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St. Jude Medical’s New Ablation Catheter Receives FDA Approval

Catheter ablation, a clinical technique for treating cardiac arrhythmias, has a brand new tool at its disposal. The Food and Drug Administration (FDA) recently approved St. Jude Medical’s FlexAbility ablation catheter for clinical use, and developers hope the new design will assist electrophysiology (EP) specialists with conducting safer procedures in more challenging cases.

FDA Releases cGMP Draft Guidance For Combination Products
The U.S. Food and Drug Administration recently issued draft guidance outlining current good manufacturing practice (cGMP) requirements for combination products. The draft guidance intends to clarify cGMP requirements for combination products and provides hypothetical scenarios illustrating compliance considerations for certain types of combination products.
Stryker To Focus On Acquisitions, Disruption
Stryker Corporation continues to consider relevant acquisitions that disrupt the market, according to remarks recently made by the company’s top executive. The comments came in the midst of speculation that Stryker will soon acquire fellow orthopedic device maker Smith & Nephew.
Robotic Hands Develop Better Motor Skills
Researchers from the German Primate Center have recently developed a way to predict hand movements by measuring neuronal activity. Studies performed with a subfamily of primates called macaques have identified the neural activity involved in many hand grasping movements, which is knowledge that could be applied to controlling robotic prostheses.

Success in today’s medical device industry requires innovative ways of thinking about traditional and evolving problems. To this end, Med Device Online is pleased to bring you Med Device Insights, a new digital publication that imparts fresh perspectives and strategies from your peers and other thought leaders in the space. Our first issue includes original articles about:

A revolutionary new approach to rapid prototyping
The unintended consequences of new payment paradigms
Factors to consider when developing your India strategy
Using Internet-of-Things-style protocols for connected devices
Steps to identify the right clinical outsourcing partner
A company developing laser-based tumor ablation systems
And more...

Check out Med Device Insights today!

The What, Why, When, And How Of Risk Management For Medical Device Manufacturers
Over the years, the discipline of quality in the medical device industry has developed from a reactive practice to one of ensuring a total quality approach throughout a product’s lifecycle.
Why You Need Cybersecurity (Even If You Think You Don’t)
Does your medical device present a threat to hospital network security? If you haven’t baked cybersecurity into your device design, the answer may be yes.
U.S. Minimally Invasive Spinal Implant Market To Outpace Growth In Traditional Spine Market
Growth in the spine market today is largely driven by the rapid rise in popularity of some motion preservation devices, most notably artificial discs, and vertebral compression fracture devices. Certain traditional fusion markets are expected to show strong rates of growth, but the overall market will eventually begin to stabilize in value as minimally invasive spine (MIS) procedures become increasingly popular among surgeons. Though the minimally invasive spine market will see the highest rates of growth, many traditional spine market segments are expected to continue to increase over the next few years.

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Using Coextrusion To Solve Challenging Medical Design Issues
Extrusion is the process of forming molten plastic into a finished part. The process involves melting and mixing a thermoplastic material in an extruder. The plastic is then forced through a die at moderate to high pressure to form a continuous shape. The still-molten part is cooled in carefully designed sizing and cooling equipment to control the final shape and tolerances. It is then cut or coiled to form a product.

Using Thermal Imaging To Detect Small Nerve Fiber Dysfunction

It is estimated that about 2% of the world population suffers from small nerve fiber dysfunction, which can result in neuropathic pain; diabetic patients represent a large portion of this population. While the dysfunction of large nerve fibers can be assessed using standard neurological examination and electromyography (EMG), currently no noninvasive techniques exist to detect and quantify small fiber dysfunction.

Reduce Risk With Exploratory Medical Device Software Testing

More and more medical devices have some sort of software component to them. The teams responsible for testing this software often rely on scripted testing, both manual and automated, to decrease the risk of defects in a product under development. The problem with this approach is that scripted testing is not meant to identify error conditions in scenarios that significantly deviate from the design or requirements, even if a comprehensive risk management plan is followed. To find these hidden or divergent risks, you need to go off script, and that’s where adding exploratory testing can help.

How To Develop A Quality Culture In Your Medical Device Manufacturing Operation

The lengths to which medical device companies go to deliver a quality product vary widely, but clearly there are some commonalities with regard to the development and maintenance of a quality management system that produces consistently excellent products. One of these has to do with the amount of attention given to manufacturing operator and technician training.

The 12 Questions To Ask When Outsourcing Medical Devices

The decision to outsource a medical device has serious consequences for your business and for your ultimate customer. This article will help you design a Q&A checklist for choosing the right outsourcing partner. In the article, you will learn the 12 questions that are most likely to elicit information critical to identifying a partner with the quality, experience, capacity (current and future), and financial stability to produce those products which are proudly labeled with your company name and logo.

