The fourth edition IEC/EN 60601-1-2 (4^th Edition) will become a mandatory standard covering safety for medical devices on December 31, 2018.^1,2 As with any new standard edition, there are changes that necessitate additional evaluations of the product beyond those required by the previous edition. Although emission and immunity tests for medical products are very similar to those applied to other product types, such as radio equipment, networking equipment and multimedia equipment, IEC 60601-1-2 requires that basic safety and essential performance of the medical device be maintained as opposed to the EMC compliance for other type of products. This is reflected in the title of 4th edition.

The value of neuromodulation devices is that they offer a “third option” in the treatment of neurological disorders — one that can provide drug-free relief from symptoms while doctors work to assess the underlying cause. According to the International Modulation Society (IMS), “conventional medicine often uses the biomedical model of disease management whereby the underlying cause is searched for and treated to relieve symptoms. Neuromodulation involves directly treating the nervous system itself, often through small implanted devices that target a specific area, to rebalance the activity of neural circuits and manage symptoms as varied as severe unremitting neuropathic pain to severe movement disorders such as Parkinson's disease, or urinary or fecal incontinence due to overactive bladder or pelvic floor injury.” IMS notes that another area of interest — and a goal of the National Institute of Neurological Disorders and Stroke — is the development of totally implantable systems for restoring motor control and sensory feedback for paralyzed individuals.

Artificial dental implants are the most reliable restoration option available for mature tooth loss. Despite their long potential lifespan, poor integration into the jaw and a slow healing process often create implant failure. Ensuring longevity requires adequate protection of the abutment-implant interface, protection achieved with surface functionalization by biocompatible coatings or advanced surface plasma treatments. The research summarized in this article examines the effect of using titanium nitride (TiN) and diamond-like carbon (DLC) thin-film coatings for implants.

Medical devices across the United States must not only keep pace with advances in technology but also with the increased use of harsh solvents and disinfectants. However, many materials commonly used in medical devices aren't able to withstand these new cleaning protocols. The nearly decade-long effort to combat healthcare-associated infections (HAIs) through increased disinfection has resulted in the degradation of their protective housings, causing cracking, crazing, discoloration, and premature failure of devices. Manufacturers must look to materials with higher levels of chemical resistance to strengthen device integrity and protect patient safety.

Contract manufacturing, or outsourcing, has typically been associated with a company using an offshore manufacturer and lower labor rates to produce their products at a lower cost than would be possible domestically. However, contract manufacturing also provides opportunities for companies looking to utilize the knowledge and experience of existing manufacturers, both domestic and foreign. This option allows companies to avoid large capital expenditures on machinery to build product, as well as the operating cost associated with running this machinery. While this can be an attractive option for companies operating in a wide array of industries, the medical equipment and device segment is one where substantial benefits can be realized.

When small and mid-sized medical device manufacturers envision a robot, many think of either huge industrial robots working in fenced-off areas in large factories or futuristic cyberbots mimicking human behavior. But between these two scenarios lies a new emerging reality: A class of robots dubbed collaborative robots — or simply cobots — are bridging the gap between fully manual assembly and fully automated manufacturing lines. This new technology is filling automation gaps for larger manufacturers that have processes that couldn't be cost-effectively automated in the past and is bringing the advantages of automation within reach for even small, specialty manufacturers.

The European Commission defines personalized medicine as, “a medical approach tailored to the patient or a group of patients for prevention, prediction and treatment . . . that moves away from the ‘one size fits all’ medical model.”

Plastics are incredibly versatile. There are thousands of types available to satisfy a myriad of medical applications. Yet, certain plastics present special challenges during the injection molding process that — if not properly addressed — can impact product quality and ultimately preclude medical devices from meeting exacting specifications. The medical device or component cannot — and must not — fail. To do otherwise increases the risk of recall, warranty claims, and litigation. In worst-case scenarios, failure may prove lethal.

Medical devices require sensors that are miniaturized, highly reliable and integrated, cost-effective, hermetic, and biocompatible. By combining thin film technology with traditional flex circuit manufacturing technologies, substrates with enhanced properties can be manufactured and assembled using standard surface-mount technology (SMT) processes.

Ensuring patient safety and quality of care has become an increasingly technology-reliant process for most healthcare providers. With 4,000 reported “retained surgery items” cases per year in the United States alone, hospitals have turned to automatic identification technology such as RFID to track medical devices and surgical instruments. Leading hospitals like the Mayo Clinic’s Saint Mary’s Hospital in Minnesota and Rush University Medical Center in Chicago have deployed RFID to track equipment, surgical instruments, and staff members.