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Thermoplastic polyurethane (TPU) is well known and specified in the medical industry for advanced medical and healthcare products, due to its high performance characteristics. Because of its excellent mechanical properties, durability, and resistance against oils and chemicals, TPU is very desirable for medical applications. Since TPU does not contain plasticizers, it also offers the medical industry an environmentally friendly replacement to PVC without sacrificing flexibility. Ether TPU types also meet the requirements of National Sanitation Foundation (NSF) Standard 61, U.S. Food and Drug Administration (FDA) 21 CFR for certain food contact applications, and USP Class VI classification.

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Hospital-acquired infections (HAIs) are a major area of concern for providers, payers, and patients alike. These infections play a significant role in the estimated 44,000 to 98,000 preventable health care-associated deaths in America each year. Plus, with new regulatory mandates for Medicare and Medicaid prohibiting federal payments to states for treatment of certain hospital-acquired conditions, there is increasing pressure on hospitals to find new and better solutions for prevention. Silicone elastomers and adhesives preloaded with anti-infective additives for medical devices provide an example of the type of materials innovation that can help advance health care in this present environment.
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Developing a medical device requires sensitivity to the delicate balance between usefulness, usability, desirability, and manufacturability. Every medical device must be useful (meet a need) and usable (easy to understand and manipulate properly) in order to gain regulatory approval. The elements of desirability (customer appeal) and manufacturability (efficient and reliable production processes) must also be woven into a medical device’s identity to satisfy business objectives.
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While physicians have largely been skeptical of the advantages of 3D technology, the findings of a new study by researchers at the Fraunhofer Institute for Telecommunications, Heinrich Hertz Institute (HHI), and Klinikum rechts der Isar university hospital in Munich, Germany, show that even experienced surgeons stand to benefit from new three-dimensional technologies.
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Before Curiosity came the Mars Exploration Rovers, Spirit and Opportunity. Before Spirit and Opportunity, came Pathfinder and Sojourner. Before Pathfinder and Sojourner, the Mars Global Surveyor, and before the Mars Global Surveyor, the Viking landers. Over the years, a host of Mars missions and programs have built on one another, spurring technology advancements that have led to the impressive collection of Mars information and images that we have today.
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With numerous developments in medical equipment and software, physicians no longer have to wait three to five days for lab results for accurate and timely blood analysis. Now, specifically designed compact laser flow cytometers (blood analyzers) can conveniently sit on a countertop in the physician’s office and analyze blood samples in fewer than 15 minutes. This technology breakthrough has become the new standard for providing on-site, real time feedback for critical blood analysis.
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Steven Conrad, MD, PhD, an emergency and critical care physician at Louisiana State University Health Science Center, New Orleans, is not your typical physician. When he’s not conducting rounds on patients or teaching residents in internal medicine, emergency medicine, or pediatrics, this biomedical engineer is using multiphysics simulation to optimize the design of artificial kidneys. Using COMSOL Multiphysics, Dr. Conrad simulates the hollow fibers that make up a dialyzer, using computer aided engineering (CAE) tools to advance the design of artificial kidneys. The simulations that he creates don’t just optimize current dialyzer designs—his simulations improve upon them by taking into account physical properties that weren’t considered in previous designs, and even allow for dialyzer improvements and optimizations on a patient by patient basis. By improving the functionality of artificial kidneys, he hopes to create artificial kidneys that will revolutionize the dialysis process.
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Will IT systems take the place of physician intermediaries?

Over the past decade, the power of physician preference has steadily diminished in the face of hospital and physician consolidation, continuing pricing pressures, and structural changes in payment systems brought about by US healthcare reform. While physicians continue to exert strong influence over health system purchasing decisions, they’re no longer the only game in town — and they’re facing increasingly stiff headwinds.
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Introduction A well-known legend has it that one of the greatest scientists and inventors of antiquity, Archimedes of Syracuse, stepped into a bath only to eject and propel himself naked throughout the city, yelling “Eureka!”, Greek for “I have found (it),” thus celebrating his discovery of how to measure the volume of irregular objects. Whether this indeed happened or not remains an open question, but a few important lessons can certainly be learned from this story. The first lesson is that good ideas could occur to us while we are taking a bath or a shower. The second lesson is that scientific or technological problems often seem to be difficult before a brilliantly simple solution is found. Does this second lesson hold true today? This is the question we will try to answer using an example of our own journey into discovery.
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Today’s medical device OEMs live in an age of abundance: both abundant options and abundant regulatory requirements. With so many options and so many restrictions, it can be very difficult to select the right contract manufacturer (CM) or electronics manufacturing services (EMS) provider. So many factors come into play. What are their testing services? Do they have clean room capabilities? How do our corporate cultures mix? Will this be a long-lasting or one-time relationship? Could they help me with miniaturization?
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Electrocardiogram (ECG or EKG) measurements typically involve time-consuming skin preparation, lead application, conductive gels, and even shaving of body hair. More recently, dry contact sensors have come into use in some sports and home health monitoring units, but these frequently experience contact problems, particularly in users with dry skin.
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NASA Technology