Development Of A Pathogen Inactivation System To Stop Ebola And Other Deadly Outbreaks
It wasn’t so long ago that the world was in an absolute panic over Ebola. One company that found itself smack in the middle of the global healthcare industry's response to Ebola was Cerus Corporation, maker of a technology that inactivates pathogens in transfused blood components. I recently had the pleasure of speaking with William “Obi” Greenman, the company's president and CEO. We discussed the Intercept system, the factors behind Cerus’ recent public stock offering, the modular premarket approval (PMA) pathway it used for Intercept, the story behind its Ebola involvement, and why it is uniquely positioned to help stop future infectious disease outbreaks.
Nearshore Or Offshore? How To Decide Where You Should Manufacture Your Medical Device
Nearshoring has become a major buzzword in recent years. But despite all the hoopla, nearshoring is not the right approach for everyone, warns medical device manufacturing consultant Mark Bonifacio, a 25-year veteran of the industry. During a recent conversation, Mark shared four questions medical device companies need to answer before making the decision to nearshore or offshore production of their products.
Google, Apple, & Other New Medtech Players: If You Can’t Beat Them, Join (Or Copy) Them
The U.S. healthcare sector is currently engaged in a bizarre game of musical chairs. Traditional participants are snatching up seats they haven’t historically occupied, while still clinging desperately to their own, and new players are constantly jumping into the fray. When the music finally stops, will medical device incumbents still have chairs to sit on?

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.

Laser Rotary Encoders For Highly Accurate Angle Sensing

Canon USA has developed laser rotary encoders that can provide 81,000 pulses with a 36-mm diameter by using the light-diffraction interference method in conjunction with a semiconductor laser acting as the light-emitting element.

RF Power Amplifier for Medical EMC Compliance Testing: 75A250A

AR's 75A250A is an RF power amplifier covering the 10 kHz to 250 MHz frequency range. It's well-suited for medical EMC compliance testing applications and offers up to 75 watts CW power when used with an RF sweep generator.

Feedthrough Technology for Medical Implants and Sub-Assemblies

Developing and manufacturing hermetically sealed feedthroughs for medical device implants and/or sub-assemblies requires knowledge in materials science, design and process engineering, wet chemical conditioning, high-vacuum metallization, resistance welding, micro sandblasting, hermeticity testing, visual inspection, and more.

Silicone Wire Wound Heaters

Heatflex silicone wire wound heaters by Heatron are an excellent choice for high flex applications. They can be used for blood/fluid and instrument warming, sterilization, temperature therapy, and in instrumentation for dialysis, CPAP, DNA analysis, blood diagnostics, and surgical irrigation.

Engineering for Plastic Products

PTI offers plastic design and engineering services for the conversion of concepts into efficiently manufactured plastic medical products. The result is an optimum design with reduced parts, ease of assembly, and a reduced overall cost. PTI’s plastics engineering services encompass the processing, design, development, and manufacture of complex geometrical plastic products.

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St. Jude Medical’s New Ablation Catheter Receives FDA Approval
Catheter ablation, a clinical technique for treating cardiac arrhythmias, has a brand new tool at its disposal. The Food and Drug Administration (FDA) recently approved St. Jude Medical’s FlexAbility ablation catheter for clinical use, and developers hope the new design will assist electrophysiology (EP) specialists with conducting safer procedures in more challenging cases.
Stomach Acid-Fueled Micromotors Show Promise For Diagnostics, Drug Delivery
Scientists from the University of California San Diego (UCSD) have set stomach acid-fueled micromotors loose inside the stomach of a mouse. Researchers claim the technology may someday be useful as a novel drug delivery system and diagnostic tool.
Fusing MRI And Ultrasound Could Improve Cancer Diagnostics
Using a new combination of magnetic resonance imaging (MRI) and ultrasound, researchers from the University of Maryland have developed a more accurate diagnostic method for detecting prostate cancer. The dual imaging approach guides prostate biopsy collection in a way that is much more effective than standard biopsy methods. Distinguishing between high-risk and low-risk cancers may now be much more straightforward, enabling a more personalized treatment approach.
Philips, Teva Launch Israeli Medtech Incubator
Philips Healthcare and Teva Pharmaceutical Industries Ltd. recently launched Sanara Ventures — an incubator for Israeli medtech and pharmaceutical companies with global aspirations.
FDA Releases cGMP Draft Guidance For Combination Products
The U.S. Food and Drug Administration recently issued draft guidance outlining current good manufacturing practice (cGMP) requirements for combination products. The draft guidance intends to clarify cGMP requirements for combination products and provides hypothetical scenarios illustrating compliance considerations for certain types of combination products.
Stryker To Focus On Acquisitions, Disruption
Stryker Corporation continues to consider relevant acquisitions that disrupt the market, according to remarks recently made by the company’s top executive. The comments came in the midst of speculation that Stryker will soon acquire fellow orthopedic device maker Smith & Nephew.
Robotic Hands Develop Better Motor Skills
Researchers from the German Primate Center have recently developed a way to predict hand movements by measuring neuronal activity. Studies performed with a subfamily of primates called macaques have identified the neural activity involved in many hand grasping movements, which is knowledge that could be applied to controlling robotic prostheses.
MIT’s Implantable Polymer Fibers Could Revolutionize Neural Prosthetics
Scientists at the Massachusetts Institute of Technology (MIT) have developed new polymer fibers that are capable of transmitting multiple brain signals simultaneously, delivering drugs, and wirelessly recording brain functions. The new technology improves on many of the drawbacks encountered in traditional neural prosthetic devices.