LEAD STORIES

Implantable Pulley Could Mechanize Human Hands

By testing a new robotic system on cadavers, Oregon State University (OSU) researchers have successfully demonstrated the efficacy of an implantable pulley system for restoring function to hands that have suffered nerve damage. The novel device may also be useful for other joints in the body.

INDUSTRY PERSPECTIVES

  • What To Expect From The Upcoming ISO 13485 Revisions, Part 1
    What To Expect From The Upcoming ISO 13485 Revisions, Part 1

    Earlier this month, 50 delegates from ISO Technical Committee 210 Working Group 1 met in Stockholm to review comments submitted by industry on the draft international standard of ISO 13485, the international quality standard for medical devices. In this three-part article series, we will look at the anticipated changes to ISO 13485, to help you prepare for its eventual publication and enforcement. This installment will explore the primary motivations behind the revisions and discuss what’s new in sections 4 through 6.

  • Demystifying 510(k) Substantial Equivalence — Part 2
    Demystifying 510(k) Substantial Equivalence — Part 2

    Part 1 of this article sought to provide a better understanding of the concept of substantial equivalence in premarket notifications, more commonly known as 510(k)’s, using easy-to-understand metaphors. We also looked at recently issued CDRH draft guidance concerning different technological characteristics of a 510(k) submission. In Part 2, we move on to another piece of recent CDRH guidance, this one dealing with the controversial topic of split predicates.

  • Designing For Humans, From Start To Finish
    Designing For Humans, From Start To Finish

    Human-centric design (HCD) can help medical device manufacturers reduce risks and development costs and maximize market acceptance — if it is engaged at the right points in the development cycle. Purposeful use of HCD principals early in the design process can make development more efficient and cost effective, and ensure that the end product is not only safe but also desirable for patients and providers. This article will explore best practices in HCD across the development cycle, from ideation to market launch.

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ARTICLES

  • The Role Of 3D Scanning In Orthopedic Development And Manufacturing
    The Role Of 3D Scanning In Orthopedic Development And Manufacturing

    To steal from old jokes, what do an orthopedist and a construction worker have in common? The answer is both use plaster. Fortunately, digital technology has helped orthopedics to make great strides and to move away from using plaster for casts and molds. In just a few years, plaster will be as rarely used by doctors as pencil and ruler designs by engineers. Plaster will be back to the construction sites, where it belongs.

Best Practices In Outsourcing Clinical Trials For Medical Device Companies

Today the U.S. is home to more than 6,000 medical device companies, and approximately 73 percent of those have fewer than 20 employees. The convergence of industry growth and development of medical devices by small companies necessitates the use of external resources to conduct product development functions, including clinical trials. 

The 10 Commandments Of Product Development

Product design and development is a journey with unexpected twists and turns. People often ask, “How can I make my design process more predictable?” In our firm’s 25 years of experience designing medical devices, we’ve found that you can’t always predict all the twists, but there are things that can be done to increase the certainty in a successful outcome. This article describes our top 10 list of important considerations.

FDA Regulation Of Mobile Medical Apps

The past decade has witnessed rapid advancement in telecommunication and computer technologies. The smartphone is one result of that technological development and has been adopted by hundreds of millions of people worldwide. Innovators in the medical device industry quickly recognized the potential to use smartphones to expand the capabilities of healthcare professionals via mobile medical applications (“apps”) resident on these devices. These apps raise unique challenges for regulation by the Food and Drug Administration (FDA). By Bruce A. MacFarlane, PhD

Certification: Is It Worth The Hassle?

In the life sciences and other regulated industries, obtaining certification in a range of international standards has become a necessity for companies hoping to access and compete in today’s global marketplace. Whether your organization is a laboratory, medical device manufacturer, or automobile maker, becoming certified by an impartial third-party accreditation body assures potential customers that you value quality and your products conform to the highest regulatory standards. This assurance can lead to tremendous marketing and business advantages. But certification can be a long and trying process. By Lisa Weeks, Marketing Communications, MasterControl

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FROM THE EDITOR

  • The DOJ & cGMP Enforcement: What The Medtech Industry Can Learn From Pharma’s Folly
    The DOJ & cGMP Enforcement: What The Medtech Industry Can Learn From Pharma’s Folly

    What would you say if I told you that failure to comply with FDA Current Good Manufacturing Practices (cGMPs) could soon cost your company millions — as much as $505 million, or even $750 million? Those are the amounts paid by pharmaceutical manufacturers in recent years to settle allegations of manufacturing adulterated product that eventually ended up in Medicaid and other government healthcare programs. If you think these examples don’t apply to you because you’re a medical device manufacturer, then think again.