You wouldn’t find a big bowl of spaghetti served on the International Space Station (ISS). In microgravity, it would be a complete mess. There is, however, something like spaghetti on the ISS: the wires that connect electrodes for an electrocardiogram (EKG). They can be just as much of a nuisance for the crew members.
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Devices that support various functions of our bodies are being used increasingly. Today, they include cardiac pacemakers or hearing aids. Tomorrow, they may be contact lenses with automatically changing focal length or computer-controlled displays generating images directly in the eye. But, none of these devices will work if not coupled to an efficient and long-lasting power supply source. Researchers from the Institute of Physical Chemistry of the Polish Academy of Sciences (IPC PAS) in Warsaw say that the best solution seems to be miniaturized biofuel cells that consume substances naturally occurring in the human body or in its immediate surroundings.
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Today, a wide array of laser technologies support an amazingly diverse range of medical and biomedical applications. In fact, it would take a large volume to discuss all the current uses of lasers in medicine. This article selects just four representative examples, and shows how key developments in disparate laser technologies have enabled or enhanced each particular procedure.
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For a patient experiencing a brain aneurysm, every second in the operating room counts in quickly and successfully clipping the aneurysm to stop blood flow and prevent permanent damage. Today, thanks to a new patented 3D surgical rehearsal platform created by Surgical Theater LLC, neurosurgeons can plan, safely rehearse, and perform complex surgeries utilizing a patient’s own CT and MRI images/scans (DICOM) before entering the operating room.
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As cardiovascular disease has increased globally in recent decades, clinical demand for transesophageal echocardiography (TEE) has risen along with it. In TEE, a clinician inserts an ultrasound probe by mouth and guides it through the esophagus to capture images of the functioning heart. The procedure is commonly used by cardiac anesthesiologists to monitor patients undergoing surgery and in intensive care—as well as by imaging specialists to diagnose valvular heart disease.
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Researchers from the Institute of Bioengineering and Nanotechnology (IBN) in Singapore, in collaboration with IBM Research say that they have developed the firstever antimicrobial hydrogel that can break apart biofilms and destroy multidrug-resistant superbugs upon contact.
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The recent publication by the U.S. Food and Drug Administration (FDA) of Guidance for Industry Pyrogen and Endotoxins Testing: Questions and Answers, dated June of 2012, the Department of Health and Human Services updated the agency’s thinking regarding pyrogen and bacterial endotoxin testing requirements—and has (rightly so) prompted medical device manufacturers to take a new look at their endotoxin testing programs.
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The medical device industry is a highly competitive arena, and earning market recognition depends on the ability to keep innovating. To remain competitive, medical device companies are pushing products out the door to be the first to market while working on the next best thing.
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High-frequency pulsed electromagnetic stimulation (EMS) devices are more powerful and effective than ever before. These devices are finding applications in many areas, including as treatments for stress and depression, osteoporosis, and soft tissue injuries. Electromagnetic therapies stimulate tissue and cell mass to recuperate faster. The base technology for pulsed electromagnetic field (PEMF) is to input electrical energy into copper windings to create a series of electromagnetic waves. The waves offer a non-invasive anti-inflammatory and accelerated healing treatment option. In many cases, these devices have a large metal content and need to dissipate hundreds of watts of heat to effectively generate and deliver pulsed electromagnetic waves.
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Instrumentation Laboratory, Bedford, MA, is a worldwide manufacturer of in vitro diagnostic instruments, related reagents, and controls for use in hospitals and independent clinical laboratories. The company’s product lines include critical care systems, hemostasis systems, and information management systems.
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Facing multiple challenges including cost pressure, global competition, and evolving market de mands, medical device companies may consider engaging with a design and manufacturing services company to achieve important goals. The right manufacturing partner can provide a range of services, from design and engineering through distribution, helping the device company accelerate time to market, control costs, and push multiple products through the pipeline simultaneously—even with limited internal resources. However, the keys to success are careful selection of the manufacturing partner, a detailed plan for the collaboration process, and an understanding of specific benefits that a manufacturing partner can deliver— and how to maximize them.
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Dip molding may not be a term that readily comes to mind when surgeons begin complicated procedures. Yet without this sophisticated, highly controllable process, many medical devices used daily in hospitals could not meet stringent certification requirements.
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The Centers for Disease Control and Prevention reported that, in 2005, 133 million Americans suffered from at least one chronic disease. The magnitude of the effect of chronic diseases on society, both in terms of cost and quality of life, is often more than a statistic, affecting nearly all of us personally. The challenge to the healthcare industry is to find cost-effective ways to manage and treat chronic diseases and to deliver these solutions to all members of society by leveraging secure connected medical devices.
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Imperial College London, London, UK
http://www3.imperial.ac.uk

A new system to allow specialists to image difficult areas of the body, which could potentially improve the way procedures such as knee replacement surgery are carried out, is being developed by researchers at Imperial College London.
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