in blood or sweat or on the skin. If you don’t have any of these fluids present and it’s a dry surface, this exchange is not going to take place. Therefore, this is a ‘smart’ material. It only turns on and delivers the silver when the environment is right for bacterial growth.”

            This material is added to the device material during the extrusion or molding process. It is not a coating. It is part of the device itself. It does not add any weight or dimensional difference to the final device or affect the strength or quality of the material. It simply makes the device antimicrobial. Different levels of antimicrobial are used based on the process, material and product, and length of use.

            “Every polymer is slightly different, so we have studied and experimented with many of  them and new ones are continually coming up. We need to understand each material and process; what loadings work best, and how to work with different processes. We are continually working with different applications.”

            Bringing Home the Bacon

            Using animal tissue in humans has been done in static applications, but until now it has not been an alternative for mobile tissue. The availability of allografts, or donor tissue from humans, is relatively limited and there are always concerns about the quality. The age of the donor has much to do with quality as do potential disease issues. It varies tremendously.

            Kevin R. Stone, MD is a busy physician in private practice at the Stone Clinic in San Francisco. He is also the founder of Aperion biologics and invented the Z-Lig® process which strips the antigens from 6 month old pig tissue so it can be used in humans to repair joint ligament damage. “When replacing a heart valve, you fix the tissue with glutaraldehyde to prevent rejection. The aldehyde treatment creates a stiff, cross-linked, durable collagen prosthesis. However, the treatment also prevents tissue in-growth. Ligaments require flexibility and remodeling to last. To minimize rejection, the antigens must be stripped from the tissue without damaging the biomechanical or regenerative properties of the tissues. We designed a process whereby an enzyme cleaves away the key carbohydrates that are responsible for rejection when animal tissue is transplanted into people,” he says.

            One primary carbohydrate, the Galactosyl (Gal) epitope, is responsible for 95% of the rejection phenomenon. The process that Stone designed uses a galactosidase, which is a specific enzyme that cleaves that Gal epitope, essentially “humanizing” pig tissue so it can be used in people. The biggest challenge Stone initially faced was that the enzyme had only been used in a solution. It had never been used in solid tissues. “We had to demonstrate that we could get the enzyme all the way through solid tissues to cleave the epitopes and make the product work in humans. That took almost seven years from inception through first primate trials to the first human trials.”

            The first product developed is designed to replace the ACL in the knee. “A knee injury in athletes is reported about 250,000 times a year just in the US, with over 800,000 reconstruction surgeries reported worldwide. The patients are typically treated by harvesting a portion of either their own patellar tendon, which injures the front of the knee, or their hamstrings, weakening the hamstrings permanently. That’s robbing Peter to pay Paul,” Stone says. “Allografts are an option in the US but not widely around the world. The quality of allografts varies widely.”

            A human clinical trial was conducted under FDA guidance as a pilot study at The Stone Clinic in 2002. The results of that study were reviewed by the FDA and accepted for moving forward to a wide clinical trial in the United States as a ligament device. This clinical trial will be conducted in ten clinical sites using 326 patients as a prospective, double-blinded trial. The date hasn’t been set yet but Stone expects it to be in 2014.

            Stone says, “Once accepted for ligaments, the process will then be applied to meniscus cartilage, articulate cartilage, heart valves, soft tissue grafts—basically anywhere tissue is needed. You can never say anything will be 100% effective due to differences in patients; however, using a product that is 100% the same off the shelf rather than guessing with donor tissue or actually harvesting from the patient’s own tissue will obviously reduce the surgery and the rehabilitation time, plus this tissue is far less expensive than human tissue.”

                                     

            A Boon To Biologicals

            Advances in biological and other injectable treatments have given rise to the quandary of how to effectively administer these large, time related dosages. West Pharmaceutical Services, Inc. is a global leader in innovative solutions for injectable drug administration. Paul Norton, Vice President of Self-Injection Systems, says that for the last five years he has been working with a group in Israel that has developed a technology for large-dose injections. “Different drugs have different needs, such as viscosity and how quickly it needs to be injected, and we are able to adapt our platform very easily to a wide range of needs,” Norton explains.

            “The SmartDose technology platform uses a Daikyo Crystal Zenith® polymer cartridge. The polymer material eliminates the problem of glass breakage and other issues that may be associated with a glass prefillable container, such as tungsten and extractables. It is a very clean, inert cartridge that provides a stable containment system for biological drugs. The dosage is determined by the type of product in the delivery system. There is no adjustment needed by the patient. The drug is packaged by the pharmaceutical company into the cartridge.

 “We engaged in detailed human factors engineering to make sure that all the sequences and all the visual and audible indicators would be intuitive so patients would be comfortable using the device properly,” he says, adding, “Years of engineering design and re-design have gone into creating a device that can handle a wide range of environments and a wide range of products and adapt to the specific needs of a particular pharmaceutical product. We were very pleased with our preliminary work and the first-in-human study was a validation that our technology is designed properly.”

            We’ll Be Back

            When this year wraps up, it will be interesting to check back with these med-tech companies and many of the others we will cover in the months ahead. Will everyone make it to the goals they set? Perhaps they will exceed them and even come up with something that will steal the spotlight away from their current star? One can only hope. That’s what makes this industry so exciting. It never stands still.

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