This article presents innovative material solutions supporting multi-use medical device applications. Respective materials support a broad range of application requirements, like transparency, property retention after autoclaving, colorability, and chemical resistance against commonly used disinfectants/cleaning agents.
With cardiovascular diseases as the leading cause of death worldwide, device manufacturers are under immense pressure to produce products to address these health concerns. However, prior to launching such devices, the technologies need to be properly tested to ensure success. This article looks at setting up a system to simulate cardiac flow for testing these medical devices.
Piezoelectric actuation is the foundation for a myriad of mission-critical high-technology applications, from semiconductor manufacturing to genomic sequencing and medical devices. Known for nanometer precisions, piezoelectric principles are proving highly adaptable to new configurations and modalities. Recently-developed mechanisms built on a variety of novel applications of piezoelectric technology have burst through the former travel limitations familiar from classical nanopositioning mechanisms. But like those time-tested mechanisms, those built on these newer principles offer high axial force, exceptional speeds, compactness, fieldlessness, and stable position-hold without dither. These long-travel piezomotors offer valuable, proven solutions for engineers grappling with tough technical and economic needs.
Silicone’s inability to expand or stretch without mechanical or chemical assistance coupled with its tacky surface makes assembly with rigid parts difficult. Connecting flexible silicone tubing to barbed fittings or mating molded silicone parts with complex geometries can be frustrating, messy, and time-consuming. As the use of silicone in the medical device industry continues to grow, so does the need for innovative methods that allow design engineers to design the most effective medical devices in the most efficient way possible.
Biosensors are critical components of diagnostic devices. They are tiny, integrated circuit chips that transmit readings from within the body to an external component that displays data for physicians and patients. Biosensors have many applications including important roles in continuous glucose monitors, sensors that monitor cell health, and magnetic sensors associated with microlabels and microfluidic cartridges, just to name a few. A big obstacle facing biosensors that are implanted into the body is longevity.
The adhesive-based medical device sector, relatively inactive for many decades, is seeing a surge of innovation. The sector continues to expand in the U.S., Europe, and Asia, with global sales expected to exceed $2 billion annually by 2015. Clinicians today have a broader selection of advanced medical adhesives to choose from than ever before.
On September 16, 2011, the America Invents Act (the “Act”) was signed into law, marking arguably the most significant modification to the U.S. patent system since 1952. Although the default effective date is September 16, 2012, medical device companies should start making adjustments to their patent strategies now to better protect their investments in the future. In this article, three main modifications are discussed: the systematic change to first-to-file system; a broadening of applicable prior art; and additional patent office proceedings to challenge patentability.
Demand for personalized implants is increasing, since younger patients and longer life spans mean that more patients are receiving their first joint replacements earlier in their lifetime. When implant materials wear out, patients may need second or even third implants, called revision implants. Thermoplastic Products Corporation (TPC) uses Sensable’s Freeform to deliver them in a novel way—restoring patients to well being, while allowing their surgeon to experience computer-based surgical planning as well.
Design engineers for medical diagnostic equipment are acutely aware of the dramatic growth and change in the healthcare industry. Medical OEMs and contract manufacturers are looking for suppliers who can help them meet new industry and federal regulations, achieve the highest quality products, support new care approaches (including patient-controlled monitoring and treatment), and drive down manufacturing costs.
Start-ups and large device makers alike have difficulty bringing new products to market without greater predictability and transparency from the FDA. According to an online survey funded by the medical technology industry’s Institute for Health Technology Studies, most medical device companies today are seeking regulatory approval and launching their products overseas first. This article will look at whether this is a good business decision for all device manufacturers.
Finding the best connections between parts to be leak tested and leak detection equipment is an inherent challenge to leak test system designs. Flat pad surface seals have a potential to mask leakage by holding parts together with leaking seams. Autocouplers that seal catheters at the distal end are a good example of best practice sealing devices for several reasons.
The healthcare industry is transitioning from a sick care system to a health improvement system, and mobile health (mHealth) services are an important factor. Equipped with new devices and services, consumers are taking charge of their own health by seeking solutions that allow them to track their fitness, and manage chronic disease therapy and overall wellness.
Cost pressures abound for just about every industry, but few experience the dual pressure to reduce cost without sacrificing quality at the level found in the medical industry. A true benefit of a strong Lean manufacturing philosophy is that it reduces cost by eliminating inefficiency, and, as a byproduct, contributes to improved quality.
Diaphragm-type vacuum pumps are often ideally suited for a variety of medical devices. Unfortunately, flow pulsation can offer a challenge to developers, specifically in flow measurement and control. This article will focus on some simple techniques for reliable and repeatable measurement of flow and pressure, particularly where the pumped media is air or an otherwise compressible gas.
In this month’s “Roundtable Q&A,” industry leaders provide insights on machining topics, including benefits of machining, use of lasers, and areas of growth for machined components.