  • Graphene Biosensors — The Next Frontier In Medical Diagnostics?
    Graphene Biosensors — The Next Frontier In Medical Diagnostics?

    Graphene — the übermaterial that is 1 million times thinner than paper, 100 times stronger than steel, and the world’s best conductor of both electricity and heat — has become one of the hottest areas of materials science R&D over the past decade. Much of the graphene research has focused on two main objectives: 1) finding a way to better manufacture the substance, and 2) identifying the best applications for it. Recently, I was introduced to a company that claims to be close to achieving both goals, and its work could have considerable influence on how graphene is used in healthcare, particularly in the area of in vitro diagnostics.

  • Window Through The Skin: The Development Of A Pocket-Sized Imaging Device
    Window Through The Skin: The Development Of A Pocket-Sized Imaging Device

    I have a confession to make: I am more than a little afraid of needles. When it comes to getting blood drawn, an IV inserted, or pretty much any other procedure that involves shoving one of those pointy little devils through my skin and into my blood vessels, I am an abject coward. So you can imagine my enthusiasm when the folks at Analogic introduced me to their new Sonic Window ultrasound device, which was recently cleared by FDA for use in peripheral IV access procedures. Read on to learn how this novel approach to handheld ultrasound imaging made its way from the university to the clinic.

More From The Editor

PRODUCT SHOWCASE

Multispectral Photodiodes: PixelSensor

Multispectral Photodiodes: PixelSensor

Multispectral photodiodes by PIXELTEQ benefit from a micro-patterned optical filter technology that shrinks spectral sensors enough to pack up to eight into a 9mm square footprint. They’re ideal for applications in color meters and monitors, portable optical sensors, biomedical instrumentation, industrial sorting and sensing, and in OEM multispectral devices.

Optical Thickness Gauge: 157 Series

Optical Thickness Gauge: 157 Series

The Model 157 optical thickness gauge uses proven optical interferometer technology to measure the absolute thickness of specialty plastic films, medical membranes, and ophthalmic products.

UV Curing Light Sources

UV Curing Light Sources

Hamamatsu offers UV-LEDs for curing adhesives in stents, catheters, needles, hearing aids, and other therapeutic medical devices. Their high output power makes them especially ideal for UV curing, and their low power consumption makes them an energy saving and environmentally friendly light source.

Silicone Overmolds for High-Heat Applications

Silicone Overmolds for High-Heat Applications

Fischer Connectors has been providing custom silicone overmolds, custom geometries, and low friction coatings for silicone cable assemblies to medical device manufactures for over 10 years now. Silicone cable assemblies need to be able to withstand steam autoclaving, high heat, and resistance to disinfectants and sterliant solutions, and Fischer Connectors designs and manufactures overmolds for silicon cable assemblies that can withstand the same thing.

Single and Quadrant Photodiodes for 1064nm

Single and Quadrant Photodiodes for 1064nm

First Sensor’s line of Single and Quadrant Photodiodes (Series Q) optimized for 1064 nm feature fast rise times, highest quantum efficiency of any silicon photodiode at 1064nm (> 35%) as well as low dark current and low capacitance making these photodiodes well suited for laser range finding, laser based target designation or any application detecting YAG lasers or similar NIR radiation sources. The components are available as single detectors, quadrant detectors or surface arrays. Quadrant photodiodes are discrete components that usually feature four optically active areas separated by a small gap. These photodiodes are used in many applications for detecting the position of laser beams, collimators and other applications to facilitate adjustment.

Miniature Linear Positioner/Stage: MX80M

Miniature Linear Positioner/Stage: MX80M

The MX80M miniature linear stage is a manually driven positioner with precision cross roller bearings, optional clean room preparation, an optional low ESD coating, dowel holes in the top and base, and positive position lock.

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UPCOMING TRAINING COURSES

Medical Device Supplier Management Programs: Building Compliant Systems

October 7, 2014
1pm-2:30pm EDT, Online Training

Got a Date with the FDA? Conducting Successful Meetings

October 20, 2014
1pm-2:30pm EDT, Online Training

Root Cause Analysis for GCP – A Risk Action Plan Guide

October 21, 2014
1pm-3pm EDT, Online Training

Process Validation: Ensuring Compliance With Multiple Standards

November 4, 2014
1pm-2:30pm EST, Online Training
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FEATURED SUPPLIERS

Carclo Technical Plastics

Carclo Technical Plastics

Carclo Technical Plastics is an international engineering based company led by engineers coupling industry standards with a Six Sigma culture.  We specialize in injection molding and contract manufacturing services for medical devices, medical equipment, optics, and electronics applications.