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.
How are you influencing implantable devices?
Medical device manufacturers that attempt to handle too many tasks in the product development process without the sufficient level of competency are simply setting themselves up for failure. It is vital for them to maintain a strong expertise in those core competencies and look outside for strategic partners who can aid them. This article examines that for the product design process.
As the rising cost of healthcare in the U.S. continues to cartwheel out of control, the medical community is demanding a much healthier ROI from the technology solutions that it deploys across multiple disciplines. The interconnect solutions arena is a case in point, as higher performance and greater dependability have become the industry’s catch words.
The Challenge: A large OEM needed a consistent motion controller for a 84-slide capacity IHC benchtop autostain machine. The Solution: A customized, four-axis 1/2-stack motion controller was selected that ran inside the OEM customer’s existing PC, reducing cost for the manufacturer and increasing lab space for the end-user.
In the effort to make medical devices smaller, what has been the most challenging obstacle you have faced and how were you able to resolve this problem?
In recent years, there has been great excitement about the use of neuromodulation to treat a wide array of medical conditions and diseases. The technology uses electrical signals to stimulate or block different nerve impulses in the body and is adapted from technology used in cardiac rhythm management. Advanced ceramic materials are playing an important role in the technology and are poised to play an even greater one as these medical devices flood onto the market to treat an increasing number of ailments.