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Which Way to Go: CE Mark or FDA Approval?

February 7, 2012 10:30 am | by Charlie Chi, Ph.D. | Comments

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.


Solving a Catheter Seal Integrity Challenge with Autocouple Devices

February 7, 2012 9:46 am | by Joe Pustka | Comments

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.

Usability and Wireless Technologies for Our Health: Improving the User Experience

January 6, 2012 11:36 am | by Donald Jones | Comments

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.


Translating Lean Principles to DfX Improvements

January 6, 2012 11:08 am | by Chris Munroe | Comments

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.

Addressing Flow Pulsation in Medical Device Pumps

January 6, 2012 6:39 am | by William Fleming | Dynaflo Pumps | Comments

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.

Roundtable Q & A: Machining

January 5, 2012 11:36 am | by Igor Lukash and Mike McCormick | Gateway Laser Services | Comments

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.

Applying Tech: Implantable Devices

January 5, 2012 11:21 am | Comments

How are you influencing implantable devices?

An Outside Perspective: Joining Forces to Bring New Technology to Market

January 5, 2012 10:53 am | by John Havard | Comments

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.


Connecting Solutions with Medical Devices

January 5, 2012 10:12 am | by Steve Sheehan | Smiths Connectors | Hypertac | Comments

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.

Accelerating Cancer Diagnosis with Customized Motion Control

January 5, 2012 9:58 am | by Scott Frederick | Comments

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.


Perspectives on Miniaturization

January 5, 2012 9:47 am | Comments

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?


Implantable Pulse Generators ‘Stimulate’ Medical Device Industry

January 4, 2012 11:46 am | by Chris Vaillancourt | Comments

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.


Inertial Measurement Sensing Technology Enables Surgical Precision

January 3, 2012 10:31 am | by Bob Scannell | Analog Devices, Inc. | Comments

Recent innovations in computer-assisted surgery are pushing the boundaries of modern medicine to new and exciting frontiers. As conventional surgical instrumentation continues to give way to advanced console- and camera-based systems, surgeons are able to operate on patients with exceptional precision.


Moving Defibrillation to the World at Large

January 3, 2012 9:59 am | by Martin Birkett | Comments

In an effort to reduce the time-to-defibrillation interval and improve cardiac arrest survival, health service providers have increasingly turned to a strategy of wider access to defibrillation to augment emergency medical services. In some countries this is being implemented by providing automated external defibrillators (AED) for use by police, first aid volunteers, and even members of the general public.

How to Build the ‘Right System’

January 3, 2012 6:29 am | by Uday Gurnani and Gene Frantz | Comments

In the field of electronics design, designing a “best in class” product with a competitive roadmap for the future is vital. For medical designs, in particular, it is especially important to use the highest quality components to ensure longevity, as these products go through long approval and use cycles. To accomplish this, system designers need to design the “right system.” But what does that mean?



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