By Jay Tourigny
These days, savvy medical device engineers, designers, and
manufacturers are partnering with suppliers to accelerate new products to
market. Whether it’s by providing advanced materials, upgraded solutions,
cleaning and regulatory training, or assisting with process validation, a
well-chosen supplier assists their customer every step of the way.
Advanced cleaning solutions have been developed to help
designers speed new product development. There are low-maintenance cleaning fluids
available that are safe for, and compatible with, a wide variety of materials. These
solvent-based cleaning fluids are hostile to pyrogenic growth, easy to use (and
reuse), clean without residue, and eliminate ongoing process and regulatory
hassles associated with aqueous cleaners.
Efficient lubricant coatings are also available to
designers. These medical grade lubricant coatings are ISO 10993 tested and will
not creep or otherwise migrate. They provide easy, consistent application,
which improves the look and feel of the finished device. The lubricant also
works to overcome assembly problems associated with stacked tolerances by
significantly reducing actuation forces of a finished device to heighten
functionality and usability.
At MicroCare Medical, we work with medical device designers and
manufacturing engineers to ensure they have an efficient manufacturing process—that
they’re using the right cleaning and lubricant solutions in the right way, and
that they’re consistently producing a high-quality product. Our in-house R&D
laboratory and expert field service technicians allow us to work directly with individual
customers to define a cleaning and/or lubrication process that are appropriate
for them and specific to their products. Customers can learn step-by-step how
to clean or coat their products in a process that is properly scaled to their
current and future needs. This process is repeatable, improves productivity and
efficiency in the cleanroom, and can help save on labor, carrying, and material
costs. In the end, the designer saves time and money in getting his or her
product to market and has an established solution to use with future projects.
In addition to improving the product development processes, a
knowledgeable supplier can also assist early on in compliance with appropriate certification
standards. Resolving such details on the front-end saves the designer time on
testing procedures on the back-end. Materials testing and certification
processes are exhaustive and can take anywhere from months to years to
complete. The best supplier knows that testing and certifying their products to
industry standards in advance provides the end user with confidence that the
product is suitable for their specialized needs.
Designers, engineers, and manufacturers are benefiting by
partnering with their suppliers. As the trends [highlighted] become
increasingly popular, designers will continue to experience time- and
cost-efficient solutions that meet their needs.
Jay Tourigny
is vice president of operations at MicroCare
Medical, a supplier of advanced cleaners, carrier additives, coatings, and
lubricants for medical device designers and manufacturers throughout North
America and Western Europe.
Stem cells are “non-specialized” cells that have the potential to form into other types of specific cells, such as blood, muscles or nerves. They are unlike "differentiated" cells which have already become whatever organ or structure they are in the body. Stem cells are present throughout our body, but more abundant in a fetus.
Medical researchers and scientists believe that stem cell therapy will, in the near future, advance medicine dramatically and change the course of disease treatment. This is because stem cells have the ability to grow into any kind of cell and, if transplanted into the body, will relocate to the damaged tissue, replacing it. For example, neural cells in the spinal cord, brain, optic nerves, or other parts of the central nervous system that have been injured can be replaced by injected stem cells. Various stem cell therapies are already practiced, a popular one being bone marrow transplants that are used to treat leukemia. In theory and in fact, lifeless cells anywhere in the body, no matter what the cause of the disease or injury, can be replaced with vigorous new cells because of the remarkable plasticity of stem cells. Biomed companies predict that with all of the research activity in stem cell therapy currently being directed toward the technology, a wider range of disease types including cancer, diabetes, spinal cord injury, and even multiple sclerosis will be effectively treated in the future. Recently announced trials are now underway to study both safety and efficacy of autologous stem cell transplantation in MS patients because of promising early results from previous trials.
History
Research into stem cells grew out of the findings of two Canadian researchers, Dr’s James Till and Ernest McCulloch at the University of Toronto in 1961. They were the first to publish their experimental results into the existence of stem cells in a scientific journal. Till and McCulloch documented the way in which embryonic stem cells differentiate themselves to become mature cell tissue. Their discovery opened the door for others to develop the first medical use of stem cells in bone marrow transplantation for leukemia. Over the next 50 years their early work has led to our current state of medical practice where modern science believes that new treatments for chronic diseases including MS, diabetes, spinal cord injuries and many more disease conditions are just around the corner.
There are a number of sources of stem cells, namely, adult cells generally extracted from bone marrow, cord cells, extracted during pregnancy and cryogenically stored, and embryonic cells, extracted from an embryo before the cells start to differentiate. As to source and method of acquiring stem cells, harvesting autologous adult cells entails the least risk and controversy.
Autologous stem cells are obtained from the patient’s own body; and since they are the patient’s own, autologous cells are better than both cord and embryonic sources as they perfectly match the patient’s own DNA, meaning that they will never be rejected by the patient’s immune system. Autologous transplantation is now happening therapeutically at several major sites world-wide and more studies on both safety and efficacy are finally being announced. With so many unrealized expectations of stem cell therapy, results to date have been both significant and hopeful, if taking longer than anticipated.
What’s been the Holdup?
Up until recently, there have been intense ethical debates about stem cells and even the studies that researchers have been allowed to do. This is because research methodology was primarily concerned with embryonic stem cells, which until recently required an aborted fetus as a source of stem cells. The topic became very much a moral dilemma and research was held up for many years in the US and Canada while political debates turned into restrictive legislation. Other countries were not as inflexible and many important research studies have been taking place elsewhere. Thankfully embryonic stem cells no longer have to be used as much more advanced and preferred methods have superseded the older technologies. While the length of time that promising research has been on hold has led many to wonder if stem cell therapy will ever be a reality for many disease types, the disputes have led to a number of important improvements in the medical technology that in the end, have satisfied both sides of the ethical issue.
CCSVI Clinic
CCSVI Clinic has been on the leading edge of MS treatment for the past several years. We are the only group facilitating the treatment of MS patients requiring a 10-day patient aftercare protocol following neck venous angioplasty that includes daily ultrasonography and other significant therapeutic features for the period including follow-up surgeries if indicated. There is a strict safety protocol, the results of which are the subject of an approved IRB study. The goal is to derive best practice standards from the data. With the addition of ASC transplantation, our research group has now preparing application for member status in International Cellular Medicine Society (ICMS), the globally-active non-profit organization dedicated to the improvement of cell-based medical therapies through education of physicians and researchers, patient safety, and creating universal standards. For more information please visit http://www.neurosurgeonindia.org/
Posted by: Leo Voisey at 3/22/2012 1:01 AM
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